The CRC Master Keyword Guide for Food: 21 CFR Regulations of the Food and Drug Administration 2003–2004

The CRC Master Keyword Guide for Food: 21 CFR Regulations of the Food and Drug Administration 2003–2004

The CRC Master Keyword Guide for Food: 21 CFR Regulations of the Food and Drug Administration 2003–2004

Interpharm /CRC Boca Raton London New York Washington, D.C.

Library of Congress Cataloging-in-Publication Data Catalog record is available from the Library of Congress This publication contains a verbatim reproduction of The Master Keyword Guide for Food: 21 Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration The text is complete and has not been altered in any manner from the original source. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microÞlming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. SpeciÞc permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identiÞcation and explanation, without intent to infringe.

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Contents

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subchapter A—General Part 1 1 2 2 5 5 5 5 70 71 73 74 80 81 82 82

General enforcement regulations – Subpart A—General Provisions General enforcement regulations – Subpart B—General Labeling Requirements General administrative rulings and decisions – Subpart A—General Provisions General administrative rulings and decisions – Subpart B—Human and Animal Foods Delegations of authority and organization – Subpart A—Delegations of Authority to the Commissioner of Food and Drugs Delegations of authority and organization – Subpart B—General Redelegations of Authority—Secs. 5.27, 5.31–5.35 Delegations of authority and organization – Subpart E—Foods and Cosmetics; Redelegations of Authority Delegations of authority and organization – Subpart M—Organization Color additives Color additive petitions Listing of color additives exempt from certification – Subpart A—Foods Listing of color additives subject to certification – Subpart A—Foods Color additive certification General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics Listing of certified provisionally listed colors and specifications – Subpart A—General Provisions Listing of certified provisionally listed colors and specifications – Subpart B—Foods, Drugs, and Cosmetics

Page 1 2 7 9 10 14 17 20 28 34 41 59 66 73 80 82

Subchapter B—Food for Human Consumption 100 101 102 104 105 106 107 108 109

General Food labeling Common or usual name for nonstandardized foods Nutritional quality guidelines for foods Foods for special dietary use Infant formula quality control procedures Infant formula Emergency permit control Unavoidable contaminants in food for human consumption and food-packaging material

83 88 221 228 232 234 240 250 258

Contents

Part 110 111 113 114 115 120 123 129 130 131 133 135 136 137 139 145 146 150 152 155 156 158 160 161 163 164 165 166 168 169 170 171 172 173 174 175 176 177 178 179 180

Current good manufacturing practice in manufacturing, packing, or holding human food Current good manufacturing practice for dietary supplements Thermally processed low-acid foods packaged in hermetically sealed containers Acidified foods Shell eggs Hazard Analysis and Critical Control Point (HACCP) systems Fish and fishery products Processing and bottling of bottled drinking water Food standards: General Milk and cream Cheeses and related cheese products Frozen desserts Bakery products Cereal flours and related products Macaroni and noodle products Canned fruits Canned fruit juices Fruit butters, jellies, preserves, and related products Fruit pies Canned vegetables Vegetable juices Frozen vegetables Eggs and egg products Fish and shellfish Cacao products Tree nut and peanut products Beverages Margarine Sweeteners and table sirups Food dressings and flavorings Food additives Food additive petitions Food additives permitted for direct addition to food for human consumption Secondary direct food additives permitted in food for human consumption Indirect food additives: General Indirect food additives: Adhesives and components of coatings Indirect food additives: Paper and paperboard components Indirect food additives: Polymers Indirect food additives: Adjuvants, production aids, and sanitizers Irradiation in the production, processing and handling of food Food additives permitted in food or in contact with food on an interim basis pending additional study 181 Prior-sanctioned food ingredients 182 Substances generally recognized as safe 184 Direct food substances affirmed as generally recognized as safe 186 Indirect food substances affirmed as generally recognized as safe 189 Substances prohibited from use in human food 190 Dietary supplements 191-199 [Reserved] 1210 Regulations under the Federal Import Milk Act 1240 Control of communicable diseases 1250 Interstate conveyance sanitation Index iv

Page 263 272 273 296 302 304 313 321 325 332 349 396 402 406 420 430 467 480 487 489 509 512 515 520 536 543 546 561 564 568 574 588 594 692 725 726 774 820 939 1046 1052 1056 1062 1081 1185 1191 1196 1197 1197 1202 1209 1223

SUBCHAPTER A—GENERAL PART 1—GENERAL ENFORCEMENT REGULATIONS Subpart A—General Provisions Sec. 1.1 1.2 1.4

General Definitions Authority Citations

Subpart B—General Labeling Requirements 1.20 1.21 1.23 1.24

Presence of mandatory label information. Failure to reveal material facts. Procedures for requesting variations and exemptions from required label statements. Exemptions from required label statements.

AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264. SOURCE: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

Subpart A—General Provisions § 1.1 General. (a) The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done. (b) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also to such terms when used in regulations promulgated under that act. (c) The definition of package in Sec. 1.20 and of principal display panel in Secs. 101.1, 201.60, 501.1, 701.10 and 801.60 of this chapter; and the requirements pertaining to uniform location, lack of qualification, and separation of the net quantity declaration in Secs. 101.105(f), 201.62(e), 501.105(f), 701.13(f) and 801.62(e) of this chapter to type size requirements for net quantity declaration in Secs. 101.105(i), 201.62(h), 501.105(i), 701.13(i) and 801.62(h) of this chapter, to initial statement of ounces in the dual declaration of net quantity in Secs. 101.105(j) and (m), 201.62(i) and (k), 501.105(j) and (m), 701.13(j) and (m) and 801.62(i) and (k) of this chapter, to initial statement of inches in declaration of net quantity in Secs. 201.62(m), 701.13(o) and 801.62(m) of this chapter, to initial statement of square inches in declaration of net quantity in Secs. 201.62(n), 701.13(p) and 801.62(n) of this chapter, to prohibition of certain supplemental net quantity statements in Secs. 101.105(o), 201.62(o), 501.105(o), 701.13(q) and 801.62(o) of this chapter, and to servings representations in Sec. 501.8 of this chapter are provided for solely by the Fair Packaging and Labeling Act. The other requirements of this part are issued under both the Fair Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act, or by the latter act solely, and are not limited in their application by section 10 of the Fair Packaging and Labeling Act. [42 FR 15553, Mar. 22, 1977, as amended at 58 FR 17085, Apr. 1, 1993]

§ 1.3 Definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) Label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.

§ 1.4

§ 1.4 Authority citations. (a) For each part of its regulations, the Food and Drug Administration includes a centralized citation of all of the statutory provisions that provide authority for any regulation that is included in that part. (b) The agency may rely on any one or more of the authorities that are listed for a particular part in implementing or enforcing any section in that part. (c) All citations of authority in this chapter will list the applicable sections in the organic statute if the statute is the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or the Fair Packaging and Labeling Act. References to an act or a section thereof include references to amendments to that act or section. These citations will also list the corresponding United States Code (U.S.C.) sections. For example, a citation to section 701 of the Federal Food, Drug, and Cosmetic Act would be listed: Sec. 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371). (d) If the organic statute is one other than those specified in paragraph (c) of this section, the citations of authority in this chapter generally will list only the applicable U.S.C. sections. For example, a citation to section 552 of the Administrative Procedure Act would be listed: 5 U.S.C. 552. The agency may, where it determines that such measures are in the interest of clarity and public understanding, list the applicable sections in the organic statute and the corresponding U.S.C. section in the same manner set out in paragraph (c) of this section. References to an act or a section thereof include references to amendments to that act or section. (e) Where there is no U.S.C. provision, the agency will include a citation to the U.S. Statutes at Large. Citations to the U.S. Statutes at Large will refer to volume and page. (f) The authority citations will include a citation to executive delegations (i.e., Executive Orders), if any, necessary to link the statutory authority to the agency. [54 FR 39630, Sept. 27, 1989]

Subpart B—General Labeling Requirements § 1.20 Presence of mandatory label information. The term package means any container or wrapping in which any food, drug, device, or cosmetic is enclosed for use in the delivery or display of such commodities to retail purchasers, but does not include: (a) Shipping containers or wrappings used solely for the transportation of any such commodity in bulk or in quantity to manufacturers, packers, processors, or wholesale or retail distributors; (b) Shipping containers or outer wrappings used by retailers to ship or deliver any such commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity; or (c) Containers subject to the provisions of the Act of August 3, 1912 (37 Stat. 250, as amended; 15 U.S.C. 231233), the Act of March 4, 1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236), the Act of August 31, 1916 (39 Stat. 673, as amended; 15 U.S.C. 251-256), or the Act of May 21, 1928 (45 Stat. 635, as amended; 15 U.S.C. 257-257i). (d) Containers used for tray pack displays in retail establishments. (e) Transparent wrappers or containers which do not bear written, printed, or graphic matter obscuring the label information required by this part. A requirement contained in this part that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or information also appears on the outer container or wrapper of the retail package of the article, or, as stated in paragraph (e) of this section, such information is easily legible by virtue of the transparency of the outer wrapper or container. Where a consumer commodity is marketed in a multiunit retail package bearing the mandatory label information as required by this part and the unit containers are not intended to be sold separately, the net weight placement requirement of Sec. 101.105(f) applicable to such unit containers is waived if the units are in compliance with all the other requirements of this part. § 1.21 Failure to reveal material facts. (a) Labeling of a food, drug, device, or cosmetic shall be deemed to be misleading if it fails to reveal facts that are: 2

§ 1.24

(1) Material in light of other representations made or suggested by statement, word, design, device or any combination thereof; or (2) Material with respect to consequences which may result from use of the article under: (i) The conditions prescribed in such labeling or (ii) such conditions of use as are customary or usual. (b) Affirmative disclosure of material facts pursuant to paragraph (a) of this section may be required, among other appropriate regulatory procedures, by (1) Regulations in this chapter promulgated pursuant to section 701(a) of the act; or (2) Direct court enforcement action. (c) Paragraph (a) of this section does not: (1) Permit a statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling for food, drugs, devices, or cosmetics under the act. (2) Permit a statement of differences of opinion with respect to the effectiveness of a drug unless each of the opinions expressed is supported by substantial evidence of effectiveness as defined in sections 505(d) and 512(d) of the act. § 1.23 Procedures for requesting variations and exemptions from required label statements. Section 403(e) of the act (in this part 1, the term act means the Federal Food, Drug, and Cosmetic Act) provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 403(i) of the act provides for the establishment by regulation of exemptions from the required declaration of ingredients where such declaration is impracticable, or results in deception or unfair competition. Section 502(b) of the act provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 602(b) of the act provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 5(b) of the Fair Packaging and Labeling Act provides for the establishment by regulation of exemptions from certain required declarations of net quantity of contents, identity of commodity, identity and location of manufacturer, packer, or distributor, and from declaration of net quantity of servings represented, based on a finding that full compliance with such required declarations is impracticable or not necessary for the adequate protection of consumers, and a further finding that the nature, form, or quantity of the packaged consumer commodity or other good and sufficient reasons justify such exemptions. The Commissioner, on his own initiative or on petition of an interested person, may propose a variation or exemption based upon any of the foregoing statutory provisions, including proposed findings if section 5(b) of the Fair Packaging and Labeling Act applies, pursuant to parts 10, 12, 13, 14, 15, 16, and 19 of this chapter. § 1.24 Exemptions from required label statements. The following exemptions are granted from label statements required by this part: (a) Foods. (1) While held for sale, a food shall be exempt from the required declaration of net quantity of contents specified in this part if said food is received in bulk containers at a retail establishment and is accurately weighed, measured, or counted either within the view of the purchaser or in compliance with the purchaser’s order. (2) Random food packages, as defined in Sec. 101.105(j) of this chapter, bearing labels declaring net weight, price per pound or per specified number of pounds, and total price shall be exempt from the type size, dual declaration and placement requirements of Sec. 101.105 of this chapter if the accurate statement of net weight is presented conspicuously on the principal display panel of the package. In the case of food packed in random packages at one place for subsequent shipment and sale at another, the price sections of the label may be left blank provided they are filled in by the seller prior to retail sale. This exemption shall also apply to uniform weight packages of cheese and cheese products labeled in the same manner and by the same type of equipment as random food packages exempted by this paragraph (a)(2) except that the labels shall bear a declaration of price per pound and not price per specified number of pounds. (3) Individual serving-size packages of foods containing less than 1/2 ounce or less than 1/2 fluid ounce for use in restaurants, institutions, and passenger carriers, and not intended for sale at retail, shall be exempt from the required declaration of net quantity of contents specified in this part. (4) Individually wrapped pieces of penny candy and other confectionery of less than one-half ounce net weight per 3

§ 1.24

individual piece shall be exempt from the labeling requirements of this part when the container in which such confectionery is shipped is in conformance with the labeling requirements of this part. Similarly, when such confectionery items are sold in bags or boxes, such items shall be exempt from the labeling requirements of this part, including the required declaration of net quantity of contents specified in this part when the declaration on the bag or box meets the requirements of this part. (5)(i) Soft drinks packaged in bottles shall be exempt from the placement requirements for the statement of identity prescribed by Sec. 101.3 (a) and (d) of this chapter if such statement appears conspicuously on the bottle closure. When such soft drinks are marketed in a multiunit retail package, the multiunit retail package shall be exempt from the statement of identity declaration requirements prescribed by Sec. 101.3 of this chapter if the statement of identity on the unit container is not obscured by the multiunit retail package. (ii) A multiunit retail package for soft drinks shall be exempt from the declaration regarding name and place of business required by Sec. 101.5 of this chapter if the package does not obscure the declaration on unit containers or if it bears a statement that the declaration can be found on the unit containers and the declaration on the unit containers complies with Sec. 101.5 of this chapter. The declaration required by Sec. 101.5 of this chapter may appear on the top or side of the closure of bottled soft drinks if the statement is conspicuous and easily legible. (iii) Soft drinks packaged in bottles which display other required label information only on the closure shall be exempt from the placement requirements for the declaration of contents prescribed by Sec. 101.105(f) of this chapter if the required content declaration is blown, formed, or molded into the surface of the bottle in close proximity to the closure. (iv) Where a trademark on a soft drink package also serves as, or is, a statement of identity, the use of such trademark on the package in lines not parallel to the base on which the package rests shall be exempted from the requirement of Sec. 101.3(d) of this chapter that the statement be in lines parallel to the base so long as there is also at least one statement of identity in lines generally parallel to the base. (v) A multiunit retail package for soft drinks in cans shall be exempt from the declaration regarding name and place of business required by Sec. 101.5 of this chapter if the package does not obscure the declaration on unit containers or if it bears a statement that the declaration can be found on the unit containers and the declaration on the unit containers complies with Sec. 101.5 of this chapter. The declaration required by Sec. 101.5 of this chapter may appear on the top of soft drinks in cans if the statement is conspicuous and easily legible, provided that when the declaration is embossed, it shall appear in type size at least one-eighth inch in height, or if it is printed, the type size shall not be less than one-sixteenth inch in height. The declaration may follow the curvature of the lid of the can and shall not be removed or obscured by the tab which opens the can. (6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water ices, quiescently frozen confections (with or without dairy ingredients), special dietary frozen desserts, and products made in semblance of the foregoing, when measured by and packaged in 1/2-liquid pint and 1/2-gallon measure-containers, as defined in the ``Measure Container Code of National Bureau of Standards Handbook 44,’’ Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,’’ which is incorporated by reference, are exempt from the requirements of Sec. 101.105(b)(2) of this chapter to the extent that net contents of 8-fluid ounces and 64-fluid ounces (or 2 quarts) may be expressed as 1/2 pint and 1/2 gallon, respectively. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. (ii) The foods named in paragraph (a)(6)(i) of this section, when measured by and packaged in 1-liquid pint, 1liquid quart, and 1/2-gallon measure-containers, as defined in the ``Measure Container Code of National Bureau of Standards Handbook 44,’’ Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,’’ which is incorporated by reference, are exempt from the dual net-contents declaration requirement of Sec. 101.105(j) of this chapter. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. (iii) The foods named in paragraph (a)(6)(i) of this section, when measured by and packaged in 1/2-liquid pint, 1liquid pint, 1-liquid quart, 1/2-gallon, and 1-gallon measured-containers, as defined in the ``Measure Container Code of National Bureau of Standards Handbook 44,’’ Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, Sec. 4.45 ``Measure-Containers,’’ which is incorporated by reference, are exempt from the requirement of Sec. 101.105(f) of this chapter that the declaration of net contents be located within the 4

§ 1.24

bottom 30 percent of the principal display panel. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. (7)(i) Milk, cream, light cream, coffee or table cream, whipping cream, light whipping cream, heavy or heavy whipping cream, sour or cultured sour cream, half-and-half, sour or cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk and milk products, skim or skimmed milk, vitamin D milk and milk products, fortified milk and milk products, homogenized milk, flavored milk and milk products, buttermilk, cultured buttermilk, cultured milk or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent butterfat), and acidified milk and milk products, when packaged in containers of 8- and 64-fluid-ounce capacity, are exempt from the requirements of Sec. 101.105(b)(2) of this chapter to the extent that net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as 1/2 pint and 1/2 gallon, respectively. (ii) The products listed in paragraph (a)(7)(i) of this section, when packaged in glass or plastic containers of 1/2pint, 1-pint, 1-quart, 1/2-gallon, and 1-gallon capacities are exempt from the placement requirement of Sec. 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the principal display panel, provided that other required label information is conspicuously displayed on the cap or outside closure and the required net quantity of contents declaration is conspicuously blown, formed, or molded into or permanently applied to that part of the glass or plastic container that is at or above the shoulder of the container. (iii) The products listed in paragraph (a)(7)(i) of this section, when packaged in containers of 1-pint, 1-quart, and 1/2-gallon capacities are exempt from the dual net-contents declaration requirement of Sec. 101.105(j) of this chapter. (8) Wheat flour products, as defined by Secs. 137.105, 137.155, 137.160, 137.165, 137.170, 137.175, 137.180, 137.185, 137.200, and 137.205 of this chapter, packaged: (i) In conventional 2-, 5-, 10-, 25-, 50-, and 100-pound packages are exempt from the placement requirement of Sec. 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the area of the principal display panel of the label; and (ii) In conventional 2-pound packages are exempt from the dual net-contents declaration requirement of Sec. 101.105(j) of this chapter provided the quantity of contents is expressed in pounds. (9)(i) Twelve shell eggs packaged in a carton designed to hold 1 dozen eggs and designed to permit the division of such carton by the retail customer at the place of purchase into two portions of one-half dozen eggs each are exempt from the labeling requirements of this part with respect to each portion of such divided carton if the carton, when undivided, is in conformance with the labeling requirements of this part. (ii) Twelve shell eggs packaged in a carton designed to hold 1 dozen eggs are exempt from the placement requirements for the declaration of contents prescribed by Sec. 101.105(f) of this chapter if the required content declaration is otherwise placed on the principal display panel of such carton and if, in the case of such cartons designed to permit division by retail customers into two portions of one-half dozen eggs each, the required content declaration is placed on the principal display panel in such a manner that the context of the content declaration is destroyed upon division of the carton. (10) Butter as defined in 42 Stat. 1500 (excluding whipped butter): (i) In 8-ounce and in 1-pound packages is exempt from the requirements of Sec. 101.105(f) of this chapter that the net contents declaration be placed within the bottom 30 percent of the area of the principal display panel; (ii) In 1-pound packages is exempt from the requirements of Sec. 101.105(j)(1) of this chapter that such declaration be in terms of ounces and pounds, to permit declaration of ``1-pound’’ or ``one pound’’; and (iii) In 4-ounce, 8-ounce, and 1-pound packages with continuous label copy wrapping is exempt from the requirements of Secs. 101.3 and 101.105(f) of this chapter that the statement of identity and net contents declaration appear in lines generally parallel to the base on which the package rests as it is designed to be displayed, provided that such statement and declaration are not so positioned on the label as to be misleading or difficult to read as the package is customarily displayed at retail. (11) Margarine as defined in Sec. 166.110 of this chapter and limitations thereof in 1-pound rectangular packages, except for packages containing whipped or soft margarine or packages that contain more than four sticks, are exempt from the requirement of Sec. 101.105(f) of this chapter that the declaration of the net quantity of contents appear within the bottom 30 percent of the principal display panel and from the requirement of Sec. 101.105(j)(1) of this chapter that such declaration be expressed both in ounces and in pounds to permit declaration of ``1-pound’’ or ``one pound,’’ provided an accurate statement of net weight appears conspicuously on the principal display panel of the package. 5

Part 2

(12) Corn flour and related products, as they are defined by Secs. 137.211, 137.215, and Secs. 137.230 through 137.290 of this chapter, packaged in conventional 5-, 10-, 25-, 50-, and 100-pound bags are exempt from the placement requirement of Sec. 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the area of the principal display panel of the label. (13)(i) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass or plastic containers of 1/2-pint, 1-pint, 1-quart, 1/2-gallon, and 1-gallon capacities are exempt from the placement requirement of Sec. 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the principal display panel: Provided, That other required label information is conspicuously displayed on the cap or outside closure and the required net quantity of contents declaration is conspicuously blown, formed, or molded into or permanently applied to that part of the glass or plastic container that is at or above the shoulder of the container. (ii) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass, plastic, or paper (fluid milk type) containers of 1-pint, 1-quart, and 1/2-gallon capacities are exempt from the dual net-contents declaration requirement of Sec. 101.105(j) of this chapter. (iii) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass, plastic, or paper (fluid milk type) containers of 8- and 64-fluid-ounce capacity, are exempt from the requirements of Sec. 101.105(b)(2) of this chapter to the extent that net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as \1/2 pint (or half pint) and 1/2 gallon (or half gallon), respectively. (14) The unit containers in a multiunit or multicomponent retail food package shall be exempt from regulations of section 403 (e)(1), (g)(2), (i)(2), (k), and (q) of the act with respect to the requirements for label declaration of the name and place of business of the manufacturer, packer, or distributor; label declaration of ingredients; and nutrition information when: (i) The multiunit or multicomponent retail food package labeling meets all the requirements of this part; (ii) The unit containers are securely enclosed within and not intended to be separated from the retail package under conditions of retail sale; and (iii) Each unit container is labeled with the statement ``This Unit Not Labeled For Retail Sale’’ in type size not less than one-sixteenth of an inch in height. The word ``Individual’’ may be used in lieu of or immediately preceding the word ``Retail’’ in the statement. (b) Drugs. Liquid over-the-counter veterinary preparations intended for injection shall be exempt from the declaration of net quantity of contents in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid-ounce subdivisions thereof as required by Sec. 201.62 (b), (i), and (j) of this chapter, and from the dual declaration requirements of Sec. 201.62(i) of this chapter, if such declaration of net quantity of contents is expressed in terms of the liter and milliliter, or cubic centimeter, with the volume expressed at 68 °F (20 °C). (c) Cosmetics. Cosmetics in packages containing less than one-fourth ounce avoirdupois or one-eighth fluid ounce shall be exempt from compliance with the requirements of section 602(b)(2) of the Federal Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging and Labeling Act: (1) When such cosmetics are affixed to a display card labeled in conformance with all labeling requirements of this part; or (2) When such cosmetics are sold at retail as part of a cosmetic package consisting of an inner and outer container and the inner container is not for separate retail sale and the outer container is labeled in conformance with all labeling requirements of this part. [42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47 FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3, 1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS Subpart A—General Provisions Sec. 2.5 2.10 2.19

Imminent hazard to the public health. Examination and investigation samples. Methods of analysis. 6

§ 2.10

Subpart B—Human and Animal Foods 2.25 2.35

Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. Use of secondhand containers for the shipment or storage of food and animal feed.

AUTHORITY: 21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 355, 360b, 361, 371, 372, 374; 15 U.S.C. 402, 409. SOURCE: 42 FR 15559, Mar. 22, 1977, unless otherwise noted.

Subpart A—General Provisions § 2.5 Imminent hazard to the public health. (a) Within the meaning of the Federal Food, Drug, and Cosmetic Act an imminent hazard to the public health is considered to exist when the evidence is sufficient to show that a product or practice, posing a significant threat of danger to health, creates a public health situation (1) that should be corrected immediately to prevent injury and (2) that should not be permitted to continue while a hearing or other formal proceeding is being held. The imminent hazard may be declared at any point in the chain of events which may ultimately result in harm to the public health. The occurrence of the final anticipated injury is not essential to establish that an imminent hazard of such occurrence exists. (b) In exercising his judgment on whether an imminent hazard exists, the Commissioner will consider the number of injuries anticipated and the nature, severity, and duration of the anticipated injury. § 2.10 Examination and investigation samples. (a)(1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Department indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory. Only samples so designated by an officer or employee of the Department shall be considered to be official samples. (2) For the purpose of determining whether or not a sample is collected for analysis, the term analysis includes examinations and tests. (3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected. (b) When an officer or employee of the Department collects an official sample of a food, drug, or cosmetic for analysis under the act, he shall collect at least twice the quantity estimated by him to be sufficient for analysis, unless: (1) The amount of the article available and reasonably accessible for sampling is less than twice the quantity so estimated, in which case he shall collect as much as is available and reasonably accessible. (2) The cost of twice the quantity so estimated exceeds $150. (3) The sample cannot by diligent use of practicable preservation techniques available to the Food and Drug Administration be kept in a state in which it could be readily and meaningfully analyzed in the same manner and for the same purposes as the Food and Drug Administration’s analysis. (4) The sample is collected from a shipment or other lot which is being imported or offered for import into the United States. (5) The sample is collected from a person named on the label of the article or his agent, and such person is also the owner of the article. (6) The sample is collected from the owner of the article, or his agent, and such article bears no label or, if it bears a label, no person is named thereon. In addition to the quantity of sample set forth in this paragraph, the officer or employee shall, if practicable, collect such further amount as he estimates will be sufficient for use as trial exhibits. (c) After the Food and Drug Administration has completed such analysis of an official sample of a food, drug, or cosmetic as it determines, in the course of analysis and interpretation of analytical results, to be adequate to establish the respects, if any, in which the article is adulterated or misbranded within the meaning of the act, or otherwise 7

§ 2.19

subject to the prohibitions of the act, and has reserved an amount of the article it estimates to be adequate for use as exhibits in the trial of any case that may arise under the act based on the sample, a part of the sample, if any remains available, shall be provided for analysis, upon written request, by any person named on the label of the article, or the owner thereof, or the attorney or agent of such person or owner, except when: (1) After collection, the sample or remaining part thereof has become decomposed or otherwise unfit for analysis, or (2) The request is not made within a reasonable time before the trial of any case under the act, based on the sample to which such person or owner is a party. The person, owner, attorney, or agent who requests the part of sample shall specify the amount desired. A request from an owner shall be accompanied by a showing of ownership, and a request from an attorney or agent by a showing of authority from such person or owner to receive the part of sample. When two or more requests for parts of the same sample are received the requests shall be complied with in the order in which they were received so long as any part of the sample remains available therefor. (d) When an official sample of food, drug, or cosmetic is the basis of a notice given under section 305 of the act, or of a case under the act, and the person to whom the notice was given, or any person who is a party to the case, has no right under paragraph (c) of this section to a part of the sample, such person or his attorney or agent may obtain a part of the sample upon request accompanied by a written waiver of right under such paragraph (c) from each person named on the label of the article and owner thereof, who has not exercised his right under such paragraph (c). The operation of this paragraph shall be subject to the exceptions, terms, and conditions prescribed in paragraph (c) of this section. (e) The Food and Drug Administration is authorized to destroy: (1) Any official sample when it determines that no analysis of such sample will be made; (2) Any official sample or part thereof when it determines that no notice under section 305 of the act, and no case under the act, is or will be based on such sample; (3) Any official sample or part thereof when the sample was the basis of a notice under section 305 of the act, and when, after opportunity for presentation of views following such notice, it determines that no other such notice, and no case under the act, is or will be based on such sample; (4) Any official sample or part thereof when the sample was the basis of a case under the act which has gone to final judgment, and when it determines that no other such case is or will be based on such sample; (5) Any official sample or part thereof if the article is perishable; (6) Any official sample or part thereof when, after collection, such sample or part has become decomposed or otherwise unfit for analysis; (7) That part of any official sample which is in excess of three times the quantity it estimates to be sufficient for analysis. [42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998]

§ 2.19 Methods of analysis. Where the method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the Association of Official Analytical Chemists (AOAC) as published in the latest edition (13th Ed., 1980) of their publication ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ and the supplements thereto (``Changes in Methods’’ as published in the March issues of the ``Journal of the Association of Official Analytical Chemists’’), which are incorporated by reference, when available and applicable. Copies are available from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. In the absence of an AOAC method, the Commissioner will furnish a copy of the particular method, or a reference to the published method, that the Food and Drug Administration will use in its enforcement program. Other methods may be used for quality control, specifications, contracts, surveys, and similar nonregulatory functions, but it is expected that they will be calibrated in terms of the method which the Food and Drug Administration uses in its enforcement program. Use of an AOAC method does not relieve the practioner of the responsibility to demonstrate that he can perform the method properly through the use of positive and negative controls and recovery and reproducibility studies. [42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54 FR 9034, Mar. 3, 1989]

8

§ 2.35

Subpart B—Human and Animal Foods § 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. (a) In recent years there has developed increasing use of poisonous treatments on seed for fungicidal and other purposes. Such treated seed, if consumed, presents a hazard to humans and livestock. It is not unusual for stocks of such treated food seeds to remain on hand after the planting season has passed. Despite the cautions required by the Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551 et seq.) in the labeling of the treated seed, the Food and Drug Administration has encountered many cases where such surplus stocks of treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed with untreated seed and sent to market for food or feed use. This has resulted in livestock injury and in legal actions under the Federal Food, Drug, and Cosmetic Act against large quantities of food adulterated through such admixture of poisonous treated seeds with good food. Criminal cases were brought against some firms and individuals. Where the treated seeds are prominently colored, buyers and users or processors of agricultural food seed for food purposes are able to detect the admixture of the poisonous seed and thus reject the lots; but most such buyers, users, and processors do not have the facilities or scientific equipment to determine the presence of the poisonous chemical at the time crops are delivered, in cases where the treated seeds have not been so colored. A suitable color for this use is one that is in sufficient contrast to the natural color of the food seed as to make admixture of treated, denatured seeds with good food easily apparent, and is so applied that it is not readily removed. (b) On and after December 31, 1964, the Food and Drug Administration will regard as adulterated any interstate shipment of the food seeds wheat, corn, oats, rye, barley, and sorghum bearing a poisonous treatment in excess of a recognized tolerance or treatment for which no tolerance or exemption from tolerance is recognized in regulations promulgated pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act, unless such seeds have been adequately denatured by a suitable color to prevent their subsequent inadvertent use as food for man or feed for animals. (c) Attention is called to the labeling requirements of the Federal Hazardous Substances Act, where applicable to denatured seeds in packages suitable for household use. § 2.35 Use of secondhand containers for the shipment or storage of food and animal feed. (a) Investigations by the Food and Drug Administration, the National Communicable Disease Center of the U.S. Public Health Service, the Consumer and Marketing Service of the U.S. Department of Agriculture, and by various State public health agencies have revealed practices whereby food and animal feed stored or shipped in secondhand containers have been rendered dangerous to health. Such contamination has been the result of the original use of these containers for the storage and shipment of articles containing or bearing disease organisms or poisonous or deleterious substances. (b) The Commissioner concludes that such dangerous or potentially dangerous practices include, but are not limited to, the following: (1) Some vegetable growers and packers employ used poultry crates for shipment of fresh vegetables, including cabbage and celery. Salmonella organisms are commonly present on dressed poultry and in excreta and fluid exudates from dressed birds. Thus wooden crates in which dressed poultry has been iced and packed are potential sources of Salmonella or other enteropathogenic microorganisms that may contaminate fresh vegetables which are frequently consumed without heat treatment. (2) Some potato growers and producers of animal feeds use secondhand bags for shipment of these articles. Such bags may have originally been used for shipping or storing pesticide-treated seed or other articles bearing or containing poisonous substances. Thus these secondhand bags are potential sources of contamination of the food or animal feed stored or shipped therein. (c) In a policy statement issued April 11, 1968, the Food and Drug Administration declared adulterated within the meaning of section 402(a) of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or other edible food in used crates or containers that may render the contents injurious to health. This policy statement is extended so that the Food and Drug Administration will regard as adulterated within the meaning of section 402(a) of the act shipments of vegetables, other edible food, or animal feed in used crates, bags, or other containers that may render the contents injurious to health. 9

Part 5

PART 5—DELEGATIONS OF AUTHORITY AND ORGANIZATION Subpart A—Delegations of Authority to the Commissioner of Food and Drugs Sec. 5.10 5.11

Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs. Reservation of authority.

Subpart B—General Redelegations of Authority 5.27 5.31 5.32 5.33 5.34 5.35

Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings. Enforcement activities. Certification following inspections. Issuance of reports of minor violations. Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. Officials authorized to make certification under 5 U.S.C. 605(b)for any proposed and final rules.

Subpart E—Foods and Cosmetics; Redelegations of Authority 5.300 5.301 5.302 5.303 5.304

Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims. Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. Detention of meat, poultry, eggs, and related products. Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program. Approval of schools providing food-processing instruction.

Subpart M—Organization 5.1100 5.1105 5.1110 5.1115

Headquarters. Chief Counsel, Food and Drug Administration. Food and Drug Administration Public Information Offices. Field structure.

AUTHORITY: 5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 15 U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C., 61-63, 141-149, 301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 2421, 242n, 242o, 243, 262, 263, 264, 265, 300u,-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 1395ym 4332, 4831(a). 10007-10008; E.O. 12591, 52 FR 13414, 3 CFR, 1998 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223. SOURCE: 66 FR 30993, June 8, 2001, unless otherwise noted.

Subpart A—Delegations of Authority to the Commissioner of Food and Drugs § 5.10 Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs. (a) The Secretary of Health and Human Services (the Secretary) has redelegated to the commissioner of Food and Drugs (Commissioner), with authority to redelegate (except when specifically prohibited), all authority as follows: (1) Functions vested in the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended, the Filled Milk Act (21 U.S.C. 61-63), the Federal Import Milk Act (21 U.S.C. 141 et seq.), the Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613, section 19, formerly section 18) and The Fair 10

§ 5.10

Packaging and Labeling Act (15 U.S.C. 1451 et seq.), under section 12 of Reorganization Plan No. IV and Reorganization Plan No. 1 of 1953, including authority to administer oaths vested in the Secretary of Agriculture by 7 U.S.C. 2217. (2) Functions vested in the Secretary under section 301 (Research and Investigations); section 307 (International Cooperation); and section 311 (Federal-State Cooperation) of the Public Health Service Act (the PHS Act) (42 U.S.C. 241, 242l, 243), as amended, which relate to the functions of the Food and Drug Administration. (3) Functions vested in the Secretary under section 361 of the PHS Act (42 U.S.C. 264), as amended, which relate to the law enforcement functions of the Food and Drug Administration concerning the following products and activities: Biologicals (including blood and blood products); interstate travel sanitation (except interstate transportation of etiologic agents under 42 CFR part 72); food (including milk and food service sanitation and shellfish sanitation); and drugs, devices, cosmetics, electronic products, and other items or products regulated by the Food and Drug Administration. (4) Functions vested in the Secretary under sections 351 and 352 of part F, subpart 1 of the PHS Act (42 U.S.C. 262 and 263), as amended (Biological Products), insofar as they relate to the functions assigned to the Food and Drug Administration. (5) Functions vested in the Secretary under section 302(a) of the PHS Act (42 U.S.C. 242(a)), as amended, which relate to the determination and reporting requirements with respect to the medicinal and scientific requirements of the United States for controlled substances. (6) Functions vested in the Secretary under section 303 of the PHS Act (42 U.S.C. 242a), as amended, which relate to the authorization of persons engaged in research on the use and effect of drugs to protect the identity of their research subjects with respect to drugs scheduled under Public Law 91-513 for which an investigational new drug application is filed with the Food and Drug Administration and with respect to all drugs not scheduled under Public Law 91-513. (7) Functions vested in the Secretary pertaining to section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 91-513, 84 Stat. 1241) which relate to the determination of the safety and effectiveness of drugs or to approve new drugs to be used in the treatment of narcotic addicts. (8) Functions vested in the Secretary pertaining to section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)), which relate to the merits of the research protocol and to the determination of the qualifications and competency of practitioners wishing to conduct research with controlled substances listed in Schedule I of the Act. (9) Functions vested in the Secretary pertaining to provisions of the Controlled Substances Act (21 U.S.C. 801 et seq.), which relate to administration of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (10) Functions vested in the Secretary under section 409(b) of the Federal Meat Inspection Act (21 U.S.C. 679(b)), which relate to the detention of any carcass, part thereof, meat, or meat product of cattle, sheep, swine, goats, or equines. (11) Functions vested in the Secretary under section 24(b) of the Poultry Products Inspection Act (21 U.S.C. 467f(b)), which relate to the detention of any poultry carcass, part thereof, or poultry product. (12) Functions vested in the Secretary under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.). (13) Functions vested in the Secretary by amendments to the foregoing statutes subsequent to Reorganization Plan No. 1 of 1953. (14) Function of issuing all regulations of the Food and Drug Administration, except as provided in Sec. 5.11. The reservation of authority contained in Chapter 2-000 of the Department Organization Manual shall not apply. (15) Functions vested in the Secretary under section 1103 of Executive Order 11490, as amended by Executive Order 11921, which relate to emergency health functions as they pertain to the operations and functional responsibilities assigned to the agency. This authority shall be exercised in accordance with section 102 and pertinent sections of part 30 of Executive Order 11490 and guidelines issued by the Federal Preparedness Agency of the General Services Administration and the Office of the Secretary. (16) Function vested in the Secretary of authorizing and approving miscellaneous and emergency expenses of enforcement activities. (17) Functions vested in the Secretary under the Federal Advisory Committee Act, Public Law 92-463, to: (i) Renew, recharter, amend and terminate established Federal Advisory Committees; (ii) Authority to approve waivers to appoint committee members to established Federal Advisory Committees; (iii) Authority to close review meetings following approval by the Office of the General Counsel based on a determination that the Advisory Committee meeting or a portion thereof may be closed to the public under the provisions of 5 U.S.C. 552b(c) and section 10(d) of the Federal Advisory Committee Act. These authorities are to be 11

§ 5.10

exercised in accordance with the requirements of 5 U.S.C. 552b; the Federal Advisory Committee Act (Public Law 92-463); Departmental regulations (45 CFR part 11, superseded by 41 CFR part 101-6); and any other applicable statutes and regulations. These authorities may be redelegated. (18) Functions vested in the Secretary under the second sentence of section 310(a) and under section 310(b) (Health Conferences and Health Education Information) of the PHS Act (42 U.S.C. 242o), as amended, to call for a conference and invite as many health authorities and officials of State or local public or private agencies or organizations as deemed necessary or proper on subjects related to the functions of the Food and Drug Administration, and to issue information related to health for the use of the public and other pertinent health information for the use of persons and institutions concerned with health services when such information is related to the functions of the Food and Drug Administration. (19) Functions vested in the Secretary under section 2701 of the PHS Act (42 U.S.C. 238), as amended, to accept offers of gifts, excluding the acceptance of gifts of real property. Only the authority to accept unconditional gifts of personal property valued at $5,000 or less may be redelegated. (20) Functions vested in the Secretary under section 362 of the PHS Act (42 U.S.C. 265), as amended, which relate to the prohibition of the introduction of foods, drugs, devices, cosmetics, electronic products, and other items or products regulated by the Food and Drug Administration into the United States when it is determined that it is required in the interest of public health when such functions relate to the law enforcement functions of the Food and Drug Administration. (21) Functions vested in the Secretary under section 401(a) of the Lead-Based Paint Poisoning Prevention Act, as amended by Public Law 94-317 (42 U.S.C. 4831(a)), relating to the prohibition of the application of lead-based paint to cooking, drinking, or eating utensils. (22) Functions vested in the Secretary for the health information and health promotion program under title XVII of the PHS Act (42 U.S.C. 300u et seq.), as amended, insofar as the authorities pertain to functions assigned to the Food and Drug Administration. The delegation includes, but is not limited to, the authorities under: Section 1702(a)(1) and (3) and section 1704(1) and (2) (42 U.S.C. 300u-1(a) and (3) and 300u-3(1) and (2)). The delegation excludes the authority to select all Senior Executive Service, supergrade and equivalent, and Schedule C (GS-12 and above) positions; issue regulations; and submit reports to the President. (23) To administer a Small Business Innovation Research Program under section 9 of the Small Business Act (15 U.S.C. 638), as amended. The delegation excludes the authority to issue regulations, establish advisory councils and committees, appoint members to advisory councils and committees, and submit reports to Congress. (24) Functions vested in the Secretary under sections 982 and 983 of the Consumer-Patient Radiation Health and Safety Act of 1981 (the Act) (42 U.S.C. 10007 and 10008), as amended. The delegation excludes the authority to issue regulations and submit reports to Congress. The authority delegated under section 983 of the Act may only be exercised as it relates to functions assigned to the Food and Drug Administration. (25) Functions vested in the Secretary under section 156 of title 35 of the U.S. Code (35 U.S.C. 156), as amended, which allows for the extension of patent terms for human drug products, medical devices, food additives, and color additives subject to the Federal Food, Drug, and Cosmetic Act (the act). These authorities may be redelegated, except the authority to make due diligence determinations under section 156(d)(2)(B), which may not be redelegated to an Office below the Office of the Commissioner of Food and Drugs. (26) Functions vested in the Secretary under the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.) (the Act), as amended, and under Executive Order 12591 of April 10, 1987, as they pertain to the functions of the Food and Drug Administration. The delegation excludes the authority to issue regulations and submit reports to Congress; under section 11(a)(2) of the Act (15 U.S.C. 3710a(a)(2)) to approve agreements and contracts with invention management organizations; and under section 11(c)(3)(B) of the Act (15 U.S.C. 3710a(c)(3)(B)) to propose necessary statutory changes regarding conflict of interest. (i) The authorities under sections 11(c)(5) (A) and (B) of the Act (15 U.S.C. 3710a (c)(5) (A) and (B)) to disapprove or require the modification of cooperative research and development agreements and licensing agreements after the agreement is presented to the Commissioner by the head of the laboratory concerned, and to transmit written explanation of such disapproval or modification to the head of the laboratory concerned, may be redelegated only to a senior official in the immediate Office of the Commissioner. (ii) The following authorities may not be redelegated: The authority under section 11(b)(3)(D) of the Act (15 U.S.C. 3710a(b)(3)(D)) to waive a right of ownership which the Federal Government may have to an invention made under a cooperative research and development agreement; the authority under section 11(b)(3)(C) of the Act (15 U.S.C. 3710a(b)(3)(C)) to permit employees or former employees to participate in efforts to commercialize inventions they 12

§ 5.10

made while in the service of the United States; the authority under section 11(c)(3)(A) of the Act (15 U.S.C. 3710a(c)(3)(A)) to review employee standards of conduct for resolving potential conflicts of interest; the authority under section 13(a)(1) of the Act (15 U.S.C. 3710c(a)(1)) to retain any royalties or other income, except as provided in section 13(a)(2) of the Act (15 U.S.C. 3710c(a)2)); and the authority under section 13(a)(1)(A)(i) of the Act (15 U.S.C. 3710c(a)(1)(A)(i)) to pay royalties or other income the agency receives on account of an invention to the inventor if the inventor was an employee of the agency at the time the invention was made. (iii) Any authorities under paragraph (a)(26) of this section delegated by the Commissioner may not be further redelegated. (27) Functions vested in the Secretary under sections 4702, 4703, and 4704 of the Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. 1401-1403) that relate to pesticide monitoring and enforcement information, foreign pesticide information, and pesticide analytical methods. The delegation excludes the authority to submit reports to Congress. (28) Functions vested in the Secretary under sections 2312(a)(1) and (2)(B), (b), and (c) (Use of Investigational New Drugs with Respect to Acquired Immunodeficiency Syndrome); 2314(c) (Scientific and Ethical Guidelines for Certain Treatments); and 2317(d) and (e) (Information Services) of title XXIII of the PHS Act (42 U.S.C. 300cc12(a)(1) and (2)(B), (b) and (c), 300cc-14(c) and 300cc-17 (d) and (e)), as amended, insofar as these authorities pertain to the functions assigned to the Food and Drug Administration. The delegation excludes the authority to issue regulations, submit reports to the Congress, establish advisory committees or national commissions, and appoint members to such committees or commissions. (29) Functions vested in the Secretary under section 2672(a)(1) (A) and (B) (Provisions Relating to Blood Banks) and section 2672(a)(2) (Information and Training Programs) of the PHS Act (42 U.S.C. 300ff-72(a)(1)(A) and (B) and (a)(2) et seq.), as amended, insofar as these authorities pertain to the functions assigned to the Food and Drug Administration. The delegations exclude the authority to issue regulations, submit reports to the Congress, establish advisory committees or national commissioners, and appoint members to such committees or commissions. (30) Functions vested in the Secretary under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of this section. The delegation excludes the authority to submit reports to Congress. (31) Functions vested in the Secretary under part C, subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25 et seq.), as amended, and the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 note), as amended hereafter, as follows: (i) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)—Recording and reporting of information. (ii) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)—-Mandate for safer childhood vaccines. (iii) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)—Manufacturer recordkeeping and reporting. (iv) Section 312 of the National Childhood Vaccine Injury Act of 1986—Related studies (42 U.S.C. 300aa-1 note). (v) Section 313 of the National Childhood Vaccine Injury Act of 1986—Study of other vaccine risks (42 U.S.C. 300aa-1 note). (vi) Section 314 of the National Childhood Vaccine Injury Act of 1986—Review of warnings, use instructions, and precautionary information (42 U.S.C. 300aa-1 note). (vii) The delegation excludes the authority to issue regulations and submit reports to Congress. (32) Functions vested in the Secretary under section 201(h)(4) of the Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended) (21 U.S.C. 811(h)(4)) to provide responses to the Drug Enforcement Administration’s temporary scheduling notices. The delegation excludes the authority to submit reports to Congress. (33) Functions vested in the Secretary under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), as amended hereafter (e.g., 21 U.S.C. 360c note, 360i note, and 360j note). The delegation excludes the authority to submit reports to Congress. (34) Functions vested in the Secretary under section 601 of Effective Medication Guides of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 1997 (Public Law 104180), as amended hereafter. The delegation excludes the authority to issue reports to Congress. (35) The Secretary has redelegated to the Commissioner of Food and Drugs, or his designee, the authority to take final action on matters pertaining to section 203 of the Equal Access to Justice Act (5 U.S.C. 504), and to develop procedures and regulations where necessary to supplement the Department’s regulations, 45 CFR part 13. 13

§ 5.11

(36) The Secretary has delegated to the Commissioner, the authority to administer and make decisions regarding the invention and patent program as they pertain to the functions of the Food and Drug Administration and to make determinations of rights in inventions and patents in which the Department has an interest. This delegation excludes the authority to submit reports to Congress and further, it excludes those authorities under the Stevenson-Wydler Technology Innovation Act of 1980, as amended by the Federal Technology Transfer Act of 1986 and the National Technology Transfer and Advancement Act of 1995, which are governed by a separate delegation (under Sec. 5.10(a)(26)). All authorities other than the authority under 35 U.S.C. section 203 (March-In Rights) may be redelegated. (37) Functions vested in the Secretary under title III, Section 354, of the PHS Act (42 U.S.C. 262 et seq.), as amended. The authority pertains to the Food and Drug Administration’s oversight of mammography facilities. (38) The Deputy Assistant Secretary for Health Management Operations, Public Health Service, has redelegated to the Commissioner of Food and Drugs, with authority to redelegate, the authority to certify true copies of any books, records, or other documents on file within the Food and Drug Administration, or extracts from such; to certify that true copies are true copies of the entire file of the Administration; to certify the complete original record or to certify the nonexistence of records on file within the Administration; and to cause the Seal of the Department to be affixed to such certifications and to agreements, awards, citations, diplomas, and similar documents. (39) The Secretary of Health and Human Services has redelegated to the Commissioner, of Food and Drugs, under 45 CFR 5b.8 regulations, appeal authority to take final action upon an individual’s appeal of a refusal to correct or amend the individual’s record when the appeal has been made by the individual under Privacy Act regulations (part 21 of this chapter and 45 CFR part 5b). The authority may not be redelegated. (b) The Chief Counsel of the Food and Drug Administration has been authorized to report apparent violations to the Department of Justice for the institution of criminal proceedings, under section 305 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335), section 4 of the Federal Import Milk Act (21 U.S.C. 144), and section 9(b) of the Federal Caustic Poison Act. § 5.11 Reservation of authority. (a) Notwithstanding provisions of Sec. 5.10 or any previous delegations of authority to the contrary, the Secretary of Health and Human Services (Secretary) reserves the authority to approve regulations of the Food and Drug Administration, except regulations to which sections 556 and 557 of title 5 U.S.C. apply, which: (1) Establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, or other subjects of regulation; or (2) Present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, or other subjects of regulation. (b) Nothing in this section precludes the Secretary from approving a regulation, or being notified in advance of an action, to which sections 556 and 557 of title 5 U.S.C. apply, which meets one of the criteria in paragraph (a) of this section. (c) This reservation of authority is intended only to improve the internal management of the Department of Health and Human Services, and it is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, the Department of Health and Human Services, the Food and Drug Administration, any agency, officer, or employee of the United States, or any person. Regulations issued by the Food and Drug Administration without the approval of the Secretary are to be conclusively viewed as falling outside the scope of this reservation of authority.

Subpart B—General Redelegations of Authority § 5.27 Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings. (a) The Deputy Commissioner is authorized to perform the due diligence determinations and informal hearings functions under section 156(d)(2)(B)(ii) of title 35 U.S.C. (35 U.S.C. 156), as amended, relative to patent term extensions. (b) The Director, Center for Drug Evaluation and Research (CDER) and the Associate Director for Regulatory 14

§ 5.32

Policy, CDER, are authorized to perform the functions delegated to the Commissioner under title 35 U.S.C. 156, as amended, except for making due diligence determinations and holding of informal hearings under title 35 U.S.C. 156(d)(2)(B). (c) The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of the Commissioner, is authorized to perform the functions delegated to the Commissioner to make due diligence determinations under title 35 U.S.C. 156 (d)(2)(B), as amended, except for holding of informal hearings under title 35 U.S.C. 156(d)(2)(B)(ii). (d) These officials may not further redelegate this authority. § 5.31 Enforcement activities. (a) Designated officers and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of Form FDA-200A, Identification Record, and Form FDA-200B, Specification of General Authority, are authorized: (1) To conduct examinations, inspections, and investigations; to collect and obtain samples; to have access to and to copy and verify records as authorized by law; to make seizures of items under section 702(e)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 372 (e) (5)); and to supervise compliance operations for the enforcement of the act, the Fair Packaging and Labeling Act (15 U.S.C. 1451-1461), the Federal Caustic Poison Act (44 Stat. 140b; see also Public Law 86-613, section 19, formerly section 18), the Import Milk Act (21 U.S.C. 141149), the Filled Milk Act (21 U.S.C. 61-64), and sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264). (2) To administer oaths and affirmations under section 1 of the act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940; and Reorganization Plan No. 1 of 1953, effective April 11, 1953. (b) Any officer or employee of the Food and Drug Administration who has been designated by the Commissioner of Food and Drugs (Commissioner) to conduct examinations, investigations, or inspections under the act relating to counterfeit drugs and issued the Food and Drug Administration Official Credential consisting of Form FDA-200D, Special Authority for Criminal Investigators, is authorized to do the following: (1) As set forth under section 702(e)(1) through (e)(5) of the act (21 U.S.C. 372 (e)(1)-(e)(5)): (i) Carry firearms; (ii) Serve and execute search warrants and arrest warrants; (iii) Execute seizure by process issued under libel under section 304 of the act (21 U.S.C. 334); (iv) Make arrests without warrant for an offense under the act with respect to counterfeit drugs if the offense is committed in the presence of the criminal investigator or, in the case of a felony, if the investigator has probable cause to believe that the person so arrested has committed, or is committing, such offense; and (v) Make, prior to the institution of libel proceedings under section 304(a)(2) of the act (21 U.S.C. 334(a)(2)), seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or the criminal investigator has reasonable grounds to believe that they are, subject to seizure and condemnation under section 304(a)(2) of the act. (2) Perform such other functions under the act, or any other law, as the Commissioner may prescribe. (3) To administer oaths and affirmations under section 1 of the act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940; and Reorganization Plan No. 1 of 1953, effective April 11, 1953. (c) Any officer or employee of the Food and Drug Administration who has been designated by the Commissioner to provide specialized law enforcement support involving criminal investigations under the act, and other duties as assigned by the Commissioner, and issued the Food and Drug Administration Official Credential consisting of Form FDA-200E, Special Authority for Criminal Investigative Specialists, is authorized to receive information as to all matters relating to such act and regulations issued under the act. (d) These officials may not further redelegate these authorities. § 5.32 Certification following inspections. Regional Food and Drug Directors and District Directors are authorized to issue certificates of sanitation under Sec. 1240.20 of this chapter. These officials may not further redelegate this authority. 15

§ 5.33

§ 5.33 Issuance of reports of minor violations. (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under section 309 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 336) (the act) regarding the issuance of written notices or warnings: (1)(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (ii) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (2)(i) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (ii) The Director and Deputy Director, Office of Compliance, CDRH. (iii) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH. (iv) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH. (3)(i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition, (CFSAN). (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Field Programs, CFSAN. (iv) The Director, Division of Enforcement and Programs, Office of Field Programs, CFSAN. (4)(i) The Director and Deputy Director, Center for Veterinary Medicine (CVM). (ii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (iii) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM. (5)(i) The Director, the Deputy Director, the Associate Director for Regulatory Policy, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (ii) The Director and Deputy Director, Office of Compliance, CDER. (iii) The Associate Director for Medical Policy, CDER. (iv) The Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, CDER. (6)(i) Regional Food and Drug Directors. (ii) District Directors. (iii) Chiefs of District Compliance Branches. (iv) The Director, St. Louis Branch. (v) The Director, Northeast Regional Laboratory, Northeast Region. (vi) The Director, Southeast Regional Laboratory, Southeast Region. (vii) The Director, Winchester Engineering and Analytical Center. (viii) The Director, National Forensic Chemistry Center. (ix) The Director, Arkansas Regional Laboratory. (b) The following officials are authorized to perform all the functions of the Commissioner under section 539(d) of the act (21 U.S.C. 360pp(d)) regarding the issuance of written notices or warnings: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (3) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH. (4) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH. (5) Regional Food and Drug Directors; District Directors; the Director, St. Louis Branch; the Director, Northeast Regional Laboratory, Northeast Region; the Director, Southeast Regional Laboratory, Southeast Region; the Director, Winchester Engineering and Analytical Center; the Director, National Forensic Chemistry Center, and the Director, Arkansas Regional Laboratory when such functions relate to: (i) Assemblers of diagnostic x-ray systems, as defined in Sec. 1020.30(b) of this chapter; and (ii) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product as defined in Sec. 1040.20(b) of this chapter. (c) These officials may not further redelegate these authorities. 16

§ 5.300

§ 5.34 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. (a) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, Center for Drug Evaluation and Research, the Director and Deputy Director, Center for Veterinary Medicine, and the Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue the following notices and make all findings required in relation to these notices under section 306 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a) which relate to the assigned functions of their organizations: (1) Notices of opportunity for hearing on proposals for mandatory or permissive debarment. (2) Notices ordering debarment when opportunity for a hearing has been waived. (3) Notices ordering debarment where the person notifies the agency that the person consents to debarment under section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)). (4) Notices of opportunity for hearing on proposals denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)). (5) Orders denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for a hearing has been waived. (b) These officials may not further redelegate these authorities. § 5.35 Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules. (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to decisions made under the Regulatory Flexibility Act (5 U.S.C. 605(b)), to certify that a proposed or final rule, if issued, will not have a significant economic impact on a substantial number of small entities: (1) The Associate Commissioner for Regulatory Affairs. (2) The Director, Center for Biologics Evaluation and Research. (3) The Director, Center for Drug Evaluation and Research. (4) The Director, Center for Devices and Radiological Health. (5) The Director, Center for Food Safety and Applied Nutrition. (6) The Director, Center for Veterinary Medicine. (7) Other Food and Drug Administration Officials authorized to issue Federal Register documents. (b) These officials may not further redelegate this authority.

Subpart E—Food and Cosmetics; Redelegations of Authority § 5.300 Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims. (a)(1) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under sections 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the issuance of notices of filing (including notices of extension of, or reopening of, the comment period), and of voluntary withdrawal, of petitions on food additives, generally recognized as safe (GRAS) substances, and color additives that relate to the assigned functions of the respective Center: (i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN). (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Premarket Approval, CFSAN. (iv) The Director and Deputy Director, Center for Veterinary Medicine (CVM). (2) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform all the functions of the Commissioner under section 401 of the act (21 U.S.C. 341) regarding the issuance of proposed rulemaking (including notices of extension of, or reopening of, the comment period) pertaining to food standards. (b)(1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform all of the functions of the Commissioner under section 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the approval of the use of food additives under section 409(e) of the act (21 U.S.C. 348(e)) and the listing of color additives under section 721(d)(1) of the act (21 U.S.C. 379e) where the listing does not involve novel or controversial 17

§ 5.300

issues and does not involve any questions about the applicability of the Delaney Anti-Cancer Clause. (2) The following officials are authorized to perform all of the functions of the Commissioner under section 401 of the act (21 U.S.C. 341) regarding the issuance of notices of temporary permits for foods varying from standards of identity under Sec. 130.17 of this chapter: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (3) The Director and Deputy Director, CVM, are authorized to perform all the functions of the Commissioner regarding approvals of the use of food additives under section 409(e) of the act (21 U.S.C. 348(e)), where these approvals do not involve novel or controversial issues, including any question about the applicability of the Delaney Anti-Cancer Clause. (c)(1) The following officials are authorized to issue 90-day letters to food additive petitioners under section 409(c)(2) of the act (21 U.S.C. 348(c)(2)) or to color additive petitions under section 721e(d)(1) (21 U.S.C. 379e(d)(1)) of the act that relate to the assigned functions of the Center: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Premarket Approval, CFSAN. (iv) The Director, Division of Product Policy, Office of Premarket Approval, CFSAN. (v) The Director, Division of Petition Control, Office of Premarket Approval, CFSAN. (2) The following officials are authorized to issue 90-day letters to food additive petitioners under section 409(c)(2) of the act (21 U.S.C. 348(c)(2)) that relate to the assigned functions of the Center: (i) The Director and Deputy Director, CVM. (ii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (iii) The Director and Deputy Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (d) The following officials are authorized to certify batches of color additives under section 721 of the act (21 U.S.C. 379e): (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Cosmetics and Colors, CFSAN. (e) The following officials are authorized to issue advance notices of proposed rulemaking pertaining to Codex Alimentarius food standards and notices terminating consideration of such standards when comments fail to support the desirability and need for proposing their adoption, under Sec. 130.6 of this chapter: (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (f) The following officials are authorized to issue notices of proposed rulemaking and issue or amend regulations affirming GRAS status of food substances under Secs. 170.35 or 570.35 of this chapter where the affirmations relate to the assigned functions of the respective Center and do not involve novel or controversial issues: (1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN. (2) The Director and Deputy Director, CVM. (g)(1) The following officials are authorized to perform all of the functions of the Commissioner under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) regarding the issuance of decisions to grant or deny petitions for nutrient content claims and health claims that do not present controversial issues and regarding the issuance of any notices of proposed rulemaking that result from such action: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (2) The following officials are authorized to perform all of the functions of the Commissioner under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) regarding the issuing of letters of filing in response to petitions for nutrient content claims and health claims: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (h) The following officials are authorized to issue letters concerning substances determined to be below the ``threshold of regulation’’ under Sec. 170.39 of this chapter: 18

§ 5.304

(1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Premarket Approval, CFSAN. (4) The Directors of the Divisions of Petition Control and Product Policy, Office of Premarket Approval, CFSAN. (i) The following officials are authorized to perform all of the functions of the Commissioner under section 409(h) of the act (21 U.S.C. 348(h)), excluding the duties to set out in section 409(h)(5) of the act (21 U.S.C. 348(h)(5)), regarding premarket notification of food-contact substances: (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Premarket Approval, CFSAN. (j) These officials may not further redelegate these authorities. § 5.301 Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. (a) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN), the Director, Office of Field Programs, CFSAN, and the Director, Division of Enforcement and Programs, Office of Field Programs, CFSAN, are authorized to issue initial emergency permit orders under Sec. 108.5 of this chapter. (b) The following officials are authorized to issue notices of confirmation of effective date of final regulations on food matters issued under section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)): (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (4) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN. (5) The Director, Office of Seafood, CFSAN. (6) The Director, Office of Field Programs, CFSAN. (7) The Director, Office of Premarket Approval, CFSAN. (c) These officials may not further redelegate these authorities. § 5.302 Detention of meat, poultry, eggs, and related products. The Regional Food and Drug Directors and District Directors are authorized to perform and to designate other officials to perform all of the functions of the Commissioner of Food and Drugs under: (a) Section 409(b) of the Federal Meat Inspection Act (21 U.S.C. 679(b)), that relates to the detention of any carcass, part thereof, meat, or meat product of cattle, sheep, swine, goats, or equines. (b) Section 24(b) of the Poultry Products Inspection Act (21 U.S.C. 467f (b)) that relates to the detention of any poultry carcass, part thereof, or poultry product. (c) The Egg Products Inspection Act (21 U.S.C. 1031 et seq.). § 5.303 Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program. The Director, Deputy Director, and Director of Regulations and Policy, Center for Food Safety and Applied Nutrition, are authorized to perform all the functions of the Commissioner of Food and Drugs under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of these sections. The delegation excludes the authority to submit reports to the Congress. These officials may not further redelegate this authority. § 5.304 Approval of schools providing food-processing instruction. (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under Sec. 113.10 of this chapter regarding the approval of schools giving instruction in retort 19

§ 5.1100

operations, processing systems operations, aseptic processing and packaging system operations, and container closure inspections: (1) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN). (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN. (b) These officials may not further redelegate this authority.

Subpart M—Organization § 5.1100 Headquarters. The central organization of the Food and Drug Administration consists of the following: OFFICE OF THE COMMISSIONER.1 Office of the Chief Counsel. Office of Equal Opportunity. Office of the Administrative Law Judge. Office of the Senior Associate Commissioner. Office of Executive Secretariat. Office of Public Affairs. Office of the Ombudsman. Office of Orphan Products Development. Office of Internal Affairs. Office of Executive Operations. Office of Science Coordination and Communication Office of Human Research Trials Office of International and Constituent Relations. Office of International Programs. Office of Consumer Affairs. Office of Women’s Health. Office of Special Health Issues. Office of Policy, Planning, and Legislation. Office of Policy. Office of Planning. Office of Legislation. Office of Management and Systems. Office of Human Resources and Management Services. Office of Information Resources Management. Office of Financial Management. Office of Facilities, Acquisitions, and Central Services.2 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.3 Office of the Center Director. Scientific Advisors and Consultants Staff. Equal Employment Opportunity and Workforce Diversity Staff. Quality Assurance Staff. Regulations and Policy Staff. Veterinary Services Staff. Office of Management. Regulatory Information Management Staff. Division of Planning, Evaluation, and Budget. 1Mailing

address: 5600 Fishers Lane, Rockville, MD 20857 address: 5630 Fishers Lane, Rockville, MD 20857. 3Mailing address: 1401 Rockville Pike, Rockville, MD 20852-1448. 2Mailing

20

§ 5.1100

Division of Management Services. Office of Information Technology Management. Division of Information Technology Operations. Division of Information Technology Development. Division of Information Technology Infrastructure. Office of Compliance and Biologics Quality. Division of Case Management Division of Manufacturing and Product Quality. Division of Inspections and Surveillance. Office of Blood Research and Review. Human Tissue Staff. Policy and Publications Staff. Division of Emerging and Transfusion Transmitted Diseases. Division of Hematology. Division of Blood Applications. Office of Therapeutics Research and Review. Division of Cellular and Gene Therapies. Division of Therapeutic Proteins. Division of Monoclonal Antibodies. Division of Clinical Trial Design and Analysis. Division of Application Review and Policy. Office of Vaccines Research and Review. Division of Bacterial, Parasitic, and Allergenic Products. Division of Viral Products. Division of Vaccines and Related Products Applications. Office of Communication, Training, and Manufacturers Assistance. Division of Disclosure and Oversight Management. Division of Manufacturers Assistance and Training. Division of Communication and Consumer Affairs. Office of Biostatistics and Epidemiology. Division of Biostatistics. Division of Epidemiology. CENTER FOR FOOD SAFETY AND APPLIED NUTRITION.4 Office of the Center Director. Food Safety Initiatives Staff. Office of Science. Quality Assurance Staff. CFSAN Staff College. Microbial Research and Risk Assessment Staff. JIFSAN Liaison Staff. CFSAN Food Advisory Committee Staff. Office of Applied Research and Safety Assessment. Muirkirk Technical Operations Staff. Division of Molecular Biology. Division of Virulence Assessment. Division of Toxicology and Nutritional Product Studies. Division of In Vitro and Biochemical Toxicology. Office of Regulations and Policy. Regulations Coordination Staff. Office of Constituent Operations. Consumer Education Staff. Industry Activities Staff. 4Mailing

address: 5100 Paint Branch Pkwy., College Park, MD 20740

21

§ 5.1100

International Activities Staff. Office of Management Systems. Safety Management Systems. Division of Information Resources Management. Division of Planning and Financial Resources Management. Division of Management Operations. Division of Administrative Services Management Office of Operations. Equal Employment Opportunity Staff. Executive Operations Staff. Office of Cosmetics and Colors. Division of Programs and Enforcement Policy. Division of Science and Applied Technology. Office of Nutritional Products, Labeling, and Dietary Supplements. Division of Compliance and Enforcement. Division of Standards and Labeling Regulations. Division of Nutrition Science Policy. Office of Premarket Approval. Division of Product Policy. Division of Petition Control. Division of Health Effects Evaluation. Division of Product Manufacture and Use. Office of Plant and Dairy Foods and Beverages. Division of Natural Products. Division of Food Processing and Packaging. Division of Plant Product Safety. Division of Dairy and Egg Safety. Division of Risk Assessment. Office of Seafood. Division of Special Programs. Division of Programs and Enforcement Policy. Division of Science and Applied Technology. Office of Field Programs. Division of Enforcement and Programs. Division of HACCP Programs. Division of Cooperative Programs. Office of Scientific Analysis and Support. Division of General Scientific Support. Division of Mathematics. Division of Market Studies. CENTER FOR DRUG EVALUATION AND RESEARCH.1 Office of the Center Director. Equal Employment Opportunity Staff. Executive Operations Staff. Office of Regulatory Policy. Division of Regulatory Policy I. Division of Regulatory Policy II. Division of Information Disclosure Policy. Office of Management.1 Strategic Planning Staff.1 Division of Management and Budget.5 Division of Management Services.5 5Mailing

address: 7500 Standish Pl., Rockville, MD 20855.

22

§ 5.1100

Office of Training and Communication.1 Medwatch Staff. Division of Library and Information Services. Division of Training and Development. Division of Public Affairs. Division of Drug Information Office of Compliance.6 Division of Manufacturing and Product Quality. Division of Prescription Drug Compliance and Surveillance. Division of Labeling and Non-Prescription Drug Compliance. Office of Information Technology.1 Quality Assurance Staff. Technology Support Services Staff. Division of Data Management and Services. Division of Applications Development and Services. Division of Infrastructure Management and Services. Office of Medical Policy.1 Division of Drug Marketing, Advertising, and Communication1 Division of Scientific Investigations.6 Office of Review Management.1 Advisors and Consultants Staff.2 Office of Drug Evaluation I.1 Division of Cardio-Renal Drug Products. Division of Neuropharmacological Drug Products. Division of Oncology Drug Products. Office of Drug Evaluation II.1 Division of Metabolic and Endocrine Drug Products. Division of Pulmonary and Allergy Drug Products. Division of Anesthetic, Critical Care, and Addiction Drug Products. Office of Drug Evaluation III.1 Division of Gastrointestinal and Coagulation Drug Products. Division of Medical Imaging and Radiopharmaceutical Drug Products. Division of Reproductive and Urologic Drug Products. Office of Drug Evaluation IV.1 Division of Anti-Infective Drug Products. Division of Anti-Viral Drug Products. Division of Special Pathogen and Immunologic Drug Products. Office of Drug Evaluation V.1 Division of Anti-Inflammatory, Analgesic, and Opthalmologic Drug Products. Division of Dermatologic and Dental Drug Products. Division of Over-the-Counter Drug Products. Office of Biostatistics.1 Quantitative Methods Research Staff. Division of Biometrics I. Division of Biometrics II. Division of Biometrics III. Office of Post-Marketing Drug Risk Assessment.1 Extramural Programs Staff. Information Technology Staff. Division of Drug Risk Evaluation I. Division of Drug Risk Evaluation II. Office of Pharmaceutical Science.1 6Mailing

address: 7520 Standish Pl., Rockville, MD 20855.

23

§ 5.1100

Quality Implementation Staff.1 Operations Staff.1 Office of Clinical Pharmacology and Biopharmaceutics. Pharmacometrics Staff. Division of Pharmaceutical Evaluation I.1 Division of Pharmaceutical Evaluation II1 Division of Pharmaceutical Evaluation III.1 Office of Generic Drugs.6 Division of Bioequivalence. Division of Chemistry I. Division of Chemistry II. Division of Labeling and Program Support. Office of New Drug Chemistry.1 Division of New Drug Chemistry I.1 Division of New Drug Chemistry II.1 Division of New Drug Chemistry III.1 Office of Testing and Research.1 Informatics and Computational Safety Analysis Staff Laboratory of Clinical Pharmacology.1 Division of Applied Pharmacology Research.7 Division of Pharmaceutical Analysis.8 Division of Product Quality Research.1 OFFICE OF REGULATORY AFFAIRS.1 Equal Employment Opportunity Staff. Office of Resource Management. Strategic Initiatives Staff. Division of Planning, Evaluation, and Management. Division of Information Systems. Division of Human Resource Development. Division of Management Operations. Division of Personnel Operations. Office of Enforcement. Division of Compliance Management and Operations. Division of Compliance Policy. Division of Compliance Information and Quality Assurance. Office of Regional Operations. Division of Federal-State Relations. Division of Field Science. Division of Emergency and Investigational Operations. Division of Import Operations and Policy. Office of Criminal Investigations. Mid-Atlantic Area Office.9 Midwest Area Office.10 Northeast Area Office.11 Pacific Area Office.12 Southeast Area Office.13

7Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708. 8Mailing address: 1114 Market St., St. Louis, MO 63101. 9Mailing address: 900 U.S. Customhouse, Second Chestnut St., Philadelphia, 10Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 60532. 11Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433. 12Mailing address: 13301 Clay St., Oakland, CA 94512. 13Mailing address: 60 Eighth St. NE., Atlanta, GA 30309.

24

PA 19106.

§ 5.1100

Southwest Area Office.14 CENTER FOR VETERINARY MEDICINE.15 Office of the Center Director. Office of Management and Communications. Administrative Staff. Communications Staff. Information Resources Management Staff. Office of New Animal Drug Evaluation. Division of Therapeutic Drugs for Food Animals. Division of Biometrics and Production Drugs. Division of Therapeutic Drugs for Nonfood Animals. Division of Manufacturing Technologies. Division of Human Food Safety. Office of Surveillance and Compliance. Division of Surveillance. Division of Animal Feeds. Division of Compliance. Division of Epidemiology. Office of Research. Administrative Staff. Division of Residue Chemistry. Division of Animal Research. Division of Animal and Food Microbiology. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.16 Office of the Center Director. Equal Employment Opportunity Staff. Office of Systems and Management. Integrity Committee and Conference Management Staff. Division of Management Operations. Division of Information Dissemination. Division of Information Technology Management. Division of Planning, Analysis, and Finance. Office of Compliance. Promotion and Advertising Policy Staff. Division of Bioresearch Monitoring. Division of Program Operations. Division of Enforcement I. Division of Enforcement II. Division of Enforcement III. Office of Device Evaluation. Program Management Staff. Program Operations Staff. Division of Cardiovascular and Respiratory Devices. Division of Reproductive, Abdominal, and Radiological Devices. Division of General, Restorative, and Neurological Devices. Division of Clinical Laboratory Devices. Division of Ophthalmic, Ear, Nose, and Throat Devices. Division of Dental, Infection Control, and General Hospital Devices. Office of Science and Technology. Division of Mechanics and Materials Science. 14Mailing 15Mailing

address: 7920 Elmbrook Rd., Dallas, TX, 75247. address: 7500 Standish Pl., MPN-2, Rockville, MD 20855. 16Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.

25

§ 5.1105

Division of Life Sciences. Division of Physical Sciences. Division of Electronics and Computer Sciences. Division of Management Information and Support Services. Office of Health and Industry Programs. Program Operations Staff. Regulations Staff. Staff College. Division of Device User Programs and Systems Analysis. Division of Small Manufacturers Assistance. Division of Mammography Quality and Radiation Programs. Division of Communication Media. Office of Surveillance and Biometrics. Issues Management Staff. Division of Biostatistics. Division of Postmarket Surveillance. Division of Surveillance Systems. NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH.17 Office of the Center Director. Environmental Health and Program Assurance Staff. Office of Research. Technology Advancement Staff. Division of Biochemical Toxicology. Division of Genetic and Reproductive Toxicology. Division of Biometry and Risk Assessment. Division of Microbiology. Division of Chemistry. Division of Neurotoxicology. Division of Veterinary Services. Division of Molecular Epidemiology. Office of Management. Office of Management Services. Contracts and Procurement Staff. Division of Facilities, Engineering, and Maintenance. Division of Administrative Services. Office of Planning, Finance and Information Technology. Division of Planning. Division of Financial Management. Division of Information Technology. [66 FR 30993, June 8, 2001 as amended at 66 FR 56035, Nov. 6, 2001] § 5.1105 Chief Counsel, Food and Drug Administration. The Office of the Chief Counsel’s mailing address is 5600 Fishers Lane, rm. 6-57, Rockville, MD 20857. § 5.1110 Food and Drug Administration Public Information Offices. (a) Dockets Management Branch (HFA-305). The Dockets Management Branch Public Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. Telephone: 301-827-6860. (b) Freedom of Information Staff (HFI-35). The Freedom of Information Public Room is located in rm. 12A-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6567. 17Mailing

address: 3900 NCTR Dr., Jefferson, AR 72079.

26

§ 5.1115

(c) Press Relations Staff (HFI-40). Press Offices are located in rm. 15-05, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6242; and in rm. 3807, FB-8, 5100 Paint Branch Pkwy., College Park, MD 20740. Telephone 202-205-4144. [66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001]

§ 5.1115 Field structure. NORTHEAST REGION Regional Field Office: 158-15 Liberty Ave., Jamaica, NY 11433. Northeast Regional Laboratory: 158-15 Liberty Ave., Jamaica, NY 11433. New York District Office: 158-15 Liberty Ave., Jamaica, NY 11433. New England District Office: One Montvale Ave., Stoneham, MA 02180. Winchester Engineering and Analytical Center: 109 Holton St., Winchester, MA 01890. CENTRAL REGION Regional Field Office: U.S. Customhouse, Second and Chestnut Sts., rm. 900, Philadelphia, PA 19106. Philadelphia District Office: U.S. Customhouse, Second and Chestnut Sts., rm. 900, Philadelphia, PA 19106. Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201-2199. Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-3097. Forensic Chemistry Center: 1141 Central Pkwy., Cincinnati, OH 45202-1097. New Jersey District Office: Waterview Corporate Center, 10 Waterview Blvd., 3d Floor, Parsippany, NJ 07054. Chicago District Office: 300 South Riverside Plaza, suite 550, South Chicago, IL 60606. Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 48207-3179. Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 55401-1912. SOUTHEAST REGION Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309. Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309. Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309. New Orleans District Office: Textron Bldg., 6600 Plaza Dr., suite 400, New Orleans, LA 70127. Nashville District Office of NOL-DO: 297 Plus Park Blvd., Nashville, TN 37217. Florida District Office: 555 Winderley, suite 200, Maitland, FL 32751. San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR 00901-3223. SOUTHWEST REGION Regional Field Office: 7920 Elmwood Rd., suite 102, Dallas, TX 75247-4982. Dallas District Office: 3310 Live Oak St., Dallas, TX 75204. Denver District Office: Bldg. 20, Denver Federal Center, Sixth and Kipling Sts., P.O. Box 25087, Denver, CO 802250087. Kansas City District Office: 11630 West 80th St., Lenexa, KS 66214-3338. St. Louis Branch: 12 Sunnen Dr., suite 122, St. Louis, MO 63143-3800. Arkansas Regional Laboratory: 3900 NCTR Rd., Bldg. 14-T, rm. 104, Jefferson, AR 72079-9502. PACIFIC REGION Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 94612-5217. San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 94502-7070. Los Angeles District Office: 19900 Mac Arthur Blvd., suite 300, Irvine, CA 92715. Seattle District Office: P.O. Box 3012, Bothell, WA 98021-3012. 27

Part 70

Pacific Regional Laboratory, SW.: 1521 West Pico Blvd., Los Angeles, CA 90015-2488. Pacific Regional Laboratory, NW.: 22201 23d Dr. SE., Bothell, WA 98021-4421.

PART 70—COLOR ADDITIVES Subpart A—General Provisions Sec. 70.3 70.5 70.10 70.11 70.19

Definitions. General restrictions on use of color additives. Color additives in standardized foods and new drugs. Related substances. Fees for listing.

Subpart B—Packaging and Labeling 70.20 70.25

Packaging requirements for straight colors (other than hair dyes). Labeling requirements for color additives (other than hair dyes).

Subpart C—Safety Evaluation 70.40 70.42 70.45 70.50 70.51 70.55

Safety factors to be considered. Criteria for evaluating the safety of color additives. Allocation of color additives. Application of the cancer clause of section 721 of the act. Advisory committee on the applicability of the anticancer clause. Request for scientific studies.

AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 379e. SOURCE: 42 FR 15636, Mar. 22, 1977 unless otherwise noted.

Subpart A—General Provisions § 70.3 Definitions. (a) Secretary means the Secretary of Health and Human Services. (b) Department means the Department of Health and Human Services. (c) Commissioner means the Commissioner of Food and Drugs. (d) Act means the Federal Food, Drug, and Cosmetic Act as amended. (e) Color Certification Branch means the unit established within the Food and Drug Administration located in the Center for Food Safety and Applied Nutrition, charged with the responsibility for the mechanics of the certification procedure hereinafter described, and including the examination of samples of color additives subject to certification. (f) A color additive is any material, not exempted under section 201(t) of the act, that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting a color thereto. Substances capable of imparting a color to a container for foods, drugs, or cosmetics are not color additives unless the customary or reasonably foreseeable handling or use of the container may reasonably be expected to result in the transmittal of the color to the contents of the package or any part thereof. Food ingredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural color when mixed with other foods are not regarded as color additives; but where a food substance such as beet juice is deliberately used as a color, as in pink lemonade, it is a color additive. Food 28

§ 70.3

ingredients as authorized by a definitions and standard of identity prescribed by regulations pursuant to section 401 of the act are color additives, where the ingredients are specifically designated in the definitions and standards of identity as permitted for use for coloring purposes. An ingredient of an animal feed whose intended function is to impart, through the biological processes of the animal, a color to the meat, milk, or eggs of the animal is a color additive and is not exempt from the requirements of the statute. This definition shall apply whether or not such ingredient has nutritive or other functions in addition to the property of imparting color. An ingested drug the intended function of which is to impart color to the human body is a color additive. For the purposes of this part, the term color includes black, white, and intermediate grays, but substances including migrants from packaging materials which do not contribute any color apparent to the naked eye are not color additives. (g) For a material otherwise meeting the definition of color additive to be exempt from section 721 of the act, on the basis that it is used (or intended to be used) solely for a purpose or purposes other than coloring, the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color.) (h) The exemption that applies to a pesticide chemical, soil or plant nutrient, or other agricultural chemical, where its coloring effect results solely from its aiding, retarding, or otherwise affecting directly or indirectly, the growth or other natural physiological processes of produce of the soil, applies only to color developed in such product through natural physiological processes such as enzymatic action. If the pesticide chemical, soil or plant nutrient, or other agricultural chemical itself acts as a color or carries as an ingredient a color, and because of this property colors the produce of the soil, it is a color additive and is not exempt. (i) Safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. (j) The term straight color means a color additive listed in parts 73, 74, and 81 of this chapter, and includes lakes and such substances as are permitted by the specifications for such color. (k) The term mixture means a color additive made by mixing two or more straight colors, or one or more straight colors and one or more diluents. (l) The term lake means a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by simple mixing process. (m) The term diluent means any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed therein to facilitate the use of the mixture in coloring foods, drugs, or cosmetics or in coloring the human body. The diluent may serve another functional purpose in the foods, drugs, or cosmetics, as for example sweetening, flavoring, emulsifying, or stabilizing, or may be a functional component of an article intended for coloring the human body. (n) The term substratum means the substance on which the pure color in a lake is extended. (o) The term pure color means the color contained in a color additive, exclusive of any intermediate or other component, or of any diluent or substratum contained therein. (p) The term batch means a homogeneous lot of color additive or color additive mixture produced by an identified production operation, which is set apart and held as a unit for the purpose of obtaining certification of such quantity. (q) The term batch number means the number assigned to a batch by the person who requests certification thereof. (r) The term lot number means an identifying number or symbol assigned to a batch by the Food and Drug Administration. (s) The term area of the eye means the area enclosed with in the circumference of the supra-orbital ridge and the infra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge. (t) The term package means the immediate container in which a color additive or color additive mixture has been packed for shipment or delivery. If the package is then packed in a shipping carton or other protective container, such container shall not be considered to be the immediate container. In the case of color additive mixtures for household use containing less than 15 percent pure color, when two or more containers of 3 ounces each or less, each containing a different color, are distributed as a unit, the immediate container for such unit shall be considered to be the package as defined in this section. (u) The hair dye exemption in section 601(a) of the act applies to coal tar hair dyes intended for use in altering the color of the hair and which are, or which bear or contain, color additives derived from coal tar with the sensitization potential of causing skin irritation in certain individuals and possible blindness when used for dyeing the eyelashes or eyebrows. The exemption is permitted with the condition that the label of any such article bear conspicuously the statutory caution and adequate directions for preliminary patch-testing. The exemption does not apply to coloring 29

§ 70.5

ingredients in hair dyes not derived from coal tar, and it does not extend to poisonous or deleterious diluents that may be introduced as wetting agents, hair conditions, emulsifiers, or other components in a color shampoo, rinse, tint, or similar dual-purpose cosmetic that alter the color of the hair. (v) The terms externally applied drugs and externally applied cosmetics mean drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane. [42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996]

§ 70.5 General restrictions on use of color additives. (a) Color additives for use in the area of the eye. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use in the area of the eye unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use in the area of the eye, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under parts 73, 74, and 81 of this chapter, even though such color additive is certified and/or listed for other uses. (b) Color additives for use in injections. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use in injections unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use in injections, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under parts 73, 74, and 81 of this chapter, even though such color additive is certified and/or listed for other uses. (c) Color additives for use in surgical sutures. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use as a surgical suture unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use as a surgical suture, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under parts 73, 74, and 81 of this chapter, even though such color additive is certified and/or listed for other uses. § 70.10 Color additives in standardized foods and new drugs. (a) Standardized foods. (1) Where a petition is received for issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a color additive in the standardized food, the provisions of the regulations in part 71 of this chapter shall apply with respect to the information that must be submitted with respect to the safety of the color additive (if such information has not previously been submitted and safety of the color additive for the intended use has not been already established), and the petition must show also that the use of the color additive in the standardized food would be in conformance with section 401 of the act or with the terms of a temporary permit issued under Sec. 130.17 of this chapter. (2) If a petition for a definition and standard of identity contains a proposal for a color additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a color additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in part 71 of this chapter. (3) A regulation will not be issued allowing the use of a color additive in a food for which a definition and standard of identity is established, unless its issuance is in conformance with section 401 of the act or with the terms of a temporary permit issued under Sec. 130.17 of this chapter. When the contemplated use of such additive complies with the terms of a temporary permit, the color additive regulation will be conditioned on such compliance and will expire with the expiration of the temporary permit. (b) New drugs. (1) Where an application for a new drug is received and this application proposes, for coloring purposes only, the inclusion of a color additive, the provisions of the regulations in part 71 of this chapter shall apply with respect to the information that must be submitted about the safety of the color additive, if such information has not previously been submitted and safety of the color additive for the intended use has not already been established. (2) If an application for a new drug inferentially contains a proposal for a color additive regulation, and the applicant fails to designate it as such, the Commissioner, upon determining that the application includes a proposal for a color additive regulation, shall so notify the applicant and shall thereafter proceed in accordance with the 30

§ 70.19

regulations in part 71 of this chapter. (3) Where a petition for a color additive must be filed in accordance with paragraph (b)(2) of this section, the date of filing of the color additive petition shall be considered as the date of filing of the new-drug application. [42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]

§ 70.11 Related substances. (a) Different color additives may cause similar or related pharmacological or biological effects, and, in the absence of evidence to the contrary, those that do so will be considered to have additive toxic effects. (b) Food additives may also cause pharmacological or biological effects similar or related to such effects caused by color additives, and, in the absence of evidence to the contrary, those that do so will be considered as having additive toxic effects. (c) Pesticide chemicals may also cause pharmacological or biological effects similar or related to such effects caused by color additives, and, in the absence of evidence to the contrary, those that do so will be considered to have additive toxic effects. (d) In establishing tolerances for color additives, the Commissioner will take into consideration, among other things, the amount of any common component permitted in other color additives, in food additives, and in pesticide chemical residues as well as the similar biological activity (such as cholinesterase inhibition) produced by such substance. § 70.19 Fees for listing. (a) Each petition for the listing of a color additive shall be accompanied by a deposit of $3,000.00 if the proposal is for listing the color additive for use generally in or on foods, in or on drugs, and in or on cosmetics. (b) If the petition for the listing is for use in or on foods only, the deposit shall be $3,000.00. (c) If the petition for the listing is for use in or on drugs and/or cosmetics only, the deposit shall be $2,600.00. (d) The provisions of paragraphs (a), (b), and (c) of this section shall be applicable, whether or not the proposal contemplates any tolerances, limitations, or other restrictions placed upon the use of the color additive. (e) If a petition proposing the issuance of a regulation is withdrawn before it is finally accepted for filing, the deposit, less a $600.00 fee for clerical handling and administrative and technical review, shall be returned to the petitioner. (f) If a petition proposing the issuance of a regulation is withdrawn within 30 days after filing, the deposit, less $1,800.00 if the petition is covered by paragraph (a) or (b) of this section, and less $1,600.00, if the petition is covered by paragraph (c) of this section, shall be returned to the petitioner. (g) When a petition is withdrawn after filing and resubmitted within 6 months, it shall be accompanied by a deposit of $1,800.00 for a petition filed under paragraph (a) or (b) of this section, and $1,600.00 for a petition filed under paragraph (c) of this section. If a petition is resubmitted after 6 months, it shall be accompanied by the deposit that would be required if it were being submitted for the first time. (h) When the resubmission pertains to a petition that had been withdrawn before acceptance for filing, a new advance deposit shall be made in full as prescribed in paragraph (a), (b), or (c) of this section. (i) After a color additive has been listed, any request for an amendment or additional tolerance shall be accompanied by a deposit of $1,800.00 for use in the items specified in paragraphs (a) and (b) of this section, or $1,600.00 for use in items specified in paragraph (c) of this section. (j) The fee for services in listing a diluent under Sec. 80.35 for use in color additive mixtures shall be $250.00. (k) Objections and request for public hearing under section 721(d) of the act or section 203(d)(2)(C) of Pub. L. 86618 (74 Stat. 404; 21 U.S.C. 379e, note) shall be accompanied by a filing fee of $250.00. (l) In the event of a referral of a petition under this section to an advisory committee, all costs related thereto (including personal compensation of committee members, travel materials, and other costs) shall be borne by the person or organization requesting the referral, such costs to be assessed on the basis of actual cost to the Government: Provided, That the compensation of such costs shall include personal compensation of advisory committee members at a rate not to exceed $75.00 per member per day. (m) In the case of requests of referrals to advisory committees, a special advance deposit shall be made in the amount of $2,500.00. Where required, further advance in increments of $2,500.00 each shall be made upon request 31

§ 70.20

of the Commissioner of Food and Drugs. All deposits for referrals to advisory committees in excess of actual expenses shall be refunded to the depositor. (n) All requests for pharmacological or other scientific studies shall be accompanied by an advance deposit of $5,000.00. Further advance deposits shall be made upon request of the Commissioner of Food and Drugs when necessary to prevent arrears in such cost. Any deposits in excess of actual expenses will be refunded to the depositor. If a request is denied the advance deposit will be refunded less such costs as are incurred for review of the request. (o) The person who files a petition for judicial review of an order under section 721(d) of the act shall pay the costs of preparing a transcript of the record on which the order is based. (p) All deposits and fees required by the regulations in this section shall be paid by money order, bank draft or certified check drawn to the order of the Food and Drug Administration, collectable at par at Washington, DC All deposits and fees shall be forwarded to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, whereupon after making appropriate record thereof they will be transmitted to the Treasurer of the United States for deposit in the special account ``Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.’’ (q) The Commissioner of Food and Drugs may waive or refund such fees in whole or in part when in his judgment such action will promote the public interest. (r) Any person who believes that payment of these fees will work a hardship on him may petition the Commissioner of Food and Drugs to waive or refund the fees. [42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

Subpart B—Packaging and Labeling § 70.20 Packaging requirements for straight colors (other than hair dyes). Straight colors shall be packaged in containers which prevent changes in composition. Packages shall be sealed so that they cannot be opened without breaking the seal. An unavoidable change in moisture content caused by the ordinary and customary exposure that occurs in good storage, packing, and distribution practice is not considered a change in composition. If the packaging material is a food additive it shall be authorized by an appropriate regulation in parts 170 through 189 of this chapter. § 70.25 Labeling requirements for color additives (other than hair dyes). (a) General labeling requirements. All color additives shall be labeled with sufficient information to assure their safe use and to allow a determination of compliance with any limitations imposed by this part and parts 71, 73, 74, 80, and 81 of this chapter. In addition to all other information required by the act, labels for color additives, except those in a form suitable for coloring the human body, shall state: (1) The name of the straight color or the name of each ingredient comprising the color additive, if it is a mixture. (2) A statement indicating general limitations for the use of the color additive, such as ``for food use only’’; ``for food, drug, and cosmetic use’’; ``for use in drugs for external application only.’’ (3) Where regulations issued impose quantitative limitations for a general or specific use of a straight color, the amount of each such straight color in terms of weight per unit/volume or percent by weight. (4) An expiration date if stability data require it. (b) Special labeling for color additives with tolerances. Where tolerances are imposed for a general or specific use of a color additive, the label shall in addition provide directions for use of the color additive which if followed will preclude the food, drug, or cosmetic to which it is added from containing an amount of the color additive in excess of the tolerance. (c) Special labeling for color additives with other limitations. If use of the color additive is subject to other limitations prescribed in this part, such limitations shall be stated on the label of the color additive by a plain and conspicuous statement. Examples of such limitation statements are: ``Do not use in products used in the area of the eye’’; ``Do not use for coloring drugs for injection.’’ (d) Special labeling for color additives not exempt from certification. Color additives not exempt from the certification procedures shall in addition include in the labeling the lot number assigned by the Color Certification 32

§ 70.50

Branch, except that in the case of any mixture for household use which contains not more than 15 percent of pure color and which is in packages containing not more than 3 ounces there appears on the label, a code number which the manufacturer has identified with the lot number by giving to the Food and Drug Administration written notice that such code number will be used in lieu of the lot number.

Subpart C—Safety Evaluation § 70.40 Safety factors to be considered. In accordance with section 721(b)(5)(A)(iii) of the act, the following safety factor will be applied in determining whether the proposed use of a color additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to man; that is, a color additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice. § 70.42 Criteria for evaluating the safety of color additives. (a) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed, the Commissioner will apply the ``safe-for-use’’ principle. This will require the presentation of all needed scientific data in support of a proposed listing to assure that each listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics when he finds from the data presented that such additive is suitable and may safely be employed for such general use; he may list an additive only for more limited use or uses for which it is proven suitable and may safely be employed; and he is authorized to prescribe broadly the conditions under which the additive may be safely employed for such use or uses. This may allow the use of a particular dye, pigment, or other substance with certain diluents, but not with others, or at a higher concentration with some than with others. (b) The safety for external color additives will normally be determined by tests for acute oral toxicity, primary irritation, sensitization, subacute dermal toxicity on intact and abraded skin, and carcinogenicity by skin application. The Commissioner may waive any of such tests if data before him otherwise establish that such test is not required to determine safety for the use proposed. (c) Upon written request describing the proposed use of a color additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive. § 70.45 Allocation of color additives. Whenever, in the consideration of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the color additive for all the uses proposed or at the levels proposed, the Commissioner will notify the petitioner and other interested persons by publication in the Federal Register that it is necessary to allocate the safe tolerance for the straight color in the color additive among the competing needs. This notice shall call for the presentation of data by all interested persons on which the allocation can be made in accordance with section 721(b)(8) of the act. The time for acting upon the petition shall be stayed until such data are presented, whereupon the time limits shall begin to run anew. As promptly as possible after presentation of the data, the Commissioner will, by order, announce the allocation and the tolerance limitations. § 70.50 Application of the cancer clause of section 721 of the act. (a) Color additives that may be ingested. Whenever (1) the scientific data before the Commissioner (either the reports from the scientific literature or the results of biological testing) suggest the possibility that the color additive including its components or impurities has induced cancer when ingested by man or animal; or (2) tests which are appropriate for the evaluation of the safety of additives in food suggest that the color additive, including its components or impurities, induces cancer in man or animal, the Commissioner shall determine whether, based on the 33

§ 70.51

judgment of appropriately qualified scientists, cancer has been induced and whether the color additive, including its components or impurities, was the causative substance. If it is his judgment that the data do not establish these facts, the cancer clause is not applicable; and if the data considered as a whole establish that the color additive will be safe under the conditions that can be specified in the applicable regulation, it may be listed for such use. But if in the judgment of the Commissioner, based on information from qualified scientists, cancer has been induced, no regulation may issue which permits its use. (b) Color additives that will not be ingested. Whenever the scientific data before the Commissioner suggest the possibility that the color additive, including its components or impurities, has induced cancer in man or animals by routes other than ingestion, the Commissioner shall determine whether, based on the judgment of appropriately qualified scientists, the test suggesting the possibility of carcinogenesis is appropriate for the evaluation of the color additive for a use which does not involve ingestion, cancer has been induced, and the color additive, including its components or impurities, was the causative substance. If it is his judgment that the data do not establish these facts, the cancer clause is not applicable to preclude external drug and cosmetic uses, and if the data as a whole establish that the color additive will be safe under conditions that can be specified in the regulations, it may be listed for such use. But if, in the judgment of the Commissioner, based on information from qualified scientists, the test is an appropriate one for the consideration of safety for the proposed external use, and cancer has been induced by the color additive, including its components or impurities, no regulation may issue which permits its use in external drugs and cosmetics. (c) Color additives for use as an ingredient of feed for animals that are raised for food production. Color additives that are an ingredient of the feed for animals raised for food production and that have the potential to contaminate human food with residues whose consumption could present a risk of cancer to people must satisfy the requirements of subpart E of part 500 of this chapter. [42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 1987]

§ 70.51 Advisory committee on the applicability of the anticancer clause. All requests for and procedures governing any advisory committee on the anticancer clause shall be subject to the provisions of part 14 of this chapter, and particularly subpart H of that part. § 70.55 Request for scientific studies. The Commissioner will consider requests by any interested person who desires the Food and Drug Administration to conduct scientific studies to support a petition for a regulation for a color additive. If favorably acted upon, such studies will be limited to pharmacological investigations, studies of the chemical and physical structure of the color additive, and methods of analysis of the pure color additive (including impurities) and its identification and determination in foods, drugs, or cosmetics, as the case may be. All requests for such studies shall be accompanied by the fee prescribed in Sec. 70.19.

PART 71—COLOR ADDITIVE PETITIONS Subpart A—General Provisions Sec. 71.1 71.2 71.4 71.6 71.15 71.18

Petitions. Notice of filing of petition. Samples; additional information. Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice. Confidentiality of data and information in color additive petitions. Petition for exemption from certification.

34

§ 71.1

Subpart B—Administrative Action on Petitions 71.20 71.22 71.25 71.26 71.27 71.30 71.37

Publication of regulation. Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued. Condition for certification. Revocation of exemption from certification. Listing and exemption from certification on the Commissioner’s initiative. Procedure for filing objections to regulations. Exemption of color additives for investigational use.

AUTHORITY: 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262. SOURCE: 42 FR 15639, Mar. 22, 1977, unless otherwise noted.

Subpart A—General Provisions § 71.1 Petitions. (a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate (quadruplicate, if intended uses include uses in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petitioner shall state the post-office address in the United States to which published notices or orders issued or objections filed pursuant to section 721 of the act may be sent. (b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted the information. Any reference to published information offered in support of a color additive petition should be accompanied by reprints or photostatic copies of such references. (c) Petitions shall include the following data and be submitted in the following form: (Date) Name of petitioner Post-office address Name of color additive and proposed use Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 Dear Sir: Petitioner submits this pursuant to section 721(b)(1) of the Federal Food, Drug, and Cosmetic Act requesting listing by the Commissioner of the color additive ______ as suitable and safe for use in or on __________ subject to the conditions that _____________. [Petitioner may propose a listing for general use in food, drugs, or cosmetics or, if such general listing is not believed suitable and safe, the petitioner shall describe the conditions under which he believes the additive can be safely used and for which it will be suitable. These conditions may include tolerance limitations, specifications as to the manner in which the additive may be added or used, and directions and other labeling or packaging safeguards that should be applied. The level of use proposed should not be higher than reasonably required to accomplish the intended color effect.] Attached hereto, in triplicate (quadruplicate, if intended uses include uses in meat, meat food product, or poultry product), and constituting a part of this petition are the following: A. The name and all pertinent information concerning the color additive, including chemical identity and composition of the color additive, its physical, chemical, and biological properties, and specifications prescribing its component(s) and identifying and limiting the reaction byproducts and other impurities. The petition shall contain a description of the chemical and physical tests relied upon to identify the color additive and shall contain a full description of the methods used in, and the facilities and controls used for, the production of the color additive. These

35

§ 71.1

shall establish that it is a substance of reproducible composition. Alternative methods and controls and variations in methods and controls, within reasonable limits, that do not affect the characteristics of the substance or the reliability of the controls may be specified. The petition shall supply a list of all substances used in the synthesis, extraction, or other method of preparation of any straight color, regardless of whether they undergo chemical change in the process. Each substance should be identified by its common or usual name and its complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitive statement of composition. Reasonable alternatives for any listed substance may be specified. If the petitioner does not himself perform all the manufacturing, processing, and packing operations for a color additive, the petitioner shall identify each person who will perform a part of such operations and designate the part. The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the color additive, the expiration period that will be employed as well as any packaging and labeling precautions needed to preserve stability. B. The amount of the color additive proposed for use and the color effect intended to be achieved, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the color additive. If the color effect results or may reasonably be expected to result from use of the color additive in packaging material, the petitioner shall show how this may occur and what residues may reasonably be anticipated. Typewritten or other draft-labeling copy will be accepted for consideration of the petition provided final printed labeling identical in content to the draft copy is submitted as soon as available, and prior to the marketing of the color additive. The printed labeling shall conform in prominence and conspicuousness with the requirements of the act. If the color additive is one for which a tolerance limitation is required to assure its safety, the level of use proposed should be no higher than the amount reasonably required to accomplish the intended physical or other technical effect, even though the safety data may support a higher tolerance. If the safety data will not support the use of the amount of the color additive reasonably needed to accomplish the desired color effect, the requested tolerance will not be established. Petitioners are expected to propose the use of color additives in accordance with sound color chemistry. C.1. A description of practicable methods to determine the pure color and all intermediates, subsidiary colors, and other components of the color additive. 2. A description of practicable methods to determine the amount of the color additive in any raw, processed, and/or finished food, drug, or cosmetic in which use of the color additive is proposed. (The tests proposed shall be those that can be used for food, drug, or cosmetic control purposes and can be applied with consistent results by any properly equipped laboratory and trained personnel.) 3. A description of methods for identification and determination of any substance formed in or on such food, drug, or cosmetic because of the use of the color additive. (If it is the petitioner’s view that any such method would not be needed, under the terms of section 721(b)(5)(A)(iv), a statement shall be submitted in lieu of methods as to the basis for such view.) D. Full reports of investigation made with respect to the safety of the color additive. (A petition will be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether or not the color additive will be safe for its intended use. The reports ordinarily should include detailed data derived from appropriate animal and other biological experiments in which the methods used and the results obtained are clearly set forth. The petition shall not omit without explanation any data that would influence the evaluation of the safety of the color additive). E. Complete data which will allow the Commissioner to consider, among other things, the probable consumption of, and/or other relevant exposure from the additive and of any substance formed in or on food, drugs, or cosmetics because of such additive; and the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in the diet including, but not limited to food additives and pesticide chemicals for which tolerances or exemptions from tolerances have been established. F. Proposed tolerances and other limitations on the use of the color additive, if tolerances and limitations are required in order to insure its safety. A petitioner may include a proposed regulation. G. If exemption from batch certification is requested, the reasons why it is believed such certification is not necessary (including supporting data to establish the safety of the intended use). H. If submitting a petition to alter an existing regulation issued pursuant to section 721(b) of the act, full information on each proposed change that is to be made in the original regulation must be submitted. The petition may omit statements made in the original petition concerning which no change is proposed. A supplemental petition must be submitted for any change beyond the variations provided for in the original petition and the regulation issued on the basis of the original petition. I. The prescribed fee of $ ________ for admitting the color additive to listing is enclosed (unless there is an advance deposit adequate to cover the fee). Yours very truly, (Petitioner) By (Indicate authority)

36

§ 71.2

J. The petitioner is required to submit either a claim for categorical exclusion under Sec. 25.30 or 25.32 of this chapter or an environmental assessment under Sec. 25.40 of this chapter.

(d) The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will be retained but not filed. A petition shall be retained but shall not be filed if any of the data listed in the above form are lacking or are not set forth so as to be readily understood or if the prescribed fee has not been submitted. The petitioner will be notified in what respects his petition is incomplete. (e) The petition must be signed by the petitioner or by his attorney or authorized agent, who is a resident of the United States. (f) The data specified under the several lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by specific reference to the earlier petition. (g) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 721(b) of the act shall include with respect to each nonclinical study contained in the petition, either a statement that the study was conducted in compliance with the good laboratory practice regulations set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (h) [Reserved] (i) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner under section 721(b) of the act shall include statements regarding each such clinical investigation contained in the petition that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with Secs. 56.104 or 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter. (j)(1) If intended uses of the color additive include uses in meat, meat food product, or poultry product subject to regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward a copy of the petition or relevant portions thereof to the Food Safety and Inspection Service, USDA, for simultaneous review under the PPIA and FMIA. (2) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA or, if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified conditions or restrictions. [42 FR 15639, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 62 FR 40598, July 29, 1997; 65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6, 2001] EFFECTIVE DATE NOTE: At 65 FR 51762, Aug. 25, 2000, Sec. 71.1 was amended in paragraph (a) by revising the third sentence, in paragraph (c) in the petition by revising the introductory paragraph preceding paragraph A., and by adding paragraph (j). The revised and added text contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.

§ 71.2 Notice of filing of petition. (a) Except where the petition involves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. If accepted, the date of the notification letter sent to petitioner becomes the date of filing for the purposes of section 721(d)(1) of the act. If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified. The date of such notification becomes the date of filing. Where the petition involves a new drug, notification to the petitioner will be made in accordance with Sec. 70.10(b)(3) of this chapter. (b) The Commissioner will cause to be published in the Federal Register within 30 days from the date of filing of such petition a notice of the filing, the name of the petitioner, and a brief description of the proposal in general terms. A copy of the notice will be mailed to the petitioner when the original document is signed. [42 FR 15639, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]

37

§ 71.4

§ 71.4 Samples; additional information. The Commissioner may request samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, and any additional information needed to clarify a submitted method or other aspect of a petition at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the color additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the color additive present in products for which it is intended to be used or adequate for any study or investigation reasonably required with respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 721(d)(1) of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the information and/or sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice. § 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice. (a) Extension of time for studying petitions. If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition. (b) Substantive amendments. After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amounts to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical laboratory study contained in the petition, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. If clinical investigations involving human subjects are involved, additional information or data submitted in support of filed petitions shall include statements regarding each such clinical investigation from which the information or data are derived, that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with Sec. 56.104 or Sec. 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter. (c) Withdrawal of petitions without prejudice. (1) In some cases the Commissioner may notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling. (2) At any time before the order provided for in Sec. 71.20 has been forwarded to the FEDERAL REGISTER for publication the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew. [42 FR 15636, Mar. 22, 1977, as amended at 43 FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27, 1981; 50 FR 7491, Feb. 22, 1985]

§ 71.15 Confidentiality of data and information in color additive petitions. (a) The following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved: (1) All safety and functionality data and information submitted with or incorporated by reference in the petition. 38

§ 71.20

(2) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in Sec. 20.61 of this chapter. (3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of: (i) Names and any information that would identify the person using the product. (ii) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution. (4) A list of all ingredients contained in a color additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within the exemption established in Sec. 20.61 of this chapter, and a notation shall be made that any such ingredient list is incomplete. (5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in Sec. 20.61 of this chapter. (6) All records showing the Food and Drug Administration’s testing of or action on a particular lot of a certifiable color additive. (b) The following data and information in a color additive petition are not available for public disclosure unless they have been previously disclosed to the public as defined in Sec. 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in Sec. 20.61 of this chapter: (1) Manufacturing methods or processes, including quality control procedures. (2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure. (3) Quantitative or semiquantitative formulas. (c) All correspondence and written summaries of oral discussions relating to a color additive petition are available for public disclosure in accordance with the provisions of part 20 of this chapter when the color additive regulation is published in the Federal Register. (d) For purposes of this regulation, safety and functionality data include all studies and tests of a color additive on animals and humans and all studies and tests on a color additive for identity, stability, purity, potency, performance, and usefulness. § 71.18 Petition for exemption from certification. A manufacturer, packer, or distributor of a color additive or color additive mixture may petition for an exemption from certification pursuant to part 10 of this chapter. Any such petition shall show why such certification is not necessary for the protection of public health.

Subpart B—Administrative Action on Petitions § 71.20 Publication of regulation. The Commissioner will forward for publication in the FEDERAL REGISTER, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 721(d)(1) of the act): (a) A regulation listing in part 73 or 74 of this chapter the color additive on the appropriate list or lists as provided under section 721(b)(1). (1) Such a regulation may list the color additive for use generally in or on foods, drugs, or cosmetics or for use in coloring the human body, as the case may be, or may prescribe the conditions under which the color additive may be safely used (including, but not limited to, specifications as to the particular food, drug, or cosmetic or classes of food, drugs, or cosmetics in or on which such color additive may be used, or for the material intended for coloring the human body; the maximum quantity of any straight color or diluent that may be used or permitted to remain in or on such food, drug, or cosmetic or article intended for coloring the human body; the manner in which such color additive may be added to or used in or on such food, drug, or cosmetic or for coloring the human body; and any directions or other labeling or packing requirements for such color additives deemed necessary to assure the safety of such use). 39

§ 71.22

(2) Such regulations shall list the color additive only for the use or uses for which it has been found suitable and for which it may safely be employed. Alternatively, the Commissioner shall by order deny the petition, and notify the petitioner of such order and the reasons therefor. (3) The regulation shall list any use or uses in meat, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq .) or the Poultry Products Inspection (PPIA) (21 U.S.C. 451 et seq.) for which the color additive has been found suitable and for which it may safely be employed. (b) Whenever the Commissioner finds that batch certification is not necessary for the protection of the public health he will, by order, exempt the color additive from the certification procedure. In determining whether certification of a color additive is necessary, the Commissioner will consider the composition of the additive, its manufacturing process, possible impurities, its toxic potential, control and analytical procedures necessary to assure compliance with the listing specifications, and the variability of its composition. [42 FR 15639, Mar. 22, 1977, as amended at 65 FR 51762, Aug. 25, 2000]

§ 71.22 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued. The Commissioner shall refuse to issue a regulation listing a color additive, if in his judgment the data before him show that such proposed use would promote deception of the consumer or would result in misbranding or adulteration within the meaning of the act. Such a finding shall be by order published in the FEDERAL REGISTER subject to the filing of objections and a request for a hearing by adversely affected parties. The issuance of a regulation for a color additive authorizing its use generally in or on a food, drug, or cosmetic shall not be construed as authorization to use the color additive in a manner that may promote deception or conceal damage or inferiority. The use of a color additive to promote deception or conceal damage or inferiority shall be considered as the use of a color additive for which no regulation has issued pursuant to section 721(b) of the act, even though the regulation is effective for other uses. § 71.25 Condition for certification. (a) When the Commissioner cannot conclude from the information before him that there is a basis for exempting a color additive from the requirement of batch certification, he will so order by appropriate listing in part 74 of this chapter. The Commissioner’s order shall state in detail the specifications that shall be met by the color additive. (b) Each order shall state a period of time after which use of a color additive subject to batch certification but not from a batch certified by procedure prescribed in this section would result in adulteration of the product in which it is used. § 71.26 Revocation of exemption from certification. If information becomes available to the Commissioner that a color additive that has been granted exemption from certification should not, for the protection of the public health, be so exempted, such exemption will be canceled by a notice published in the Federal Register. § 71.27 Listing and exemption from certification on the Commissioner’s initiative. Where a petition for a regulation to list a color additive has not been received and the Commissioner has available facts which demonstrate that a color additive should be listed and/or that certification procedure is not necessary in order to protect the public health, he may list such color additive by appropriate regulation and listing in part 73 or 74 of this chapter. § 71.30 Procedure for filing objections to regulations. (a) Objections and hearings relating to color additive regulations under section 721 (b) and (c) of the act shall be governed by parts 10, 12, 13, 14, 15, 16, and 19 of this chapter. (b) The fees specified in Sec. 70.19 of this chapter shall be applicable. 40

Part 73

§ 71.37 Exemption of color additives for investigational use. (a) A shipment or other delivery of a color additive or of a food, drug, or cosmetic containing such a color additive for investigational use by experts qualified to determine safety shall be exempt from the requirements of section 402(c), 501(a), or 601(e) of the act, provided that the color additive or the food, drug, or cosmetic containing the color additive bears a label which states prominently, ``Caution—Contains new color additive—For investigational use only.’’ No animals used in such investigations, or their products, such as milk or eggs, shall be used for food purposes, unless the sponsor or the investigator has submitted to the Commissioner data demonstrating that such use will be consistent with the public health, and the Commissioner, proceeding as he would in a matter involving section 409(i) of the act, has notified the sponsor or investigator that the proposed disposition for food is authorized. Any person who contests a refusal to grant such authorization shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter. (b) The person who introduced such shipment or who delivers the color additive or a food, drug, or cosmetic containing such an additive into interstate commerce shall maintain adequate records showing the name and postoffice address of the expert to whom the color additive is shipped, date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment and delivery. Upon the request of a properly authorized employee of the Department, at reasonable times, he shall make such records available for inspection and copying.

PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Subpart A—Foods Sec. 73.1 73.30 73.35 73.40 73.50 73.75 73.85 73.90 73.95 73.100 73.140 73.160 73.165 73.169 73.170 73.185 73.200 73.250 73.260 73.275 73.295 73.300 73.315 73.340 73.345 73.355 73.450 73.500 73.575

Diluents in color additive mixtures for food use exempt from certification. Annatto extract. Astaxanthin. Dehydrated beets (beet powder). Ultramarine blue. Canthaxanthin. Caramel. ß-Apo-8’-carotenal. ß-Carotene. Cochineal extract; carmine. Toasted partially defatted cooked cottonseed flour. Ferrous gluconate. Ferrous lactate. Grape color extract. Grape skin extract (enocianina). Haematococcus algae meal. Synthetic iron oxide. Fruit juice. Vegetable juice. Dried algae meal. Tagetes (Aztec marigold) meal and extract. Carrot oil. Corn endosperm oil. Paprika. Paprika oleoresin. Phaffia yeast. Riboflavin. Saffron. Titanium dioxide. 41

§ 73.1

73.600 Turmeric. 73.615 Turmeric oleoresin. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. SOURCE: 42 FR 15643, Mar. 22, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001.

Subpart A—Foods § 73.1 Diluents in color additive mixtures for food use exempt from certification. The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use. (a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201(s) of the act. (2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations. (3) The following: Substances

Definitions and Specifications

Calcium disodium EDTA (calcium disodium ethyl-enediaminetetraacetate).

Contains calcium disodium ethylenediamine-tetraacetate dihydrate (CAS Reg. No. 6766-87-6) as set forth in the Food Chemicals Codex, 3d ed., p. 50, 1981.

Castor oil..............................................

As set forth in U.S.P. XVI.....................

Dioctylsodium sulfosuccinate...............

Disodium EDTA (disodium ethylenediamine-tetraacetate).

As set forth in sec. 172.810 of this chapter.

Contains disodium ethyl-enediaminetetraacetate dihydrate (CAS Reg. No. 6381-92-6) as set forth in the Food Chemicals Codex, 3d ed., p. 104, 1981.

Restrictions May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous calcium disodium ethylenediamine-tetraacetate). Not more than 500 p.p.m. in the finished food. Labeling of color additive mixtures containing castor oil shall bear adequate directions for use that will result in a food meeting this restriction. Not more than 9 p.p.m. in the finished food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous disodium ethyl-enediaminetetraacetate).

(b) Special use—(1) Diluents in color additive mixtures for marking food—(i) Inks for marking food supplements in tablet form, gum, and confectionery. Items listed in paragraph (a) of this section and the following:

42

§ 73.1

Definitions and Specifications

Substances Alcohol, SDA-3A................................... n-Butyl alcohol...................................... Cetyl alcohol......................................... Cyclohexane......................................... Ethyl cellulose Ethylene glycol monoethyl ether. Isobutyl alcohol..................................... Isopropyl alcohol................................... Polyoxyethylene sorbitan monooleate (polysorbate 80). Polyvinyl acetate................................... Polyvinylpyrrolidone.............................. Rosin and rosin derivatives.................. Shellac, purified....................................

As set forth in 26 CFR pt. 212. .............................................................. As set forth in N.F. XI. .............................................................. As set forth in sec. 172.868 of this chapter. .............................................................. .............................................................. .............................................................. As set forth in sec. 172.840 of this chapter. Molecular weight, minimum 2,000. As set forth in sec. 173.55 of this chapter. As set forth in sec. 172.615 of this chapter. Food grade...........................................

Restrictions

No residue. Do. Do. Do.

Do. Do. Do.

(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following: Substances Acetone................................................. Alcohol, SDA-3A................................... Benzoin................................................. Copal, Manila........................................ Ethyl acetate......................................... Ethyl cellulose....................................... Methylene chloride............................... Polyvinylpyrrolidone.............................. Rosin and rosin derivatives.................. Silicon dioxide....................................... Terpene resins, natural......................... Terpene resins, synthetic......................

Restrictions

Definitions and Specifications As set forth in N.F. XI. As set forth in 26 CFR pt. 212. As set forth in U.S.P. XVI. .............................................................. As set forth in N.F. XI. As set forth in sec. 172.868 of this chapter. .............................................................. As set forth in sec. 173.55 of this chapter. As set forth in sec. 172.615 of this chapter. As set forth in sec. 172.480 of this chapter. As set forth in sec. 172.615 of this chapter. Polymers of α-and β-pinene.

No residue Do.

Do.

Do.

Not more than 2 pct of the ink solids.

(2) Diluents in color additive mixtures for coloring shell eggs. Items listed in paragraph (a) of this section and the following, subject to the condition that there is no penetration of the color additive mixture or any of its components through the eggshell into the egg: Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service. Damar gum (resin). Diethylene glycol distearate. Dioctyl sodium sulfosuccinate. Ethyl cellulose (as identified in Sec. 172.868 of this chapter). Ethylene glycol distearate. Japan wax. Limed rosin. Naphtha. Pentaerythritol ester of fumaric acid-rosin adduct. Polyethylene glycol 6000 (as identified in Sec. 172.820 of this chapter). Polyvinyl alcohol. Rosin and rosin derivatives (as identified in Sec. 172.820 of this chapter).

43

§ 73.30

(3) Miscellaneous special uses. Items listed in paragraph (a) of this section and the following: Substances Polyvinylpyrrolidone..............................

Definitions and Specifications As set forth in sec. 173.55 of this chapter.

Restrictions In or as food-tablet coatings; limit, not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidone shall bear adequate directions for use that will result in a food meeting this restriction.

[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992]

§ 73.30 Annatto extract. (a) Identity. (1) The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., using any one or an appropriate combination of the food-grade extractants listed in paragraph (a)(1) (i) and (ii) of this section: (i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity. (ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene. (2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications: (1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million. (2) When solvents listed under paragraph (a)(1)(ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter. (c) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. Labels shall bear information showing that the color is derived from annatto seed. The requirements of Sec. 70.25(a) of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in paragraph (a)(1)(ii) of this section. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.35 Astaxanthin. (a) Identity. (1) The color additive astaxanthin is 3, 3’-dihydroxy-[beta], [beta]-carotene-4, 4’-dione. (2) Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Astaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Physical state, solid. 0.05 percent solution in chloroform, complete and clear. Absorption maximum wavelength 484-493 nanometers (in chloroform).

44

§ 73.50

Residue on ignition, not more than 0.1 percent. Total carotenoids other than astaxanthin, not more than 4 percent. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals, not more than 10 parts per million. Assay, minimum 96 percent.

(c) Uses and restrictions. Astaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of color additive in feed is such that the color additive shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by Sec. 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with Sec. 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin shall be declared in accordance with Secs. 101.22(k)(2) and 101.100(a)(2) of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [60 FR 18738, Apr. 13, 1995] § 73.40 Dehydrated beets (beet powder). (a) Identity. (1) The color additive dehydrated beets is a dark red powder prepared by dehydrating sound, mature, good quality, edible beets. (2) Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. The color additive shall conform to the following specifications: Volatile matter, not more than 4 percent. Acid insoluble ash, not more than 0.5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million.

(c) Uses and restrictions. Dehydrated beets may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.50 Ultramarine blue. (a) Identity. The color additive ultramarine blue is a blue pigment obtained by calcining a mixture of kaolin, sulfur, sodium carbonate, and carbon at temperatures above 700 °C. Sodium sulfate and silica may also be incorporated in the mixture in order to vary the shade. The pigment is a complex sodium aluminum sulfo-silicate having the approximate formula Na7Ai6Si6O24S3. 45

§ 73.75

(b) Specifications. Ultramarine blue shall conform to the following specifications: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million.

(c) Uses and restrictions. The color additive ultramarine blue may be safely used for coloring salt intended for animal feed subject to the restriction that the quantity of ultramarine blue does not exceed 0.5 percent by weight of the salt. (d) Labeling requirements. The color additive shall be labeled in accordance with the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.75 Canthaxanthin. (a) Identity. (1) The color additive canthaxanthin is ß-carotene-4,4’-dione. (2) Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Canthaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Physical state, solid. 1 percent solution in chloroform, complete and clear. Melting range (decomposition), 207 °C. to 212 °C. (corrected). Loss on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Total carotenoids other than trans-canthaxanthin, not more than 5 percent. Lead, not more than 10 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Assay, 96 to 101 percent.

(c) Use and restrictions. (1) The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions: (i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and (ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (2) Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of canthaxanthin incorporated in the feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect. (3) Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (i) Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture; (ii) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and (iii) The quantity of color additive in feed shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (2) For purposes of coloring fish, the labeling of the color additive and any premixes prepared therefrom shall bear expiration dates (established through generally accepted stability testing methods) for the sealed and open container, other information required by Sec. 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c)(3) of this section. 46

§ 73.85

(3) The presence of the color additive in finished fish feed prepared according to paragraph (c)(3) of this section shall be declared in accordance with Sec. 501.4 of this chapter. (4) The presence of the color additive in salmonid fish that have been fed feeds containing canthaxanthin shall be declared in accordance with Secs. 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, 1998]

§ 73.85 Caramel. (a) Identity. (1) The color additive caramel is the dark-brown liquid or solid material resulting from the carefully controlled heat treatment of the following food-grade carbohydrates: Dextrose. Invert sugar. Lactose. Malt sirup. Molasses. Starch hydrolysates and fractions thereof. Sucrose.

(2) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practice. (i) Acids: Acetic acid. Citric acid. Phosphoric acid. Sulfuric acid. Sulfurous acid.

(ii) Alkalis: Ammonium hydroxide. Calcium hydroxide U.S.P. Potassium hydroxide. Sodium hydroxide.

(iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite. (3) Polyglycerol esters of fatty acids, identified in Sec. 172.854 of this chapter, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect. (4) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Caramel shall conform to the following specifications: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 0.1 part per million.

(c) Uses and restrictions. Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. 47

§ 73.90

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.90 ß-Apo-8’-carotenal. (a) Identity. (1) The color additive is ß-apo-8’-carotenal. (2) Color additive mixtures for food use made with ß-apo-8’-carotenal may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. ß-Apo-8’-carotenal shall conform to the following specifications: Physical state, solid. 1 percent solution in chloroform, clear. Melting point (decomposition), 136 °C.-140 °C. (corrected). Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Assay (spectrophotometric), 96-101 percent.

(c) Uses and restrictions. The color additive ß-apo-8’-carotenal may be safely used for coloring foods generally, subject to the following restrictions: (1) The quantity of ß-apo-8’-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food. (2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.95 ß-Carotene. (a) Identity. (1) The color additive is ß-carotene prepared synthetically or obtained from natural sources. (2) Color additive mixtures for food use made with ß-carotene may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. ß-carotene shall conform to the following specifications: Physical state, solid. 1 percent solution in chloroform, clear. Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Assay (spectrophotometric), 96-101 percent.

(c) Uses and restrictions. The color additive ß-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color those foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

48

§ 73.140

§ 73.100 Cochineal extract; carmine. (a) Identity. (1) The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of cochineal (Dactylopius coccus costa (Coccus cacti L.)). The coloring principle is chiefly carminic acid. (2) The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal (Dactylopius coccus costa (Coccus cacti L.)). (3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. (1) Cochineal extract shall conform to the following specifications: pH, not less than 5.0 and not more than 5.5 at 25 °C. Protein (N x 6.25), not more than 2.2 percent. Total solids, not less than 5.7 and not more than 6.3 percent. Methyl alcohol, not more than 150 parts per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 1.8 percent.

(2) Carmine shall conform to the following specifications: Volatile matter (at 135 °C. for 3 hours), not more than 20.0 percent. Ash, not more than 12.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 50.0 percent.

Carmine and cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine and cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in section 201(s) of the act or, if they are food additives as so defined, are used in conformity with regulations established pursuant to section 409 of the act. (c) Uses and restrictions. Carmine and cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling requirements. The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.140 Toasted partially defatted cooked cottonseed flour. (a) Identity. (1) The color additive toasted partially defatted cooked cottonseed flour is a product prepared as follows: Food quality cottonseed is delinted and decorticated; the meats are screened, aspirated, and rolled; moisture is adjusted, the meats heated, and the oil expressed; the cooked meats are cooled, ground, and reheated to obtain a product varying in shade from light to dark brown. (2) Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Toasted partially defatted cooked cottonseed flour shall conform to the following specifications: Arsenic: It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As.

49

§ 73.160

Lead (as Pb), not more than 10 parts per million. Free gossypol content, not more than 450 parts per million.

(c) Uses and restrictions. The color additive toasted partially defatted cooked cottonseed flour may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.160 Ferrous gluconate. (a) Identity. The color additive ferrous gluconate is the ferrous gluconate defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. (b) Specifications. Ferrous gluconate shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section. (c) Uses and restrictions. Ferrous gluconate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives. (d) Labeling. The label of the color additive shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [42 FR 15643, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984]

§ 73.165 Ferrous lactate. (a) Identity. The color additive ferrous lactate is the ferrous lactate defined in Sec. 184.1311 of this chapter. (b) Specifications. Ferrous lactate shall meet the specifications given in the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) Uses and restrictions. Ferrous lactate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives. (d) Labeling. The label of the color additive shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act (the act). [61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001]

§ 73.169 Grape color extract. (a) Identity. (1) The color additive grape color extract is an aqueous solution of anthocyanin grape pigments made from Concord grapes or a dehydrated water soluble powder prepared from the aqueous solution. The aqueous solution is prepared by extracting the pigments from precipitated lees produced during the storage of Concord grape juice. It contains the common components of grape juice, namely anthocyanins, tartrates, malates, sugars, and minerals, etc., but not in the same proportion as found in grape juice. The dehydrated water soluble powder is prepared by spray drying the aqueous solution containing added malto-dextrin. 50

§ 73.185

(2) Color additive mixtures for food use made with grape color extract may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Grape color extract shall conform to the following specifications: Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. (c) Uses and restrictions. Grape color extract may be safely used for the coloring of nonbeverage food, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The color additive and any mixtures prepared there from intended solely or in part for coloring purposes shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches are exempt from the certification requirements of section 721(c) of the Act. [46 FR 47532, Sept. 29, 1981]

§ 73.170 Grape skin extract (enocianina). (a) Identity. (1) The color additive grape skin extract (enocianina) is a purplish-red liquid prepared by the aqueous extraction (steeping) of the fresh deseeded marc remaining after grapes have been pressed to produce grape juice or wine. It contains the common components of grape juice; namely, anthocyanins, tartaric acid, tannins, sugars, minerals, etc., but not in the same proportions as found in grape juice. During the steeping process, sulphur dioxide is added and most of the extracted sugars are fermented to alcohol. The extract is concentrated by vacuum evaporation, during which practically all of the alcohol is removed. A small amount of sulphur dioxide may be present. (2) Color additive mixtures for food use made with grape skin extract (enocianina) may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Grape skin extract (enocianina) shall conform to the following specifications: Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million.

(c) Uses and restrictions. Grape skin extract (enocianina) may be safely used for the coloring of still and carbonated drinks and ades, beverage bases, and alcoholic beverages subject to the following restrictions: (1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards. (2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. The common or usual name of the color additive is ``grape skin extract’’ followed, if desired, by ``(enocianina)’’. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.185 Haematococcus algae meal. (a) Identity. (1) The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis. (2) Haematococcus algae meal may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with haematococcus algae meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Haematococcus algae meal shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: 51

§ 73.200

Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 1.5 percent.

(c) Uses and restrictions. Haematococcus algae meal may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by Sec. 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with Sec. 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing haematococcus algae meal shall be declared in accordance with Secs. 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [65 FR 41584, July 6, 2000]

§ 73.200 Synthetic iron oxide. (a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances. (2) Color additive mixtures for food use made with synthetic iron oxide may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Synthetic iron oxide for human food use shall conform to the following specifications: Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg) , not more than 1 part per million.

(2) Synthetic iron oxide for dog and cat food use shall conform to the following specifications: Arsenic (as As), not more than 5 parts per million. Lead (as Pb), not more than 20 parts per million. Mercury (as Hg), not more than 3 parts per million.

(c) Uses and restrictions. (1) Synthetic iron oxide may be safely used for the coloring of sausage casings intended for human consumption in an amount not exceeding 0.10 percent by weight of the finished food. (2) Synthetic iron oxide may be safely used for the coloring of dog and cat foods in an amount not exceeding 0.25 percent by weight of the finished food. (d) Labeling requirements. The label of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994]

52

§ 73.275

§ 73.250 Fruit juice. (a) Identity. (1) The color additive fruit juice is prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. The color additive may be concentrated or dried. The definition of fruit juice in this paragraph is for the purpose of identity as a color additive only and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular fruit juice has been promulgated under section 401 of the act, it shall conform to such standard. (2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995]

§ 73.260 Vegetable juice. (a) Identity. (1) The color additive vegetable juice is prepared either by expressing the juice from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable. The color additive may be concentrated or dried. The definition of vegetable juice in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular vegetable juice has been promulgated under section 401 of the act, it shall conform to such standard. (2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995]

§ 73.275 Dried algae meal. (a) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, separated from its culture broth), molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. The algae cells are produced by suitable fermentation, under controlled conditions, from a pure culture of the genus Spongiococcum. (b) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in accordance with the following prescribed conditions: (1) The color additive is used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (b)(1) of this section; and (ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in Sec. 573.380 of this chapter. (c) Labeling. The label of the color additives and any premixes prepared therefrom shall bear in addition to the information required by Sec. 70.25 of this chapter. 53

§ 73.295

(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein. (2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (b) of this section. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.295 Tagetes (Aztec marigold) meal and extract. (a) Identity. (1) The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold (Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin. (2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold (Tagetes erecta L.). It is mixed with an edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible vegetable oil, and not more than 0.3 percent ethoxyquin. It may also be mixed with soy flour or corn meal as a carrier. (b) Specifications. (1) Tagetes (Aztec marigold) meal is free from admixture with other plant material from Tageteserecta L. or from plant material or flowers of any other species of plants. (2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications: Melting point............................. Iodine value.............................. Saponification value...................... Acid value................................ Titer..................................... Unsaponifiable matter..................... Hexane residue............................

53.5-55.0 °C. 132-145. 175-200. 0.60-1.20. 35.5 °-37.0 °C. 23.0 percent-27.0 percent. Not more than 25 p.p.m.

All determinations, except the hexane residue, shall be made on the initial extract of the flower petals (after drying in a vacuum oven at 60 °C. for 24 hours) prior to the addition of the oils and ethoxyquin. The hexane determination shall be made on the color additive after the addition of the vegetable oils, hydrogenated vegetable oils, and ethoxyquin. (c) Uses and restrictions. The color additives tagetes (Aztec marigold) meal and extract may be safely used in chicken feed in accordance with the following prescribed conditions: (1) The color additives are used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additives incorporated in the feed is such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section; and (ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in Sec. 573.380 of this chapter. (d) Labeling requirements. The label of the color additives and any premixes prepared therefrom shall bear, in addition to the information required by Sec. 70.25 of this chapter: (1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein. (2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (c) of this section. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.300 Carrot oil. (a) Identity. (1) The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots (Daucus carota L.) with subsequent removal of the hexane by vacuum distillation. The resultant mixture of solid and liquid extractives consists chiefly of oils, fats, waxes, and carrotenoids naturally occurring in carrots. The definition of carrot oil in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for carrot oil or carrot oleoresin under section 401 of the act. (2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this subpart 54

§ 73.340

as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Carrot oil shall contain no more than 25 parts per million of hexane. (c) Uses and restrictions. Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless the use of added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.315 Corn endosperm oil. (a) Identity. (1) The color additive corn endosperm oil is a reddish-brown liquid composed chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments obtained by isopropyl alcohol and hexane extraction from the gluten fraction of yellow corn grain. The definition of corn endosperm oil in this paragraph is for the purpose of definition as a color additive only and shall not be construed as a food standard of identity under section 401 of the act. (2) Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Corn endosperm oil conforms to the following specifications: Total fatty acids, not less than 85 percent. Iodine value, 118 to 134. Saponification value, 165 to 185. Unsaponifiable matter, not more than 14 percent. Hexane, not more than 25 narts per millimn. Isopropyl alcohol, not more than 100 parts per million.

(c) Uses and restrictions. The color additive corn endosperm oil may be safely used in chicken feed in accordance with the following prescribed conditions: (1) The color additive is used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section. (d) Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required by Sec. 70.25 of this chapter, a statement of the concentration of xanthophyll contained therein. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.340 Paprika. (a) Identity. (1) The color additive paprika is the ground dried pod of mild capsicum (Capsicum annuum L.). The definition of paprika in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for paprika under section 401 of the act. (2) Color additive mixtures made with paprika may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Paprika may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. 55

§ 73.345

§ 73.345 Paprika oleoresin. (a) Identity. (1) The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika (Capsicum annuum L.) by extraction, using any one or a combination of the following solvents: Acetone Ethyl alcohol Ethylene dichloride Hexane Isopropyl alcohol Methyl alcohol Methylene chloride Trichloroethylene

The definition of paprika oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for paprika oleoresin under section 401 of the act. (2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Paprika oleoresin shall contain no more residue of the solvents listed in paragraph (a)(1) of this section than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter. (c) Uses and restrictions. Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.355 Phaffia yeast. (a) Identity. (1) The color additive phaffia yeast consists of the killed, dried cells of a nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma. (2) Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Phaffia yeast shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 0.4 percent.

(c) Uses and restrictions. Phaffia yeast may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear 56

§ 73.575

expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by Sec. 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with Sec. 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing phaffia yeast shall be declared in accordance with Secs. 101.22(b), (c), and (k)(2) and 101.100(a)(2) of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [65 FR 41587, July 6, 2000]

§ 73.450 Riboflavin. (a) Identity. (1) The color additive riboflavin is the riboflavin defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 262-263, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. (2) Color additive mixtures made with riboflavin may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. Riboflavin shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a)(1) of this section. (c) Uses and restrictions. Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice; except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The label of the color additive shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Act. § 73.500 Saffron. (a) Identity. (1) The color additive saffron is the dried stigma of Crocus sativus L. The definition of saffron in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for saffron under section 401 of the act. (2) Color additive mixtures made with saffron may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Saffron may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.575 Titanium dioxide. (a) Identity. (1) The color additive titanium dioxide is synthetically prepared TiO2 free from admixture with other substances. (2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO2 and/or aluminum oxide, Al2O3 as dispersing aids—not more than 2 percent total. 57

§ 73.600

(b) Specifications. Titanium dioxide shall conform to the following specifications: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Antimony (as Sb), not more than 2 parts per million. Mercury (as Hg), not more than 1 part per million. Loss on ignition at 800 °C. (after drying for 3 hours at 105 °C.), not more than 0.5 percent. Water soluble substances, not more than 0.3 percent. Acid soluble substances, not more than 0.5 percent. TiO2 not less than 99.0 percent after drying for 3 hours at 105 °C.

Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5N hydrochloric acid. (c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions: (1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food. (2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.600 Turmeric. (a) Identity. (1) The color additive turmeric is the ground rhizome of Curcuma longa L. The definition of turmeric in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric under section 401 of the act. (2) Color additive mixtures made with turmeric may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Turmeric may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. Sec. 73.615 Turmeric oleoresin. (a) Identity. (1) The color additive turmeric oleoresin is the combination of flavor and color principles obtained from turmeric (Curcuma longa L.) by extraction using any one or a combination of the following solvents: Acetone Ethyl alcohol Ethylene dichloride Hexane Isopropyl alcohol Methyl alcohol Methylene chloride Trichloroethylene

The definition of turmeric oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric oleoresin under section 401 of the act. 58

§ 74.101

(2) Color additive mixtures made with turmeric oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Turmeric oleoresin shall contain no more residue of the solvents listed under paragraph (a)(1) of this section than is permitted for the corresponding solvents in spice oleoresins under applicable food additive regulation in parts 170 through 189 of this chapter. (c) Uses and restrictions. Turmeric oleoresin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of Sec. 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION Subpart A—Foods Sec. 74.101 74.102 74.203 74.250 74.302 74.303 74.340 74.705 74.706

FD&C Blue No. 1. FD&C Blue No. 2. FD&C Green No. 3. Orange B. Citrus Red No. 2. FD&C Red No. 3. FD&C Red No. 40. FD&C Yellow No. 5. FD&C Yellow No. 6.

APPENDIX A TO PART 74—THE PROCEDURE FOR DETERMINING ETHER SOLUBLE MATERIAL IN D&C RED NOS. 6 AND 7. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. SOURCE: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.

Subpart A—Foods § 74.101 FD&C Blue No. 1. (a) Identity. (1) The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl [4-[p-[ethyl (msulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene]-2,5 -cyclohexadien-1-ylidene] (m-sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]α-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o-sulfobenzyl) amino] - α - (o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (osulfobenzyl) ammonium hydroxide inner salt. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. FD&C Blue No. 1 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:

59

§ 74.102

Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent. N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent. Subsidiary colors, not more than 6.0 percent. Chromium (as Cr), not more than 50 parts per million. Manganese (as Mn), not more than 100 parts per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Total color, not less than 85.0 percent.

(c) Uses and restrictions. FD&C Blue No. 1 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993]

§ 74.102 FD&C Blue No. 2. (a) Identity. (1) The color additive FD&C Blue No. 2 is principally the disodium salt of 2-(1,3-dihydro-3-oxo-5sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 860-22-0) with smaller amounts of the disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5sulfonic acid (CAS Reg. No. 54947-75-0) and the sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 605-18-5). Additionally, FD&C Blue No. 2 is obtained by heating indigo (or indigo paste) in the presence of sulfuric acid. The color additive is isolated and subjected to purification procedures. The indigo (or indigo paste) used above is manufactured by the fusion of N-phenylglycine (prepared from aniline and formaldehyde) in a molten mixture of sodamide and sodium and potassium hydroxides under ammonia pressure. The indigo is isolated and subjected to purification procedures prior to sulfonation. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. The color additive FD&C Blue No. 2 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water insoluble matter, not more than 0.4 percent. Isatin-5-sulfonic acid, not more than 0.4 percent. 5-Sulfoanthranilic acid, not more than 0.2 percent. Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than 18 percent. Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than 2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent.

(c) Uses and restrictions. The color additive FD&C Blue No. 2 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards. 60

§ 74.203

(d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 2 shall be certified in accordance with regulations in part 80 of this chapter. [48 FR 5260, Feb. 4, 1983]

§ 74.203 FD&C Green No. 3. (a) Identity. (1) The color additive FD&C Green No. 3 is principally the inner salt disodium salt of N-ethyl-N-[4[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1ylidene]-3-sulfobenzenemethanaminium hydroxide (CAS Reg. No. 2353-45-9); with smaller amounts of the isomeric inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl] amino]phenyl](4-hydroxy-2sulfophenyl)methylene]-2,5 -cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium hydroxide; of N-ethyl-N-[4[[4-[ethyl[(4-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1ylidene]-4-sulfobenzenemethanaminium hydroxide and of N-ethyl-N-[4-[[4-[ethyl[(2-sulfophenyl) methyl] amino] phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide. Additionally, FD&C Green No. 3 is manufactured by the acid catalyzed condensation of one molecule of 2-formyl-5-hydroxybenzenesulfonic acid with two molecules from a mixture consisting principally of 3[(ethylphenylamino)methyl] benzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid or with dichromate and acid to form the dye. The intermediate 2-formyl5-hydroxybenzenesulfonic acid is prepared by the potassium permanganate oxidation of 2,2’-(1,2-ethenediyl)-bis(5aminobenzenesulfonic acid) to sodium 5-amino-2-formylbenzenesulfonate. This amine is diazotized and the resulting diazonium salt is hydrolyzed to the desired 2-formyl-5-hydroxybenzenesulfonic acid. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring food. (b) Specifications. The color additive FD&C Green No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than 0.5 percent. Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic acid, disodium salts, not more than 0.3 percent. 2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 percent. Subsidiary colors, not more than 6 percent. Chromium (as Cr), not more than 50 parts per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent.

(c) Uses and restrictions. The color additive FD&C Green No. 3 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of FD&C Green No. 3 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982]

61

§ 74.250

§ 74.250 Orange B. (a) Identity. (1) The color additive Orange B is principally the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy4-(4-sulfonaphthylazo)-5-hydro-xypyrazole. (2) The diluents in color additive mixtures for food use containing Orange B are limited to those listed in part 73 of this chapter as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Orange B shall conform to the following specifications: Volatile matter (at 135 °C.), not more than 6.0 percent. Chlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent. Water insoluble matter, not more than 0.2 percent. 1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent. Naphthionic acid, not more than 0.2 percent. Phenylhydrazine-p-sulfonic acid, not more than 0.2 percent. The trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent. Other subsidiary dyes, not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 87.0 percent.

(c) Uses and restrictions. Orange B may be safely used for coloring the casings or surfaces of frankfurters and sausages subject to the restriction that the quantity of the color additive does not exceed 150 parts per million by weight of the finished food. (d) Labeling requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of Orange B shall be certified in accordance with regulations promulgated under part 80 of this chapter. § 74.302 Citrus Red No. 2. (a) Identity. (1) The color additive Citrus Red No. 2 is principally 1-(2,5-dimethoxyphenylazo)-2-naphthol. (2) The following diluents may be used in aqueous suspension, in the percentages specified, to facilitate application to oranges in accordance with paragraph (c)(1) of this section: (i) Suitable diluents used in accordance with Sec. 73.1(a) of this chapter. (ii) Volatile solvents that leave no residue after application to the orange. (iii) Salts of fatty acids meeting the requirements of Sec. 172.863 of this chapter. (iv) Sodium tripolyphosphate, not more than 0.05 percent. (b) Specifications. Citrus Red No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 100 °C.), not more than 0.5 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 0.5 percent. Uncombined intermediates, not more than 0.05 percent. Subsidiary dyes, not more than 2.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 98 percent.

(c) Uses and restrictions. (1) Citrus Red No. 2 shall be used only for coloring the skins of oranges that are not intended or used for processing (or if so used are designated in the trade as Packinghouse elimination) and that meet minimum maturity standards established by or under the laws of the States in which the oranges are grown. (2) Oranges colored with Citrus Red No. 2 shall bear not more than 2.0 parts per million of such color additive, calculated on the basis of the weight of the whole fruit. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for 62

§ 74.340

coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. To meet the requirements of Sec. 70.25 (b) and (c) of this chapter the label shall bear: (1) The statement (or its equivalent) ``To be used only for coloring skins of oranges.’’ (2) Directions for use to limit the amount of the color additive to ot more than 2.0 parts per million, calculated on the basis of the weight of the whole fruit. (e) Certification. All batches of Citrus Red No. 2 shall be certified in accordance with regulations in part 80 of this chapter. § 74.303 FD&C Red No. 3. (a) Identity. (1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 (o- carboxyphenyl)-6hydroxy - 2,4,5,7-tetraiodo-3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated fluoresceins. (2) Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. FD&C Red No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 135 °C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. Unhalogenated intermediates, total not more than 0.1 percent. Sodium iodide, not more than 0.4 percent. Triiodoresorcinol, not more than 0.2 percent. 2(2’,4’-Dihydroxy-3’, 5’-diiodobenzoyl) benzoic acid, not more than 0.2 percent. Monoiodofluoresceins not more than 1.0 percent. Other lower iodinated fluoresceins, not more than 9.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 87.0 percent.

(c) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring foods generally (including dietary supplements) in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter. § 74.340 FD&C Red No. 40. (a) Identity. (1) The color additive FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (3) The listing of this color additive includes lakes prepared as described in Sec. 82.51 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by Sec. 82.51 of this chapter. (b) Specifications. FD&C Red No. 40 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent. Water-insoluble matter, not more than 0.2 percent. Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.

63

§ 74.705

Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent. Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -8-(2-methoxy-5-methyl-4-sulfophenoxy)-2naphthalenesulfonic acid, not more than 1.0 percent. Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer’s salt), not more than 0.3 percent. 4-Amino-5-methoxy-o- toluenesulfonic acid, not more than 0.2 percent. Disodium salt of 6,6’-oxybis (2-naphthalene-sulfonic acid), not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 85.0 percent.

(c) Uses and restrictions. FD&C Red No. 40 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of Sec. 70.25 of this chapter. (e) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations in part 80 of this chapter. § 74.705 FD&C Yellow No. 5. (a) Identity. (1) The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4sulfophenyl)-4-[4-sulfophenyl-azo]-1H-pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-amino-benzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (2) Color additive mixtures for food use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4’-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4’,5-Disulfo[1,1’-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5oxo-4-(phenylazo)-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4’-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent.

(c) Uses and restrictions. FD&C Yellow No. 5 may be safely used for coloring foods (including dietary 64

§ 74.706

supplements) generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of Sec. 70.25 of this chapter. (2) Foods for human use that contain FD&C Yellow No. 5, including butter, cheese, and ice cream, shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5 among the list of ingredients. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at 44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986] § 74.706 FD&C Yellow No. 6. (a) Identity. (1) The color additive FD&C Yellow No. 6 is principally the disodium salt of 6-hydroxy-5-[(4sulfophenyl)azo]-2-naphthalenesulfonic acid (CAS Reg. No. 2783-94-0). The trisodium salt of sulfophenyl)azo]-2,7naphthalenedisulfonic acid (CAS Reg. No. 50880-65-4) may be added in small amounts. The color additive is manufactured by diazotizing 4-aminobenzenesulfonic acid using hydrochloric acid and sodium nitrite or sulfuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulfonic acid. The dye is isolated as the sodium salt and dried. The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid which may be blended with the principal color is prepared in the same manner except the diazo benzenesulfonic acid is coupled with 3-hydroxy-2,7-naphthalenedisulfonic acid. (2) Color additive mixtures for food use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. The color additive FD&C Yellow No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water insoluble matter, not more than 0.2 percent. Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent. Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 percent. Disodium salt of 6,6’-oxybis[2-naphthalenesulfonic acid], not more than 1 percent. Disodium salt of 4,4’-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not more than 0.1 percent. Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic acid and the sodium salt of 4-[(2-hydroxy-1naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent. Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not more than 5 percent. 4-Aminoazobenzene, not more than 50 parts per billion. 4-Aminobiphenyl, not more than 15 parts per billion. Aniline, not more than 250 parts per billion. Azobenzene, not more than 200 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. 1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent.

(c) Uses and restrictions. The color additive FD&C Yellow No. 6 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. 65

Part 80

(d) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of Sec. 70.25 of this chapter. (2) [Reserved] (e) Certification. All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988]

PART 80—COLOR ADDITIVE CERTIFICATION Subpart A—General Provisions Sec. 80.10 80.21

Fees for certification services. Request for certification.

Subpart B—Certification Procedures 80.22 80.31 80.32 80.34 80.35 80.37 80.38 80.39

Samples to accompany requests for certification. Certification. Limitations of certificates. Authority to refuse certification service. Color additive mixtures; certification and exemption from certification. Treatment of batch pending certification. Treatment of batch after certification. Records of distribution.

AUTHORITY: 21 U.S.C. 371, 379e. SOURCE: 42 FR 15662, Mar. 22, 1977, unless otherwise noted.

Subpart A—General Provisions § 80.10 Fees for certification services. (a) Fees for straight colors including lakes. The fee for the services provided by the regulations in this part in the case of each request for certification submitted in accordance with Sec. 80.21(j)(1) and (j)(2) shall be 30 cents per pound of the batch covered by such requests, but no such fee shall be less than $192. (b) Fees for repacks of certified color additives and color additive mixtures. The fees for the services provided under the regulations in this part in the case of each request for certification submitted in accordance with Sec. 80.21(j)(3) and (j)(4) shall be: (1) 100 pounds or less—$30. (2) Over 100 pounds but not over 1,000 pounds—$30 plus 6 cents for each pound over 100 pounds. (3) Over 1,000 pounds—$84 plus 2 cents for each pound over 1,000 pounds. (c) Advance deposits. Any person regularly requesting certification services may deposit funds in advance of requests as prepayment of fees required by this section. (d) Method of payment. All deposits and fees required by this section shall be paid by money order, bank draft, or certified check, drawn to the order of the Food and Drug Administration, collectable at par at Washington, DC. All such deposits and fees shall be forwarded to the Center for Food Safety and Applied Nutrition (HFS-100), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, whereupon after making appropriate records thereof, they will be transmitted to the Treasurer of the United States for deposit to the special account ``Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.’’ (e) Refunds from advance deposits. Whenever in the judgment of the Commissioner the ratio between fees collected 66

§ 80.21

(which are based upon experience and the best estimate of costs and the best estimate of earnings) and the costs of providing the service during an elapsed period of time, in the light of all circumstances and contingencies, warrants a refund from the fund collected during such period, he shall make ratable refunds to those persons to whom the services were rendered and charged, except that no refund shall be made where the computed ratable amount for the elapsed period is less than $5.00. [42 FR 15662, Mar. 22, 1977, as amended at 47 FR 24692, June 8, 1982; 54 FR 24890, June 12, 1989; 59 FR 60899, Nov. 29, 1994; 61 FR 3572, Feb. 1, 1996; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

§ 80.21 Request for certification. A request for certification of a batch of color additive shall: (a) Be addressed to the Commissioner of Food and Drugs. (b) Be prepared in the manner set forth in paragraph (j) of this section. (c) Be submitted in duplicate. (d) Be signed by a responsible officer of the person requesting certification of the batch. In the case of a foreign manufacturer, the request for certification must be signed by a responsible officer of such firm, and, by his agent who resides in the United States. (e) Show the name and post office address of the actual manufacturer in case such manufacturer is not the person requesting certification of the batch. (f) Be accompanied by the fee prescribed in Sec. 80.10 unless the person has established with the Food and Drug Administration an advanced deposit to be used for prepayment of such fees. In no case shall the Commissioner consider a request for certification of a batch of color additive if the fee accompanying such request is less than that required by Sec. 80.10 or if such fee exceeds the amount held in the advance deposit account of the manufacturer submitting such request for certification. (g) Be accompanied by the sample prescribed in Sec. 80.22 consisting of: (1) Four ounces in the case of straight colors and lakes. (2) Two ounces in the case of repacks and mixtures. A sample accompanying a request for certification must be submitted under separate cover and should be addressed to the Color Certification Branch. (h) The name of a color additive shall be given in the following manner: (1) The name of a straight color shall be the name of the color as listed in parts 74 and 81 of this chapter. (2) The name of a lake shall be the name derived in the manner described in part 82 of this chapter. (3) The name of a mixture shall be the name given to such mixture by the person requesting certification. (4) The name of a repack shall be the name described in paragraph (h)(1), (2), or (3) of this section, whichever is applicable. (i) The information and samples enumerated in paragraphs (a) to (h), inclusive, of this section are the minimum required. Additional information and samples shall be submitted at the request of the Food and Drug Administration when such additional information and samples are necessary to determine compliance with the requirements of Sec. 80.31 for the issuance of a certificate. (j) The form for submission of the application shall be one of the following, depending upon whether the color additive is a straight color, a lake, a repack of a previously certified color additive, or a color additive mixture. (1) Request for certification of a batch of straight color additive. Date ___________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of straight color additive. Name of color___________________________________________________________(As listed in 21 CFR part 74)

67

§ 80.21

Batch number___________________________________________________________(Manufacturer’s number) Batch weighs _______ pounds Batch manufactured by __________ at _________________ (Name and address of actual manufacturer) How stored pending certification_____________________________________________ ________________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in___________________________________ ________________________________________________________________________ ________________________________________________________________________ (State proposed uses) Required fee, $______ (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) ________________________ By ____________________________ _______________________________ (Title)

(2) Request for certification of a batch of color additive lake. Date ___________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive lake. Name of color____________________________________________________________ Batch number____________________________________________________________ (Manufacturer’s number) Batch weighs _____ pounds Name of color used_______________________________________________________ _______________________________________________________________________ Quantity _____ pounds Lot number_____________________________________________________________ (When certification of the lake for use in foods is requested) Precipitant used__________________________________________________________ Substratum used__________________________________________________________ Quantity _____ pounds Batch manufactured by _________ at _______________________(Name and address of actual manufacturer) How stored pending certification_____________________________________________ ________________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in___________________________________ ________________________________________________________________________ ________________________________________________________________________ (State proposed uses) Required fee, $______ (drawn to the order of Food and Drug Administration).

68

§ 80.21

The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) ________________________ By ____________________________ _______________________________ (Title)

(3) Request for certification of a repack of a batch of certified color additive. Date ___________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive repack. Name of color___________________________________________________________ (As listed in regulations and as certified; or repacker’s name, if a mixture) Original lot number_______________________________________________________ Certified color content_____________________________________________________ This color obtained from___________________________________________________ Batch number____________________________________________________________ Batch weighs ______ pounds How stored pending certification_____________________________________________ ________________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested for use in_____________________________________________ ________________________________________________________________________ ________________________________________________________________________ (State proposed uses) Required fee, $______ (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) ________________________ By ____________________________ _______________________________ (Title)

(4) Request for certification of a batch of color additive mixture. Date ___________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive mixture. Name of mixture_________________________________________________________ (Manufacturer’s trade name) Batch number____________________________________________________________ (Manufacturer’s number)

69

§ 80.22

Weight of batch _____ pounds Volume of batch______ (If liquid) gallons Batch manufactured by____________________________________________________ Constituents of the mixture: 1. Color(s). (List separately each color and each lot number.) Name of color as certified Lot number ________________________________________________________________________ ________________________________________________________________________ Quantity used (in pounds) Obtained from ________________________________________________________________________ ________________________________________________________________________ 2. List of diluents. (List separately each diluent.) Name of diluent ________________________________________________________________________ ________________________________________________________________________ Quantity used By volume By weight (if liquid) ________________________________________________________________________ ________________________________________________________________________ Batch mixed as follows_____________________________________________________ (Describe in detail) How stored pending certification_____________________________________________ ________________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested for use in_____________________________________________ ________________________________________________________________________ ________________________________________________________________________ (State proposed uses) Required fee, $______ (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) ________________________ By ____________________________ _______________________________ (Title) [42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979; 44 FR 22053, Apr. 13, 1979, as amended at 54 FR 24890, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

Subpart B—Certification Procedures § 80.22 Samples to accompany requests for certification. A sample of a batch of color additive which is to accompany a request for certification shall: (a) Be taken only after such batch has been so thoroughly mixed as to be of uniform composition throughout. (b) Held under the control of the person requesting certification until certified. (c) Be labeled to show: (1) The name of the color additive. 70

§ 80.32

(2) The manufacturer’s batch number. (3) The quantity of such batch. (4) The name and post-office address of the person requesting certification of such batch. (5) Be accompanied by any label or labeling intended to be used. § 80.31 Certification. (a) If the Commissioner determines, after such investigations as he considers to be necessary, that: (1) A request submitted in accordance with Sec. 80.21 appears to contain no untrue statement of a material fact; (2) Such color additive conforms to the specifications and any other conditions set forth therefor in parts 81 and 82 of this chapter. (3) The batch covered by such request otherwise appears to comply with the regulations in this chapter, the Commissioner shall issue to the person who submitted such request a certificate showing the lot number assigned to such batch and that such batch, subject to the terms, conditions, and restrictions prescribed by part 74, 81, and 82 of this chapter, is a certified batch. (b) If the Commissioner determines, after such investigation as he considers to be necessary, that a request submitted in accordance with Sec. 80.21, or the batch of color additive covered by such request, does not comply with the requirements prescribed by paragraph (a) of this section for the issuance of a certificate, the Commissioner shall refuse to certify such batch and shall give notice thereof to the person who submitted such request, stating his reasons for refusal. Any person who contests such refusal shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter. § 80.32 Limitations of certificates. (a) If a certificate is obtained through fraud or misrepresentation of a material fact, such certificate shall not be effective, and a color additive from the batch on which such certificate was issued shall be considered to be from a batch that has not been certified in accordance with the regulations in this part. Whenever, the Commissioner learns that any certificate has been obtained through fraud or material misrepresentation, he shall notify the holder of the certificate that it is of no effect. (b) If between the time a sample of color additive accompanying a request for certification is taken and the time a certificate covering the batch of such color additive is received by the person to whom it is issued, any such color additive becomes changed in composition, such certificates shall not be effective with respect to such changed color additive and such changed color additive shall be considered to be from a batch that has not been certified in accordance with the regulations in this part. (c) If at any time after a certificate is received by the person to whom it is issued any color additive from the batch covered by such certificate becomes changed in composition, such certificate shall expire with respect to such changed color additive. After such expiration, such color additive shall be considered to be from a batch that has not been certified in accordance with this part; except that such color additive shall not be so considered when used for coloring a food, drug, or cosmetic, or for the purpose of certifying a batch of a mixture in which such color additive was used as an ingredient, or for use in preparing a batch of a mixture for which exemption from certification has been authorized, if such change resulted solely from such use. (d) A certificate shall expire with respect to any color additive covered thereby if the package in which such color additive was closed for shipment or delivery is opened. After such expiration such color additive shall be considered to be from a batch that has not been certified, except that such color additive shall not be so considered when the package is opened; (1) and such color additive is used, subject to the restrictions prescribed by paragraphs (f), (g), and (h) of this section, in coloring a food, drug, or cosmetic; (2) for the purpose of certifying a batch made by repacking such color; (3) for the purpose of certifying a batch of a mixture in which such color is used as an ingredient; or (4) for the purpose of preparing a batch of a mixture for which exemption from certification has been authorized; or (5) when the package is reopened solely for repackaging by the person to whom such certificate was issued. (e) A certificate shall not be effective with respect to a package of color additive and such color additive shall be considered to be from a batch that has not been certified if such package is shipped or delivered under a label which does not bear all words, statements, and other information required by Sec. 70.25 of this chapter to appear thereon. 71

§ 80.34

(f) A certificate shall not be effective with respect to a package of color additive, and such color additive shall be considered to be from a batch that has not been certified if: (1) Such package has not been sealed in accordance with Sec. 70.20 of this chapter. (2) Such package has been sealed in accordance with Sec. 70.20 of this chapter and the seal has been broken, intentionally or accidentally, unless such seal has been broken for the purpose of using color additive in accordance with Sec. 80.38, or, such package has been opened by a duly authorized representative of the Administration or Department in the performance of his official duties, and he has immediately resealed the package in conformance with Sec. 70.20 of this chapter. (g) A certificate shall not be effective with respect to a package of color additive and such color additive shall be considered to be from a batch that has not been certified if such color additive is used in any manner other than that for which it was certified. (h) When the listing or the specifications for a color additive are revoked or amended, the final order effecting the revocation or amendment may specify, in addition to its own effective date, a date on which all certificates for existing batches and portions of batches of such a color additive theretofore issued under such revoked or amended regulations shall cease to be effective; and any such lots of the color additive shall be regarded as uncertified after the date specified unless a new certificate can be and is obtained in conformance with the new regulations. When a certificate thus ceases to be effective for a color additive, any certificates previously issued for a color additive mixture containing that color additive shall cease to be effective on the same date. Use of such color additive or color additive mixture after such specified date without the new certificate in preparing foods, drugs, or cosmetics will result in such food, drugs, or cosmetics being adulterated. When a certified color additive has been used in food, drugs, or cosmetics and the status of the color additive is thereafter changed by amendment or revocation of its listing or specification regulations, such food, drugs, and cosmetics will not be regarded as adulterated by reason of the use of such color additive, unless the hazard to health is such that existing stocks of the foods, drugs, or cosmetics cannot be safely used, in which cases findings to that effect will be made and regulations appropriate for such special cases will be issued. § 80.34 Authority to refuse certification service. (a) When it appears to the Commissioner that a person has: (1) Obtained, or attempted to obtain, a certificate through fraud or misrepresentation of a material fact. (2) Falsified the records required to be kept by Sec. 80.39; or (3) Failed to keep such records, or to make them available, or to accord full opportunity to make inventory of stocks on hand or otherwise to check the correctness of such records, as required by Sec. 80.39; or (4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived; he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken. (b) Any person who contests suspension of service shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter. § 80.35 Color additive mixtures; certification and exemption from certification. (a) Color additive mixtures to be certified. Any color additive mixture that contains one or more straight colors listed in part 74 of this chapter, together with any diluents listed in such subparts for use with such straight colors, shall be certified if intended for use in foods, drugs, or cosmetics, or in coloring the human body, as the case may be, subject to any restriction prescribed in parts 70 and 71 of this chapter. (b) Color additive mixtures exempted from certification. A color additive mixture prepared from a previously certified batch of one or more straight colors, with or without any diluent that has been listed in part 73 of this chapter for use in mixtures, shall be exempt from batch certification if the straight color used has not changed in composition in any manner whatsoever since its certification and if it is simply mixed with the approved diluents for exempt mixtures. The label of such color additive mixtures shall not bear the lot number assigned by the Food and Drug Administration to the certified straight color components, but shall bear the manufacturer’s control number through which the history of the straight color can be determined. 72

Part 81

(c) Additions to the list of diluents. A person requesting additions to the list of diluents authorized for the purposes described in paragraphs (a) and (b) of this section shall submit a petition in accordance with the provisions of Sec. 71.1 of this chapter. Each such petition shall be accompanied by the fee prescribed in Sec. 70.19 of this chapter, unless there is an advance deposit to be used for prepayment of such fees. NOTE: The provisions of Sec. 80.35 with respect only to diluents for use in cosmetic color additive mixtures were stayed, until a regulation is effected listing safe diluents for cosmetic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964.

§ 80.37 Treatment of batch pending certification. Immediately after the sample that is to accompany a request for certification of a batch of color additive is taken, the batch shall be: (a) Stored in containers of such kind as to prevent change in composition. (b) Held under the control of the person requesting certification until certified. (c) Marked, by labeling or otherwise, in a manner such that there can be no question as to the identity of the batch and no question that it is not to be used until the requested certificate has been issued. § 80.38 Treatment of batch after certification. (a) Immediately upon notification that a batch of color additive has been certified, the person requesting certification thereof shall identify such batch, by labeling, with the certified lot number. (b) The person requesting certification shall maintain storage in such manner as to prevent change in composition until such batch has been packaged and labeled as required by Secs. 70.20 and 70.25 of this chapter, except that the person requesting certification may use such color additive for the purpose of coloring a food, drug, or cosmetic. § 80.39 Records of distribution. (a) The person to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate. Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee acting on behalf of the Secretary of Health and Human Services, such person, at all reasonable hours until at least 2 years after disposal of all such color additive, shall make such records available to any such officer or employee, and shall accord to such officer or employee full opportunity to make inventory of stocks of such color additive on hand and otherwise to check the correctness of such records. (b) The records required to be kept by paragraph (a) of this section shall show: (1) Each quantity used by such person from such batch and the date and kind of such use. (2) The date and quantity of each shipment or delivery from such batch, and the name and post-office address of the person to whom such shipment or delivery was made. (c) The records required to be kept by paragraph (a) of this section shall be kept separately from all other records.

PART 81—GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS Sec. 81.1 81.10 81.30 81.32

Provisional lists of color additives. Termination of provisional listings of color additives. Cancellation of certificates. Limitation of certificates.

AUTHORITY: 21 U.S.C. 371, 379e, 379e note.

73

§ 81.1

§ 81.1 Provisional lists of color additives. The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 379e note)). Except for color additives for which petitions have been filed, progress reports are required by January 1, 1968, and at 6month intervals thereafter. Specifications for color additives listed in paragraphs (a), (b), and (c) of this section appear in the respective designated sections. The listing of color additives in this section is not to be construed as a listing for surgical suture use unless color additive petitions have been submitted for such use or the Commissioner has been notified of studies underway to establish the safety of the color additive for such use. The color additives listed in paragraphs (a), (b), and (c) of this section may not be used in products which are intended to be used in the area of the eye. The color additives listed in paragraphs (a), (b), and (c) of this section are provisionally listed until the closing dates set forth therein. (a) Color additives previously and presently subject to certification and provisionally listed for food, drug, and cosmetic use. ————————————————————————————————————— Closing date _______________________ Color additive Drug and Restrictions Food use cosmetic use ————————————————————————————————————— Lakes (FD&C) (sec. 82.51 of this chapter). —————————————————————————————————————

(b) Color additives previously and presently subject to certification and provisionally listed for drug and cosmetic use. ————————————————————————————————————— Closing date Restrictions ————————————————————————————————————— Lakes (D&C) (Sec. 82.2051 of this chapter). —————————————————————————————————————

(c) Color additives previously and presently subject to certification and provisionally listed for use in externally applied drugs and cosmetics. ————————————————————————————————————— Closing date Restrictions ————————————————————————————————————— Lakes (Ext. D&C) (sec. 82.105(1) of this chapter) —————————————————————————————————————

[42 FR 15665, Mar. 22, 1977] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting Sec. 5.10, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 81.10 Termination of provisional listings of color additives. (a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced with any assurance that they do not contain [beta]-naphthylamine as an impurity. While it has been asserted that the two colors can be produced without the impurity named, no method of analysis has been suggested to establish the fact. [beta]-Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in products to be used in contact with the skin. The Commissioner of Food and Drugs, having concluded that such action is necessary to protect the public health, hereby terminated the provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No. 10. (b) [Reserved] (c) FD&C Red No. 1. Results of recent feeding tests of this color additive have demonstrated it to be toxic upon ingestion: (1) Groups of 50 rats are being fed diets containing FD&C Red No. 1 at levels of 5 percent, 2 percent, 1 percent, 0.5 percent, and 0 percent. At this stage of the tests, which have now been in progress for from 15 months to 18 months, 116 animals from the 250 being fed FD&C Red No. 1 at various levels and 27 of the 100 controls have died. 74

§ 81.1

Of these, 11 being fed at the 5 percent level, 16 being fed at the 2 percent level, 11 being fed at the 1 percent level, and 2 being fed at the 0.5 percent level, have shown liver damage. None of the controls that have died have shown liver damage. (2) Groups of 100 mice are being fed diets containing 2 percent, 1 percent, 0.5 percent, and 0.1 percent FD&C Red No. 1, with 400 mice as controls. All mice on dosage levels of 2 percent and 1 percent died before the seventieth week. Gross liver damage has been observed in all groups fed at the 0.5 percent diet and above. (3) Groups of 4 dogs are being fed diets containing 2 percent, 1 percent, 0.25 percent, and 0 percent FD&C Red No. 1. Three of the dogs on the 2 percent dosage level died before 32 weeks; the other is living. Three of the dogs on the 1 percent dosage level died or were sacrificed within 13 months. All deceased or sacrificed dogs have shown liver damage grossly and/or microscopically. Deceased dogs on the 1 percent and 2 percent dosage level showed poor physical condition. The Commissioner of Food and Drugs having concluded that ingestion of this color additive over a long period of time would be unsafe, and in order to protect the public health, hereby terminates the provisional listing of FD&C Red No. 1 for use in foods, drugs, and cosmetics. (d) FD&C Red No. 4. Feeding tests of this color additive have been conducted with three species: (1) Rats of the Osborne-Mendel and Sprague-Dawley strains were fed FD&C Red No. 4 for 2 years at levels of 5 percent, 2 percent, 1 percent, and 0.5 percent of the diet. No effect was found. (2) Mice of the C3Hf and C57BL strains were fed FD&C Red No. 4 for 2 years at levels of 2 percent and 1 percent of the diet. No effect was found. (3) Dogs were fed FD&C Red No. 4 at levels of 2 percent and 1 percent of the diet. Adverse effects were found at both levels in the urinary bladder and in the adrenals. Three dogs of five fed on the 2-percent level died after 6 months, 9 months, and 5 1/2 years on the test. Two of the dogs on the 2-percent level and all five of the dogs on the 1-percent level survived to the completion of the 7 year study. The Commissioner of Food and Drugs has concluded that available data do not permit the establishment of a safe level of use of this color additive in food, ingested drugs and ingested cosmetics. In order to protect the public health, the Commissioner hereby terminates the provisional listing of FD&C Red No. 4 for use in food and ingested drugs. The Commissioner has previously terminated the provisional listing of FD&C Red No. 4 for use in ingested cosmetics. FD&C Red No. 4 is listed for use in externally applied drugs and cosmetics by Secs. 74.1304 and 74.2304 of this chapter, respectively. Section 82.304 of this chapter is retained in part 82 of this chapter to permit the use of lakes of FD&C Red No. 4 in externally applied drugs and cosmetics. (e) FD&C Violet No. 1. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of FD&C Violet No. 1 for use in foods, drugs, and cosmetics. (f) FD&C Red No. 2. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of FD&C Red No. 2 for use in food, drugs, and cosmetics. (g) Carbon black (prepared by the ``impingement’’ or ``channel’’ process). The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of carbon black (prepared by the impingement or channel process) for use in food, drugs, and cosmetics. (h) D&C Red Nos. 10, 11, 12, and 13. The petition for these color additives was withdrawn so that there no longer exists a basis for their continued provisional listing. In addition, the Commissioner has learned of the possible contamination of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13 with ß-naphthylamine. The Commissioner concludes that these colors cannot be produced with any reasonable assurance that they will not contain ß-naphthylamine as an impurity or not yield ß-naphthylamine from the metabolism of subsidiary colors present in them. ß-Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in drugs or cosmetics. The Commissioner of Food and Drugs, upon withdrawal of the petition for their use and in order to protect the public health, hereby terminates the provisional listing of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13 for use in drugs and cosmetics, effective December 13, 1977. (i) Ext. D&C Yellow No. 1. The Commissioner has learned of the contamination of Ext. D&C Yellow No. 1 with 4aminobiphenyl. The Commissioner concludes that this color cannot be produced with any reasonable assurance that it will not contain 4-aminobiphenyl as an impurity or not yield benzidine from the decomposition of a subsidiary reaction product that might be present in the color. 4-Aminobiphenyl and benzidine are known carcinogens; therefore, there is no scientific evidence that will support a safe tolerance for these colors in drugs or cosmetics. In 75

§ 81.1

addition, insufficient data have been submitted to permit establishment of appropriate specifications for the batch certification of the color. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of Ext. D&C Yellow No. 1 for use in externally applied drugs and cosmetics, effective December 13, 1977. (j) Graphite. Data have been developed that show the contamination of graphite with polynuclear aromatic hydrocarbons (PNA’s). There is no reasonable assurance this color can be produced so that it will not contain PNA’s as an impurity. The presence of certain PNA’s in graphite would indicate that PNA’s known to be carcinogenic to animals and humans may also be present. Therefore, there is no scientific evidence that will support a safe tolerance for this color in drugs or cosmetics. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of graphite for use in externally applied cosmetics, effective November 29, 1977. (k) Ext. D&C Green No. 1. The Commissioner concludes that there are inadequate analytical methods to permit certification of the color additive Ext. D&C Green No. 1. In addition, the Commissioner has found that there was a failure to comply with the conditions attached to the postponement of the closing date in accordance with section 203(a)(2) of the transitional provisions of the Color Additive Amendments of 1960. The Commissioner of Food and Drugs hereby terminates the provisional listing of Ext. D&C Green No. 1 for use in externally applied drugs and cosmetics, effective November 29, 1977. (l) [Reserved] (m) D&C Orange Nos. 10 and 11. In the absense of a petition to list D&C Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and cosmetics, there no longer exists a basis for provisional listing for such uses. Therefore, FDA is terminating the provisional listing of D&C Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and cosmetics, effective April 28, 1981. (n) D&C Blue No. 6. The Commissioner of Food and Drugs, having concluded that unresolved questions remain concerning the chemistry of unidentified minor components, hereby terminates the provisional listing of D&C Blue No. 6 for use in drugs and cosmetics. (o) D&C Green No. 6. In the absence of a petition to list D&C Green No. 6 for use in ingested drugs and cosmetics, there no longer exists a basis for provisional listing for such uses. Accordingly, the Commissioner of Food and Drugs hereby terminates the provisional listing of D&C Green No. 6 for use in ingested drugs and cosmetics, effective March 27, 1981. (p) [Reserved] (q)(1) D&C Red No. 19 and D&C Red No. 37. Having concluded that, when ingested, D&C Red No. 19 causes cancer in rats and mice, the agency hereby terminates the provisional listings of D&C Red No. 19 and chemically related D&C Red No. 37 for use in ingested drugs and ingested cosmetics, effective February 4, 1983. (2) D&C Red No. 37. In the absence of a petition to list D&C Red No. 37 for external uses, there no longer exists a basis for provisional listing for such uses. Accordingly, the Commissioner of Food and Drugs hereby terminates the provisional listings of D&C Red No. 37 for use in externally applied drugs and cosmetics, effective June 6, 1986. (r) [Reserved] (s) D&C Orange No. 17. Having concluded that, when ingested, D&C Orange No. 17 causes cancer in rats and mice, the agency has terminated the provisional listing of D&C Orange No. 17 for use in ingested drugs and ingested cosmetics, effective March 31, 1983. (t) D&C Red No. 8 and D&C Red No. 9. In the absence of a petition to list D&C Red No. 8 and D&C Red No. 9 for mouthwash, dentifrices, and ingested drugs, except ingested drug lip products, there no longer exists a basis for provisional listing for such uses. Accordingly, the Commissioner of Food and Drugs hereby terminates the provisional listings of D&C Red No. 8 and D&C Red No. 9 for use in mouthwash, dentifrices, and ingested drugs, except ingested drug lip products, effective January 6, 1987. (u) FD&C Red No. 3. Having concluded that FD&C Red No. 3 causes cancer in rats, the agency hereby terminates the provisional listing of FD&C Red No. 3 for use in cosmetics and externally applied drugs and the provisional listing of the lakes of FD&C Red No. 3 for use in food, drug, and cosmetic products, effective January 29, 1990. [42 FR 15665, Mar. 22, 1977] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting Sec. 5.10, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

76

§ 81.30

§ 81.30 Cancellation of certificates. (a) Certificates issued heretofore for colors being removed from the provisional list (Sec. 81.10(a)) are cancelled and of no effect after December 1, 1960, and use of such color additives in drugs or cosmetics after that date will result in adulteration. (b)(1) Certificates issued heretofore for the color additive designated FD&C Red No. 1 are cancelled as of the date of the publication of this Order, and use of this color additive in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration. (2) The Commissioner finds that no action needs to be taken to remove foods, drugs, and cosmetics containing this color additive from the market on the basis of the scientific evidence before him, taking into account that the additive is not an acute toxic substance and that it is only used in small amounts in foods, drugs, and cosmetics. (c) Certificates issued for FD&C Red No. 4 and all mixtures containing this color additive are cancelled and have no effect after September 23, 1976 insofar as food, ingested drugs, and ingested cosmetics are concerned, and use of this color additive in the manufacture of food, ingested drugs, and ingested cosmetics after this date will result in adulteration. The certificates shall continue in effect for the use of FD&C Red No. 4 in externally applied drugs and cosmetics. The Commissioner finds, on the basis of the scientific evidence before him that no action has to be taken to remove from the market food, ingested drugs and ingested cosmetics containing the color additive. (d) Certificates issued for the following color additives and all mixtures containing these color additives are canceled and have no effect after October 4, 1966, and use of such color additives in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration: FD&C Green No. 1. FD&C Green No. 2. D&C Green No. 7. D&C Red No. 5. D&C Red No. 14. D&C Red No. 18. D&C Red No. 24. D&C Red No. 29. D&C Red No. 35. D&C Red No. 38. D&C Orange No. 3. D&C Orange No. 8. D&C Orange No. 14. D&C Orange No. 15. D&C Orange No. 16. D&C Blue No. 7. D&C Black No. 1. Ext. D&C Yellow No. 5. Ext. D&C Yellow No. 6. Ext. D&C Red No. 1. Ext. D&C Red No. 2. Ext. D&C Red No. 3. Ext. D&C Red No. 10. Ext. D&C Red No. 11. Ext. D&C Red No. 13. Ext. D&C Red No. 14. Ext. D&C Red No. 15. Ext. D&C Blue No. 1. Ext. D&C Blue No. 4. Ext. D&C Orange No. 1. Ext. D&C Orange No. 4.

(e) Certificates issued for the following color additives and all mixtures containing these color additives are canceled and have no effect after July 1, 1968, and use of such color additives in the manufacture of drugs or cosmetics after that date will result in adulteration: 77

§ 81.30

Ext. D&C Yellow No. 3. Ext. D&C Red No. 8 Ext. D&C Orange No. 3.

(f) Certificates issued for D&C Yellow No. 11 and all mixtures containing this color additive are canceled and have no effect after April 30, 1968, insofar as ingested use is concerned. Use of this color additive in the manufacture of ingested drugs or cosmetics subject to ingestion after that date will result in adulteration. (g) Certificates issued for D&C Red No. 17, D&C Red No. 31, D&C Red No. 34, D&C Orange No. 4, and D&C Violet No. 2, and all mixtures containing these color additives, are canceled and have no effect after December 31, 1968, insofar as ingested use is concerned. Use of these color additives in the manufacture of ingested drugs or cosmetics subject to ingestion after that date will result in adulteration. (h)(1) Certificates issued for FD&C Violet No. 1 and all mixtures containing this color additive are canceled and have no effect after April 10, 1973, and use of such color additive in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration. (2) The Commissioner finds that no action needs to be taken to remove foods, drugs, and cosmetics containing this color additive from the market on the basis of the scientific evidence before him. (i) Certificates issued prior to July 1, 1968, for D&C Brown No. 1 and Ext. D&C Violet No. 2 and all mixtures containing these colors are canceled and have no effect. This cancellation does not apply to certificates issued after March 15, 1973, for D&C Brown No. 1 and Ext. D&C Violet No. 2, which are provisionally listed in Sec. 81.1(b) and (c) respectively for coloring externally applied cosmetics. (j)(1) Certificates issued for FD&C Red No. 2 and all mixtures containing this color additive are canceled and have no effect after January 28, 1976, and use of this color additive in the manufacture of food, drugs, or cosmetics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market food, drugs, and cosmetics containing the color additive. (k)(1) Certificates issued for D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13, their lakes and all mixtures containing these color additives or their lakes are cancelled and have no effect after December 13, 1977, and use of these color additivies in the manufacture of drugs or cosmetics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market, drug and cosmetic products containing the color additives. (l)(1) Certificates issued for Ext. D&C Yellow No. 1 and all mixtures containing this color additive are cancelled and have no effect after December 13, 1977, and use of this color additive in the manufacture of drugs or cosmetics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cosmetics containing the color additive. (m)(1) Certificates issued for Ext. D&C Green No. 1 and all mixtures containing this color additive are cancelled and have no effect after November 29, 1977, and use of the color additive in the manufacture of drugs or cosmetics after this date will result in adulteration. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cosmetics containing the color additive. (n)(1) Certificates issued for D&C Orange No. 10, D&C Orange No. 11, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after April 28, 1981 and use of these color additives in the manufacture of ingested drugs or cosmetics after this date will result in adulteration. (2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market drugs and cosmetics to which the color additives were added on or before April 28, 1981. (o)(1) Certificates issued for D&C Blue No. 6 and all mixtures containing this color additive are cancelled insofar as its use in drugs and cosmetics is concerned and have no effect after December 13, 1977, and use of the color additive in the manufacture of drugs or cosmetics after this date will result in adulteration. The color will continue to be certified for use in the coloring of surgical sutures. (2) The Commissioner finds, on the basis of the scientific evidence before him, that no action has to be taken to remove from the market drugs and cosmetics containing the color additive. (p)(1) Certificates issued for D&C Green No. 6, its lakes and all mixtures containing this color additive are 78

§ 81.30

cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after May 4, 1982 and use of the color additive in the manufacture of ingested drugs or cosmetics after this date will result in adulteration. (2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market ingested drugs and cosmetics containing the color additive. (q) [Reserved] (r)(1) Certificates issued for D&C Red No. 19 and D&C Red No. 37, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drugs and cosmetics after February 4, 1983, and use of these color additives in the manufacture of ingested drugs or cosmetics after this date will result in adulteration. (2) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market ingested drugs and cosmetics to which D&C Red No. 19 and D&C Red No. 37 were added on or before February 4, 1983, or externally applied drugs and cosmetics to which D&C Red No. 37 was added on or before June 6, 1986. (3) Certificates issued for D&C Red No. 37, its lakes, and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in externally applied drugs and cosmetics after June 6, 1986, and use of this color additive in the manufacture of externally applied drugs or cosmetics after this date will result in adulteration. (4) Certificates issued for D&C Red No. 19, its lakes, and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the manufacture of externally applied drugs or cosmetics after this date will result in adulteration. (5) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market externally applied drugs and cosmetics to which D&C Red No. 19 was added on or before July 15, 1988. (s)(1) Certificates issued for D&C Red No. 8 and D&C Red No. 9, their lakes, and all mixtures containing these color additives are canceled and have no effect as pertains to their use in mouthwash, dentifrices, and ingested drugs, except ingested drug lip products, after January 6, 1987, and use of these color additives in the manufacture of mouthwash, dentifrices, and ingested drugs, except ingested drug lip products, after this date will result in adulteration. (2) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market mouthwash, dentifrices, and ingested drugs to which the color additives were added on or before January 6, 1987. Ingested drug lip products, however, are regulated for use in Secs. 74.1308 and 74.1309. (3) Certificates issued for D&C Red No. 8, and D&C Red No. 9, their lakes, and all mixtures containing these color additives are cancelled and have no effect as pertains to their use in ingested drug and cosmetic lip products and in externally applied drugs and cosmetics after July 15, 1988, and use of these color additives in the manufacture of ingested drugs and cosmetic lip products and in externally applied drugs and cosmetics after this date will result in adulteration. (4) The agency finds, on the basis of the scientific evidence before it, that no action has to be taken to remove from the market ingested drug and cosmetic lip products and externally applied drugs and cosmetics to which the color additives were added on or before July 15, 1988. (t)(1) Certificates issued for D&C Orange No. 17, its lakes, and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in ingested drugs and ingested cosmetics after March 31, 1983 and use of this color additive in the manufacture of ingested drugs or ingested cosmetics after this date will result in adulteration. (2) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market drugs and cosmetics to which the color additive was added on or before March 31, 1983. (3) Certificates issued for D&C Orange No. 17, its lakes and all mixtures containing this color additive are cancelled and have no effect as pertains to its use in externally applied drugs and cosmetics after July 15, 1988, and use of this color in the manufacture of externally applied drugs or cosmetics after this date will result in adulteration. (4) The agency finds, on the scientific evidence before it, that no action has to be taken to remove from the market externally applied drugs and cosmetics to which D&C Orange No. 17 was added on or before July 15, 1988. (u)(1) Certificates issued for FD&C Red No. 3 and all mixtures containing this color additive are cancelled and have no effect as pertains to their use in cosmetics and externally applied drugs after January 29, 1990. Certificates issued for FD&C Red No. 3 lakes and all mixtures containing these lakes are cancelled and have no effect as pertains to their use in food, drugs, and cosmetics after January 29, 1990. Certificates issued for D&C Red No. 3 lakes and all mixtures containing those lakes are cancelled and have no effect as pertains to their use in drugs and cosmetics after January 29, 1990. Use of this color additve in the manufacture of cosmetics and of externally applied drugs and any use of the lakes of FD&C Red No. 3 (including the lakes of D&C Red No. 3) after this date will result in 79

§ 81.32

adulteration. (2) The agency finds, on the scientific evidence before it, that no action must be taken to remove from the market food, drugs, and cosmetics to which the provisionally listed color additive or its lakes were added on or before January 29, 1990. [42 FR 15665, Mar. 22, 1977] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting Sec. 5.10, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 81.32 Limitation of certificates. Certificates issued for the color additives listed in Sec. 81.25 and for all mixtures containing these color additives are limited to the conditions stated in Sec. 81.25. The use of these color additives in drugs and cosmetics in any other manner will result in adulteration. Each of these color additives shall bear a label statement of the tolerance and use limitations applicable to it. [44 FR 48966, Aug. 21, 1979]

PART 82—LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS Subpart A—General Provisions Sec. 82.3 82.5 82.6

Definitions. General specifications for straight colors. Certifiable mixtures.

Subpart B—Foods, Drugs, and Cosmetics 82.50 82.51 82.101 82.102 82.203 82.304 82.705 82.706

General. Lakes (FD&C). FD&C Blue No. 1. FD&C Blue No. 2. FD&C Green No. 3. FD&C Red No. 4. FD&C Yellow No. 5. FD&C Yellow No. 6.

AUTHORITY: 21 U.S.C. 371, 379e, 379e note. SOURCE: 42 FR 15669, Mar. 22, 1977, unless otherwise noted.

Subpart A—General Provisions § 82.3 Definitions. For the purposes of this part: (a)-(f) [Reserved] (g) The term alumina means a suspension in water of precipitated aluminum hydroxide. (h) The term blanc fixe means a suspension in water of precipitated barium sulfate. (i) The term gloss white means a suspension in water of co-precipitated aluminum hydroxide and barium sulfate. (j) The term mixed oxides means the sum of the quantities of aluminum, iron, calcium, and magnesium (in whatever 80

§ 82.6

combination they may exist in a coal-tar color) calculated as aluminum trioxide, ferric oxide, calcium oxide, and magnesium oxide. (k)-(m) [Reserved] (n) The term externally applied drugs and cosmetics means drugs and cosmetics which are applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane. (o)-(p) [Reserved] (q) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also to such terms when used in this part. § 82.5 General specifications for straight colors. No batch of a straight color listed in subpart B, C, or D shall be certified under this part unless: (a) It is free from all impurities (other than those named in paragraph (b) of this section or in the specifications set forth in such paragraph for such color) to the extent that such impurities can be avoided by good manufacturing practice. (b) It conforms to the following specifications: (1) In the case of a straight color listed in subpart B: (i) Lead (as Pb), not more than 0.001 percent. (ii) Arsenic (as As2O3), not more than 0.00014 percent. (iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than trace. (2) In the case of a straight color listed in subpart C or D: (i) Lead (as Pb), not more than 0.002 percent. (ii) Arsenic (as As2O3), not more than 0.0002 percent. (iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than 0.003 percent. (3) In the case of a straight color which contains a barium salt listed in subpart C or D—soluble barium (in dilute HCl) (as BaCl2), not more than 0.05 percent. § 82.6 Certifiable mixtures. (a) A batch of a mixture which contains no straight color listed in subpart C or D may be certified for use in food, drugs and cosmetics, if: (1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture; (2) Each diluent in such batch of mixture is harmless and suitable for use therein; and (3) No diluent (except resins, natural gum, pectin and, in the case of mixtures which are aqueous solutions or aqueous pastes, sodium benzoate in a quantity of not more than 1/10 of 1 percent) in such mixture is a nonnutritive substance, unless such mixture is for external application to shell eggs, or for use in coloring a food specified in the requests for certification of such batch submitted in accordance with Sec. 80.21 of this chapter, and such diluent, in the usual process of manufacturing such food, is removed and does not become a component of such food. (b) A batch of a mixture which contains no straight color listed in subpart D, or which contains a diluent not permitted by paragraph (a)(3) of this section, may be certified in accordance with the provisions of this part, for use only in drugs and cosmetics, if: (1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture. (2) Each diluent in such batch of mixture is harmless and suitable for use therein. (c) A batch of a mixture which contains a straight color listed in subpart D may be certified in accordance with the provisions of this part, for use only in externally applied drugs and cosmetics, if: (1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture; and (2) Each diluent in such batch of mixture is harmless and suitable for use therein. 81

§ 82.50

Subpart B—Foods, Drugs, and Cosmetics § 82.50 General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of the regulations in this part, for use in food, drugs, and cosmetics, if such batch conforms to the requirements of Sec. 82.5 and to the specifications in this subpart set forth for such color. § 82.51 Lakes (FD&C). (a)(1) General. Any lake made by extending on a substratum of alumina, a salt prepared from one of the certified water-soluble straight colors hereinbefore listed in this subpart by combining such color with the basic radical aluminum or calcium. (2) Specifications. Prepared from previously certified colors listed in this subpart. Soluble chlorides and sulfates (as sodium salts), not more than 2.0 percent. Inorganic matter, insoluble HCl, not more than 0.5 percent.

(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows: (1) The listed name of the color from which the lake is prepared; (2) The name of the basic radical combined in such color; and (3) The word ``Lake’’. (For example, the name of a lake prepared by extending the aluminum salt prepared from FD&C Blue No. 1 upon the substratum would be FD&C Blue No. 1—Aluminum Lake.) § 82.101 FD&C Blue No. 1. The color additive FD&C Blue No. 1 shall conform in identity and specifications to the requirements of Sec. 74.101(a)(1) and (b) of this chapter. § 82.102 FD&C Blue No. 2. The color additive FD&C Blue No. 2 shall conform in identity and specifications to the requirements of Sec. 74.102(a)(1) and (b) of this chapter. [48 FR 5261, Feb. 4, 1983]

§ 82.203 FD&C Green No. 3. The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of Sec. 74.203(a)(1) and (b) of this chapter. [47 FR 52144, Nov. 19, 1982]

§ 82.304 FD&C Red No. 4. The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of Sec. 74.1304(a)(1) and (b) of this chapter. FD&C Red No. 4 is restricted to use in externally applied drugs and cosmetics. § 82.705 FD&C Yellow No. 5. The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of Sec. 74.705 (a)(1) and (b) of this chapter. [51 FR 24519, July 7, 1986]

82

§ 82.706

§ 82.706 FD&C Yellow No. 6. (a) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of Sec. 74.706 (a)(1) and (b) of this chapter. (b) All lakes including current D&C external and D&C lakes of FD&C Yellow No. 6 shall be manufactured from previously certified batches of the straight color additive. [52 FR 21509, June 8, 1987]

83

84

Part 100

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION PART 100—GENERAL Subpart A—State and Local Requirements Sec. 100.1 100.2

Petitions requesting exemption from preemption for State or local requirements. State enforcement of Federal regulations.

Subparts B-E [Reserved] Subpart F—Misbranding for Reasons Other Than Labeling 100.100 Misleading containers. Subpart G—Specific Administrative Rulings and Decisions 100.155 Salt and iodized salt. AUTHORITY: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371. SOURCE: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.

Subpart A—State and Local Requirements § 100.1 Petitions requesting exemption from preemption for State or local requirements. (a) Scope and purpose. (1) This subpart applies to the submission and consideration of petitions under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act), by a State or a political subdivision of a State, requesting exemption of a State requirement from preemption under section 403A(a) of the act. (2) Section 403A(b) of the act provides that where a State requirement has been preempted under section 403A(a) of the act, the State may petition the agency for an exemption. The agency may grant the exemption, under such conditions as it may prescribe by regulation, if the agency finds that the State requirement will not cause any food to be in violation of any applicable requirement under Federal law, will not unduly burden interstate commerce, and is designed to address a particular need for information that is not met by the preemptive Federal requirement. (b) Definitions. (1) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). (2) Agency means the Food and Drug Administration. (3) Commissioner means the Commissioner of Food and Drugs. (4) State means a State as defined in section 201(a)(1) of the act (which includes a territory of the United States, the District of Columbia, and Puerto Rico) or any political subdivision of a State having authority to issue food standards and food labeling regulations having force of law. (5) State requirement means any statute, standard, regulation, or other requirement that is issued by a State. (c) Prerequisites for petitions for exemption from preemption. The Food and Drug Administration will consider a petition for exemption from preemption on its merits only if the petition demonstrates that: (1) The State requirement was enacted or was issued as a final rule by an authorized official of the State and is in effect or would be in effect but for the provisions of section 403A of the act.

85

§ 100.1

(2) The State requirement is subject to preemption under section 403A(a) of the act because of a statutory provision listed in that section or because of a Federal standard or other Federal regulation that is in effect, or that has been published as a final rule with a designated effective date, and that was issued under the authority of a statutory provision listed in that section. For the purposes of this subpart, all petitions seeking exemption from preemption under section 403A(a)(3) through (a)(5) of the act submitted before May 8, 1992, will be considered timely even though the applicable statutory provisions or regulations are not yet in effect. (3) The petitioner is an official of a State having authority to act for, or on behalf of, the Government in applying for an exemption of State requirements from preemption. (4) The State requirement is subject to preemption under section 403A(a) of the act because it is not identical to the requirement of the preemptive Federal statutory provision or regulation including a standard of identity, quality, and fill. ``Not identical to’’ does not refer to the specific words in the requirement but instead means that the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food, or concerning a food container, that: (i) Are not imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act; or (ii) Differ from those specifically imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act. (d) Form of petition. (1) All information included in the petition should meet the general requirements of Sec. 10.20(c) of this chapter. (2) An original and one copy of the petition shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. (Petitioners interested in submitting a disk should contact the Center for Food Safety and Applied Nutrition for details.) (3) Petitions for exemption from preemption for a State requirement shall be submitted to the Dockets Management Branch in the following form: (Date) ________________ Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. PETITION REQUESTING EXEMPTION FROM PREEMPTION FOR STATE REQUIREMENT The undersigned submits this petition under section 403A(b)of the Federal Food, Drug, and Cosmetic Act to request that the Food and Drug Administration exempt a State requirement from preemption. The undersigned has authority to act for, or on behalf of, the (identify State or political subdivision of the State) because (document petitioner’s authority to submit petition on behalf of the State). A. Action Requested 1. Identify and give the exact wording of the State requirement and give date it was enacted or issued in final form. 2. Identify the specific standard or regulation that is believed to preempt the State requirement and the section and paragraph of the act that the standard or regulation implements. B. Documentation of State Requirement Provide a copy of the State requirement that is the subject of the application. Where available, the application should also include copies of any legislative history or background materials used in issuing the requirement, including hearing reports or studies concerning the development or consideration of the requirement.

86

§ 100.1

C. Statement of Grounds A petition for an exemption from preemption should contain the following: 1. An explanation of the State requirement and its rationale, and a comparison of State and Federal requirements to show differences. 2. An explanation of why compliance with the State requirement would not cause a food to be in violation of any applicable requirement under Federal law. 3. Information on the effect that granting the State petition will have on interstate commerce. The petition should contain information on economic feasibility, i.e., whether the State and Federal requirements have significantly different effects on the production and distribution of the food product; comparison of the costs of compliance as shown by data or information on the actual or anticipated effect of the State and Federal requirements on the sale and price of the food product in interstate commerce; and the effect of the State requirement on the availability of the food product to consumers. To the extent possible, the petition should include information showing that it is practical and feasible for producers of food products to comply with the State requirement. Such information may be submitted in the form of statements from affected persons indicating their ability to comply. 4. Identification of a particular need for information that the State requirement is designed to meet, which need is not met by Federal law. The petition should describe the conditions that require the State to petition for an exemption, the information need that the State requirement fulfills, the inadequacy of the Federal requirement in addressing this need, and the geographical area or political subdivision in which such need exists. D. Environmental Impact The petition shall contain a claim for categorical exclusion under 21 CFR 25.24 or an environmental assessment under 21 CFR 25.31. E. Notification Provide name and address of person, branch, department, or other instrumentality of the State government that should be notified of the Commissioner’s action concerning the petition. F. Certification The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies. (Signature) ________________________ (Name of petitioner) ________________ (Mailing address) __________________ (Telephone number) ________________ (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB number 0910-0277)

(e) Submission of petition for exemption; public disclosure. The availability for public disclosure of a petition for exemption will be governed by the rules specified in Sec. 10.20(j) of this chapter. (f) Agency consideration of petitions. (1) Unless otherwise specified in this section, all relevant provisions and requirements of subpart B of part 10 of this chapter, are applicable to State petitions requesting exemption from Federal preemption under section 403A(b) of the act. (2) If a petition does not meet the prerequisite requirements of paragraph (c) of this section, the agency will issue a letter to the petitioner denying the petition and stating in what respect the petition does not meet these requirements. (3) If a petition appears to meet the prerequisite requirements in paragraph (c) of this section, it will be filed by the Dockets Management Branch, stamped with the date of filing, and assigned a docket number. The docket number identifies the file established by the Dockets Management Branch for all submissions relating to the petition, as provided in this part. Subsequent submissions relating to the matter must refer to the docket number and will be filed in the docket file. The Dockets Management Branch will promptly notify the petitioner in writing of the filing and docket number of a petition. (4) Any interested person may submit written comments to the Dockets Management Branch on a filed petition as provided in Sec. 10.30(d) of this chapter. (5) Within 90 days of the date of filing the agency will furnish a response to the petitioner. The response will either: (i) State that the agency has tentatively determined that the petition merits the granting of an exemption, and that it intends to publish in the Federal Register a proposal to grant the exemption through rulemaking; 87

§ 100.2

(ii) Deny the petition and state the reasons for such denial; or (iii) Provide a tentative response indicating why the agency has been unable to reach a decision on the petition, e.g., because of other agency priorities or a need for additional information. (g) If a State submitted a petition for exemption of a State requirement from preemption under section 403A(a)(3) through (a)(5) of the act before May 8, 1992, that State requirement will not be subject to preemption until: (1) November 8, 1992; or (2) Action on the petition, whichever occurs later. [58 FR 2468, Jan. 6, 1993]

§ 100.2 State enforcement of Federal regulations. (a) Under section 307 of the Federal Food, Drug, and Cosmetic Act (the act), a State may bring, in its own name and within its own jurisdiction, proceedings for the civil enforcement, or to restrain violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f), 403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food that is the subject of the proceedings is located in the State. (b) No proceeding may be commenced by a State under paragraph (a) of this section: (1) Before 30 days after the State has given notice to the Food and Drug Administration (FDA) that the State intends to bring such proceeding. (2) Before 90 days after the State has given notice to FDA of such intent if FDA has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding. (3) If FDA is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food. (c) A State may intervene as a matter of right, in any court proceeding described in paragraph (b)(3) of this section. (d) The notification that a State submits in accordance with paragraph (b) of this section should include the following information and be submitted in the following recommended format: (Date) ________________ Name of State agency ____________ Post office address ____________ Street address ____________ City, State, and ZIP code ____________ Name of product(s) covered by the notification ____________ Reporting official, title, and telephone no. ____________ FAX No. ____________ Agency contact (if different from reporting official), title, and telephone no. ____________ Director, Division of Enforcement (HFS-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. To Whom It May Concern: The undersigned, ______, submits this letter of notification pursuant to section 307(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 337(b)(1)) with respect to ________. (name of products covered by the notification and the enforcement action that is to be initiated) Attached hereto, and constituting a part of this letter of notification are the following: A. The name of the product. B. The type and size of each product container. C. Copy of the label and labeling of the product. D. Manufacturing code (if applicable). E. Name and address of firm believed to be responsible for violations. F. Name and address of parent firm (if known). G. Reason for the anticipated State enforcement action (list specific violations, including sections of the law violated). H. Name of firm against which action is anticipated (if applicable). I. Type of enforcement action.

88

§ 100.100

Yours very truly, Reporting Agency By ____________ (Indicate authority)

(e) The letter of notification should be signed by a State official authorized by the State to institute the contemplated enforcement actions. (f) The letter of notification should be sent to the Division of Enforcement (HFS-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, FAX number 202-205-4642. (g) FDA will notify the State of the date in which its letter of notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-605) (within 2 working days after date of receipt). This date will be the date of notification for the purposes of paragraph (b) of this section. (h) The Director, Division of Enforcement, Office of Field Programs, Center for Food Safety and Applied Nutrition, FDA, will respond to the State’s notification within 30 days of the date of notification by advising: (1) Whether FDA has commenced an informal or formal enforcement action pertaining to the food that is the subject of the notification; or (2) Whether FDA is prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled informal or formal enforcement action pertaining to such food. (i) Information contained in State notification letters shall be exempt from public disclosure to the same extent to which such information would be so exempt pursuant to Secs. 20.61, 20.64, and 20.88 of this chapter. (j) Definitions. (1) Informal enforcement actions include warning letters, recalls, detentions, or other administrative enforcement actions that pertain to the food in question. (2) Formal enforcement actions include seizures, injunctions, or other civil judicial enforcement actions that pertain to the food in question. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0275.) [58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 66 FR 56035, Nov. 6, 2001]

Subparts B-E [Reserved]

Subpart F—Misbranding for Reasons Other Than Labeling § 100.100 Misleading containers. In accordance with section 403(d) of the act, a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading. (a) A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein. Nonfunctional slack-fill is the empty space in a package that is filled to less than its capacity for reasons other than: (1) Protection of the contents of the package; (2) The requirements of the machines used for enclosing the contents in such package; (3) Unavoidable product settling during shipping and handling; (4) The need for the package to perform a specific function (e.g., where packaging plays a role in the preparation or consumption of a food), where such function is inherent to the nature of the food and is clearly communicated to consumers; (5) The fact that the product consists of a food packaged in a reusable container where the container is part of the presentation of the food and has value which is both significant in proportion to the value of the product and independent of its function to hold the food, e.g., a gift product consisting of a food or foods combined with a container that is intended for further use after the food is consumed; or durable commemorative or promotional packages; or 89

§ 100.155

(6) Inability to increase level of fill or to further reduce the size of the package (e.g., where some minimum package size is necessary to accommodate required food labeling (excluding any vignettes or other nonmandatory designs or label information), discourage pilfering, facilitate handling, or accommodate tamper-resistant devices). (b) [Reserved] [59 FR 537, Jan. 5, 1994]

Subpart G—Specific Administrative Rulings and Decisions § 100.155 Salt and iodized salt. (a) For the purposes of this section, the term iodized salt or iodized table salt is designated as the name of salt for human food use to which iodide has been added in the form of cuprous iodide or potassium iodide permitted by Secs. 184.1265 and 184.1634 of this chapter. In the labeling of such products, all words in the name shall be equal in prominence and type size. The statement ``This salt supplies iodide, a necessary nutrient’’ shall appear on the label immediately following the name and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in Sec. 101.105 of this chapter. (b) Salt or table salt for human food use to which iodide has not been added shall bear the statement, ``This salt does not supply iodide, a necessary nutrient.’’ This statement shall appear immediately following the name of the food and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in Sec. 101.105 of this chapter. (c) Salt, table salt, iodized salt, or iodized table salt to which anticaking agents have been added may bear in addition to the ingredient statement designating the anticaking agent(s), a label statement describing the characteristics imparted by such agent(s) (for example, ``free flowing’’), providing such statement does not appear with greater prominence or in type size larger than the statements which immediately follow the name of the food as required by paragraphs (a) and (b) of this section. (d) Individual serving-sized packages containing less than 1/2 ounce and packages containing more than 2 1/2 pounds of a food described in this section shall be exempt from declaration of the statements which paragraphs (a) and (b) of this section require immediately following the name of the food. Such exemption shall not apply to the outer container or wrapper of a multiunit retail package. (e) All salt, table salt, iodized salt, or iodized table salt in packages intended for retail sale shipped in interstate commerce 18 months after the date of publication of this statement of policy in the Federal Register, shall be labeled as prescribed by this section; and if not so labeled, the Food and Drug Administration will regard them as misbranded within the meaning of sections 403 (a) and (f) of the Federal Food, Drug, and Cosmetic Act. [42 FR 14306, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 49 FR 24119, June 12, 1984]

PART 101—FOOD LABELING Subpart A—General Provisions Sec. 101.1 101.2 101.3 101.4 101.5 101.9 101.10 101.12 101.13 101.14

Principal display panel of package form food. Information panel of package form food. Identity labeling of food in packaged form. Food; designation of ingredients. Food; name and place of business of manufacturer, packer, or distributor. Nutrition labeling of food. Nutrition labeling of restaurant foods. Reference amounts customarily consumed per eating occasion. Nutrient content claims—general principles. Health claims: general requirements. 90

Part 101

101.15 Food; prominence of required statements. 101.17 Food labeling warning, notice, and safe handling statements. 101.18 Misbranding of food. Subpart B—Specific Food Labeling Requirements 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives. 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice. Subpart C—Specific Nutrition Labeling Requirements and Guidelines 101.36 Nutrition labeling of dietary supplements. 101.42 Nutrition labeling of raw fruit, vegetables, and fish. 101.43 Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish. 101.44 Identification of the 20 most frequently consumed raw fruit, vegetables, and fish in the United States. 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish. Subpart D—Specific Requirements for Nutrient Content Claims 101.54 101.56 101.60 101.61 101.62 101.65 101.67 101.69

Nutrient content claims for ``good source,’’ ``high,’’ ``more,’’ and ``high potency.’’ Nutrient content claims for ``light’’ or ``lite.’’ Nutrient content claims for the calorie content of foods. Nutrient content claims for the sodium content of foods. Nutrient content claims for fat, fatty acid, and cholesterol content of foods. Implied nutrient content claims and related label statements. Use of nutrient content claims for butter. Petitions for nutrient content claims.

Subpart E—Specific Requirments for Health Claims 101.70 101.71 101.72 101.73 101.74 101.75 101.76 101.77 101.78 101.79 101.80 101.81 101.82 101.83

Petitions for health claims. Health claims: claims not authorized. Health claims: calcium and osteoporosis. Health claims: dietary lipids and cancer. Health claims: sodium and hypertension. Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease. Health claims: fiber-containing grain products, fruits, and vegetables and cancer. Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. Health claims: fruits and vegetables and cancer. Health claims: Folate and neural tube defects. Health claims: dietary sugar alcohols and dental caries. Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD). Health claims: Soy protein and risk of coronary heart disease (CHD). Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).

Subpart F—Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims Nor Health Claims 101.93 Certain types of statements for dietary supplements. 101.95 ``Fresh,’’ ``freshly frozen,’’ ``fresh frozen,’’ ``frozen fresh.’’

91

§ 101.1

Subpart G—Exemptions From Food Labeling Requirements 101.100 Food; exemptions from labeling. 101.105 Declaration of net quantity of contents when exempt. 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments. APPENDIX A TO PART 101—MONIER-WILLIAMS PROCEDURE (WITH MODIFICATIONS) FOR SULFITES IN FOOD, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION (NOVEMBER 1985) APPENDIX B TO PART 101—GRAPHIC ENHANCEMENTS USED BY THE FDA APPENDIX C TO PART 101—NUTRITION FACTS FOR RAW FRUITS AND VEGETABLES APPENDIX D TO PART 101—NUTRITION FACTS FOR COOKED FISH AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. SOURCE: 42 FR 14308. Mar. 15, 1977 unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 101 appear at 63 FR 14035, Mar. 24, 1998, 66 FR 17358, Mar. 30, 2001, and 66 FR 56035, Nov. 6, 2001.

Subpart A—General Provisions § 101.1 Principal display panel of package form food. The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; (c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious ``principal display panel’’ such as the top of a triangular or circular package of cheese, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. § 101.2 Information panel of package form food. (a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions: (1) If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used. (2) If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel. (3) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel. 92

§ 101.2

(b) All information required to appear on the label of any package of food under Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter. (c) All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than one-sixteenth inch in height unless an exemption pursuant to paragraph (f) of this section is established. The requirements for conspicuousness and legibility shall include the specifications of Secs. 101.105(h) (1) and (2) and 101.15. (1)(i) Soft drinks packaged in bottles manufactured before October 31, 1975 shall be exempt from the requirements prescribed by this section to the extent that information which is blown, lithographed, or formed onto the surface of the bottle is exempt from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be exempt from the size and placement requirements prescribed by this section if all of the following conditions are met: (A) If the soft drink is packaged in a bottle bearing a paper, plastic foam jacket, or foil label, or is packaged in a nonreusable bottle bearing a label lithographed onto the surface of the bottle or is packaged in metal cans, the product shall not be exempt from any requirement of this section other than the exemptions created by Sec. 1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all required information in the specified minimum type size, except the label will not be required to bear the information required by Sec. 101.5 if this information appears on the bottle closure or on the lid of the can in a type size not less than one-sixteenth inch in height, or if embossed on the lid of the can in a type size not less than one-eighth inch in height. (B) If the soft drink is packaged in a bottle which does not bear a paper, plastic foam jacket or foil label, or is packaged in a reusable bottle bearing a label lithographed onto the surface of the bottle: (1) Neither the bottle nor the closure is required to bear nutrition labeling in compliance with Sec. 101.9, except that any multiunit retail package in which it is contained shall bear nutrition labeling if required by Sec. 101.9; and any vending machine in which it is contained shall bear nutrition labeling if nutrition labeling is not present on the bottle or closure, if required by Sec. 101.9. (2) All other information pursuant to this section shall appear on the top of the bottle closure prominently and conspicuously in letters and/or numbers no less than one thirty-second inch in height, except that if the information required by Sec. 101.5 is placed on the side of the closure in accordance with Sec. 1.24(a)(5)(ii) of this chapter, such information shall appear in letters and/or numbers no less than one-sixteenth inch in height. (3) Upon the petition of any interested person demonstrating that the bottle closure is too small to accommodate this information, the Commissioner may by regulation establish an alternative method of disseminating such information. Information appearing on the closure shall appear in the following priority: (i) The statement of ingredients. (ii) The name and address of the manufacturer, packer, or distributor. (iii) The statement of identity. (2) Individual serving-size packages of food served with meals in restaurants, institutions, and on board passenger carriers, and not intended for sale at retail, are exempt from type-size requirements of this paragraph, provided: (i) The package has a total area of 3 square inches or less available to bear labeling; (ii) There is insufficient area on the package available to print all required information in a type size of \1/16\ inch in height; (iii) The information required by paragraph (b) of this section appears on the label in accordance with the provisions of this paragraph, except that the type size is not less than \1/32\ inch in height. (d)(1) Except as provided by Secs. 101.9(j)(13) and (j)(17) and 101.36(i)(2) and (i)(5), all information required to appear on the principal display panel or on the information panel under this section shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as provided by Secs. 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and other nonmandatory label information shall not be considered. If there is insufficient space for all of this information to appear on a single panel, it may be divided between these two panels, except that the information required under any given section or part shall all appear on the same panel. A food whose label is required to bear the ingredient statement on the principal display panel may bear all other information specified in paragraph (b) of this section on the information panel. (2) Any food, not otherwise exempted in this section, if packaged in a container consisting of a separate lid and body, and bearing nutrition labeling pursuant to Sec. 101.9, and if the lid qualifies for and is designed to serve as a principal display panel, shall be exempt from the placement requirements of this section in the following respects: (i) The name and place of business information required by Sec. 101.5 shall not be required on the body of the container if this information appears on the lid in accordance with this section. 93

§ 101.3

(ii) The nutrition information required by Sec. 101.9 shall not be required on the lid if this information appears on the container body in accordance with this section. (iii) The statement of ingredients required by Sec. 101.4 shall not be required on the lid if this information appears on the container body in accordance with this section. Further, the statement of ingredients is not required on the container body if this information appears on the lid in accordance with this section. (e) All information appearing on the information panel pursuant to this section shall appear in one place without other intervening material. (f) If the label of any package of food is too small to accommodate all of the information required by Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter, the Commissioner may establish by regulation an acceptable alternative method of disseminating such information to the public, e.g., a type size smaller than one-sixteenth inch in height, or labeling attached to or inserted in the package or available at the point of purchase. A petition requesting such a regulation, as an amendment to this paragraph, shall be submitted under part 10 of this chapter. [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006, Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58 FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 12, 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, Mar. 27, 1998]

§ 101.3 Identity labeling of food in packaged form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of: (1) The name now or hereafter specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) The common or usual name of the food; or, in the absence thereof, (3) An appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. (c) Where a food is marketed in various optional forms (whole, slices, diced, etc.), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bearing a reasonable relation to the size of the letters forming the other components of the statement of identity; except that if the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the statement. This specification does not affect the required declarations of identity under definitions and standards for foods promulgated pursuant to section 401 of the act. (d) This statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. (e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word ``imitation’’ and, immediately thereafter, the name of the food imitated. (1) A food shall be deemed to be an imitation and thus subject to the requirements of section 403(c) of the act if it is a substitute for and resembles another food but is nutritionally inferior to that food. (2) A food that is a substitute for and resembles another food shall not be deemed to be an imitation provided it meets each of the following requirements: (i) It is not nutritionally inferior to the food for which it substitutes and which it resembles. (ii) Its label bears a common or usual name that complies with the provisions of Sec. 102.5 of this chapter and that is not false or misleading, or in the absence of an existing common or usual name, an appropriately descriptive term that is not false or misleading. The label may, in addition, bear a fanciful name which is not false or misleading. (3) A food for which a common or usual name is established by regulation (e.g., in a standard of identity pursuant to section 401 of the act, in a common or usual name regulation pursuant to part 102 of this chapter, or in a regulation establishing a nutritional quality guideline pursuant to part 104 of this chapter), and which complies with all of the applicable requirements of such regulation(s), shall not be deemed to be an imitation. (4) Nutritional inferiority includes: (i) Any reduction in the content of an essential nutrient that is present in a measurable amount, but does not include a reduction in the caloric or fat content provided the food is labeled pursuant 94

§ 101.4

to the provisions of Sec. 101.9, and provided the labeling with respect to any reduction in caloric content complies with the provisions applicable to caloric content in part 105 of this chapter. (ii) For the purpose of this section, a measurable amount of an essential nutrient in a food shall be considered to be 2 percent or more of the Daily Reference Value (DRV) of protein listed under Sec. 101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) per reference amount customarily consumed and 2 percent or more of the Reference Daily Intake (RDI) of any vitamin or mineral listed under Sec. 101.9(c)(8)(iv) per reference amount customarily consumed, except that selenium, molybdenum, chromium, and chloride need not be considered. (iii) If the Commissioner concludes that a food is a substitute for and resembles another food but is inferior to the food imitated for reasons other than those set forth in this paragraph, he may propose appropriate revisions to this regulation or he may propose a separate regulation governing the particular food. (f) A label may be required to bear the percentage(s) of a characterizing ingredient(s) or information concerning the presence or absence of an ingredient(s) or the need to add an ingredient(s) as part of the common or usual name of the food pursuant to subpart B of part 102 of this chapter. (g) Dietary supplements shall be identified by the term ``dietary supplement’’ as a part of the statement of identity, except that the word ``dietary’’ may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins). [42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, Sept. 23, 1997]

§ 101.4 Food; designation of ingredients. (a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by Sec. 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of Sec. 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with Sec. 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products. (2) The descending order of predominance requirements of paragraph (a)(1) of this section do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., ``Contains __ percent or less of ______’’ or ``Less than __ percent of ______.’’ The blank percentage within the quantifying statement shall be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying phrase applies may be present in an amount greater than the stated threshold. (b) The name of an ingredient shall be a specific name and not a collective (generic) name, except that: (1) Spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of Sec. 101.22. (2) An ingredient which itself contains two or more ingredients and which has an established common or usual name, conforms to a standard established pursuant to the Meat Inspection or Poultry Products Inspection Acts by the U.S. Department of Agriculture, or conforms to a definition and standard of identity established pursuant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement of ingredients on the label of such food by either of the following alternatives: (i) By declaring the established common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance except that, if the ingredient is a food subject to a definition and standard of identity established in subchapter B of this chapter that has specific labeling provisions for optional ingredients, optional ingredients may be declared within the parenthetical listing in accordance with those provisions. (ii) By incorporating into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself. (3) Skim milk, concentrated skim milk, reconstituted skim milk, and nonfat dry milk may be declared as ``skim milk’’ or ``nonfat milk’’. (4) Milk, concentrated milk, reconstituted milk, and dry whole milk may be declared as ``milk’’. (5) Bacterial cultures may be declared by the word ``cultured’’ followed by the name of the substrate, e.g., ``made from cultured skim milk or cultured buttermilk’’. 95

§ 101.4

(6) Sweetcream buttermilk, concentrated sweetcream buttermilk, reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may be declared as ``buttermilk’’. (7) Whey, concentrated whey, reconstituted whey, and dried whey may be declared as ``whey’’. (8) Cream, reconstituted cream, dried cream, and plastic cream (sometimes known as concentrated milk fat) may be declared as ``cream’’. (9) Butteroil and anhydrous butterfat may be declared as ``butterfat’’. (10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may be declared as ``eggs’’. (11) Dried egg whites, frozen egg whites, and liquid egg whites may be declared as ``egg whites’’. (12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be declared as ``egg yolks’’. (13) [Reserved] (14) Each individual fat and/or oil ingredient of a food intended for human consumption shall be declared by its specific common or usual name (e.g., ``beef fat’’, ``cottonseed oil’’) in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as ``______ shortening’’ or ``blend of ______ oils’’, the blank to be filled in with the word ``vegetable’’, ``animal’’, ``marine’’, with or without the terms ``fat’’ or ``oils’’, or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed oil)’’. For products that are blends of fats and/or oils and for foods in which fats and/or oils constitute the predominant ingredient, i.e., in which the combined weight of all fat and/or oil ingredients equals or exceeds the weight of the most predominant ingredient that is not a fat or oil, the listing of the common or usual names of such fats and/or oils in parentheses shall be in descending order of predominance. In all other foods in which a blend of fats and/or oils is used as an ingredient, the listing of the common or usual names in parentheses need not be in descending order of predominance if the manufacturer, because of the use of varying mixtures, is unable to adhere to a constant pattern of fats and/or oils in the product. If the fat or oil is completely hydrogenated, the name shall include the term hydrogenated, or if partially hydrogenated, the name shall include the term partially hydrogenated. If each fat and/or oil in a blend or the blend is completely hydrogenated, the term ``hydrogenated’’ may precede the term(s) describing the blend, e.g., ``hydrogenated vegetable oil (soybean, cottonseed, and palm oils)’’, rather than preceding the name of each individual fat and/or oil; if the blend of fats and/or oils is partially hydrogenated, the term ``partially hydrogenated’’ may be used in the same manner. Fat and/or oil ingredients not present in the product may be listed if they may sometimes be used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as ``or’’, ``and/or’’, ``contains one or more of the following:’’, e.g., ``vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)’’. No fat or oil ingredient shall be listed unless actually present if the fats and/or oils constitute the predominant ingredient of the product, as defined in this paragraph (b)(14). (15) When all the ingredients of a wheat flour are declared in an ingredient statement, the principal ingredient of the flour shall be declared by the name(s) specified in Secs. 137.105, 137.200, 137.220 and 137.225 of this chapter, i.e., the first ingredient designated in the ingredient list of flour, or bromated flour, or enriched flour, or self-rising flour is ``flour’’, ``white flour’’, ``wheat flour’’, or ``plain flour’’; the first ingredient designated in the ingredient list of durum flour is ``durum flour’’; the first ingredient designated in the ingredient list of whole wheat flour, or bromated whole wheat flour is ``whole wheat flour’’, ``graham flour’’, or ``entire wheat flour’’; and the first ingredient designated in the ingredient list of whole durum wheat flour is ``whole durum wheat flour’’. (16) Ingredients that act as leavening agents in food may be declared in the ingredient statement by stating the specific common or usual name of each individual leavening agent in parentheses following the collective name ``leavening’’, e.g., ``leavening (baking soda, monocalcium phosphate, and calcium carbonate)’’. The listing of the common or usual name of each individual leavening agent in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of leavening agents in the product, the listing of individual leavening agents need not be in descending order of predominance. Leavening agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as ``or’’, ``and/or’’, ``contains one or more of the following:’’. (17) Ingredients that act as yeast nutrients in foods may be declared in the ingredient statement by stating the specific common or usual name of each individual yeast nutrient in parentheses following the collective name ``yeast nutrients’’, e.g., ``yeast nutrients (calcium sulfate and ammonium phosphate)’’. The listing of the common or usual name of each individual yeast nutrient in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of yeast nutrients in the product, the listing of the common 96

§ 101.4

or usual names of individual yeast nutrients need not be in descending order of predominance. Yeast nutrients not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as ``or’’, ``and/or’’, or ``contains one or more of the following:’’. (18) Ingredients that act as dough conditioners may be declared in the ingredient statement by stating the specific common or usual name of each individual dough conditioner in parentheses following the collective name ``dough conditioner’’, e.g., ``dough conditioners (L-cysteine, ammonium sulfate)’’. The listing of the common or usual name of each dough conditioner in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of dough conditioners in the product, the listing of the common or usual names of individual dough conditioners need not be in descending order of predominance. Dough conditioners not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as ``or’’, ``and/or’’, or ``contains one or more of the following:’’. (19) Ingredients that act as firming agents in food (e.g., salts of calcium and other safe and suitable salts in canned vegetables) may be declared in the ingredient statement, in order of predominance appropriate for the total of all firming agents in the food, by stating the specific common or usual name of each individual firming agent in descending order of predominance in parentheses following the collective name ``firming agents’’. If the manufacturer is unable to adhere to a constant pattern of firming agents in the food, the listing of the individual firming agents need not be in descending order of predominance. Firming agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as ``or’’, ``and/or’’, ``contains one or more of the following:’’. (20) For purposes of ingredient labeling, the term sugar shall refer to sucrose, which is obtained from sugar cane or sugar beets in accordance with the provisions of Sec. 184.1854 of this chapter. (21) [Reserved] (22) Wax and resin ingredients on fresh produce when such produce is held for retail sale, or when held for other than retail sale by packers or repackers shall be declared collectively by the phrase ``coated with food-grade animalbased wax, to maintain freshness’’ or the phrase ``coated with food-grade vegetable-, petroleum-, beeswax-, and/or shellac-based wax or resin, to maintain freshness’’ as appropriate. The terms ``food-grade’’ and ``to maintain freshness’’ are optional. The term lac-resin may be substituted for the term shellac. (23) When processed seafood products contain fish protein ingredients consisting primarily of the myofibrillar protein fraction from one or more fish species and the manufacturer is unable to adhere to a constant pattern of fish species in the fish protein ingredient, because of seasonal or other limitations of species availability, the common or usual name of each individual fish species need not be listed in descending order of predominance. Fish species not present in the fish protein ingredient may be listed if they are sometimes used in the product. Such ingredients must be identified by words indicating that they may not be present, such as ``or’’, ``and/or’’, or ``contains one or more of the following:’’ Fish protein ingredients may be declared in the ingredient statement by stating the specific common or usual name of each fish species that may be present in parentheses following the collective name ``fish protein’’, e.g., ``fish protein (contains one or more of the following: Pollock, cod, and/or pacific whiting)’’. (c) When water is added to reconstitute, completely or partially, an ingredient permitted by paragraph (b) of this section to be declared by a class name, the position of the ingredient class name in the ingredient statement shall be determined by the weight of the unreconstituted ingredient plus the weight of the quantity of water added to reconstitute that ingredient, up to the amount of water needed to reconstitute the ingredient to single strength. Any water added in excess of the amount of water needed to reconstitute the ingredient to single strength shall be declared as ``water’’ in the ingredient statement. (d) When foods characterized on the label as ``nondairy’’ contain a caseinate ingredient, the caseinate ingredient shall be followed by a parenthetical statement identifying its source. For example, if the manufacturer uses the term ``nondairy’’ on a creamer that contains sodium caseinate, it shall include a parenthetical term such as ``a milk derivative’’ after the listing of sodium caseinate in the ingredient list. (e) If the percentage of an ingredient is included in the statement of ingredients, it shall be shown in parentheses following the name of the ingredient and expressed in terms of percent by weight. Percentage declarations shall be expressed to the nearest 1 percent, except that where ingredients are present at levels of 2 percent or less, they may be grouped together and expressed in accordance with the quantifying guidance set forth in paragraph (a)(2) of this section. 97

§ 101.5

(f) Except as provided in Sec. 101.100, ingredients that must be declared on labeling because there is no label for the food, including foods that comply with standards of identity, shall be listed prominently and conspicuously by common or usual name in the manner prescribed by paragraph (b) of this section. (g) When present, the ingredient list on dietary supplement products shall be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label and shall be preceded by the word ``Ingredients,’’ unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with Sec. 101.36(d), in which case the ingredients listed outside the nutrition label shall be in a list preceded by the words ``Other ingredients.’’ Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders, shall be included in the ingredient list. (h) The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Herbal Products Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-588-1171, FAX 301-588-1174, e-mail: [email protected], or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 Capital St. NW., suite 700, Washington, DC. The listing of these names on the label shall be followed by statements of: (1) The part of the plant (e.g., root, leaves) from which the dietary ingredient is derived (e.g., ``Garlic bulb’’ or ``Garlic (bulb)’’), except that this designation is not required for algae. The name of the part of the plant shall be expressed in English (e.g., ``flower’’ rather than ``flos’’); (2) The Latin binomial name of the plant, in parentheses, except that this name is not required when it is available in the reference entitled: Herbs of Commerce for the common or usual name listed on the label, and, when required, the Latin binomial name may be listed before the part of the plant. Any name in Latin form shall be in accordance with internationally accepted rules on nomenclature, such as those found in the International Code of Botanical Nomenclature and shall include the designation of the author or authors who published the Latin name, when a positive identification cannot be made in its absence. The International Code of Botanical Nomenclature (Tokyo Code), 1994 edition, a publication of the International Association for Plant Taxonomy, is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the International Code of Botanical Nomenclature may be obtained from Koeltz Scientific Books, D-61453 Konigstein, Germany, and University Bookstore, Southern Illinois University, Carbondale, IL 62901-4422, 618-536-3321, FAX 618-453-5207, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., Suite 700, Washington DC. (3) On labels of single-ingredient dietary supplements that do not include an ingredient list, the identification of the Latin binomial name, when needed, and the part of the plant may be prominently placed on the principal display panel or information panel, or included in the nutrition label. [42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978; 43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr. 25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR 64634, Dec. 8, 1997; 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. 30, 2001; 66 FR 66742, Dec. 27, 2001]

§ 101.5 Food; name and place of business of manufacturer, packer, or distributor. (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. (b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. (c) Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as ``Manufactured for ______’’, ``Distributed by ______’’, or any other wording that expresses the facts. (d) The statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP code shall apply only to consumer commodity labels developed or revised after the effective date 98

§ 101.9

of this section. In the case of nonconsumer packages, the ZIP code shall appear either on the label or the labeling (including invoice). (e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading. § 101.9 Nutrition labeling of food. (a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section. (1) When food is in package form, the required nutrition labeling information shall appear on the label in the format specified in this section. (2) When food is not in package form, the required nutrition labeling information shall be displayed clearly at the point of purchase (e.g., on a counter card, sign, tag affixed to the product, or some other appropriate device). Alternatively, the required information may be placed in a booklet, looseleaf binder, or other appropriate format that is available at the point of purchase. (3) Solicitation of requests for nutrition information by a statement ``For nutrition information write to ______’’ on the label or in the labeling or advertising for a food, or providing such information in a direct written reply to a solicited or unsolicited request, does not subject the label or the labeling of a food exempted under paragraph (j) of this section to the requirements of this section if the reply to the request conforms to the requirements of this section. (4) If any vitamin or mineral is added to a food so that a single serving provides 50 percent or more of the Reference Daily Intake (RDI) for the age group for which the product is intended, as specified in paragraph (c)(8)(iv) of this section, of any one of the added vitamins or minerals, unless such addition is permitted or required in other regulations, e.g., a standard of identity or nutritional quality guideline, or is otherwise exempted by the Commissioner, the food shall be considered a food for special dietary use within the meaning of Sec. 105.3(a)(1)(iii) of this chapter. (b) Except as provided in Sec. 101.9(h)(3), all nutrient and food component quantities shall be declared in relation to a serving as defined in this section. (1) The term serving or serving size means an amount of food customarily consumed per eating occasion by persons 4 years of age or older which is expressed in a common household measure that is appropriate to the food. When the food is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. (2) Except as provided in paragraphs (b)(3), (b)(4), and (b)(6) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, serving size declared on a product label shall be determined from the ``Reference Amounts Customarily Consumed Per Eating Occasion * * * *’’ (reference amounts) that appear in Sec. 101.12(b) using the procedures described below. For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, ``for sale only through the ______ program’’ (fill in the blank with the name of the appropriate weight-control program, e.g., Smith’s Weight Control), on the principal display panel. However, the reference amounts in Sec. 101.12(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrient content claims or health claims. (i) For products in discrete units (e.g., muffins, sliced products, such as sliced bread, or individually packaged products within a multiserving package) and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., pancakes and syrup), the serving size shall be declared as follows: (A) If a unit weighs 50 percent or less of the reference amount, the serving size shall be the number of whole units that most closely approximates the reference amount for the product category; (B) If a unit weighs more than 50 percent, but less than 67 percent of the reference amount, the manufacturer may declare one unit or two units as the serving size; (C) If a unit weighs 67 percent or more, but less than 200 percent of the reference amount, the serving size shall be one unit; (D) If a unit weighs 200 percent or more of the reference amount, the manufacturer may declare one unit as the serving size if the whole unit can reasonably be consumed at a single-eating occasion. 99

§ 101.9

(E) For products that have reference amounts of 100 grams (g) (or milliliter (mL)) or larger and are individual units within a multiserving package, if a unit contains more than 150 percent but less than 200 percent of the reference amount, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings. (F) The serving size for maraschino cherries shall be expressed as 1 cherry with the parenthetical metric measure equal to the average weight of a medium size cherry. (G) The serving size for products that naturally vary in size (e.g., pickles, shellfish, whole fish, and fillet of fish) may be the amount in ounces that most closely approximates the reference amount for the product category. Manufacturers shall adhere to the requirements in paragraph (b)(5)(vi) of this section for expressing the serving size in ounces. (H) For products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., pancakes and syrup), the serving size may be the number of discrete units represented as the main ingredient plus proportioned minor ingredients used to make the reference amount for the combined product determined in Sec. 101.12(f). (I) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in Sec. 101.9 (that is, are labeled appropriately for individual sale as single-serving containers), the serving size shall be 1 unit. (ii) For products in large discrete units that are usually divided for consumption (e.g., cake, pie, pizza, melon, cabbage), for unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., cake mix, pizza kit), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a large discrete unit usually divided for consumption (e.g., prepared cake packaged with a can of frosting), the serving size shall be the fractional slice of the ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/6 cabbage) that most closely approximates the reference amount for the product category, and may be the fraction of the package used to make the reference amount for the unprepared product determined in Sec. 101.12(c) or the fraction of the large discrete unit represented as the main ingredient plus proportioned minor ingredients used to make the reference amount for the combined product determined in Sec. 101.12(f). In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/4, 1/5, 1/6, or smaller fractions that can be generated by further division by 2 or 3. (iii) For nondiscrete bulk products (e.g., breakfast cereal, flour, sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese kits), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., peanut butter and jelly), the serving size shall be the amount in household measure that most closely approximates the reference amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the reference amount for the combined product determined in Sec. 101.12(f). (3) The serving size for meal products and main dish products as defined in Sec. 101.13 (l) and (m) that comes in single-serving containers as defined in paragraph (b)(6) of this section shall be the entire content (edible portion only) of the package. Serving size for meal products and main dish products in multiserving containers shall be based on the reference amount applicable to the product in Sec. 101.12(b) if the product is listed in Sec. 101.12(b). Serving size for meal products and main dish products in multiserving containers that are not listed in Sec. 101.12(b) shall be based on the reference amount according to Sec. 101.12(f). (4) A variety pack, such as a package containing several varieties of single-serving units as defined in paragraph (b)(2)(i) of this section, and a product having two or more compartments with each compartment containing a different food, shall provide nutrition information for each variety or food per serving size that is derived from the reference amount in Sec. 101.12(b) applicable for each variety or food and the procedures to convert the reference amount to serving size in paragraph (b)(2) of this section. (5) For labeling purposes, the term common household measure or common household unit means cup, tablespoon, teaspoon, piece, slice, fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other common household equipment used to package food products (e.g., jar, tray). In expressing serving size in household measures, except as specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and (b)(5)(vii) of this section, the following rules shall be used: (i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate except for beverages. For beverages, a manufacturer may use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup increments. Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3, 2, or 3 tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 teaspoons. 100

§ 101.9

(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used. (iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not applicable, ounces may be used with an appropriate visual unit of measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2 pickle). Ounce measurements shall be expressed in 0.5 oz increments most closely approximating the reference amount. (iv) A description of the individual container or package shall be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). (v) For unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., cake mix, pizza kit), the fraction or portion of the package may be used. (vi) Ounces with an appropriate visual unit of measure, as described in paragraph (b)(5)(iii) of this section, may be used for products that naturally vary in size as provided for in paragraph (b)(2)(i)(G) of this section. (vii) As provided for in Sec. 101.9(h)(1), for products that consist of two or more distinct ingredients or components packaged and presented to be consumed together (e.g. dry macaroni and cheese mix, cake and muffin mixes with separate ingredient packages, pancakes and syrup), nutrition information may be declared for each component or as a composite. The serving size may be provided in accordance with the provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this section, or alternatively in ounces with an appropriate visual unit of measure, as described in paragraph (b)(5)(iii) of this section (e.g., declared as separate components: ``3 oz dry macaroni (84 g/about 2/3 cup)’’ and ``1 oz dry cheese mix (28 g/about 2 tbsp);’’ declared as a composite value: ``4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry cheese mix)’’). (viii) For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz means 30 mL, and 1 oz in weight means 28 g. (ix) When a serving size, determined from the reference amount in Sec. 101.12(b) and the procedures described in this section, falls exactly half way between two serving sizes, e.g., 2.5 tbsp, manufacturers shall round the serving size up to the next incremental size. (6) A product that is packaged and sold individually and that contains less than 200 percent of the applicable reference amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving except for products that have reference amounts of 100 g (or mL) or larger, manufacturers may decide whether a package that contains more than 150 percent but less than 200 percent of the reference amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable reference amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion. (7) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(6) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams) except for single-serving containers. (i) For a single-serving container, the parenthetical metric quantity, which will be presented as part of the net weight statement on the principal display panel, is not required except where nutrition information is required on a drained weight basis according to Sec. 101.9(b)(9). However, if a manufacturer voluntarily provides the metric quantity on products that can be sold as single servings, then the numerical value provided as part of the serving size declaration must be identical to the metric quantity declaration provided as part of the net quantity of contents statement. (ii) The gram or milliliter quantity equivalent to the household measure should be rounded to the nearest whole number except for quantities that are less than 5 g (mL). The gram (mL) quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) increments. (iii) In addition, serving size may be declared in ounce and fluid ounce, in parenthesis, following the metric measure separated by a slash where other common household measures are used as the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced bread. The ounce quantity equivalent to the metric quantity should be expressed in 0.1 oz increments. (iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for fluid ounce. (v) For products that only require the addition of water or another ingredient that contains insignificant amounts of nutrients in the amount added and that are prepared in such a way that there are no significant changes to the nutrient profile, the amount of the finished product may be declared in parentheses at the end of the serving size declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup prepared)). 101

§ 101.9

(vi) To promote uniformity in label serving sizes in household measures declared by different manufacturers, FDA has provided a guidance document entitled, ``Guidelines for Determining the Gram Weight of the Household Measure.’’ The guidance document can be obtained from the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (8) Determination of the number of servings per container shall be based on the serving size of the product determined by following the procedures described in this section. (i) The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term about (e.g., about 2 servings, about 3.5 servings). (ii) When the serving size is required to be expressed on a drained solids basis and the number of servings varies because of a natural variation in unit size (e.g., maraschino cherries, pickles), the manufacturer may state the typical number of servings per container (e.g., usually 5 servings). (iii) For random weight products, a manufacturer may declare ``varied’’ for the number of servings per container provided the nutrition information is based on the reference amount expressed in ounces. The manufacturer may provide the typical number of servings in parenthesis following the ``varied’’ statement. (iv) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in Sec. 101.9 (that is, are labeled appropriately for individual sale as single-serving containers), the number of servings shall be the number of individual packages within the total package. (v) For packages containing several individually packaged multiserving units, the number of servings shall be determined by multiplying the number of individual multiserving units in the total package by the number of servings in each individual unit. (9) The declaration of nutrient and food component content shall be on the basis of food as packaged or purchased with the exception of raw fish covered under Sec. 101.42 (see 101.44), packaged single-ingredient products that consist of fish or game meat as provided for in paragraph (j)(11) of this section, and of foods that are packed or canned in water, brine, or oil but whose liquid packing medium is not customarily consumed (e.g., canned fish, maraschino cherries, pickled fruits, and pickled vegetables). Declaration of nutrient and food component content of raw fish shall follow the provisions in Sec. 101.45. Declaration of the nutrient and food component content of foods that are packed in liquid which is not customarily consumed shall be based on the drained solids. (10) Another column of figures may be used to declare the nutrient and food component information: (i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as packaged or purchased; (ii) Per one unit if the serving size of a product in discrete units in a multiserving container is more than 1 unit; (iii) Per cup popped for popcorn in a multiserving container. (11) If a product is promoted on the label, labeling, or advertising for a use that differs in quantity by twofold or greater from the use upon which the reference amount in Sec. 101.12(b) was based (e.g., liquid cream substitutes promoted for use with breakfast cereals), the manufacturer shall provide a second column of nutrition information based on the amount customarily consumed in the promoted use, in addition to the nutrition information per serving derived from the reference amount in Sec. 101.12(b), except that nondiscrete bulk products that are used primarily as ingredients (e.g., flour, sweeteners, shortenings, oils), or traditionally used for multipurposes (e.g., eggs, butter, margarine), and multipurpose baking mixes are exempt from this requirement. (c) The declaration of nutrition information on the label and in labeling of a food shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraphs (f) or (j) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraphs (d) or (e) of this section. (1) ``Calories, total,’’ ``Total calories,’’ or ``Calories’’: A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parentheses immediately following the statement of the caloric content. (i) Caloric content may be calculated by the following methods. Where either specific or general food factors are used, the factors shall be applied to the actual amount (i.e., before rounding) of food components (e.g., fat, carbohydrate, protein, or ingredients with specific food factors) present per serving. 102

§ 101.9

(A) Using specific Atwater factors (i. e., the Atwater method) given in Table 13, ``Energy Value of Foods—Basis and Derivation,’’ by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA) Handbook No. 74 (slightly revised, 1973), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is available from the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be inspected at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.; (B) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively, as described in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section); (C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, respectively, as described in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section; (D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of this chapter, or by other means, as appropriate; or (E) Using bomb calorimetry data subtracting 1.25 calories per gram protein to correct for incomplete digestibility, as described in USDA Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section). (ii) ``Calories from fat’’: A statement of the caloric content derived from total fat as defined in paragraph (c)(2) of this section in a serving, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that label declaration of ``calories from fat’’ is not required on products that contain less than 0.5 gram of fat in a serving and amounts less than 5 calories may be expressed as zero. This statement shall be declared as provided in paragraph (d)(5) of this section. Except as provided for in paragraph (f) of this section, if ``Calories from fat’’ is not required and, as a result, not declared, the statement ``Not a significant source of calories from fat’’ shall be placed at the bottom of the table of nutrient values in the same type size. (iii) ``Calories from saturated fat’’ or ``Calories from saturated’’ (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section in a serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories from fat as provided in paragraph (d)(5) of this section. (2) ``Fat, total’’ or ``Total fat’’: A statement of the number of grams of total fat in a serving defined as total lipid fatty acids and expressed as triglycerides. Amounts shall be expressed to the nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero. (i) ``Saturated fat,’’ or ``Saturated’’: A statement of the number of grams of saturated fat in a serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat in a serving if no claims are made about fat or cholesterol content, and if ``calories from saturated fat’’ is not declared. Except as provided for in paragraph (f) of this section, if a statement of the saturated fat content is not required and, as a result, not declared, the statement ``Not a significant source of saturated fat’’ shall be placed at the bottom of the table of nutrient values in the same type size. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero. (ii) ``Polyunsaturated fat’’ or ``Polyunsaturated’’ (VOLUNTARY): A statement of the number of grams of polyunsaturated fat in a serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a food other than one that meets the criteria in Sec. 101.62(b)(1) for a claim for ``fat free,’’ label declaration of polyunsaturated fat is required. Polyunsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero. 103

§ 101.9

(iii) ``Monounsaturated fat’’ or ``Monounsaturated’’ (VOLUNTARY): A statement of the number of grams of monounsaturated fat in a serving defined as cis-monounsaturated fatty acids may be declared voluntarily except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a food other than one that meets the criteria in Sec. 101.62(b)(1) for a claim for ``fat free,’’ label declaration of monounsaturated fat is required. Monounsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero. (3) ``Cholesterol’’: A statement of the cholesterol content in a serving expressed in milligrams to the nearest 5milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams cholesterol in a serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. Except as provided for in paragraph (f) of this section, if cholesterol content is not required and, as a result, not declared, the statement ``Not a significant source of cholesterol’’ shall be placed at the bottom of the table of nutrient values in the same type size. If the food contains 2 to 5 milligrams of cholesterol per serving, the content may be stated as ``less than 5 milligrams.’’ (4) ``Sodium’’: A statement of the number of milligrams of sodium in a specified serving of food expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams. (5) ``Potassium’’ (VOLUNTARY): A statement of the number of milligrams of potassium in a specified serving of food may be declared voluntarily, except that when a claim is made about potassium content, label declaration shall be required. Potassium content shall be expressed as zero when the serving contains less than 5 milligrams of potassium, to the nearest 5-milligram increment when the serving contains less than or equal to 140 milligrams of potassium, and to the nearest 10-milligram increment when the serving contains more than 140 milligrams. (6) ``Carbohydrate, total’’ or ``Total carbohydrate’’: A statement of the number of grams of total carbohydrate in a serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, or if the serving contains less than 0.5 gram, the content may be expressed as zero. Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the food. This calculation method is described in A. L. Merrill and B. K. Watt, ``Energy Value of Foods—Basis and Derivation,’’ USDA Handbook 74 (slightly revised 1973) pp. 2 and 3, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section). (i) ``Dietary fiber’’: A statement of the number of grams of total dietary fiber in a serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required or, alternatively, the statement ``Contains less than 1 gram’’ or ``less than 1 gram’’ may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero. Except as provided for in paragraph (f) of this section, if dietary fiber content is not required and as a result, not declared, the statement ``Not a significant source of dietary fiber’’ shall be placed at the bottom of the table of nutrient values in the same type size. (A) ``Soluble fiber’’ (VOLUNTARY): A statement of the number of grams of soluble dietary fiber in a serving may be declared voluntarily except when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. (B) ``Insoluble fiber’’ (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. (ii) ``Sugars’’: A statement of the number of grams of sugars in a serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars in a serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Except as provided for in paragraph (f) of this section, if a statement of the sugars content is not required and, as a result, not declared, the statement ``Not a significant source of sugars’’ shall be placed at the bottom of the table of nutrient values in the same type size. Sugars shall be defined as the sum 104

§ 101.9

of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less then 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. (iii) ``Sugar alcohol’’ (VOLUNTARY): A statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term ``sugar alcohol,’’ the name of the specific sugar alcohol (e.g., ``xylitol’’) present in the food may be used in the nutrition label provided that only one sugar alcohol is present in the food. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less then 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. (iv) ``Other carbohydrate’’ (VOLUNTARY): A statement of the number of grams of other carbohydrates may be declared voluntarily. Other carbohydrates shall be defined as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared (even if present), it shall be defined as the difference between total carbohydrate and the sum of dietary fiber and sugars. Other carbohydrate content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. (7) ``Protein’’: A statement of the number of grams of protein in a serving, expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram’’ or ``less than 1 gram’’ may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in foods represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a food represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement ``not a significant source of protein,’’ or a listing aligned under the column headed ``Percent Daily Value’’ of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as Percent of Daily Value. When the protein quality in a food as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a food represented or purported to be for infants, the statement ``not a significant source of protein’’ shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis as given in the ``Official Methods of Analysis of the AOAC International’’ (formerly the Association of Official Analytical Chemists), 15th Ed. (1990), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, except when the official procedure for a specific food requires another factor. Copies may be obtained from Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be inspected at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be for use by infants or children under 4 years of age. When such a declaration is provided, it shall be placed on the label adjacent to the statement of grams of protein and aligned under the column headed ``Percent Daily Value,’’ and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the food is represented or purported to be for use by infants and the protein quality value is less than 40 percent of the reference standard. (ii) The ``corrected amount of protein (gram) per serving’’ for foods represented or purported for adults and children 1 or more years of age is equal to the actual amount of protein (gram) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in 105

§ 101.9

``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,’’ Rome, 1990, except that when official AOAC procedures described in section (c)(7) of this paragraph require a specific food factor other than 6.25, that specific factor shall be used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation’’ as published by the Food and Agriculture Organization of the United Nations/World Health Organization is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be inspected at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. For foods represented or purported for infants, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject food protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00. (iii) For the purpose of labeling with a percent of the Daily Reference Value (DRV) or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, and the RDI for protein for children less than 4 years of age, infants, pregnant women, and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, respectively. (8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, calculated as a percent of the RDI and expressed as percent of Daily Value. (i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d), (e), and (f) of this section, foods represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI’s that are specified for the intended group. For foods represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on foods represented or purported to be for use by both pregnant and lactating women. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. All other foods shall use the RDI for adults and children 4 or more years of age. (ii) The declaration of vitamins and minerals as a percent of the RDI shall include vitamin A, vitamin C, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added as a nutrient supplement, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or in labeling or advertising and the vitamins and minerals are: (A) Required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and that standardized food is included as an ingredient (i.e., component) in another food; or (B) Included in a food solely for technological purposes and declared only in the ingredient statement. The declaration may also include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are naturally occurring in the food. The additional vitamins and minerals shall be listed in the order established in paragraph (c)(8)(iv) of this section. (iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50percent level, and the nearest 10-percent increment above the 50-percent level. Amounts of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement ``Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients)’’ or ``Contains < 2 percent of the Daily Value of this (these) nutrient (nutrients).’’ Alternatively, except as provided for in paragraph (f) of this section, if vitamin A, vitamin C, calcium, or iron is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement ``Not a significant source of __ (listing the vitamins or minerals omitted)’’ is placed at the bottom of the table of nutrient values. Either statement shall be in the same type size as nutrients that are indented. (iv) The following RDI’s and nomenclature are established for the following vitamins and minerals which are essential in human nutrition:

106

§ 101.9

Vitamin A, 5,000 International Units Vitamin C, 60 milligrams Calcium, 1,000 milligrams Iron, 18 milligrams Vitamin D, 400 International Units Vitamin E, 30 International Units Vitamin K, 80 micrograms Thiamin, 1.5 milligrams Riboflavin, 1.7 milligrams Niacin, 20 milligrams Vitamin B6, 2.0 milligrams Folate, 400 micrograms Vitamin B12,6 micrograms Biotin, 300 micrograms Pantothenic acid, 10 milligrams Phosphorus, 1,000 milligrams Iodine, 150 micrograms Magnesium, 400 milligrams Zinc, 15 milligrams Selenium, 70 micrograms Copper, 2.0 milligrams Manganese, 2.0 milligrams Chromium, 120 micrograms Molybdenum, 75 micrograms Chloride, 3,400 milligrams

(v) The following synonyms may be added in parentheses immediately following the name of the nutrient or dietary component: Calories—Energy Vitamin C—Ascorbic acid Thiamin—Vitamin B1 Riboflavin—Vitamin B2 Folate—Folic acid or Folacin. Alternatively, folic acid or folacin may be listed without parentheses in place of folate.

(vi) A statement of the percent of vitamin A that is present as beta-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent DV of vitamin A in the food (e.g., ``Percent Daily Value: Vitamin A 50 (90 percent as beta-carotene)’’). When declared, the percentages shall be expressed in the same increments as are provided for vitamins and minerals in paragraph (c)(8)(iii) of this section. (9) For the purpose of labeling with a percent of the DRV, the following DRV’s are established for the following food components based on the reference caloric intake of 2,000 calories: Food component

Unit of measurement

DRV

Fat...................................... Saturated fatty acids.......... Cholesterol......................... Total carbohydrate............. Fiber................................... Sodium............................... Potassium.......................... Protein...............................

gram (g).......................... do.................................... milligrams (mg)............... grams (g)........................ do.................................... milligrams (mg)............... do.................................... grams (g)........................

65 20 300 300 25 2,400 3,500 50

(d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on foods in the following format, as shown in paragraph (d)(12) of this section, except on foods on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those food products on which the simplified format is required to be used as provided for in paragraph (f) of this section, on foods for infants and children less than 4 107

§ 101.9

years of age as provided for in paragraph (j)(5) of this section, and on foods in small or intermediate-sized packages as provided for in paragraph (j)(13) of this section. In the interest of uniformity of presentation, FDA urges that the nutrition information be presented using the graphic specifications set forth in appendix B to part 101. (i) The nutrition information shall be set off in a box by use of hairlines and shall be all black or one color type, printed on a white or other neutral contrasting background whenever practical. (ii) All information within the nutrition label shall utilize: (A) A single easy-to-read type style, (B) Upper and lower case letters, (C) At least one point leading (i.e., space between two lines of text) except that at least four points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section as shown in paragraph (d)(12), and (D) Letters should never touch. (iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and (d)(8) of this section shall be in type size no smaller than 8 point. Except for the heading ``Nutrition Facts,’’ the information required in paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other information contained within the nutrition label shall be in type size no smaller than 6 point. When provided, the information described in paragraph (d)(10) of this section shall also be in type no smaller than 6 point. (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) of this section (i.e., ``Nutrition Facts,’’ ``Amount per Serving,’’ and ``% Daily Value*’’), the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., ``Calories,’’ ``Total Fat,’’ ``Cholesterol,’’ ``Sodium,’’ ``Total Carbohydrate,’’ and ``Protein’’), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted by bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. No other information shall be highlighted. (v) A hairline rule that is centered between the lines of text shall separate ``Amount Per Serving’’ from the calorie statements required in paragraph (d)(5) of this section and shall separate each nutrient and its corresponding percent Daily Value required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent Daily Value above and below it, as shown in paragraph (d)(12) of this section. (2) The information shall be presented under the identifying heading of ``Nutrition Facts’’ which shall be set in a type size larger than all other print size in the nutrition label and, except for labels presented according to the format provided for in paragraph (d)(11) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section, as shown in paragraph (d)(12) of this section. (3) Information on serving size shall immediately follow the heading as shown in paragraph (d)(12) of this section. Such information shall include: (i) ``Serving Size’’: A statement of the serving size as specified in paragraph (b)(7) of this section. (ii) ``Servings Per Container’’: The number of servings per container, except that this statement is not required on single serving containers as defined in paragraph (b)(6) of this section or on other food containers when this information is stated in the net quantity of contents declaration. (4) A subheading ``Amount Per Serving’’ shall be separated from serving size information by a bar as shown in paragraph (d)(12) of this section. (5) Information on calories shall immediately follow the heading ``Amount Per Serving’’ and shall be declared in one line, leaving sufficient space between the declaration of ``Calories’’ and ``Calories from fat’’ to allow clear differentiation, or, if ``Calories from saturated fat’’ is declared, in a column with total ``Calories’’ at the top, followed by ``Calories from fat’’ (indented), and ``Calories from saturated fat’’ (indented). (6) The column heading ``% Daily Value,’’ followed by an asterisk (e.g., ``% Daily Value*’’), shall be separated from information on calories by a bar as shown in paragraph (d)(12) of this section. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the left of, and below, this column heading. The column headings ``Percent Daily Value,’’ ``Percent DV,’’ or ``% DV’’ may be substituted for ``% Daily Value.’’ (7) Except as provided for in paragraph (j)(13) of this section, nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label, except vitamins and minerals, shall be declared as follows: (i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a ``g’’ for grams or a ``mg’’ for milligrams as shown in paragraph (d)(12) of this section. The symbol ``0.95 g/cm3 and polypropylene containers that contact food only of the types identified in Sec. 176.170(c) of this chapter, Table 1, under types I, VI-B, VII-B, and VIII, under the conditions of use E through G described in Table 2 of Sec. 176.170(c) of this chapter, provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.1 percent by weight in molded or extruded polypropylene homopolymers and copolymers that contact food only of the types identified in Sec. 176.170(c) of this chapter, Table 1, under Types II, III,

991

§ 178.3130

————————————————————————————————————————— List of substances Limitations ————————————————————————————————————————— IV, V, VII-A, and IX, under the conditions of use C through G described in Table 2 of Sec. 176.170(c) of this chapter. N,N-Bis(2-hydroxyethyl) alkylamine, For use only: 1. As an antistatic agent at where the alkyl groups (C14-C18) are derived from tallow. levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in Sec. 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of Sec. 176.170(c) of this chapter provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of foodcontact surface in vinylidene chloride copolymer coatings complying with Sec. 175.320, Sec. 177.1200, or Sec. 177.1630 of this chapter, provided that such coatings contact food only of the types identified in Sec. 176.170(c) of this chapter, table 1, under Types I, IV, VII, VIII, and IX under the conditions of use E through G described in table 2 of Sec. 176.170(c) of this chapter. The finished copolymers shall contain at least 70 weight pct of polymer units derived from vinylidene chloride; and shall contain not more than 5 weight pct of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid. N,N-Bis(2-hydroxyethyl)dodecanamide For use only: produced when diethanolamine is made 1. As an antistatic agent at to react with methyl laurate such that levels not to exceed 0.5 the finished product: Has a minimum percent by weight of molded or melting point of 36 1/2C; has a extruded polyethylene minimum amide assay of 90 percent; containers intended for contains no more than 2 percent by contact with honey, chocolate weight of free diethanolamine; and syrup, liquid sweeteners, contains no more than 0.5 percent by condiments, flavor extracts weight of N,N, bis(2and liquid flavor hydroxyethyl)piperazine, as determined concentrates, grated cheese, by paper chromatography method. light and heavy cream, yogurt, and foods of Type VIII as described in table 1 of Sec. 176.170(c) of this chapter. 2. As an antistatic agent at levels not to exceed 0.2 percent by weight in polypropylene films complying with Sec. 177.1520 of this chapter, and used in contact with food of Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table 1 of Sec. 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. The average thickness of such polypropylene film shall not exceed 0.001 inches (30 micrometers). N,N-Bis(2-hydroxyethyl) dodecanamide For use only as an antistatic produced when diethanolamine is made agent at levels not to exceed to react with methyl laurate such that 0.5 percent by weight of

992

§ 178.3130

————————————————————————————————————————— List of substances Limitations ————————————————————————————————————————— the finished product: Has a minimum molded or extruded melting point of 36 °C; has a minimum polyethylene containers amide assay of 90 percent; contains no intended for contact with more than 2 percent by weight of free honey, chocolate syrup, liquid diethanolamine; and contains no more sweeteners, condiments, flavor than 0.5 percent by weight of N,N’extracts and liquid flavor bis(2-hydroxyethyl) piperazine, as concentrates, grated cheese, determined by paper chromatography light and heavy cream, yogurt, method. and foods of Type VIII as described in table 1 of Sec. 176.170(c) of this chapter. N,N-Bis(2-hydroxyethyl) octadecylamine, For use only as an antistatic Chemical Abstracts Service Registry agent at levels not to exceed No. 10213-78-2, N-(2-hydroxyethyl)-N0.45 percent by weight in octadecylglycine (monosodium salt), polypropylene films complying Chemical Abstracts Service Registry with Sec. 177.1520 of this No. 66810-88-6, and N,N-Bis(2chapter, and used for hydroxyethyl)-N-(carboxymethyl) packaging food of Types I, II, octadecanaminum hydroxide (inner III, IV, V, VI-B, VII, VIII, salt), Chemical Abstracts Service and IX described in table 1 of Registry No. 24170-14-7, as the major Sec. 176.170(c) of this components of a mixture prepared by chapter, and under conditions reacting ethylene oxide with of use B through H described octadecylamine and further reacting in table 2 of Sec. this product with sodium 176.170(c). The average monochloroacetate and sodium thickness of such hydroxide, such that the final product polypropylene film shall not has: A nitrogen content of 3.3-3.8 exceed 0.002 inch. percent; a melting point of 42-50 °C; and a pH of 10.0-11.5 in a 1 percent by weight aqueous solution. α-n-Dodecanol-omegaFor use only as an antistatic hydroxypoly (oxyethylene) produced by agent at levels not to exceed the condensation of 1 mole of n0.2 pct by weight in lowdodecanol with an average of 9.5 moles density polyethylene film of ethylene oxide to form a condensate having an average thickness having a hydroxyl content of 2.7 to not exceeding 0.005 inch. 2.9 pct and having a cloud point of 80 °C to 92 °C in 1 pct by weight aqueous solution. Glycerol ester mixtures of ricinoleic As an antifogging agent at acid, containing not more than 50 levels not exceeding 1.5 pct percent monoricinoleate, 45 pct by weight of permitted diricinoleate, 10 pct triricinoleate, plasticized vinyl chloride and 3.3 pct free glycerine. homo-and/or copolymers. N-Methacryloyloxyethyl-N, NFor use only as an antistatic dimethylammonium-α-N-methyl agent at levels not to exceed carboxylate chloride sodium salt, 0.2 percent by weight of octadecyl methacrylate, ethyl polyolefin films that contact methacrylate, cyclohexyl methacrylate, foods under the conditions of N-vinyl-2-pyrrolidone copolymer (CAS use B through H described in Reg. No. 66822-60-4). table 2 of Sec. 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch). Octadecanoic acid 2-[2-hydroxyethyl) For use only as an antistatic octadecylamino]ethyl ester (CAS Reg. agent at levels such that the No. 52497-24-2), (octadecylimino) product of film thickness in diethylene distearate (CAS Reg. No. microns times the weight 94945-28-5), and octadecyl percent additive does not bis(hydroxyethyl)amine (CAS Reg. No. exceed 16, in polypropylene 10213-78-2), as the major components films complying with Sec. of a mixture prepared by reacting 177.1520(c)1.1 of this ethylene oxide with octadecylamine and chapter, and used for further reacting this product with packaging food (except for octadecanoic acid, such that the final food containing more than 8 product has: a maximum acid value of 5 percent alcohol) under mg KOH/g and total amine value of conditions of use B through H 86±6 mg KOH/g as determined described in table 2 of Sec. by a method entitled ``Total Amine 176.170(c) of this chapter. Value,’’ which is incorporated by reference. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. —————————————————————————————————————————

[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999]

993

§ 178.3280

§ 178.3280 Castor oil, hydrogenated. Hydrogenated castor oil may be safely used in the manufacture of articles or components of articles intended for use in contact with food subject to the provisions of this section. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) The additive is used as follows: ———————————————————————————————————————— Use Limitations ———————————————————————————————————————— 1. As a lubricant for vinyl chloride For use only at levels not to polymers used in the manufacture of exceed 4 pct by weight of articles or components of articles vinyl chloride polymers. authorized for food-contact use. 2. As a component of cellophane........ Complying with Sec. 177.1200 of this chapter. 3. As a component of resinous and Complying with Sec. 175.300 of polymeric coatings. this chapter. 4. As a component of paper and Complying with Sec. 176.170 of paperboard in contact with aqueous and this chapter. fatty food. 5. As a component of closures with Complying with Sec. 177.1210 sealing gaskets for food containers. of this chapter. 6. As a component of cross-linked Complying with Sec. 177.2420 polyester resins. of this chapter. 7. As a component of olefin polymers For use only at levels not to complying with Sec. 177.1520 of this exceed 2 percent by weight of chapter. the polymer. ————————————————————————————————————————

[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990] § 178.3290 Chromic chloride complexes. Myristo chromic chloride complex and stearato chromic chloride complex may be safely used as release agents in the closure area of packaging containers intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The quantity used shall not exceed that reasonably required to accomplish the intended technical effect nor exceed 7 micrograms of chromium per square inch of closure area. (b) The packaging container which has its closure area treated with the release agent shall have a capacity of not less than 120 grams of food per square inch of such treated closure area. § 178.3295 Clarifying agents for polymers. Clarifying agents may be safely used in polymers that are articles or components of articles intended for use in contact with food, subject to the provisions of this section: ———————————————————————————————————————— Substances Limitations ———————————————————————————————————————— Aluminum, hydroxybis[2,4,8,10For use only as a clarifying tetrakis(1,1-dimethylethyl)-6-hydroxyagent at levels not to exceed 12H-dibenzo[d,g][1,3,2]dioxaphosphocin 0.25 percent by weight of 6-oxidato]-(CAS Reg. No. 151841-65-5). polypropylene and polypropylene copolymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2. The finished polymers contact food only of types I, II, IV-B, VIB, VII-B, and VIII as identified in Table 1 of Sec. 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of Sec. 176.170(c) of this chapter or foods only of types III, IV-A, V, VI-A, VI-C, VIIA, and IX as identified in Table 1 of Sec. 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of Sec. 176.170(c) of this chapter.

994

§ 178.3295

———————————————————————————————————————— Substances Limitations ———————————————————————————————————————— Bis(p-ethylbenzylidene) sorbitol (CAS For use only as a clarifying Reg. No. 79072-96-1). agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or 3.2b, where the copolymers complying with items 3.1a, 3.2a, or 3.2b contain not less than 85 weight percent of polymer units derived from propylene. Di(p-tolylidene) sorbitol (CAS Reg. No. For use only as a clarifying 54686-97-4). agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with Sec. 177.1520(c) of this chapter, item 1.1, and in olefin copolymers complying with Sec. 177.1520(c) of this chapter, item 3.1 (containing at least 85 weight percent of polymer units derived from propylene), in contact with all food types under conditions of use C through G described in table 2 of Sec. 176.170(c) of this chapter. Dibenzylidene sorbitol (CAS Reg. No. For use only as a clarifying 32647-67-9) formed by the condensation agent for olefin polymers of two moles of benzaldehyde with one complying with Sec. mole of sorbitol, such that the final 177.1520(c) 1.1, 3.1, and 3.2 product has a minimum content of 95 of this chapter under percent dibenzylidene sorbitol. conditions of use C, D, E, F, and G, described in table 2 of Sec. 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer. Dimethyldibenzylidene sorbitol (CAS For use only as a clarifying Reg. No. 135861-56-2) agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene. The finished polymers shall be used in contact with food under conditions of use A through H described in table 2 of Sec. 176.170(c) of this chapter. Polyvinylcyclohexane (CAS Reg. No. For use only as a clarfiying 25498-06-0). agent for polypropylene complying with Sec. 177.1520(c) of this chapter, item 1.1., and in propylene containing copolymers complying with Sec. 177.1520(c) of this chapter, items 3.1 and 3.2, at a level not exceeding 0.1 percent by weight of the polyolefin. Sodium di(p-tert-butylphenyl)phosphate For use only as a clarifying (CAS Reg. No. 10491-31-3). agent at a level not exceeding 0.35 parts per hundred of the resin in olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene). Sodium 2,2’-methylenebis(4,6-di-tertFor use only: butylphenyl)phosphate (CAS Reg. No. 1. As a clarifying agent at a 85209-91-2). level not exceeding 0.30

995

§ 178.3297

———————————————————————————————————————— Substances Limitations ———————————————————————————————————————— percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene). The finished polymers contact foods only of types I, II, IV-B, VI-B, VIIB, and VIII as identified in table 1 of Sec. 176.170(c) of this chapter and limited to conditions of use B through H, described in table 2 of Sec. 176.170(c), or foods of all types, limited to conditions of use C through H described in table 2 of Sec. 176.170(c). 2. As a clarifying agent at levels not exceeding 0.10 percent by weight of polypropylene complying with Sec. 177.1520(c) of this chapter, items 1.1(a) or 1.1(b) and of olefin polymers complying with Sec. 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not less than 85 weight percent of the polymer units derived from polypropylene.) The finished polymers shall be used in contact with foods only under conditions of use A through H described in Table 2 of Sec. 176.170(c) of this chapter. 3. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with Sec. 177.1520(c) of this chapter, item 2.2, where the finished polymer contacts food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identified in Table 1 of Sec. 176.170(c) of this chapter, and limited to conditions of use B through H described in Table 2 of Sec. 176.170(c) of this chapter, or foods of types III, IV-A, V, VI-C, and VII-A as identified in Table 1 of Sec. 176.170(c) of this chapter and limited to conditions of use C through G described in Table 2 of Sec. 176.170(c) of this chapter. ———————————————————————————————————————

[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]

§ 178.3297 Colorants for polymers. The substances listed in paragraph (e) of this section may be safely used as colorants in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions and definitions set forth in this section: (a) The term colorant means a dye, pigment, or other substance that is used to impart color to or to alter the color of a food-contact material, but that does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye. For the purpose of this section, the term ``colorant’’ includes substances such as optical 996

§ 178.3297

brighteners and fluorescent whiteners, which may not themselves be colored, but whose use is intended to affect the color of a food-contact material. (b) The colorant must be used in accordance with current good manufacturing practice, including use levels which are not in excess of those reasonably required to accomplish the intended coloring effect. (c) Colorants in this section must conform to the description and specifications indicated. If a polymer described in this section is itself the subject of a regulation promulgated under section 409 of the Federal Food, Drug, and Cosmetic Act, it shall also comply with any specifications and limitations prescribed by that regulation. Extraction testing guidelines to conduct studies for additional uses of colorants under this section are available from the Food and Drug Administration free of charge from the Center for Food Safety and Applied Nutrition, (HFS-200) Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (d) Color additives and their lakes listed for direct use in foods, under the provisions of the color additive regulations in parts 73, 74, 81, and 82 of this chapter, may also be used as colorants for food-contact polymers. (e) List of substances: ————————————————————————————————————————— Substances Limitations ————————————————————————————————————————— Aluminum............................... Aluminum hydrate....................... Aluminum and potassium silicate (mica). Aluminum mono-, di-, and tristearate... Aluminum silicate (China clay)......... 4-[[5-[[[4-(Aminocarbonyl) phenyl] For use at levels not to exceed amino]carbonyl]- 2-methoxyphenyl]azo]1 percent by weight of N-(5-chloro-2,4-dimethoxyphenyl)-3polymers. The finished hydroxy-2-naphthalene-carboxamide articles are to contact foods (C.I. Pigment Red 187, CAS Reg. No. only under conditions of use B 59487-23-9). through H described in table 2 of Sec. 176.170(c) of this chapter. N-[4-(Aminocarbonyl)phenyl]-4-[[1For use at levels not to exceed [[(2,3-dihydro-2-oxo-1H-benzimidazol-51 percent by weight of yl)amino]carbonyl]-2polymers. The finished oxopropyl]azo]benzamide (C. I. Pigment articles are to contact food Yellow 181, CAS Reg. No. 74441-05-7). only under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. Anthra(2,1,9-def:(6,5,10For use at levels not to exceed d’e’f)diisoquinoline-1,3,8,10(2H,9H)1% by weight of polymers. The tetrone (C.I. Pigment Violet 29; CAS finished articles are to Reg. No. 81-33-4). contact food only under conditions of use B through H as described in Table 2 of Sec. 176.170(c) of this chapter. Barium sulfate......................... Bentonite.............................. Bentonite, modified with 3dimethyldioctadecylammonium ion. 1,4-Bis[(2,4,6-trimethylphenyl)amino]For use at levels not to exceed 9,10-anthracenedione (CAS Reg. No. 1160.0004 percent by weight of 75-6). polyethylene phthalate polymers complying with Sec. 177.1630 of this chapter. 3,6-Bis(4-chlorophenyl)-2,5-dihydroFor use only at levels not to pyrrolo[3,4-c]pyrrole-1,4-dione (C.I. exceed 1 percent by weight of Pigment Red 254, CAS Reg. No. 84632-65polymers. The finished 5). articles are to contact food only under conditions of use B through H, described in table 2 of Sec. 176.170(c) of this chapter. 4,4’-Bis(4-anilino-6-diethanolamineFor use only in the textile α-triazin-2-ylamino)-2,2’fibers specified in Sec. stilbene disulfonic acid, disodium 177.2800 of this chapter. salt. 4,4’-Bis(4-anilino-6-methylethanolamineDo. α-triazin-2-ylamino)-2,2’stilbene disulfonic acid, disodium salt. Burnt umber............................ Calcium carbonate...................... Calcium silicate....................... Calcium sulfate........................ Carbon black (channel process, prepared by the impingement process from stripped natural gas).

997

§ 178.3297

————————————————————————————————————————— Substances Limitations ————————————————————————————————————————— 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3For use at levels not to exceed sulfophenyl)-1H-pyrazol-4-yl]azo]-51.0 percent by weight of the methylbenzenesulfonic acid, calcium finished polymers. The salt (1:1); (C.I. Pigment Yellow 191, finished articles are to CAS Reg. No. 129423-54-7). contact food only under conditions of use B through H as described in table 2 of Sec. 176.170(c) of this chapter. 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3For use at levels not to sulfophenyl)-1H-pyrazol-4-yl]azo]-5exceed 0.5 percent by weight methylbenzenesulfonic acid, diammonium of polymers. The finished salt (1:2): (C.I. Pigment Yellow articles are to contact food 191:1, CAS Reg. No. 154946-66-4). under conditions of use A through H described in Table 2 of Sec. 176.170(c) of this chapter. Chrome antimony titanium buff rutile For use at levels not to exceed (C.I. Pigment Brown 24, CAS Reg. No. 1 percent by weight of 68186-90-3). polymers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of Sec. 176.170(c) of this chapter. For use only: Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. 77288). 1. In polymers used in contact with food at a level not to exceed 5 percent by weight of the polymer, except as specified below. 2. In olefin polymers complying with Sec. 177.1520 of this chapter. 3. In repeat-use rubber articles complying with Sec. 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber articles. Cobalt aluminate....................... For use only: 1. In resinous and polymeric coatings complying with Sec. 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with Sec. 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 44’isopropylidenediphenolepichlorohydrin epoxy resins complying with Sec. 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with Sec. 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with Sec. 177.1900 of this chapter. 6. At levels not to exceed 5 percent by weight of all polymers except those listed under limitations 1 through 5 of this item. The finished articles are to contact food under conditions of use A through H described in table 2 of Sec. 176.170(c) of this chapter. Copper chromite black spinel (C.I. For use at levels not to exceed Pigment Black 28, CAS Reg. No. 681865 percent by weight of 91-4). polymers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of Sec. 176.170(c) of this chapter. D&C Red No. 7 and its lakes............ Diatomaceous earth.....................

998

§ 178.3297

————————————————————————————————————————— Substances Limitations ————————————————————————————————————————— 4,4’-Diamino-[1,1’-bianthracene]For use at levels not to exceed 9,9’,10,10’-tetrone (CAS Reg. No. 40511 percent by weight of 63-2). polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. 2,9-Dichloro-5,12-dihydroquinone[2,3For use at levels not to exceed b]acridine-7,14-dione (C.I. Pigment 1.0 percent by weight of Red 202, CAS Reg. No. 3089-17-6). polymers. 4,5-Dichloro-2-((5-hydroxy-3-methyl-1For use only: (3-sulfophenyl)-1H-pyrazol-41. At levels not to exceed 1 yl)azo)benzenesulfonic acid, calcium percent by weight of salt(1:1), (C.I. Pigment Yellow 183, polypropylene polymers and CAS Reg. No. 65212-77-3). copolymers complying with Sec. 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, 1.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.4, or 3.5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of Sec. 176.170(c) of this chapter. 2. At levels not to exceed 1 percent by weight of high density polyethylene polymers and copolymers complying with Sec. 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.6 (density not less than 0.94 grams per cubic centimeter), or 5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of Sec. 176.170(c) of this chapter. 5-[(2,3-Dihydro-6-methyl-2-oxo-1HFor use at levels not to exceed benzimidazol-5-yl)azo]-2,4,6(1H, 3H, 1 percent by weight of 5H)-pyrimidinetrione (CAS Reg. No. polymers. The finished 72102-84-2). articles are to contact food only under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. 2,9-Dimethylanthra(2,1,9-def:6,5,10For use at levels not to exceed d’e’f’)diisoquinoline-1,3,8,10(2H,9H)1 percent by weight of tetrone (C.I. Pigment Red 179, CAS polymers. The finished Reg. No. 5521-31-3). articles are to contact food only under conditions of use B through H as described in Table 2 of Sec. 176.170(c) of this chapter. 3,3’-[(2,5-Dimethyl-1,4For use at levels not to exceed phenylene)bis[imino(1-acetyl-2-oxo-2,11 percent by weight of ethanediyl)azo]]bis[4-chloro-N-(5polymers. The finished chloro-2-methylphenyl)-benzamide] (CAS articles are to contact food Reg. No. 5280-80-8). only under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. 3,3’-[(2,5-Dimethyl-1,4For use at levels not to exceed phenylene)bis[imino-carbonyl(2-hydroxy1 percent by weight of 3,1-naphthalenediyl) azo]] bis(4polymers. The finished methylbenzoic acid), bis(2articles are to contact food chloroethyl) ester (CAS Reg. No. 68259only under conditions of use B 05-2). through H described in table 2 of Sec. 176.170(c) of this chapter. 2,2’-[1,2-Ethanediylbis(oxy-2,1For use at levels not to exceed phenyleneazo)]bis[N-(2,3-dihydro-2-oxo1.0 percent by weight of 1H-benzimidazol-5-yl)]-3-oxopolymers. The finished butanamide (C.I. Pigment Yellow 180, articles are to contact food CAS Reg. No. 77804-81-0). only under conditions of use B through G described in table 2 of Sec. 176.170(c) of this chapter. 2,2’-(1,2-Ethenediyldi-4,1-phenylene) For use as an optical bis(benzoxazole) (CAS Reg. No. 1533-45brightener for all polymers at 5). a level not to exceed 0.025

999

§ 178.3297

————————————————————————————————————————— Substances Limitations ————————————————————————————————————————— percent by weight of polymer. The finished polymer shall contact foods only of the types identified in table 1 of Sec. 176.170(c) of this chapter, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII at temperatures not to exceed 275 °F. High-purity furnace black (CAS Reg. No. For use at levels not to exceed 1333-86-4) containing total 2.5 percent by weight of the polynuclear aromatic hydrocarbons not polymer. to exceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled ``Determination of PAH Content of Carbon Black,’’ dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. Iron oxides............................ Kaolin-modified, produced by treating For use only in olefin polymers kaolin with a reaction product of complying with Sec. 177.1520 isopropyl titanate and oleic acid in of this chapter at levels not which 1 mole of isopropyl titanate is to exceed 40 percent by weight reacted with 1 to 2 moles of oleic of olefin polymer. acid. The reaction product will not exceed 8 percent of the modified kaolin. The oleic acid used shall meet the requirements specified in Sec. 172.860 of this chapter. Magnesium oxide........................ Magnesium silicate (talc).............. Manganese Violet (manganese ammonium For use at levels not to exceed pyrophosphate; CAS Reg. No. 10101-662 percent by weight of 3).. polymers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of Sec. 176.170(c) of this chapter. Mixed methylated 4,4’-bis(2For use as an optical benzoxazolyl)stilbenes with the major brightener only at levels not portion consisting of 4-(2to exceed 0.05 percent by benzoxazolyl)-4’-(5-methyl-2weight of rigid and semirigid benzoxazolyl)stilbene (CAS Registry polyvinyl chloride and not to No. 5242-49-9) and lesser portions exceed 0.03 percent by weight consisting of 4,4’-bis(5-methyl-2in all other polymers. The benzoxazolyl)stilbene (CAS Registry finished food-contact articles No. 2397-00-4) and 4,4’-bis(2shall be used only under benzoxazolyl)stilbene (CAS Registry conditions of use D, E, F, and No. 1533-45-5). G described in table 2 of Sec. 176.170(c) of this chapter. 7-(2H-Naphtho[1,2-d]triazol-2-yl)-3For use as an optical phenylcoumarin (CAS Reg. No. 3333-62brightener only in: 8) having a melting point of 250 °C to 1. Olefin polymers complying 251 °C and a nitrogen content of 10.7 with Sec. 177.1520 of this to 11.2 percent. chapter only at levels such that the product of concentration of the optical brightener (expressed in parts per million by weight of the olefin polymer) multiplied by the thickness of the olefin polymer (expressed in thousandths of an inch and limited to no more than 0.400 inch) shall not exceed 500; provided that the level of the brightener shall not exceed 20

1000

§ 178.3297

————————————————————————————————————————— Substances Limitations ————————————————————————————————————————— parts per million by weight of the olefin polymer, and further that the olefin polymers shall comply with specifications for items 1.1, 2.1, 3.1, 3.3, and 4 of Sec. 177.1520(c) of this chapter. The polymer may be used under the conditions described in Sec. 176.170(c) of this chapter, table 2, under conditions of use E, F, and G. 2. Polyethylene terephthalate specified in Sec. 177.2800(d)(5)(i) of this chapter at a level not to exceed 0.035 percent by weight of the finished fibers. Nickel antimony titanium yellow rutile For use at levels not to exceed (C.I. Pigment Yellow 53, CAS Reg. No. 1 percent by weight of 8007-18-9). polymers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of Sec. 176.170(c) of this chapter. 1,1’-[(6-Phenyl-1,3,5-triazine-2,4For use at levels not to exceed diyl)diimino]bis-9,10-anthracenedione 0.25 percent by weight of (CAS Reg. No. 4118-16-5). polyethylene phthalate polymers that comply with Sec. 177.1630 of this chapter. The finished articles are to contact food only under conditions of use E, F, and G described in table 2, Sec. 176.170(c) of this chapter, except, when such articles are used with food types III, IVA, and V, described in table 1, Sec. 176.170(c) of this chapter, the finished articles are to contact food only under conditions of use D, E, F, and G. Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147-14-8). Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260). C.I. Pigment red 38 (C.I. No. 21120)... For use only in rubber articles for repeated use complying with Sec. 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article. Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900). Sienna (raw and burnt)................. Silica................................. 2,3,4,5-Tetrachloro-6-cyanobenzoic For use only at levels not to acid, methyl ester reaction products exceed 1 percent by weight of with p-phenyllenediamine and sodium polymers. The finished methoxide (CAS reg. No. 106276-80-6). articles are to contact food only under conditins of use B through H, described in table 2, of Sec. 176.170(c) of this chapter. 4,5,6,7-Tetrachloro-2-[2-(4,5,6,7For use only at levels not to tetrachloro-2,3-dihydro-1,3-dioxo-1Hexceed 1 percent by weight of inden-2-yl)-8-quinolinyl]-1H-isoindolepolymers. The finished 1,3(2H)-dione (C. I. Pigment Yellow articles are to contact food 138, CAS Reg. No.30125-47-4). only under conditions of use C through H, as described in table 2 of Sec. 176.170(c) of this chapter; provided further that the finished articles shall not be filled at temperatures exceeding 158 °F (70 °C). 2,2’-(2,5-Thiophenediyl)-bis(5-tertFor use as an optical butylbenzoxazole) (CAS Reg. No. 7128brightener: 64-5). 1. In all polymers at levels not to exceed 0.015 percent by weight of the polymer. The

1001

§ 178.3297

————————————————————————————————————————— Substances Limitations ————————————————————————————————————————— finished articles are to contact food only under conditions of use A through H described in table 2 of Sec. 176.170(c) of this chapter. 2. In all polymers at levels not to exceed 0.05 percent by weight of the polymer. The finished articles shall contact foods only of the types identified in table 1 of Sec. 176.170(c) of this chapter, under Categories I, II, IV-B, VI-A, VI-B, VI-C, VII-B, and VIII under conditions of use A through H described in table 2 of Sec. 176.170(c) of this chapter. 3. In adhesives complying with Sec. 175.105 of this chapter and in pressure-sensitive adhesives complying with Sec. 175.125 of this chapter. Titanium dioxide....................... Titanium dioxide-barium sulfate........ Titanium dioxide-magnesium silicate.... Ultramarines........................... As identified in Sec. 73.2725 of this chapter. Zinc carbonate......................... For use only: 1. In resinous and polymeric coatings complying with Sec. 175.300 of this chapter. 2. Melamineformaldehyde resins in molded articles complying with Sec. 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4’isopropylidene diphenolepichlorohydrin epoxy resins complying with Sec. 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with Sec. 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with Sec. 177.1900 of this chapter. Zinc chromate.......................... For use only in rubber articles for repeated use complying with Sec. 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article. Zinc oxide............................. For use only: 1. In resinous and polymeric coatings complying with Sec. 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with Sec. 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4’isopropylidene-diphenolepichlorohydrin epoxy resins complying with Sec. 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with Sec. 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with Sec. 177.1900 of this chapter. Zinc sulfide........................... For use at levels not to exceed 10 percent by weight. —————————————————————————————————————————

[48 FR 46775, Oct. 14, 1983] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting Sec. 178.3297, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

1002

§ 178.3400

§ 178.3300 Corrosion inhibitors used for steel or tinplate. Corrosion inhibitors may be safely used for steel or tinplate intended for use in, or to be fabricated as, food containers or food-processing or handling equipment, subject to the provisions of this section. (a) The corrosion inhibitors are prepared from substances identified in this section and used subject to the limitations prescribed. (b) The following corrosion inhibitors or adjuvants are used in amounts not to exceed those reasonably required to accomplish the intended physical or technical effect: (1) Corrosion inhibitors (active ingredients) used in packaging materials for the packaging of steel or tinplate or articles fabricated therefrom: ———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Dicyclohexylamine and its salts of fatty acids derived from animal or vegetable oil. Dicyclohexylamine nitrite................. Morpholine and its salts of fatty acids derived from animal or vegetable oils. ————————————————————————————————————————

(2) Adjuvants employed in the application and use of corrosion inhibitors: ———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Propylene glycol.......................... ————————————————————————————————————————

§ 178.3400 Emulsifiers and/or surface-active agents. The substances listed in paragraph (c) of this section may be safely used as emulsifiers and/or surface-active agents in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect; and the quantity that may become a component of food as a result of such use shall not be intended to, nor in fact, accomplish any physical or technical effect in the food itself. (b) The use as an emulsifier and/or surface-active agent in any substance or article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with any specifications and limitations prescribed by such regulation for the finished form of the substance or article. (c) List of substances: ———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— α-Alkyl-, α-alkenyl-, For use only at levels not to and α-alkylaryl-omegaexceed 0.5 pct by weight of hydroxypoly(oxyethylene) mixture coatings complying with Sec. consisting of 30 weight pct of 175.320 of this chapter and α-(2,4,6-triisobutylphenyl)-omegalimited to use as an hydroxypoly(oxyethylene) having an emulsifier for polyhydric average poly(oxyethylene) content of 7 alcohol diesters used as moles and 70 weight pct of a 1:1 provided in Sec. 178.3770(b). weight ratio mixture of α-(Z)The weight of the finished 9-octadecenyl-omegacoating shall not exceed 2 hydroxypoly(oxyethylene) having an milligrams per square inch of average poly(oxyethylene) content of food-contact surface. 18 moles and α-alkyl(C16-C18)omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles. n-Alkylbenzenesulfonic acid (alkyl For use only as emulsifiers and/ group consisting of not less than 95 or surface active agents as components of nonfood articles percent C10 to C16) and its ammonium, calcium, magnesium, potassium, and complying with Secs. 175.300, sodium salts. 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010, 177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of this chapter and Sec. 178.3120.

1003

§ 178.3400

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Alkyl mono- and disulfonic acids, For use only: sodium salts (produced from n-alkanes 1. As provided in Sec. 176.170 in the range of C10-C18 with not less of this chapter. than 50 percent C14-C16). 2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with Sec. 177.1980 of this chapter. 3. As emulsifiers in vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished polymer contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX as identified in table 1 of Sec. 176.170(c) of this chapter, and limited to conditions of use E, F, and G described in table 2 of Sec. 176.170 of this chapter. 4. As emulsifiers and/or surface-active agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene complying with Sec. 177.1640(c) of this chapter under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. α-Alkyl-omegahydroxypoly(oxyethylene) produced by condensation of 1 mole of C11-C15 straight-chain randomly substitued secondary alcohols with an average of 7-20 moles of ethylene oxide. alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium salts.

Alpha-sulfo-omega(dodecyloxy)poly(oxyethylene) ammonium salt (CAS Reg. No. 30174-67-5).

Ammonium salt of epoxidized oleic acid, produced from epoxidized oleic acid (predominantly dihydroxystearic and acetoxyhydroxystearic acids) meeting the following specifications: Acid

For use only: 1. In acrylonitrile-butadiene copolymers identified in Sec. 177.2600(c)(4)(i) of this chapter. 2. At levels not to exceed 1 percent by weight of acrylic coatings complying with Sec. 175.300(b)(3)(xx) of this chapter and having a maximum thickness of 0.051 millimeter (0.002 inch). The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of Sec. 176.170(c) of this chapter. 3. At levels not to exceed 2 percent by weight of vinyl chloride copolymer coatings having a maximum thickness of 0.051 millimeter (0.002 inch) and complying with Sec. 175.300(b)(3)(xv) of this chapter. The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of Sec. 176.170(c) of this chapter. 4. As provided in Sec. 175.105 of this chapter. For use only as an emulsifier at levels not to exceed 0.3 percent by weight of styrenebutadiene copolymer coatings for paper and paperboard complying with Sec. 176.170 of this chapter. For use only: 1. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride polymers used

1004

§ 178.3400

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— number 160-180, saponification number as components of nonfood 210-235, iodine number 2-15, and epoxy articles complying with Secs. groups 0-0.4 percent. 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter. Such vinyl chloride polymers are limited to polyvinyl chloride and/or vinyl chloride copolymers complying with Sec. 177.1980 of this chapter. 2. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride-vinyl acetate copolymers used as components of nonfood articles complying with Secs. 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter. For use as a surface active Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also agent as provided in Secs. known as butanedioic acid, sulfo-1,4175.105, 175.125, 176.170, and diisodecyl ester, ammonium salt [CAS 176.180 of this chapter. Reg. No. 144093-88-9]).. α-Di-sec-butylphenyl-omegahydroxypoly(oxyethylene) produced by the condensation of 1 mole of di-secbutylphenol with an average of 4-14 or 30-50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 30-50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents. Disodium 4-isodecyl sulfosuccinate (CAS For use only as an emulsifier Reg. No. 37294-49-8). at levels not to exceed 5 percent by weight of polymers intended for use in coatings. α-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 103-111 and that are produced by the esterification of the condensation product of 1 mole of ndodecyl alcohol with 4-4.5 moles of ethylene oxide. α-(p-Dodecylphenyl)-omegahydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an average of 4-14 or 30-50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 3050. Naphthalene sulfonic acid-formaldehyde For use only: condensate, sodium salt (CAS Reg. No. 1. At levels not to exceed 10 9084-06-4). micrograms/in2 (0.16 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings applied to films of propylene polymers complying with Sec. 177.1520 of this chapter. 2. At levels not to exceed 14 micrograms/in2 (0.21 mg/dm2) in vinylidene chloride copolymer or homopolymer coatings applied to films of polyethylene phthalate polymers complying with Sec. 177.1630 of this chapter. α-(p-nonylphenyl)-omegahydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49-59 and that

1005

§ 178.3400

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— are produced by the esterification of a-(p-nonylphenyl)-omegahydroxypoly (oxyethylene) complying with the identity prescribed in Sec. 178.3400(c) and having an average poly(oxyethylene) content of 5.5-6.5 moles. α-(p-Nonylphenyl)-omegahydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 62-72 and that are produced by the esterification of ‘-(p-nonylphenyl)omega-hydroxypoly (oxyethylene) complying with the identity prescribed in Sec. 178.3400(c) and having an average poly(oxyethylene) content of 9-10 moles. α-(p-Nonylphenyl)-omegahydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 98-110 and that are produced by the esterification of α-(p-nonylphenyl)-omegahydroxypoly (oxyethylene) complying with the identity prescribed in Sec. 178.3400(c) and having an average poly(oxyethylene) content of 45-55 moles. α-(p-Nonylphenyl)-omegahydroxypoly (oxyethylene) produced by the condensation of 1 mole of nonylphenol (nonyl group is a propylene trimer isomer) with an average of 4-14 or 30-50 moles of ethylene oxide: if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 3050. α-(p-Nonylphenyl)-omegahydroxypoly (oxyethylene) sulfate, ammonium or sodium salt: the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content average 4 moles. For use only at levels not to Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate, disodium salt (CAS exceed 5 percent by weight of Reg. No. 68954-91-6). total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. Poly[(methylene-p-nonylphenoxy) For use in coatings at levels poly(oxypropylene)(4-12 moles) not to exceed 1 mg per square propanol] of minimum molecular weight foot of food-contact surface. 3500. Poly(oxypropylene) (45-48 moles) block For use only as a surfacepolymer with poly(oxyethylene). The active agent at levels not to finished block polymers meet the exceed 0.5 percent by weight following specifications: Average of polyolefin film or molecular weight 11,000-18,000; polyolefin coatings. Such hydroxyl number 6.2-10.2; • cloud polyolefin film and polyolefin point above 100 °C. for 10 pct solution. coatings shall have an average thickness not to exceed 0.005 inch and shall be limited to use in contact with foods that have a pH above 5.0 and that contain no more than 8 pct of alcohol. Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate) meeting the following specifications: Saponification number 40-50, acid number 0-2, hydroxyl number 60-108, oxyethylene content 70-74 pct. Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41-52, oxyethylene content 66-70.5 pct.

1006

§ 178.3400

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Polysorbate 60 conforming to the identity prescribed in Sec. 172.836 of this chapter. Polysorbate 65 conforming to the identity prescribed in Sec. 172.838 of this chapter. Polysorbate 80 conforming to the identity prescribed in Sec. 172.840 of this chapter. Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meeting the following specifications: Saponification number 80-95, oxyethylene content 46-50 percent. Sodium 1,4-dicylcohexyl sulfosuccinate. Sodium 1,4-dihexyl sulfosuccinate...... Sodium 1,4 diisobutyl sulfosuccinate... Sodium dioctyl sulfosuccinate.......... Sodium 1,4-dipentyl sulfosuccinate..... Sodium 1,4-ditridecyl sulfosuccinate... Sodium lauryl sulfate.................. Sodium monoalkylphenoxybenzenedisulfonate and sodium dialkylphenoxybenzenedisulfonate mixtures containing not less than 70 pct of the monoalkylated product where the alkyl group is C8-C16. Sorbitan monolaurate meeting the following specifications. Saponification number 153-170; and hydroxyl number 330-360. Sorbitan monooleate meeting the following specifications: Saponification number 145-160, hydroxyl number 193-210. Sorbitan monopalmitate meeting the following specifications: Saponification No. 140-150; and hydroxyl No. 275-305. Sorbitan monostearate conforming to the identity prescribed in Sec. 172.842 of this chapter. Sorbitan trioleate meeting the following specifications: Saponification No. 170-190; and hydroxyl No. 55-70. Sorbitan tristearate meeting the following specifications: Saponification No. 176-188; and hydroxyl No. 66-80. Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, disodium salt (CAS Reg. No. 39354-455).

Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, disodium salt (alcohol moiety produced by condensation of 1 mole nonylphenol and an average of 9-10 moles of ethylene oxide) (CAS Reg. No. 9040-384). α-[p-(1,1,3,3Tetramethylbutyl)phenyl] omegahydroxypoly(oxyethylene) produced by the condensation of 1 mole of p(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-40 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 3050. Tetrasodium N-(1,2-dicarboxyethyl)-Noctadecyl-sulfosuccinate.

For use only at levels not to exceed 5 percent by weight of total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard. For use only at levels not to exceed 5 percent by weight of the total coating monomers used in the emulsion polymerization of polyvinyl acetate and vinyl-acrylate copolymers intended for use as coatings for paper and paperboard.

For use only as a polymerization emulsifier for resins applied to tea-bag material.

1007

§ 178.3450

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— α-Tridecyl-omegahydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 75-85 and that are produced by the esterification of the condensation product of one mole of ``oxo’’ process tridecyl alcohol with 5.5-6.5 moles of ethylene oxide. α-Tridecyl-omegahydroxypoly (oxyethyl-ene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 58-70 and that are produced by the esterification of the condensation product of one mole of ``oxo’’ process tridecyl alcohol with 9-10 moles of ethylene oxide. ————————————————————————————————————————

(d) The provisions of this section are not applicable to emulsifiers and/or surface-active agents listed in Sec. 175.105(c)(5) of this chapter and used in food-packaging adhesives complying with Sec. 175.105 of this chapter. EDITORIAL NOTE: For FEDERAL REGISTER citations affecting Sec. 178.3400, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 178.3450 Esters of stearic and palmitic acids. The ester stearyl palmitate or palmityl stearate or mixtures thereof may be safely used as adjuvants in foodpackaging materials when used in accordance with the following prescribed conditions: (a) They are used or intended for use as plasticizers or lubricants in polystyrene intended for use in contact with food. (b) They are added to the formulated polymer prior to extrusion. (c) The quantity used shall not exceed that required to accomplish the intended technical effect. § 178.3480 Fatty alcohols, synthetic. Synthetic fatty alcohols may be safely used as components of articles intended for use in contact with food, and in synthesizing food additives and other substances permitted for use as components of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) The food additive consists of fatty alcohols meeting the specifications and definition prescribed in Sec. 172.864 of this chapter, except as provided in paragraph (c) of this section. (b) It is used or intended for use as follows: (1) As substitutes for the corresponding naturally derived fatty alcohols permitted for use as components of articles intended for use in contact with food by existing regulations in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter: Provided, That the use is in compliance with any prescribed limitations. (2) As substitutes for the corresponding naturally derived fatty alcohols used as intermediates in the synthesis of food additives and ther substances permitted for use as components of food-contact articles. (c) Synthetic fatty alcohols identified in paragraph (c)(1) of this section may contain not more than 0.8 weight percent of total diols as determined by a method titled ``Diols in Monohydroxy Alcohol by Miniature Thin Layer Chromatography (MTLC),’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl alcohols meeting the specifications and definition prescribed in Sec. 172.864 of this chapter, except that they may contain not more than 0.8 weight percent total diols. (ii) Lauryl, myristyl, cetyl, and stearyl alcohols manufactured by the process described in Sec. 172.864(a)(2) of this chapter such that lauryl and myristyl alcohols meet the specifications in Sec. 172.864(a)(1)(i) of this chapter, and cetyl and stearyl alcohols meet the specifications in Sec. 172.864(a)(1)(ii) of this chapter. 1008

§ 178.3520

(2) Conditions of use. (i) Synthetic fatty alcohols as substitutes for the corresponding naturally derived fatty alcohols permitted for use in compliance with Sec. 178.3910. (ii) Synthetic lauryl alcohol as a substitute for the naturally derived lauryl alcohol permitted as an intermediate in the synthesis of sodium lauryl sulfate used in compliance with Sec. 178.3400. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989]

§ 178.3500 Glycerin, synthetic. Synthetic glycerin may be safely used as a component of articles intended for use in packaging materials for food, subject to the provisions of this section: (a) It is produced by the hydrogenolysis of carbohydrates, and shall contain not in excess of 0.2 percent by weight of a mixture of butanetriols. (b) It is used in a quantity not to exceed that amount reasonably required to produce its intended physical or technical effect, and in accordance with any limitations prescribed by applicable regulations in parts 174, 175, 176, 177, 178 and 179 of this chapter. It shall not be intended to, nor in fact accomplish, any direct physical or technical effect in the food itself. § 178.3505 Glyceryl tri-(12-acetoxystearate). Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The additive is applied to the surface of calcium carbonate at a level not to exceed 1 weight-percent of the total mixture. (b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture is used as an adjuvant in polymers in contact with nonfatty foods at a level not to exceed 20 weight-percent of the polymer. [50 FR 1503, Jan. 11, 1985]

§ 178.3520 Industrial starch-modified. Industrial starch-modified may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) Industrial starch-modified is identified as follows: (1) A food starch-modified or starch or any combination thereof that has been modified by treatment with one of the reactants hereinafter specified, in an amount reasonably required to achieve the desired functional effect but in no event in excess of any limitation prescribed, with or without subsequent treatment as authorized in Sec. 172.892 of this chapter. ———————————————————————————————————————— List of reactants Limitations ———————————————————————————————————————— Ammonium persulfate, not to exceed 0.3 pct. or in alkaline starch not to exceed 0.6 pct.. (4-Chlorobutene-2) trimethylammonium Industrial starch modified by chloride, not to exceed 5 pct. this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging. β-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct. Dimethylaminoethyl methacrylate, not to exceed 3 pct. Dimethylol ethylene urea, not to exceed Industrial starch modified by 0.375 pct. this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging.

1009

§ 178.3530

———————————————————————————————————————— List of reactants Limitations ———————————————————————————————————————— 2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5 pct. Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide in finished product. Phosphoric acid, not to exceed 6 pct Industrial starch modified by and urea, not to exceed 20 pct. this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging and as surface sizing and coating for paper and paperboard that contact food only of Types IVA, V, VII, VIII, and IX described in table 1 of Sec. 176.170(c) of this chapter. ————————————————————————————————————————

(2) A starch irradiated under one of the following conditions to produce free radicals for subsequent graft polymerization with the reactants listed in this paragraph (a)(2): (i) Radiation from a sealed cobalt 60 source, maximum absorbed dose not to exceed 5.0 megarads. (ii) An electron beam source at a maximum energy of 7 million electron volts of ionizing radiation, maximum absorbed dose not to exceed 5.0 megarads. ———————————————————————————————————————— List of reactants Limitations ———————————————————————————————————————— Acrylamide and [2-(methacryloyloxy) For use only as a retention aid ethyl]trimethylammonium methyl and dry strength agent sulfate, such that the finished employed before the sheetindustrial starch-modified shall forming operation in the contain: manufacture of paper and paperboard intended to contact food, and used at a level not to exceed 0.25 pct by weight of the finished dry paper and paperboard fibers. 1. Not more than 60 weight percent vinyl copolymer (of which not more than 32 weight percent is [2(methacryloyloxy)ethyl] trimethylammonium methyl sulfate). 2. Not more than 0.20 pct residual acrylamide. 3. A minimum nitrogen content of 9.0 pct. ————————————————————————————————————————

(b) The following adjuvants may be used as surface-active agents in the processing of industrial starch-modified: Polyethylene glycol (400) dilaurate. Polyethylene glycol (400) monolaurate. Polyoxyethylene (4) lauryl ether.

(c) To insure safe use of the industrial starch-modified, the label of the food additive container shall bear the name of the additive ``industrial starch-modified,’’ and in the instance of an industrial starch-modified which is limited with respect to conditions of use, the label of the food additive container shall contain a statement of such limited use. [42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27, 1977]

§ 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic. Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used in the production of nonfood articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The isoparaffinic petroleum hydrocarbons, produced by synthesis from petroleum gases consist of a mixture of liquid hydrocarbons meeting the following specifications:

1010

§ 178.3570

Boiling point 63 ° -260 °C, as determined by ASTM method D86-82, ``Standard Method for Distillation of Petroleum Products,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Ultraviolet absorbance: 260-319 millimicrons—1.5 maximum. 320-329 millimicrons—0.08 maximum. 330-350 millimicrons—0.05 maximum. Nonvolatile residue 0.002 gram per 100 milliliters maximum. Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under ``Specifications’’ on page 66 of the ``Journal of the Association of Official Agricultural Chemists,’’ Vol. 45 (February 1962), which is incorporated by reference, disregarding the last sentence of that procedure. For hydrocarbons boiling below 121 °C, the nonvolatile residue shall be determined by ASTM method D1353-78, ``Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;’’ for those boiling above 121 °C, ASTM procedure D381-80, ``Standard Test Method for Existent Gum in Fuels by Jet Evaporation,’’ which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (b) Isoparaffinic petroleum hydrocarbons may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended technical effect. (c) Isoparaffinic petroleum hydrocarbons are used in the production of nonfood articles. The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect, and the residual remaining in the finished article shall be the minimum amount reasonably attainable. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984]

§ 178.3570 Lubricants with incidental food contact. Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The lubricants are prepared from one or more of the following substances: (1) Substances generally recognized as safe for use in food. (2) Substances used in accordance with the provisions of a prior sanction or approval. (3) Substances identified in this paragraph (a)(3). ——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— Aluminum stearoyl benzoyl hydroxide.... For use only as a thickening agent in mineral oil lubricants at a level not to exceed 10 pct by weight of the mineral oil. N,N-Bis(2-ethylhexyl)-ar-methyl-1HFor use as a copper deactivator benzotriazole-1-methanamine (CAS Reg. at a level not to exceed 0.1 No. 94270-86-7). percent by weight of the lubricant. BHA.................................... BHT.................................... α-Butyl-omegaAddition to food not to exceed hydroxypoly(oxyethylene) 10 parts per million. poly(oxypropylene) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9038-95-3.

1011

§ 178.3570

——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— α-Butyl-omegaDo. hydroxypoly(oxypropylene); minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003-138. Castor oil............................. Do. Castor oil, dehydrated................. Do. Castor oil, partially dehydrated....... Do. Dialkyldimethylammonium aluminum For use only as a gelling agent silicate (CAS Reg. No. 68953-58-2), in mineral oil lubricants at a which may contain up to 7 percent by level not to exceed 15 percent weight 1,6-hexanediol (CAS Reg. No. by weight of the mineral oil. 629-11-8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14-C18) and where the aluminum silicate is derived from bentonite. Dimethylpolysiloxane (viscosity greater than 300 centistokes). Di (n-octyl) phosphite (CAS Reg. No. 1809-14-9).

Disodium decanedioate (CAS Reg. No. 17265-14-4).

Disodium EDTA (CAS Reg. No. 139-33-3)..

Ethoxylated resin phosphate ester mixture consisting of the following compounds:

1. Poly(methylene-p-tert-butylphenoxy)poly-(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-tert-butylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide;. 2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-nonylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide; and. 3. n-Tridecyl alcohol mixture of dihydrogen phosphate and monohydrogen phosphate esters (40 to 80 percent of the mixture; CAS Reg. No. 56831-62-0). Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids. 2-(8-Heptadecenyl)-4,5-dihydro-1Himidazole-1-ethanol (CAS Reg. No. 9538-5). Hexamethylenebis(3,5-di-tert-butyl-4hydroxyhydrocinnamate) (CAS Reg. No. 35074-77-2).

Addition to food not to exceed 1 part per million. For use only as an extreme pressure-antiwear adjuvant at a level not to exceed 0.5 percent by weight of the lubricant. For use only: 1. As a corrosion inhibitor or rust preventative in mineral oil-bentonite lubricants at a level not to exceed 2 percent by weight of the grease. 2. As a corrosion inhibitor or rust preventative only in greases at a level not to exceed 2 percent by weight of the grease. For use only as a chelating agent and sequestrant at a level not to exceed 0.06 percent by weight of lubricant at final use dilution. For use only as a surfactant to improve lubricity in lubricating fluids complying with this section at a level not to exceed 5 percent by weight of the lubricating fluid. ...............................

...............................

For use at levels not to exceed 0.5 percent by weight of the lubricant. For use as an antioxidant at levels not to exceed 0.5 percent by weight of the lubricant.

1012

§ 178.3570

——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— α-Hydro-omega-hydroxypoly Addition to food not to exceed (oxyethylene) poly(oxypropylene) 10 parts per million. produced by random condensation of mixtures of ethylene oxide and propylene oxide containing 25 to 75 percent by weight of ethylene oxide; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003-11-6. 12-Hydroxystearic acid................. Isopropyl oleate....................... For use only as an adjuvant (to improve lubricity) in mineral oil lubricants. Magnesium ricinoleate.................. For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil. Mineral oil............................ Addition to food not to exceed 10 parts per million. N-Methyl-N-(1-oxo-9For use as a corrosion octadecenyl)glycine (CAS Reg. No. 110inhibitor at levels not to 25-8). exceed 0.5 percent by weight of the lubricant. N-phenylbenzenamine, reaction products For use only as an antioxidant with 2,4,4-trimethylpentene (CAS Reg. at levels not to exceed 0.5 No. 68411-46-1). percent by weight of the lubricant. Petrolatum............................. Complying with Sec. 178.3700. Addition to food not to exceed 10 parts per million. Phenyl-α-and/or phenylFor use only, singly or in β>-naphthylamine. combination, as antioxidant in mineral oil lubricants at a level not to exceed a total of 1 percent by weight of the mineral oil. Phosphoric acid, mono- and dihexyl For use only as an adjuvant at esters, compounds with levels not to exceed 0.5 percent by weight of the tetramethylnonylamines and C11-C14 alkylamines. lubricant. Phosphoric acid, mono- and diisooctyl For use only as a corrosion esters, reacted with tert-alkyl and inhibitor or rust preventative (C12-C14) primary amines (CAS Reg. No. inlubricants at a level not to 68187-67-7). exceed 0.5 percent by weight of the lubricant. Phosphorothioic acid, O, O, O-triphenyl For use only as an extreme ester, tert-butyl derivatives (CAS pressure-antiwear adjuvant at Reg. No. 192268-65-8). a level not to exceed 0.5 by weight of the lubricant. Polyurea, having a nitrogen content of For use only as an adjuvant in 9-14 percent based on the dry polyurea mineral oil lubricants at a weight, produced by reacting tolylene level not to exceed 10 percent diisocyanate with tall oil fatty acid by weight of the mineral oil. (C16 and C18) amine and ethylene diamine in a 2:2:1 molar ratio. Polybutene (minimum average molecular weight 80,000). Polybutene, hydrogenated; complying with the identity prescribed under Sec. 178.3740. Polyethylene........................... Polyisobutylene (average molecular weight 35,000-140,000 (Flory)). Sodium nitrite.........................

Tetrakis[methylene(3,5-di-tert-butyl-4hydroxyhydro-cinnamate)]methane (CAS Reg. No. 6683-19-8). Thiodiethylenebis (3,5-di-tert-butyl-4hydroxyhydrocinnamate) (CAS Reg. No. 41484-35-9). Tri[2(or 4)-C9-C10-branched alkylphenyl]phosphorothioate (CAS Reg. No. 126019-82-7).

Addition to food not to exceed 10 parts per million. Do.

Do. For use only as a thickening agent in mineral oil lubricants. For use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil. For use only as an antioxidant in lubricants at a level not to exceed 0.5 percent by weight of the lubricant. For use as an antioxidant at levels not to exceed 0.5 percent by weight of the lubricant. For use only as an extreme pressure-antiwear adjuvant at levels not to exceed 0.5 percent by weight of the lubricant.

1013

§ 178.3600

——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— Triphenyl phosphorothionate (CAS Reg. For use as an adjuvant in No. 597-82-0). lubricants herein listed at a level not to exceed 0.5 percent by weight of the lubricant. Tris(2,4-di-tert-butylphenyl)phosphite For use only as a stabilizer at (CAS Reg. NO. 31570-04-4). levels not to exceed 0.5 percent by weight of the lubricant. Thiodiethylenebis(3,5-di-tert-butyl-4For use as an antioxidant at hydroxy-hydro- cinnamate) (CAS Reg. levels not to exceed 0.5 No. 41484-35-9). percent by weight of the lubricant. Zinc sulfide........................... For use at levels not to exceed 10 percent by weight of the lubricant. ———————————————————————————————————————

(b) The lubricants are used on food-processing equipment as a protective antirust film, as a release agent on gaskets or seals of tank closures, and as a lubricant for machine parts and equipment in locations in which there is exposure of the lubricated part to food. The amount used is the minimum required to accomplish the desired technical effect on the equipment, and the addition to food of any constituent identified in this section does not exceed the limitations prescribed. (c) Any substance employed in the production of the lubricants described in this section that is the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter conforms with any specification in such regulation. [42 FR 14609, Mar. 15, 1977] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting Sec. 178.3570, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 178.3600 Methyl glucoside-coconut oil ester. Methyl glucoside-coconut oil ester identified in Sec. 172.816(a) of this chapter may be safely used as a processing aid (filter aid) in the manufacture of starch, including industrial starch-modified complying with Sec. 178.3520, intended for use as a component of articles that contact food. § 178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated. Hydrogenated α-methylstyrene-vinyltoluene copolymer resins having a molar ratio of 1 α-methylstyrene to 3 vinyltoluene may be safely used as components of polyolefin film intended for use in contact with food, subject to the following provisions: (a) Hydrogenated α-methylstyrene-vinyltoluene copolymer resins have a drop-softening point of 125 ° to 165 °C and a maximum absorptivity of 0.17 liter per gram centimeter at 266 nanometers, as determined by methods titled ``Determination of Softening Point (Drop Method)’’ and ``Determination of Unsaturation of Resin 1977,’’ which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (b) The polyolefin film is produced from olefin polymers complying with Sec. 177.1520 of this chapter, and the average thickness of the film in the form in which it contacts food does not exceed 0.002 inch. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989]

§ 178.3620 Mineral oil. Mineral oil may be safely used as a component of nonfood articles intended for use in contact with food, subject to the provisions of this section: 1014

§ 178.3620

(a) White mineral oil meeting the specifications prescribed in Sec. 172.878 of this chapter may be used as a component of nonfood articles provided such use complies with any applicable limitations in parts 170 through 189 of this chapter. The use of white mineral oil in or on food itself, including the use of white mineral oil as a protective coating or release agent for food, is subject to the provisions of Sec. 172.878 of this chapter. (b) Technical white mineral oil identified in paragraph (b)(1) of this section may be used as provided in paragraph (b)(2) of this section. (1) Technical white mineral oil consists of specially refined distillates of virgin petroleum or of specially refined distillates that are produced synthetically from petroleum gases. Technical white mineral oil meets the following specifications: (i) Saybolt color 20 minimum as determined by ASTM method D156-82, ``Standard Test Method for Saybolt Color of Petroleum Products (Saybolt Chromometer Method),’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (ii) Ultraviolet absorbance limits as follows: ———————————————————————————————————— Maximum absorbance per centimeter Wavelength (mµ) optical pathlength ———————————————————————————————————— 280 to 289.................................................. 4.0 290 to 299.................................................. 3.3 300 to 329.................................................. 2.3 330 to 350.................................................. 0.8 ————————————————————————————————————

Technical white mineral oil containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under ``Specification’’ on page 66 of the ``Journal of the Association of Official Agricultural Chemists,’’ Volume 45 (February 1962) (which is incorporated by reference; copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), disregarding the last two sentences of that procedure and substituting therefor the following: Determine the absorbance of the mineral oil extract in a 10-millimeter cell in the range from 260-350 mµ, inclusive, compared to the solvent control. If the absorbance so measured exceeds 2.0 at any point in range 280-350 mµ, inclusive, dilute the extract and the solvent control, respectively, to twice their volume with dimethyl sulfoxide and remeasure the absorbance. Multiply the remeasured absorbance values by 2 to determine the absorbance of the mineral oil extract per centimeter optical pathlength. (2) Technical white mineral oil may be used wherever mineral oil is permitted for use as a component of nonfood articles complying with Secs. 175.105, 176.200, 176.210, 177.2260, 177.2600, and 177.2800 of this chapter and Secs. 178.3570 and 178.3910. (3) Technical white mineral oil may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the Act, in an amount not greater than that required to produce its intended effect. (c) Mineral oil identified in paragraph (c)(1) of this section may be used as provided in paragraph (c)(2) of this section. (1) The mineral oil consists of virgin petroleum distillates refined to meet the following specifications: (i) Initial boiling point of 450 °F minimum. (ii) Color 5.5 maximum as determined by ASTM method D1500-82, ``Standard Test Method for ASTM Color of Petroleum Products (ASTM Color Scale),’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1)(i) of this section. (iii) Ultraviolet absorbance limits as follows as determined by the analytical method described in paragraph (c)(3) of this section:

1015

§ 178.3620

———————————————————————————————————— Maximum absorbance per centimeter Wavelength (mµ) optical pathlength ———————————————————————————————————— 280 to 289.................................................. 0.7 290 to 299.................................................. 0.6 300 to 359.................................................. 0.4 360 to 400.................................................. .09 ————————————————————————————————————

(2) The mineral oil may be used wherever mineral oil is permitted for use as a component of nonfood articles complying with Secs. 175.105 and 176.210 of this chapter and Sec. 178.3910 (for use only in rolling of metallic foil and sheet stock), Secs. 176.200, 177.2260, 177.2600, and 177.2800 of this chapter. (3) The analytical method for determining ultraviolet absorbance limit is as follows: GENERAL INSTRUCTIONS

Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of oil samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light. APPARATUS

Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks. Reservoir. 500-milliliter capacity, equipped with a 24/40 standard taper male fitting at the bottom and a suitable ball-joint at the top for connecting to the nitrogen supply. The male fitting should be equipped with glass hooks. Chromatographic tube. 180 millimeters in length, inside diameter to be 15.7 millimeters ±0.1 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of the column with the female joint is 235 millimeters.) The female fitting should be equipped with glass hooks. Disc. Tetrafluoroethylene polymer 2-inch diameter disk approximately 3/16-inch thick with a hole bored in the center to closely fit the stem of the chromatographic tube. Suction flask. 250-milliliter or 500-milliliter filter flask. Condenser. 24/40 joints, fitted with a drying tube, length optional. Evaporation flask (optional). 250-milliliter or 500-milliliter capacity all-glass flask equipped with standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated. Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeter ±0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1,000 centimeter ±0.005 centimeter. With distilled water in the cells, determine any absorbance differences. Spectrophotometer. Spectral range 250 millimicrons—400 millimicrons with spectral slit width of 2 millimicrons or less; under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements: Absorbance repeatability, ±0.01 at 0.4 absorbance. Absorbance accuracy 1±0.05 at 0.4 absorbance. Wavelength accuracy, ±1.0 millimicron. Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

1As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. Circular 484 is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

1016

§ 178.3620

REAGENTS AND MATERIALS

Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane, benzene, acetone, and methyl alcohol designated in the list following this paragraph shall pass the following test: To the specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane and evaporate on the steam bath under a stream of nitrogen (a loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains. (To the residue from benzene add a 10-milliliter portion of purified isooctane, reevaporate, and repeat once to insure complete removal of benzene.) Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and nhexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask. Dissolve the 1 milliliter of hexadecane residue in isooctane and make to 25 milliliters volume. Determine the absorbance in the 5-centimeter path length cells compared to isooctane as reference. The absorbance of the solution of the solvent residue (except for methyl alcohol) shall not exceed 0.01 per centimeter path length between 280 and 400 mµ. For methyl alcohol this absorbance value shall be 0.00. Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test described in the preceding paragraph. Purify, if necessary, by passage through a column of activated silica gel (Grade 12, Davison Chemical Company, Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter. Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. Purify, if necessary, by distillation or otherwise. Acetone, A.C.S. reagent grade. Use 200 milliliters for the test. Purify, if necessary, by distillation. Eluting mixtures: 1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene into a 250-milliliter glass-stoppered volumetric flask and adjust to volume with isooctane, with mixing. 2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene into a 250-milliliter glass-stoppered volumetric flask and adjust to volume with isooctane, with mixing. 3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380 milliliters of acetone and 200 milliliters of benzene, and mix. n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference point between 280 mµ-400 mµ. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation. Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl alcohol. Purify, if necessary, by distillation. Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach Corporation, Camas, Washington, or equivalent). Absorbance (1-centimeter cell, distilled water reference, sample completely saturated with nitrogen). ———————————————————————————————————— Absorbance Wavelength (maximum) ———————————————————————————————————— 261.5....................................................... 1.00 270......................................................... .20 275......................................................... .09 280......................................................... .06 300......................................................... .015 ————————————————————————————————————

There shall be no irregularities in the absorbance curve within these wavelengths. Phosphoric acid. 85 percent A.C.S. reagent grade. Sodium borohydride. 98 percent. Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco Division, distributed by chemical supply firms, or equivalent). Place 100 grams of the magnesium oxide in a large beaker, add 700 milliliters of distilled water to make a thin slurry, and heat on a steam bath for 30 minutes with intermittent stirring. Stir well initially to insure that all the adsorbent is completely wetted. Using a Buchner funnel and a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable diameter, filter with suction. Continue suction until water no longer drips from the funnel. Transfer the adsorbent to a glass trough lined with aluminum foil (free from rolling oil). Break up the magnesia with a clean spatula and spread out the adsorbent on the aluminum foil in a layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 160 °C ±1 °C. Pulverize the magnesia with mortar and pestle. Sieve the pulverized adsorbent between 60-180 mesh. Use the magnesia retained on the 180-mesh sieve. Celite 545. Johns Mansville Company, diatomaceous earth, or equivalent. Magnesium oxide-Celite 545 mixture (2+1) by weight. Place the magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions, respectively, by weight in a glass-stoppered flask large enough for adequate mixing. Shake vigorously for 10 minutes.

1017

§ 178.3620

Transfer the mixture to a glass trough lined with aluminum foil (free from rolling oil) and spread it out on a layer about 1 centimeter to 2 centimeters thick. Reheat the mixture at 160 °C ±1 °C for 2 hours, and store in a tightly closed flask. Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter course, fritted-glass funnel or in a 65-millimeter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter path length between 280 mµ and 400 mµ when tested as prescribed under ``Organic solvents.’’ Usually three portions of wash solvent are sufficient. Before proceeding with analysis of a sample, determine the absorbance in a 5-centimeter path cell between 250 millimicrons and 400 millimicrons for the reagent blank by carrying out the procedure, without an oil sample, recording the spectra after the extraction stage and after the complete procedure as prescribed. The absorbance per centimeter pathlength following the extraction stage should not exceed 0.02 in the wavelength range from 280 mµ to 400 mµ; the absorbance per centimeter pathlength following the complete procedure should not exceed 0.02 in the wavelength range from 280 mµ to 400 mµ. If in either spectrum the characteristic benzene peaks in the 250 mµ-260 mµ region are present, remove the benzene by the procedure under ``Organic solvents’’ and record absorbance again. Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to pre-equilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks. Weigh a 20-gram sample of the oil and transfer to a 500-milliliter separatory funnel containing 100 milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture. Complete the transfer of the sample with small portions of preequilibrated isooctane to give a total volume of the oil and solvent of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of pre-equilibrated isooctane. After separation of liquid phases, carefully draw off lower layer into the first 250-milliliter separatory funnel and wash in tandem with the 30-milliliter portions of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture and wash each extractive in tandem through the same three portions of isooctane. Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter) containing 480 milliliters of distilled water; mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 80-milliliter extractives three times with 100-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents and Materials’’ for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once. Quantitatively transfer the residue with isooctane to a 200-milliliter volumetric flask, make to volume, and mix. Determine the absorbance of the solution in the 1-centimeter pathlength cells compared to isooctane as reference between 280 mµ-400 mµ (take care to lose none of the solution in filling the sample cell). Correct the absorbance values for any absorbance derived from reagents as determined by carrying out the procedure without an oil sample. If the corrected absorbance does not exceed the limits prescribed in this paragraph, the oil meets the ultraviolet absorbance specifications. If the corrected absorbance per centimeter pathlength exceeds the limits prescribed in this paragraph, proceed as follows: Quantitatively transfer the isooctane solution to a 125-milliliter flask equipped with 24/40 joint, and evaporate the isooctane on the steam bath under a stream of nitrogen to a volume of 1 milliliter of hexadecane. Add 10 milliliters of methyl alcohol and approximately 0.3 gram of sodium borohydride. (Minimize exposure of the borohydride to the atmosphere. A measuring dipper may be used.) Immediately fit a water-cooled condenser equipped with a 24/40 joint and with a drying tube into the flask, mix until the borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with intermittent swirling. At the end of this period, disconnect the flask and evaporate the methyl alcohol on the steam bath under nitrogen until the sodium borohydride begins to come out of the solution. Then add 10 milliliters of isooctane and evaporate to a volume of about 2-3 milliliters. Again, add 10 milliliters of isooctane and concentrate to a volume of approximately 5 milliliters. Swirl the flask repeatedly to assure adequate washing of the sodium borohydride residues. Fit the tetrafluoroethylene polymer disc on the upper part of the stem of the chromatographic tube, then place the tube with the disc on the suction flask and apply the vacuum (approximately 135 millimeters Hg pressure). Weigh out 14 grams of the 2:1 magnesium oxide-Celite 545 mixture and pour the adsorbent mixture into the chromatographic tube in approximately 3-centimeter layers. After the addition of each layer, level off the top of the adsorbent with a flat glass rod or metal plunger by pressing down firmly until the adsorbent is well packed. Loosen the topmost few millimeters of each adsorbent layer with the end of a metal rod

1018

§ 178.3620

before the addition of the next layer. Continue packing in this manner until all the 14 grams of the adsorbent is added to the tube. Level off the top of the adsorbent by pressing down firmly with a flat glass rod or metal plunger to make the depth of the adsorbent bed approximately 12.5 centimeters in depth. Turn off the vacuum and remove the suction flask. Fit the 500-milliliter reservoir onto the top of the chromatographic column and prewet the column by passing 100 milliliters of isooctane through the column. Adjust the nitrogen pressure so that the rate of descent of the isooctane coming off the column is between 2-3 milliliters per minute. Discontinue pressure just before the last of the isooctane reaches the level of the adsorbent. (Caution: Do not allow the liquid level to recede below the adsorbent level at any time.) Remove the reservoir and decant the 5-milliliter isooctane concentrate solution onto the column and with slight pressure again allow the liquid level to recede to barely above the adsorbent level. Rapidly complete the transfer similarly with two 5-milliliter portions of isooctane, swirling the flask repeatedly each time to assure adequate washing of the residue. Just before the final 5-milliliter wash reaches the top of the adsorbent, add 100 milliliters of isooctane to the reservoir and continue the percolation at the 2-3 milliliters per minute rate. Just before the last of the isooctane reaches the adsorbent level, add 100 milliliters of 10 percent benzene in isooctane to the reservoir and continue the percolation at the aforementioned rate. Just before the solvent mixture reaches adsorbent level, add 25 milliliters of 20 percent benzene in isooctane to the reservoir and continue the percolation at 2-3 milliliters per minute until all this solvent mixture has been removed from the column. Discard all the elution solvents collected up to this point. Add 300 milliliters of the acetonebenzene-water mixture to the reservoir and percolate through the column to eluate the polynuclear compounds. Collect the eluate in a clean 1-liter separatory funnel. Allow the column to drain until most of the solvent mixture is removed. Wash the eluate three times with 300-milliliter portions of distilled water, shaking well for each wash. (The addition of small amounts of sodium chloride facilitates separation.) Discard the aqueous layer after each wash. After the final separation, filter the residual benzene through anhydrous sodium sulfate pre-washed with benzene (see Sodium sulfate under ``Reagents and Materials’’ for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the separatory funnel with two additional 20-milliliter portions of benzene which are also filtered through the sodium sulfate. Add 1 milliliter of n-hexadecane and completely remove the benzene by evaporation under nitrogen, using the special procedure to eliminate benzene as previously described under ``Organic solvents.’’ Quantitatively transfer the residue with isooctane to a 200-milliliter volumetric flask and adjust to volume. Determine the absorbance of the solution in the 1-centimeter pathlength cells compared to isooctane as reference between 250 mµ-400 mµ. Correct for any absorbance derived from the reagents as determined by carrying out the procedure without an oil sample. If either spectrum shows the characteristic benzene peaks in the 250 mµ-260 mµ region, evaporate the solution to remove benzene by the procedure under ``Organic solvents.’’ Dissolve the residue, transfer quantitatively, and adjust to volume in isooctane in a 200-milliliter volumetric flask. Record the absorbance again. If the corrected absorbance does not exceed the limits proposed in this paragraph, the oil meets the proposed ultraviolet absorbance specifications.

(d) Mineral oil identified in paragraph (d)(1) of this section may be used as provided in paragraph (d)(2) of this section. (1) The mineral oil consists of virgin petroleum distillates refined to meet the following specifications: (i) Distillation endpoint at 760 millimeters pressure not to exceed 371°C, with a maximum residue not to exceed 2 percent, as determined by ASTM method D86-82, ``Standard Method for Distillation of Petroleum Products,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1)(i) of this section. (ii) Ultraviolet absorbance limits as follows as determined by the method described in paragraph (d)(3) of this section. ———————————————————————————————————— Maximum absorbance per Wavelength (mm) centimeter optical pathlength ———————————————————————————————————— 280 to 299.................................................. 2.3 300 to 319.................................................. 1.2 320 to 359.................................................. .8 360 to 400.................................................. .3 ————————————————————————————————————

(iii) Pyrene content not to exceed a maximum of 25 parts per million as determined by the method described in paragraph (d)(3) of this section. (2) The mineral oil may be used only in the processing of jute fiber employed in the production of textile bags intended for use in contact with the following types of food: Dry grains and dry seeds (for example, beans, peas, rice, and lentils); whole root crop vegetables of the types identified in 40 CFR 180.34(f); unshelled and shelled nuts (including peanuts); and dry animal feed. The finished processed jute fiber shall contain no more than 6 percent by weight of residual mineral oil. (3) The analytical method for determining ultraviolet absorbance limits and pyrene content is as follows: 1019

§ 178.3620

I. Apparatus. A. Assorted beakers, separatory funnels fitted with tetrafluoroethylene polymer stopcocks, and graduated cylinders. B. Volumetric flasks, 200-milliliter. C. A chromatographic column made from nominal 1.3 centimeters outside diameter x 75 centimeters glass tubing tapered at one end and joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The opposite end is flanged and joined to a female 24/40 standard taper fitting. This provides for accommodating the 500-milliliter reservoir described in item I.E below. D. A chromatographic column made from nominal 1.7 centimeters outside diameter x 115 centimeters glass tubing tapered at one end and joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The opposite end is flanged and joined to a 2.5 centimeters outside diameter x 9.0 centimeters glass tube having a female 24/40 standard taper fitting. This provides for accommodating the 500-milliliter reservoir described in item I. E below. E. A 500-milliliter reservoir having a 24/40 standard taper male fitting at bottom and a suitable ball joint at the top for connecting to the nitrogen supply. The female fitting of the chromatographic columns described in items I. C and D above and the male fitting of the reservoir described in this item E should both be equipped with glass hooks. (NOTE: Rubber stoppers are not to be used. Stopcock grease is not to be used on ground-glass joints in this method.) F. A spectrophotometer equipped to automatically record absorbance of liquid samples in 1-centimeter pathlength cells in the spectral region of 280-400 mµ with a spectral slit width of 2 mµ or less. At an absorbance level of about 0.4, absorbance measurements shall be repeatable within ±0.01 and accurate within ±0.05. Wavelength measurements shall be repeatable with ±0.2 mµ and accurate within ±1.0 mµ. Instrument operating conditions are selected to realize this performance under dynamic (automatic) recording operations. Accuracy of absorbance measurements are determined at 290, 345, and 400 mµ, using potassium chromate as the reference standard. (National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, 1949.) G. Two fused quartz cells having pathlengths of 1.00±0.005 centimeter or better. II. Purity of reagents and materials. Reagent-grade chemicals shall be used in all tests. It is further specified that each chemical shall be tested for purity in accordance with the instruction given under ``Reagents and Materials’’ in III below. In addition, a blank run by the procedure shall be made on each purified lot of reagents and materials. Unless otherwise indicated, references to water shall be understood to mean distilled water. III. Reagents and materials— A. Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this section III. The isooctane, benzene, cyclohexane, nitromethane, and n-hexadecane designated shall pass the following test: To the specified quantity of solvent in a 150-milliliter beaker, add 1 milliliter of purified n-hexadecane and evaporate on the steam bath under a stream of nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains (to the residue from benzene and nitromethane add a 10-milliliter portion of purified isooctane, re-evaporate, and repeat once to insure complete removal of solvent). Dissolve the 1 milliliter of n-hexadecane residue in isooctane and make to 10-milliliter volume. Determine the absorbance in 1.0-centimeter pathlength cells compared to water as reference. The absorbance of the solution of solvent residue shall not exceed 0.05 between 280 and 400 mµ. 1. Isooctane (2,2,4-trimethylpentane). Use 240 milliliters for the above test. Purify, if necessary, by passage through a column of activated silica gel. 2. Benzene. Use 200 milliliters for the above test. Purify, if necessary, by distillation or otherwise. 3. Cyclohexane. Use 70 milliliters for the above test. Purify, if necessary, by distillation, silica gel percolation, or otherwise. 4. Nitromethane. Use 125 milliliters for the above test. Purify, if necessary, by distillation or otherwise. 5. n-Hexadecane. Determine the absorbance on this solvent directly. Purify, if necessary, by silica gel percolation or otherwise. B. Other materials—1. Pyrene standard reference. Pyrene, reagent grade, melting point range 150-152 °C. (Organic Chemical 3627, Eastman Kodak Co., Rochester, N.Y., or equivalent). The standard reference absorbance is the absorbance at 334 millimicrons of a standard reference solution of pyrene containing a concentration of 1.0 milligram per liter in purified isooctane measured against isooctane of the same spectral purity in 1.0-centimeter cells. (This absorbance will be approximately 0.28.) 2. Chrysene solution. Prepare a solution at a concentration of 5.0 milligrams per liter by dissolving 5.0 milligrams of chrysene in purified isooctane in a 1-liter volumetric flask. Adjust to volume with isooctane. 3. Nitrogen gas. Water pumped or equivalent purity, cylinder with regulator, and valve control flow at 5 p.s.i. 4. Silica gel. 100-200 mesh (Davison Chemical, Baltimore, Md., Grade 923, or equivalent), purified and activated by the following procedure: Place about 1 kilogram of silica gel in a large column and wash with contaminant-free benzene until a 200milliliter sample of the benzene coming off the column will pass the ultraviolet absorption test for benzene. This test is performed as stipulated under ``Organic solvents’’ in A under III above. When the silica gel has been sufficiently cleaned, activate the gel before use by placing the 1-kilogram batch in a shallow container in a layer no greater than 1 inch in depth and heating in an oven (Caution! Explosion Hazard) at 130 °C. for 16 hours, and store in a vacuum desiccator. Reheating about once a week is necessary if the silica gel is repeatedly removed from the desiccator. 5. Aluminum oxide (Aluminum Co. of America, Grade F-20, or equivalent grade). 80-200 mesh, purified and activated by the following procedure: Place about 1 kilogram of aluminum oxide in a large column and wash with contaminant-free benzene until a 200-milliliter sample of the benzene coming off the column will pass the ultraviolet absorption test for benzene. This test is

1020

§ 178.3620

performed as stipulated under ``Organic solvents’’ in A under III above. (Caution! Remove Benzene From Adsorbent Under Vacuum To Minimize Explosion Hazard in Subsequent Heating!) When the aluminum oxide has been sufficiently cleaned and freed of solvent, activate it before use by placing the 1-kilogram batch in a shallow container in a layer no greater than 1 inch in depth. Heat in an oven at 130 °C for 16 hours. Upon removal from heat, store at atmospheric pressure over 80 percent (by weight) sulfuric acid in a desiccator for at least 36 hours before use. This gives aluminum oxide with between 6 to 9.5 percent volatiles. This is determined by heating a weighed sample of the prepared aluminum oxide at 2,000 °F for 2 hours and then quickly reweighing. To insure the proper adsorptive properties of the aluminum oxide, perform the following test: a. Weigh 50 grams ±1 gram of the activated aluminum oxide and pack into the chromatographic column (1.3 centimeters x 75 centimeters) described under ``Apparatus’’ in C under I above. Use glass wool at the column exit to prevent the aluminum oxide from passing through the column. b. Place a 250-milliliter graduated cylinder under the column to measure the amount of eluate coming from the column. c. Prewet the aluminum oxide by passing 40 milliliters of isooctane through the column. Adjust the nitrogen pressure so that the rate of descent of the isooctane coming off the column is between 1.5 to 2.5 milliliters per minute. d. Just prior to the last of the isooctane reaching the top of the aluminum oxide bed, add 10 milliliters of the isooctane solution containing 5.0 milligrams of chrysene per liter. e. Continue percolation until the isooctane is just above the aluminum oxide. Then add 200 milliliters of a mixture of benzene and isooctane (33 1/3 percent benzene and 66 2/3 percent isooctane by volume) to the reservoir and continue percolation. f. Continue percolation, collecting the eluates (40 milliliters of the prewet solution, 10 milliliters of the sample solution, and 200 milliliters of the gradient solution) in the 250-milliliter graduated cylinder until the level of the gradient solution is just above the aluminum oxide. Add 200 milliliters of the eluting solution of benzene and isooctane (90 percent benzene and 10 percent isooctane by volume) to the column and continue collecting until a total of 250 milliliters of solution has been obtained. This may be discarded. Now begin to collect the final eluate. g. Place a 100-milliliter graduated cylinder under the column and continue the percolation until a 100-milliliter eluate has been obtained. h. Measure the amount of chrysene in this 100-milliliter fraction by ultraviolet analysis. If the aluminum oxide is satisfactory, more than 80 percent of the original amount of chrysene should be found in this fraction. (NOTE: If the amount of chrysene recovered is less than 80 percent, the original batch of aluminum oxide should be sieved between 100-160 mesh. Activation and testing of this sieved batch should indicate a satisfactory aluminum oxide for use.) IV. Sampling. Precautions must be taken to insure that an uncontaminated sample of the mineral oil is obtained since ultraviolet absorption is very sensitive to small amounts of extraneous material contaminating the sample through careless handling. V. Procedure. A. Blank. Before proceeding with the analysis of a sample, determine the absorbance of the solvent residues by carrying out the procedure without a sample. B. Sample. 1. Weigh out 20.0 grams ±0.1 gram of the mineral oil into a beaker and transfer to a 250-milliliter separatory funnel fitted with a tetrafluoroethylene polymer stopcock, using enough cyclohexane (25 milliliters) to give a final total volume of 50 milliliters (mineral oil plus cyclohexane). 2. Add 25 milliliters of nitromethane saturated with cyclohexane and shake by hand vigorously for 3 minutes. Recover the lower nitromethane layer in a 150-milliliter beaker containing 1 milliliter of n-hexadecane and evaporate on the steam bath under nitrogen. Repeat the extraction four more times, recovering each extract in the 150-milliliter beaker. Exercise care not to fill the beaker to such a capacity that solvent losses may occur. Evaporate the combined nitromethane extracts to 1 milliliter of nhexadecane residue containing the nitromethane-soluble mineral oil extractives. (NOTE: Complete removal of the nitromethane is essential. This can be assured by two successive additions of 5 milliliters of isooctane and reevaporation.) 3. Remove the beaker from the steam bath and allow to cool. 4. Weigh 50 grams ±1 gram of activated aluminum oxide and pack into the chromatographic column (1.3 centimeters x 75 centimeters) described under ``Apparatus’’ in C under I above. (NOTE: A small plug of glass wool is placed at the column exit to prevent the aluminum oxide from passing through the column. After adding aluminum oxide, tap the column lightly to remove air voids. All percolations using aluminum oxide are performed under nitrogen pressure. The 500-milliliter reservoir described under ``Apparatus’’ in E under I above is to be used to hold the elution solvents.) 5. Prewet the column by adding 40 milliliters of isooctane to the column. Adjust nitrogen pressure so that rate of descent of the isooctane coming off the column is 2.0 to 3.0 milliliters per minute. Be careful to maintain the level of solvent in the reservoir to prevent air from entering the aluminum oxide bed. New or additional solvent is added just before the last portion of the previous solvent enters the bed. To minimize possible photo-oxidation effects, the following procedures (steps 6 through 18) shall be carried out in subdued light. 6. Before the last of the isooctane reaches the top of the aluminum oxide bed, release the nitrogen pressure and turn off the stopcock on the column. Transfer the n-hexadecane residue from the 150-milliliter beaker from procedure step 3 above onto the column, using several washes of isooctane (total volume of washes should be no greater than 10-15 milliliters). 7. Open the stopcock and continue percolation until the isooctane is about 1 centimeter above the top of the aluminum oxide bed. Add 200 milliliters of isooctane to the reservoir, and continue the percolation at the specified rate. 8. Just before the isooctane surface reaches the top of the aluminum oxide bed, add 200 milliliters of a mixture of benzene and isooctane (33 1/3 percent benzene and 66 2/3 percent isooctane by volume) to the reservoir, and continue the percolation. 9. Just before the surface of this mixture reaches the top of the aluminum oxide bed, release the nitrogen pressure, turn off the

1021

§ 178.3620

stopcock, and discard all the elution solvents collected up to this point. 10. Add to the reservoir 300 milliliters of a mixture of benzene and isooctane (90 percent benzene and 10 percent isooctane by volume), place a 25-milliliter graduated cylinder under the column, continue the percolation until 20 milliliters of eluate has been collected, and then discard the eluate. 11. At this point, place a clean 250-milliliter Erlenmeyer flask under the column. Continue the percolation and collect all the remaining eluate. (NOTE: Allow the column to drain completely. An increase in the nitrogen pressure may be necessary as the last of the solvent comes off the column.) 12. Place 1 milliliter of n-hexadecane into a 150-milliliter beaker. Place this onto a steam bath under a nitrogen stream and transfer in small portions the eluate from step 11 above. Wash out the Erlenmeyer flask with small amounts of benzene and transfer to the evaporation beaker. Evaporate until only 1 milliliter of hexadecane residue remains. (NOTE: Complete removal of the benzene is essential. This can be assured by two successive additions of 5 milliliters of isooctane and reevaporation.) 13. Remove the beaker from the steam bath and cool. 14. Place a sample of 113.5 grams activated 100- 200-mesh silica gel in a 500-milliliter glass-stoppered Erlenmeyer flask. Add to the silica gel 46.2 grams (41 milliliters) of nitromethane. Stopper and shake the flask vigorously until no lumps of silica gel are observed and then shake occasionally during a period of 1 hour. The resultant nitromethane-treated silica gel is 29 weight-percent nitro-methane and 71 weight-percent silica gel. 15. Place a small plug of glass wool in the tapered end of the 1.7 centimeters outside diameter × 115 centimeters column, described under ``Apparatus’’ in D of I above, adjacent to the stopcock to prevent silica gel from passing through the stopcock. Pack the nitromethane-treated silica gel into the column, tapping lightly. The resultant silica gel bed should be about 95 centimeters in depth. Place into a flask 170 milliliters of isooctane saturated with nitromethane. 16. Place a 100-milliliter graduated cylinder under the column and transfer the residue from the beaker in procedure step 13 above with several washes of the 170 milliliters of isooctane, saturated with nitromethane, onto the top of the column. (Total volume of washes should be no greater than 10 to 15 milliliters.) Permit isooctane solution to enter the silica gel bed until the liquid level is at the top bed level. Place the remaining amount of the 170 milliliters of isooctane, saturated with nitromethane, in the reservoir above the bed for percolation through the silica gel. Apply nitrogen pressure to the top of the column, adjusting the pressure so that the isooctane is collected at the rate of 2.5 to 3.5 milliliters per minute, and percolate isooctane through the bed until a quantity of 75.0 milliliters of eluate is collected. Discard the 75 milliliters of eluate. Turn off the stopcock and add 250 milliliters of benzene to the reservoir above the bed. Use a 400-milliliter beaker to collect the remaining eluate. 17. Open the stopcock, renew the pressure, and percolate the remaining isooctane and benzene through the column eluting the remaining aromatics. Transfer the eluate in small portions from the 400 milliliter beaker to a 150-milliliter beaker containing 1 milliliter of n-hexadecane and evaporate on the steam bath under nitrogen. Rinse the 400-milliliter beaker well with small portions of isooctane to obtain a complete transfer. (NOTE: Complete removal of the nitromethane and benzene is essential. This can be assured by successive additions of 5 milliliters of isooctane and reevaporation.) 18. Transfer the residue with several washes of isooctane into a 200-milliliter volumetric flask. Add isooctane to mark. 19. Record the spectrum of the sample solution in a 1-centimeter cell compared to isooctane from 270 to 400 mµ. After making necessary corrections in the spectrum for cell differences and for the blank absorbance, record the maximum absorbance in each of the wavelength intervals (mµ), 280-299, 300-319, 320-359, 360-400. a. If the spectrum then shows no discernible peak corresponding to the absorbance maximum of the pyrene reference standard solution at 334 mµ, the maximum absorbances in the respective wavelength intervals recorded shall not exceed those prescribed in paragraph (d)(1)(ii) of this section. b. If such a peak is evident in the spectrum of the sample solution, and the spectrum as a whole is not incompatible with that of a pyrene contaminant yielding such a peak of the observed absorbance, calculate the concentration of pyrene that would yield this peak (334 m) by the base-line technique described in ASTM method E169-63 (Reapproved 1981), ``Standard Recommended Practices for General Techniques of Ultraviolet Quantitative Analysis,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1)(i) of this section. Correct each of the maximum absorbances in the respective specified wavelength intervals by subtracting the absorbance due to pyrene, determined as follows:

Absorbance due to pyrene = Cp × Sa Sp where: Cp=Calculated concentration of pyrene in sample solution; Sp=Concentration of pyrene reference standard solution in same units of concentration; Sa=Absorbance of pyrene reference standard solution at wavelength of maximum absorbance of sample solution in the respective specified wavelength intervals.

1022

§ 178.3690

Also calculate the pyrene content of the oil sample in parts per million as follows:

Pyrene content (200/1000) × C = = 10C (p.p.m.) 20/1000 where: C=Calculated concentration of pyrene in milligrams per liter of sample solution.

c. The pyrene content so determined shall not exceed 25 p.p.m. The maximum absorbances corrected for pyrene content as described in this step 19 for each of the specified wavelength intervals shall not exceed the limits prescribed in paragraph (d)(1)(ii) of this section. d. If the spectrum as a whole of the sample solution is in any respect clearly incompatible with the presence of pyrene as the source of the peak at 334 mµ, then the maximum absorbances in the respective wavelength intervals without correction for any assumed pyrene content shall not exceed the limits prescribed in paragraph (d)(1)(ii) of this section. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989]

§ 178.3650 Odorless light petroleum hydrocarbons. Odorless light petroleum hydrocarbons may be safely used, as a component of nonfood articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive is a mixture of liquid hydrocarbons derived from petroleum or synthesized from petroleum gases. The additive is chiefly paraffinic, isoparaffinic, or naphthenic in nature. (b) The additive meets the following specifications: (1) Odor is faint and not kerosenic. (2) Initial boiling point is 300 °F minimum. (3) Final boiling point is 650 °F maximum. (4) Ultraviolet absorbance limits determined by method specified in Sec. 178.3620(b)(1)(ii), as follows: ——————————————————————————————————————— Maximum absorbance per centimeter Wavelength (Mµ) optical pathlength ——————————————————————————————————————— 280 to 289.................................................. 4.0 290 to 299.................................................. 3.3 300 to 329.................................................. 2.3 330 to 360.................................................. .8 ———————————————————————————————————————

(c) The additive is used as follows: ——————————————————————————————————————— Use Limitations ——————————————————————————————————————— As a plasticizer and absorber oil in In an amount not to exceed that the manufacture of polyolefin articles required to produce intended authorized for food contact use. effect, consistent with good manufacturing practice. As a lubricant of fibers of textiles At a use level not to exceed authorized for food contact use. 0.15 percent by weight of finished fibers. As a component of adhesives............ Complying with Sec. 175.105 of this chapter. As a defoamer in the manufacture of Complying with Sec. 176.210 of paper and paperboard. this chapter. As a defoamer in coatings.............. Complying with Sec. 176.200 of this chapter. ———————————————————————————————————————

§ 178.3690 Pentaerythritol adipate-stearate. Pentaerythritol adipate-stearate identified in paragraph (a) of this section may be safely used as a lubricant in the fabrication of rigid and semi-rigid polyvinyl chloride and/or vinyl chloride-propylene copolymers complying with Sec. 177.1980 of this chapter used as articles or components of articles that contact food, excluding food with alcohol 1023

§ 178.3700

content greater than 8 percent under conditions of use of E, F, and G described in table 2 in Sec. 175.300(d) of this chapter, subject to the provisions of this section. (a) Identity. For the purpose of this section, pentaerythritol adipate-stearate is an ester of pentaerythritol with adipic acid and stearic acid and its associated fatty acids (chiefly palmitic), with adipic acid comprising 14 percent and stearic acid and its associated acids (chiefly palmitic) comprising 71 percent of the organic moieties. (b) Specifications. Pentaerythritol adipate-stearate has the following specifications: (1) Melting point (dropping) of 55-58 °C as determined by ASTM method D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of Lubricating Grease,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (2) Acid value not to exceed 15 as determined by ASTM method D1386-78, ``Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (3) Saponification number of 270-280 as determined by ASTM method D1387-78, ``Standard Test Method for Acid Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (4) Iodine number not to exceed 2 as determined by Iodine Absorption Number, Hanus Method, of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ sections 28.018-28.019, 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The total amount of ester (calculated as free pentaerythritol) shall not exceed 0.4 percent by weight of the polyvinyl chloride and/or the vinyl chloride-propylene copolymers complying with Sec. 177.1980. [45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. 29, 1992]

§ 178.3700 Petrolatum. Petrolatum may be safety used as a component of nonfood articles in contact with food, in accordance with the following conditions: (a) Petrolatum complies with the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for yellow petrolatum. (b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in Sec. 172.886(b) of this chapter: Ultraviolet absorbance per centimeter pathlength: ———————————————————————————————————— Millimicrons Maximum ———————————————————————————————————— 280 to 289.................................................. 0.25 290 to 299.................................................. .20 300 to 359.................................................. .14 360 to 400.................................................. .04 ————————————————————————————————————

(c) It is used or intended for use as a protective coating of the surfaces of metal or wood tanks used in fermentation process, in an amount not in excess of that required to produce its intended effect. (d) Petrolatum as defined by this section may be used for the functions described and within the limitations prescribed by specific regulations in parts 175, 176, 177, and 178 of this chapter which prescribe uses of petrolatum. For the purpose of cross-reference, such specific regulations include: Secs. 175.105, 175.125, 175.300, 176.170, 176.200, 176.210, 177.2600, 177.2800, and 178.3570 of this chapter. (e) Petrolatum may contain any antioxidant permitted in food by regulations issued pursuant to section 409 of the act, in an amount not greater than that required to produce its intended effect. [42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, 1990]

1024

§ 178.3725

§ 178.3710 Petroleum wax. Petroleum wax may be safely used as a component of nonfood articles in contact with food, in accordance with the following conditions: (a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, derived from petroleum, and refined to meet the specifications prescribed in this section. (b) The petroleum wax meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in Sec. 172.886(b) of this chapter. Ultraviolet absorbance per centimeter pathlength: ——————————————————————————————————————— Millimicrons Maximum ——————————————————————————————————————— 280 to 289.................................................. 0.15 290 to 299.................................................. .12 300 to 359.................................................. .08 360 to 400.................................................. .02 ———————————————————————————————————————

(c) Petroleum wax may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the act, in an amount not greater than that required to produce its intended effect. (d) Petroleum wax may contain a total of not more than 1 weight percent of residues of the following polymers when such residues result from use of the polymers as processing aids (filter aids) in the production of the petroleum wax: Homopolymers and/or copolymers derived from one or more of the mixed n-alkyl (C12,C14, C16, and C18) methacrylate esters where the C12 and C14 alkyl groups are derived from coconut oil and the C16 and C18 groups are derived from tallow. (e) Petroleum wax may contain 2-hydroxy-4-n-octoxybenzophenone as a stabilizer at a level not to exceed 0.01 weight percent of the petroleum wax. (f) Petroleum wax may contain poly(alkylacrylate) (CAS Reg. No. 27029-57-8), as described in Sec. 172.886(c)(2) of this chapter, as a processing aid in the manufacture of petroleum wax. [42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986]

§ 178.3720 Petroleum wax, synthetic. Synthetic petroleum wax may be safely used in applications and under the same conditions where naturally derived petroleum wax is permitted in subchapter B of this chapter as a component of articles intended to contact food, provided that the synthetic petroleum wax meets the definition and specifications prescribed in Sec. 172.888 of this chapter. § 178.3725 Pigment dispersants. Subject to the provisions of this regulation, the substances listed in this section may be safely used as pigment dispersants in food-contact materials. ——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— Dimethylolpropionic acid (CAS Reg. No. For use only at levels not to 4767-03-7). exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all foods under conditions of use A through H as described in Table 2 of Sec. 176.170(c) of this chapter. Phosphorylated tall oil fatty acids For use only at levels not to (CAS Reg. No. 68604-99-9), prepared by exceed 1.0 percent by weight the reaction of dimethyl hydrogen of the pigment. The pigmented phosphite with tall oil fatty acids. polymeric films may contact all food under conditions of use D, E, F, and G described in table 2 of Sec. 176.170(c) of this chapter.

1025

§ 178.3730

——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— Propanoic acid, 3-hydroxy-2For use only at levels not to (hydroxymethyl)-2-methyl-, compd. with exceed 0.45 percent by weight 1,1’,1’’-nitrilotris [2-propanol] of the pigment. The pigmented (1:1) (CAS Reg. No. 221281-21-6). articles may contact all food under conditions of use A through H as described in Table 2 of Sec. 176.170(c) of this chapter. Siloxanes and silicones; cetylmethyl, For use only at levels not to dimethyl, methyl 11-methoxy-11exceed 0.5 percent by weight oxoundecyl (CAS Reg. No. 155419-59-3). of the pigment. The pigmented polymers may contact all foods under conditions of use C, D, E, F, and G described in Table 2 of Sec. 176.170(c) of this chapter. Trimethylolethane (CAS Reg. No. 77-85For use only at levels not to 0). exceed 0.45 percent by weight of inorganic pigment. The pigmented articles may contact all food under conditions of use A through H described in Table 2 of Sec. 176.170(c) of this chapter. ———————————————————————————————————————

[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]

§ 178.3730 Piperonyl butoxide and pyrethrins as components of bags. Piperonyl butoxide in combination with pyrethrins may be safely used for insect control on bags that are intended for use in contact with dried feed in compliance with Secs. 561.310 and 561.340 of this chapter, or that are intended for use in contact with dried food in compliance with Secs. 193.60 and 193.390 of this chapter. § 178.3740 Plasticizers in polymeric substances. Subject to the provisions of this regulation, the substances listed in paragraph (b) of this section may be safely used as plasticizers in polymeric substances used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) List of substances: ———————————————————————————————————————————— Substances Limitations ———————————————————————————————————————————— Butylbenzyl phthalate........... For use only: 1. As provided in Secs. 175.105 and 176.180 of this chapter. 2. In polymeric substances used in food-contact articles complying with Sec. 175.300, Sec. 175.320, or Sec. 176.170 of this chapter: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate. 3. In polymeric substances used in other permitted food-contact articles: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate; and Provided further, That the finished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of Sec. 175.300(d) of this chapter, shall yield net chloroform-soluble extractives not to exceed 0.5 mg. per square inch, as determined by the methods prescribed in Sec.

1026

§ 178.3740

———————————————————————————————————————————— Substances Limitations ———————————————————————————————————————————— 175.300(e) of this chapter. 1,3-Butylene glycoladipic acid For use at levels not exceeding 33 polyester (1,700-2,200 percent by weight of polyvinyl molecular weight) terminated chloride homopolymers used in contact with a 16 percent by weight with food (except foods that contain mixture of myristic, palmitic, more than 8 percent of alcohol) at and stearic acids. temperatures not to exceed room temperature. The average thickness of such homopolymers in the form in which they contact food shall not exceed 0.004 inch. For use only under the conditions Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl groups listed below, and excluding use as a are derived from linear alpha component of resinous and polymeric olefins by the oxo process. coatings described in Sec. 175.300 of this chapter. 1. At levels not to exceed 24 percent by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not to exceed 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymer in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. For use only: Di-n-alkyl adipate made from C6 C8-C10 (predominately C8 and 1. At levels not exceeding 24 pct by C10) or C8-C10 synthetic fatty weight of permitted vinyl chloride alcohols complying with Sec. homo- and/or copolymers used in 172.864 of this chapter. contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.

1027

§ 178.3740

———————————————————————————————————————————— Substances Limitations ———————————————————————————————————————————— 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in which they contact food shall not exceed 0.002 inch. Dicyclohexyl phthalate.......... For use only: 1. As provided in Secs. 175.105, 176.170, 176.180, and 177.1200 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with Sec. 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid. Di(2-ethylhexyl) adipate........ ...................................... Diisononyl adipate.............. For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch. 3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. 4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch. Diisononyl phthalate............ For use only at levels not exceeding 43 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with food only of the types identified in Sec. 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.

1028

§ 178.3740

———————————————————————————————————————————— Substances Limitations ———————————————————————————————————————————— Di(2-ethylhexyl) azelate........ For use only: 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic food. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. 2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter, with fatty, nonalcoholic food having a fat and oil content not exceeding a total of 30 percent by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. Di-n-hexylazelate............... For use only: 1. In polymeric substances used in contact with nonfatty food. 2. In polymeric substances used in contact with fatty food and limited to use at levels not exceeding 15 pct by weight of such polymeric substance except as provided under limitation 3. 3. At levels greater than 15 but not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F or G described in table 2 of Sec. 176.170(c) of this chapter, with fatty food having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch. Dihexyl phthalate............... For use only: 1. As provided in Sec. 175.105 of this chapter. 2. In articles that contact food only of the types identified in Sec. 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B, and VIII. Diphenyl phthalate.............. For use only: 1. As provided in Sec. 175.105 of this chapter. 2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with Sec. 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid. Epoxidized butyl esters of Iodine number, maximum 5; oxirane linseed oil fatty acids. oxygen, minimum 7.8 pct. Epoxidized linseed oil.......... Iodine number, maximum 5; oxirane oxygen, minimum 9-pct. Mineral oil, white.............. Polybutene, hydrogenated For use only: (minimum viscosity at 99 °F, 39 1. In polymeric substances used in Saybolt Universal seconds, as contact with non-fatty food. determined by ASTM methods D4452. In polyethylene complying with Sec. 82 (``Standard Test Method for 177.1520 of this chapter and used in Kinematic Viscosity of contact with fatty food, provided Transparent and Opaque Liquids that the hydrogenated polybutene is (and the Calculation of Dynamic added in an amount not to exceed 0.5 Viscosity)’’) and D2161-82 pct by weight of the polyethylene, (``Standard Method for and further provided that such Conversion of Kinematic plasticized polyethylene shall not be Viscosity to Saybolt Universal used as a component of articles Viscosity or to Saybolt Furol intended for packing or holding food Viscosity’’), and bromine during cooking.

1029

§ 178.3750

———————————————————————————————————————————— Substances Limitations ———————————————————————————————————————————— number of 3 or less, as 3. In polystyrene complying with Sec. determined by ASTM method D1492177.1640 of this chapter and used in 78 (``Standard Test Method for contact with fatty food, provided Bromine Index of Aromatic that the hydrogenated polybutene is Hydrocarbons by Coulometric added in an amount not to exceed 5 Titration’’), which are pct by weight of the polystyrene, and incorporated by reference. further provided that such Copies may be obtained from the plasticized polystyrene shall not be American Society for Testing used as a component of articles Materials, 1916 Race St., intended for packing or holding food Philadelphia, PA 19103, or may during cooking. be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Polyisobutylene (mol weight 300For use in polyethylene complying with 5,000). Sec. 177.1520 of this chapter, provided that the polyisobutylene is added in an amount not exceeding 0.5 pct by weight of the polyethylene, and further provided that such plasticized polyethylene shall not be used as a component of articles intended for packing or holding food during cooking. Polyisobutylene complying with Sec. 177.1420 of this chapter. Polypropylene glycol (CAS For use only in polystyrene plastics, registry No. 25322-69-4) identified in Sec. 177.1640(a)(1), (minimum mean molecular weight in an amount not to exceed 6 pct by 1,200). weight of the finished food-contact article. Propylene glycol azelate For use only at levels not exceeding (average mol. weight 3,000). 41 pct by weight of permitted polyvinyl chloride coatings. Such coatings shall be used only as bulk food contact surfaces of articles intended for repeated use, complying with Sec. 177.2600 of this chapter. Triethylene glycol.............. Diethylene glycol content not to exceed 0.1 pct. 2,2,4-Trimethyl-1,3-pentanediol For use only in cellulosic plastics in diisobutyrate. an amount not to exceed 15 pct by weight of the finished food-contact article, provided that the finished plastic article contacts food only of the types identified in Sec. 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII. ————————————————————————————————————————————

(c) The use of the plasticizers in any polymeric substance or article subject to any regulation in parts 174, 175, 176, 177, 178 and 179 of this chapter must comply with any specifications and limitations prescribed by such regulation for the finished form of the substance or article. [42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986]

§ 178.3750 Polyethylene glycol (mean molecular weight 200-9,500). Polyethylene glycol identified in this section may be safely used as a component of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive is an addition polymer of ethylene oxide and water with a mean molecular weight of 200 to 9,500. (b) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols if its mean molecular weight is 350 or higher and no more than 0.5 percent total by weight of ethylene and diethylene glycols if its mean molecular weight is below 350, when tested by the analytical methods prescribed in Sec. 172.820(b) of this chapter. (c) The provisions of paragraph (b) of this section are not applicable to polyethylene glycols used in food-packaging adhesives complying with Sec. 175.105 of this chapter.

1030

§ 178.3770

§ 178.3760 Polyethylene glycol (400) monolaurate. Polyethylene glycol (400) monolaurate containing not more than 0.1 percent by weight of ethylene and/or diethylene glycol may be used at a level not to exceed 0.3 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with Sec. 177.1500 of this chapter. § 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids. Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids identified in this section may be safely used as components of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) The polyhydric alcohol esters identified in this paragraph may be used as lubricants in the fabrication of vinyl chloride plastic food-contact articles prepared from polyvinyl chloride and/or from vinyl chloride copolymers complying with Sec. 177.1980 of this chapter. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids by either ethylene glycol or 1,3butanediol with or without neutralization of unreacted carboxylic groups with calcium hydroxide: (1) Dropping point 76 °-105 °C, as determined by ASTM method D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of Lubricating Grease,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (2) Acid value 10-20, as determined by ASTM method D1386-78 (``Standard Test Method for Acid Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408) using as solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio. (3) Saponification value 100-160, as determined by ASTM method D1387-78 (``Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408) using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl alcohol in preparation of potassium hydroxide solution. (4) Ultraviolet absorbance limits as follows, as determined by the analytical method described in this subparagraph: Ultraviolet absorbance per centimeter pathlength. ———————————————————————————————————— Millimicrons Maximum ———————————————————————————————————— 280 to 289.................................................. 0.07 290 to 299.................................................. .06 300 to 359.................................................. .04 360 to 400.................................................. .01 ————————————————————————————————————

ANALYTICAL METHOD GENERAL INSTRUCTIONS

Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of wax samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light. APPARATUS

Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.

1031

§ 178.3770

Reservoir. 1,000-milliliter capacity, equipped with a 24/40 standard taper male fitting at the bottom and a suitable balljoint at the top. Chromatographic tube. 1,200 millimeters in length, inside diameter to be 16.5 millimeters ±0.5 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of the column with the female joint is 1,255 millimeters.) The female fitting should be equipped with glass hooks. Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 3/16-inch thick with a hole bored in the center to closely fit the stem of the chromatographic tube. Heating jackets. Conical, for 500-milliliter and 1,000-milliliter separatory funnels. (Used with variable transformer heat control.) Suction flask. 250-milliliter or 500-milliliter filter flask. Condenser. 24/40 joints, fitted with a drying tube, length optional. Evaporation flasks (optional). A 250-milliliter or 500-milliliter capacity and a 1-liter capacity all-glass flask equipped with standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated. Vacuum distillation assembly. All glass (for purification of dimethyl sulfoxide) 2-liter distillation flask with heating mantle; Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters in length and distilling head with separable cold finger condenser. Use of tetrafluoroethylene polymer sleeves on the glass joints will prevent freezing. Do not use grease on stopcocks or joints. Oil bath. Capable of heating to 90 °C. Spectrophotometric cells. Fused quartz cells, optical pathlength in the range 1.000 centimeter ±0.005 centimeter. With distilled water in the cells, determine any absorbance differences. Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons with spectral slit width of 0.2 millimicron or less; under instrument operating conditions for these absorbance measurements. The spectrophotometer shall also meet the following performance requirements: Absorbance repeatability, ±0.01 at 0.4 absorbance. Absorbance accuracy, 1±0.05 at 0.4 absorbance. Wavelength repeatability, ±0.2 millimicron. Wavelength accuracy, ±1.0 millimicron. Recording time, 50 seconds. Time constant, 0.6 second. Sensitivity, 30. Ordinate scale, 90-100 percent transmission through scale. Abscissa scale, 8X. Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g. REAGENTS AND MATERIALS

Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane and benzene designated in the list following this paragraph shall pass the following test: To be specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane and evaporate on the steam bath under a stream of nitrogen (a loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains. (To the residue from benzene add a 10-milliliter portion of purified isooctane, reevaporate, and repeat once to insure complete removal of benzene.) Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and nhexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask. Dissolve the 1 milliliter of hexadecane residue in isooctane and make up to 25 milliliters volume. Determine the absorbance in the 1-centimeter pathlength cells compared to isooctane as reference. The absorbance of the solution of the solvent residue (except for methyl alcohol) shall not exceed 0.01 per centimeter pathlength between 280 mµ and 400 mµ. Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test described in the preceding paragraph. Purify, if necessary, by

1As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrometry, U.S. Department of Commerce (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. Circular 484 is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

1032

§ 178.3770

passage through a column of activated silica gel (Grade 12, Davison Chemical Co., Baltimore, Md., or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter. Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. Purify, if necessary, by distillation or otherwise. n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-hexadecane to 25 milliliters with isooctane and determine the absorbance in a 1-centimeter cell compared to isooctane as reference point between 280 mµ-400 mµ. The absorbance per centimeter pathlength shall not exceed 0.00 in this range. If necessary, purify by filtering through a column containing 100 grams of aluminum oxide (use same grade as described below) in the lower half and 100 grams of activated silica gel in the upper half keeping the column at 150 °C., for a period of 15 hours or overnight. The first 100 milliliters of eluate are used. Purification can also be accomplished by distillation. Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18° minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 milliliters of distilled water in a 500-milliliter separatory funnel, mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second 500-milliliter separatory funnel and repeat the extraction with 40 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 40-milliliter extractives three times with 50-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents and materials’’ for preparation of filter), into a 250-milliliter Erlenmeyer flask, or optionally into the evaporating flask. Wash the first separatory funnel with the second 40milliliter isooctane extractive, and pass through the sodium sulfate into the flask. Then wash the second and first separatory funnels successively with a 10-milliliter portion of isooctane, and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane and reevaporate to 1 milliliter of hexadecane. Again, add 10 milliliters of isooctane to the residue and evaporate to 1 milliliter of hexadecane to insure complete removal of all volatile materials. Dissolve the 1 milliliter of hexadecane in isooctane and make to 25-milliliter volume. Determine the absorbance in 1-centimeter pathlength cells compared to isooctane as reference. The absorbance of the solution should not exceed 0.02 per centimeter pathlength in the 280 mµ-400 mµ range. (NOTE: Difficulty in meeting this absorbance specification may be due to organic impurities in the distilled water. Repetition of the test omitting the dimethyl sulfoxide will disclose their presence. If necessary to meet the specification, purify the water by redistillation, passage through an ion-exchange resin, or otherwise.) Purify, if necessary, by the following procedure: To 1,500 milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, add 6.0 milliliters of phosphoric acid and 50 grams of Norit A (decolorizing carbon, alkaline) or equivalent. Stopper the flask, and with the use of a magnetic stirrer (tetrafluoroethylene polymer coated bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide through four thicknesses of fluted paper (18.5 centimeters, Schleicher & Schuell, No. 597, or equivalent). If the initial filtrate contains carbon fines, refilter through the same filter until a clear filtrate is obtained. Protect the sulfoxide from air and moisture during this operation by covering the solvent in the funnel and collection flask with a layer of isooctane. Transfer the filtrate to a 2-liter separatory funnel and draw off the dimethyl sulfoxide into the 2-liter distillation flask of the vacuum distillation assembly and distill at approximately 3-millimeter Hg pressure or less. Discard the first 200-milliliter fraction of the distillate and replace the distillate collection flask with a clean one. Continue the distillation until approximately 1 liter of the sulfoxide has been collected. At completion of the distillation, the reagent should be stored in glass-stoppered bottles since it is very hygroscopic and will react with some metal containers in the presence of air. Phosphoric acid. 85 percent A.C.S. reagent grade. Aluminum oxide (80-200 mesh Woelm neutral activity grade 1 [Brockmann], Alupharm Chemicals, New Orleans, La., or equivalent). Pipette 1 milliliter of distilled water into a dry 250-milliliter Erlenmeyer flask equipped with a ground-glass stopper. Stopper the flask and rotate it in such a manner as to completely wet out the inside surfaces. When this has been done add 180 grams of the aluminum oxide and shake until no lumps or wet spots remain. Allow to stand at room temperature for a period of 2 hours. At the end of this time the water should be evenly distributed throughout the aluminum oxide powder, and it should have the same free flowing properties as the original material (flow velocity with water 0.2 milliliter per minute). At this point the aluminum oxide has an activity of 1 as expressed in Brockmann degrees, and the amount of added water is 0.5 percent by volume. This product is used in toto and as is, without further screening. Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-millimeter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter pathlength between 280 mµ and 400 mµ when tested as prescribed under ``Organic solvents.’’ Usually three portions of wash solvent are sufficient. PROCEDURE

Before proceeding with analysis of a sample, determine the absorbance in a 1-centimeter path cell between 250 mµ and 400 mµ for the reagent blank by carrying out the procedure, without a wax sample, at room temperature, recording the spectrum after the

1033

§ 178.3770

complete procedure as prescribed. The absorbance per centimeter pathlength following the complete procedure should not exceed 0.04 in the wavelength range from 280 mµ to 299 mµ, inclusive, nor 0.02 in the wavelength range from 300 mµ to 400 mµ. If in either spectrum the characteristic benzene peaks in the 250 mµ260 mµ region are present, remove the benzene by the procedure under ``Organic solvents’’ and record absorbance again. Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to preequilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks. In a 1-liter separatory funnel place a representative 25-gram sample of wax, add 50 milliliters of isooctane, heat gently, stir until the wax is in solution; add 100 milliliters of preequilibrated sulfoxide-phosphoric acid mixture and shake, making sure it remains in solution. If the wax comes out of solution during these operations, let the stoppered funnel remain in the jacket until the wax redissolves. (Remove stopper from the funnel at intervals to release pressure.) When the wax is in solution, remove the funnel from the jacket and shake it vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of preequilibrated isooctane. After separation of the liquid phases, allow to cool until the main portion of the waxisooctane solution begins to show a precipitate. Gently swirl the funnel when precipitation first occurs on the inside surface of the funnel to accelerate this process. Carefully draw off the lower layer, filter it slowly through a thin layer of glass wool fitted loosely in a filter funnel into the first 250-milliliter separatory funnel, and wash in tandem with the 30-milliliter portions of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture, replacing the funnel in the jacket after each extraction to keep the wax in solution and washing each extractive in tandem through the same three portions of isooctane. Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter), containing 480 milliliters of distilled water, mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 80-milliliter extractives three times with 100-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents and Materials’’ for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane using an aspirator vacuum under nitrogen and in an oil bath temperature of approximately 90 °C. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once. Reserve the residue for column chromatography on the aluminum oxide. Fit the tetrafluoroethylene polymer disc on the upper part of the stem of the chromatographic tube, then place the tube with the disc on the suction flask and apply the vacuum (approximately 135 millimeters Hg pressure). Weigh out 180 grams of the aluminum oxide and pour the adsorbent mixture into the chromatographic tube in approximately 30-centimeter layers. After the addition of each layer, level off the top of the adsorbent with a flat glass rod or metal plunger by pressing down firmly until the adsorbent is well packed. Loosen the topmost few millimeters of each adsorbent layer with the end of a metal rod before the addition of the next layer. Continue packing in this manner until all the 180 grams of the adsorbent is added to the tube. Level off the top of the adsorbent by pressing down firmly with a flat glass rod or metal plunger to make the depth of the adsorbent bed approximately 80 centimeters in depth. Turn off the vacuum and remove the suction flask. Dissolve the hexadecane residue in 10 milliliters of warm benzene and decant the solution onto the column and allow the liquid level to recede to barely above the adsorbent level. Rapidly complete the transfer similarly with two 10-milliliter portions of benzene swirling the flask repeatedly each time to assure adequate washing of the residue. Fix the 1,000-milliliter reservoir onto the top of the chromatographic column. Just before the final 10-milliliter wash reaches the top of the adsorbent, add 670 milliliters of benzene to the reservoir and continue the percolation at the 2-3 milliliter per minute rate until a total of 670 milliliters of benzene has been utilized. Collect the eluate in a clean 1-liter Erlenmeyer flask (or optionally into a 1-liter evaporation flask). Allow the column to drain until most of the solvent mixture is removed. Add 1 milliliter of nhexadecane and completely remove the benzene by evaporation under nitrogen, using the special procedure to eliminate benzene as previously described under ``Organic Solvents.’’ Quantitatively transfer the residue with isooctane to a 25-milliliter volumetric flask and adjust to volume. Determine the absorbance of the solution in the 1-centimeter pathlength cells compared to isooctane as reference between 250 mµ-400 mµ. Correct for any absorbance derived from the reagents as determined by carrying out the procedure without a wax sample. If either spectrum shows the characteristic benzene peaks in the 250 mµ-260 mµ region, evaporate the solution to remove benzene by the procedure under ``Organic Solvents.’’ Dissolve the residue, transfer quantitatively, and adjust to volume in isooctane in a 25milliliter volumetric flask. Record the absorbance again. If the corrected absorbance does not exceed the limits prescribed in paragraph (a) of this section, the wax meets the ultraviolet absorbance specifications.

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§ 178.3770

(b) The polyhydric alcohol esters identified in this paragraph may be used as release agents in resinous and polymeric coatings for polyolefin films complying with Sec. 175.320 of this chapter. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids with equimolar proportions of ethylene glycol and 1,3-butanediol: (1) Dropping point 77 °-82 °C, as determined by ASTM method D566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of Lubricating Grease,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a)(1) of this section. (2) Acid value 25-35, as determined by ASTM method D1386-78 (``Standard Test Method for Acid Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408) using as solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 1:2 ratio. (3) Saponification value 135-150, as determined by ASTM method D1387-78 (``Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408) using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl alcohol in preparation of potassium hydroxide solution. (4) Ultraviolet absorbance limits specified in paragraph (a)(4) of this section, as determined by the analytical method described therein. (c) The polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids, identified in paragraph (a) or (b) of this section, may also be used as a component of an aqueous dispersion of vinylidene chloride copolymers, subject to the conditions described in paragraphs (c) (1) and (2) of this section. (1) The aqueous dispersion of the additive contains not more that 18 percent polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids, not more than 2 percent poly(oxyethylene) (minimum 20 moles of ethylene oxide) oleyl ether (CAS Reg. No. 9005-98-2), and not more than 1 percent poly(oxyethylene) (minimum 3 moles ethylene oxide) cetyl alcohols (CAS Reg. No. 9004-95-9). (2) The aqueous dispersion described in paragraph (c)(1) of this section is used as an additive to aqueous dispersions of vinylidene chloride copolymers, regulated in Secs. 175.300, 175.320, 175.360, 176.170, 176,180, and 177.1630 of this chapter, at levels not to exceed 1.5 percent (solids basis) in the finished coating. (d) The polyhydric alcohol esters identified in this paragraph may be used as lubricants in the fabrication of vinyl chloride plastic food contact articles prepared from vinyl chloride polymers. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids with glycerol followed by neutralization: (1) Dropping point 79 to 85 °C, as determined by the American Society for Testing and Materials (ASTM), Method D-566-76 (Reapproved 1982), ``Standard Test Method for Dropping Point of Lubricating Grease,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (a)(1) of this section. (2) Acid value 20-30, as determined by ASTM Method D-1386-78 ``Standard Test Method for Acid Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978) (which is incorporated by reference in accordance with 5 U.S.C. 552(a); the availability of this incorporation by reference is given in paragraph (a)(2) of this section), using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio. (3) Saponification value 130-160, as determined by ASTM Method D-1387-78 ``Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes’’ (Revised 1978), (which is incorporated by reference in accordance with 5 U.S.C. 552(a); the availability of this incorporation by reference is given in paragraph (a)(3) of this section), using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl alcohol in the preparation of potassium hydroxide solution. (4) Ultraviolet absorbance limits specified in paragraph (a)(4) of this section, as determined by the analytical method described therein. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR 17512, Apr. 5, 1993]

1035

§ 178.3780

§ 178.3780 Polyhydric alcohol esters of long chain monobasic acids. Polyhydric alcohol esters of long chain monobasic acids identified in this section may be safely used as lubricants in the fabrication of polyvinyl chloride and/or polyvinyl chloride copolymer articles complying with Sec. 177.1980 of this chapter that contact food of Types I, II, IV-B, VI-B, VII-B, and VIII identified in table 1 in Sec. 176.170(c) of this chapter under conditions of use E, F, and G described in table 2 in Sec. 176.170(c) of this chapter, subject to the provisions of this section. (a) Identity. For the purpose of this section, polyhydric alcohol esters of long chain monobasic acids consist of polyhydric alcohol esters having number average molecular weights in the range of 1,050 to 1,700. The esters are produced by the reaction of either ethylene glycol or glycerol with long chain monobasic acids containing from 9 to 49 carbon atoms obtained by the ozonization of long chain alpha-olefins, the unreacted carboxylic acids in the formation of the glycerol esters being neutralized with calcium hydroxide to produce a composition having up to 2 percent by weight calcium. The alpha-olefins, obtained from the polymerization of ethylene, have 20 to 50 carbon atoms and contain a minimum of 75 percent by weight straight chain alpha-olefins and not more than 25 percent vinylidene compounds. (b) Specifications. The polyhydric alcohol esters have the following specifications: (1) Melting point of 60-80 °C for the ethylene glycol ester and 90-105 °C for the glycerol ester as determined by the Fisher Johns method as described in ``Semimicro Qualitative Organic Analysis—The Systematic Identification of Organic Compounds,’’ by Cheronis and Entrikin, 2d Ed., Interscience Publishers, NY, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (2) Acid value 15-25 for each ester as determined by the A.O.C.S. method Trla-64T ``Titer Test,’’ which is incorporated by reference. Copies are available from American Association of Oil Chemists, 36 East Wacker Drive, Chicago, IL 60601, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The method is modified to use as the acid solvent a 1:1 volume mixture of anhydrous isopropyl alcohol and toluene. The solution is titrated with 0.1N methanolic sodium hydroxide. (3) Saponification value 120-160 for the ethylene glycol ester and 90-130 for the glycerol ester as determined the A.O.C.S. method Trla-64T ``Saponification Value,’’ which is incorporated by reference. Copies are available from American Association of Oil Chemists, 36 East Wacker Drive, Chicago, IL 60601, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (4) Ultraviolet absorbance as specified in Sec. 178.3770(a)(4) of this chapter when tested by the analytical method described therein. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14481, Apr. 2, 1996]

§ 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics. The polymers identified in paragraph (a) of this section may be safely admixed, alone or in mixture with other permitted polymers, as modifiers in semirigid and rigid vinyl chloride plastic food-contact articles prepared from vinyl chloride homopolymers and/or from vinyl chloride copolymers complying with Sec. 177.1950, Sec. 177.1970, and/or Sec. 177.1980 of this chapter, in accordance with the following prescribed conditions: (a) For the purpose of this section, the polymer modifiers are identified as follows: (1) Acrylic polymers identified in this subparagraph provided that such polymers contain at least 50 weight-percent of polymer units derived from one or more of the monomers listed in paragraph (a)(1)(i) of this section. (i) Homopolymers and copolymers of the following monomers: n-Butyl acrylate. n-Butyl methacrylate. Ethyl acrylate. Methyl methacrylate.

(ii) Copolymers produced by copolymerizing one or more of the monomers listed in paragraph (a)(1)(i) of this section with one or more of the following monomers: 1036

§ 178.3800

Acrylonitrile. Butadiene. a-Methylstyrene. Styrene. Vinylidene chloride.

(iii) Polymers identified in paragraphs (a)(1) (i) and (ii) of this section containing no more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the following monomers: Acrylic acid. 1,3-Butylene glycol dimethacrylate. Divinylbenzene. Methacrylic acid.

(iv) Mixtures of polymers identified in paragraph (a)(1) (i), (ii), and (iii) of this section; provided that no chemical reactions, other than addition reactions, occur when they are mixed. (2) Polymers identified in paragraph (a)(1) of this section combined during their polymerization with butadienestyrene copolymers; provided that no chemical reactions, other than addition reactions, occur when they are combined. Such combined polymers may contain 50 weight-percent or more of total polymer units derived from the butadiene-styrene copolymers. (b) The polymer content of the finished plastic food-contact article consists of: (1) Not less than 80 weight-percent of polymer units derived from the vinyl chloride polymers identified in the introduction to this section and not more than 5 weight-percent of polymer units derived from polymers identified in paragraph (a)(1) of this section and may optionally contain up to 15 weight-percent of polymer units derived from butadiene-styrene copolymers; or (2) Not less than 50 weight-percent of polymer units derived from the vinyl chloride polymers identified in the introduction to this section, not more than 50 weight-percent of polymer units derived from homopolymers and/or copolymers of ethyl acrylate and methyl methacrylate, and not more than 30 weight-percent of polymer units derived from copolymers of methyl methacrylate, a-methylstyrene and acrylonitrile and may optionally contain up to 15 weight-percent of polymer units derived from butadiene-styrene copolymers. (c) No chemical reactions, other than addition reactions, occur among the vinyl chloride polymers and the modifying polymers present in the polymer mixture used in the manufacture of the finished plastic food-contact article. (d) The finished plastic food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of Sec. 176.170(c) of this chapter, yields extractives not to exceed the limits prescribed in Sec. 177.1010 (b) (1), (2), (3), and (4) of this chapter when tested by the methods prescribed in Sec. 177.1010 (c) of this chapter. (e) Acrylonitrile copolymers identified in this section shall comply with the provisions of Sec. 180.22 of this chapter. § 178.3800 Preservatives for wood. Preservatives may be safely used on wooden articles that are used or intended for use in packaging, transporting, or holding raw agricultural products subject to the provisions of this section: (a) The preservatives are prepared from substances identified in paragraph (b) of this section and applied in amounts not to exceed those necessary to accomplish the technical effect of protecting the wood from decay, mildew, and water absorption. (b) The substances permitted are as follows:

1037

§ 178.3850

—————————————————————————————————————— List of substances Limitations —————————————————————————————————————— Copper-8-quinolinolate................. Mineral spirits........................ Paraffin wax........................... Used singly or in combination so as to constitute not less than 50% of the solids. Petroleum hydrocarbon resin, produced Do. by the homo- and copolymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene type from distillates of cracked petroleum stocks. Pentachlorophenol and its sodium salt.. Not to exceed 50 p.p.m. in the treated wood, calculated as pentachlorophenol. Rosins and rosin derivatives........... As provided in Sec. 178.3870. Zinc salt of sulfonated petroleum...... ——————————————————————————————————————

§ 178.3850 Reinforced wax. Reinforced wax may be safely used as an article or component of articles intended for use in producing, manufacturing, packing, processing, transporting, or holding food subject to the provisions of this section. (a) Reinforced wax consists of petroleum wax to which have been added certain optional substances required in its production, or added to impart desired physical or technical properties. (b) The quantity of any optional adjuvant substance employed in the production of or added to reinforced wax does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation provided in this section. (c) Any substance employed in the production of reinforced wax, including any optional substance, that is the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, conforms with any specification in such regulation. (d) The substances and optional adjuvant substances employed in the production of or added to reinforced wax include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction for use in reinforced wax and used in accordance with such sanction or approval. (3) Substances identified in this subparagraph and subject to any limitations provided therein: —————————————————————————————————————— List of substances Limitations —————————————————————————————————————— Copolymer of isobutylene modified with isoprene. Petroleum wax, Type I and Type II......... Polyethylene.............................. Rosins and rosin derivatives as provided in Sec. 178.3870. Synthetic wax polymer as described in Sec. Not to exceed 5 percent by 176.170(a)(5) of this chapter. weight of the petroleum wax. ——————————————————————————————————————

(e) Reinforced wax conforming with the specifications in this paragraph is used as provided in paragraph (e)(2) of this section. (1) The chloroform-soluble portion of the water extract obtained by exposing reinforced wax to demineralized water at 70 °F for 48 hours shall not exceed 0.5 milligram per square inch of food-contact surface. (2) It is used as a packaging material or component of packaging materials for cheese and cheese products. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 1288, Jan. 12, 1982]

§ 178.3860 Release agents. Substances listed in paragraph (b) of this section may be safely used as release agents in petroleum wax complying with Sec. 178.3710 and in polymeric resins that contact food, subject to the provisions of this section. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect or any limitations prescribed in this section. (b) Release agents: 1038

§ 178.3870

—————————————————————————————————————————— List of substances Limitations —————————————————————————————————————————— Erucamide (erucylamide)......... Formaldehyde, polymer with 1For use only as an antiscaling or naphthalenol (CAS Reg. No. release agent, applied on the 25359-91-5). internal parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million. N,N’-Dioleoylethylenediamine.... For use only in polyvinyl chloride films in amounts such that the concentration of the substance in these films in the form in which the films contact food shall not exceed 0.055 milligram of the substance per square inch of film. Oleyl palmitamide............... Polybutene, hydrogenated; For use only subject to the complying with the identity limitations prescribed for prescribed under Sec. hydrogenated polybutene under Sec. 178.3740(b). 178.3740(b). Poly(vinyl acetate/vinyl NFor use only in application to the octadecylcarbamate) (CAS Reg. backing of pressuresensitive adhesive No. 70892-21-6) produced by the tapes at levels not to exceed 0.2 reaction between milligram per square centimeter (1.29 stoichiometrically equivalent milligrams per square inch) of amounts of octadecyl isocyanate backing. and vinyl alcohol/vinyl acetate copolymer; minimum average molecular weight is 500,000. Rice bran wax................... For use only in plastics intended for contact with dry foods identified as Type VIII in table 1 of Sec. 176.170(c) of this chapter, at levels not in excess of 1.0 percent by weight of the polymer. Saturated fatty acid amides manufactured from fatty acids derived from animal, marine, or vegetable fats and oils. Stearyl erucamide............... ——————————————————————————————————————————

[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]

§ 178.3870 Rosins and rosin derivatives. The rosins and rosin derivatives identified in paragraph (a) of this section may safely be used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The rosins and rosin derivatives are identified as follows: (1) Rosins: (i) Gum rosin, refined to color grade of K or paler. (ii) Wood rosin, refined to color grade of K or paler. (iii) Tall oil rosin, refined to color grade of K or paler. (iv) Dark tall oil rosin, a fraction resulting from the refining of tall oil rosin produced by multicolumnar distillation of crude tall oil to effect removal of fatty acids and pitch components and having a saponification number of from 110-135 and 32 percent-44 percent rosin acids. (v) Dark wood rosin, all or part of the residue after the volatile terpene oils are distilled from the oleoresin extracted from pine wood. (2) Modified rosins manufactured from rosins identified in paragraph (a)(1) of this section: (i) Partially hydrogenated rosin, catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C, and a color of WG or paler. (ii) Fully hydrogenated rosin, catalytically hydrogenated to a maximum dehydroabietic acid content of 2 percent, a minimum drop-softening point of 79 °C, and a color of X or paler. (iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst to a drop-softening point of 95 °.-105 °C and a color of WG or paler. (iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and from which sufficient nondimerized rosin has 1039

§ 178.3870

been removed by distillation to achieve a minimum drop-softening point of 143 °C, and a color of H or paler. (v) Disproportionated rosin, catalytically disproportionated to a minimum dehydroabietic acid content of 35 percent, a maximum abietic acid content of 1 percent, a maximum content of substituted phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler. (3) Rosin esters manufactured from rosins and modified rosins identified in paragraphs (a)(1) and (2) of this section: (i) Glycerol ester of wood rosin purified by steam stripping to have an acid number of 3 to 9, a drop-softening point of 88 °-96 °C, and a color of N or paler. (ii) Glycerol ester of partially hydrogenated wood rosin, having an acid number of 3 to 10, a drop-softening point of 79 °-88 °C, and a color of N or paler. (iii) Glycerol ester of partially dimerized rosin, having an acid number of 3 to 8, a drop-softening point of 109 °119 °C, and a color of M or paler. (iv) Glycerol ester of fully dimerized rosin, having an acid number of 5 to 16, a drop-softening point of 165 °175°C, and a color of H or paler. (v) Glycerol ester of maleic anhydride-modified wood rosin, having an acid number of 30 to 40, a drop-softening point of 138 °-146 °C, a color of M or paler, and a saponification number less than 280. (vi) Methyl ester of rosin, partially hydrogenated, purified by steam stripping to have an acid number of 4 to 8, a refractive index of 1.5170 to 1.5205 at 20 °C, and a viscosity of 23 to 66 poises at 25 °C. (vii) Pentaerythritol ester of wood rosin, having an acid number of 6 to 16, a drop-softening point of 109 °-116 °C, and a color of M or paler. (viii) Pentaerythritol ester of partially hydrogenated wood rosin, having an acid number of 7 to 18, a drop-softening point of 102 °-110 °C, and a color of K or paler. (ix) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 8 to 16, a dropsoftening point of 154 °-162 °C, a color of M or paler, and having a saponification number less than 280. (x) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 9 to 16, a dropsoftening point of 130 °-140 °C, a color of N or paler, and having a saponification number less than 280. (xi) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 134 to 145, a dropsoftening point of 127 °-137 °C, a color of M or paler, and having a saponification number less than 280. (xii) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 30 to 40, a dropsoftening point of 131 °-137 °C, a color of N or paler, and having a saponification number less than 280. (xiii) Pentaerythritol ester of maleic anhydride-modified wood rosin, further modified by reaction with 4,4’isopropyl-idenediphenol-formaldehyde condensate, having an acid number of 10 to 22, a drop-softening point of 162 °-172 °C, a color of K or paler, a saponification number less than 280, and amaximum ultraviolet absorbance of 0.14 at 296 mµ (using a 1-centimeter cell and 200 milligrams of the rosin ester per liter of solvent consisting of ethyl alcohol made alkaline by addition of 0.1 percent of potassium hydroxide). (xiv) Mixed methyl and pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 73 to 83, a drop-softening point of 113 °-123 °C, a color of M or paler, and a saponification number less than 280. (xv) Triethylene glycol ester of partially hydrogenated wood rosin, having an acid number of 2 to 10, a color of K or paler, and a viscosity of 350 to 425 seconds Saybolt at 100 °C. (xvi) Glycerol ester of maleic anhydride-modified wood rosin, having an acid number of 17 to 23, a drop-softening point of 136 °-140 °C, a color of M or paler, and a saponification number less than 280. For use only in cellophane complying with Sec. 177.1200 of this chapter. (xvii) Citric acid-modified glycerol ester of rosin, having an acid number less than 20, a drop-softening point of 105 °-115 °C, and a color of K or paler. For use only as a blending agent in coatings for cellophane complying with Sec. 177.1200 of this chapter. (xviii) Glycerol ester of tall oil rosin, purified by steam stripping to have an acid number of 5-12, a softening point of 80 °-88 °C, and a color of N or paler. (xix) Glycerol ester of maleic anhydride-modified tall oil rosin, having an acid number of 30 to 40, a drop-softening point of 141 °- 146 °C, a color of N or paler, and a saponification number less than 280. (xx) Glycerol ester of disproportionated tall oil rosin, having an acid number of 5 to 10, a drop-softening point of 84 °-93 °C, a color of WG or paler, and a saponification number less than 180. (4) Rosin salts and sizes—Ammonium, calcium, potassium, sodium, or zinc salts of rosin manufactured by the partial or complete saponification of any one of the rosins or modified rosins identified in paragraph (a)(1) and (2) of this section, or blends thereof, and with or without modification by reaction with one or more of the following: 1040

§ 178.3900

(i) Formaldehyde. (ii) Fumaric acid. (iii) Maleic anhydride. (iv) Saligenin. (b) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (c) The use in any substance or article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter shall conform with any specifications and limitations prescribed by such regulation for the finished form of the substance or article. (d) The provisions of this section are not applicable to rosins and rosin derivatives identified in Sec. 175.300(b)(3)(v) of this chapter and used in resinous and polymeric coatings complying with Sec. 175.300 of this chapter. (e) The provisions of this section are not applicable to rosins and rosin derivatives identified in Sec. 175.105(c)(5) of this chapter and used in defoaming agents complying with Sec. 176.210 of this chapter, food-packaging adhesives complying with Sec. 175.105 of this chapter, and rubber articles complying with Sec. 177.2600 of this chapter. (f) The analytical methods for determining whether rosins and rosin derivatives conform to the specifications prescribed in paragraph (a) of this section are as follows: (1) Color: Color shall be as determined by ASTM method D509-70 (Reapproved 1981), ``Standard Methods of Sampling and Grading Rosin,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (2) Refractive index: Refractive index shall be as determined by ASTM method D1747-62 (Reapproved 1978), ``Standard Test Method for Refractive Index of Viscous Materials,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section. (3) Acid number: Acid number shall be as determined by ASTM method D465-82, ``Standard Test Methods for Acid Number of Rosin,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section. (4) Viscosity: Viscosity in poises shall be as determined by ASTM method D1824-66 (Reapproved 1980), ``Standard Test Method for Apparent Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield Viscometer,’’ and in Saybolt seconds by ASTM method D88-81, ``Standard Test Method for Saybolt Viscosity,’’ which are incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section. (5) Softening point: Softening point shall be as determined by ASTM method E28-67, ``Standard Test Method for Softening Point by Ring and Ball Apparatus’’ (Reapproved 1977), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 1916 Race St., Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (6) Analytical methods for determining drop-softening point, saponification number, and any other specifications not listed under paragraphs (f)(1) through (5) of this section, titled: (i) ``Determination of Abeitic Acid and Dehydroabietic Acid in Rosins’’; (ii) ``Determination of Softening Point of Solid Resins’’; (iii) ``Determination of Saponification Number of Rosin Esters,’’ and (iv) ``Determination of Phenolic Modification of Rosin Derivatives,’’ which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

§ 178.3900 Sodium pentachlorophenate. Sodium pentachlorophenate may be safely used as a preservative for ammonium alginate employed as a processing aid in the manufacture of polyvinyl chloride emulsion polymers intended for use as articles or components of articles that contact food at temperatures not to exceed room temperature. The quantity of sodium pentachlorophenate used shall not exceed 0.5 percent by weight of ammonium alginate solids. 1041

§ 178.3910

§ 178.3910 Surface lubricants used in the manufacture of metallic articles. The substances listed in this section may be safely used in surface lubricants employed in the manufacture of metallic articles that contact food, subject to the provisions of this section. (a) The following substances may be used in surface lubricants used in the rolling of metallic foil or sheet stock provided that total residual lubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.015 milligram per square inch of metallic food-contact surface: (1) Substances identified in paragraphs (b)(1) and (2) of this section. (2) Substances identified in this paragraph. ———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— α-Butyl-Ω—hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038-95-3) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol and having a minimum molecular weight of 1,000. α-Butyl-Ωhydroxypoly(oxypropylene) (CAS Reg. No. 9003-13-8) having a minimum molecular weight of 1000. α-Lauroyl-Ωhydroxpoly(oxyethylene) (CAS Reg. No. 9004-81-3) having a minimum molecular weight of 200. Acetate esters derived from synthetic straight chain alcohols (complying with Sec. 172.864 of this chapter) that have even numbers of carbon atoms in the range C8-C18. alpha-Alkyl-omegahydroxypoly(oxyethylene) produced by the condensation of 1 mole of C12-C15 straight chain primary alcohols with an average of 3 moles of ethylene oxide (CAS Reg. No. 6002-97-1). Benzotriazole (CAS Reg. No. 95-14-7)... Bis(hydrogenated tallow alkyl)amine Not to be used in combination (CAS Reg. No. 61789-79-5). with sodium nitrite. Bis(hydrogenated tallow ............................... alkyl)aminoethanol (CAS Reg. No. 116438-56-3). N,N-Bis(2-hydroxyethyl)butylamine (CAS ............................... Reg. No. 102-79-4). Tert-Butyl alcohol..................... Di(2-ethylhexyl)phthalate.............. Diethyl phthalate...................... Diethylene glycol monobutylether (CAS ............................... Reg. No. 112-34-5). Dimers, trimers, and/or their partial For use only at a level not to methyl esters; such dimers and trimers exceed 10 percent by weight of finished lubricant are of unsaturated C18 fatty acids derived from animal and vegetable fats formulation. and oils and/or tall oil, and such partial methyl esters meet the following specifications: Saponification value 180-200, acid value 70-130, and maximum iodine value 120. Di-n-octyl sebacate.................... Ethylenediaminetetraacetic acid, sodium salts. Isopropyl alcohol...................... Isopropyl laurate (CAS Reg. No. 10233For use at a level not to 13-3). exceed 10 percent by weight of the finished lubricant formulation. Isopropyl oleate....................... Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043-30-5). Methyl esters of coconut oil fatty acids. Methyl esters of fatty acids (C16-C18) derived from animal and vegetable fats and oils. Polybutene, hydrogenated: complying with the identity prescribed under Sec. 178.3740(b).

1042

§ 178.3910

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Polyethylene glycol (400) monostearate. Polyisobutylene (minimum molecular weight 300). Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791-26-2). Polyvinyl alcohol...................... Sodium nitrite......................... For use only as a rust inhibitor in lubricant formulations provided the total residual sodium nitrite on the metallic article in the form in which it contacts food does not exceed 0.007 milligram per square inch of metallic food-contact surface. Sodium petroleum sulfonate, MW 440-450 (CAS Reg. No. 68608-24-4) derived from naphthenic oil having a Saybolt viscosity range of 500-600 Saybolt Universal Seconds (SUS at 37-8 C (100 F) as determined by ASTM method D8881, ``Standard Test Method for Saybolt Viscosity,’’ which is incorporated by reference. Copies are available from the American Society for Testing Materials, 1961 Race St., Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. Synthetic alcohol mixture of straightand branched-chain alcohols that have even numbers of carbon atoms in the range C4-C18 and that are prepared from ethylene, aluminum, and hydrogen such that the finished synthetic alcohol mixture contains not less than 75 pct of straight-chain primary alcohols and contains not less than 85 pct total C10 and C12 alcohols. Synthetic primary alcohol mixture of For use at a level not to straight- and branched-chain alcohols exceed 8 pct by weight of the that contain at least 99 pct primary finished lubricant alcohols consisting of the following: formulation. not less than 70 pct normal alcohols; not less than 96.5 pct C12-C15 alcohols; and not more than 2.5 pct alpha, omega, C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight, 207±4; hydroxyl number, 266- 276. Synthetic primary alcohol mixture of For use only at a level not to straight- and branched-chain alcohols exceed 8 pct by weight of the that contain at least 99 pct primary finished lubricant alcohols consisting of the following: formulation. not less than 70 percent normal alcohols; not less than 93 pct C12-C13 alcohols; not more than 5 pct C14-C15 alcohols; and not more than 2.5 pct alpha, omega, C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight 194±5; hydroxyl number, 283-296. Tallow, sulfonated..................... Triethanolamine........................ ————————————————————————————————————————

(3) Mineral oil conforming to the identity prescribed in Sec. 178.3620(c). (4) Light petroleum hydrocarbons identified in paragraph (a)(4) (i) of this section: Provided, That the total residual lubricant on the metallic article in the form in which it contacts food meets the ultraviolet absorbance limits 1043

§ 178.3910

prescribed in paragraph (a) (4) (ii) of this section as determined by the analytical method described in paragraph (a) (4) (iii) of this section. (i) Light petroleum hydrocarbons are derived by distillation from virgin petroleum stocks or are synthesized from petroleum gases. They are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature, and meet the following specifications: (a) Initial boiling point is 24 °C minimum and final boiling point is 288 °C maximum, as determined by ASTM method D86-82, ``Standard Method for Distillation of Petroleum Products,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (b) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum, as determined by ASTM method D381-80, ``Standard Test Method for Existent Gum in Fuels by Jet Evaporation,’’ when the final boiling point is 121°C or above and by ASTM method D1353-78, ``Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products,’’ when the final boiling point is below 121 °C. These ASTM methods are incorporated by reference. The availability of these incorporations by reference is given in paragraph (a)(4)(i)(a) of this section. (c) Saybolt color 20 minimum as determined by ASTM method D156-82, ``Standard Test Method for Saybolt Color of Petroleum Products (Saybolt Chromometer Method),’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a)(4)(i)(a) of this section. (d) Aromatic component content shall not exceed 32 percent. (e) Conforms with ultraviolet absorbance limits prescribed in Sec. 178.3620(c) as determined by the analytical method described therein. (ii) Ultraviolet absorbance limits on residual lubricants are as follows: ———————————————————————————————————— Maximum absorbance per 5 centimeters Wavelength (mm) optical pathlength ———————————————————————————————————— 280-289............................................... 0.7 290-299............................................... .6 300-359.............................................. .4 360-400.............................................. .09 ————————————————————————————————————

(iii) The analytical method for determining ultraviolet absorbance limits on residual lubricants is as follows: GENERAL INSTRUCTIONS

Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent, residues, etc. Examine all glassware including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of oil samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light. APPARATUS

Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks. Evaporation flask (optional). 250-milliliter or 500-milliliter capacity all-glass flask equipped with standard-taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated. Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeters ±0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1.000 centimeter ±0.005 centimeter. With distilled water in the cells, determine any absorbance differences. Spectrophotometer. Special range 250 millicrons-400 millimicrons with spectral slit width of 2 millimicrons or less; under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements: Absorbance repeatability, ±0.01 at 0.4 absorbance.

1044

§ 178.3910

Absorbance accuracy, 1±0.05 at 0.4 absorbance. Wavelength repeatability, ±0.2 millimicron. Wavelength accuracy, ±1.0 millimicron. Soxhlet apparatus. 60-millimeter diameter body tubes fitted with condenser and 500-milliliter round-bottom boiling flask. A supply of paper thimbles to fit is required. Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g. REAGENTS AND MATERIALS

Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane (2,2,4-trimethylpentane) shall pass the following test: Place 180 milliliters of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane and evaporate on the steam bath under a stream of nitrogen (a loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains. Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and nhexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask. Dissolve the 1 milliliter of hexadecane residue in isooctane and make to 25 milliliters volume. Determine the absorbance in the 5-centimeter path length cells compared to isooctane as reference. The absorbance of the solution of the solvent residue shall not exceed 0.01 per centimeter path length between 280 and 400 mµ. Purify, if necessary, by passage through a column of activated silica gel (Grade 12, Davison Chemical Co., Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter. n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n-hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference point between 280 mµ-400 mµ. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation. Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach Corp., Camas, Washington, or equivalent). Absorbance (1centimeter cell, distilled water reference, sample completely saturated with nitrogen). ———————————————————————————————————— Absorbance Wavelength maximum) ———————————————————————————————————— 261.5....................................................... 1.00 270......................................................... .20 275......................................................... .09 280......................................................... .06 300......................................................... .015 ————————————————————————————————————

There shall be no irregularities in the absorbance curve within these wavelengths. Phosphoric acid. 85 percent A.C.S. reagent grade. Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-milliliter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter path length between 280 mµ and 400 mµ when tested as prescribed under ``Organic solvents.’’ Usually three portions of wash solvent are sufficient. Before proceeding with analysis of a sample, determine the absorbance in a 5-centimeter path cell between 250 millimicrons and 400 millimicrons for the reagent blank by carrying out the procedure, without a metal sample. The absorbance per centimeter path length should not exceed 0.02 in the wavelength range from 280 mµ to 400 mµ. Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to pre-equilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks. 1As

determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrometry, U.S. Department of Commerce (1949), which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The accuracy is to be determined by comparison with the standard values at 210, 345, and 400 millimicrons.

1045

§ 178.3910

PROCEDURE

Sample. Select metal foil or sheet stock for the test which has not been previously contaminated by careless handling or exposure to atmospheric dust and fumes. A commercial coil in the form supplied for spindle mounting in a packaging line or wrapping machine is most suitable. Strip off the outside turn of metal and discard. Carefully avoid contamination or damage from handling the metal (wear gloves). Remove a 16-18-foot length from the coil and place it on a flat surface protected by a length of new kraft paper. Cut four 15-foot strips from the sample, each 3 inches wide (avoid tearing the edges of the strips). Using a piece of suitable glass rod, roll the strips of metal into loose coils and insert each into a Soxhlet thimble. Each turn of coil should be visibly separated from the adjacent turn. Extraction. Fill each of the four Soxhlet tubes with purified isooctane (see under heading ``Reagents and Materials,’’ above) until siphon action occurs and then refill the tube body. Supply heat to the boiling flask and allow extraction to continue for at least 8 hours or until repeated weighings of the dried and cooled coil show no further Combine the isooctane extracts from the four Soxhlet units in a suitable beaker, rinsing each tube and flask into the beaker with fresh purified solvent. Evaporate the solvent under an atmosphere of inert gas (nitrogen) to residual volume of 50-60 milliliters and transfer this solution to a 500milliliter separatory funnel containing 100 milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture. Complete the transfer of the sample with small portions of pre-equilibrated isooctane to give a total volume of the residue and solvent of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of preequilibrated isooctane. After separation of liquid phases, carefully draw off lower layer into the first 250-milliliter separatory funnel and wash in tandem with the 30-milliliter portion of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture and wash each extractive in tandem through the same three portions of isooctane. Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter) containing 480 milliliters of distilled water; mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliter of isooctane. Draw off and discard the aqueous layer. Wash each of the 80 milliliter extractives three times with 100-milliliter portions distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate pre-washed with isooctane (see sodium sulfate under ``Reagents and Materials’’ for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once. Quantitatively transfer the residue with isooctane to a 25-milliliter volumetric flask, make to volume, and mix. Determine the absorbance of the solution in 5-centimeter pathlength cells compared to isooctane as reference between 280mµ-400mµ (take care to lose none of the solution in filling the sample cell). Correct the absorbance values for any absorbance derived from reagents as determined by carrying out the procedure without a metal sample. If the corrected absorbance does not exceed the limits prescribed in this paragraph, the residue meets the ultraviolet absorbance specifications.

(b) The following substances may be used in surface lubricants used to facilitate the drawing, stamping, or forming of metallic articles from rolled foil or sheet stock by further processing provided that the total residuallubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.2 milligram per square inch of food-contact surface: (1) Antioxidants used in compliance with regulations in parts 170 through 189 of this chapter. (2) Substances identified in this subparagraph. ———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Acetyl tributyl citrate................ Acetyl triethyl citrate................ Butyl stearate......................... Castor oil............................. Dibutyl sebacate....................... Di(2-ethylhexyl) azelate............... Di(2-ethylhexyl) sebacate.............. Diisodecyl phthalate................... Dimethylpolysiloxane................... Conforming to the identity prescribed in Sec. 181.28 of this chapter. Dipropylene glycol..................... Epoxidized soybean oil................. Conforming to the identity prescribed in Sec. 181.27 of this chapter.

1046

§ 178.3930

———————————————————————————————————————— List of substances Limitations ———————————————————————————————————————— Fatty acids derived from animal and vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum Magnesium Potassium Sodium Zinc Fatty alcohols, straight-chain with even number carbon atoms (C10 or greater). Isobutyl stearate...................... Lanolin................................ Linoleic acid amide.................... Mineral oil............................

Mono-, di-, and tristearyl citrate..... Oleic acid amide....................... Palmitic acid amide.................... Petrolatum............................. Phosphoric acid, mono- and dihexyl esters, compounds with tetramethylnonylamines and C11-14alkylamines (CAS Reg. No. 80939-62-4). Polyethylene glycol (molecular weight 300 or greater).

Conforming to the identity prescribed in Sec. 178.3620 (a) or (b).

Conforming to the identity prescribed in Sec. 178.3700. For use only at levels not to exceed 0.5 percent by weight of the finished surface lubricant formulation. Mono- and diethylene glycol content not to exceed a total of 0.2 pct.

Stannous stearate...................... Stearic acid amide..................... Stearyl stearate....................... Tetrakis[methylene (3,5-di-tert-butyl-4hydroxyhydrocinnamate)] methane (CAS Registry No. 6683-19-8).

For use at a level not to exceed 0.5 percent by weight of the finished surface lubricant formulation. Triethylene glycol..................... Diethylene glycol content not to exceed 0.1 pct. Wax, petroleum......................... Complying with Sec. 178.3710. ————————————————————————————————————————

(c) The substances identified in paragraph (a)(2) of this section may be used in surface lubricants used to facilitate the drawing, stamping, and forming of metallic articles from rolled foil and sheet stock provided that total residual lubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.015 milligram per square inch of food-contact surface. (d) Subject to any prescribed limitations, the quantity of surface lubricant used in the manufacture of metallic articles shall not exceed the least amount reasonably required to accomplish the intended technical effect and shall not be intended to nor, in fact, accomplish any technical effect in the food itself. (e) The use of the surface lubricants in the manufacture of any article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter must comply with any specifications prescribed by such regulation for the finished form of the article. (f) Any substance that is listed in this section and the subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter shall comply with any applicable specifications prescribed by such regulation. [42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999]

§ 178.3930 Terpene resins. The terpene resins identified in paragraph (a) of this section may be safely used as components of polypropylene film intended for use in contact with food, and the terpene resins identified in paragraph (b) of this section may be safely used as components of polyolefin film intended for use in contact with food; (a) Terpene resins consisting of the hydrogenated polymers of terpene hydrocarbons obtainable from sulfate turpentine and meeting the following specifications: Drop-softening point of 118 °-138 °C; iodine value less than 20.

1047

§ 178.3940

(b) Terpene resins consisting of polymers of beta-pinene and meeting the following specifications: Acid value less than 1; saponification number less than 1; color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution. § 178.3940 Tetraethylene glycol di-(2-ethylhexoate). Tetraethylene glycol di-(2-ethylhexoate) containing not more than 22 parts per million ethylene and/or diethylene glycols may be used at a level not to exceed 0.7 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with Sec. 177.1500 of this chapter. § 178.3950 Tetrahydrofuran. Tetrahydrofuran may be safely used in the fabrication of articles intended for packaging, transporting, or storing foods, subject to the provisions of this section. (a) It is used as a solvent in the casting of film from a solution of polymeric resins of vinyl chloride, vinyl acetate, or vinylidene chloride that have been polymerized singly or copolymerized with one another in any combination, or it may be used as a solvent in the casting of film prepared from vinyl chloride copolymers complying with Sec. 177.1980 of this chapter. (b) The residual amount of tetrahydrofuran in the film does not exceed 1.5 percent by weight of film.

PART 179—IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD Subpart A [Reserved] Subpart B—Radiation and Radiation Sources Sec. 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing. 179.25 General provisions for food irradiation. 179.26 Ionizing radiation for the treatment of food. 179.30 Radiofrequency radiation for the heating of food, including microwave frequencies. 179.39 Ultraviolet radiation for the processing and treatment of food. 179.41 Pulsed light for the treatment of food. Subpart C—Packaging Materials for Irradiated Foods 179.45 Packaging materials for use during the irradiation of prepackaged foods. AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 373, 374. SOURCE: 42 FR 14635, Mar. 15, 1977, unless otherwise noted.

Subpart A [Reserved] Subpart B—Radiation and Radiation Sources § 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing. Sources of radiation for the purposes of inspection of foods, for inspection of packaged food, and for controlling food processing may be safely used under the following conditions: (a) The radiation source is one of the following: 1048

§ 179.26

(1) X-ray tubes producing X-radiation from operation of the tube source at a voltage of 500 kilovolt peak or lower. (2) Sealed units producing radiations at energy levels of not more than 2.2 million electron volts from one of the following isotopes: Americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, and strontium-90. (3) Sealed units producing neutron radiation from the isotope Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food. (4) Machine sources producing X-radiation at energies no greater than 10 million electron volts (MeV). (b) To assure safe use of these radiation sources: (1) The label of the sources shall bear, in addition to the other information required by the Act: (i) Appropriate and accurate information identifying the source of radiation. (ii) The maximum energy of radiation emitted by X-ray tube sources. (iii) The maximum energy of X-radiation emitted by machine source. (2) The label or accompanying labeling shall bear: (i) Adequate directions for installation and use. (ii) A statement that no food shall be exposed to radiation sources listed in paragraph (a) (1) and (2) of this section so as to receive an absorbed dose in excess of 10 grays. (iii) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(3) of this section so as to receive an absorbed dose in excess of 2 milligrays. (iv) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(4) of this section so as to receive a dose in excess of 0.5 gray (Gy). [42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, Apr. 10, 2001]

§ 179.25 General provisions for food irradiation. For the purposes of Sec. 179.26, current good manufacturing practice is defined to include the following restrictions: (a) Any firm that treats foods with ionizing radiation shall comply with the requirements of part 110 of this chapter and other applicable regulations. (b) Food treated with ionizing radiation shall receive the minimum radiation dose reasonably required to accomplish its intended technical effect and not more than the maximum dose specified by the applicable regulation for that use. (c) Packaging materials subjected to irradiation incidental to the radiation treatment and processing of prepackaged foods shall comply with Sec. 179.45. (d) Radiation treatment of food shall conform to a scheduled process. A scheduled process for food irradiation is a written procedure that ensures that the radiation dose range selected by the food irradiation processor is adequate under commercial processing conditions (including atmosphere and temperature) for the radiation to achieve its intended effect on a specific product and in a specific facility. A food irradiation processor shall operate with a scheduled process established by qualified persons having expert knowledge in radiation processing requirements of food and specific for that food and for that irradiation processor’s treatment facility. (e) A food irradiation processor shall maintain records as specified in this section for a period of time that exceeds the shelf life of the irradiated food product by 1 year, up to a maximum of 3 years, whichever period is shorter, and shall make these records available for inspection and copy by authorized employees of the Food and Drug Administration. Such records shall include the food treated, lot identification, scheduled process, evidence of compliance with the scheduled process, ionizing energy source, source calibration, dosimetry, dose distribution in the product, and the date of irradiation. [51 FR 13399, Apr. 18, 1986, as amended at 67 FR 9585, Mar. 4, 2002]

§ 179.26 Ionizing radiation for the treatment of food. Ionizing radiation for treatment of foods may be safely used under the following conditions: (a) Energy sources. Ionizing radiation is limited to: (1) Gamma rays from sealed units of the radionuclides cobalt-60 or cesium-137. 1049

§ 179.26

(2) Electrons generated from machine sources at energies not to exceed 10 million electron volts. (3) X-rays generated from machine sources at energies not to exceed 5 million electron volts. (b) Limitations. ———————————————————————————————————————— Use Limitations ———————————————————————————————————————— 1. For control of Trichinella spiralis in Minimum dose 0.3 kiloGray pork carcasses or fresh, non-heat(kGy) (30 kilorad (krad)); processed cuts of pork carcasses. maximum dose not to exceed 1 kGy (100 krad). 2. For growth and maturation inhibition of Not to exceed 1 kGy (100 fresh foods. krad). 3. For disinfestation of arthropod pests Do. in food. 4. For microbial disinfection of dry or Not to exceed 10 kGy (1 dehydrated enzyme preparations (including megarad (Mrad)). immobilized enzymes). 5. For microbial disinfection of the Not to exceed 30 kGy (3 following dry or dehydrated aromatic Mrad). vegetable substances when used as ingredients in small amounts solely for flavoring or aroma: culinary herbs, seeds, spices, vegetable seasonings that are used to impart flavor but that are not either represented as, or appear to be, a vegetable that is eaten for its own sake, and blends of these aromatic vegetable substances. Turmeric and paprika may also be irradiated when they are to be used as color additives. The blends may contain sodium chloride and minor amounts of dry food ingredients ordinarily used in such blends. 6. For control of food-borne pathogens in Not to exceed 3 kGy (300 fresh or frozen, uncooked poultry krad); any packaging used products that are: (1) Whole carcasses or shall not exclude oxygen. disjointed portions of such carcasses that are ``ready-to-cook poultry’’ within the meaning of 9 CFR 381.1(b)(44), or (2) mechanically separated poultry product (a finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses). 7. For the sterilization of frozen, Minimum dose 44 kGy (4.4 packaged meats used solely in the Mrad). Packaging materials National Aeronautics and Space used need not comply with Administration space flight programs. Sec. 179.25(c) provided that their use is otherwise permitted by applicable regulations in parts 174 through 186 of this chapter. 8. For control of foodborne pathogens in, Not to exceed 4.5 kGy and extension of the shelf-life of, maximum for refrigerated refrigerated or frozen, uncooked products products; not to exceed 7.0 that are meat within the meaning of 9 CFR kGy maximum for frozen 301.2(rr), meat byproducts within the products. meaning of 9 CFR 301.2(tt), or meat food products within the meaning of 9 CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise composed solely of intact or ground meat, meat byproducts, or both meat and meat byproducts. 9. For control of Salmonella in fresh Not to exceed 3.0 kGy. shell eggs.. 10. For control of microbial pathogens on Not to exceed 8.0 kGy. seeds for sprouting.. ————————————————————————————————————————

(c) Labeling. (1) The label and labeling of retail packages of foods irradiated in conformance with paragraph (b) of this section shall bear the following logo along with either the statement ``Treated with radiation’’ or the statement ``Treated by irradiation’’ in addition to information required by other regulations. The logo shall be placed prominently and conspicuously in conjunction with the required statement. The radiation disclosure statement is not required to be more prominent than the declaration of ingredients required under Sec. 101.4 of this chapter. As used in this provision, the term ``radiation disclosure statement’’ means the written statement that discloses that a food has been intentionally subject to irradiation.

1050

§ 179.39

(2) For irradiated foods not in package form, the required logo and phrase ``Treated with radiation’’ or ``Treated by irradiation’’ shall be displayed to the purchaser with either (i) the labeling of the bulk container plainly in view or (ii) a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. As an alternative, each item of food may be individually labeled. In either case, the information must be prominently and conspicuously displayed to purchasers. The labeling requirement applies only to a food that has been irradiated, not to a food that merely contains an irradiated ingredient but that has not itself been irradiated. (3) For a food, any portion of which is irradiated in conformance with paragraph (b) of this section, the label and labeling and invoices or bills of lading shall bear either the statement ``Treated with radiation—do not irradiate again’’ or the statement ``Treated by irradiation—do not irradiate again’’ when shipped to a food manufacturer or processor for further processing, labeling, or packing. [51 FR 13399, Apr. 18, 1986, as amended at 53 FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, 2000; 65 FR 64607, Oct. 30, 2000]

§ 179.30 Radiofrequency radiation for the heating of food, including microwave frequencies. Radiofrequency radiation, including microwave frequencies, may be safely used for heating food under the following conditions: (a) The radiation source consists of electronic equipment producing radio waves with specific frequencies for this purpose authorized by the Federal Communications Commission. (b) The radiation is used or intended for use in the production of heat in food wherever heat is necessary and effective in the treatment or processing of food. § 179.39 Ultraviolet radiation for the processing and treatment of food. Ultraviolet radiation for the processing and treatment of food may be safely used under the following conditions: (a) The radiation sources consist of low pressure mercury lamps emitting 90 percent of the emission at a wavelength of 253.7 nanometers (2,537 Angstroms). (b) The ultraviolet radiation is used or intended for use as follows: ———————————————————————————————————————————————————————— Irradiated food Limitations Use ———————————————————————————————————————————————————————— Food and food products........... Without ozone production: high fatSurface microorganism content food irradiated in vacuum or in control. an inert atmosphere; intensity of radiation, 1 W (of 2,537 A. radiation) per 5 to 10 ft.2. Potable water............................ Without ozone production; coefficient of Sterilization of water used absorption, 0.19 per cm or less; flow in food production. rate, 100 gal/h per watt of 2,537 A. radiation; water depth, 1 cm or less; lamp-operating temperature, 36 to 46 °C.. Juice products........................... Turbulent flow through tubes with a Reduction of human minimum Reynolds number of 2,200.. pathogens and other microorganisms. ————————————————————————————————————————————————————————

[42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000]

1051

§ 179.41

§ 179.41 Pulsed light for the treatment of food. Pulsed light may be safely used for treatment of foods under the following conditions: (a) The radiation sources consist of xenon flashlamps designed to emit broadband radiation consisting of wavelengths covering the range of 200 to 1,100 nanometers (nm), and operated so that the pulse duration is no longer than 2 milliseconds (msec); (b) The treatment is used for surface microorganism control; (c) Foods treated with pulsed light shall receive the minimum treatment reasonably required to accomplish the intended technical effect; and (d) The total cumulative treatment shall not exceed 12.0 Joules/square centimeter (J/cm2.) [61 FR 42383, Aug. 15, 1996]

Subpart C—Packaging Materials for Irradiated Foods § 179.45 Packaging materials for use during the irradiation of prepackaged foods. The packaging materials identified in this section may be safely subjected to irradiation incidental to the radiation treatment and processing of prepackaged foods, subject to the provisions of this section and to the requirement that no induced radioactivity is detectable in the packaging material itself: (a) The radiation of the food itself shall comply with regulations in this part. (b) The following packaging materials may be subjected to a dose of radiation, not to exceed 10 kilograys, unless otherwise indicated, incidental to the use of gamma, electron beam, or X-radiation in the radiation treatment of prepackaged foods: (1) Nitrocellulose-coated or vinylidene chloride copolymer-coated cellophane complying with Sec. 177.1200 of this chapter. (2) Glassine paper complying with Sec. 176.170 of this chapter. (3) Wax-coated paperboard complying with Sec. 176.170 of this chapter. (4) Polyolefin film prepared from one or more of the basic olefin polymers complying with Sec. 177.1520 of this chapter. The finished film may contain: (i) Adjuvant substances used in compliance with Secs. 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, polyvinyl chloride, and materials as listed in paragraph (d)(2)(i) of this section. (ii) Coatings comprising a vinylidene chloride copolymer containing a minimum of 85 percent vinylidene chloride with one or more of the following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate. (5) Kraft paper prepared from unbleached sulfate pulp to which rosin, complying with Sec. 178.3870 of this chapter, and alum may be added. The kraft paper is used only as a container for flour and is irradiated with a dose not exceeding 500 grays. (6) Polyethylene terephthalate film prepared from the basic polymer as described in Sec. 177.1630(e)(4)(i) and (ii) of this chapter. The finished film may contain: (i) Adjuvant substances used in compliance with Secs. 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, polyvinyl chloride, and materials as listed in paragraph (d)(2)(i) of this section. (ii) Coatings comprising a vinylidene chloride copolymer containing a minimum of 85 percent vinylidene chloride with one or more of the following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate. (iii) Coatings consisting of polyethylene conforming to Sec. 177.1520 of this chapter. (7) Polystyrene film prepared from styrene basic polymer. The finished film may contain adjuvant substances used in compliance with Secs. 178.3740 and 181.22 through 181.30 of this chapter. (8) Rubber hydrochloride film prepared from rubber hydrochloride basic polymer having a chlorine content of 3032 weight percent and having a maximum extractable fraction of 2 weight percent when extracted with n-hexane at reflux temperature for 2 hours. The finished film may contain adjuvant substances used in compliance with Secs. 178.3740 and 181.22 through 181.30 of this chapter. 1052

§ 179.45

(9) Vinylidene chloride-vinyl chloride copolymer film prepared from vinylidene chloride-vinyl chloride basic copolymers containing not less than 70 weight percent of vinylidene chloride and having a viscosity of 0.50-1.50 centipoises as determined by ASTM method D729-81, ``Standard Specification for Vinylidene Chloride Molding Compounds,’’ which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The finished film may contain adjuvant substances used in compliance with Secs. 178.3740 and 181.22 through 181.30 of this chapter. (10) Nylon 11 conforming to Sec. 177.1500 of this chapter. (c) Ethylene-vinyl acetate copolymers complying with Sec. 177.1350 of this chapter. The ethylene-vinyl acetate packaging materials may be subjected to a dose of radiation, not to exceed 30 kilogray (3 megarads), incidental to the use of gamma, electron beam, or X-radiation in the radiation treatment of packaged foods. (d) The following packaging materials may be subjected to a dose of radiation, not to exceed 60 kilograys incidental to the use of gamma, electron beam, or X-radiation in the radiation processing of prepackaged foods: (1) Vegetable parchments, consisting of a cellulose material made from waterleaf paper (unsized) treated with concentrated sulfuric acid, neutralized, and thoroughly washed with distilled water. (2) Films prepared from basic polymers and with or without adjuvants, as follows: (i) Polyethylene film prepared from the basic polymer as described in Sec. 177.1520(a) of this chapter. The finished film may contain one or more of the following added substances: ——————————————————————————————————————— Substances Limitations ——————————————————————————————————————— Amides of erucic, linoleic, oleic, Not to exceed 1 pct by weight palmitic, and stearic acid. of the polymer. BHA as described in Sec. 172.110 of Do. this chapter. BHT as described in Sec. 172.115 of Do. this chapter. Calcium and sodium propionates......... Do. Petroleum wax as described in Sec. Do. 178.3710 of this chapter. Polypropylene, noncrystalline, as Not to exceed 2 pct by weight described in Sec. 177.1520(c) of this of the polymer. chapter. Stearates of aluminum, calcium, Not to exceed 1 pct by weight magnesium, potassium, and sodium as of the polymer. described in Sec. 172.863(a) of this chapter. Triethylene glycol as described in Sec. Do. 178.3740(b) of this chapter. Mineral oil as described in Sec. Do. 178.3620 (a) or (b) of this chapter. ———————————————————————————————————————

(ii) Polyethylene terephthalate film prepared from the basic polymer as described in Sec. 177.1630(e)(4)(ii) of this chapter. The finished film may contain one or more of the added substances listed in paragraph (d)(2)(i) of this section. (iii) Nylon 6 films prepared from the nylon 6 basic polymer as described in Sec. 177.1500(a)(6) of this chapter and meeting the specifications of item 6.1 of the table in Sec. 177.1500(b) of this chapter. The finished film may contain one or more of the added substances listed in paragraph (d)(2)(i) of this section. (iv) Vinyl chloride-vinyl acetate copolymer film prepared from the basic copolymer containing 88.5 to 90.0 weight percent of vinyl chloride with 10.0 to 11.5 weight percent of vinyl acetate and having a maximum volatility of not over 3.0 percent (1 hour at 105 °C) and viscosity not less than 0.30 determined by ASTM method D1243-79, ``Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,’’ Method A, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(9) of this section. The finished film may contain one or more of the added substances listed in paragraph (d)(2)(i) of this section. (e) Acrylonitrile copolymers identified in this section shall comply with the provisions of Sec. 180.22 of this chapter. [42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR 10575, Feb. 16, 2001]

1053

Part 180

PART 180—FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY Subpart A—General Provisions Sec. 180.1

General.

Subpart B—Specific Requirements for Certain Food Additives Sec. 180.22 180.25 180.30 180.37

Acrylonitrile copolymers. Mannitol. Brominated vegetable oil. Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin.

AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241. EDITORIAL NOTE: Nomenclature changes to part 180 appear at 61 FR 14482, Apr. 2, 1996. and 66 FR 56035, Nov. 6, 2001.

Subpart A—General Provisions § 180.1 General. (a) Substances having a history of use in food for human consumption or in food contact surfaces may at any time have their safety or functionality brought into question by new information that in itself is not conclusive. An interim food additive regulation for the use of any such substance may be promulgated in this subpart when new information raises a substantial question about the safety or functionality of the substance but there is a reasonable certainty that the substance is not harmful and that no harm to the public health will result from the continued use of the substance for a limited period of time while the question raised is being resolved by further study. (b) No interim food additive regulation may be promulgated if the new information is conclusive with respect to the question raised or if there is a reasonable likelihood that the substance is harmful or that continued use of the substance will result in harm to the public health. (c) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose an interim food additive regulation. A final order promulgating an interim food additive regulation shall provide that continued use of the substance in food is subject to each of the following conditions: (1) Use of the substance in food or food contact surfaces must comply with whatever limitations the Commissioner deems to be appropriate under the circumstances. (2) Within 60 days following the effective date of the regulation, an interested person shall satisfy the Commissioner in writing that studies adequate and appropriate to resolve the questions raised about the substance have been undertaken, or the Food and Drug Administration may undertake the studies. The Commissioner may extend this 60-day period if necessary to review and act on proposed protocols. If no such commitment is made, or adequate and appropriate studies are not undertaken, an order shall immediately be published in the Federal Register revoking the interim food additive regulation effective upon publication. (3) A progress report shall be filed on the studies every January 1 and July 1 until completion. If the progress report is inadequate or if the Commissioner concludes that the studies are not being pursued promptly and diligently or if interim results indicate a reasonable likelihood that a health hazard exists, an order will promptly be published in the Federal Register revoking the interim food additive regulation effective upon publication. (4) If nonclinical laboratory studies are involved, studies filed with the Commissioner shall include, with respect to each study, either a statement that the study has been or will be conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (5) [Reserved] 1054

§ 180.22

(6) If clinical investigations involving human subjects are involved, such investigations filed with the Commissioner shall include, with respect to each investigation, a statement that the investigation either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with Secs. 56.104 or 56.105, and that it has been or will be conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter. (d) Promptly upon completion of the studies undertaken on the substance, the Commissioner will review all available data, will terminate the interim food additive regulation, and will either issue a food additive regulation or will require elimination of the substance from the food supply. (e) The Commissioner may consult with advisory committees, professional organizations, or other experts in the field, in evaluating: (1) Whether an interim food additive regulation is justified, (2) The type of studies necessary and appropriate to resolve questions raised about a substance, (3) Whether interim results indicate the reasonable likelihood that a health hazard exists, or (4) Whether the data available at the conclusion of those studies justify a food additive regulation. (f) Where appropriate, an emergency action level may be issued for a substance subject to paragraph (a) of this section that is not an approved food additive, pending the issuance of a final interim food additive regulation. Such an action level shall be issued pursuant to sections 306 and 402(a) of the act to identify, based upon available data, a safe level of use for the substance. Such an action level shall be issued in a notice published in the Federal Register and shall be followed as soon as practicable by a proposed interim food additive regulation. Where the available data do not permit establishing an action level for the safe use of a substance, use of the substance may be prohibited. The identification of a prohibited substance may be made in part 189 of this chapter when appropriate. [42 FR 14636, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR 39634, Sept. 27, 1989]

Subpart B—Specific Requirements for Certain Food Additives § 180.22 Acrylonitrile copolymers. Acrylonitrile copolymers may be safely used on an interim basis as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) Limitations for acrylonitrile monomer extraction for finished food-contact articles, determined by a method of analysis titled ``Gas-Solid Chromatographic Procedure for determining Acrylonitrile Monomer in AcrylonitrileContaining Polymers and Food Simulating Solvents,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408, are as follows: (1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food contact surface—0.003 milligram/square inch when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use. (2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food contact surface—0.3 part per million calculated on the basis of the volume of the container when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use. (3) In the case of repeated-use articles—0.003 milligram/square inch when extracted at a time equivalent to initial batch usage utilizing food-simulating solvents and temperatures appropriate to the intended conditions of use. The food-simulating solvents shall include, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either n-heptane or an appropriate oil or fat. (b) Where necessary, current regulations permitting the use of acrylonitrile copolymers shall be revised to specify limitations on acrylonitrile/mercaptan complexes utilized in the production of acrylonitrile copolymers. Such copolymers, if they contain reversible acrylonitrile/mercaptan complexes and are used in other than repeated-use conditions, shall be tested to determine the identity of the complex and the level of the complex present in the foodcontact article. Such testing shall include determination of the rate of decomposition of the complex at temperatures of 100 °F, 160 °F, and 212 °F using 3 percent acetic acid as the hydrolic agent. Acrylonitrile monomer levels, 1055

§ 180.22

acrylonitrile/mercaptan complex levels, acrylonitrile oligomer levels, descriptions of the analytical methods used to determine the complex and the acrylonitrile migration, and validation studies of these analytical methods shall be submitted by June 9, 1977, to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, unless an extension is granted by the Food and Drug Administration for good cause shown. Analytical methods for the determination of acrylonitrile complexes with n-dodecyl-mercaptan, n-octyl mercaptan, and 2-mercaptoethanol, titled ``Determination of β-Dodecylmercaptopropionitrile in NR-16R Aqueous Extracts’’ and ``Measurement of β-(2-Hdroxyethylmercapto) Propionitrile in Heptane Food-Simulating Solvent,’’ are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The following data shall be provided for finished food-contact articles intended for repeated use: (1) Qualitative and quantitative migration values at a time equivalent to initial batch usage, utilizing solvents and temperatures appropriate to the intended conditions of use. (2) Qualitative and quantitative migration values at the time of equilibrium extractions, utilizing solvents and temperatures appropriate to the intended conditions of use. (3) Data on the volume and/or weight of food handled during the initial batch time period(s), during the equilibrium test period, and over the estimated life of the food-contact surface. (d) Where acrylonitrile copolymers represent only a minor component of a polymer system, calculations based on 100 percent migration of the acrylonitrile component may be submitted in lieu of the requirements of paragraphs (a), (b), and (c) of this section in support of the continued safe use of acrylonitrile copolymers. (e) On or before September 13, 1976, any interested person shall satisfy the Commissioner of Food and Drugs that toxicological feeding studies adequate and appropriate to establish safe conditions for the use of acrylonitrile copolymers have been, or soon will be, undertaken. Toxicity studies of acrylonitrile monomer shall include: (1) Lifetime feeding studies with a mammalian species, preferably with animals exposed in utero to the chemical, (2) studies of multigeneration reproduction with oral administration of the test material, (3) assessment of teratogenic and mutagenic potentials, (4) subchronic oral administration in a nonrodent mammal, (5) tests to determine any synergistic toxic effects between acrylonitrile monomer and cyanide ion, and (6) a literature search on the effects of chronic ingestion of hydrogen cyanide. Data on levels of acrylamide extractable from acrylonitrile copolymers shall also be submitted. Protocols of testing should be submitted for review to the Center for Food Safety and Applied Nutrition (HFS-200, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (f) Acrylonitrile copolymers may be used in contact with food only if authorized in parts 174 through 179 or Sec. 181.32 of this chapter, except that other uses of acrylonitrile copolymers in use prior to June 14, 1976, may continue under the following conditions: (1) On or before August 13, 1976, each use of acrylonitrile copolymers in a manner not authorized by Sec. 181.32 of this chapter or parts 174 through 179 of this chapter shall be the subject of a notice to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Such notice shall be accompanied by a statement of the basis, including any articles and correspondence, on which the user in good faith believed the use to be prior-sanctioned. The Commissioner of Food and Drugs shall, by notice in the Federal Register, identify any use of acrylonitrile copolymers not in accordance with this paragraph. Those uses are thereafter unapproved food additives and consequently unlawful. (2) Any use of acrylonitrile copolymers subject to paragraph (f)(1) of this section shall be the subject of a petition submitted on or before December 13, 1976, in accordance with Sec. 171.1 of this chapter, unless an extension of time is granted by the Food and Drug Administration for good cause shown. Any application for extension shall be by petition submitted in accordance with the requirements of part 10 of this chapter. If a petition is denied, in whole or in part, those uses subject to the denial are thereafter unapproved food additives and consequently unlawful. (3) Any use of acrylonitrile copolymers subject to paragraph (f)(1) of this section shall meet the acrylonitrile monomer extraction limitation set forth in paragraph (a) of this section and shall be subject to the requirements of paragraph (b) of this section. (g) In addition to the requirements of this section, the use of acrylonitrile copolymers shall comply with all applicable requirements in other regulations in this part. [42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14246, Apr. 1, 1996]

1056

§ 180.30

§ 180.25 Mannitol. (a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol (C6H14O6) a hexahydric alcohol, differing from sorbitol principally by having a different optical rotation. Mannitol is produced by one of the following processes: (1) The electrolytic reduction or transition metal catalytic hydrogenation of sugar solutions containing glucose or fructose. (2) The fermentation of sugars or sugar alcohols such as glucose, sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 188-190, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an anticaking agent and free-flow agent as defined in Sec. 170.3(o)(1) of this chapter, formulation aid as defined in Sec. 170.3(o) (14) of this chapter, firming agent as defined in Sec. 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter, lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter, nutritive sweetener as defined in Sec. 170.3(o)(21) of this chapter, processing aid as defined in Sec. 170.3(o)(24) of this chapter, stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter, surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter, and texturizer as defined in Sec. 170.3(o)(32) of this chapter. (d) The ingredient is used in food at levels not to exceed 98 percent in pressed mints and 5 percent in all other hard candy and cough drops as defined in Sec. 170.3(n)(25) of this chapter, 31 percent in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 40 percent in soft candy as defined in Sec. 170.3(n)(38) of this chapter, 8 percent in confections and frostings as defined in Sec. 170.3(n)(9) of this chapter, 15 percent in nonstandardized jams and jellies, commercial, as defined in Sec. 170.3(n)(28) of this chapter, and at levels less than 2.5 percent in all other foods. (e) The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 20 grams of mannitol shall bear the statement ``Excess consumption may have a laxative effect’’. (f) In accordance with Sec. 180.1, adequate and appropriate feeding studies have been undertaken for this substance. Continued uses of this ingredient are contingent upon timely and adequate progress reports of such tests, and no indication of increased risk to public health during the test period. (g) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996]

§ 180.30 Brominated vegetable oil. The food additive brominated vegetable oil may be safely used in accordance with the following prescribed conditions: (a) The additive complies with specifications prescribed in the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 4041, which is incorporated by reference, except that free fatty acids (as oleic) shall not exceed 2.5 percent and iodine value shall not exceed 16. Copies of the material incorporated by reference may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20418. (b) The additive is used on an interim basis as a stabilizer for flavoring oils used in fruit-flavored beverages, for which any applicable standards of identity do not preclude such use, in an amount not to exceed 15 parts per million in the finished beverage, pending the outcome of additional toxicological studies on which periodic reports at 6month intervals are to be furnished and final results submitted to the Food and Drug Administration promptly after completion of the studies. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]

1057

§ 180.37

§ 180.37 Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin. The food additives saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin may be safely used as sweetening agents in food in accordance with the following conditions, if the substitution for nutritive sweeteners is for a valid special dietary purpose and is in accord with current special dietary food regulations and policies or if the use or intended use is for an authorized technological purpose other than calorie reduction: (a) Saccharin is the chemical, 1,2-benzisothiazolin-3-one - 1,1 - dioxide (C7H5NO3S). The named salts of saccharin are produced by the additional neutralization of saccharin with the proper base to yield the desired salt. (b) The food additives meet the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 22, 62, 266-267, 297-299, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) Authority for such use shall expire when the Commissioner receives the final reports on the ongoing studies in Canada and publishes an order on the safety of saccharin and its salts based on those reports and other available data. (d) The additives are used or intended for use as a sweetening agent only in special dietary foods, as follows: (1) In beverages, fruit juice drinks, and bases or mixes when prepared for consumption in accordance with directions, in amounts not to exceed 12 milligrams of the additive, calculated as saccharin, per fluid ounce. (2) As a sugar substitute for cooking or table use, in amounts not to exceed 20 milligrams of the additive, calculated as saccharin, for each expressed teaspoonful of sugar sweetening equivalency. (3) In processed foods, in amounts not to exceed 30 milligrams of the additive, calculated as saccharin, per serving of designated size. (e) The additives are used or intended for use only for the following technological purposes: (1) To reduce bulk and enhance flavors in chewable vitamin tablets, chewable mineral tablets, or combinations thereof. (2) To retain flavor and physical properties of chewing gum. (3) To enhance flavor of flavor chips used in nonstandardized bakery products. (f) To assure safe use of the additives, in addition to the other information required by the Act: (1) The label of the additive and any intermediate mixes of the additive for manufacturing purposes shall bear: (i) The name of the additive. (ii) A statement of the concentration of the additive, expressed as saccharin, in any intermediate mix. (iii) Adequate directions for use to provide a final food product that complies with the limitations prescribed in paragraphs (d) and (e) of this section. (2) The label of any finished food product containing the additive shall bear: (i) The name of the additive. (ii) The amount of the additive, calculated as saccharin, as follows: (a) For beverages, in milligrams per fluid ounce; (b) For cooking or table use products, in milligrams per dispensing unit; (c) For processed foods, in terms of the weight or size of a serving which shall be that quantity of the food containing 30 milligrams or less of the additive. (iii) When the additive is used for calorie reduction, such other labeling as is required by part 105 or Sec. 100.130 of this chapter. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]

PART 181—PRIOR-SANCTIONED FOOD INGREDIENTS Subpart A—General Provisions Sec. 181.1 181.5

General. Prior sanctions.

1058

§ 181.5

Subpart B—Specific Prior-Sanctioned Food Ingredients 181.22 181.23 181.24 181.25 181.26 181.27 181.28 181.29 181.30 181.32 181.33 181.34

Certain substances employed in the manufacture of food-packaging materials. Antimycotics. Antioxidants. Driers. Drying oils as components of finished resins. Plasticizers. Release agents. Stabilizers. Substances used in the manufacture of paper and paperboard used in food packaging. Acrylonitrile copolymers and resins. Sodium nitrate and potassium nitrate. Sodium nitrite and potassium nitrite.

AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14638, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 181 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.

Subpart A—General Provisions § 181.1 General. (a) An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201(s)(4) of the Act is exempt from classification as a food additive. The Commissioner will publish in this part all known prior sanctions. Any interested person may submit to the Commissioner a request for publication of a prior sanction, supported by evidence to show that it falls within section 201(s)(4) of the Act. (b) Based upon scientific data or information that shows that use of a prior-sanctioned food ingredient may be injurious to health, and thus in violation of section 402 of the Act, the Commissioner will establish or amend an applicable prior sanction regulation to impose whatever limitations or conditions are necessary for the safe use of the ingredient, or to prohibit use of the ingredient. (c) Where appropriate, an emergency action level may be issued for a prior-sanctioned substance, pending the issuance of a final regulation in accordance with paragraph (b) of this section. Such an action level shall be issued pursuant to section 402(a) of the Act to identify, based upon available data, conditions of use of the substance that may be injurious to health. Such an action level shall be issued in a notice published in the FEDERAL REGISTER and shall be followed as soon as practicable by a proposed regulation in accordance with paragraph (b) of this section. Where the available data demonstrate that the substance may be injurious at any level, use of the substance may be prohibited. The identification of a prohibited substance may be made in part 189 of this chapter when appropriate. [42 FR 14638, Mar. 15, 1977, as amended at 42 FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, 1989]

§ 181.5 Prior sanctions. (a) A prior sanction shall exist only for a specific use(s) of a substance in food, i.e., the level(s), condition(s), product(s), etc., for which there was explicit approval by the Food and Drug Administration or the United States Department of Agriculture prior to September 6, 1958. (b) The existence of a prior sanction exempts the sanctioned use(s) from the food additive provisions of the Act but not from the other adulteration or the misbranding provisions of the Act. (c) All known prior sanctions shall be the subject of a regulation published in this part. Any such regulation is subject to amendment to impose whatever limitation(s) or condition(s) may be necessary for the safe use of the ingredient, or revocation to prohibit use of the ingredient, in order to prevent the adulteration of food in violation of section 402 of the Act. (d) In proposing, after a general evaluation of use of an ingredient, regulations affirming the GRAS status of 1059

§ 181.22

substances added directly to human food in part 184 of this chapter or substances in food-contact surfaces in part 186 of this chapter, or establishing a food additive regulation for substances added directly to human food in parts 172 and 173 of this chapter or food additives in food-contact surfaces in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this chapter, the Commissioner shall, if he is aware of any prior sanction for use of the ingredient under conditions different from those proposed in the regulation, concurrently propose a separate regulation covering such use of the ingredient under this part. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any food additive or GRAS regulation promulgated after a general evaluation of use of an ingredient constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to a proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under this part, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal.

Subpart B—Specific Prior-Sanctioned Food Ingredients § 181.22 Certain substances employed in the manufacture of food-packaging materials. Prior to the enactment of the food additives amendment to the Federal Food, Drug, and Cosmetic Act, sanctions were granted for the usage of the substances listed in Secs. 181.23, 181.24, 181.25, 181.26, 181.27, 181.28, 181.29, and 181.30 in the manufacture of packaging materials. So used, these substances are not considered ``food additives’’ within the meaning of section 201(s) of the Act, provided that they are of good commercial grade, are suitable for association with food, and are used in accordance with good manufacturing practice. For the purpose of this subpart, good manufacturing practice for food-packaging materials includes the restriction that the quantity of any of these substances which becomes a component of food as a result of use in food-packaging materials shall not be intended to accomplish any physical or technical effect in the food itself, shall be reduced to the least amount reasonably possible, and shall not exceed any limit specified in this subpart. [42 FR 56728, Oct. 28, 1977]

§ 181.23 Antimycotics. Substances classified as antimycotics, when migrating from food-packaging material shall include: Calcium propionate. Methylparaben (methyl p-hydroxybenzoate). Propylparaben (propyl p-hydroxybenzoate). Sodium benzoate. Sodium propionate. Sorbic acid. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

§ 181.24 Antioxidants. Substances classified as antioxidants, when migrating from food-packaging material (limit of addition to food, 0.005 percent) shall include: Butylated hydroxyanisole. Butylated hydroxytoluene. Dilauryl thiodipropionate. Distearyl thiodipropionate. Gum guaiac. Nordihydroguairetic acid.

1060

§ 181.27

Propyl gallate. Thiodipropionic acid. 2,4,5-Trihydroxy butyrophenone. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

§ 181.25 Driers. Substances classified as driers, when migrating from food-packaging material shall include: Cobalt caprylate. Cobalt linoleate. Cobalt naphthenate. Cobalt tallate. Iron caprylate. Iron linoleate. Iron naphthenate. Iron tallate. Manganese caprylate. Manganese linoleate. Manganese naphthenate. Manganese tallate. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

§ 181.26 Drying oils as components of finished resins. Substances classified as drying oils, when migrating from food-packaging material (as components of finished resins) shall include: Chinawood oil (tung oil). Dehydrated castor oil. Linseed oil. Tall oil. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

§ 181.27 Plasticizers. Substances classified as plasticizers, when migrating from food-packaging material shall include: Acetyl tributyl citrate. Acetyl triethyl citrate. p-tert-Butylphenyl salicylate. Butyl stearate. Butylphthalyl butyl glycolate. Dibutyl sebacate. Di-(2-ethylhexyl) phthalate (for foods of high water content only). Diethyl phthalate. Diisobutyl adipate. Diisooctyl phthalate (for foods of high water content only). Diphenyl-2-ethylhexyl phosphate. Epoxidized soybean oil (iodine number maximum 6; and oxirane oxygen, minimum, 6.0 percent). Ethylphthalyl ethyl glycolate. Glycerol monooleate. Monoisopropyl citrate. Mono, di-, and tristearyl citrate.

1061

§ 181.28

Triacetin (glycerol triacetate). Triethyl citrate. 3-(2-Xenolyl)-1,2-epoxypropane. [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 50 FR 49536, Dec. 3, 1985]

§ 181.28 Release agents. Substances classified as release agents, when migrating from food-packaging material shall include: Dimethylpolysiloxane (substantially free from hydrolyzable chloride and alkoxy groups, no more than 18 percent loss in weight after heating 4 hours at 200 °C.; viscosity 300 centisokes, 600 centisokes at 25 °C, specific gravity 0.96 to 0.97 at 25 °C, refractive index 1.400 to 1.404 at 25 °C). Linoleamide (linoleic acid amide). Oleamide (oleic acid amide). Palmitamide (palmitic acid amide). Stearamide (stearic acid amide). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

§ 181.29 Stabilizers. Substances classified as stabilizers, when migrating from food-packaging material shall include: Aluminum mono-, di-, and tristearate. Ammonium citrate. Ammonium potassium hydrogen phosphate. Calcium glycerophosphate. Calcium phosphate. Calcium hydrogen phosphate. Calcium oleate. Calcium acetate. Calcium carbonate. Calcium ricinoleate. Calcium stearate. Disodium hydrogen phosphate. Magnesium glycerophosphate. Magnesium stearate. Magnesium phosphate. Magnesium hydrogen phosphate. Mono-, di-, and trisodium citrate. Mono-, di-, and tripotassium citrate. Potassium oleate. Potassium stearate. Sodium pyrophosphate. Sodium stearate. Sodium tetrapyrophosphate. Stannous stearate (not to exceed 50 parts per million tin as a migrant in finished food). Zinc orthophosphate (not to exceed 50 parts per million zinc as a migrant in finished food). Zinc resinate (not to exceed 50 parts per million zinc as a migrant in finished food). [42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

1062

§ 181.32

§ 181.30 Substances used in the manufacture of paper and paperboard products used in food packaging. Substances used in the manufacture of paper and paperboard products used in food packaging shall include: Aliphatic polyoxyethylene ethers.* 1-Alkyl (C6-C18)3-amino-3-aminopropane monoacetate.* Borax or boric acid for use in adhesives, sizes, and coatings.* Butadiene-styrene copolymer. Chromium complex of perfluoro-octane sulfonyl glycine for use on paper and paperboard which is waxed.* Disodium cyanodithioimidocarbamate with ethylene diamine and potassium N-methyl dithiocarbamate and/or sodium 2mercaptobenzothiazole (slimicides).* Ethyl acrylate and methyl methacrylate copolymers of itaconic acid or methacrylic acid for use only on paper and paperboard which is waxed.* Hexamethylene tetramine as a setting agent for protein, including casein.* 1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl (C6-C17) imidazolinium chloride.* Itaconic acid (polymerized). Melamine formaldehyde polymer. Methyl acrylate (polymerized). Methyl ethers of mono-, di-, and tripropylene glycol.* Myristo chromic chloride complex. Nitrocellulose. Polyethylene glycol 400. Polyvinyl acetate. Potassium pentachlorophenate as a slime control agent.* Potassium trichlorophenate as a slime control agent.* Resins from high and low viscosity polyvinyl alcohol for fatty foods only. Rubber hydrochloride. Sodium pentachlorophenate as a slime control agent.* Sodium-trichlorophenate as a slime control agent.* Stearato-chromic chloride complex. Titanium dioxide.* Urea formaldehyde polymer. Vinylidine chlorides (polymerized).

§ 181.32 Acrylonitrile copolymers and resins. (a) Acrylonitrile copolymers and resins listed in this section, containing less than 30 percent acrylonitrile and complying with the requirements of paragraph (b) of this section, may be safely used as follows: (1) Films. (i) Acrylonitrile/butadiene/styrene copolymers—no restrictions. (ii) Acrylonitrile/butadiene copolymers—no restrictions. (iii) Acrylonitrile/butadiene copolymer blended with vinyl chloride-vinyl acetate (optional at level up to 5 percent by weight of the vinyl chloride resin) resin—for use only in contact with oleomargarine. (iv) Acrylonitrile/styrene copolymer—no restrictions. (2) Coatings. (i) Acrylonitrile/butadiene copolymer blended with polyvinyl chloride resins—for use only on paper and paperboard in contact with meats and lard. (ii) Polyvinyl chloride resin blended with either acrylonitrile/butadiene copolymer or acrylonitrile/butadiene styrene copolymer mixed with neoprene, for use as components of conveyor belts to be used with fresh fruits, vegetables, and fish. (iii) Acrylonitrile/butadiene/styrene copolymer—no restrictions. (iv) Acrylonitrile/styrene copolymer—no restrictions. (3) Rigid and semirigid containers. (i) Acrylonitrile/butadiene/styrene copolymer—for use only as piping for handling food products and for repeated-use articles intended to contact food. (ii) Acrylonitrile/styrene resin—no restrictions. (iii) Acrylonitrile/butadiene copolymer blended with polyvinyl chloride resin—for use only as extruded pipe. *Under the conditions of normal use, these substances would not reasonably be expected to migrate to food, based on available scientific information and data.

1063

§ 181.33

(b) Limitations for acrylonitrile monomer extraction for finished food-contact articles, determined by using the method of analysis titled ``Gas-Solid Chromatographic Procedure for Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers and Food-Simulating Solvents,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408, are as follows: (1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food-contact surface—0.003 milligram/square inch when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use. (2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food-contact surface—0.3 part per million calculated on the basis of the volume of the container when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use. (3) In the case of repeated-use articles—0.003 milligram/square inch when extracted at a time equivalent to initial batch usage utilizing food-simulating solvents and temperatures appropriate to the intended conditions of use. The food-simulating solvents shall include, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either n-heptane or an appropriate oil or fat. (c) Acrylonitrile monomer may present a hazard to health when ingested. Accordingly, any food-contact article containing acrylonitrile copolymers or resins that yield acrylonitrile monomer in excess of that amount provided for in paragraph (b) of this section shall be deemed to be adulterated in violation of section 402 of the Act. [42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989]

§ 181.33 Sodium nitrate and potassium nitrate. Sodium nitrate and potassium nitrate are subject to prior sanctions issued by the U.S. Department of Agriculture for use as sources of nitrite, with or without sodium or potassium nitrite, in the production of cured red meat products and cured poultry products. [48 FR 1705, Jan. 14, 1983]

§ 181.34 Sodium nitrite and potassium nitrite. Sodium nitrite and potassium nitrite are subject to prior sanctions issued by the U.S. Department of Agriculture for use as color fixatives and preservative agents, with or without sodium or potassium nitrate, in the curing of red meat and poultry products. [48 FR 1705, Jan. 14, 1983]

PART 182—SUBSTANCES GENERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 182.1 182.10 182.20 182.40 182.50 182.60 182.70 182.90 182.99

Substances that are generally recognized as safe. Spices and other natural seasonings and flavorings. Essential oils, oleoresins (solvent-free), and natural extractives (including distillates). Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings. Certain other spices, seasonings, essential oils, oleoresins, and natural extracts. Synthetic flavoring substances and adjuvants. Substances migrating from cotton and cotton fabrics used in dry food packaging. Substances migrating to food from paper and paperboard products. Adjuvants for pesticide chemicals. 1064

Part 182

Subpart B—Multiple Purpose GRAS Food Substances 182.1045 Glutamic acid. 182.1047 Glutamic acid hydrochloride. 182.1057 Hydrochloric acid. 182.1073 Phosphoric acid. 182.1087 Sodium acid pyrophosphate. 182.1125 Aluminum sulfate. 182.1127 Aluminum ammonium sulfate. 182.1129 Aluminum potassium sulfate. 182.1131 Aluminum sodium sulfate. 182.1180 Caffeine. 182.1217 Calcium phosphate. 182.1235 Caramel. 182.1320 Glycerin. 182.1480 Methylcellulose. 182.1500 Monoammonium glutamate. 182.1516 Monopotassium glutamate. 182.1711 Silica aerogel. 182.1745 Sodium carboxymethylcellulose. 182.1748 Sodium caseinate. 182.1778 Sodium phosphate. 182.1781 Sodium aluminum phosphate. 182.1810 Sodium tripolyphosphate. Subpart C—Anticaking Agents 182.2122 Aluminum calcium silicate. 182.2227 Calcium silicate. 182.2437 Magnesium silicate. 182.2727 Sodium aluminosilicate. 182.2729 Sodium calcium aluminosilicate, hydrated. 182.2906 Tricalcium silicate. Subpart D—Chemical Preservatives 182.3013 Ascorbic acid. 182.3041 Erythorbic acid. 182.3089 Sorbic acid. 182.3109 Thiodipropionic acid. 182.3149 Ascorbyl palmitate. 182.3169 Butylated hydroxyanisole. 182.3173 Butylated hydroxytoluene. 182.3189 Calcium ascorbate. 182.3225 Calcium sorbate. 182.3280 Dilauryl thiodipropionate. 182.3616 Potassium bisulfite. 182.3637 Potassium metabisulfite. 182.3640 Potassium sorbate. 182.3731 Sodium ascorbate. 182.3739 Sodium bisulfite. 182.3766 Sodium metabisulfite. 182.3795 Sodium sorbate. 182.3798 Sodium sulfite. 1065

§ 182.1

182.3862 Sulfur dioxide. 182.3890 Tocopherols. Subpart E—Emulsifying Agents [Reserved] Subpart F—Dietary Supplements [Reserved] Subpart G—Sequestrants 182.6085 Sodium acid phosphate. 182.6197 Calcium diacetate. 182.6203 Calcium hexametaphosphate. 182.6215 Monobasic calcium phosphate. 182.6285 Dipotassium phosphate. 182.6290 Disodium phosphate. 182.6757 Sodium gluconate. 182.6760 Sodium hexametaphosphate. 182.6769 Sodium metaphosphate. 182.6778 Sodium phosphate. 182.6787 Sodium pyrophosphate. 182.6789 Tetra sodium pyrophosphate. 182.6810 Sodium tripolyphosphate. Subpart H—Stabilizers 182.7255 Chondrus extract. Subpart I—Nutrients 182.8013 Ascorbic acid. 182.8159 Biotin. 182.8217 Calcium phosphate. 182.8223 Calcium pyrophosphate. 182.8250 Choline bitartrate. 182.8252 Choline chloride. 182.8778 Sodium phosphate. 182.8890 Tocopherols. 182.8892 a-Tocopherol acetate. 182.8985 Zinc chloride. 182.8988 Zinc gluconate. 182.8991 Zinc oxide. 182.8994 Zinc stearate. 182.8997 Zinc sulfate. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.

Subpart A—General Provisions § 182.1 Substances that are generally recognized as safe. (a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, 1066

§ 182.10

and monosodium glutamate as safe for their intended use. This part includes additional substances that, when used for the purposes indicated, in accordance with good manufacturing practice, are regarded by the Commissioner as generaly recognized as safe for such uses. (b) For the purposes of this section, good manufacturing practice shall be defined to include the following restrictions: (1) The quantity of a substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritional, or other technical effect in food; and (2) The quantity of a substance that becomes a component of food as a result of its use in the manufacturing, processing, or packaging of food, and which is not intended to accomplish any physical or other technical effect in the food itself, shall be reduced to the extent reasonably possible. (3) The substance is of appropriate food grade and is prepared and handled as a food ingredient. Upon request the Commissioner will offer an opinion, based on specifications and intended use, as to whether or not a particular grade or lot of the substance is of suitable purity for use in food and would generally be regarded as safe for the purpose intended, by experts qualified to evaluate its safety. (c) The inclusion of substances in the list of nutrients does not constitute a finding on the part of the Department that the substance is useful as a supplement to the diet for humans. (d) Substances that are generally recognized as safe for their intended use within the meaning of section 409 of the act are listed in this part. When the status of a substance has been reevaluated, it will be deleted from this part, and will be issued as a new regulation under the appropriate part, e.g., ``affirmed as GRAS’’ under part 184 or 186 of this chapter; ``food additive regulation’’ under parts 170 through 180 of this chapter; ``interim food additive regulation’’ under part 180 of this chapter; or ``prohibited from use in food’’ under part 189 of this chapter. [42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]

§ 182.10 Spices and other natural seasonings and flavorings. Spices and other natural seasonings and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: ——————————————————————————————————————————— Common name Botanical name of plant source ——————————————————————————————————————————— Alfalfa herb and seed........... Medicago sativa L. Allspice........................ Pimenta officinalis Lindl. Ambrette seed................... Hibiscus abelmoschus L. Angelica........................ Angelica archangelica L. or other spp. of Angelica. Angelica root................... Do. Angelica seed................... Do. Angostura (cusparia bark)....... Galipea officinalis Hancock. Anise........................... Pimpinella anisum L. Anise, star..................... Illicium verum Hook. f. Balm (lemon balm)............... Melissa officinalis L. Basil, bush..................... Ocimum minimum L. Basil, sweet.................... Ocimum basilicum L. Bay............................. Laurus nobilis L. Calendula....................... Calendula officinalis L. Camomile (chamomile), English or Anthemis nobilis L. Roman. Camomile (chamomile), German or Matricaria chamomilla L. Hungarian. Capers.......................... Capparis spinosa L. Capsicum........................ Capsicum frutescens L. or Capsicum annuum L. Caraway......................... Carum carvi L. Caraway, black (black cumin).... Nigella sativa L. Cardamom (cardamon)............. Elettaria cardamomum Maton. Cassia, Chinese................. Cinnamomum cassia Blume. Cassia, Padang or Batavia....... Cinnamomum burmanni Blume. Cassia, Saigon.................. Cinnamomum loureirii Nees. Cayenne pepper.................. Capsicum frutescens L. or Capsicum annuum L. Celery seed..................... Apium graveolens L. Chervil......................... Anthriscus cerefolium (L.) Hoffm. Chives.......................... Allium schoenoprasum L. Cinnamon, Ceylon................ Cinnamomum zeylanicum Nees. Cinnamon, Chinese............... Cinnamomum cassia Blume. Cinnamon, Saigon................ Cinnamomum loureirii Nees. Clary (clary sage).............. Salvia sclarea L. Clover.......................... Trifolium spp. Coriander....................... Coriandrum sativum L. Cumin (cummin).................. Cuminum cyminum L. Cumin, black (black caraway).... Nigella sativa L. Elder flowers................... Sambucus canadensis L.

1067

§ 182.20

——————————————————————————————————————————— Common name Botanical name of plant source ——————————————————————————————————————————— Fennel, common.................. Foeniculum vulgare Mill. Fennel, sweet (finocchio, Foeniculum vulgare Mill. var. duice Florence fennel). (DC.) Alex. Fenugreek....................... Trigonella foenum-graecum L. Galanga (galangal).............. Alpinia officinarum Hance. Geranium........................ Pelargonium spp. Ginger.......................... Zingiber officinale Rosc. Grains of paradise.............. Amomum melegueta Rosc. Horehound (hoarhound)........... Marrubium vulgare L. Horseradish..................... Armoracia lapathifolia Gilib. Hyssop.......................... Hyssopus officinalis L. Lavender........................ Lavandula officinalis Chaix. Linden flowers.................. Tilia spp. Mace............................ Myristica fragrans Houtt. Marigold, pot................... Calendula officinalis L. Marjoram, pot................... Majorana onites (L.) Benth. Marjoram, sweet................. Majorana hortensis Moench. Mustard, black or brown......... Brassica nigra (L.) Koch. Mustard, brown.................. Brassica juncea (L.) Coss. Mustard, white or yellow........ Brassica hirta Moench. Nutmeg.......................... Myristica fragrans Houtt. Oregano (oreganum, Mexican Lippia spp. oregano, Mexican sage, origan). Paprika......................... Capsicum annuum L. Parsley......................... Petroselinum crispum (Mill.) Mansf. Pepper, black................... Piper nigrum L. Pepper, cayenne................. Capsicum frutescens L. or Capsicum annuum L. Pepper, red..................... Do. Pepper, white................... Piper nigrum L. Peppermint...................... Mentha piperita L. Poppy seed...................... Papayer somniferum L. Pot marigold.................... Calendula officinalis L. Pot marjoram.................... Majorana onites (L.) Benth. Rosemary........................ Rosmarinus officinalis L. Saffron......................... Crocus sativus L. Sage............................ Salvia officinalis L. Sage, Greek..................... Salvia triloba L. Savory, summer.................. Satureia hortensis L. (Satureja). Savory, winter.................. Satureia montana L. (Satureja). Sesame.......................... Sesamum indicum L. Spearmint....................... Mentha spicata L. Star anise...................... Illicium verum Hook. f. Tarragon........................ Artemisia dracunculus L. Thyme........................... Thymus vulgaris L. Thyme, wild or creeping......... Thymus serpyllum L. Turmeric........................ Curcuma longa L. Vanilla......................... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Zedoary......................... Curcuma zedoaria Rosc. ———————————————————————————————————————————

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

§ 182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates). Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: ——————————————————————————————————————————— Common name Botanical name of plant source ——————————————————————————————————————————— Alfalfa......................... Medicago sativa L. Allspice........................ Pimenta officinalis Lindl. Almond, bitter (free from Prunus amygdalus Batsch, Prunus prussic acid). armeniaca L., or Prunus persica (L.) Batsch. Ambrette (seed)................. Hibiscus moschatus Moench. Angelica root................... Angelica archangelica L. Angelica seed................... Do. Angelica stem................... Do. Angostura (cusparia bark)....... Galipea officinalis Hancock. Anise........................... Pimpinella anisum L. Asafetida....................... Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm)............... Melissa officinalis L. Balsam of Peru.................. Myroxylon pereirae Klotzsch. Basil........................... Ocimum basilicum L. Bay leaves...................... Laurus nobilis L. Bay (myrcia oil)................ Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange)...... Citrus aurantium L. subsp. bergamia Wright et Arn.

1068

§ 182.20

——————————————————————————————————————————— Common name Botanical name of plant source ——————————————————————————————————————————— Bitter almond (free from prussic Prunus amygdalus Batsch, Prunus acid). armeniaca L., or Prunus persica (L.) Batsch. Bois de rose.................... Aniba rosaeodora Ducke. Cacao........................... Theobroma cacao L. Camomile (chamomile) flowers, Matricaria chamomilla L. Hungarian. Camomile (chamomile) flowers, Anthemis nobilis L. Roman or English. Cananga......................... Cananga odorata Hook. f. and Thoms. Capsicum........................ Capsicum frutescens L. and Capsicum annuum L. Caraway......................... Carum carvi L. Cardamom seed (cardamon)........ Elettaria cardamomum Maton. Carob bean...................... Ceratonia siliqua L. Carrot.......................... Daucus carota L. Cascarilla bark................. Croton eluteria Benn. Cassia bark, Chinese............ Cinnamomum cassia Blume. Cassia bark, Padang or Batavia.. Cinnamomum burmanni Blume. Cassia bark, Saigon............. Cinnamomum loureirii Nees. Celery seed..................... Apium graveolens L. Cherry, wild, bark.............. Prunus serotina Ehrh. Chervil......................... Anthriscus cerefolium (L.) Hoffm. Chicory......................... Cichorium intybus L. Cinnamon bark, Ceylon........... Cinnamomum zeylanicum Nees. Cinnamon bark, Chinese.......... Cinnamomum cassia Blume. Cinnamon bark, Saigon........... Cinnamomum loureirii Nees. Cinnamon leaf, Ceylon........... Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese.......... Cinnamomum cassia Blume. Cinnamon leaf, Saigon........... Cinnamomum loureirii Nees. Citronella...................... Cymbopogon nardus Rendle. Citrus peels.................... Citrus spp. Clary (clary sage).............. Salvia sclarea L. Clover.......................... Trifolium spp. Coca (decocainized)............. Erythroxylum coca Lam. and other spp. of Erythroxylum. Coffee.......................... Coffea spp. Cola nut........................ Cola acuminata Schott and Endl., and other spp. of Cola. Coriander....................... Coriandrum sativum L. Cumin (cummin).................. Cuminum cyminum L. Curacao orange peel (orange, Citrus aurantium L. bitter peel). Cusparia bark................... Galipea officinalis Hancock. Dandelion....................... Taraxacum officinale Weber and T. laevigatum DC. Dandelion root.................. Do. Dog grass (quackgrass, triticum) Agropyron repens (L.) Beauv. Elder flowers................... Sambucus canadensis L. and S. nigra I. Estragole (esdragol, esdragon, Artemisia dracunculus L. tarragon). Estragon (tarragon)............. Do. Fennel, sweet................... Foeniculum vulgare Mill. Fenugreek....................... Trigonella foenum-graecum L. Galanga (galangal).............. Alpinia officinarum Hance. Geranium........................ Pelargonium spp. Geranium, East Indian........... Cymbopogon martini Stapf. Geranium, rose.................. Pelargonium graveolens L’Her. Ginger.......................... Zingiber officinale Rosc. Grapefruit...................... Citrus paradisi Macf. Guava........................... Psidium spp. Hickory bark.................... Carya spp. Horehound (hoarhound)........... Marrubium vulgare L. Hops............................ Humulus lupulus L. Horsemint....................... Monarda punctata L. Hyssop.......................... Hyssopus officinalis L. Immortelle...................... Helichrysum augustifolium DC. Jasmine......................... Jasminum officinale L. and other spp. of Jasminum. Juniper (berries)............... Juniperus communis L. Kola nut........................ Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries.................. Laurus nobilis L. Laurel leaves................... Laurus spp. Lavender........................ Lavandula officinalis Chaix. Lavender, spike................. Lavandula latifolia Vill. Lavandin........................ Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lemon........................... Citrus limon (L.) Burm. f. Lemon balm (see balm)........... Lemon grass..................... Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf. Lemon peel...................... Citrus limon (L.) Burm. f. Lime............................ Citrus aurantifolia Swingle.

1069

§ 182.20

——————————————————————————————————————————— Common name Botanical name of plant source ——————————————————————————————————————————— Linden flowers.................. Tilia spp. Locust bean..................... Ceratonia siliqua L, Lupulin......................... Humulus lupulus L. Mace............................ Myristica fragrans Houtt. Mandarin........................ Citrus reticulata Blanco. Marjoram, sweet................. Majorana hortensis Moench. Mate............................ Ilex paraguariensis St. Hil. Melissa (see balm).............. Menthol......................... Mentha spp. Menthyl acetate................. Do. Molasses (extract).............. Saccarum officinarum L. Mustard......................... Brassica spp. Naringin........................ Citrus paradisi Macf. Neroli, bigarade................ Citrus aurantium L. Nutmeg.......................... Myristica fragrans Houtt. Onion........................... Allium cepa L. Orange, bitter, flowers......... Citrus aurantium L. Orange, bitter, peel............ Do. Orange leaf..................... Citrus sinensis (L.) Osbeck. Orange, sweet................... Do. Orange, sweet, flowers.......... Do. Orange, sweet, peel............. Do. Origanum........................ Origanum spp. Palmarosa....................... Cymbopogon martini Stapf. Paprika......................... Capsicum annuum L. Parsley......................... Petroselinum crispum (Mill.) Mansf. Pepper, black................... Piper nigrum L. Pepper, white................... Do. Peppermint...................... Mentha piperita L. Peruvian balsam................. Myroxylon pereirae Klotzsch. Petitgrain...................... Citrus aurantium L. Petitgrain lemon................ Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine Citrus reticulata Blanco. Pimenta......................... Pimenta officinalis Lindl. Pimenta leaf.................... Pimenta officinalis Lindl. Pipsissewa leaves............... Chimaphila umbellata Nutt. Pomegranate..................... Punica granatum L. Prickly ash bark................ Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clavaherculis L. Rose absolute................... Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of Do. roses). Rose buds....................... Do. Rose flowers.................... Do. Rose fruit (hips)............... Do. Rose geranium................... Pelargonium graveolens L’Her. Rose leaves..................... Rosa spp. Rosemary........................ Rosmarinus officinalis L. Saffron......................... Crocus sativus L. Sage............................ Salvia officinalis L. Sage, Greek..................... Salvia triloba L. Sage, Spanish................... Salvia lavandulaefolia Vahl. St. John’s bread................ Ceratonia siliqua L. Savory, summer.................. Satureia hortensis L. Savory, winter.................. Satureia montana L. Schinus molle................... Schinus molle L. Sloe berries (blackthorn Prunus spinosa L. berries). Spearmint....................... Mentha spicata L. Spike lavender.................. Lavandula latifolia Vill. Tamarind........................ Tamarindus indica L. Tangerine....................... Citrus reticulata Blanco. Tarragon........................ Artemisia dracunculus L. Tea............................. Thea sinensis L. Thyme........................... Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white.................... Do. Thyme, wild or creeping......... Thymus serpyllum L. Triticum (see dog grass)........ Tuberose........................ Polianthes tuberosa L. Turmeric........................ Curcuma longa L. Vanilla......................... Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers.................. Viola odorata L. Violet leaves................... Do. Violet leaves absolute.......... Do. Wild cherry bark................ Prunus serotina Ehrh. Ylang-ylang..................... Cananga odorata Hook. f. and Thoms. Zedoary bark.................... Curcuma zedoaria Rosc. ———————————————————————————————————————————

[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043 and 21044, May 22, 1985]

1070

§ 182.60

§ 182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings. Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: ———————————————————————————————————— Common name Botanical name of plant source ———————————————————————————————————— Apricot kernel (persic oil)..... Prunus armeniaca L. Peach kernel (persic oil)....... Prunus persica Sieb. et Zucc. Peanut stearine................. Arachis hypogaea L. Persic oil (see apricot kernel and peach kernel). Quince seed..................... Cydonia oblonga Miller. ————————————————————————————————————

[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]

§ 182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts. Certain other spices, seasonings, essential oils, oleoresins, and natural extracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: ———————————————————————————————————— Common name Derivation ———————————————————————————————————— Ambergris....................... Physeter macrocephalus L. Castoreum....................... Castor fiber L. and C. canadensis Kuhl. Civet (zibeth, zibet, zibetum).. Civet cats, Viverra civetta Schreber and Viverra zibetha Schreber. Cognac oil, white and green..... Ethyl oenanthate, so-called. Musk (Tonquin musk)............. Musk deer, Moschus moschiferus L. ————————————————————————————————————

§ 182.60 Synthetic flavoring substances and adjuvants. Synthetic flavoring substances and adjuvants that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anisole). Benzaldehyde (benzoic aldehyde). N-Butyric acid (butanoic acid). d- or l-Carvone (carvol). Cinnamaldehyde (cinnamic aldehyde). Citral (2,6-dimethyloctadien-2,6-al-8, gera-nial, neral). Decanal (N-decylaldehyde, capraldehyde, capric aldehyde, caprinaldehyde, aldehyde C-10). Ethyl acetate. Ethyl butyrate. 3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-glycidate, so-called strawberry aldehyde, C-16 aldehyde). Ethyl vanillin. Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1-ol). Geranyl acetate (geraniol acetate). Limonene (d-, l-, and dl-). Linalool (linalol, 3,7-dimethyl-1,6-octadien-3-ol). Linalyl acetate (bergamol). Methyl anthranilate (methyl-2-aminobenzoate). Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin). Vanillin. [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17, 1978; 44 FR 3963, Jan. 19, 1979; 44 FR 20656, Apr. 6, 1979; 48 FR 51907, Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989]

1071

§ 182.70

§ 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging. Substances migrating to food from cotton and cotton fabrics used in dry food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Beef tallow. Carboxymethylcellulose. Coconut oil, refined. Cornstarch. Gelatin. Lard. Lard oil. Oleic acid. Peanut oil. Potato starch. Sodium acetate. Sodium chloride. Sodium silicate. Sodium tripolyphosphate. Soybean oil (hydrogenated). Talc. Tallow (hydrogenated). Tallow flakes. Tapioca starch. Tetrasodium pyrophosphate. Wheat starch. Zinc chloride. [42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, 1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30, 1986; 60 FR 62208, Dec. 5, 1995]

§ 182.90 Substances migrating to food from paper and paperboard products. Substances migrating to food from paper and paperboard products used in food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Alum (double sulfate of aluminum and ammonium potassium, or sodium). Aluminum hydroxide. Aluminum oleate. Aluminum palmitate. Casein. Cellulose acetate. Cornstarch. Diatomaceous earth filler. Ethyl cellulose. Ethyl vanillin. Glycerin. Oleic acid. Potassium sorbate. Silicon dioxides. Sodium aluminate. Sodium chloride. Sodium hexametaphosphate. Sodium hydrosulfite. Sodium phosphoaluminate. Sodium silicate. Sodium sorbate.

1072

§ 182.1087

Sodium tripolyphosphate. Sorbitol. Soy protein, isolated. Starch, acid modified. Starch, pregelatinized. Starch, unmodified. Talc. Vanillin. Zinc hydrosulfite. Zinc sulfate. [42 FR 14640, Mar. 15, 1977] EDITORIAL NOTE: For additional FEDERAL REGISTER citations affecting Sec. 182.90, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 182.99 Adjuvants for pesticide chemicals. Adjuvants, identified and used in accordance with 40 CFR 180.1001 (c) and (d), which are added to pesticide use dilutions by a grower or applicator prior to application to the raw agricultural commodity, are exempt from the requirement of tolerances under section 409 of the Act.

Subpart B—Multiple Purpose GRAS Food Substances § 182.1045 Glutamic acid. (a) Product. Glutamic acid. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice. § 182.1047 Glutamic acid hydrochloride. (a) Product. Glutamic acid hydrochloride. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice. § 182.1057 Hydrochloric acid. (a) Product. Hydrochloric acid. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a buffer and neutralizing agent in accordance with good manufacturing practice. § 182.1073 Phosphoric acid. (a) Product. Phosphoric acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1087 Sodium acid pyrophosphate. (a) Product. Sodium acid pyrophosphate. 1073

§ 182.1125

(b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1125 Aluminum sulfate. (a) Product. Aluminum sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1127 Aluminum ammonium sulfate. (a) Product. Aluminum ammonium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1129 Aluminum potassium sulfate. (a) Product. Aluminum potassium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1131 Aluminum sodium sulfate. (a) Product. Aluminum sodium sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1180 Caffeine. (a) Product. Caffeine. (b) Tolerance. 0.02 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in cola-type beverages in accordance with good manufacturing practice. § 182.1217 Calcium phosphate. (a) Product. Calcium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1235 Caramel. (a) Product. Caramel. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1320 Glycerin. (a) Product. Glycerin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

1074

§ 182.1781

§ 182.1320 Methylcellulose. (a) Product. U.S.P. methylcellulose, except that the methoxy content shall not be less than 27.5 percent and not more than 31.5 percent on a dry-weight basis. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1500 Monoammonium glutamate. (a) Product. Monoammonium glutamate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1516 Monopotassium glutamate. (a) Product. Monopotassium glutamate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1711 Silica aerogel. (a) Product. Silica aerogel as a finely powdered microcellular silica foam having a minimum silica content of 89.5 percent. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used as a component of an anti-foaming agent in accordance with good manufacturing practice. § 182.1745 Sodium carboxymethylcellulose. (a) Product. Sodium carboxymethylcellulose is the sodium salt of carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with maximum substitution of 0.95 carboxymethyl groups per anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1748 Sodium caseinate. (a) Product. Sodium caseinate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.1781 Sodium aluminum phosphate. (a) Product. Sodium aluminum phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

1075

§ 182.1810

§ 182.1810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Subpart C—Anticaking Agents § 182.2122 Aluminum calcium silicate. (a) Product. Aluminum calcium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice. § 182.2227 Calcium silicate. (a) Product. Calcium silicate. (b) Tolerance. 2 percent and 5 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used at levels not exceeding 2 percent in table salt and 5 percent in baking powder in accordance with good manufacturing practice. § 182.2437 Magnesium silicate. (a) Product. Magnesium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice. § 182.2727 Sodium aluminosilicate. (a) Product. Sodium aluminosilicate (sodium silicoaluminate). (b) Tolerance. This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing practice. § 182.2729 Sodium calcium aluminosilicate, hydrated. (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium silicoaluminate). (b) Tolerance. This substance is generally recognized as safe for use at a level not exceeding 2 percent in accordance with good manufacturing practice. § 182.2906 Tricalcium silicate. (a) Product. Tricalcium silicate. (b) Tolerance. 2 percent. (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in table salt in accordance with good manufacturing practice.

1076

§ 182.3189

Subpart D—Chemical Preservatives § 182.3013 Ascorbic acid. (a) Product. Ascorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3041 Erythorbic acid. (a) Product. Erythorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3089 Sorbic acid. (a) Product. Sorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3109 Thiodipropionic acid. (a) Product. Thiodipropionic acid. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing practice. § 182.3149 Ascorbyl palmitate. (a) Product. Ascorbyl palmitate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3169 Butylated hydroxyanisole. (a) Product. Butylated hydroxyanisole. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of food, provided the substance is used in accordance with good manufacturing practice. § 182.3173 Butylated hydroxytoluene. (a) Product. Butylated hydroxytoluene. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of food, provided the substance is used in accordance with good manufacturing practice. § 182.3189 Calcium ascorbate. (a) Product. Calcium ascorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

1077

§ 182.3225

§ 182.3225 Calcium sorbate. (a) Product. Calcium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3280 Dilauryl thiodipropionate. (a) Product. Dilauryl thiodipropionate. (b) Tolerance. This substance is generally recognized as safe for use in food when the total content of antioxidants is not over 0.02 percent of fat or oil content, including essential (volatile) oil content of the food, provided the substance is used in accordance with good manufacturing practice. § 182.3616 Potassium bisulfite. (a) Product. Potassium bisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3637 Potassium metabisulfite. (a) Product. Potassium metabisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits and vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3640 Potassium sorbate. (a) Product. Potassium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3731 Sodium ascorbate. (a) Product. Sodium ascorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3739 Sodium bisulfite. (a) Product. Sodium bisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B1; 1078

§ 182.3890

on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to the consumer as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9832, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3766 Sodium metabisulfite. (a) Product. Sodium metabisulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3795 Sodium sorbate. (a) Product. Sodium sorbate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.3798 Sodium sulfite. (a) Product. Sodium sulfite. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3862 Sulfur dioxide. (a) Product. Sulfur dioxide. (b) [Reserved] (c) Limitations, restrictions, or explanation. This substance is generally recognized as safe when used in accordance with good manufacturing practice, except that it is not used in meats; in food recognized as a source of vitamin B1; on fruits or vegetables intended to be served raw to consumers or sold raw to consumers, or to be presented to consumers as fresh. [42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986; 55 FR 9833, Mar. 15, 1990; 59 FR 65939, Dec. 22, 1994]

§ 182.3890 Tocopherols. (a) Product. Tocopherols. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Subpart E—Emulsifying Agents [Reserved] Subpart F—Dietary Supplements [Reserved] 1079

§ 182.6085

Subpart G—Sequestrants1 § 182.6085 Sodium acid phosphate. (a) Product. Sodium acid phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6197 Calcium diacetate. (a) Product. Calcium diacetate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6203 Calcium hexametaphosphate. (a) Product. Calcium hexametaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6215 Monobasic calcium phosphate. (a) Product. Monobasic calcium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6285 Dipotassium phosphate. (a) Product. Dipotassium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6290 Disodium phosphate. (a) Product. Disodium phosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6757 Sodium gluconate. (a) Product. Sodium gluconate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6760 Sodium hexametaphosphate. (a) Product. Sodium hexametaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

1For

the purpose of this subpart, no attempt has been made to designate those sequestrants that may also function as chemical preservatives.

1080

§ 182.8159

§ 182.6760 Sodium metaphosphate. (a) Product. Sodium metaphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. Sec. 182.6778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6787 Sodium pyrophosphate. (a) Product. Sodium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6789 Tetra sodium pyrophosphate. (a) Product. Tetra sodium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.6810 Sodium tripolyphosphate. (a) Product. Sodium tripolyphosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Subpart H—Stabilizers § 182.7255 Chondrus extract. (a) Product. Chondrus extract (carrageenin). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

Subpart I—Nutrients § 182.8013 Ascorbic acid. SOURCE: 45 FR 58838, Sept. 5, 1980, unless otherwise noted.

(a) Product. Ascorbic acid. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8159 Biotin. (a) Product. Biotin. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. 1081

§ 182.8217

§ 182.8217 Calcium phosphate. (a) Product. Calcium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8223 Calcium pyrophosphate. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8250 Choline bitartrate. (a) Product. Choline bitartrate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8252 Choline chloride. (a) Product. Choline chloride. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate (mono-, di-, and tribasic). (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8890 Tocopherols. (a) Product. Tocopherols. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8892 α-Tocopherol acetate. (a) Product. α-Tocopherol acetate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8985 Zinc chloride. (a) Product. Zinc chloride. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8988 Zinc gluconate. (a) Product. Zinc gluconate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. 1082

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§ 182.8991 Zinc oxide. (a) Product. Zinc oxide. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8994 Zinc stearate. (a) Product. Zinc stearate prepared from stearic acid free from chickedema factor. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice. § 182.8997 Zinc sulfate. (a) Product. Zinc sulfate. (b) Conditions of use. This substance is generally recognized as safe when used in accordance with good manufacturing practice.

PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 184.1

Substances added directly to human food affirmed as generally recognized as safe (GRAS).

Subpart B—Listing of Specific Substances Affirmed as GRAS 184.1005 184.1007 184.1009 184.1011 184.1012 184.1021 184.1024 184.1025 184.1027 184.1033 184.1034 184.1061 184.1063 184.1065 184.1069 184.1077 184.1081 184.1090 184.1091 184.1095 184.1097 184.1099 184.1101 184.1115 184.1120 184.1121

Acetic acid. Aconitic acid. Adipic acid. Alginic acid. α-Amylase enzyme preparation from Bacillus stearothermophilus. Benzoic acid. Bromelain. Caprylic acid. Mixed carbohydrase and protease enzyme product. Citric acid. Catalase (bovine liver). Lactic acid. Enzyme-modified lecithin. Linoleic acid. Malic acid. Potassium acid tartrate. Propionic acid. Stearic acid. Succinic acid. Sulfuric acid. Tannic acid. Tartaric acid. Diacetyl tartaric acid esters of mono- and diglycerides. Agar-agar. Brown algae. Red algae. 1083

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184.1133 Ammonium alginate. 184.1135 Ammonium bicarbonate. 184.1137 Ammonium carbonate. 184.1138 Ammonium chloride. 184.1139 Ammonium hydroxide. 184.1140 Ammonium citrate, dibasic. 184.1141a Ammonium phosphate, monobasic. 184.1141b Ammonium phosphate, dibasic. 184.1143 Ammonium sulfate. 184.1148 Bacterially-derived carbohydrase enzyme preparation. 184.1150 Bacterially-derived protease enzyme preparation. 184.1155 Bentonite. 184.1157 Benzoyl peroxide. 184.1165 n-Butane and iso-butane. 184.1185 Calcium acetate. 184.1187 Calcium alginate. 184.1191 Calcium carbonate. 184.1193 Calcium chloride. 184.1195 Calcium citrate. 184.1199 Calcium gluconate. 184.1201 Calcium glycerophosphate. 184.1205 Calcium hydroxide. 184.1206 Calcium iodate. 184.1207 Calcium lactate. 184.1210 Calcium oxide. 184.1212 Calcium pantothenate. 184.1221 Calcium propionate. 184.1229 Calcium stearate. 184.1230 Calcium sulfate. 184.1240 Carbon dioxide. 184.1245 Beta-carotene. 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachiatum. 184.1257 Clove and its derivatives. 184.1259 Cocoa butter substitute. 184.1260 Copper gluconate. 184.1261 Copper sulfate. 184.1262 Corn silk and corn silk extract. 184.1265 Cuprous iodide. 184.1271 L-Cysteine. 184.1272 L-Cysteine monohydrochloride. 184.1277 Dextrin. 184.1278 Diacetyl. 184.1282 Dill and its derivatives. 184.1287 Enzyme-modified fats. 184.1293 Ethyl alcohol. 184.1295 Ethyl formate. 184.1296 Ferric ammonium citrate. 184.1297 Ferric chloride. 184.1298 Ferric citrate. 184.1301 Ferric phosphate. 184.1304 Ferric pyrophosphate. 184.1307 Ferric sulfate. 184.1307a Ferrous ascorbate. 184.1307b Ferrous carbonate. 1084

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184.1307c Ferrous citrate. 184.1307d Ferrous fumarate. 184.1308 Ferrous gluconate. 184.1311 Ferrous lactate. 184.1315 Ferrous sulfate. 184.1316 Ficin. 184.1317 Garlic and its derivatives. 184.1318 Glucono delta-lactone. 184.1321 Corn gluten. 184.1322 Wheat gluten. 184.1323 Glyceryl monooleate. 184.1324 Glyceryl monostearate. 184.1328 Glyceryl behenate. 184.1329 Glyceryl palmitostearate. 184.1330 Acacia (gum arabic). 184.1333 Gum ghatti. 184.1339 Guar gum. 184.1343 Locust (carob) bean gum. 184.1349 Karaya gum (sterculia gum). 184.1351 Gum tragacanth. 184.1355 Helium. 184.1366 Hydrogen peroxide. 184.1370 Inositol. 184.1372 Insoluble glucose isomerase enzyme preparations. 184.1375 Iron, elemental. 184.1386 Isopropyl citrate. 184.1387 Lactase enzyme preparation from Candida pseudotropicalis. 184.1388 Lactase enzyme preparation from Kluyveromyces lactis. 184.1400 Lecithin. 184.1408 Licorice and licorice derivatives. 184.1409 Ground limestone. 184.1415 Animal lipase. 184.1420 Lipase enzyme preparation derived from Rhizopus niveus. 184.1425 Magnesium carbonate. 184.1426 Magnesium chloride. 184.1428 Magnesium hydroxide. 184.1431 Magnesium oxide. 184.1434 Magnesium phosphate. 184.1440 Magnesium stearate. 184.1443 Magnesium sulfate. 184.1443a Malt. 184.1444 Maltodextrin. 184.1445 Malt syrup (malt extract). 184.1446 Manganese chloride. 184.1449 Manganese citrate. 184.1452 Manganese gluconate. 184.1461 Manganese sulfate. 184.1472 Menhaden oil. 184.1490 Methylparaben. 184.1498 Microparticulated protein product. 184.1505 Mono- and diglycerides. 184.1521 Monosodium phosphate derivatives of mono- and diglycerides. 184.1530 Niacin. 184.1535 Niacinamide. 1085

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184.1537 184.1538 184.1540 184.1545 184.1553 184.1555 184.1560 184.1563 184.1583 184.1585 184.1588 184.1595 184.1610 184.1613 184.1619 184.1622 184.1625 184.1631 184.1634 184.1635 184.1639 184.1643 184.1655 184.1660 184.1666 184.1670 184.1676 184.1685 184.1695 184.1697 184.1698 184.1699 184.1702 184.1721 184.1724 184.1733 184.1736 184.1742 184.1751 184.1754 184.1763 184.1764 184.1768 184.1769a 184.1784 184.1792 184.1801 184.1804 184.1807 184.1835 184.1845 184.1848 184.1851 184.1854

Nickel. Nisin preparation. Nitrogen. Nitrous oxide. Peptones. Rapeseed oil. Ox bile extract. Ozone. Pancreatin. Papain. Pectins. Pepsin. Potassium alginate. Potassium bicarbonate. Potassium carbonate. Potassium chloride. Potassium citrate. Potassium hydroxide. Potassium iodide. Potassium iodate. Potassium lactate. Potassium sulfate. Propane. Propyl gallate. Propylene glycol. Propylparaben. Pyridoxine hydrochloride. Rennet (animal-derived) and chymosin preparation (fermentation-derived). Riboflavin. Riboflavin-5’-phosphate (sodium). Rue. Oil of rue. Sheanut oil. Sodium acetate. Sodium alginate. Sodium benzoate. Sodium bicarbonate. Sodium carbonate. Sodium citrate. Sodium diacetate. Sodium hydroxide. Sodium hypophosphite. Sodium lactate. Sodium metasilicate. Sodium propionate. Sodium sesquicarbonate. Sodium tartrate. Sodium potassium tartrate. Sodium thiosulfate. Sorbitol. Stannous chloride (anhydrous and dihydrated). Starter distillate. Stearyl citrate. Sucrose. 1086

§ 184.1

184.1857 Corn sugar. 184.1859 Invert sugar. 184.1865 Corn syrup. 184.1866 High fructose corn syrup. 184.1875 Thiamine hydrochloride. 184.1878 Thiamine mononitrate. 184.1890 α-Tocopherols. 184.1901 Triacetin. 184.1903 Tributyrin. 184.1911 Triethyl citrate. 184.1914 Trypsin. 184.1923 Urea. 184.1924 Urease enzyme preparation from Lactobacillus fermentum. 184.1930 Vitamin A. 184.1945 Vitamin B12. 184.1950 Vitamin D. 184.1973 Beeswax (yellow and white). 184.1976 Candelilla wax. 184.1978 Carnauba wax. 184.1979 Whey. 184.1979a Reduced lactose whey. 184.1979b Reduced minerals whey. 184.1979c Whey protein concentrate. 184.1983 Bakers yeast extract. 184.1984 Zein. 184.1985 Aminopeptidase enzyme preparation derived from lactococcus lactis. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14653, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. 27, 2001.

Subpart A—General Provisions § 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS). (a) The direct human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed. The regulations in this part shall sufficiently describe each ingredient to identify the characteristics of the ingredient that has been affirmed as GRAS and to differentiate it from other possible versions of the ingredient that have not been affirmed as GRAS. Ingredients affirmed as GRAS in this part are also GRAS as indirect human food ingredients, subject to any limitations prescribed in parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter or in part 186 of this chapter. The purity specifications in this part do not apply when the ingredient is used in indirect applications. However, when used in indirect applications, the ingredient must be of a purity suitable for its intended use in accordance with Sec. 170.30(h)(1) of this chapter. (b) Any ingredient affirmed as GRAS in this part shall be used in accordance with current good manufacturing practice. For the purpose of this part, current good manufacturing practice includes the requirements that a direct human food ingredient be of appropriate food grade; that it be prepared and handled as a food ingredient; and that the quantity of the ingredient added to food does not exceed the amount reasonably required to accomplish the intended physical, nutritional, or other technical effect in food. (1) If the ingredient is affirmed as GRAS with no limitations on its conditions of use other than current good manufacturing practice, it shall be regarded as GRAS if its conditions of use are consistent with the requirements of paragraph (b), (c), and (d) of this section. When the Food and Drug Administration (FDA) determines that it is appropriate, the agency will describe one or more current good manufacturing practice conditions of use in the 1087

§ 184.1005

regulation that affirms the GRAS status of the ingredient. For example, when the safety of an ingredient has been evaluated on the basis of limited conditions of use, the agency will describe in the regulation that affirms the GRAS status of the ingredient, one or more of these limited conditions of use, which may include the category of food(s), the technical effect(s) or functional use(s) of the ingredient, and the level(s) of use. If the ingredient is used under conditions that are significantly different from those described in the regulation, that use of the ingredient may not be GRAS. In such a case, a manufacturer may not rely on the regulation as authorizing that use but shall independently establish that that use is GRAS or shall use the ingredient in accordance with a food additive regulation. Persons seeking FDA approval of an independent determination that a use of an ingredient is GRAS may submit a GRAS petition in accordance with Sec. 170.35 of this chapter. (2) If the ingredient is affirmed as GRAS with specific limitation(s), it shall be used in food only within such limitation(s), including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use. Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation. (3) If the ingredient is affirmed as GRAS for a specific use, without a general evaluation of use of the ingredient, other uses may also be GRAS. (c) The listing of a food ingredient in this part does not authorize the use of such substance in a manner that may lead to deception of the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act). (d) The listing of more than one ingredient to produce the same technological effect does not authorize use of a combination of two or more ingredients to accomplish the same technological effect in any one food at a combined level greater than the highest level permitted for one of the ingredients. (e) If the Commissioner of Food and Drugs is aware of any prior sanction for use of an ingredient under conditions different from those proposed to be affirmed as GRAS, he will concurrently propose a separate regulation covering such use of the ingredient under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal. (f) The label and labeling of the ingredient and any intermediate mix of the ingredient for use in finished food shall bear, in addition to the other labeling required by the Act: (1) The name of the ingredient, except where exempted from such labeling in part 101 of this chapter. (2) A statement of concentration of the ingredient in any intermediate mix; or other information to permit a food processor independently to determine that use of the ingredients will be in accordance with any limitations and good manufacturing practice gudelines prescribed. (3) Adequate directions for use to provide a final food product that complies with any limitations prescribed for the ingredient(s). [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. 19, 1983; 62 FR 15110, Mar. 31, 1997]

Subpart B—Listing of Specific Substances Affirmed as GRAS § 184.1005 Acetic acid. (a) Acetic acid (C2H4O2, CAS Reg. No. 64-19-7) is known as ethanoic acid. It occurs naturally in plant and animal tissues. It is produced by fermentation of carbohydrates or by organic synthesis. The principal synthetic methods currently employed are oxidation of acetaldehyde derived from ethylene, liquid phase oxidation of butane, and reaction of carbon monoxide with methanol derived from natural gas. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 8, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 1088

§ 184.1007

20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a curing and pickling agent as defined in Sec. 170.3(o)(5) of this chapter; flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; as a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter; and as a boiler water additive complying with Sec. 173.310 of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level as served, of 0.25 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.8 percent for cheeses as defined in Sec. 170.3(n)(5) of this chapter and dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; 0.5 percent for chewing gum as defined in Sec. 170.3(n)(6) of this chapter; 9.0 percent for condiments and relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.5 percent for fats and oils as defined in Sec. 170.3(n)(12) of this chapter; 3.0 percent for gravies and sauces as defined in Sec. 170.3(n)(24) of this chapter; 0.6 percent for meat products as defined in Sec. 170.3(n)(29) of this chapter; and 0.15 percent or less for all other food categories. The ingredient may also be used in boiler water additives at levels not to exceed current good manufacturing practice. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 27814, June 25, 1982]

§ 184.1007 Aconitic acid. (a) Aconitic acid (1,2,3-propenetricarboxylic acid (C6H6O6), CAS Reg. No. 000499-12-7) occurs in the leaves and tubers of Aconitum napellus L. and other Ranunculaceae. Transaconitic acid can be isolated during sugarcane processing, by precipitation as the calcium salt from cane sugar or molasses. It may be synthesized by sulfuric acid dehydration of citric acid, but not by the methanesulfonic acid method. (b) The ingredient meets the following specifications: (1) Assay. Not less than 98.0 percent of C3H3(COOH)3, using the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 102-103, test for citric acid, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and a molecular weight of 174.11. Copies of the material incorporated by reference are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (2) Melting point. Not less than 195 °C and the determination results in decomposition of aconitic acid. (3) Heavy metals (as Pb). Not more than 10 parts per million. (4) Arsenic (as As). Not more than 3 parts per million. (5) Oxalate. Passes test. (6) Readily carbonizable substances. Passes the test for citric acid of the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 102-103, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section. (7) Residue on ignition. Not more than 0.1 percent as determined by the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 102-103, test for citric acid, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section. (c) The ingredient is used as a flavoring substance and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredient is used in food, in accordance with Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.003 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter, 0.002 percent for alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy products as defined in Sec. 170.3(n)(20) of this chapter, 0.0035 percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter, and 0.0005 percent or less for all other food categories. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 47724, Oct. 17, 1978, as amended at 49 FR 5610, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999]

1089

§ 184.1009

§ 184.1009 Adipic acid. (a) Adipic acid (C6H10O4, CAS Reg. No. 00124-04-9) is also known as 1,4-butanedicarboxylic acid or hexanedioic acid. It is prepared by nitric acid oxidation of cyclohexanol or cyclohexanone or a mixture of the two. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 11, which is incorporated by reference (copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), and the following additional specifications: (1) The adipic acid is converted to its corresponding amide. The amide is purified by recrystallization from water or aqueous ethanol. The melting range of the amide is 219 ° to 220 °C. (2) The adipic acid is converted to its corresponding bis-p-p-bromophenacyl ester. The ester is purified by recrystallization from ethanol. The melting range of the ester is 153 ° to 154 °C. (c) The ingredient is used as a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter; leavening agent as defined in Sec. 170.3(o)(17) of this chapter; and pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (d) The ingredient is used in foods at levels not to exceed current good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in maximum levels, as served, of 0.05 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.005 percent for nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; 5.0 percent for condiments and relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.45 percent for dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; 0.3 percent for fats and oil as defined in Sec. 170.3(n)(12) of this chapter; 0.0004 percent for frozen dairy desserts as defined in Sec. 170.3(n)(20) of this chapter; 0.55 percent for gelatin and puddings as defined in Sec. 170.3(n)(22) of this chapter; 0.1 percent for gravies as defined in Sec. 170.3(n)(24) of this chapter; 0.3 percent for meat products as defined in Sec. 170.3(n)(29) of this chapter; 1.3 percent for snack foods as defined in Sec. 170.3(n)(37) of this chapter; and 0.02 percent or less for all other food categories. (e) Prior sanctions for adipic acid different from the uses established in this section do not exist or have been waived. [47 FR 27810, June 25, 1982]

§ 184.1011 Alginic acid. (a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained from certain brown algae by alkaline extraction. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 13, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ——————————————————————————————————————— Maximum level of Category of food use in food (as Functional use served) ——————————————————————————————————————— Soup and soup mixes, Sec. Not to exceed Emulsifier, 170.3(n) (40) of this chapter. current good emulsifier salt, manufacturing Sec. 170.3(o)(8) practice. of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer, thickener, Sec. 170.3(o)(28) of this chapter. ———————————————————————————————————————

(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [47 FR 47375, Oct. 26, 1982]

1090

§ 184.1024 § 184.1012 α-Amylase enzyme preparation from Bacillus stearothermophilus. (a) α-Amylase enzyme preparation is obtained from the culture filtrate that results from a pure culture fermentation of a nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus. Its characterizing enzyme activity is α-amylase (1,4 α-D glucan glucanohydrolase (E.C. 3.2.1.1)). (b) The ingredient meets the general and additional requirements for enzyme preparations in the ``Food Chemicals Codex,’’ 3d ed. (1981), pp. 107-110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., suite 1200, Washington, DC, or the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practices. The affirmation of this ingredient as GRAS as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme, as defined in Sec. 170.3(o)(9) of this chapter, in the hydrolysis of edible starch to produce maltodextrins and nutritive carbohydrate sweeteners. (2) The ingredient is used at levels not to exceed current good manufacturing practices. [60 FR 55789, Nov. 3, 1995]

§ 184.1021 Benzoic acid. (a) Benzoic acid is the chemical benzenecarboxylic acid (C7H6O2), occurring in nature in free and combined forms. Among the foods in which benzoic acid occurs naturally are cranberries, prunes, plums, cinnamon, ripe cloves, and most berries. Benzoic acid is manufactured by treating molten phthalic anhydride with steam in the presence of a zinc oxide catalyst, by the hydrolysis of benzotrichloride, or by the oxidation of toluene with nitric acid or sodium bichromate or with air in the presence of a transition metal salt catalyst. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 35, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice. Current usage results in a maximum level of 0.1 percent in food. (The Food and Drug Administration has not determined whether significantly different conditions of use would be GRAS). (e) Prior sanctions for this ingredient different from those uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984]

§ 184.1024 Bromelain. (a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation derived from the pineapples Ananas comosus and A. bracteatus L. It is a white to light tan amorphous powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.32). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: 1091

§ 184.1025

(1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32910, June 26, 1995]

§ 184.1025 Caprylic acid. (a) Caprylic acid [CH3(CH2)6COOH, CAS Reg. No. 124-07-2] is the chemical name for octanoic acid. It is considered to be a short or medium chain fatty acid. It occurs normally in various foods and is commercially prepared by oxidation of n-octanol or by fermentation and fractional distillation of the volatile fatty acids present in coconut oil. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 207, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredient is used in foods in accordance with Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice. Current good manufacturing practices result in maximum levels, as served, of: 0.013 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.04 percent for cheeses as defined in Sec. 170.3(n)(5) of this chapter; 0.005 percent for fats and oils as defined in Sec. 170.3(n)(12) of this chapter, for frozen dairy desserts as defined in Sec. 170.3(n)(20) of this chapter, for gelatins and puddings as defined in Sec. 170.3(n)(22) of this chapter, for meat products as defined in Sec. 170.3(n)(29) of this chapter, and for soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.016 percent for snack foods as defined in Sec. 170.3(n)(37) of this chapter; and 0.001 percent or less for all other food categories. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 19843, May 9, 1978, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1027 Mixed carbohydrase and protease enzyme product. (a) Mixed carbohydrase and protease enzyme product is an enzyme preparation that includes carbohydrase and protease activity. It is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic strain of B. licheniformis. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 107, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme, as defined in Sec. 170.3(o)(9) of this chapter, to hydrolyze proteins or carbohydrates. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: alcoholic beverages, as defined in Sec. 170.3(n)(2) of this chapter, candy, nutritive sweeteners, and protein hydrolyzates. [48 FR 240, Jan. 4, 1983]

§ 184.1033 Citric acid. (a) Citric acid (C6H8O7, CAS Reg. No. 77-92-9) is the compound 2-hydroxy-1,2,3-propanetricarboxylic acid. It is a naturally occurring constituent of plant and animal tissues. It occurs as colorless crystals or a white powder and 1092

§ 184.1061

may be anhydrous or contain one mole of water per mole of citric acid. Citric acid may be produced by recovery from sources such as lemon or pineapple juice; by mycological fermentation using Candida spp., described in Secs. 173.160 and 173.165 of this chapter; and by the solvent extraction process described in Sec. 173.280 of this chapter for the recovery of citric acid from Aspergillus niger fermentation liquor. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 86-87, and its third supplement (March 1992), pp. 107-108, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [59 FR 63895, Dec. 12, 1994]

§ 184.1034 Catalase (bovine liver). (a) Catalase (bovine liver) (CAS Reg. No. 9001-05-2) is an enzyme preparation obtained from extracts of bovine liver. It is a partially purified liquid or powder. Its characterizing enzyme activity is catalase (EC 1.11.1.6). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St., SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to decompose hydrogen peroxide. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32910, June 26, 1995]

§ 184.1061 Lactic acid. (a) Lactic acid (C3H6O3, CAS Reg. Nos.: DL mixture, 598-82-3; L-isomer, 79-33-4; D-isomer, 10326-41-7), the chemical 2-hydroxypropanoic acid, occurs naturally in several foods. It is produced commercially either by fermentation of carbohydrates such as glucose, sucrose, or lactose, or by a procedure involving formation of lactonitrile from acetaldehyde and hydrogen cyanide and subsequent hydrolysis to lactic acid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 159, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Avenue, NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter; a curing and pickling agent as defined in Sec. 170.3(o)(5) of this chapter; a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter. 1093

§ 184.1063

(2) The ingredient is used in food, except in infant foods and infant formulas, at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 35367, Sept. 7, 1984]

§ 184.1063 Enzyme-modified lecithin. (a) Enzyme-modified lecithin is prepared by treating lecithin with either phospholipase A2 (EC 3.1.1.4) or pancreatin. (b) The ingredient meets the specifications in paragraphs (b)(1) through (b)(8) of this section. Unless otherwise noted, compliance with the specifications listed below is determined according to the methods set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp. 220-221, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (1) Acetone-insoluble matter (phosphatides), not less than 50.0 percent. (2) Acid value, not more than 40. (3) Lead, not more than 1.0 part per million, as determined by atomic absorption spectroscopy. (4) Heavy metals (as Pb), not more than 20 parts per million. (5) Hexane-insoluble matter, not more than 0.3 percent. (6) Peroxide value, not more than 20. (7) Water, not more than 4.0 percent. (8) Lysolecithin, 50 to 80 mole percent of total phosphatides as determined by ``Determination of Lysolecithin Content of Enzyme-Modified Lecithin: Method I,’’ dated 1985, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Division of Petition Control, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an emulsifier as defined in Sec. 170.3(o)(8) of this chapter. (2) The ingredient is used at levels not to exceed current good manufacturing practice. [61 FR 45889, Aug. 30, 1996]

§ 184.1065 Linoleic acid. (a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid (C17H31COOH) (CAS Reg. No. 60-33-3)), a straight chain unsaturated fatty acid with a molecular weight of 280.5, is a colorless oil at room temperature. Linoleic acid may be prepared from edible fats and oils by various methods including hydrolysis and saponification, the Twitchell method, low pressure splitting with catalyst, continuous high pressure counter current splitting, and medium pressure autoclave splitting with catalyst. (b) FDA is developing food-grade specifications for linoleic acid in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. The ingredient must also meet the specifications in Sec. 172.860(b) of this chapter. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter and as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. 1094

§ 184.1077

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 48534, Dec. 13, 1984]

§ 184.1069 Malic acid. (a) Malic acid (C4H6O5, CAS Reg. No. of L-form 97-67-6, CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L (+) malic acid, referred to as L-malic acid, occurs naturally in various foods. Racemic DL-malic acid does not occur naturally. It is made commercially by hydration of fumaric acid or maleic acid. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 183-184, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredients are used as a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter, flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter, and pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (d) The ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 3.4 percent for nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; 3.0 percent for chewing gum as defined in Sec. 170.3(n)(6) of this chapter; 0.8 percent for gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; 6.9 percent for hard candy as defined in Sec. 170.3(n)(25) of this chapter; 2.6 percent for jams and jellies as defined in Sec. 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit juices as defined in Sec. 170.3(n)(35) of this chapter; 3.0 percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter; and 0.7 percent for all other food categories. (e) Prior sanctions for malic acid different from the uses established in this section do not exist or have been waived. [44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1077 Potassium acid tartrate. (a) Potassium acid tartrate (C4H5KO6, CAS Reg. No. 868-14-4) is the potassium acid salt of L–(+)–tartaric acid and is also called potassium bitartrate or cream of tartar. It occurs as colorless or slightly opaque crystals or as a white, crystalline powder. It has a pleasant, acid taste. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), P. 238, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an anticaking agent as defined in Sec. 170.3(o)(1) of this chapter; an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter; a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; a humectant as defined in Sec. 170.3(o)(16) of this chapter; a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; A pH control agent as defined in Sec. 170.3(o)(23) of this chapter; a processing aid as defined in Sec. 170.3(o)(24) of this chapter; a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; and a surfaceactive agent as defined in Sec. 170.3(o)(29) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; gelatins and puddings as defined in Sec. 170.3(n)(22) of this chapter; hard candy as defined in Sec. 1095

§ 184.1081

170.3(n)(25) of this chapter; jams and jellies as defined in Sec. 170.3(n)(28) of this chapter; and soft candy as defined in Sec. 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52446, Nov. 18, 1983]

§ 184.1081 Propionic acid. (a) Propionic acid (C3H6O2, CAS Reg. No. 79-09-4) is an oily liquid having a slightly pungent, rancid odor. It is manufactured by chemical synthesis or by bacterial fermentation. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 254, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter and a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 13141, Apr. 3, 1984]

§ 184.1090 Stearic acid. (a) Stearic acid (C16H36O2, CAS Reg. No. 57-11-4) is a white to yellowish white solid. It occurs naturally as a glyceride in tallow and other animal or vegetable fats and oils and is a principal constituent of most commercially hydrogenated fats. It is produced commercially from hydrolyzed tallow derived from edible sources or from hydrolyzed, completely hydrogenated vegetable oil derived from edible sources. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 313, which is incorporated by reference, and the requirements of Sec. 172.860(b)(2) of this chapter. Copies of the Food Chemicals Codex are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52445, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]

§ 184.1091 Succinic acid. (a) Succinic acid (C4H6O4, CAS Reg. No. 110-15-6), also referred to as amber acid and ethylenesuccinic acid, is the chemical 1,4-butanedioic acid. It is commercially prepared by hydrogenation of maleic or fumaric acid. It can also be produced by aqueous alkali or acid hydrolysis of succinonitrile. 1096

§ 184.1097

(b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 314-315, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter and pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.084 percent in condiments and relishes as defined in Sec. 170.3(n)(8) of this chapter and 0.0061 percent in meat products as defined in Sec. 170.3(n)(29) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1095 Sulfuric acid. (a) Sulfuric acid (H2SO4, CAS Reg. No. 7664-93-9), also known as oil of vitriol, is a clear, colorless, oily liquid. It is prepared by reacting sulfur dioxide (SO2) with oxygen and mixing the resultant sulfur trioxide (SO3) with water, or by reacting nitric oxide (NO) with sulfur dioxide and water. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 317-318, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter and processing aid as defined in Sec. 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.014 percent for alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter and 0.0003 percent for cheeses as defined in Sec. 170.3(n)(5) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [45 FR 6085, Jan. 25, 1980, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1097 Tannic acid. (a) Tannic acid (CAS Reg. No. 1401-55-4), or hydrolyzable gallotannin, is a complex polyphenolic organic structure that yields gallic acid and either glucose or quinic acid as hydrolysis products. It is a yellowish-white to light brown substance in the form of an amorphous, bulky powder, glistening scales, or spongy masses. It is also ordorless, or has a faint characteristic odor, and has an astringent taste. Tannic acid is obtained by solvent extraction of nutgalls or excrescences that form on the young twigs of Quercus infectoria Oliver and related species of Quercus. Tannic acid is also obtained by solvent extraction of the seed pods of Tara (Caesalpinia spinosa) or the nutgalls of various sumac species, including Rhus semialata, R. coriaria, R. galabra, and R. typhia. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 319, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c)(1) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

1097

§ 184.1099

—————————————————————————————————————————— Maximum level of use Category of food in food (as Functional use served) (percent) —————————————————————————————————————————— Baked goods and baking mixes, Sec. 0.01 Flavoring agent and 170.3(n)(1) of this chapter. adjuvant, Sec. 170.3(o)(12) of this chapter. Alcoholic beverages, Sec. 0.015 Flavor enhancer, Sec. 170.3(n)(2) of this chapter. 170.3(o)(11) of this chapter; flavoring agent and adjuvant, Sec. 170.3(o)(12) of this chapter; processing aid, Sec. 170.3(o)(24) of this chapter. Nonalcoholic beverages and 0.005 Flavoring agent and beverage bases, Sec. 170.3(n)(3) adjuvant, Sec. of this chapter and for gelatins, 170.3(o)(12) of this puddings, and fillings, Sec. chapter; pH control 170.3(n)(22) of this chapter. agent, Sec. 170.3(o)(23) of this chapter. Frozen dairy desserts and mixes, 0.04 Flavoring agent and Sec. 170.3(n)(20) of this adjuvant, Sec. chapter and for soft candy, Sec. 170.3(o)(12) of this 170.3(n)(38) of this chapter. chapter. Hard candy and cough drops, Sec. 0.013 Do. 170.3(n)(25) of this chapter. Meat products, Sec. 170.3(n)(29) 0.001 Do. of this chapter. ——————————————————————————————————————————

(2) Tannic acid may be used in rendered animal fat in accordance with 9 CFR 318.7. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 21043, May 22, 1985]

§ 184.1099 Tartaric acid. (a) Food grade tartaric acid (C4H6O6, CAS Reg. No. 87-69-4) has the L configuration. The L form of tartaric acid is dextrorotatory in solution and is also known as L – (+) – tartaric acid. Tartaric acid occurs as colorless or translucent crystals or as a white, crystalline powder. It is odorless and has an acid taste. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), P. 320, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a firming agent as defined in Sec. 170.3(o)(10) of this chapter; a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter; a humectant as defined in Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52447, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]

1098

§ 184.1115

§ 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides. (a) Diacetyl tartaric acid esters of mono- and diglycerides, also know as DATEM, are composed of mixed esters of glycerin in which one or more of the hydroxyl groups of glycerin has been esterified by diacetyl tartaric acid and by fatty acids. The ingredient is prepared by the reaction of diacetyl tartaric anhydride with mono- and diglycerides that are derived from edible sources. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20005. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an emulsifier and emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter and a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in Sec. 170.3(n)(l) of this chapter; nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; and fats and oils as defined in Sec. 170.3(n)(12) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. (e) Labeling: The acronym ``DATEM’’ may be used on food labeling as the alternate common or usual name for the ingredient diacetyl tartaric acid esters of mono- and diglycerides. [54 FR 7403, Feb. 21, 1989, as amended at 54 FR 13168, Mar. 31, 1989; 54 FR 18382, Apr. 28, 1989; 60 FR 15872, Mar. 28, 1995]

§ 184.1115 Agar-agar. (a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic, colloidal polysaccharide extracted from one of a number of related species of red algae (class Rhodophyceae). (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 11, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used in food in accordance with Sec. 184.1(b)(2) under the following conditions: MAXIMUM USAGE LEVELS PERMITTED ———————————————————————————————————————————— Foods (as served) Percent Functions ———————————————————————————————————————————— Baked goods and baking mixes, 0.8 Drying agent, Sec. Sec. 170.3(n)(1) of this 170.3(o)(7) of this chapter; chapter. flavoring agent, Sec. 170.3(o)(12) of this chapter; stabilizer, thickener, Sec. 170.3(o)(28) of this chapter. Confections and frostings, 2.0 Flavoring agent, Sec. Sec. 170.3(n)(9) of this 170.3(o)(12) of this chapter. chapter; stabilizer, thickener, Sec. 170.3(o)(28) of this chapter; surface finisher, Sec. 170.3(o)(30) of this chapter. Soft candy, Sec. 1.2 Stabilizer and thickener, 170.3(n)(38) of this chapter. Sec. 170.3(o)(28) of this chapter.

1099

§ 184.1120

———————————————————————————————————————————— Foods (as served) Percent Functions ———————————————————————————————————————————— All other food categories.... .25 Flavoring agent, Sec. 170.3(o)(12) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; humectant, Sec. 170.3(o)(16) of this chapter; stabilizer, thickener, Sec. 170.3(o)(28) of this chapter. ————————————————————————————————————————————

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [44 FR 19391, Apr. 3, 1979, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1120 Brown algae. (a) Brown algae are seaweeds of the species Analipus japonicus, Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria angustata, Laminaria claustonia, Laminaria digitata, Laminaria japonica, Laminaria longicruris, Laminaria longissima, Laminaria ochotensis, Laminaria saccharina, Macrocystis pyrifera, Petalonia fascia, Scytosiphon lomentaria and Undaria pinnatifida. They are harvested principally in coastal waters of the northern Atlantic and Pacific oceans. The material is dried and ground or chopped for use in food. (b) The ingredient meets the specifications for kelp in the Food Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ———————————————————————————————————————————— Maximum level of Category of food use in food (as Functional use served) ———————————————————————————————————————————— Spices, seasonings, and Not to exceed Flavor enhancer, flavorings, Sec. 170.3(n) (26) current good Sec. 170.3(o)(11) of this chapter. manufacturing of this practice. chapter; flavor adjuvant, Sec. 170.3(o)(12) of this chapter. ————————————————————————————————————————————

(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [47 FR 47376, Oct. 26, 1982]

§ 184.1121 Red algae. (a) Red algae are seaweeds of the species Gloiopeltis furcata, Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra suborbiculata, Porphyra tenera and Rhodymenia palmata. Porphyra and Rhodymenia are harvested principally along the coasts of Japan, Korea, China, Taiwan, and the East and West coasts of the United States. Gloiopeltis is harvested principally in southern Pacific coastal waters. The material is dried and ground or chopped for use in food. (b) The ingredient meets the specifications for kelp in the Food Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by reference, except that the loss on drying is not more than 20 percent and the maximum allowable level for iodine is 0.05 percent. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

1100

§ 184.1135

————————————————————————————————————————— Maximum level of Category of food use in food (as Functional use served) ————————————————————————————————————————— Spices, seasonings, and Not to exceed Flavor enhancer, flavorings, Sec. 170.3(n) (26) current good Sec. 170.3(o)(11) of this chapter. manufacturing of this practice. chapter; flavor adjuvant, Sec. 170.3(o)(12) of this chapter. —————————————————————————————————————————

(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [47 FR 47376, Oct. 26, 1982]

§ 184.1133 Ammonium alginate. (a) Ammonium alginate (CAS Reg. No. 9005-34-9) is the ammonium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Ammonium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 18, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ————————————————————————————————————————— Maximum level of Category of food use in food (as Functional use served) ————————————————————————————————————————— Confections, frostings, Sec. 0.4 Stabilizer, thickener, 170.3(n)(9) of this chapter. Sec. 170.3(o)(28) of this chapter. Fats and oils, Sec. 170.3(n)(12) of 0.5 Do. this chapter. Gelatins, puddings, Sec. 0.5 Do. 170.3(n)(22) of this chapter. Gravies and sauces, Sec. 0.4 Do. 170.3(n)(24) of this chapter. Jams and jellies, Sec. 170.3(n)(28) 0.4 Do. of this chapter. Sweet sauces, Sec. 170.3(n)(43) of 0.5 Do. this chapter. All other food categories........... 0.1 Humectant, Sec. 170.3(o)(16) of this chapter; stabilizer, thickener, Sec. 170.3(o)(28) of this chapter. —————————————————————————————————————————

(d) Prior sanctions for ammonium alginate different from the uses established in this section do not exist or have been waived. [47 FR 29950, July 9, 1982]

§ 184.1135 Ammonium bicarbonate. (a) Ammonium bicarbonate (NH4HCO3, CAS Reg. No. 1066-33-7) is prepared by reacting gaseous carbon dioxide with aqueous ammonia. Crystals of ammonium bicarbonate are precipitated from solution and subsequently washed and dried. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1101

§ 184.1137

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter; a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and a texturizer as defined in Sec. 170.3(o)(32) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52439, Nov. 18, 1983]

§ 184.1137 Ammonium carbonate. (a) Ammonium carbonate ((NH4)2CO3, CAS Reg. No. 8000-73-5) is a mixture of ammonium bicarbonate (NH4HCO3) and ammonium carbamate (NH2COONH4). It is prepared by the sublimation of a mixture of ammonium sulfate and calcium carbonate and occurs as a white powder or a hard, white or translucent mass. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a leavening agent as defined in Sec. 170.3(o)(17) of this chapter and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52439, Nov. 18, 1983]

§ 184.1138 Ammonium chloride. (a) Ammonium chloride (NH4Cl, CAS Reg. No. 12125-02-9) is produced by the reaction of sodium chloride and an ammonium salt in solution. The less soluble sodium salt separates out at elevated temperatures, and ammonium chloride is recovered from the filtrate on cooling. Alternatively, hydrogen chloride formed by the burning of hydrogen in chlorine is dissolved in water and then reacted with gaseous ammonia. Ammonium chloride is crystallized from the solution. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave, NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter; a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; and a processing aid as defined in Sec. 107.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52439, Nov. 18, 1983]

1102

§ 184.1141a

§ 184.1139 Ammonium hydroxide. (a) Ammonium hydroxide (NH4 OH, CAS Reg. No. 1336-21-6) is produced by passing ammonia gas into water. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter; and as a boiler water additive complying with Sec. 173.310 of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. The ingredient may also be used as a boiler water additive at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52440, Nov. 18, 1983, as amended at 59 FR 14551, Mar. 29, 1994]

§ 184.1140 Ammonium citrate, dibasic. (a) Ammonium citrate, dibasic ((NH4)2HC6H5O7, CAS Reg. No. 3012-65-5) is the diammonium salt of citric acid. It is prepared by partially neutralizing citric acid with ammonia. (b) The Food and Drug Administration, in cooperation with the National Academy of Sciences, is developing foodgrade specifications for ammonium citrate, dibasic. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter and as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter and in cheeses as defined in Sec. 170.3(n)(5) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. [59 FR 63896, Dec. 12, 1994]

§ 184.1141a Ammonium phosphate, monobasic. (a) Ammonium phosphate, monobasic (NH4H2PO4, CAS Reg. No. 7722-76-1) is manufactured by reacting ammonia with phosphoric acid at a pH below 5.8. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. 1103

§ 184.1141b

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52440, Nov. 18, 1983]

§ 184.1141b Ammonium phosphate, dibasic. (a) Ammonium phosphate, dibasic ((NH4)2HPO4, CAS Reg. No. 7783-28-0) is manufactured by reacting ammonia with phosphoric acid at a pH above 5.8. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter; a firming agent as defined in Sec. 170.3(o)(10) of this chapter; a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52440, Nov. 18, 1983]

§ 184.1143 Ammonium sulfate. (a) Ammonium sulfate ((NH4)2SO4, CAS Reg. No. 7783-20-2) occurs naturally and consists of colorless or white, odorless crystals or granules. It is prepared by the neutralization of sulfuric acid with ammonium hydroxide. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 22-23, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter, firming agent as defined in Sec. 170.3(o)(10) of this chapter, and processing aid as defined in Sec. 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.15 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter and 0.1 percent for gelatins and puddings as defined in Sec. 170.1(n)(22) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, 1980, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1148 Bacterially-derived carbohydrase enzyme preparation. (a) Bacterially-derived carbohydrase enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes α-amylase (EC 3.2.1.1) and β-glucanase (EC 3.2.1.6), which catalyze the hydrolysis of O-glycosyl bonds in carbohydrates. (b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 1104

§ 184.1155

Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method ``Determination of antibiotic activity’’ in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to ``http://www.fao.org’’. Copies may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze polysaccharides (e.g., starch). (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [64 FR 19894, Apr. 23, 1999]

§ 184.1150 Bacterially-derived protease enzyme preparation. (a) Bacterially-derived protease enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC 3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins. (b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol Street, NW., Suite 700 Washington, DC. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method ``Determination of antibiotic activity’’ in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to ``http://www.fao.org’’. Copies may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [64 FR 19895, Apr. 23, 1999]

§ 184.1155 Bentonite. (a) Bentonite (Al2O34SiO2nH2O, CAS Reg. No. 1302-0978-099) is principally a colloidal hydrated aluminum silicate. Bentonite contains varying quantities of iron, alkalies, and alkaline earths in the commercial products. Depending on the cations present, natural deposits of bentonite range in color from white to gray, yellow, green, or blue. Bentonite’s fine particles provide large total surface area and, hence, pronounced adsorptive capability. (b) FDA is developing food-grade specifications for bentonite in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a suitable purity for its intended use. 1105

§ 184.1157

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice results in no significant residue in foods. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 43367, Oct. 1, 1982]

§ 184.1157 Benzoyl peroxide. (a) Benzoyl peroxide ((C6H5CO)2O2, CAS Reg. No. 94-36-0) is a colorless, rhombic crystalline solid. It is prepared by reaction of benzoyl chloride, sodium hydroxide, and hydrogen peroxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 35, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a bleaching agent in food. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: flour; milk used for production of Asiago fresh and Asiago soft cheese (Sec. 133.102), Asiago medium cheese (Sec. 133.103), Asiago old cheese (Sec. 133.104), Blue cheese (Sec. 133.106), Caciocavallo siciliano chesse (Sec. 133.111), Gorgonzola cheese (Sec. 133.141), Parmesan and reggiano cheese (Sec. 133.165), Provolone cheese (Sec. 133.181), Romano cheese (Sec. 133.183), and Swiss and emmentaler cheese (Sec. 133.195) in part 133 of this chapter; and annatto-colored whey, such that the final bleached product conforms to the descriptions and specifications for whey, concentrated whey, or dried whey in Sec. 184.1979(a) (1), (2), or (3), respectively. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 27173, July 30, 1986]

§ 184.1165 n-Butane and iso-butane. (a) n-Butane and iso-butane (empirical formula C4H10, CAS Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, odorless, flammable gases at normal temperatures and pressures. They are easily liquefied under pressure at room temperature and are stored and shipped in the liquid state. The butanes are obtained from natural gas by fractionation following absorption in oil, adsorption to surface-active agents, or refrigeration. (b) The Food and Drug Administration is developing food-grade specifications for n-butane and iso-butane in cooperation with the National Academy of Sciences. In the interim, the ingredients must be of a purity suitable for their intended use. (c) In accordance with Sec. 184.1(b)(1), these ingredients are used in food with no limitations other than current good manufacturing practice. The affirmation of these ingredients as generally recognized as safe (GRAS) as direct human food ingredients is based upon the following current good manufacturing practice conditions of use: (1) The ingredients are used as propellants, aerating agents, and gases as defined in Sec. 170.3(o)(25) of this chapter. (2) The ingredients are used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [48 FR 57270, Dec. 29, 1983]

1106

§ 184.1187

§ 184.1185 Calcium acetate. (a) Calcium acetate (Ca (C2H3O2)2, CAS Reg. No. 62-54-4), also known as acetate of lime or vinegar salts, is the calcium salt of acetic acid. It may be produced by the calcium hydroxide neutralization of acetic acid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 44, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a firming agent as defined in Sec. 170.3(o)(10) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; processing aid as defined in Sec. 170.3(o)(24) of this chapter; sequestrant as defined in Sec. 170.3(o)(26) of this chapter; stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; and texturizer as defined in Sec. 170.3(o)(32) of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practices in accordance with Sec. 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 0.2 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.02 percent for cheese as defined in Sec. 170.3(n)(5) of this chapter; 0.2 percent for gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; 0.15 percent for sweet sauces, toppings, and syrups as defined in Sec. 170.3(n)(43) of this chapter; and 0.0001 percent for all other food categories. (e) Prior sanctions for this ingredient different from the uses established in this section or in part 181 of this chapter do not exist or have been waived. [47 FR 27807, June 25, 1982]

§ 184.1187 Calcium alginate. (a) Calcium alginate (CAS Reg. No. 9005-35-0) is the calcium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Calcium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents, or from sodium alginate by metathesis with appropriate calcium salts. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 45, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ————————————————————————————————————————— Maximum level of use in food (as Category of food served) (percent) Functional use ————————————————————————————————————————— Baked goods, Sec. 170.3(n)(1) of 0.002 Stabilizer, thickener, this chapter. Sec. 170.3(o)(28) of this chapter. Alcoholic beverages, Sec. 0.4 Do. 170.3(n)(2) of this chapter. Confections and frostings, Sec. 0.4 Do. 170.3(n)(9) of this chapter. Egg products, Sec. 170.3(n)(11) of 0.6 Do. this chapter. Fats and oils, Sec. 170.3(n)(12) of 0.5 Do. this chapter. Gelatins, puddings, Sec. 0.25 Do. 170.3(n)(22) of this chapter. Gravies and sauces, Sec. 0.4 Do. 170.3(n)(24) of this chapter. Jams and jellies, Sec. 170.3(n)(28) 0.5 Do. of this chapter. Sweet sauces, Sec. 170.3(n)(43) of 0.5 Do. this chapter. All other food categories........... 0.3 Do. —————————————————————————————————————————

(d) Prior sanctions for calcium alginate different from the uses established in this section do not exist or have been waived. [47 FR 29951, July 9, 1982]

1107

§ 184.1191

§ 184.1191 Calcium carbonate. (a) Calcium carbonate (CaCO3, CAS Reg. No. 471-34-1) is prepared by three common methods of manufacture: (1) As a byproduct in the ``Lime soda process’’; (2) By precipitation of calcium carbonate from calcium hydroxide in the ``Carbonation process’’; or (3) By precipitation of calcium carbonate from calcium chloride in the ``Calcium chloride process’’. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 46, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived. [48 FR 52441, Nov. 18, 1983]

§ 184.1193 Calcium chloride. (a) Calcium chloride (CaCl2 ⋅ 2H2O, CAS Reg. No. 10035-04-8) or anhydrous calcium chloride (CaCl2, CAS Reg. No. 10043-52-4) may be commercially obtained as a byproduct in the ammonia-soda (Solvay) process and as a joint product from natural salt brines, or it may be prepared by substitution reactions with other calcium and chloride salts. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 47, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an anticaking agent as defined in Sec. 170.3(o)(1) of this chapter; antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter; curing or pickling agent as defined in Sec. 170.3(o)(5) of this chapter; firming agent as defined in Sec. 170.3(o)(10) of this chapter; flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; humectant as defined in Sec. 170.3(o)(16) of this chapter; nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; processing aid as defined in Sec. 170.3(o)(24) of this chapter; stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; surface-active agent as defined in Sec. 170.3(o)(29) of this chapter; synergist as defined in Sec. 170.3(o)(31) of this chapter; and texturizer as defined in Sec. 170.3(o)(32) of this chapter. (d) The ingredient is used in foods at levels not to exceed current good manufacturing practices in accordance with Sec. 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 0.3 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter and for dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; 0.22 percent for nonalcoholic beverages and beverage bases as defined in Sec. 170.3(n)(3) of this chapter; 0.2 percent for cheese as defined in Sec. 170.3(n)(5) of this chapter and for processed fruit and fruit juices as defined in Sec. 170.3(n)(35) of this chapter; 0.32 percent for coffee and tea as defined in Sec. 170.3(n)(7) of this chapter; 0.4 percent for condiments and relishes as defined in Sec. 170.3(n)(8) of this chapter; 0.2 percent for gravies and sauces as defined in Sec. 170.3(n)(24) of this chapter; 0.1 percent for commercial jams and jellies as defined in Sec. 170.3(n)(28) of this chapter; 0.25 percent for meat products as defined in Sec. 170.3(n)(29) of this chapter; 2.0 percent for plant protein products as defined in Sec. 170.3(n)(33) of this chapter; 0.4 percent for processed vegetables and vegetable juices as defined in Sec. 170.3(n)(36) of this chapter; and 0.05 percent for all other food categories. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 27808, June 25, 1982, as amended at 61 FR 14247, Apr. 1, 1996]

1108

§ 184.1201

§ 184.1195 Calcium citrate. (a) Calcium citrate (Ca3(C6H5O7)2 ⋅ 4H2O, CAS Reg. No. 813-0994-095) is the calcium salt of citric acid. It is prepared by neutralizing citric acid with calcium hydroxide or calcium carbonate. It occurs as a fine white, odorless powder and usually contains four moles of water per mole of calcium citrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 49 and 50, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. Calcium citrate may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [59 FR 63896, Dec. 12, 1994]

§ 184.1199 Calcium gluconate. (a) Calcium gluconate ([CH2OH(CHOH)4COO]2Ca, CAS Reg. No. 299-28-5) is the calcium salt of gluconic acid which may be produced by neutralization of gluconic acid with lime or calcium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 51, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a firming agent as defined in Sec. 170.3(o)(10) of this chapter; formulation aid as defined in Sec. 170.3(o)(14) of this chapter; sequestrant as defined in Sec. 170.3(o)(26) of this chapter; stabilizer or thickener as defined in Sec. 170.3(o)(28) of this chapter; and texturizer as defined in Sec. 170.3(o)(32) of this chapter. (d) The ingredient is used in foods at levels not to exceed current good manufacturing practices in accordance with Sec. 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 1.75 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.4 percent for dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; 4.5 percent for gelatins and puddings as defined in Sec. 170.3(n)(22) of this chapter; and 0.01 percent for sugar substitutes as defined in Sec. 170.3(n)(42) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 27808, June 25, 1982]

§ 184.1201 Calcium glycerophosphate. (a) Calcium glycerophosphate (C3H7CaO6P, CAS Reg. No. 27214-00-2) is a fine, white, odorless, almost tasteless, slightly hygroscopic powder. It is prepared by neutralizing glycerophosphoric acid with calcium hydroxide or calcium carbonate. The commercial product is a mixture of calcium fl-, and D-, and L-a-glycerophosphate. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 51-52, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter. 1109

§ 184.1205

(d) Prior sanctions for this ingredient different from the uses established in this section or different from that as set forth in part 181 of this chapter, do not exist or have been waived. [57 FR 10813, Mar. 31, 1992]

§ 184.1205 Calcium hydroxide. (a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305-62-0) is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 52, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 26714, June 29, 1984]

§ 184.1206 Calcium iodate. (a) Calcium iodate [Ca(IO3)2 ⋅ H2O, CAS Reg. No. 7789-80-2], also referred to as lautarite, does not occur naturally but can be prepared by passing chlorine into a hot solution of lime (CaCO3) in which iodine has been dissolved. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 53, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter. (d) The ingredient is used in the manufacture of bread in accordance with Sec. 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 percent based on the weight of the flour. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1207 Calcium lactate. (a) Calcium lactate (C6H10CaO6 xH2O, where x is any integer up to 5, CAS Reg. No. 814-80-2) is prepared commercially by the neutralization of lactic acid with calcium carbonate or calcium hydroxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 53, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a firming agent as defined in Sec. 170.3(o)(10) of this chapter; a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; and a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter. (2) The ingredient is used in food, except in infant foods and infant formulas, at levels not to exceed current good manufacturing practice. 1110

§ 184.1221

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 35367, Sept. 7, 1984]

§ 184.1210 Calcium oxide. (a) Calcium oxide (CaO, CAS Reg. No. 1305-78-8) is also known as lime, quick lime, burnt lime, or calx. It is produced from calcium carbonate, limestone, or oyster shells by calcination at temperatures of 1,700-2,450 °F. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 55, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 26714, June 29, 1984]

§ 184.1212 Calcium pantothenate. (a) Calcium pantothenate ((C9H16NO5)2Ca, CAS Reg. No. of the D-isomer, 137-08-6) is a salt of pantothenic acid, one of the vitamins of the B complex. Only the D-isomer of pantothenic acid has vitamin activity, although both the D-isomer and the DL-racemic mixture of calcium pantothenate are used in food. Commercial calcium pantothenate is prepared synthetically from isobutyraldehyde and formaldehyde via 1,1-dimethyl-2-hydroxy-propionaldehyde and pantolactone. (b) Calcium pantothenate meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 56, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. Calcium pantothenate may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51908, Nov. 15, 1983]

§ 184.1221 Calcium propionate. (a) Calcium propionate (C6H10CaO4, CAS Reg. No. 4075-81-4) is the calcium salt of propionic acid. It occurs as white crystals or a crystalline solid, possessing not more than a faint odor of propionic acid. It is prepared by neutralizing propionic acid with calcium hydroxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 60, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

1111

§ 184.1229

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; cheeses as defined in Sec. 170.3(n)(5) of this chapter; confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; and jams and jellies as defined in Sec. 170.3(n)(28) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 13141, Apr. 3, 1984]

§ 184.1229 Calcium stearate. (a) Calcium stearate (Ca(C17H35COO)2, CAS Reg. No. 1529-23-0) is the calcium salt of stearic acid derived from edible sources. It is prepared as a white precipitate by mixing calcium chloride and sodium stearate in aqueous solution. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 64, which is incorporated by reference, and the requirements of Sec. 172.860(b)(2) of this chapter. Copies of the Food Chemicals Codex are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter; and a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52445, Nov. 18, 1983]

§ 184.1230 Calcium sulfate. (a) Calcium sulfate (CaSO4, CAS Reg. No. 7778-18-9 or CaSO4 × 2H2O, CAS Reg. No. 10101-41-4), also known as plaster of Paris, anhydrite, and gypsum, occurs naturally and exists as a fine, white to slightly yellow-white odorless powder. The anhydrous form is prepared by complete dehydration of gypsum, below 300 °C, in an electric oven. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 66, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an anticaking agent as defined in Sec. 170.3(o)(1) of this chapter, color and coloring adjunct as defined in Sec. 170.3(o)(4) of this chapter, dough strengthener as defined in Sec. 170.3(o)(6) of this chapter, drying agent as defined in Sec. 170.3(o)(7) of this chapter, firming agent as defined in Sec. 170.3(o)(10) of this chapter, flour treating agent as defined in Sec. 170.3(o)(13) of this chapter, formulation aid as defined in Sec. 170.3(o)(14) of this chapter, leavening agent as defined in Sec. 170.3(o)(17) of this chapter, nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, pH control agent as defined in Sec. 170.3(o)(23) of this chapter, processing aid as defined in Sec. 170.3(o)(24) of this chapter, stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter, synergist as defined in Sec. 170.3(o)(31) of this chapter, and texturizer as defined in Sec. 170.3(o)(32) of this chapter. 1112

§ 184.1245

(d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 1.3 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter, 3.0 percent for confections and frostings as defined in Sec. 170.3(n)(9) of this chapter, 0.5 percent for frozen dairy desserts and mixes as defined in Sec. 170.3(n)(20) of this chapter, 0.4 percent for gelatins and puddings as defined in Sec. 170.3(n)(22) of this chapter, 0.5 percent for grain products and pastas as defined in Sec. 170.3(n)(23) of this chapter, 0.35 percent for processed vegetables as defined in Sec. 170.3(n)(36) of this chapter, and 0.07 percent or less for all other food categories. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, 1980, as amended at 49 FR 5611, Feb. 14, 1984]

§ 184.1240 Carbon dioxide. (a) Carbon dioxide (empirical formula CO2, CAS Reg. No. 124-38-9) occurs as a colorless, odorless, noncombustible gas at normal temperatures and pressures. The solid form, dry ice, sublimes under atmospheric pressure at a temperature of -78.5 °C. Carbon dioxide is prepared as a byproduct of the manufacture of lime during the ``burning’’ of limestone, from the combustion of carbonaceous material, from fermentation processes, and from gases found in certain natural springs and wells. (b) The Food and Drug Administration is developing food-grade specifications for carbon dioxide in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a leavening agent as defined in Sec. 170.3(o)(17) of this chapter; a processing aid as defined in Sec. 170.3(o)(24) of this chapter; and a propellant, aerating agent, and gas as defined in Sec. 170.3(o)(25) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 57270, Dec. 29, 1983]

§ 184.1245 Beta-carotene. (a) Beta-carotene (CAS Reg. No. 7235-40-7) has the molecular formula C40H56. It is synthesized by saponification of vitamin A acetate. The resulting alcohol is either reacted to form vitamin A Wittig reagent or oxidized to vitamin A aldehyde. Vitamin A Wittig reagent and vitamin A aldehyde are reacted together to form beta-carotene. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washingtion, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; fats and oils as defined in Sec. 170.3(n)(12) of this chapter; and processed fruits and fruit juices as defined in Sec. 170.3(n)(35) of this chapter. Beta-carotene may be used in infant formula as a source of vitamin A in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act or with regulations promulgated under section 412(g) of the act.

1113

§ 184.1250

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [52 FR 25211, July 6, 1987]

§ 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachiatum. (a) Cellulase enzyme preparation is derived from a nonpathogenic, nontoxicogenic strain of Trichoderma longibrachiatum (formerly T. reesei). The enzyme, cellulase, catalyzes the endohydrolysis of 1,4-beta-glycosidic linkages in cellulose. It is obtained from the culture filtrate resulting from a pure culture fermentation process. (b) The ingredient meets the general and additional requirements for enzyme preparations in the monograph specifications on enzyme preparations in the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 129 to 134, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Box 285, Washington, DC 20055 (Internet ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an enzyme as defined in Sec. 170.3(o)(9) of this chapter for the breakdown of cellulose. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [64 FR 28361, May 26, 1999]

§ 184.1257 Clove and its derivatives. (a) Cloves are the dried unopened flower buds and calyx tubes, harvested before the flowers have opened, of the clove tree Eugenia caryophyllata Thunberg, native to tropical Asia. Their derivatives include essential oils (cloves, CAS Reg. No. 8000-34-8; buds; leaves, CAS Reg. No. 8015-97-2; stems, CAS Reg. No. 8015-98-3; and eugenol, CAS Reg. No. 97-53-0), oleoresins, and natural extractives obtained from clove buds, leaves, and stems. (b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet the specifications of the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 104-105, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. As determined by analytical methods in the ``Food Chemicals Codex,’’ clove oleoresin or other natural extractives (other than clove oils) meet the ``Food Chemicals Codex’’ specifications for clove (clove bud) oil and the following modifications: (1) The assay for phenols, as eugenol, by the ``Food Chemicals Codex’’ test, 4th ed. (pp. 104-105), or the volatile oils content by the ``Food Chemicals Codex’’ test, 4th ed. (pp. 104-105) should conform to the representation of the vendor; (2) Optical rotation of the volatile oil between –2 ° and 0 °; (3) Refractive index of the volatile oil between 1.527 and 1.538 at 20 °C; (4) Specific gravity of the volatile oil between 1.036 and 1.060; and (5) Residual solvent free, except those solvents that are GRAS or within tolerance levels as specified in part 173, subpart C, of this chapter. (c) Clove and its derivatives are used as flavoring agents and adjuvants as defined in Sec. 170.3(0)(12) of this chapter. (d) The ingredients are used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1).

1114

§ 184.1259

(e) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [44 FR 3964, Jan 19, 1979, as amended at 47 FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; 64 FR 1759, Jan. 12, 1999]

§ 184.1259 Cocoa butter substitute. (a) The common or usual name for the triglyceride 1-palmitoyl-2-oleoyl-3-stearin is ``cocoa butter substitute primarily from palm oil.’’ The common or usual name for the triglyceride 1-3-distearoyl-2-olein is ``cocoa butter substitute primarily from high-oleic safflower or sunflower oil.’’ (1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured by: (i) Directed esterification of fully saturated 1,3-diglycerides (derived from palm oil) with the anhydride of foodgrade oleic acid in the presence of the catalyst trifluoromethane sulfonic acid (Sec. 173.395 of this chapter), or (ii) By interesterification of partially saturated 1,2,3-triglycerides (derived from palm oil) with ethyl stearate in the presence of a suitable lipase enzyme preparation that is either generally recognized as safe (GRAS) or has food additive approval for such use. (2) The ingredient 1-3-distearoyl-2-olein is manufactured by interesterification of partially unsaturated 1,2,3triglycerides (derived from high-oleic safflower or sunflower oil) with ethyl stearate or stearic acid in the presence of a suitable lipase enzyme preparation that is either GRAS or has food additive approval for such use. (b) The ingredient meets the following specifications: (1) Over 90 percent triglycerides, not more than 7 percent diglycerides, not more than 1 percent monoglycerides, and not more than 1 percent free fatty acids. (2) Total glycerides—98 percent minimum. (3) Heavy metals (as lead), not more than 10 milligrams per kilogram, as determined by the Heavy Metals Test of the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 760-761, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (4) Color—clear, bright, and free from suspended matter. (5) Odor and taste—free from foreign and rancid odor and taste. (6) Residual catalyst (``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections 25.049-25.055, which is incorporated by reference), residual fluorine; limit of detection 0.2 part per million F; multiply fluoride result by 2.63 to convert to residual catalyst. Copies of the material incorporated by reference may be obtained from the Association of Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, Washington, DC 20044, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. The ingredient shall be washed three times in batches with 0.5 percent sodium bicarbonate to remove catalyst residuals in accordance with good manufacturing practice. (7) Residual methanol—5 parts per million maximum. (8) Residual fatty acid ethyl esters—not more than 20 parts per million as determined by a ``Modification of Japan Institute of Oils and Fats: Analysis Method of Residual Ethyl Esters of Fatty Acids’’ issued by the Fuji Oil Co., which is incorporated by reference. Copies are available from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (9) Hexane—not more than 5 parts per million as determined by the method of Dupuy et al., ``Rapid Quantitative Determination of Residual Hexane in Oils by Direct Gas Chromatography,’’ published in the ``Journal of the American Oil Chemists’ Society,’’ Vol. 52, p. 118-120, 1975, which is incorporated by reference. Copies are available from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in the following food categories at levels not to exceed current good manufacturing practice: Confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; coatings of soft candy as defined in Sec. 170.3(n)(38) of this chapter; and sweet sauces and toppings as defined in 1115

§ 184.1260

Sec. 170.3(n)(43) of this chapter; except that the ingredient may not be used in a standardized food unless permitted by the standard of identity. (d) The ingredient is used in food in accordance with Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice. [43 FR 54239, Nov. 11, 1978, as amended at 47 FR 11852, Mar. 19, 1982; 49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR 36290, July 10, 1996; 64 FR 1760, Jan. 12, 1999]

§ 184.1260 Copper gluconate. (a) Copper gluconate (cupric gluconate (CH2OH(CHOH)4COO)2Cu, CAS Reg. No. 527-09-3) is a substance that occurs as light blue to bluish-green, odorless crystals, or as a fine, light blue powder. It is prepared by the reaction of gluconic acid solutions with cupric oxide or basic cupric carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 90, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC. 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter and as a synergist as defined in Sec. 170.3(o)(31) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Copper gluconate may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 24119, June 12, 1984]

§ 184.1261 Copper sulfate. (a) Copper sulfate (cupric sulfate, CuSO4 ⋅ 5H2O, CAS Reg. No. 7758-98-7) usually is used in the pentahydrate form. This form occurs as large, deep blue or ultramarine, triclinic crystals; as blue granules, or as a light blue powder. The ingredient is prepared by the reaction of sulfuric acid with cupric oxide or with copper metal. (b) FDA is developing food-grade specifications for copper sulfate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter and as a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Copper sulfate may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 24119, June 12, 1984]

1116

§ 184.1271

§ 184.1262 Corn silk and corn silk extract. (a) Corn silk is the fresh styles and stigmas of Zea mays L. collected when the corn is in milk. The filaments are extracted with dilute ethanol to produce corn silk extract. The extract may be concentrated at a temperature not exceeding 60 °C. (b) The Food and Drug Administration, in cooperation with the National Academy of Sciences, is developing foodgrade specifications for corn silk and corn silk extract. In the interim, this ingredient must be of a suitable purity for its intended use. (c) In accordance with Sec. 184.1(b)(2), the ingredients are used in food only within the following specific limitations: ————————————————————————————————————————— Maximum level of use in food (as Category of food served) (percent) Functional use ————————————————————————————————————————— Baked goods and baking mixes, Sec. 30 Flavoring agent, Sec. 170.3(n)(1) of this chapter. 170.3(o)(12) of this chapter. Nonalcoholic beverages, Sec. 20 Do. 170.3(n)(3) of this chapter. Frozen dairy desserts, Sec. 10 Do. 170.3(n)(20) of this chapter. Soft candy, Sec. 170.3(n)(38) of 20 Do. this chapter. All other food categories........... 4 Do. ————————————————————————————————————————— 1Parts per million.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 29953, July 9, 1982]

§ 184.1265 Cuprous iodide. (a) Cuprous iodide (copper (I) iodide, CuI, CAS Reg. No. 7681-65-4) is a pure white crystalline powder. It is prepared by the reaction of copper sulfate with potassium iodide under slightly acidic conditions. (b) FDA is developing food-grade specifications for cuprous iodide in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ————————————————————————————————————————— Maximum treatment Category of food level in food Functional use ————————————————————————————————————————— Table salt...................... 0.01 percent...... Source of dietary iodine. —————————————————————————————————————————

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 24119, June 12, 1984]

§ 184.1271 L-Cysteine. (a) L-Cysteine is the chemical L-2-amino-3-mercaptopropanoic acid (C3H7O2NS). (b) The ingredient meets the appropriate part of the specification set forth in the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 92-93, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used to supply up to 0.009 part of total L-cysteine per 100 parts of flour in dough as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter in yeast-leavened baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter. 1117

§ 184.1272

(d) This regulation is issued prior to a general evaluation of use of this ingredient in order to affirm as GRAS the specific use named. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]

§ 184.1272 L-Cysteine monohydrochloride. (a) L-Cysteine monohydrochloride is the chemical L-2-amino-3-mercaptopropanoic acid monohydrochloride monohydrate (C3H7O2NS HCl H2O). (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 92-93, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used to supply up to 0.009 part of total L-cysteine per 100 parts of flour in dough as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter in yeast-leavened baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter. (d) This regulation is issued prior to a general evaluation of use of this ingredient in order to affirm as GRAS the specific use named. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]

§ 184.1277 Dextrin. (a) Dextrin ((C6H10O5)n ⋅ H2O, CAS Reg. No. 9004-53-9) is an incompletely hydrolyzed starch. It is prepared by dry heating corn, waxy maize, waxy milo, potato, arrowroot, wheat, rice, tapioca, or sago starches, or by dry heating the starches after: (1) Treatment with safe and suitable alkalis, acids, or pH control agents and (2) drying the acid or alkali treated starch. (b) The ingredient meets the specification of the Food Chemicals Codex, 3d Ed. (1981), p. 96, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; as a processing aid as defined in Sec. 170.3(o)(24) of this chapter; as a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; and as a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51909, Nov. 15, 1983]

§ 184.1278 Diacetyl. (a) Diacetyl (C4H6O2, CAS Reg. No. 431-03-8) is a clear yellow to yellowish green liquid with a strong pungent odor. It is also known as 2,3-butanedione and is chemically synthesized from methyl ethyl ketone. It is miscible in water, glycerin, alcohol, and ether, and in very dilute water solution, it has a typical buttery odor and flavor. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 368, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

1118

§ 184.1287

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51907, Nov. 15, 1983]

§ 184.1282 Dill and its derivatives. (a) Dill (American or European) is the herb and seeds from Anethum graveolens L., and dill (Indian) is the herb and seeds from Anethum sowa, D.C. Its derivatives include essential oils, oleoresins, and natural extractives obtained from these sources of dill. (b) Dill oils meet the description and specifications of the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 122-123, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) Dill and its derivatives are used as flavoring agents and adjuvants as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredients are used in food at levels not to exceed good manufacturing practice. (e) [Reserved] (f) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, 1999]

§ 184.1287 Enzyme-modified fats. (a) Enzyme-modified refined beef fat, enzyme-modified butterfat, and enzyme-modified steam-rendered chicken fat are prepared from refined beef fat; butterfat or milkfat; and steam-rendered chicken fat, respectively, with enzymes that are generally recognized as safe (GRAS). Enzyme-modified milk powder may be prepared with GRAS enzymes from reconstituted milk powder, whole milk, condensed or concentrated whole milk, evaporated milk, or milk powder. The lipolysis is maintained at a temperature that is optimal for the action of the enzyme until appropriate acid development is attained. The enzymes are then inactivated. The resulting product is concentrated or dried. (b) FDA is developing food-grade specifications for these enzyme-modified ingredients in cooperation with the National Academy of Sciences. In the interim, the ingredients must be of purity suitable for their intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as generally recognized as safe (GRAS) as direct human food ingredients is based upon the following current good manufacturing practice conditions of use: (1) The ingredients are used as flavoring agents and adjuvants as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredients are used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [52 FR 25976, July 10, 1987]

1119

§ 184.1293

§ 184.1293 Ethyl alcohol. (a) Ethyl alcohol (ethanol) is the chemical C2H5OH. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 4th ed. (1996), p. 136, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter on pizza crusts prior to final baking at levels not to exceed 2.0 percent by product weight. (d) This regulation is issued prior to general evaluation of use of this ingredient in order to affirm as GRAS the specific use named. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984; 64 FR 1760, Jan. 12, 1999]

§ 184.1295 Ethyl formate. (a) Ethyl formate (C3H6O2, CAS Reg. No. 109-94-4) is also referred to as ethyl methanoate. It is an ester of formic acid and is prepared by esterification of formic acid with ethyl alcohol or by distillation of ethyl acetate and formic acid in the presence of concentrated sulfuric acid. Ethyl formate occurs naturally in some plant oils, fruits, and juices but does not occur naturally in the animal kingdom. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 376, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.05 percent in baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.04 percent in chewing gum as defined in Sec. 170.3(n)(6), hard candy as defined in Sec. 170.3(n)(25), and soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.02 percent in frozen dairy desserts as defined in Sec. 170.3(n)(20) of this chapter; 0.03 percent in gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; and 0.01 percent in all other food categories. (e) Prior sanctions for ethyl formate different from the uses established in this section do not exist or have been waived. [45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 1984]

§ 184.1296 Ferric ammonium citrate. (a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared by the reaction of ferric hydroxide with citric acid, followed by treatment with ammonium hydroxide, evaporating, and drying. The resulting product occurs in two forms depending on the stoichiometry of the initial reactants. (1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. No. 1332-98-5) is a complex salt of undetermined structure composed of 16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65 percent citric acid and occurs as reddish brown or garnet red scales or granules or as a brownish-yellowish powder. (2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. No. 1333-00-2) is a complex salt of undetermined structure composed of 14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75 percent citric acid and occurs as thin transparent green scales, as granules, as a powder, or as transparent green crystals. (b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 116-117 (Ferric ammonium citrate, brown) and p. 117 (Ferric ammonium citrate, green), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1120

§ 184.1301

(c) In accordance with Sec. 184.1(b)(1), the ingredients are used in food as nutrient supplements as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredients may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [53 FR 16864, May 12, 1988]

§ 184.1297 Ferric chloride. (a) Ferric chloride (iron (III) chloride, FeC13, CAS Reg. No. 7705-08-0) may be prepared from iron and chlorine or from ferric oxide and hydrogen chloride. The pure material occurs as hydroscopic, hexagonal, dark crystals. Ferric chloride hexahydrate (iron (III) chloride hexahydrate, FeC13.6H20, CAS Reg. No. 10025-77-1) is readily formed when ferric chloride is exposed to moisture. (b) The Food and Drug Administration is developing food-grade specifications for ferric chloride in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1) the ingredient is used in food as a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter, with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16864, May 12, 1988]

§ 184.1298 Ferric citrate. (a) Ferric citrate (iron (III) citrate, C6H5FeO7, CAS Reg. No. 2338-05-8) is prepared from reaction of citric acid with ferric hydroxide. It is a compound of indefinite ratio of citric acid and iron. (b) The Food and Drug Administration is developing food-grade specifications for ferric citrate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988]

§ 184.1301 Ferric phosphate. (a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate, FePO4 ⋅ xH2O, CAS Reg. No. 10045-86-0) is an odorless, yellowish-white to buff-colored powder and contains from one to four molecules of water of hydration. It is prepared by reaction of sodium phosphate with ferric chloride or ferric citrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 118-120, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). 1121

§ 184.1304

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988]

§ 184.1304 Ferric pyrophosphate. (a) Ferric pyrophosphate (iron (III) pyrophosphate, Fe4(P207)3 ⋅ xH2O, CAS Reg. No. 10058-44-3) is a tan or yellowish white colorless powder. It is prepared by reacting sodium pyrophosphate with ferric citrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 120, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988]

§ 184.1307 Ferric sulfate. (a) Ferric sulfate (iron (III) sulfate, Fe2(SO4)3, CAS Reg. No. 10028-22-5) is a yellow substance that may be prepared by oxidizing iron (II) sulfate or by treating ferric oxide or ferric hydroxide with sulfuric acid. (b) The Food and Drug Administration is developing food-grade specifications for ferric sulfate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter, with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988]

§ 184.1307a Ferrous ascorbate. (a) Ferrous ascorbate (CAS Reg. No. 14536-17-5) is a reaction product of ferrous hydroxide and ascorbic acid. It is a blue-violet product containing 16 percent iron. (b) The Food and Drug Administration is developing food-grade specifications for ferrous ascorbate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988]

1122

§ 184.1307d

§ 184.1307b Ferrous carbonate. (a) Ferrous carbonate (iron (II) carbonate, FeCO3, CAS Reg. No. 563-71-3) is an odorless, white solid prepared by treating solutions of iron (II) salts with alkali carbonate salts. (b) The Food and Drug Administration is developing food-grade specifications for ferrous carbonate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Foods, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988]

§ 184.1307c Ferrous citrate. (a) Ferrous citrate (iron (II) citrate, (C6H6FeO7), CAS Reg. No. 23383-11-1) is a slightly colored powder or white crystals. It is prepared from the reaction of sodium citrate with ferrous sulfate or by direct action of citric acid on iron filings. (b) The Food and Drug Administration is developing food-grade specifications for ferrous citrate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1) the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16866, May 12, 1988]

§ 184.1307d Ferrous fumarate. (a) Ferrous fumarate (iron (II) fumarate, (C4H2FeO4), CAS Reg. No. 141-01-5) is an odorless, reddish-orange to reddish-brown powder. It may contain soft lumps that produce a yellow streak when crushed. It is prepared by admixing hot solutions of ferrous sulfate and sodium fumarate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 120-122, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1) the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)), or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16866, May 12, 1988]

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§ 184.1308

§ 184.1308 Ferrous gluconate. (a) Ferrous gluconate (iron (II) gluconate dihydrate, C12H22FeO14 ⋅ 2H2O, CAS Reg. No. 6047-12-7) is a fine yellowish-gray or pale greenish-yellow powder or granules. It is prepared by reacting hot solutions of barium or calcium gluconate with ferrous sulfate or by heating freshly prepared ferrous carbonate with gluconic acid in aqueous solution. (b) The ingredient meets the specifications of the Food Chemcials Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16866, May 12, 1988; 53 FR 20939, June 7, 1988]

§ 184.1311 Ferrous lactate. (a) Ferrous lactate (iron (II) lactate, C6H10FeO6, CAS Reg. No. 5905-52-2) in the trihydrate form is a greenishwhite powder or crystalline mass. It is prepared by reacting calcium lactate or sodium lactate with ferrous sulfate, direct reaction of lactic acid with iron filings, reaction of ferrous chloride with sodium lactate, or reaction of ferrous sulfate with ammonium lactate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter and as a color fixative for ripe olives, with no other limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16866, May 12, 1988, as amended at 61 FR 40319, Aug. 2, 1996]

§ 184.1315 Ferrous sulfate. (a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate, FeSO4 ⋅ 7H2O, CAS Reg. No. 7782-63-0) is prepared by the action of sulfuric acid on iron. It occurs as pale, bluish-green crystals or granules. Progressive heating of ferrous sulfate heptahydrate produces ferrous sulfate (dried). Ferrous sulfate (dried) consists primarily of ferrous sulfate monohydrate (CAS Reg. No. 17375-41-6) with varying amounts of ferrous sulfate tetrahydrate (CAS Reg. No. 20908-72-9) and occurs as a grayish-white to buff-colored powder. (b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p. 124 (ferrous sulfate, dried), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or available for inspection at the Office of Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in food as nutrient supplements as defined in Sec. 170.3(o)(20) of this chapter and as a processing aid as defined in Sec. 170.3(o)(24) of this chapter, with no limitation other than current good manufacturing practice. The ingredients may also be used in infant formula in accordance 1124

§ 184.1318

with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)). (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [53 FR 16866, May 12, 1988]

§ 184.1316 Ficin. (a) Ficin (CAS Reg. No. 9001-33-6) is an enzyme preparation obtained from the latex of species of the genus Ficus, which include a variety of tropical fig trees. It is a white to off-white powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.3). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St., SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32910, June 26, 1995]

§ 184.1317 Garlic and its derivatives. (a) Garlic is the fresh or dehydrated bulb or cloves obtained from Allium sativum, a genus of the lily family. Its derivatives include essential oils, oleo-resins, and natural extractives obtained from garlic. (b) Garlic oil meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 132, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) Garlic and its derivatives are used as flavoring agents and adjuvants as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredients are used in food at levels not to exceed good manufacturing practice. (e) [Reserved] (f) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984]

§ 184.1318 Glucono delta-lactone. (a) Glucono delta-lactone (C6H10O6, CAS Reg. No. 90-80-2), also called D-gluconic acid delta-lactone or Dglucono-1,5-lactone, is the cyclic 1,5-intramolecular ester of D-gluconic acid. It is prepared by direct crystallization from the aqueous solution of gluconic acid. Gluconic acid may be produced by the oxidation of D-glucose with bromine water, by the oxidation of D-glucose by microorganisms that are nonpathogenic and nontoxicogenic to man or other animals, or by the oxidation of D-glucose with enzymes derived from these microorganisms. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 134, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW.,

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§ 184.1321

Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a curing and pickling agent as defined in Sec. 170.3(o)(5) of this chapter, leavening agent as defined in Sec. 170.3(o)(17) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and sequestrant as defined in Sec. 170.3(o)(26) of this chapter. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 33896, Sept. 24, 1986]

§ 184.1321 Corn gluten. (a) Corn gluten (CAS Reg. No. 66071-96-3), also known as corn gluten meal, is the principal protein component of corn endosperm. It consists mainly of zein and glutelin. Corn gluten is a byproduct of the wet milling of corn for starch. The gluten fraction is washed to remove residual water soluble proteins. Corn gluten is also produced as a byproduct during the conversion of the starch in whole or various fractions of dry milled corn to corn syrups. (b) FDA is developing food-grade specifications for corn gluten in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter and a texturizer as defined in Sec. 170.3(o)(32) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 8998, Mar. 6, 1985]

§ 184.1322 Wheat gluten. (a) Wheat gluten (CAS Reg. No. 8002-80-0) is the principal protein component of wheat and consists mainly of gliadin and glutenin. Wheat gluten is obtained by hydrating wheat flour and mechanically working the sticky mass to separate the wheat gluten from the starch and other flour components. Vital gluten is dried gluten that has retained its elastic properties. (b) FDA is developing food-grade specifications for wheat gluten in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter; a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; a processing aid as defined in Sec. 170.3(o)(24) of this chapter; a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter; and a texturizing agent as defined in Sec. 170.3(o)(32) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 8998, Mar. 6, 1985]

1126

§ 184.1328

§ 184.1323 Glyceryl monooleate. (a) Glyceryl monooleate is prepared by esterification of commerical oleic acid that is derived either from edible sources or from tall oil fatty acids meeting the requirements of Sec. 172.862 of this chapter. It contains glyceryl monooleate (C21H40O4, CAS Reg. No. 25496-72-4) and glyceryl esters of fatty acids present in commercial oleic acid. (b) FDA is developing food-grade specifications for glyceryl monooleate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter and as a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage bases as defined in Sec. 170.3(n)(3) of this chapter; chewing gum as defined in Sec. 170.3(n)(6) of this chapter; and meat products as defined in Sec. 170.3(n)(29) of this chapter. (d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [54 FR 7403 Feb. 21, 1989]

§ 184.1324 Glyceryl monostearate. (a) Glyceryl monostearate, also known as monostearin, is a mixture of variable proportions of glyceryl monostearate (C21H42O4, CAS Reg. No. 31566-31-1), glyceryl monopalmitate (C19H38O4, CAS Reg. No. 26657-965) and glyceryl esters of fatty acids present in commercial stearic acid. Glyceryl monostearate is prepared by glycerolysis of certain fats or oils that are derived from edible sources or by esterification, with glycerin, of stearic acid that is derived from edible sources. (b) FDA is developing food-grade specifications for glyceryl monostearate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not not exist or have been waived. [54 FR 7403 Feb. 21, 1989]

§ 184.1328 Glyceryl behenate. (a) Glyceryl behenate is a mixture of glyceryl esters of behenic acid made from glycerin and behenic acid (a saturated C22 fatty acid). The mixture contains predominately glyceryl dibehenate. (b) The ingredient meets the following specifications: (1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26 to 38 percent triglyceride, and not more than 2.5 percent free fatty acids. (2) Behenic acid. Between 80 and 90 percent of the total fatty acid content. (3) Acid value. Not more than 4. (4) Saponification value. Between 145 and 165. (5) Iodine number. Not more than 3. (6) Heavy metals (as Pb). Not more than 10 parts per million. (c) In accordance with Sec. 184.1(b)(1) of this chapter, the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient is generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: 1127

§ 184.1329

(1) The ingredient is used as a formulation aid, as defined in Sec. 170.3(o)(14) of this chapter. (2) The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice. [52 FR 42430, Nov. 5, 1987]

§ 184.1329 Glyceryl palmitostearate. (a) Glyceryl palmitostearate is a mixture of mono-, di-, and triglyceryl esters of palmitic and stearic acids made from glycerin, palmitic acid, and stearic acid. (b) The ingredient meets the following specifications: (1) The substance is a mixture of mono-, di-, and triglycerides of palmitic acid and stearic acid. (2) Heavy metals (as lead): Not more than 10 parts per million. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a formulation aid, as defined in Sec. 170.3(o)(14) of this chapter. (2) The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice. [60 FR 63621, Dec. 12, 1995]

§ 184.1330 Acacia (gum arabic). (a) Acacia (gum arabic) is the dried gummy exudate from stems and branches of trees of various species of the genus Acacia, family Leguminosae. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 7, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used in food under the following conditions: MAXIMUM USAGE LEVELS PERMITTED —————————————————————————————————————————————— Food (as served) Percent Function —————————————————————————————————————————————— Beverages and beverage bases, 2.0 Emulsifier and emulsifier Sec. 170.3(n)(3) of this salt, Sec. 170.3(o)(8) of chapter. this chapter; flavoring agent and adjuvant, Sec. 170.3(o)(12) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Chewing gum, Sec. 5.6 Flavoring agent and adjuvant, 170.3(n)(6) of this chapter. Sec. 170.3(o)(12) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; humectant, Sec. 170.3(o)(16) of this chapter; surface-finishing agent, Sec. 170.3(o)(30) of this chapter. Confections and frostings, 12.4 Formulation aid, Sec. Sec. 170.3(n)(9) of this 170.3(o)(14) of this chapter. chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter; surface-finishing agent, Sec. 170.3(o)(30) of this chapter.

1128

§ 184.1330

MAXIMUM USAGE LEVELS PERMITTED—CONTINUED —————————————————————————————————————————————— Food (as served) Percent Function —————————————————————————————————————————————— Dairy product analogs, Sec. 1.3 Formulation aid, Sec. 170.3(n)(10) of this chapter. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Fats and oils, Sec. 1.5 Formulation aid, Sec. 170.3(n)(12) of this chapter. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Gelatins, puddings, and 2.5 Emulsifier and emulsifier fillings, Sec. 170.3(n)(22) salt, Sec. 170.3(o)(8) of of this chapter. this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter.; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Hard candy and cough drops, 46.5 Flavoring agent and adjuvant, Sec. 170.3(n)(25) of this Sec. 170.3(o)(12) of this chapter. chapter; formulation aid, Sec. 170.3(o)(14) of this chapter. Nuts and nut products, Sec. 8.3 Formulation aid, Sec. 170.3(n)(32) of this chapter. 170.3(o)(14) of this chapter; surface-finishing agent, Sec. 170.3(o)(30) of this chapter. Quiescently frozen confection 6.0 Formulation aid, Sec. products. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Snack foods, Sec. 4.0 Emulsifier and emulsifier 170.3(n)(37) of this chapter. salt, Sec. 170.3(o)(8) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter. Soft candy, Sec. 85.0 Emulsifier and emulsifier 170.3(n)(38) of this chapter. salt, Sec. 170.3(o)(8) of this chapter; firming agent, Sec. 170.3(o)(10) of this chapter; flavoring agent and adjuvant, Sec. 170.3(o)(12) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter, humectant, Sec. 170.3(o)(16) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter; surface-finishing agent, Sec. 170.3(o)(30) of this chapter. All other food categories.... 1.0 Emulsifier and emulsifier salt, Sec. 170.3(o)(8) of this chapter; flavoring agent and adjuvant, Sec. 170.3(o)(12) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; processing aid, Sec. 170.3(o)(24) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter; surface-finishing agent, Sec. 170.3(o)(30) of this chapter; texturizer, Sec. 170.3(o)(32) of this chapter. ——————————————————————————————————————————————

(d) [Reserved] (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1983; 53 FR 5766, Feb. 26, 1988]

1129

§ 184.1333

§ 184.1333 Gum ghatti. (a) Gum ghatti (Indian gum) is an exudate from wounds in the bark of Anogeissus latifolia, a large tree found in the dry deciduous forests of India and Ceylon. (b) The ingredient complies with the following specifications: (1) Viscosity of a 1-percent solution. Not less than the minimum or within the range claimed by the vendor. (2) Limits of impurities—(i) Arsenic (as AL). Not more than 3 parts per million (0.0003 percent); (ii) Ash (acid-insoluble). Not more than 1.75 percent; (iii) Ash (total). Not more than 6.0 percent; (iv) Heavy metals (as Pb). Not more than 40 parts per million (0.004 percent); and (v) Lead. Not more than 10 parts per million (0.001 percent). (3) Loss on drying. Not more than 14 percent dried at 105 °C for 5 hours. (4) Identification test. Add 0.2 ml of diluted lead acetate as outlined in ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), section 31.178(b), p. 529, under ``Dilute Basic Lead Acetate Standard Solution,’’ which is incorporated by reference (copies are available from the Association of Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, Washington, DC 20044, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), to 5 ml of a cold 1-in-100 aqueous solution of the gum. An immediate, voluminous, opaque precipitate indicates acacia. A small precipitate or clear solution which produces an opaque flocculent precipitate upon the additon of 1 ml of 3 N ammonimum hydroxide indicates gum ghatti. (c) The ingredient is used in food under the following conditions: MAXIMUM USAGE LEVELS PERMITTED ——————————————————————————————————————————— Food (as served) Percent Function ——————————————————————————————————————————— Beverages and beverage bases, 0.2 Emulsifier and emulsifier nonalcoholic, Sec. salt, Sec. 170.3(o)(8) of 170.3(n)(3) of this chapter. this chapter. All other food categories.... .1 Emulsifier and emulsifier salt, Sec. 170.3(o)(8) of this chapter. ———————————————————————————————————————————

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]

§ 184.1339 Guar gum. (a) Guar gum is the natural substance obtained from the maceration of the seed of the guar plant, Cyamopsis tetragonoloba (Linne) Taub., or Cyamopsis psoraloides (Lam.) D.C. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 141, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used in food under the following conditions: MAXIMUM USAGE LEVELS PERMITTED ———————————————————————————————————————————— Food (as served) Percent Function ———————————————————————————————————————————— Baked goods and baking mixes, 0.35 Emulsifier and emulsifier Sec. 170.3(n)(1) of this salts, Sec. 170.3(o)(8) of chapter. this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener; Sec. 170.3(o)(28) of this chapter.

1130

§ 184.1343

MAXIMUM USAGE LEVELS PERMITTED—CONTINUED ———————————————————————————————————————————— Food (as served) Percent Function ———————————————————————————————————————————— Breakfast cereals, Sec. 1.2 Formulation aid, Sec. 170.3(n)(4) of this chapter. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Cheese, Sec. 170.3(n)(5) of .8 Do. this chapter. Dairy products analogs, Sec. 1.0 Firming agent, Sec. 170.3(n)(10) of this chapter. 170.3(o)(10) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Fats and oils, Sec. 2.0 Do. 170.3(n)(12) of this chapter. Gravies and sauces, Sec. 1.2 Formulation aid, Sec. 170.3(n)(24) of this chapter. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Jams and jellies, commercial, 1.0 Do. Sec. 170.3(n)(28) of this chapter. Milk products, Sec. .6 Do. 170.3(n)(31) of this chapter. Processed vegetables and 2.0 Formulation aid, Sec. vegetable juices, Sec. 170.3(o)(14) of this 170.3(n)(36) of this chapter. chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Soups and soup mixes, Sec. .8 Do. 170.3(n)(40) of this chapter. Sweet sauces, toppings and 1.0 Do. syrups, Sec. 170.3(n)(43) of this chapter. All other food categories.... .5 Emulsifier and emulsifier salts, Sec. 170.3(o)(8) of this chapter; firming agent, Sec. 170.3(o)(10) of this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. ————————————————————————————————————————————

(d) [Reserved] (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984]

§ 184.1343 Locust (carob) bean gum. (a) Locust (carob) bean gum is primarily the macerated endosperm of the seed of the locust (carob) bean tree, Ceratonia siliqua (Linne), a leguminous evergreen tree, with lesser quantities of seed coat and germ. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 174-175, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used at levels not to exceed the following maximum levels:

1131

§ 184.1349

MAXIMUM USAGE LEVELS PERMITTED —————————————————————————————————————————— Food (as served) Percent Function —————————————————————————————————————————— Baked goods and baking mixes, 0.15 Stabilizer and thickener, Sec. 170.3(n)(1) of this Sec. 170.3(o)(28) of this chapter. chapter. Beverages and beverage bases, .25 Do. nonalcoholic, Sec. 170.3(n)(3) of this chapter. Cheeses, Sec. 170.3(n)(5) of .8 Do. this chapter. Gelatins, puddings, and .75 Do. fillings, Sec. 170.3(n)(22) of this chapter. Jams and jellies, commercial, .75 Do. Sec. 170.3(n)(28) of this chapter. All other food categories.... .5 Do. ——————————————————————————————————————————

(d) [Reserved] (e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984]

§ 184.1349 Karaya gum (sterculia gum). (a) Karaya gum (sterculia gum) is the dried gummy exudate from the trunk of trees of various species of the genus Sterculia. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 157, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used in food under the following conditions: MAXIMUM USAGE LEVELS PERMITTED ——————————————————————————————————————————— Food (as served) Percent Function ——————————————————————————————————————————— Frozen dairy desserts and 0.3 Formulation aid, Sec. mixes, Sec. 170.3(n)(20) of 170.3(o)(14) of this this chapter. chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Milk products, Sec. .02 Stabilizer and thickener, 170.3(n)(31) of this chapter. Sec. 170.3(o)(28) of this chapter. Soft candy, Sec. .9 Emulsifier and emulsifier 170.3(n)(38) of this chapter. salt, Sec. 170.3(o)(8) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. All other food categories.... .002 Formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. ———————————————————————————————————————————

(d) [Reserved] (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984]

1132

§ 184.1355

§ 184.1351 Gum tragacanth. (a) Gum tragacanth is the exudate from one of several species of Astragalus gummifier Labillardiere, a shrub that grows wild in mountainous regions of the Middle East. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 337, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used in food under the following conditions:

MAXIMUM USAGE LEVELS PERMITTED ——————————————————————————————————————————— Food (as served) Percent Function ——————————————————————————————————————————— Baked goods and baking mixes, 0.2 Emulsifier and emulsifier Sec. 170.3(n)(1) of this salt, Sec. 170.3(o)(8) of chapter. this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Condiments and relishes, Sec. .7 Do. 170.3(n)(8) of this chapter. Fats and oils, Sec. 1.3 Do. 170.3(n)(12) of this chapter. Gravies and sauces, Sec. .8 Do. 170.3(n)(24) of this chapter. Meat products, Sec. .2 Formulation aid, Sec. 170.3(n)(29) of this chapter. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. Processed fruits and fruit .2 Emulsifier and emulsifier juices, Sec. 170.3(n)(35) salt, Sec. 170.3(o)(8) of of this chapter. this chapter; formulation aid, Sec. 170.3(o)(14) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter. All other food categories.... .1 Do. ———————————————————————————————————————————

(d) [Reserved] (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984]

§ 184.1355 Helium. (a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a colorless, odorless, flavorless, nonflammable, inert gas. It is lighter than air and is produced by the liquefaction and purification of natural gas. (b) The Food and Drug Administration is developing food-grade specifications for helium in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 57270, Dec. 29, 1983]

1133

§ 184.1366

§ 184.1366 Hydrogen peroxide. (a) Hydrogen peroxide (H2O2, CAS Reg. No. 7722-84-1) is also referred to as hydrogen dioxide. It is made by the electrolytic oxidation of sulfuric acid or a sulfate to persulfuric acid or a persulfuric acid salt with subsequent hydrolysis and distillation of the hydrogen peroxide formed; by decomposition of barium peroxide with sulfuric or phosphoric acid; by hydrogen reduction of 2-ethylanthraquinone, followed by oxidation with air, to regenerate the quinone and produce hydrogen peroxide; or by electrical discharge through a mixture of hydrogen, oxygen, and water vapor. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 146-147,1 which is incorporated by reference. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to treat food only within the following specific limitations: ——————————————————————————————————————————— Maximum treatment Food level in food Functional use (percent) ——————————————————————————————————————————— Milk, intended for use during 0.05.................. Antimicrobial the cheesemaking process as agent as permitted in the appropriate defined in Sec. standards of identity for 170.3 (o)(2) cheese and related cheese of this chapter products under part 133 of this chapter. Whey, during the preparation 0.04.................. do. of modified whey by electrodialysis methods. Dried eggs, dried egg whites, Amount sufficient for Oxidizing and and dried egg yolks as in the purpose. reducing agent Secs. 160.105, 160.145, and as defined in 160.185 of this chapter. Sec. 170.3 (o)(22) of this chapter Tripe......................... do.................... Bleaching agent. Beef feet..................... Amount sufficient for Bleaching agent. the purpose. (Hydrogen peroxide may be in the form of a compound salt, sodium carbonate peroxide). Herring....................... Amount sufficient for do. the purpose. Wine.......................... do.................... Oxidizing and reducing agent as defined in Sec. 170.3 (o)(22) of this chapter. Starch........................ 0.15.................. Antimicrobial agent as defined in Sec. 170.3 (o)(2) of this chapter, to produce thermophilefree starch; Remove sulfur dioxide from starch slurry following steeping and grinding operations of corn refining. Instant tea................... Amount sufficient for Bleaching agent. the purpose. Corn syrup.................... 0.15.................. Reduce sulfur dioxide levels in the finished corn syrup. Colored (annatto) cheese whey. 0.05.................. Bleaching agent.

1Copies may be obtained from the National Academy of Sciences, 2101 Constitution Ave. NW, Washington, DC 20037, or examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

1134

§ 184.1372

——————————————————————————————————————————— Maximum treatment Food level in food Functional use (percent) ——————————————————————————————————————————— Wine vinegar.................. Amount sufficient for Remove sulfur the purpose. dioxide from wine prior to fermentation to produce vinegar. Emulsifiers containing fatty 1.25.................. Bleaching agent. acid esters. ———————————————————————————————————————————

(d) Residual hydrogen peroxide is removed by appropriate physical and chemical means during the processing of food where it has been used according to paragraph (c) of this section. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [46 FR 44439, Sept. 4, 1981, as amended at 51 FR 27172, July 30, 1986]

§ 184.1370 Inositol. (a) Inositol, or myo-inositol (C6H12O6, CAS Reg. No. 87-89-8), is cis-1,2,3,5-trans-4,6-cyclohexanehexol. It occurs naturally and is prepared from an aqueous (0.2 percent sulfur dioxide) extract of corn kernels by precipitation and hydrolysis of crude phytate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 150, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in special dietary foods as defined in part 105 of this chapter at levels not to exceed current good manufacturing practice. It may also be used in infant formula in accordance with section 412(g) of the Act, or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established by this section do not exist or have been waived. [47 FR 38278, Aug. 31, 1982]

§ 184.1372 Insoluble glucose isomerase enzyme preparations. (a) Insoluble glucose isomerase enzyme preparations are used in the production of high fructose corn syrup described in Sec. 184.1866. They are derived from recognized species of precisely classified nonpathogenic and nontoxicogenic microorganisms, including Streptomyces rubiginosus, Actinoplanes missouriensis, Streptomyces olivaceus, Streptomyces olivochromogenes, and Bacillus coagulans, that have been grown in a pure culture fermentation that produces no antibiotics. They are fixed (rendered insoluble) for batch production with GRAS ingredients or may be fixed for further immobilization with either GRAS ingredients or materials approved under Sec. 173.357 of this chapter. (b) The ingredient meets the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: 1135

§ 184.1375

(1) The ingredient is used as an enzyme, as defined in Sec. 170.3(o)(9) of this chapter, to convert glucose to fructose. (2) The ingredient is used in high fructose corn syrup, at levels not to exceed current good manufacturing practice. [48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 1996]

§ 184.1375 Iron, elemental. (a) Iron, elemental (CAS Reg. No. 7439-89-6) is metallic iron obtained by any of the following processes: reduced iron, electrolytic iron, and carbonyl iron. (1) Reduced iron is prepared by reacting ground ferric oxide with hydrogen or carbon monoxide at an elevated temperature. The process results in a grayish-black powder, all of which should pass through a 100-mesh sieve. It is lusterless or has not more than a slight luster. When viewed under a microscope, it appears as an amorphous powder free from particles having a crystalline structure. It is stable in dry air. (2) Electrolytic iron is prepared by electrodeposition. It is an amorphous, lusterless, grayish-black powder. It is stable in dry air. (3) Carbonyl iron is prepared by the decomposition of iron pentacarbonyl. It occurs as a dark gray powder. When viewed under a microscope, it appears as spheres built up with concentric shells. It is stable in dry air. (b) Iron, elemental (carbonyl, electrolytic, or reduced) meets the specifications of the Food Chemicals Codex, 3d Ed. (1981) (iron, carbonyl, p. 151; iron, electrolytic, pp. 151-152; iron, reduced; pp. 152-153), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(2)). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16867, May 12, 1988]

§ 184.1386 Isopropyl citrate. (a) Isopropyl citrate is a mixture of the mono-, di-, and triisopropyl esters of citric acid. It is prepared by esterifying citric acid with isopropanol. (b) The Food and Drug Administration, in cooperation with the National Academy of Sciences, is developing foodgrade specifications for isopropyl citrate. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an antioxidant as defined in Sec. 170.3(o)(3) of this chapter; a sequestrant as defined in Sec. 170.3(o)(26) of this chapter; and a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter. (2) The ingredient is used in margarine in accordance with Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in Sec. 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. [59 FR 63896, Dec. 12, 1994]

1136

§ 184.1400

§ 184.1387 Lactase enzyme preparation from Candida pseudotropicalis. (a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast C. pseudotropicalis. It contains the enzyme lactase (β-D-galactoside galactohydrolase, EC 3.2.1.23), which converts lactose to glucose and galactose. It is prepared from yeast that has been grown by a pure culture fermentation process. (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), pp. 107-110, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme, as defined in Sec. 170.3(o)(9) of this chapter, to convert lactose to glucose and galactose. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice is limited to use of this ingredient to reduce the lactose content in milk and milk-derived food products where food standards do not preclude such use. [61 FR 7704, Feb. 29, 1996]

§ 184.1388 Lactase enzyme preparation from Kluyveromyces lactis. (a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast Kluyveromyces lactis (previously named Saccharomyces lactis). It contains the enzyme B-galactoside galactohydrase (CAS Reg. No. CBS 683), which converts lactose to glucose and galactose. It is prepared from yeast that has been grown in a pure culture fermentation and by using materials that are generally recognized as safe or are food additives that have been approved for this use by the Food and Drug Administration. (b) The ingredient meets the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107-110, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to convert lactose to glucose and galactose. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice is to use this ingredient in milk to produce lactase-treated milk, which contains less lactose than regular milk, or lactose-reduced milk, which contains at least 70 percent less lactose than regular milk. [49 FR 47387, Dec. 4, 1984]

§ 184.1400 Lecithin. (a) Commercial lecithin is a naturally occurring mixture of the phosphatides of choline, ethanolamine, and inositol, with smaller amounts of othe lipids. It is isolated as a gum following hydration of solvent-extracted soy, safflower, or corn oils. Lecithin is bleached, if desired, by hydrogen peroxide and benzoyl peroxide and dried by heating. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 166-167, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1137

§ 184.1408

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51150, Nov. 7, 1983]

§ 184.1408 Licorice and licorice derivatives. (a)(1) Licorice (glycyrrhiza) root is the dried and ground rhizome and root portions of Glycyrrhiza glabra or other species of Glycyrrhiza. Licorice extract is that portion of the licorice root that is, after maceration, extracted by boiling water. The extract can be further purified by filtration and by treatment with acids and ethyl alcohol. Licorice extract is sold as a liquid, paste (``block’’), or spray-dried powder. (2) Ammoniated glycyrrhizin is prepared from the water extract of licorice root by acid precipitation followed by neutralization with dilute ammonia. Monoammonium glycyrrhizinate (C42H61O16NH45H2O, CAS Reg. No. 140703-0) is prepared from ammoniated glycyrrhizin by solvent extraction and separation techniques. (b) The ingredients shall meet the following specifications when analyzed: (1) Assay. The glycyrrhizin content of each flavoring ingredient shall be determined by the method in the Official Methods of Analysis of the Association of Official Analytical Chemists, 13th Ed., Secs. 19.136-19.140, which is incorporated by reference, or by methods 19.CO1 through 19.CO4 in the Journal of the Association of Official Analytical Chemists, 65:471-472 (1982), which are also incorporated by reference. Copies of all of these methods are available from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (2) Ash. Not more than 9.5 percent for licorice, 2.5 percent for ammoniated glycyrrhizin, and 0.5 percent for monoammonium glycyrrhizinate on an anhydrous basis as determined by the method in the Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (3) Acid unsoluble ash. Not more than 2.5 percent for licorice on an anhydrous basis as determined by the method in the Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by reference. (4) Heavy metals (as Pb). Not more than 40 parts per million as determined by method II in the Food Chemicals Codex, 3d Ed. (1981), p. 512, which is incorporated by reference. (5) Arsenic (As). Not more than 3 parts per million as determined by the method in the Food Chemicals Codex. 3d Ed. (1981), p. 464, which is incorporated by reference. (c) In accordance with Sec. 184.1(b)(2), these ingredients are used in food only within the following specific limitations: ———————————————————————————————————————— Maximum level in food (percent Category of food glycyrrhizin Functional use content of food) (as served) ———————————————————————————————————————— Baked foods, Sec. 170.3(n)(1) 0.05 Flavor enhancer, of this chapter. Sec. 170.3(o)(11) of this chapter; flavoring agent, Sec. 170.3(o)(12) of this chapter. Alcoholic beverages, Sec. 0.1 Flavor enhancer, 170.3(n)(2) of this chapter. Sec. 170.3(o)(11) of this chapter; flavoring agent, Sec. 170.3(o)(12) of this chapter; surface-active agent, Sec. 170.3(o)(29) of this chapter. Nonalcoholic beverages, Sec. 0.15 Do. 170.3(n)(3) of this chapter.

1138

§ 184.1415

———————————————————————————————————————— Maximum level in food (percent Category of food glycyrrhizin Functional use content of food) (as served) ———————————————————————————————————————— Chewing gum, Sec. 170.3(n)(6) 1.1 Flavor enhancer, of this chapter. Sec. 170.3(o)(11) of this chapter; flavoring agent, Sec. 170.3(n)(12) of this chapter. Hard candy, Sec. 170.3(n)(25) 16.0 Do. of this chapter. Herbs and seasonings, Sec. 0.15 Do. 170.3(n)(26) of this chapter. Plant protein products, Sec. 0.15 Do. 170.3(n)(33) of this chapter. Soft candy, Sec. 170.3(n)(38) 3.1 Do. of this chapter. Vitamin or mineral dietary 0.5 Do. supplements. All other foods except sugar 0.1 Do. substitutes, Sec. 170.3(n)(42) of this chapter. The ingredient is not permitted to be used as a nonnutritive sweetener in sugar substitutes. ————————————————————————————————————————

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989]

§ 184.1409 Ground limestone. (a) Ground limestone consists essentially (not less than 94 percent) of calcium carbonate (CaCO3) and is prepared by the crushing, grinding, and classifying of naturally occurring limestone. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 173, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52442, Nov. 18, 1983]

§ 184.1415 Animal lipase. (a) Animal lipase (CAS Reg. No. 9001-62-1) is an enzyme preparation obtained from edible forestomach tissue of calves, kids, or lambs, or from animal pancreatic tissue. The enzyme preparation may be produced as a tissue preparation or as an aqueous extract. Its characterizing enzyme activity is that of a triacylglycerol hydrolase (EC 3.1.1.3). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St., SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: 1139

§ 184.1420

(1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze fatty acid glycerides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32911, June 26, 1995]

§ 184.1420 Lipase enzyme preparation derived from Rhizopus niveus. (a) Lipase enzyme preparation contains lipase enzyme (CAS Reg. No. 9001-62-1), which is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Rhizopus niveus. The enzyme preparation also contains diatomaceous earth as a carrier. The characterizing activity of the enzyme, which catalyzes the interesterification of fats and oils at the 1- and 3-positions of triglycerides, is triacylglycerol lipase (EC 3.1.1.3). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the monograph on Enzyme Preparations in the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 133 and 134, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter for the interesterification of fats and oils. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [63 FR 24419, May 4, 1998]

§ 184.1425 Magnesium carbonate. (a) Magnesium carbonate (molecular formula approximately (MgCO3)4 ⋅ Mg(OH)2 ⋅ 5H2O, CAS Reg. No. 3940982-0) is also known as magnesium carbonate hydroxide. It is a white powder formed either by adding an alkaline carbonate (such as sodium carbonate) to a solution of magnesium sulfate or by carbonation of a slurry of magnesium hydroxide followed by boiling of the resulting magnesium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 177, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an anticaking and free-flow agent as defined in Sec. 170.3(o)(1) of this chapter; a flour treating agent as defined in Sec. 170.3(o)(13) of this chapter; a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; a processing aid as defined in Sec. 170.3(o)(24) of this chapter; and a synergist as defined in Sec. 170.3(o)(31) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985]

1140

§ 184.1431

§ 184.1426 Magnesium chloride. (a) Magnesium chloride (MgC12 ⋅ 6H2O, CAS Reg. No. 7786-30-3) is a colorless, deliquescent, crystalline material that occurs naturally as the mineral bischofite. It is prepared by dissolving magnesium oxide, hydroxide, or carbonate in aqueous hydrochloric acid solution and crystallizing out magnesium chloride hexahydrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 177, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter and a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985]

§ 184.1428 Magnesium hydroxide. (a) Magnesium hydroxide (Mg(OH)2, CAS Reg. No. 1309-42-8) occurs naturally as the colorless, crystalline mineral brucite. It is prepared as a white precipitate by the addition of sodium hydroxide to a water soluble magnesium salt or by hydration of reactive grades of magnesium oxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13559, Apr. 5, 1985, as amended at 64 FR 405, Jan. 5, 1999]

§ 184.1431 Magnesium oxide. (a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally as the colorless, crystalline mineral periclase. It is produced either as a bulky white powder (light) or a relatively dense white powder (heavy) by heating magnesium hydroxide or carbonate. Heating these magnesium salts under moderate conditions (400 ° to 900 °C for a few hours) produces light magnesium oxide. Heating the salts under more rigorous conditions (1200 °C for 12 hours) produces heavy magnesium oxide. Light magnesium oxide is converted to heavy magnesium oxide by sustained heating at high temperatures. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., 1141

§ 184.1434

Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an anticaking and free-flow agent as defined in Sec. 170.3(o)(1) of this chapter; a firming agent as defined in Sec. 170.3(o)(10) of this chapter; a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in foods at levels not be exceed current good manufacturing practice. The ingredient also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13559, Apr. 5, 1985]

§ 184.1434 Magnesium phosphate. (a) Magnesium phosphate includes both magnesium phosphate, dibasic, and magnesium phosphate, tribasic. Magnesium phosphate, dibasic (MgHPO4 ⋅ 3H2O, CAS Reg. No. 7782-0975-094) occurs naturally as the white, crystalline mineral newberyite. It is prepared commercially as a precipitate formed by treating a solution of magnesium sulfate with disodium phosphate under controlled conditions. Magnesium phosphate, tribasic (Mg3(PO4)2 x xH2O, CAS Reg. No. 7727-0987-091) may contain 4, 5, or 8 molecules of water of hydration. It is produced as a precipitate from a solution of magnesite with phosphoric acid. (b) Magnesium phosphate, dibasic, meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 179, which is incorporated by reference. Magnesium phosphate, tribasic, meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 180, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13560, Apr. 5, 1985]

§ 184.1440 Magnesium stearate. (a) Magnesium stearate (Mg(C17H34COO)2, CAS Reg. No. 557-04-0) is the magnesium salt of stearic acid. It is produced as a white precipitate by the addition of an aqueous solution of magnesium chloride to an aqueous solution of sodium stearate derived from stearic acid that is obtained from edible sources and that conforms to the requirements of Sec. 172.860(b)(2) of this chapter. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 182, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1142

§ 184.1443a

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; and a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13560, Apr. 5, 1985]

§ 184.1443 Magnesium sulfate. (a) Magnesium sulfate (MgSO4 ⋅ 7H2O, CAS Reg. No. 10034-99-8) occurs naturally as the mineral epsomite. It is prepared by neutralization of magnesium oxide, hydroxide, or carbonate with sulfuric acid and evaporating the solution to crystallization. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 183, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; and a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 13560, Apr. 5, 1985]

§ 184.1443a Malt. (a) Malt is an enzyme preparation obtained from barley which has been softened by a series of steeping operations and germinated under controlled conditions. It is a brown, sweet, and viscous liquid or a white to tan powder. Its characterizing enzyme activities are α-amylase (EC 3.2.1.1.) and β-amylase (EC 3.2.1.2). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St., SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze starch or starchderived polysaccharides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32911, June 26, 1995]

1143

§ 184.1444

§ 184.1444 Maltodextrin. (a) Maltodextrin ((C6H10O5)n, CAS Reg. No. 9050-36-6) is a nonsweet nutritive saccharide polymer that consists of D-glucose units linked primarily by α-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is prepared as a white powder or concentrated solution by partial hydrolysis of corn starch, potato starch, or rice starch with safe and suitable acids and enzymes. (b)(1) Maltodextrin derived from corn starch must be of a purity suitable for its intended use. (2) Maltodextrin derived from potato starch meets the specifications of the Food Chemicals Codex, 3d ed., 3d supp. (1992), p. 125, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capital St. NW., suite 700, Washington, DC 20408, or at the Division of Petition Control (HFS-217), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (3) Maltodextrin derived from rice starch meets the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 239 and 240, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51911, Nov. 15, 1983; as amended at 60 FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, 1998]

§ 184.1445 Malt syrup (malt extract). (a) Malt is the product of barley (Hordeum vulgare L.) germinated under controlled conditions. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of water extract of germinated barley grain, with or without added safe preservative. Malt syrup is usually a brown, sweet, and viscous liquid containing varying amounts of amylolytic enzymes and plant constituents. Barley is first softened after cleaning by steeping operations and then allowed to germinate under controlled conditions. The germinated grain then undergoes processing, such as drying, grinding, extracting, filtering, and evaporating, to produce malt syrup (malt extract) with 75 to 80 percent solids or dried malt syrup with higher solids content. (b) FDA is developing food-grade specifications for malt syrup (malt extract) in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51613, Nov. 10, 1983]

§ 184.1446 Manganese chloride. (a) Manganese chloride (MnCl2 ⋅ 4H2O, CAS Reg. No. 7773-01-5) is a pink, translucent, crystalline product. It is also known as manganese dichloride. It is prepared by dissolving manganous oxide, pyrolusite ore (MnO2), or reduced manganese ore in hydrochloric acid. The resulting solution is neutralized to precipitate heavy metals, filtered, concentrated, and crystallized. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., 1144

§ 184.1452

Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 19165, May 7, 1985]

§ 184.1449 Manganese citrate. (a) Manganese citrate (Mn3(C6H5O7)2, CAS Reg. No. 1002-46-65) is a pale orange or pinkish white powder. It is obtained by precipitating manganese carbonate from manganese sulfate and sodium carbonate solutions. The filtered and washed precipitate is digested first with sufficient citric acid solution to form manganous citrate and then with sodium citrate to complete the reaction. (b) FDA is developing food-grade specifications for manganese citrate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; fish products as defined in Sec. 170.3(n)(13) of this chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter; milk products as defined in Sec. 170.3(n)(31) of this chapter; and poultry products as defined in Sec. 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 19166, May 7, 1985]

§ 184.1452 Manganese gluconate. (a) Manganese gluconate (C12H22MnO14 ⋅ 2H2O, CAS Reg. No. 648-0953-0998) is a slightly pink colored powder. It is obtained by reacting manganese carbonate with gluconic acid in aqueous medium and then crystallizing the product. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; fish products as defined in Sec. 170.3(n)(13) of this chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter; milk products as defined 1145

§ 184.1461

in Sec. 170.3(n)(31) of this chapter; and poultry products as defined in Sec. 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 19166, May 7, 1985]

§ 184.1461 Manganese sulfate. (a) Manganese sulfate (MnSO4 ⋅ H2O, CAS Reg. No. 7785-0987-097) is a pale pink, granular, odorless powder. It is obtained by reacting manganese compounds with sulfuric acid. It is also obtained as a byproduct in the manufacture of hydroquinone. Other manufacturing processes include the action of sulfur dioxide on a slurry of manganese dioxide in sulfuric acid, and the roasting of pyrolusite (MnO2) ore with solid ferrous sulfate and coal, followed by leaching and crystallization. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 188, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; fish products as defined in Sec. 170.3(n(13) of this chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter; milk products as defined in Sec. 170.3(n)(31) of this chapter; and poultry products as defined in Sec. 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 19166, May 7, 1985]

§ 184.1472 Menhaden oil. (a) Menhaden oil. (1) Menhaden oil is prepared from fish of the genus Brevoortia, commonly known as menhaden, by cooking and pressing. The resulting crude oil is then refined using the following steps: Storage (winterization), degumming (optional), neutralization, bleaching, and deodorization. Winterization may separate the oil and produce a solid fraction. (2) Menhaden oil meets the following specifications: (i) Color and state. Yellow liquid to white solid. (ii) Odor. Odorless to slightly fishy. (iii) Saponification value. Between 180 and 200 as determined by the American Oil Chemists’ Society Official Method Cd 3-25—``Saponification Value’’ (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (iv) Iodine number. Not less than 120 as determined by the American Oil Chemists’ Society Recommended Practice Cd 1d-92—``Iodine Value of Fats and Oils, Cyclohexane—Acetic Acid Method,’’ which is incorporated by reference 1146

§ 184.1472

in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (v) Unsaponifiable matter. Not more than 1.5 percent as determined by the American Oil Chemists’ Society Official Method Ca 6b-53—``Unsaponifiable Matter’’ (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (vi) Free fatty acids. Not more than 0.1 percent as determined by the American Oil Chemists’ Society Official Method Ca 5a-40—``Free Fatty Acids’’ (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (vii) Peroxide value. Not more than 5 milliequivalents per kilogram of oil as determined by the American Oil Chemists’ Society Official Method Cd 8-53—``Peroxide Value, Acetic Acid—Chloroform Method’’ (updated 1992) or Recommended Practice Cd 8b-90—``Peroxide Value, Acetic Acid—Isooctane Method’’ (updated 1992), which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (viii) Lead. Not more than 0.1 part per million as determined by the American Oil Chemists’ Society Official Method Ca 18c-91—``Determination of Lead by Direct Graphite Furnace Atomic Absorption Spectrometry’’ (revised 1992), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (ix) Mercury. Not more than 0.5 part per million as determined by the method entitled ``Biomedical Test Materials Program: Analytical Methods for the Quality Assurance of Fish Oil,’’ published in the ``NOAA Technical Memorandum NMFS-SEFC-211,’’ F. M. Van Dolah and S. B. Galloway, editors, National Marine Fisheries Service, U. S. Department of Commerce, pages 71-88, November, 1988, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (3) In accordance with Sec. 184.1(b)(2), the ingredient may be used in food only within the following specific limitations: —————————————————————————————————————— Maximum level of use in food Category of food (as served) —————————————————————————————————————— Cookies, crackers, Sec. 170.3(n)(1) of 5.0 percent this chapter. Breads, rolls (white & dark), Sec. 1.0 percent 170.3(n)(1) of this chapter. Fruit pies, custard pies, Sec. 7.0 percent 170.3(n)(1) of this chapter. Cakes, Sec. 170.3(n)(1) of this 10.0 percent chapter. Cereals, Sec. 170.3(n)(4) of this 4.0 percent chapter. Fats, oils, Sec. 170.3(n)(12) of this 20.0 percent chapter, but not in infant formula. Yogurt, Sec. 170.3(n)(31) of this 4.0 percent chapter. Cheese products, Sec. 170.3(n)(5) of 5.0 percent this chapter. Frozen dairy products, Sec. 5.0 percent 170.3(n)(20) of this chapter. Meat products, Sec. 170.3(n)(29) of 10.0 percent this chapter. Egg products, Sec. 170.3(n)(11) of 5.0 percent this chapter. Fish products, Sec. 170.3(n)(13) of 20.0 percent this chapter. Condiments, Sec. 170.3(n)(8) of this 5.0 percent chapter. Soup mixes, Sec. 170.3(n)(40) of this 3.0 percent chapter. Snack foods, Sec. 170.3(n)(37) of this 5.0 percent chapter. Nut products, Sec. 170.3(n)(32) of 5.0 percent this chapter. Gravies, sauces, Sec. 170.3(n)(24) of 5.0 percent this chapter. ——————————————————————————————————————

(b) Hydrogenated and partially hydrogenated menhaden oils. (1) Partially hydrogenated and hydrogenated menhaden oils are prepared by feeding hydrogen gas under pressure to a converter containing crude menhaden oil 1147

§ 184.1490

and a nickel catalyst. The reaction is begun at 150 to 160 1/2C and after 1 hour the temperature is raised to 180 1/2C until the desired degree of hydrogenation is reached. Hydrogenated menhaden oil is fully hydrogenated. (2) Partially hydrogenated and hydrogenated menhaden oils meet the following specifications: (i) Color. Opaque white solid. (ii) Odor. Odorless. (iii) Saponification value. Between 180 and 200. (iv) Iodine number. Not more than 119 for partially hydrogenated menhaden oil and not more than 10 for fully hydrogenated menhaden oil. (v) Unsaponifiable matter. Not more than 1.5 percent.(vi) Free fatty acids. Not more than 0.1 percent. (vii) Peroxide value. Not more than 5 milliequivalents per kilogram of oil. (viii) Nickel. Not more than 0.5 part per million. (ix) Mercury. Not more than 0.5 part per million. (x) Arsenic (as As). Not more than 0.1 part per million. (xi) Lead. Not more than 0.1 part per million. (3) Partially hydrogenated and hydrogenated menhaden oils are used as edible fats or oils, as defined in Sec. 170.3(n)(12) of this chapter, in food at levels not to exceed current good manufacturing practice. (4) If the fat or oil is fully hydrogenated, the name to be used on the label of a product containing it shall include the term ``hydrogenated,’’ or if it is partially hydrogenated, the name shall include the term ``partially hydrogenated,’’ in accordance with Sec. 101.4(b)(14) of this chapter. [62 FR 30756, June 5, 1997]

§ 184.1490 Methylparaben. (a) Methylparaben is the chemical methyl p-hydroxybenzoate. It is produced by the methanol esterification of phydroxybenzoic acid in the presence of sulfuric acid, with subsequent distillation. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 199, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food. (e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]

§ 184.1498 Microparticulated protein product. (a) Microparticulated protein product is prepared from egg whites or milk protein or a combination of egg whites and milk protein. These protein sources may be used alone or in combination with other safe and suitable ingredients to form the microparticulated product. The mixture of ingredients is high-shear heat processed to achieve a smooth and creamy texture similar to that of fat. Safe and suitable ingredients used in the preparation of the microparticulated protein product must be used in compliance with the limitations of the appropriate regulations in parts 172, 182, and 184 of this chapter. (b) The ingredient is used in food in accordance with Sec. 184.1(b)(2) at levels not to exceed current good manufacturing practice. The affirmation of the use of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following conditions of use: (1) The ingredient is used in food as a thickener as defined in Sec. 170.3(o)(28) of this chapter or as a texturizer as defined in Sec. 170.3(o)(32) of this chapter. (2) The ingredient is used in frozen dessert-type products except that the ingredient may not be used to replace the milk fat required in standardized frozen desserts. 1148

§ 184.1521

(3) The name of the ingredient used in the ingredient statement on both bulk and packaged food must include the source of the protein (e.g., ``microparticulated egg white protein’’), followed by a parenthetical listing of each of the ingredients in the microparticulated protein product, in descending order of predominance. Microparticulated protein product must be used in accordance with this requirement or its addition to food will be considered by FDA to constitute the use of an unapproved food additive (see Sec. 184.1(b)(2)). [55 FR 6391, Feb. 23, 1990]

§ 184.1505 Mono- and diglycerides. (a) Mono- and diglycerides consist of a mixture of glyceryl mono- and diesters, and minor amounts of triesters, that are prepared from fats or oils or fat-forming acids that are derived from edible sources. The most prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by the reaction of glycerin with fatty acids or the reaction of glycerin with triglycerides in the presence of an alkaline catalyst. The products are further purified to obtain a mixture of glycerides, free fatty acids, and free glycerin that contains at least 90 percent-by-weight glycerides. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 201, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20005. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter; an emulsifier and emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter; a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter; a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter; a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; a surface-active agent as defined in Sec. 170.3(o)(29) of this chapter; a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter; and a texturizer as defined in Sec. 170.3(o)(32) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar.27, 1992]

§ 184.1521 Monosodium phosphate derivatives of mono- and diglycerides. (a) Monosodium phophate derivatives of mono- and diglycerides are composed of glyceride derivatives formed by reacting mono- and diglycerides that are derived from edible sources with phosphorus pentoxide (tetraphosphorus decoxide) followed by neutralization with sodium carbonate. (b) FDA is developing food-grade specifications for monosodium phosphate mono- and diglycerides in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an emulsifier and emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter, a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter, and as a surface-active agent as defined in Sec. 170.3(o)(29) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter and soft candy as defined in Sec. 170.3(n)(38) of this chapter. 1149

§ 184.1530

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [54 FR 7404, Feb. 21, 1989]

§ 184.1530 Niacin. (a) Niacin (C6H5NO2, CAS Reg. No. 59-67-6) is the chemical 3-pyridinecarboxylic acid (nicotinic acid). It is a non-hygroscopic, stable, white, crystalline solid that sublimes without decomposition at about 230 °C. It is soluble in water and alcohol. It is insoluble in ether. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 4th ed. (1996), p. 264, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983, as amended at 64 FR 1760, Jan. 12, 1999]

§ 184.1535 Niacinamide. (a) Niacinamide (C6H6N2O, CAS Reg. No. 98-92-0) is the chemical 3-pyridinecarboxylic acid amide (nicotinamide). It is a white crystalline powder that is soluble in water, alcohol, ether, and glycerol. It melts between 128 ° and 131 °C. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 205, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983]

§ 184.1537 Nickel. (a) Elemental nickel (CAS Reg. No. 7440-02-0) is obtained from nickel ore by transforming it to nickel sulfide (Ni3S2). The sulfide is roasted in air to give nickel oxide (NiO). The oxide is then reduced with carbon to give elemental nickel. 1150

§ 184.1540

(b) The Food and Drug Administration is developing food-grade specifications for nickel in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a catalyst as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in the hydrogenation of fats and oils as defined in Sec. 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. Current good manufacturing practice includes the removal of nickel from fats and oils following hydrogenation. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51618, Nov. 10, 1983]

§ 184.1538 Nisin preparation. (a) Nisin preparation is derived from pure culture fermentations of certain strains of Streptococcus lactis Lancefield Group N. Nisin preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related peptides with antibiotic activity. (b) The ingredient is a concentrate or dry material that meets the specifications that follow when it is tested as described in ``Specifications for Identity and Purity of Some Antibiotics,’’ World Health Organization, FAO Nutrition Meeting Report Series, No. 45A, 1969, which is incorporated by reference. Copies are available from the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (1) Nisin content, not less than 900 international units per milligram. (2) Arsenic, not more than 1 part per million. (3) Lead, not more than 2 parts per million. (4) Zinc, not more than 25 parts per million. (5) Copper, zinc plus copper not more than 50 parts per million. (6) Total plate count, not more than 10 per gram. (7) Escherichia coli, absent in 10 grams. (8) Salmonella, absent in 10 grams. (9) Coagulase positive staphylococci, absent in 10 grams. (c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter to inhibit the outgrowth of Clostridium botulinum spores and toxin formation in pasteurized cheese spreads and pasteurized process cheese spreads listed in Sec. 133.175; pasteurized cheese spread with fruits, vegetables, or meats as defined in Sec. 133.176; pasteurized process cheese spread as defined in Sec. 133.179; pasteurized process cheese spread with fruits, vegetables, or meats as defined in Sec. 133.180 of this chapter. (d) The ingredient is used at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1) of this chapter. The current good manufacturing practice level is the quantity of the ingredient that delivers a maximum of 250 parts per million of nisin in the finished product as determined by the British Standards Institution Methods, ``Methods for the Estimation and Differentiation of Nisin in Processed Cheese,’’ BS 4020 (1974), which is incorporated by reference. Copies are available from the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994]

§ 184.1540 Nitrogen. (a) Nitrogen (empirical formula N2, CAS Reg. No. 7727-37-9) is a colorless, odorless, flavorless gas that is produced commercially by the fractionation of liquid air. 1151

§ 184.1545

(b) The Food and Drug Administration is developing food-grade specifications for nitrogen in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a propellant, aerating agent, and gas as defined in Sec. 170.3(o)(25) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 57270, Dec. 29, 1983]

§ 184.1545 Nitrous oxide. (a) Nitrous oxide (empirical formula N2O, CAS Reg. No. 10024-97-2) is also known as dinitrogen monoxide or laughing gas. It is a colorless gas, about 50 percent heavier than air, with a slightly sweet smell. It does not burn but will support combustion. Nitrous oxide is manufactured by the thermal decomposition of ammonium nitrate. Higher oxides of nitrogen are removed by passing the dry gas through a series of scrubbing towers. (b) The Food and Drug Administration is developing food-grade specifications for nitrous oxide in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a propellant, aerating agent, and gas as defined in Sec. 170.3(o)(25) of this chapter. (2) The ingredient is used in dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 57270, Dec. 29, 1983]

§ 184.1553 Peptones. (a) Peptones are a variable mixture of polypeptides, oligopeptides, and amino acids that are produced by partial hydrolysis of casein, animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg albumin, or lactalbumin (whey protein). Peptones are produced from these proteins using proteolytic enzymes that either are considered to be generally recognized as safe (GRAS) or are regulated as food additives. Peptones are also produced by denaturing any of the proteins listed in this paragraph with safe and suitable acids or heat. (b) FDA is developing food-grade specifications for peptones in cooperation with the National Academy of Sciences. In the interim, these ingredients must be of a purity suitable for their intended use. (c) In accordance with Sec. 184.1(b)(1), these ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as GRAS as direct human food ingredients is based upon the following current good manufacturing practice conditions of use: (1) These ingredients are used as nutrient supplements as defined in Sec. 170.3(o)(20) of this chapter; as processing aids as defined in Sec. 170.3(o)(24) of this chapter; and as surface-active agents as defined in Sec. 170.3(o)(29) of this chapter. (2) These ingredients are used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985]

1152

§ 184.1560

§ 184.1555 Rapeseed oil. (a) Fully hydrogenated rapeseed oil. (1) Fully hydrogenated rapeseed oil is a mixture of triglycerides in which the fatty acid composition is a mixture of saturated fatty acids. The fatty acids are present in the same porportions which result from the full hydrogenation of fatty acids occurring in natural rapeseed oil. The rapeseed oil is obtained from the napus and campestris varieties of Brassica of the family Cruciferae. It is prepared by fully hydrogenating refined and bleached rapeseed oil at 310-375 °F, using a catalyst such as nickel, until the iodine number is 4 or less. (2) The ingredient meets the following specifications: Acid value not more than 6, arsenic not more than 3 parts per million, free glycerin not more than 7 percent, heavy metals (as Pb) not more than 10 parts per million, iodine number not more than 4, residue on ignition not more than 0.5 percent. (3) The ingredient is used as a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter in peanut butter. The use level of the ingredient is limited by good manufacturing practice (GMP) to the minimum amount required to produce the intended effect. Current good manufacturing practices result in a maximum level of 2 percent in peanut butter. (b) Superglycerinated fully hydrogenated rapeseed oil. (1) Superglycerinated fully hydrogenated rapeseed oil is a mixture of mono- and diglycerides with triglycerides as a minor component. The fatty acid composition is a mixture of saturated fatty acids present in the same proportions as those resulting from the full hydrogenation of fatty acids in natural rapeseed oil. It is made by adding excess glycerol to the fully hydrogenated rapeseed oil and heating, in the presence of a sodium hydroxide catalyst, to 330 °F under partial vacuum and steam sparging agitation. (2) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 201, relating to mono- and diglycerides, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. An additional specification requires the iodine number to be 4 or less. (3) The ingredient is used as an emulsifier as defined in Sec. 170.3(o)(8) of this chapter in shortenings for cake mixes. The use level of the ingredient is limited by good manufacturing practice (GMP) to the minimum amount required to produce the intended effect. Current good manufacturing practices result in a maximum level, as served, of 4 percent of the shortening or 0.5 percent of the total weight of the cake mix. (c) Low erucic acid rapeseed oil. (1) Low erucic acid rapeseed oil, also known as canola oil, is the fully refined, bleached, and deodorized edible oil obtained from certain varieties of Brassica Napus or B. Campestris of the family Cruciferae. The plant varieties are those producing oil-bearing seeds with a low erucic acid content. Chemically, low erucic acid rapeseed oil is a mixture of triglycerides, composed of both saturated and unsaturated fatty acids, with an erucic acid content of no more than 2 percent of the component fatty acids. (2) Low erucic acid rapeseed oil as defined in paragraph (c)(1) of this section may be partially hydrogenated to reduce the proportion of unsaturated fatty acids. When the partially hydrogenated low erucic acid rapeseed oil is used, it shall be referred to as partially hydrogenated low erucic acid rapeseed oil. (3) In addition to limiting the content of erucic acid to a level not exceeding 2 percent of the component fatty acids, FDA is developing other food-grade specifications for low erucic acid rapeseed oil and partially hydrogenated low erucic acid rapeseed oil in cooperation with the National Academy of Sciences. In the interim, the ingredients must be of a purity suitable for their intended use. (4) Low erucic acid rapeseed oil and partially hydrogenated low erucic acid rapeseed oil are used as edible fats and oils in food, except in infant formula, at levels not to exceed current good manufacturing practice. [42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, 1985; 53 FR 52682, Dec. 29, 1988]

§ 184.1560 Ox bile extract. (a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified oxgall or sodium choleate, is a yellowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste. It is the purified portion of the bile of an ox obtained by evaporating the alcohol extract of concentrated bile. (b) Food-grade ox bile extract shall meet the specifications of the U.S. Pharmacopeia (USP), XIV, 1950, p. 410.1 (c) The ingredient is used as a surfactant as defined in Sec. 170.3 (o)(29) of this chapter. 1Copies

may be obtained from: U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.

1153

§ 184.1563

(d) The ingredient is used in food in accordance with Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.002 percent for cheese as defined in Sec. 170.3(n)(5) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985]

§ 184.1563 Ozone. (a) Ozone (O3, CAS Reg. No. 10028-15-6) is an unstable blue gas with a pungent, characteristic odor, which occurs freely in nature, It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The ingredient must be of a purity suitable for its intended use in accordance with Sec. 170.30(h)(1) of this chapter. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to treat food only within the following specific limitations: —————————————————————————————————————— Maximum treatment Category of food level in food Functional use —————————————————————————————————————— Bottled water that prior to Not to exceed Antimicrobial ozonation meets the current good agent, Sec. microbiological, physical, manufacturing 170.3 (o)(2) of chemical, and radiological practice. Current this chapter. quality standards of Sec. good manufacturing 165.110 (b)(2) through (b)(5) practice results of this chapter. in a maximum residual level at the time of bottling of 0.4 milligram of ozone per liter of bottled water. ——————————————————————————————————————

[47 FR 50210, Nov. 5, 1982, as amended at 60 FR 57130, Nov. 13, 1995]

§ 184.1583 Pancreatin. (a) Pancreatin (CAS Reg. No. 8049-47-6) is an enzyme preparation obtained from porcine or bovine pancreatic tissue. It is a white to tan powder. Its characterizing enzyme activity that of a peptide hydrolase (EC 3.4.21.36). (b) The ingredient meets the general requirements and additional requirements in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32911, June 26, 1995]

§ 184.1585 Papain. (a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived from Carica papaya L. Crude latex containing the enzyme is collected from slashed unripe papaya. The food-grade product is obtained by repeated 1154

§ 184.1595

filtration of the crude latex or an aqueous solution of latex or by precipitation from an aqueous solution of latex. The resulting enzyme preparation may be used in a liquid or dry form. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 107-110, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than currect good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter; processing aid as defined in Sec. 170.3(o)(24) of this chapter; and texturizer as defined in Sec. 170.3(o)(32) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 48806, Oct. 21, 1983]

§ 184.1588 Pectins. (a) The pectins (CAS Reg. No. 9000-69-5) are a group of complex, high molecular weight polysaccharides found in plants and composed chiefly of partially methylated polygalacturonic acid units. Portions of the carboxly group occur as methyl esters, and the remaining carboxyl groups exist in the form of the free acid or as its ammonium, potassium, or sodium (CAS Reg. No. 9000-59-8) salts, and in some types as the acid amide. Thus, the pectins regulated in this section are the high-ester pectins, low-ester pectins, amidated pectins, pectinic acids, and pectinates. Pectin is produced commercially by extracting citrus peel, apple pomace, or beet pulp with hot dilute acid (pH 1.0 to 3.5, 70 ° to 90 °C). The extract is filtered, and pectin is then precipitated from the clear extract with ethanol or isopropanol, or as the copper or aluminum salt. The acid extract is sometimes spray- or roller-dried, or it is concentrated to be sold as liquid pectin. (b) The ingredients meet the specifications of the Food Chemical Codex, 3d Ed. (1981), p. 215, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as generally recognized as safe (GRAS) as direct human food ingredients is based upon the following current good manufacturing practice conditions of use: (1) The ingredients are used as emulsifiers as defined in Sec. 170.3(o)(8) of this chapter and as stabilizers and thickeners as defined in Sec. 170.3(o)(28) of this chapter. (2) The ingredients are used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [48 FR 51149, Nov. 7, 1983]

§ 184.1595 Pepsin. (a) Pepsin (CAS Reg. No. 9001-75-6) is an enzyme preparation obtained from the glandular layer of hog stomach. It is a white to light tan powder, amber paste, or clear amber to brown liquid. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.23.1). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. 1155

§ 184.1610

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32911, June 26, 1995]

§ 184.1610 Potassium alginate. (a) Potassium alginate (CAS Reg. No. 9005-36-1) is the potassium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Potassium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ———————————————————————————————————————— Maximum level of use in Category of food food (as Functional use served) (percent) ———————————————————————————————————————— Confections and frostings, Sec. 0.1 Stabilizer, thickener, 170.3(n)(9) of this chapter. Sec. 170.3(o)(28) of this chapter Gelatins and puddings, Sec. 0.7 Do. 170.3(n)(22) of this chapter. Processed fruits and fruit juices, 0.25 Do. Sec. 170.3(n)(35) of this chapter. All other food categories........... 0.01 Do. ————————————————————————————————————————

(d) Prior sanctions for potassium alginate different from the uses established in this section do not exist or have been waived. [47 FR 29951, July 9, 1982]

§ 184.1613 Potassium bicarbonate. (a) Potassium bicarbonate (KHCO3, CAS Reg. No. 298-14-6) is made by the following processes: (1) By treating a solution of potassium hydroxide with carbon dioxide; (2) By treating a solution of potassium carbonate with carbon dioxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; nutrient supplemlent as defined in Sec. 170.3(o)(20) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52442, Nov. 18, 1983]

1156

§ 184.1625

§ 184.1619 Potassium carbonate. (a) Potassium carbonate (K2CO3, CAS Reg. No. 584-08-7) is produced by the following methods of manufacture: (1) By electrolysis of potassium chloride followed by exposing the resultant potassium to carbon dioxide; (2) By treating a solution of potassium hydroxide with excess carbon dioxide to produce potassium carbonate; (3) By treating a solution of potassium hydroxide with carbon dioxide to produce potassium bicarbonate, which is then heated to yield potassium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 240, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, D.C. 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. the affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52442, Nov. 18, 1983]

§ 184.1622 Potassium chloride. (a) Potassium chloride (KCl, CAS Reg. No. 7447-40-7) is a white, odorless solid prepared from source minerals by fractional crystallization or flotation. It is soluble in water and glycerol and has a saline taste at low concentration levels. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 241, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; as a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter; as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter; as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and as a stabilizer or thickener as defined in Sec. 170.3(o)(28) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Potassium chloride may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51614, Nov. 10, 1983]

§ 184.1625 Potassium citrate. (a) Potassium citrate (C6H5K3O7 ⋅ H2O, CAS Reg. No. 006100-0905-096) is the potassium salt of citric acid. It is prepared by neutralizing citric acid with potassium hydroxide or potassium carbonate. It occurs as transparent crystals or a white granular powder, is odorless and deliquescent, and contains one mole of water per mole of potassium citrate. 1157

§ 184.1631

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), p. 242, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. [59 FR 63896, Dec. 12, 1994]

§ 184.1631 Potassium hydroxide. (a) Potassium hydroxide (KOH, CAS Reg. No. 1310-58-3) is also known as caustic potash, potash lye, and potassa. The empirical formula is KOH. It is a white, highly deliquescent caustic solid, which is marketed in several forms, including pellets, flakes, sticks, lumps, and powders. Potassium hydroxide is obtained commercially from the electrolysis of potassium chloride solution in the presence of a porous diaphragm. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available from inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; a pH control agent as defined in Sec. 170.3(o)(23) of the chapter; a processing aid as defined in Sec. 170.3(o)(24) of this chapter; and a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52444, Nov. 18, 1983]

§ 184.1634 Potassium iodide. (a) Potassium iodide (KI, CAS Reg. No. 7681-11-0) is the potassium salt of hydriodic acid. It occurs naturally in sea water and in salt deposits, but can be prepared by reacting hydriodic acid (HI) with potassium bicarbonate (KHCO3). (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 246-247, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (d) The ingredient is used in table salt in accordance with Sec. 184.1(b)(2) of this chapter as a source of dietary iodine at a maximum level of 0.01 percent. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, 1996]

1158

§ 184.1643

§ 184.1635 Potassium iodate. (a) Potassium iodate (KIO3, CAS Reg. No. 7758-05-6) does not occur naturally but can be prepared by reacting iodine with potassium hydroxide. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 245-246, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a dough strengthener as defined in Sec. 170.3(o)(6) of this chapter. (d) The ingredient is used in the manufacture of bread in accordance with Sec. 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 percent based on the weight of the flour. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984] § 184.1639 Potassium lactate. (a) Potassium lactate (C3H5O3K, CAS Reg. No. 996-31-6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (b) FDA is developing food-grade specifications for potassium lactate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. This regulation does not authorize its use in infant foods and infant formulas. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a humectant as defined in Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [52 FR 10886, Apr. 6, 1987]

§ 184.1643 Potassium sulfate. (a) Potassium sulfate (K2SO4, CAS Reg. No. 7778-80-5) occurs naturally and consists of colorless or white crystals or crystalline powder having a bitter, saline taste. It is prepared by the neutralization of sulfuric acid with potassium hydroxide or potassium carbonate. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 252, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.015 percent for nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [45 FR 6086, Jan. 25, 1980, as amended at 49 FR 5613, Feb. 14, 1984]

1159

§ 184.1655

§ 184.1655 Propane. (a) Propane (empirical formula C3H8, CAS Reg. No. 74-98-6) is also known as dimethylmethane or propyl hydrid. It is a colorless, odorless, flammable gas at normal temperatures and pressures. It is easily liquefied under pressure at room temperature and is stored and shipped in the liquid state. Propane is obtained from natural gas by fractionation following absorption in oil, adsorption to surface-active agents, or refrigeration. (b) The Food and Drug Administration is developing food-grade specifications for propane in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a propellant, aerating agent, and gas as defined in Sec. 170.3(o)(25) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 57271, Dec. 29, 1983]

§ 184.1660 Propyl gallate. (a) Propyl gallate is the n-propylester of 3,4,5-trihydroxybenzoic acid (C10H12O5). Natural occurrence of propyl gallate has not been reported. It is commercially prepared by esterification of gallic acid with propyl alcohol followed by distillation to remove excess alcohol. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 257-258, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an antioxidant as defined in Sec. 170.3(o)(3) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with Sec. 184.1(b)(1). Good manufacturing practice results in a maximum total content of antioxidants of 0.02 percent of the fat or oil content, including the essential (volatile) oil content, of the food. (e) Prior sanctions for this ingredient different from the uses established in this section, or different from that stated in part 181 of this chapter, do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 44 FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, 1984]

§ 184.1666 Propylene glycol. (a) Propylene glycol (C3H8O2, CAS Reg. No. 57-55-6) is known as 1,2-propanediol. It does not occur in nature. Propylene glycol is manufactured by treating propylene with chlorinated water to form the chlorohydrin which is converted to the glycol by treatment with sodium carbonate solution. It is also prepared by heating glyercol with sodium hydroxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 255, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418. It is also available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an anticaking agent as defined in Sec. 170.3(o)(1) of this chapter; antioxidant as defined in Sec. 170.3(o)(3) of this chapter; dough strengthener as defined in Sec. 170.3(o)(6) of this chapter; emulsifier as defined in Sec. 170.3(o)(8) of this chapter; flavor agent as defined in Sec. 170.3(o)(12) of this chapter; formulation aid as defined in Sec. 170.3(o)(14) of this chapter; humectant as defined in Sec. 170.3(o)(16) of this chapter; processing aid as defined in Sec. 170.3(o)(24) of this chapter; solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter; stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter; surface-active agent as defined in Sec. 170.3(o)(29) of this chapter; and texturizer as defined in Sec. 170.3(o)(32) of this chapter. 1160

§ 184.1676

(d) The ingredient is used in foods at levels not to exceed current good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in maximum levels, as served, of 5 percent for alcoholic beverages, as defined in Sec. 170.3(n)(2) of this chapter; 24 percent for confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; 2.5 percent for frozen dairy products as defined in Sec. 170.3(n)(20) of this chapter; 97 percent for seasonings and flavorings as defined in Sec. 170.3(n)(26) of this chapter; 5 percent for nuts and nut products as defined in Sec. 170.3(n)(32) of this chapter; and 2.0 percent for all other food categories. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 27812, June 25, 1982] § 184.1670 Propylparaben. (a) Propylparaben is the chemical propyl p-hydroxybenzoate. It is produced by the n-propanol esterification of phydroxybenzoic acid in the presence of sulfuric acid, with subsequent distillation. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 258, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food. (e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]

§ 184.1676 Pyridoxine hydrochloride. (a) Pyridoxine hydrochloride (C8H11NO3 ⋅ HCl, CAS Reg. No. 58-56-0) is the chemical 3-hydroxy-4,5dihydroxymethy-2-methylpyridine hydrochloride that is prepared by chemical synthesis. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 260, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage bases as defined in Sec. 170.3(n)(3) of this chapter; breakfast cereals as defined in Sec. 170.3(n)(4) of this chapter; dairy product analogs as defined in Sec. 170.3(n)(10) of this chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter; milk products as defined in Sec. 170.3(n)(31) of this chapter; plant protein products as defined in Sec. 170.3(n)(33) of this chapter; and snack foods as defined in Sec. 170.3(n)(37) of this chapter. Pyridoxine hydrochloride may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51615, Nov. 10, 1983]

1161

§ 184.1685

§ 184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived). (a)(1) Rennet and bovine rennet are commercial extracts containing the active enzyme rennin (CAS Reg. No. 900198-3), also known as chymosin (International Union of Biochemistry Enzyme Commission (E.C.) 3.4.23.4). Rennet is the aqueous extract prepared from cleaned, frozen, salted, or dried fourth stomachs (abomasa) of calves, kids, or lambs. Bovine rennet is the product from adults of the animals listed above. Both products are called rennet and are clear amber to dark brown liquid preparations or white to tan powders. (2) Chymosin preparation is a clear solution containing the active enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpathogenic and nontoxigenic strain of Escherichia coli K-12 containing the prochymosin gene. The prochymosin is isolated as an insoluble aggregate that is acid-treated to destroy residual cellular material and, after solubilization, is acid-treated to form chymosin. It must be processed with materials that are generally recognized as safe, or are food additives that have been approved by the Food and Drug Administration for this use. (3) Chymosin preparation is a clear solution containing the active enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpathogenic and nontoxigenic strain of Kluyveromyces marxianus variety lactis, containing the prochymosin gene. The prochymosin is secreted by cells into fermentation broth and converted to chymosin by acid treatment. All materials used in the processing and formulating of chymosin must be either generally recognized as safe (GRAS), or be food additives that have been approved by the Food and Drug Administration for this use. (4) Chymosin preparation is a clear solution containing the active enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpathogenic and nontoxigenic strain of Aspergillus niger van Tieghem variety awamori (Nakazawa) Al-Musallam (synonym A. awamori Nakazawa) containing the prochymosin gene. Chymosin is recovered from the fermentation broth after acid treatment. All materials used in the processing and formulating of chymosin preparation must be either generally recognized as safe (GRAS) or be food additives that have been approved by the Food and Drug Administration for this use. (b) Rennet and chymosin preparation meet the general and additional requirements for enzyme preparations of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 107-110, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or are available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter; a processing aid as defined in Sec. 170.3(o)(24) of this chapter; and a stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: In cheeses as defined in Sec. 170.3(n)(5) of this chapter; frozen dairy desserts and mixes as defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; and milk products as defined in Sec. 170.3(n)(31) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [55 FR 10935, Mar. 23, 1990, as amended at 57 FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 1993]

§ 184.1695 Riboflavin. (a) Riboflavin (C17H20N4O6, CAS Reg. No. 83-88-5) occurs as yellow to orange-yellow needles that are crystallized from 2N acetic acid, alcohol, water, or pyridine. It may be prepared by chemical synthesis, biosynthetically by the organism Eremothecium ashbyii, or isolated from natural sources. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 262, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

1162

§ 184.1699

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51148, Nov. 7, 1983]

§ 184.1697 Riboflavin-5’-phosphate (sodium). (a) Riboflavin-5’-phosphate (sodium) (C17H20N4O9PNa ⋅ 2H2O, CAS Reg. No 130-40-5) occurs as the dihydrate in yellow to orange-yellow crystals. It is prepared by phosphorylation of riboflavin with chlorophosphoric acid, pyrophosphoric acid, metaphosphoric acid, or pyrocatechol cyclic phosphate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 263, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as defined in Sec. 170.3(n)(31) of this chapter, at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51148, Nov. 7, 1983]

§ 184.1698 Rue. (a) Rue is the perennial herb of several species of Ruta (Ruta montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis L.). The leaves, buds, and stems from the top of the plant are gathered, dried, and then crushed in preparation for use, or left whole. (b) The ingredient is used in all categories of food in accordance with Sec. 184.1(b)(2) of this chapter at concentrations not to exceed 2 parts per million. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 3705, Jan. 27, 1978]

§ 184.1699 Oil of rue. (a) Oil of rue is the natural substance obtained by steam distillation of the fresh blossoming plants of rue, the perennial herb of several species of Ruta—Ruta montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis L. (b) Oil of rue meets the specifications of the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 342-343, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address 1163

§ 184.1702

``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) The ingredient is used in food under the following conditions: MAXIMUM USAGE LEVELS PERMITTED ——————————————————————————————————————— Parts per Food (as served) million Function ——————————————————————————————————————— Baked goods and baking mixes, 10 Flavoring agent and adjuvant, Sec. 170.3(n)(1), of this Sec. 170.3(o)(12) of this chapter. chapter. Frozen dairy desserts and 10 Do. mixes, Sec. 170.3 (n)(20) of this chapter. Soft candy, Sec. 10 Do. 170.3(n)(38) of this chapter. All other food categories.... 4 Do. ———————————————————————————————————————

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, 1999]

§ 184.1702 Sheanut oil. (a) Sheanut oil is produced from sheanuts derived from the Shea tree Butyrospermum parkii and is composed principally of triglycerides containing an oleic acid moiety at the 2-position and saturated fatty acids, usually stearic or palmitic acids, at the 1- and 3-positions. (b) The ingredient meets the following specifications when tested using any appropriate validated methodology: (1) Saponification value of 185 to 195, (2) Iodine value of 28 to 43, (3) Unsaponifiable matter not to exceed 1.5 percent, (4) Free fatty acids not more than 0.1 percent as oleic acid, (5) Peroxide value not more than 10 milliequivalents/equivalent (meq/eq), (6) Lead not more than 0.1 part per million (ppm), (7) Copper not more than 0.1 ppm. (c) In accordance with Sec. 184.1(b)(3), the ingredient is used in the following food categories at levels not to exceed current good manufacturing practice, except that the ingredient may not be used in a standardized food unless permitted by the standard of identity: Confections and frostings as defined in Sec. 170.3(n)(9) of this chapter, coatings of soft candy as defined in Sec. 170.3(n)(38) of this chapter, and sweet sauces and toppings as defined in Sec. 170.3(n)(43) of this chapter. [63 FR 28895, May 27, 1998]

§ 184.1721 Sodium acetate. (a) Sodium acetate (C2H3O2Na, CAS Reg. No. 127-09-3 or C2H3O2Na ⋅ 3H2O, CAS Reg. No. 6131-90-4) is the sodium salt of acetic acid and occurs naturally in plant and animal tissues. Sodium acetate may occur in either the anhydrous or trihydrated form. It is produced synthetically by the neutralization of acetic acid with sodium carbonate or by treating calcium acetate with sodium sulfate and sodium bicarbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 272, 273 which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; and as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. 1164

§ 184.1724

(d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.007 percent for breakfast cereals as defined in Sec. 170.3(n)(4) of this chapter; 0.5 percent for fats and oils as defined in Sec. 170.3(n)(12) of this chapter; 0.6 percent for grain products and pastas as defined in Sec. 170.3(n)(23) of this chapter and snack foods as defined in Sec. 170.3(n)(37) of this chapter; 0.15 percent for hard candy as defined in Sec. 170.3(n)(25) of this chapter; 0.12 percent for jams and jellies as defined in Sec. 170.3(n)(28) of this chapter and meat products as defined in Sec. 170.3(n)(29) of this chapter; 0.2 percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.05 percent for soups and soup mixes as defined in Sec. 170.3(n)(40) of this chapter and sweet sauces as defined in Sec. 170.3(n)(43) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 27815, June 25, 1982]

§ 184.1724 Sodium alginate. (a) Sodium alginate (CAS Reg. No. 9005-38-3) is the sodium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Sodium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 274, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(2), the ingredient is used in food only within the following specific limitations: ———————————————————————————————————————— Maximum level of use in Category of food food (as Functional use served) (percent) ———————————————————————————————————————— Condiments and relishes, Sec. 1.0 Texturizer, Sec. 170.3(n)(8) of this chapter, except 170.3(o)(32) of this pimento ribbon for stuffed olives. chapter, formulation aid Sec. 170.3(o)(14) of this chapter, stabilizer, thickener, Sec. 170.3(o)(28) of this chapter. Pimento ribbon for stuffed olives... 6.0 Do. Confections and frostings, Sec. 0.3 Stabilizer, thickener, 170.3(n)(9) of this chapter. Sec. 170.3(o)(28) of this chapter. Gelatins and puddings, Sec. 4.0 Firming agent, Sec. 170.3(n)(22) of this chapter. 170.3(o)(10) of this chapter; flavor adjuvant, Sec. 170.3(o)(12) of this chapter; stabilizer, thickener, Sec. 170.3(o)(28) of this chapter. Hard candy, Sec. 170.3(n)(25) of 10.0 Stabilizer, thickener, this chapter. Sec. 170.3(o)(28) of this chapter. Processed fruits and fruit juices, 2.0 Formulation aid, Sec. Sec. 170.3(n)(35) of this chapter. 170.3(o)(14) of this chapter; texturizer, Sec. 170.3(o)(32) of this chapter.

1165

§ 184.1733

———————————————————————————————————————— Maximum level of use in Category of food food (as Functional use served) (percent) ———————————————————————————————————————— All other food categories........... 1.0 Emulsifier, Sec. 170.3(o)(8) of this chapter; firming agent, Sec. 170.3(o)(10) of this chapter; flavor enhancer, Sec. 170.3(o)(11) of this chapter; flavor adjuvant, Sec. 170.3(o)(12) of this chapter; processing aid, Sec. 170.3(o)(24) of this chapter; stabilizer and thickener, Sec. 170.3(o)(28) of this chapter; surface active agent, Sec. 170.3(o)(29) of this chapter. ————————————————————————————————————————

(d) Prior sanctions for sodium alginate different from the uses established in this section do not exist or have been waived. [47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983]

§ 184.1733 Sodium benzoate. (a) Sodium benzoate is the chemical benzoate of soda (C7H5NaO2), produced by the neutralization of benzoic acid with sodium bicarbonate, sodium carbonate, or sodium hydroxide. The salt is not found to occur naturally. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 278, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice. Current usage results in a maximum level of 0.1 percent in food. (The Food and Drug Administration has not determined whether significally different conditions of use would be GRAS.) (e) Prior sanctions for this ingredient different from the uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]

§ 184.1736 Sodium bicarbonate. (a) Sodium bicarbonate (NaHCO3, CAS Reg. No. 144-55-8) is prepared by treating a sodium carbonate or a sodium carbonate and sodium bicarbonate solution with carbon dioxide. As carbon dioxide is absorbed, a suspension of sodium bicarbonate forms. The slurry is filtered, forming a cake which is washed and dried. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 278, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. 1166

§ 184.1754

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52442, Nov. 18, 1983]

§ 184.1742 Sodium carbonate. (a) Sodium carbonate (Na2CO3, CAS Reg. No. 497-19-8) is produced (1) from purified trona ore that has been calcined to soda ash; (2) from trona ore calcined to impure soda ash and then purified; or (3) synthesized from limestone by the Solvay process. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 280, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an antioxidant as defined in Sec. 170.3(o)(3) of this chapter; curing and pickling agent as defined in Sec. 170.3(o)(5) of this chapter; flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; pH control agent as defined in Sec. 170.3(o)(23) of this chapter; and processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52442, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985]

§ 184.1751 Sodium citrate. (a) Sodium citrate (C6H5Na3O7 ⋅ 2H2O, CAS Reg. No. 68-0904-092) is the sodium salt of citric acid. It is prepared by neutralizing citric acid with sodium hydroxide or sodium carbonate. The product occurs as colorless crystals or a white crystalline powder. It may be prepared in an anhydrous state or may contain two moles of water per mole of sodium citrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 283-284, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. [59 FR 63896, Dec. 12, 1994]

§ 184.1754 Sodium diacetate. (a) Sodium diacetate (C4H7O4Na ⋅ xH2O, CAS Reg. No. 126-96-5) is a molecular compound of acetic acid, sodium acetate, and water of hydration. The technical grade is prepared synthetically by reacting sodium carbonate with acetic acid. Special grades are produced by reacting anhydrous sodium acetate and acetic acid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 284, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. 1167

§ 184.1763

(c) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter; flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; and pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with Sec. 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, 0.4 percent for baked goods as defined in Sec. 170.3(n)(1) of this chapter; 0.1 percent for fats and oils as defined in Sec. 170.3(n)(12) of this chapter, meat products as defined in Sec. 170.3(n)(29) of this chapter and soft candy as defined in Sec. 170.3(n)(38) of this chapter; 0.25 percent for gravies and sauces as defined in Sec. 170.3(n)(24) of this chapter; and 0.05 percent for snack foods as defined in Sec. 170.3(n)(37) of this chapter and soups and soup mixes as defined in Sec. 170.3(n)(40) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 27815, June 25, 1982]

§ 184.1763 Sodium hydroxide. (a) Sodium hydroxide (NaOH, CAS Reg. No. 1310-73-2) is also known as sodium hydrate, soda lye, caustic soda, white caustic, and lye. The empirical formula is NaOH. Sodium hydroxide is prepared commercially by the electrolysis of sodium chloride solution and also by reacting calcium hydroxide with sodium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter and as a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52444, Nov. 18, 1983]

§ 184.1764 Sodium hypophosphite. (a) Sodium hypophosphite (NaH2PO2, CAS Reg. No. 7681-53-0) is a white, odorless, deliquescent granular powder with a saline taste. It is also prepared as colorless, pearly crystalline plates. It is soluble in water, alcohol, and glycerol. It is prepared by neutralization of hypophosphorous acid or by direct aqueous alkaline hydrolysis of white phosphorus. (b) FDA is developing food-grade specifications for sodium hypophosphite in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a suitable purity for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an emulsifier or stabilizer, as defined in Secs. 170.3(o)(8) and 170.3(o)(28) of this chapter. (2) The ingredient is used in cod-liver oil emulsions at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [47 FR 38277, Aug. 31, 1982]

1168

§ 184.1784

§ 184.1768 Sodium lactate. (a) Sodium lactate (C3H5O3Na, CAS Reg. No. 72-17-3) is the sodium salt of lactic acid. It is prepared commercially by the neutralization of lactic acid with sodium hydroxide. (b) FDA is developing food-grade specifications for sodium lactate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. This regulation does not authorize its use in infant foods and infant formulas. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an emulsifier as defined in Sec. 170.3(o)(8) of this chapter; a flavor enhancer as defined in Sec. 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a humectant as defined in Sec. 170.3(o)(16) of this chapter; and a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [52 FR 10886, Apr. 6, 1987]

§ 184.1769a Sodium metasilicate. (a) Sodium metasilicate (CAS Reg. No. 6834-92-0) is a strongly alkaline white powder. It does not occur naturally but rather is synthesized by melting sand with sodium carbonate at 1400 °C. The commercially available forms of sodium metasilicate are the anhydrous form (Na2SiO3), the pentahydrate (Na2SiO3 ⋅ 5H2O), and the nonahydrate (Na2SiO3 ⋅ 9H2O). (b) FDA is developing food-grade specifications for sodium metasilicate in cooperation with the National Academy of Sciences. In the interim, the ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a processing aid as defined in Sec. 170.3(o)(24) of this chapter. (2) The ingredient is used to treat the following foods at levels not to exceed current good manufacturing practice: for use in washing and lye peeling of fruits, vegetables, and nuts when used in accordance with Sec. 173.315 of this chapter; for use as a denuding agent in tripe; for use as a hog scald agent in removing hair; and for use as a corrosion preventative in canned and bottled water when used in accordance with Sec. 103.35 of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 1985]

§ 184.1784 Sodium propionate. (a) Sodium propionate (C3H5NaO2, CAS Reg. No. 137-40-6) is the sodium salt of propionic acid. It occurs as colorless, transparent crystals or a granular crystalline powder. It is odorless, or has a faint acetic-butyric acid odor, and is deliquescent. It is prepared by neutralizing propionic acid with sodium hydroxide. (b) The ingredients meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 296, which is incorporated by reference. Copies are available from the the National Academy Press, 2101 Constitution Ave. NW., Washington DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: 1169

§ 184.1792

(1) The ingredient is used as an antimicrobial agent as defined in Sec. 170.3(o)(2) of this chapter and a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; cheeses as defined in Sec. 170.3(n)(5) of this chapter; confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; gelatins, puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; jams and jellies as defined in Sec. 170.3(n)(28) of this chapter; meat products as defined in Sec. 170.3(n)(29) of this chapter; and soft candy as defined in Sec. 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [49 FR 13142, Apr. 3, 1984]

§ 184.1792 Sodium sesquicarbonate. (a) Sodium sesquicarbonate (Na2CO3 ⋅ NaHCO3 ⋅ 2H2O, CAS Reg. No. 533-96-0) is prepared by: (1) Partial carbonation of soda ash solution followed by crystallization, centrifugation, and drying; (2) double refining of trona ore, a naturally occurring impure sodium sesquicarbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 299, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in cream at levels not to exceed current good manufacturing practice. Current good manufacturing practice utilizes a level of the ingredient sufficient to control lactic acid prior to pasteurization and churning of cream into butter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52443, Nov. 18, 1983]

§ 184.1801 Sodium tartrate. (a) Sodium tartrate (C4H4Na2O6 ⋅ 2H2O, CAS Reg. No. 868-18-8) is the disodium salt of L − (+) − tartaric acid. It occurs as transparent, colorless, and odorless crystals. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 303, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an emulsifier as defined in Sec. 170.3(o)(8) of this chapter and as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: cheeses as defined inSec. 170.3(n)(5) of this chapter; fats and oils as defined in Sec. 170.3(n)(12) of this chapter; and jams and jellies as defined in Sec. 170.3(n)(28) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52447, Nov. 18, 1983]

1170

§ 184.1835

§ 184.1804 Sodium potassium tartrate. (a) Sodium potassium tartrate (C4H4KNaO6 ⋅ 4H2O, CAS Reg. No. 304-59-6) is the sodium potassium salt of L − (+) − tartaric acid and is also called the Rochelle salt. It occurs as colorless crystals or as a white, crystalline powder and has a cooling saline taste. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 296, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an emulsifier as defined in Sec. 170.3(o)(8) of this chapter and as a pH control agent as defined in Sec. 170.3(o)(23) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: cheeses as defined in Sec. 170.3(n)(5) of this chapter and jams and jellies as defined in Sec. 170.3(n)(28) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 52447, Nov. 18, 1983]

§ 184.1807 Sodium thiosulfate. (a) Sodium thiosulfate (Na2S2O3 ⋅ 5H2O, CAS Reg. No. 010102-0917-097) is also known as sodium hyposulfite. It is prepared synthetically by the reaction of sulfides and sulfur dioxide (SO2), the reaction of sulfur and sulfite, or the oxidation of metal sulfides and hydrosulfides. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 304, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter and reducing agent as defined in Sec. 170.3(o)(22) of this chapter. (d) The ingredient is used in alcoholic beverages and table salt in accordance with Sec. 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.00005 percent for alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter and 0.1 percent for table salt as defined in Sec. 170.3(n)(26) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984]

§ 184.1835 Sorbitol. (a) Sorbitol is the chemical 1,2,3,4,5,6-hexanehexol (C6H14O6), a hexahydric alcohol, differing from mannitol principally by having a different optical rotation. Sorbitol is produced by the electrolytic reduction, or the transition metal catalytic hydrogenation of sugar solutions containing glucose or fructose. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), p. 308, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an anticaking agent and free-flow agent as defined in Sec. 170.3(o)(1) of this chapter, curing and pickling agent as defined in Sec. 170.3(o)(5) of this chapter, drying agent as defined in Sec. 170.3(o)(7) of this chapter, emulsifier and emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter, firming agent as defined 1171

§ 184.1845

in Sec. 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter, formulation aid as defined in Sec. 170.3(o)(14) of this chapter, humectant as defined in Sec. 170.3(o)(16) of this chapter, lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter, nutritive sweetener as defined in Sec. 170.3(o)(21) of this chapter, sequestrant as defined in Sec. 170.3(o)(26) of this chapter, stabilizer and thickener as defined in Sec. 170.3(o)(28) of this chapter, surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter, and texturizer as defined in Sec. 170.3(o)(32) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice in the use of sorbitol results in a maximum level of 99 percent in hard candy and cough drops as defined in Sec. 170.3(n)(25) of this chapter, 75 percent in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 98 percent in soft candy as defined in Sec. 170.3(n)(38) of this chapter, 30 percent in nonstandardized jams and jellies, commercial, as defined in Sec. 170.3(n)(28) of this chapter, 30 percent in baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter, 17 percent in frozen dairy desserts and mixes as defined in Sec. 170.3(n)(20) of this chapter, and 12 percent in all other foods. (e) The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 50 grams of sorbitol shall bear the statement: ``Excess consumption may have a laxative effect.’’ (f) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]

§ 184.1845 Stannous chloride (anhydrous and dihydrated). (a) Stannous chloride is anhydrous or contains two molecules of water of hydration. Anhydrous stannous chloride (SnCl2, CAS Reg. No. 7772-99-8) is the chloride salt of metallic tin. It is prepared by reacting molten tin with either chlorine or gaseous tin tetrachloride. Dihydrated stannous chloride (SnCl2 x 2H2O, CAS Reg. No. 10025-0969-091) is the chloride salt of metallic tin that contains two molecules of water. It is prepared from granulated tin suspended in water and hydrochloric acid or chlorine. (b) Both forms of the ingredient meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 312, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as an antioxidant as defined in Sec. 170.3(o)(3) of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with Sec. 184.(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.0015 percent or less; calculated as tin, for all food categories. (e) Prior sanctions for this ingredient different from those uses established in this section do not exist or have been waived. [47 FR 27816, June 25, 1982]

§ 184.1848 Starter distillate. (a) Starter distillate (butter starter distillate) is a steam distillate of the culture of any or all of the following species of bacteria grown on a medium consisting of skim milk usually fortified with about 0.1 percent citric acid: Streptococcus lactis, S. cremoris, S. lactis subsp. diacetylactis, Leuconostoc citrovorum, and L. dextranicum. The ingredient contains more than 98 percent water, and the remainder is a mixture of butterlike flavor compounds. Diacetyl is the major flavor component, constituting as much as 80 to 90 percent of the mixture of organic flavor compounds. Besides diacetyl, starter distillate contains minor amounts of acetaldehyde, ethyl formate, ethyl acetate, acetone, ethyl alcohol, 2-butanone, acetic acid, and acetoin. (b) FDA is developing food-grade specifications for starter distillate in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: 1172

§ 184.1857

(1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51907, Nov. 15, 1983]

§ 184.1851 Stearyl citrate. (a) Stearyl citrate is a mixture of the mono-, di-, and tristearyl esters of citric acid. It is prepared by esterifying citric acid with stearyl alcohol. (b) The Food and Drug Administration, in cooperation with the National Academy of Sciences, is developing foodgrade specifications for stearyl citrate. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an antioxidant as defined in Sec. 170.3(o)(3) of this chapter; an emulsifier and emulsifier salt as defined in Sec. 170.3(o)(8) of this chapter; a sequestrant as defined in Sec. 170.3(o)(26) of this chapter; and a surface-active agent as defined in Sec. 170.3(o)(29) of this chapter. (2) The ingredient is used in margarine in accordance with Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in Sec. 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. [59 FR 63897, Dec. 12, 1994]

§ 184.1854 Sucrose. (a) Sucrose (C12H22O11, CAS Reg. No. 57-50-11-1) sugar, cane sugar, or beet sugar is the chemical β-Dfructofuranosyl-α-D-glucopyranoside. Sucrose is obtained by crystallization from sugar cane or sugar beet juice that has been extracted by pressing or diffusion, then clarified and evaporated. (b) FDA is developing food-grade specifications for sucrose in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989]

§ 184.1857 Corn sugar. (a) Corn sugar (C6H12O6, CAS Reg. No. 50-99-7), commonly called D-glucose or dextrose, is the chemical α-Dglucopyranose. It occurs as the anhydrous or the monohydrate form and is produced by the complete hydrolysis of corn starch with safe and suitable acids or enzymes, followed by refinement and crystallization from the resulting hydrolysate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 97-98 under the heading ``Dextrose,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 1. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. 1173

§ 184.1859

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 44876, Nov. 7, 1988]

§ 184.1859 Invert sugar. (a) Invert sugar (CAS Reg. No. 8013-17-0) is an aqueous solution of inverted or partly inverted, refined or partly refined sucrose, the solids of which contain not more than 0.3 percent by weight of ash. The solution is colorless, odorless, and flavorless, except for sweetness. It is produced by the hydrolysis or partial hydrolysis of sucrose with safe and suitable acids or enzymes. (b) FDA is developing food-grade specifications for invert sugar in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989]

§ 184.1865 Corn syrup. (a) Corn syrup, commonly called ``glucose sirup’’ or ``glucose syrup,’’ is obtained by partial hydrolysis of corn starch with safe and suitable acids or enzymes. It may also occur in the dehydrated form (dried glucose sirup). Depending on the degree of hydrolysis, corn syrup may contain, in addition to glucose, maltose and higher saccharides. (b) The ingredient meets the specifications as defined and determined in Sec. 168.120(b) or Sec. 168.121(a) of this chapter, as appropriate. FDA, in cooperation with the National Academy of Sciences, is undertaking a study to determine if additional food-grade specifications for corn syrup are necessary. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 44876, Nov. 7, 1988]

§ 184.1866 High fructose corn syrup. (a) High fructose corn syrup, a sweet, nutritive saccharide mixture containing either approximately 42 or 55 percent fructose, is prepared as a clear aqueous solution from high dextrose-equivalent corn starch hydrolysate by partial enzymatic conversion of glucose (dextrose) to fructose using an insoluble glucose isomerase enzyme preparation described in Sec. 184.1372. The product containing more than 50 percent fructose (dry weight) is prepared through concentration of the fructose portion of the mixture containing less than 50 percent fructose. (b) The ingredient shall conform to the identity and specifications listed in the monograph entitled ``High-Fructose Corn Syrup’’ in the Food Chemicals Codex, 4th ed. (1996), pp. 191-192, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. [61 FR 43450, Aug.23, 1996]

1174

§ 184.1890

§ 184.1875 Thiamine hydrochloride. (a) Thiamine hydrochloride (C12H17C1N4OS ⋅ HCl, CAS Reg. No. 67-03-8) is the chloride-hydrochloride salt of thiamine. It occurs as hygroscopic white crystals or a white crystalline powder. The usual method of preparing this substance is by linking the preformed thiazole and pyrimidine ring systems. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 324, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter or as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Thiamine hydrochloride may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 55124, Dec. 9, 1983]

§ 184.1878 Thiamine mononitrate. (a) Thiamine mononitrate (C12H17N5O4S, CAS Reg. No. 532-43-4) is the mononitrate salt of thiamine. It occurs as white crystals or a white crystalline powder and is prepared from thiamine hydrochloride by dissolving the hydrochloride salt in alkaline solution followed by precipitation of the nitrate half-salt with a stoichiometric amount of nitric acid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 325, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Thiamine mononitrate may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 55124, Dec. 9, 1983]

§ 184.1890 α-Tocopherols. (a) The α-tocopherols that are the subject of this GRAS affirmation regulation are limited to the following: (1) d-α-Tocopherol (CAS Reg. No. 59-02-9) is the chemical [2R,4’R,8prime;R]-2,5,7,8-tetramethyl-2-(4’,8’,12’trimethyl-tridecyl)-6-chromanol. It occurs commercially as a concentrate and is a red, nearly odorless, viscous oil. It is obtained by vacuum steam distillation of edible vegetable oil products. (2) dl-α-Tocopherol (CAS Reg. No. 10191-41-0) is a mixture of stereoisomers of 2,5,7,8-tetramethyl-2-(4’,8’,12’trimethyl-tridecyl)-6-chromanol. It is chemically synthesized by condensing racemic isophytol with trimethyl hydroquinone. It is a pale yellow viscous oil at room temperature. 1175

§ 184.1901

(b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 330-331, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(3), the affirmation of the ingredients as generally recognized as safe is limited to the following conditions of use while the agency concludes the general evaluation of all food uses of tocopherols: (1) The ingredients are used as inhibitors of nitrosamine formation. (2) The ingredients are used in pump-cured bacon at levels not to exceed current good manufacturing practice. [49 FR 13348, Apr. 4, 1984]

§ 184.1901 Triacetin. (a) Triacetin (C8H14O6, CAS Reg. No. 102-76-1), also known as 1,2,3,-propanetriol triacetate or glyceryl triacetate, is the triester of glycerin and acetic acid. Triacetin can be prepared by heating glycerin with acetic anhydride alone or in the presence of finely divided potassium hydrogen sulfate. It can also be prepared by the reaction of oxygen with a liquid-phase mixture of allyl acetate and acetic acid using a bromide salt as a catalyst. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 337-338, as revised by the First Supplement to the 3d Ed., which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2102 Constitution Ave., NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20005. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; and humectant as defined in Sec. 170.3(o)(16) of this chapter; and a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter, alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages and beverage bases as defined in Sec. 170.3(n)(3) of this chapter; chewing gum as defined in Sec. 170.3(n)(6) of this chapter; confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; frozen dairy dessert and mixes as defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings, and fillngs as defined in Sec. 170.3(n)(22) of this chapter; hard candy as defined in Sec. 170.3(n)(25) of this chapter; and soft candy as defined in Sec. 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [54 FR 7404, Feb. 21, 1989]

§ 184.1903 Tributyrin. (a) Tributyrin (C15H26O6, CAS Reg. No. 60-01-5), also known as butyrin or glyceryl tributyrate, is the triester of glycerin and butyric acid. It is prepared by esterification of glycerin with excess butyric acid. (b) The ingredient meets the specification of the Food Chemicals Codex, 3d Ed. (1981), p. 416, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20005. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generaly recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice; baked goods as defined in Sec. 170.3(n)(1) of this chapter; alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter; nonalcoholic beverages as defined in Sec. 170.3(n)(3) of this chapter; fats and oils as defined in Sec. 1176

§ 184.1923

170.3(n)(12) of this chapter; frozen dairy desserts and mixes as defined in Sec. 170.3(n)(20) of this chapter; gelatins, puddings and fillngs as defined in Sec. 170.3(n)(22) of this chapter; and soft candy as defined in Sec. 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, 1989]

§ 184.1911 Triethyl citrate. (a) Triethyl citrate (C12H20O7, CAS Reg. No. 77-93-0) is the triethyl ester of citric acid. It is prepared by esterifying citric acid with ethyl alcohol and occurs as an odorless, practically colorless, oily liquid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), p. 339, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter; a solvent and vehicle as defined in Sec. 170.3(o)(27) of this chapter; and a surface-active agent as defined in Sec. 170.3(o)(29) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. [59 FR 63897, Dec. 12, 1994]

§ 184.1914 Trypsin. (a) Trypsin (CAS Reg. No. 9002-07-7) is an enzyme preparation obtained from purified extracts of porcine or bovine pancreas. It is a white to tan amorphous powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.21.4). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. [60 FR 32911, June 26, 1995]

§ 184.1923 Urea. (a) Urea (CO(NH2)2, CAS Reg. No. 57-13-6) is the diamide of carbonic acid and is also known as carbamide. It is a white, odorless solid and is commonly produced from CO2 by ammonolysis or from cyanamide by hydrolysis. 1177

§ 184.1924

(b) FDA is developing food-grade specifications for urea in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter and as a fermentation aid. (2) The ingredient is used in yeast-raised bakery products; in alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter; and in gelatin products. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984]

§ 184.1924 Urease enzyme preparation from Lactobacillus fermentum. (a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic bacterium Lactobacillus fermentum. It contains the enzyme urease (CAS Reg. No. 9002-13-5), which facilitates the hydrolysis of urea to ammonia and carbon dioxide. It is produced by a pure culture fermentation process and by using materials that are generally recognized as safe (GRAS) or are food additives that have been approved for this use by the Food and Drug Administration (FDA). (b) The ingredient meets the general and additional requirements for enzyme preparations in the ``Food Chemicals Codex,’’ 3d ed. (1981), pp. 107-110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in wine, as defined in 27 CFR 2.5 and 4.10, as an enzyme as defined in Sec. 170.3(o)(9) of this chapter to convert urea to ammonia and carbon dioxide. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice is limited to use of this ingredient in wine to inhibit formation of ethyl carbamate. [57 FR 60473, Dec. 21, 1992]

§ 184.1930 Vitamin A. (a)(1) Vitamin A (retinol; CAS Reg. No. 68-26-8) is the alcohol 9,13-dimethyl-7-(1,1,5-trimethyl-6-cyclohexen-5yl)-7,9,11,13-nonatetraen-15-ol. It may be nearly odorless or have a mild fishy odor. Vitamin A is extracted from fish liver oils or produced by total synthesis from β-ionone and a propargyl halide. (2) Vitamin A acetate (retinyl acetate; CAS Reg. No. 127-47-9) is the acetate ester of retinol. It is prepared by esterifying retinol with acetic acid. (3) Vitamin A palmitate (retinyl palmitate; CAS Reg. No. 79-81-2) is the palmitate ester of retinol. It is prepared by esterifying retinol with palmitic acid. (b) The ingredient meets the specifications for vitamin A in the Food Chemicals Codex, 3d Ed. (1981), p. 342, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. 1178

§ 184.1950

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. Vitamin A may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51610, Nov. 10, 1983]

§ 184.1945 Vitamin B12. (a) Vitamin B12, also known as cyanocobalamin (C63H88CoN14O14P, CAS Reg. No. 68-0919-099), is produced commercially from cultures of Streptomyces griseus. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 343, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Vitamin B12 also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 6341, Feb. 15, 1985]

§ 184.1950 Vitamin D. (a) Vitamin D is added to food as the following food ingredients: (1) Crystalline vitamin D2(C28H44O, CAS Reg. No. 50-14-6), also known as ergocalciferol, is the chemical 9,10seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The ingredient is produced by ultraviolet irradiation of ergosterol isolated from yeast and related fungi and is purified by crystallization. (2) Crystalline vitamin D3(C27H44O, CAS Reg. No. 67-97-0), also known as cholecalciferol, is the chemical 9,10seco(5Z,7E,)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in, and is isolated from, fish liver oils. It is also manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol. It is purified by crystallization. Vitamin D3 is the vitamin D form that is produced endogenously in humans through sunlight activation of 7-dehydrocholesterol in the skin. (3) Vitamin D3 resin and vitamin D3 resin are the concentrated forms of irradiated ergosterol (D2) and irradiated 7dehydrocholesterol (D3) that are separated from the reacting materials in paragraphs (a) (1) and (2) of this section. The resulting products are sold as food sources of vitamin D without further purification. (b) Vitamin D2 and vitamin D3 as crystals meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 344 and 345, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. FDA is developing food-grade specifications for vitamin D D2 resin and vitamin D3 resin in cooperation with the National Academy of Sciences. In the interim, these resins must be of a purity suitable for their intended use. (c)(1) In accordance with Sec. 184.1(b)(2), the ingredients are used in food as the sole source of added vitamin D only within the following specific limitations:

1179

§ 184.1973

——————————————————————————————————————— Maximum levels in Category of food food (as served) Functional use ——————————————————————————————————————— Breakfast cereals, Sec. 350 (IU/100 grams) Nutrient 170.3(n)(4) of this chapter. supplement, Sec. 170.3(o)(20) of this chapter. Grain products and pastas, Sec. 90(IU/100 grams).. Do. 170.3(n)(23) of this chapter. Milk, Sec. 170.3(n)(30) of this 42 (IU/100 grams). Do. chapter. Milk products, Sec. 89 (IU/100 grams). Do. 170.3(n)(31) of this chapter. ———————————————————————————————————————

(2) Vitamin D may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (3) Vitamin D may be used in margarine in accordance with Sec. 166.110 of this chapter. (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. [50 FR 30152, July 24, 1985]

§ 184.1973 Beeswax (yellow and white). (a) Beeswax (CAS Reg. No. 8012-89-3) is a secretory product of honey bees used as a structural material in honeycombs. Beeswax is prepared from honeycombs after removal of the honey by draining or centrifuging. The combs are melted in hot water or steam or with solar heat, and strained. The wax is refined by melting in hot water to which sulfuric acid or alkali may be added to extract impurities. The resulting wax is referred to as yellow beeswax. White beeswax is produced by bleaching the constituent pigments of yellow beeswax with peroxides, or preferably it is bleached by sun light. (b) The ingredient meets the specifications of the ``Food Chemicals Codex,’’ 3d Ed. (1981), pp. 34-35, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter, as a lubricant as defined in Sec. 170.3(o)(18) of this chapter, and as a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter. (d) The ingredient is used in food, in accordance with Sec. 184.1(b)(1) of this chapter, at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of: 0.065 percent for chewing gum as defined in Sec. 170.3(n)(6) of this chapter; 0.005 percent for confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; 0.04 percent for hard candy as defined in Sec. 170.3(n)(25) of this chapter; 0.1 percent for soft candy as defined in Sec. 170.3(n)(38) of this chapter; and 0.002 percent or less for all other food categories. [43 FR 14644, Apr. 7, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 50 FR 49536, Dec. 3, 1985]

§ 184.1976 Candelilla wax. (a) Candelilla wax (CAS Reg. No. 8006-44-8) is obtained from the candelilla plant. It is a hard, yellowish-brown, opaque-to-translucent wax. Candelilla wax is prepared by immersing the plants in boiling water containing sulfuric acid and skimming off the wax that rises to the surface. It is composed of about 50 percent hydrocarbons with smaller amounts of esters and free acids. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 67, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: 1180

§ 184.1979

(1) The ingredient is used as a lubricant as defined in Sec. 170.3(o)(18) of this chapter and as a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: in chewing gum as defined in Sec. 170.3(n)(6) of this chapter and in hard candy as defined in Sec. 170.3(n)(25) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51617, Nov. 10, 1983]

§ 184.1978 Carnauba wax. (a) Carnauba wax (CAS Reg. No. 008-015-869) is obtained from the leaves and buds of the Brazilian wax palm Copernicia cerifera Martius. The wax is hard, brittle, sparingly soluble in cold organic solvents and insoluble in water. It is marketed in five grades designated No. 1 through No. 5. Grades No. 4 and No. 5 represent the bulk of the commercial trade volume. These commercial grades consist chiefly of C24 to C32 normal saturated monofunctional fatty acids and normal saturated monofunctional primary alcohols. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an anticaking agent as defined Sec. 170.3(o)(1) of this chapter; as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter; as a lubricant and release agent as defined in Sec. 170.3(o)(18) of this chapter; and as a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this chapter; chewing gun as defined in Sec. 170.3(n)(6) of this chapter; confections and frostings as defined in Sec. 170.3(n)(9) of this chapter; fresh fruits and fruit juices as defined in Sec. 170.3(n)(16) of this chapter; gravies and sauces as defined in Sec. 170.3(n)(24) of this chapter; processed fruits and fruit juices as defined in Sec. 170.3(n)(35) of this chapter; and soft candy as defined in Sec. 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [48 FR 51147, Nov. 7, 1983]

§ 184.1979 Whey. (a)(1) Whey. Whey is the liquid substance obtained by separating the coagulum from milk, cream, or skim milk in cheesemaking. Whey obtained from a procedure, in which a significant amount of lactose is converted to lactic acid, or from the curd formation by direct acidification of milk, is known as acid whey. Whey obtained from a procedure in which there is insignificant conversion of lactose to lactic acid is known as sweet whey. Sweet whey has a maximum titratable acidity of not more than 0.16 percent, calculated as lactic acid, and an alkalinity of ash of not more than 225 milliliters of 0.1N hydrochloric acid per 100 grams. The acidity of whey, sweet or acid, may be adjusted by the addition of safe and suitable pH-adjusting ingredients. (2) Concentrated whey. Concentrated whey is the liquid substance obtained by the partial removal of water from whey, while leaving all other constituents in the same relative proportions as in whey. (3) Dry or dried whey. Dry or dried whey is the dry substance obtained by the removal of water from whey, while leaving all other constituents in the same relative proportions as in whey. (b) The ingredients meet the following specifications: (1) The analysis of whey, concentrated whey, and dry (dried) whey, on a dry product basis, based on analytical methods in the referenced sections of ``Official Methods of Analysis of the Association of Official Analytical 1181

§ 184.1979a

Chemists,’’ 13th ed. (1980), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (i) Protein content, 10 to 15 percent—as determined by the methods prescribed in section 16.036 (liquid sample), entitled ``Total Nitrogen—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.193 (dry sample), entitled ``Kjeldahl Method’’ under the heading ``Protein—Official Final Action.’’ (ii) Fat content, 0.2 to 2.0 percent—as determined by the methods prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method [Reference Method] (11)—Official Final Action’’ under the heading ``Fat,’’ or in section 16.199 (dry sample), entitled ``Fat in Dried Milk (45)—Official Final Action.’’ (iii) Ash content, 7 to 14 percent—as determined by the methods prescribed in section 16.035 (liquid sample), entitled ``Ash (5)—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.196 (dry sample), entitled ``Ash—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (iv) Lactose content, 61 to 75 percent—as determined by the methods prescribed in section 16.057 (liquid sample), entitled ``Gravimetric Method—Official Final Action’’ under the heading ``Lactose,’’ or in section 31.061 (dry sample), entitled ``Lane-Eynon General Volumetric Method’’ under the heading ``Lactose—Chemical Methods— Official Final Action.’’ (v) Moisture content, 1 to 8 percent—as determined by the methods prescribed in section 16.192, entitled ``Moisture (41)—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (vi) Solids content, variable—as determined by the methods prescribed in section 16.032, entitled ``Method I— Official Final Action’’ under the heading ``Total Solids.’’ (vii) Titratable Acidity, variable—as determined by the methods prescribed in section 16.023, entitled ``Acidity (2)—Official Final Action’’ under the heading ``Milk,’’ or by an equivalent potentiometric method. (2) Limits of impurities are: Heavy metals (as lead). Not more than 10 parts per million (0.001 percent) as determined by the method described in the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 760-761, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (3) The whey must be derived from milk that has been pasteurized, or the whey and modified whey product must be subjected to pasteurization techniques or its equivalent before use in food. (c) Whey, concentrated whey, and dry (dried) whey may be used in food in accordance with good manufacturing practice as indicated in Sec. 184.1(b)(1). (d) The label on the whey form sold to food manufacturers shall read as follows: (1) For whey: ``(Sweet or acid) whey’’ or ``whey (——% titratable acidity). (2) For concentrated whey: ``Concentrated (sweet or acid) whey, ——% solids’’ or ``Concentrated whey (——% titratable acidity), ——% solids’’. (3) For dry (dried) whey: ``Dry (dried) (sweet or acid) whey’’ or ``dry (dried) whey, (——% titratable acidity)’’. (e) Whey, concentrated whey, or dry (dried) whey in a finished food product shall be listed as ``whey.’’ [46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, 1982, as amended at 54 FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, 1999]

§ 184.1979a Reduced lactose whey. (a) Reduced lactose whey is the substance obtained by the removal of lactose from whey. The lactose content of the finished dry product shall not exceed 60 percent. Removal of the lactose is accomplished by physical separation techniques such as precipitation, filtration, or dialysis. As with whey, reduced lactose whey can be used as a fluid, concentrate, or a dry product form. The acidity of reduced lactose whey may be adjusted by the addition of safe and suitable pH-adjusting ingredients. (b) The reduced lactose whey meets the following specifications: 1182

§ 184.1979b

(1) The analysis of reduced lactose whey, on a dry product basis, based on analytical methods in the referenced sections of ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th ed. (1980), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (i) Protein content, 16 to 24 percent—as determined by the methods prescribed in section 16.036 (liquid sample), entitled ``Total Nitrogen—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.193 (dry sample), entitled ``Kjeldahl Method’’ under the heading ``Protein—Official Final Action.’’ (ii) Fat content, 1 to 4 percent—as determined by the methods prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method [Reference Method] (11)—Official Final Action’’ under the heading ``Fat,’’ or in section 16.199 (dry sample), entitled ``Fat in Dried Milk (45)—Official Final Action.’’ (iii) Ash content, 11 to 27 percent—as determined by the methods prescribed in section 16.035 (liquid sample), entitled ``Ash (5)—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.196 (dry sample), entitled ``Ash—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (iv) Lactose content, not more than 60 percent—as determined by the methods prescribed in section 16.057 (liquid sample), entitled ``Gravimetric Method—Official Final Action’’ under the heading ``Lactose,’’ or in section 31.061 (dry sample), entitled ``Lane-Eynon General Volumetric Method’’ under the heading ``Lactose—Chemical Methods—Official Final Action.’’ (v) Moisture content, 1 to 6 percent—as determined by the method prescribed in section 16.192, entitled ``Moisture (41)—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (vi) Solids content, variable—as determined by the methods prescribed in section 16.032, entitled ``Method I— Official Final Action’’ under the heading ``Total Solids.’’ (vii) Titratable Acidity, variable—as determined by the methods prescribed in section 16.023, entitled ``Acidity (2)—Official Final Action’’ under the heading ``Milk,’’ or by an equivalent potentiometric method. (2) Limits of impurities are: Heavy metals (as lead). Not more than 10 parts per million (0.001 percent), as determined by the method described in the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 760-761, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (3) The reduced lactose whey shall be derived from milk that has been pasteurized, or the reduced lactose whey shall be subjected to pasteurization techniques or its equivalent before use in food. (c) Reduced lactose whey may be used in food in accordance with good manufacturing practice as indicated in Sec. 184.1(b)(1). (d) The percent of lactose present on a dry product basis, i.e., ``reduced lactose whey (——% lactose),’’ shall be declared on the label of the package sold to food manufacturers. The percent of lactose may be declared in 5-percent increments, expressed as a multiple of 5, not greater than the actual percentage of lactose in the product, or as a actual percentage provided that an analysis of the product on which the actual percentage is based is supplied to the food manufacturer. (e) The presence of reduced lactose whey in a finished food product shall be listed as ``reduced lactose whey.’’ [46 FR 44440, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 64 FR 1760, Jan. 12, 1999]

§ 184.1979b Reduced minerals whey. (a) Reduced minerals whey is the substance obtained by the removal of a portion of the minerals from whey. The dry product shall not contain more than 7 percent ash. Reduced minerals whey is produced by physical separation techniques such as precipitation, filtration, or dialysis. As with whey, reduced minerals whey can be used as a fluid, concentrate, or a dry product form. The acidity of reduced minerals whey may be adjusted by the additional of safe and suitable pH-adjusting ingredients. 1183

§ 184.1979c

(b) The reduced minerals whey meets the following specifications: (1) The analysis of reduced minerals whey, on a dry product basis, based on analytical methods in the referenced sections of ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th ed. (1980), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (i) Protein content, 10 to 24 percent—as determined by the methods prescribed in section 16.036 (liquid sample), entitled ``Total Nitrogen—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.193 (dry sample), entitled ``Kjeldahl Method’’ under the heading ``Protein—Official Final Action.’’ (ii) Fat content, 1 to 4 percent—as determined by the methods prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method [Reference Method] (11)—Official Final Action’’ under the heading ``Fat,’’ or in section 16.199 (dry sample), entitled ``Fat in Dried Milk (45)—Official Final Action.’’ (iii) Ash content, maximum 7 percent—as determined by the methods prescribed in section 16.035 (liquid sample), entitled ``Ash (5)—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.196 (dry sample), entitled ``Ash—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (iv) Lactose content, maximum 85 percent—as determined by the methods prescribed in section 16.057 (liquid sample), entitled ``Gravimetric Method—Official Final Action’’ under the heading ``Lactose,’’ or in section 31.061 (dry sample), entitled ``Lane-Eynon General Volumetric Method’’ under the heading ``Lactose—Chemical Methods—Official Final Action.’’ (v) Moisture content, 1 to 6 percent—as determined by the methods prescribed in section 16.192, entitled ``Moisture (41)—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (vi) Solids content, variable—as determined by the methods prescribed in section 16.032, entitled ``Method I— Official Final Action’’ under the heading ``Total Solid.’’ (vii) Titratable Acidity, variable—as determined by the methods prescribed in section 16.023, entitled ``Acidity (2)—Official Final Action’’ under the heading ``Milk,’’ or by an equivalent potentiometric method. (2) Limits of impurities are: Heavy metals (as lead). Not more than 10 parts per million (0.001 percent), as determined by the method described in the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 760-761, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (3) The reduced minerals whey shall be derived from milk that has been pasteurized, or the reduced minerals whey shall be subjected to pasteurization techniques or its equivalent before use in food. (c) The reduced minerals whey may be used in food in accordance with good manufacturing practice as indicated in Sec. 184.1(b)(1). (d) The percent of minerals present on a dry product basis, i.e., ``reduced minerals whey (——% minerals),’’ shall be declared on the label of the package sold to food manufacturers. The percent of minerals may be declared in 2percent increments expressed as a multiple of 2, not greater than the actual percentage of minerals in the product, or as an actual percentage provided that an analysis of the product on which the actual percentage is based is supplied to the food manufacturer. (e) The presence of reduced minerals whey in a finished food product shall be listed as ``reduced minerals whey’’. [46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, 1999]

§ 184.1979c Whey protein concentrate. (a) Whey protein concentrate is the substance obtained by the removal of sufficient nonprotein constituents from whey so that the finished dry product contains not less than 25 percent protein. Whey protein concentrate is produced by physical separation techniques such as precipitation, filtration, or dialysis. As with whey, whey protein concentrate can be used as a fluid, concentrate, or dry product form. The acidity of whey protein concentrate may be adjusted by the addition of safe and suitable pH-adjusting ingredients. 1184

§ 184.1983

(b) The whey protein concentrate meets the following specifications: (1) The analysis of whey protein concentrate, on a dry product basis, based on analytical methods in the referenced sections of ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th ed. (1980), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (i) Protein content, minimum 25 percent—as determined by the methods prescribed in section 16.036 (liquid sample), entitled ``Total Nitrogen—Officials Final Action’’ under the heading ``Total Solids,’’ or in section 16.193 (dry sample), entitled ``Kjeldahl Method’’ under the heading ``Protein—Official Final Action.’’ (ii) Fat content, 1 to 10 percent—as determined by the methods prescribed in section 16.059 (liquid sample), ``Reese-Gottlieb Method [Reference Method] (11)—Official Final Action’’ under the heading ``Fat,’’ or in section 16.199 (dry sample), entitled ``Fat in Dried Milk (45)—Official Final Action.’’ (iii) Ash content, 2 to 15 percent—as determined by the methods prescribed in section 16.035 (liquid sample), entitled ``Ash (5)—Official Final Action’’ under the heading ``Total Solids,’’ or in section 16.196 (dry sample), entitled ``Ash—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (iv) Lactose content, maximum 60 percent—as determined by the methods prescribed in section 16.057 (liquid sample), entitled ``Gravimetric Method—Official Final Action’’ under the heading ``Lactose,’’ or in section 31.061 (dry sample), entitled ``Lane-Eynon General Volumetric Method’’ under the heading ``Lactose—Chemical Methods—Official Final Action.’’ (v) Moisture content, 1 to 6 percent—as determined by the methods prescribed in section 16.192, entitled ``Moisture (41)—Official Final Action’’ under the heading ``Dried Milk, Nonfat Dry Milk, and Malted Milk.’’ (vi) Solids content, variable—as determined by the methods prescribed in section 16.032, entitled ``Method I— Official Final Action’’ under the heading ``Total Solids.’’ (vii) Titratable Acidity, variable—as determined by the methods prescribed in section 16.023, entitled ``Acidity (2)—Official Final Action’’ under the heading ``Milk,’’ or by an equivalent potentiometric method. (2) Limits of impurities are: Heavy metals (as lead). Not more than 10 parts per million (0.001 percent), as determined by the method described in the ``Food Chemicals Codex,’’ 4th ed. (1996), pp. 760-761, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://www.nap.edu’’), or may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (3) The whey protein concentrate shall be derived from milk that has been pasteurized, or the whey protein concentrate shall be subjected to pasteurization techniques or its equivalent before use in food. (c) The whey protein concentrate may be used in food in accordance with good manufacturing practice as indicated in Sec. 184.1(b)(1). (d) The percent of protein present on a dry product basis, i.e., ``whey protein concentrate (——% protein),’’ shall be declared on the label of the package sold to food manufacturers. The percent of protein may be declared in 5percent increments, expressed as a multiple of 5, not greater than the actual percentage of protein in the product, or as an actual percentage provided that an analysis of the product on which the actual percentage is based is supplied to the food manufacturer. (e) The presence of whey protein concentrate in a finished food product shall be listed as ``whey protein concentrate’’. [46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12, 1989; 64 FR 1761, Jan. 12, 1999]

§ 184.1983 Bakers yeast extract. (a) Bakers yeast extract is the food ingredient resulting from concentration of the solubles of mechanically ruptured cells of a selected strain of yeast, Saccharomyces cerevisiae. It may be concentrated or dried. (b) The ingredient meets the following specifications on a dry weight basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc. 1185

§ 184.1984

(c) The viable microbial content of the finished ingredient as a (1) Less than 10,000 organisms/gram by aerobic plate count. (2) Less than 10 yeasts and molds/gram. (3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium , or any other recognized microbial pathogen or any harmful microbial toxin. (d) The ingredient is used as a flavoring agent and adjuvant as defined in Sec. 170.3(o)(12) of this chapter at a level not to exceed 5 percent in food. (e) This regulation is issued prior to general evaluation of use of this ingredient in order to affirm as GRAS the specific use named. § 184.1984 Zein. (a) Zein (CAS Reg. No. 9010-66-6) is one of the components of corn gluten. It is produced commercially by extraction from corn gluten with alkaline aqueous isopropyl alcohol containing sodium hydroxide. The extract is then cooled, which causes the zein to precipitate. (b) FDA is developing food-grade specifications for zein in cooperation with the National Academy of Sciences. In the interim, the igredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a surface-finishing agent as defined in Sec. 170.3(o)(30) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [50 FR 8999, Mar. 6, 1985]

§ 184.1985 Aminopeptidase enzyme preparation derived from lactococcus lactis. (a) Aminopeptidase enzyme preparation is derived from the nonpathogenic and nontoxicogenic bacterium Lactococcus lactis (previously named Streptococcus lactis). The preparation contains the enzyme aminopeptidase (CAS Reg. No. 9031-94-1; EC 3.4.11.1) and other peptidases that hydrolyze milk proteins. The preparation is produced by pure culture fermentation. (b) The ingredient meets the specifications for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), pp. 107-110, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., suite 1200, Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as an enzyme, as defined in Sec. 170.3(o)(9) of this chapter, as an optional ingredient for flavor development in the manufacture of cheddar cheese, in accordance with Sec. 133.113 of this chapter, and in the preparation of protein hydrolysates. (2) The ingredient is used at levels not to exceed current good manufacturing practice. [60 FR 54193, Oct. 20, 1995]

1186

Part 186

PART 186—INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE Subpart A—General Provisions Sec. 186.1

Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).

Subpart B—Listing of Specific Substances Affirmed as GRAS 186.1093 186.1256 186.1275 186.1300 186.1316 186.1374 186.1551 186.1555 186.1557 186.1673 186.1750 186.1756 186.1770 186.1771 186.1797 186.1839

Sulfamic acid. Clay (kaolin). Dextrans. Ferric oxide. Formic acid. Iron oxides. Hydrogenated fish oil. Japan wax. Tall oil. Pulp. Sodium chlorite. Sodium formate. Sodium oleate. Sodium palmitate. Sodium sulfate. Sorbose.

AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14658, Mar. 15, 1977, unless otherwise noted.

Subpart A—General Provisions § 186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS). (a) The indirect human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed, providing they comply with the purity specifications listed in this part or, in the absence of purity specifications, are of a purity suitable for their intended use in accordance with Sec. 170.30(h)(1) of this chapter. Certain ingredients in this part may also be used in food-contact surfaces in accordance with parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter. Ingredients affirmed as GRAS for direct use in part 184 of this chapter are also GRAS as indirect human food ingredients in accordance with Sec. 184.1(a) of this chapter. (b) The regulations in this part do not authorize direct addition of any food ingredient to a food. They authorize only the use of these ingredients as indirect ingredients of food, through migration from their immediate wrapper, container, or other food-contact surface. Any ingredient affirmed as GRAS in this part shall be used in accordance with current good manufacturing practice. For the purpose of this part, current good manufacturing practice includes the requirements that an indirect human food ingredient be of a purity suitable for its intended use, and that it be used at a level no higher than reasonably required to achieve its intended technical effect in the food-contact article. (1) If the ingredient is affirmed as GRAS with no limitations on its conditions of use other than current good manufacturing practice, it shall be regarded as GRAS if its conditions of use are consistent with the requirements of paragraphs (b), (c), and (d) of this section. When the Food and Drug Administration (FDA) determines that it is appropriate, the agency will describe one or more current good manufacturing practice conditions of use in the regulation that affirms the GRAS status of the indirect ingredient. For example, when the safety of an ingredient has been evaluated on the basis of limited conditions of use, the agency will describe in the regulation that affirms the GRAS status of the indirect ingredient, one or more of these limited conditions of use, which may include the 1187

§ 186.1093

category of food-contact surface(s), technical effect(s) or functional use(s) of the indirect ingredient, and the level(s) of use. If the ingredient is used under conditions that are significantly different from those described in the regulation, such use of a substance may not be GRAS. In such a case, a manufacturer may not rely on the regulation as authorizing that use but shall independently establish that the use is GRAS or shall use the ingredient in accordance with a food additive regulation. Persons seeking FDA approval of an independent determination that a use of an ingredient is GRAS may submit a GRAS petition in accordance with Sec. 170.35 of this chapter. (2) If the ingredient is affirmed as GRAS with specific limitation(s), it shall be used in food-contact surfaces only within such limitation(s), including the category of food-contact surface(s), the functional use(s) of the ingredient, and the level(s) of use. Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation. (3) If the ingredient is affirmed as GRAS for a specific use, prior to general evaluation of use of the ingredient, other uses may also be GRAS. (c) The listing of a food ingredient in this part does not authorize the use of such substance for the purpose of adding the ingredient to the food through extraction from the food-contact surface. (d) The listing of a food ingredient in this part does not authorize the use of such substance in a manner that may lead to deception to the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act). (e) If the Commissioner of Food and Drugs is aware of any prior sanction for use of an ingredient under conditions different from those proposed to be affirmed as GRAS, he will concurrently propose a separate regulation covering such use of the ingredient under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal. [42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19, 1983]

Subpart B—Listing of Specific Substances Affirmed as GRAS § 186.1093 Sulfamic acid. (a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329-14-6) is a white crystalline solid manufactured from urea, sulfur trioxide, and sulfuric acid. It is soluble and highly ionized in water. (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as an indirect food ingredient with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the current good manufacturing practice of using this ingredient in the manufacture of paper and paperboard that contact food. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [47 FR 29954, July 9, 1982]

§ 186.1256 Clay (kaolin). (a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332-58-7) consists of hydrated aluminum silicate. The commercial products of clay (kaolin) contain varying quantities of alkalies and alkaline earths. Clay (kaolin) is a white to yellowish or grayish fine powder. There are at least three different minerals, kaolinite, dickite, and nacrite, classified as kaolin. Kaolinite or china clay is whiter, less contaminated with extraneous minerals, and less plastic in water. 1188

§ 186.1316

(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used in the manufacture of paper and paperboard that contact food. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [47 FR 43367, Oct. 1, 1982]

§ 186.1275 Dextrans. (a) Dextrans (CAS Reg. No. 9004-54-0) are high molecular weight polysaccharides produced by bacterial fermentation of sucrose. Commercially available dextrans are synthesized from sucrose by Leuconostoc mesenteroides strain NRRL B-512(F). Partial depolymerization and purification of the fermented mixture shall produce a product that is free of viable microorganisms. (b) The ingredient is used or intended for use as a constituent of food-contact surfaces. (c) The ingredient is used at levels not to exceed good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983]

§ 186.1300 Ferric oxide. (a) Ferric oxide (iron (III) oxide, Fe2O3, CAS Reg. No. 1309-37-1) occurs naturally as the mineral hematite. It may be prepared synthetically by heating brown iron hydroxide oxide. The product is red-brown to black trigonal crystals. (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a constituent of paper and paperboard used for food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]

§ 186.1316 Formic acid. (a) Formic acid (CH2O2, CAS Reg. No. 64-18-6) is also referred to as methanoic acid or hydrogen carboxylic acid. It occurs naturally in some insects and is contained in the free acid state in a number of plants. Formic acid is prepared by the reaction of sodium formate with sulfuric acid and is isolated by distillation. (b) Formic acid is used as a constituent of paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with Sec. 186.1(b)(1). (d) Prior sanctions for formic acid different from the uses established in this section do not exist or have been waived. [45 FR 22915, Apr. 4, 1980]

1189

§ 186.1374

§ 186.1374 Iron oxides. (a) Iron oxides (oxides of iron, CAS Reg. No. 97705-33-85) are undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black cubic crystals) and iron (III) oxide (CAS Reg. No. 1309-37-1, red-brown to black trigonal crystals). (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a constituent of paper and paperboard used for food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]

§ 186.1551 Hydrogenated fish oil. (a) Hydrogenated fish oil (CAS Reg. No. 91078-95-4) is a class of oils produced by partial hydrogenation of oils expressed from fish, primarily menhaden, and secondarily herring or tuna. Hydrogenation of fish oils uses catalysts composed of either elemental nickel, elemental copper, or a mixture of these elements. The crude hydrogenated fish oil is further processed by alkali refining, bleaching, and deodorization by steam stripping. (b) Hydrogenation of fish oils results in a final product with a melting point greater than 32 °C as determined by Section Cc 1-25, Official and Tentative Methods of the American Oil Chemists’ Society method (reapproved 1973) or equivalent. The product has an approximate fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to 55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3 to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic or higher polyenoic fatty acids. The approximate percentages of total fatty acids by carbon chain length are 15 to 30 percent each of C16, C18, C20, C22, less than 10 percent C14 or lower carbon chain length, and less than 1 percent C24 or higher carbon chain length fatty acids. (c) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging. (d) The ingredient is used at levels not to exceed good manufacturing practice in accordance with Sec. 186.1(b)(1). (e) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. [44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14. 1984; 58 FR 17099, Apr. 1, 1993]

§ 186.1555 Japan wax. (a) Japan wax (CAS Reg. No. 8001-39-6), also known as Japan tallow or sumac wax, is a pale yellow vegetable tallow, containing glycerides of the C19−C23 dibasic acids and a high content of tripalmitin. It is prepared from the mesocarp by hot pressing of immature fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan, and IndoChina), R. vernicifera (Japan), and R. trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble in hot alcohol, benzene, and naphtha, and insoluble in water and in cold alcohol. (b) In accordance with paragraph (b)(1) of this section, the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based on the following current good manufacturing practice conditions of use: (1) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [60 FR 62208, Dec. 5, 1995] 1190

§ 186.1770

§ 186.1557 Tall oil. (a) Tall oil (CAS Reg. No. 8002-26-4) is essentially the sap of the pine tree. It is obtained commercially from the waste liquors of pinewood pulp mills and consists mainly of tall oil resin acids and tall oil fatty acids. (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as an indirect human food ingredient with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based on the following current good manufacturing practice conditions of use: (1) The ingredient is used as a constituent of cotton and cotton fabrics used for dry food packaging. (2) The ingredient is used at levels not to exceed current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section, or from those listed in part 181 of this chapter, do not exist or have been waived. [51 FR 16830, May 7, 1986]

§ 186.1673 Pulp. (a) Pulp is the soft, spongy pith inside the stem of a plant such as wood, straw, sugarcane, or other natural plant sources. (b) The ingredient is used or intended for use as a constituent of food packaging containers. (c) The ingredient is used in paper and paperboard made by conventional paper-making processes at levels not to exceed good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. § 186.1750 Sodium chlorite. (a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758-19-2) exists as slightly hygroscopic white crystals or flakes. It is manufactured by passing chlorine dioxide into a solution of sodium hydroxide and hydrogen peroxide. (b) the ingredient is used at levels from 125 to 250 parts per million as a slimicide in the manufacture of paper and paperboard that contact food. [45 FR 16470, Mar. 14, 1980]

§ 186.1756 Sodium formate. (a) Sodium formate (CHNaO2, CAS Reg. No. 141-53-7) is the sodium salt of formic acid. It is produced by the reaction of carbon monoxide with sodium hydroxide. (b) The ingredient is used as a constituent of paper and paperboard used for food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with Sec. 186.1(b)(1). (d) Prior sanctions for sodium formate different from the uses established in this section do not exist or have been waived. [45 FR 22915, Apr. 4, 1980]

§ 186.1770 Sodium oleate. (a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143-19-1) is the sodium salt of oleic acid (cis-9-octadecenoic acid). It exists as a white to yellowish powder with a slight tallow-like odor. Commercially, sodium oleate is made by mixing and heating flaked sodium hydroxide and oleic acid. (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a constituent of paper and paperboard for food packaging and as a component of lubricants with incidental food contact in accordance with Sec. 178.3570 of this chapter, with no limitation other than current good manufacturing practice. 1191

§ 186.1771

(c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 39372, Oct. 28, 1986]

§ 186.1771 Sodium palmitate. (a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408-35-5) is the sodium salt of palmitic acid (hexadecanoic acid). It exists as a white to yellow powder. Commercially, sodium palmitate is made by mixing and heating flaked sodium hydroxide and palmitic acid. (b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a constituent of paper and paperboard for food packaging with no limitation other than current good manufacturing practice. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [51 FR 39372, Oct. 28, 1986]

§ 186.1797 Sodium sulfate. (a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757-82-6), also known as Glauber’s salt, occurs naturally and exists as colorless crystals or as a fine, white crystalline powder. It is prepared by the neutralization of sulfuric acid with sodium hydroxide. (b) The ingredient is used as a constituent of paper and paperboard used for food packaging, and cotton and cotton fabric used for dry food packaging. (c) The ingredient is used at levels not to exceed good manufacturing practice in accordance with Sec. 186.1(b)(1). (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [45 FR 6086, Jan. 25, 1980]

§ 186.1839 Sorbose. (a) Sorbose (L-sorbose, sorbinose) (C6H12O6, CAS Reg. No. 87-79-6) is an orthorhombic, bisphenoidal crystalline ketohexose. It was originally identifed in the juice of mature berries from the mountain ash (Sorbus aucuparia) where it occurs as the result of microbial oxidation of sorbitol. It also occurs naturally in other plants. Sorbose can be synthesized by the catalytic hydrogenation of glucose to D-sorbitol. The resulting sorbitol can be oxidized by Acetobacter xylinum or by Acetobacter suboxydans. (b) The ingredient is used or intended for indirect food use as a constituent of cotton, cotton fabrics, paper, and paperboard in contact with dry food. (c) The ingredient migrates to food at levels not to exceed good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19, 1983]

1192

§ 189.1

PART 189—SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD Subpart A—General Provisions Sec. 189.1

Substances prohibited from use in human food.

Subpart B—Substances Generally Prohibited From Direct Addition or Use as Human Food 189.110 189.113 189.120 189.130 189.135 189.140 189.145 189.155 189.165 189.175 189.180 189.190 189.191

Calamus and its derivatives. Cinnamyl anthranilate. Cobaltous salts and its derivatives. Coumarin. Cyclamate and its derivatives. Diethylpyrocarbonate (DEPC). Dulcin. Monochloroacetic acid. Nordihydroguaiaretic acid (NDGA). P-4000. Safrole. Thiourea. Chlorofluorocarbon propellants.

Subpart C—Substances Prohibited From Indirect Addition to Human Food Through Food-Contact Surfaces 189.220 189.240 189.250 189.280 189.300 189.301

Flectol H. Lead solders. Mercaptoimidazoline and 2-mercaptoimidazoline. 4,4’-Methylenebis (2-chloroanaline). Hydrogenated 4,4’-isopropylidene-diphenolphosphite ester resins. Tin-coated lead foil capsules for wine bottles.

AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14659, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 189 appear at 61 FR 14482, Apr. 2, 1996, and on 66 FR 56035, Nov. 6, 2001.

Subpart A—General Provisions § 189.1 Substances prohibited from use in human food. (a) The food ingredients listed in this section have been prohibited from use in human food by the Food and Drug Administration because of a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in human food. Use of any of these substances in violation of this section causes the food involved to be adulterated in violation of the act. (b) This section includes only a partial list of substances prohibited from use in human food, for easy reference purposes, and is not a complete list of substances that may not lawfully be used in human food. No substance may be used in human food unless it meets all applicable requirements of the act. (c) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish, amend, or repeal a regulation under this section on the basis of new scientific evaluation or information. Any such petition shall include an adequate scientific basis to support the petition, pursuant to part 10 of this chapter, and will be published for comment if it contains reasonable grounds. [42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989]

1193

§ 189.110

Subpart B—Substances Generally Prohibited From Direct Addition or Use as Human Food § 189.110 Calamus and its derivatives. (a) Calamus is the dried rhizome of Acorus calamus L. It has been used as a flavoring compound, especially as the oil or extract. (b) Food containing any added calamus, oil of calamus, or extract of calamus is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of May 9, 1968 (33 FR 6967). (c) The analytical method used for detecting oil of calamus (β-asarone) is in the ``Journal of the Association of Official Analytical Chemists,’’ Volume 56, (Number 5), pages 1281 to 1283, September 1973, which is incorporated by reference. Copies are available from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, also from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19, 1982; 54 FR 24899, June 12, 1989]

§ 189.113 Cinnamyl anthranilate. (a) The food additive cinnamyl anthranilate (C16H15NO2, CAS Reg. No. 87-29-6) is the ester of cinnamyl alcohol and anthranilic acid. Cinnamyl anthranilate is a synthetic chemical that has not been identified in natural products at levels detectable by available methodology. It has been used as a flavoring agent in food. (b) Food containing any added cinnamyl anthranilate is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of October 23, 1985. [50 FR 42932, Oct. 23, 1985]

§ 189.120 Cobaltous salts and its derivatives. (a) Cobaltous salts are the chemicals, CoC4H6O4, CoCl2, and CoSO4.They have been used in fermented malt beverages as a foam stabilizer and to prevent ``gushing.’’ (b) Food containing any added cobaltous salts is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of August 12, 1966 (31 FR 8788). § 189.130 Coumarin. (a) Coumarin is the chemical 1,2-benzopyrone, C9H6O2. It is found in tonka beans and extract of tonka beans, among other natural sources, and is also synthesized. It has been used as a flavoring compound. (b) Food containing any added coumarin as such or as a constituent of tonka beans or tonka extract is deemed to be adulterated under the act, based upon an order published in the Federal Register of March 5, 1954 (19 FR 1239). (c) The analytical methods used for detecting coumarin in food are in sections 19.016-19.024 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

§ 189.135 Cyclamate and its derivatives. (a) Calcium, sodium, magnesium and potassium salts of cyclohexane sulfamic acid, (C6H12NO3S)2Ca, (C6H12NO3S)Na, (C6H12NO3S)2Mg, and (C6H12NO3S)K. Cyclamates are synthetic chemicals having a sweet taste 1194

§ 189.155

30 to 40 times that of sucrose, are not found in natural products at levels detectable by the official methodology, and have been used as artificial sweeteners. (b) Food containing any added or detectable level of cyclamate is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of October 21, 1969 (34 FR 17063). (c) The analytical methods used for detecting cyclamate in food are in sections 20.162-20.172 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

§ 189.140 Diethylpyrocarbonate (DEPC). (a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl ester, C6H10O5. It is a synthetic chemical not found in natural products at levels detectable by available methodology and has been used as a ferment inhibitor in alcoholic and nonalcoholic beverages. (b) Food containing any added or detectable level of DEPC is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of August 2, 1972 (37 FR 15426). § 189.145 Dulcin. (a) Dulcin is the chemical 4-ethoxyphenylurea, C9H12N2O2. It is a synthetic chemical having a sweet taste about 250 times that of sucrose, is not found in natural products at levels detectable by the official methodology, and has been proposed for use as an artificial sweetener. (b) Food containing any added or detectable level of dulcin is deemed to be adulterated in violation of the act, based upon an order published in the Federal Register of January 19, 1950 (15 FR 321). (c) The analytical methods used for detecting dulcin in food are in sections 20.173-20.176 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

§ 189.155 Monochloroacetic acid. (a) Monochloroacetic acid is the chemical chloroacetic acid, C2H3C1O2. It is a synthetic chemical not found in natural products, and has been proposed as a preservative in alcoholic and nonalcoholic beverages. Monochloroacetic acid is permitted in food package adhesives with an accepted migration level up to 10 parts per billion (ppb) under Sec. 175.105 of this chapter. The official methods do not detect monochloroacetic acid at the 10 ppb level. (b) Food containing any added or detectable level of monochloroacetic acid is deemed to be adulterated in violation of the act based upon trade correspondence dated December 29, 1941 (TC-377). (c) The analytical methods used for detecting monochloroacetic acid in food are in sections 20.067-20.072 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

1195

§ 189.165

§ 189.165 Nordihydroguaiaretic acid (NDGA). (a) Nordihydroguaiaretic acid is the chemical 4,4’-(2,3-dimethyltetramethylene) dipyrocatechol, C18H22O4. It occurs naturally in the resinous exudates of certain plants. The commercial product, which is synthesized, has been used as an antioxidant in foods. (b) Food containing any added NDGA is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of April 11, 1968 (33 FR 5619). (c) The analytical method used for detecting NDGA in food is in section 20.008(b) of the ``Official Methods of Analysis of the Association of Official Analytical Chemists International,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989]

§ 189.175 P-4000. (a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, C9H12N2O3. It is a synthetic chemical having a sweet taste about 4000 times that of sucrose, is not found in natural products at levels detectable by the official methodology, and has been proposed for use as an artificial sweetener. (b) Food containing any added or detectable level of P-4000 is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of January 19, 1950 (15 FR 321). (c) The analytical methods used for detecting P-4000 in food are in sections 20.177-20.181 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989]

§ 189.180 Safrole. (a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene, C10H10O2. It is a natural constituent of the sassafras plant. Oil of sassafras is about 80 percent safrole. Isosafrole and dihydrosafrole are derivatives of safrole, and have been used as flavoring compounds. (b) Food containing any added safrole, oil of sassafras, isosafrole, or dihydrosafrole, as such, or food containing any safrole, oil of sassafras, isosafrole, or dihydrosafrole, e.g., sassafras bark, which is intended solely or primarily as a vehicle for imparting such substances to another food, e.g., sassafras tea, is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of December 3, 1960 (25 FR 12412). (c) The analytical method used for detecting safrole, isosafrole and dihydrosafrole is in the ``Journal of the Association of Official Analytical Chemists,’’ Volume 54 (Number 4), pages 900 to 902, July 1971, which is incorporated by reference. Copies are available from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 42 FR 56729, Oct. 28, 1977; 47 FR 11855, Mar. 19, 1982; 54 FR 24900, June 12, 1989]

§ 189.190 Thiourea. (a) Thiourea is the chemical thiocarbamide, CH4N2S. It is a synthetic chemical, is not found in natural products at levels detectable by the official methodology, and has been proposed as an antimycotic for use in dipping citrus. (b) Food containing any added or detectable level of thiourea is deemed to be adulterated under the act. 1196

§ 189.280

(c) The analytical methods used for detecting thiourea are in sections 20.115-20.126 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. [42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24900, June 12, 1989]

§ 189.191 Chlorofluorocarbon propellants. The use of chlorofluorocarbons in human food as propellants in self-pressurized containers is prohibited as provided by Sec. 2.125 of this chapter. [43 FR 11317, Mar. 17, 1978]

Subpart C—Substances Prohibited From Indirect Addition to Human Food Through Food-Contact Surfaces § 189.220 Flectol H. (a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, polymerized, C12H15N. It is a synthetic chemical not found in natural products, and has been used as a component of food packaging adhesives. (b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of April 7, 1967 (32 FR 5675). [42 FR 14659, Mar.15, 1977, as amended at 58 FR 17099, Apr. 1, 1993]

§ 189.240 Lead solders. (a) Lead solders are alloys of metals that include lead and are used in the construction of metal food cans. (b) Food packaged in any container that makes use of lead in can solder is deemed to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act, based upon an order published in the Federal Register of June 27, 1995. [60 FR 33109, June 27, 1995]

§ 189.250 Mercaptoimidazoline and 2-mercaptoimidazoline. (a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the molecular formula C3H6N2S. They are synthetic chemicals not found in natural products and have been used in the production of rubber articles that may come into contact with food. (b) Food containing any added or delectable levels of these substances is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of November 30, 1973 (38 FR 33072). § 189.280 4,4’-Methylenebis (2-chloroanaline). (a) 4,4’-Methylenebis (2-chloroanaline) has the molecular formula, C13H12Cl2N2. It is a synthetic chemical not found in natural products and has been used as a polyurethane curing agent and as a component of food packaging adhesives and polyurethane resins. (b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of December 2, 1969 (34 FR 19073).

1197

§ 189.300

§ 189.300 Hydrogenated 4,4’-isopropylidene-diphenolphosphite ester resins. (a) Hydrogenated 4,4’-isopropylidene-diphenolphosphite ester resins are the condensation product of 1 mole of triphenyl phosphite and 1.5 moles of hydrogenated 4,4’-isopropylidene-diphenol such that the finished resins have a molecular weight in the range of 2,400 to 3,000. They are synthetic chemicals not found in natural products and have been used as antioxidants and as stabilizers in vinyl chloride polymer resins when such polymer resins are used in the manufacture of rigid vinyl chloride polymer bottles. (b) Food containing any added or detectable levels of these substances is deemed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act, based upon an order published in the Federal Register of September 9, 1987 (52 FR 33929). [54 FR 7188, Feb. 17, 1989]

§ 189.301 Tin-coated lead foil capsules for wine bottles. (a) Tin-coated lead foil is composed of a lead foil coated on one or both sides with a thin layer of tin. Tin-coated lead foil has been used as a capsule (i.e., as a covering applied over the cork and neck areas) on wine bottles to prevent insect infestation, as a barrier to oxygen, and for decorative purposes. Information received by the Food and Drug Administration establishes that the use of such a capsule on wine bottles may reasonably be expected to result in lead becoming a component of the wine. (b) The capping of any bottles of wine after February 8, 1996, with a tin-coated lead foil capsule renders the wine adulterated and in violation of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act because lead from the capsule, which is an unsafe food additive within the meaning of section 409 of the act, may reasonably be expected to become a component of the wine. [61 FR 4820, Feb. 8, 1996]

PART 190—DIETARY SUPPLEMENTS Subpart A [Reserved] Subpart B—New Dietary Ingredient Notification § 190.6 Requirement for premarket notification. (a) At least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, information including any citation to published articles that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. An original and two copies of this notification shall be submitted. (b) The notification required by paragraph (a) of this section shall include: (1) The name and complete address of the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient; (2) The name of the new dietary ingredient that is the subject of the premarket notification, including the Latin binomial name (including the author) of any herb or other botanical; (3) A description of the dietary supplement or dietary supplements that contain the new dietary ingredient including: (i) The level of the new dietary ingredient in the dietary supplement; and (ii) The conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement; 1198

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(4) The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe, including any citation to published articles or other evidence that is the basis on which the distributor or manufacturer of the dietary supplement that contains the new dietary ingredient has concluded that the new dietary supplement will reasonably be expected to be safe. Any reference to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and (5) The signature of the person designated by the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient. (c) FDA will acknowledge its receipt of a notification made under section 413 of the Federal Food, Drug, and Cosmetic Act (the act) and will notify the submitter of the date of receipt of such a notification. The date that the agency receives the notification submitted under paragraph (a) of this section is the filing date for the notification. For 75 days after the filing date, the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient shall not introduce, or deliver for introduction, into interstate commerce the dietary supplement that contains the new dietary ingredient. (d) If the manufacturer or distributor of a dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient, provides additional information in support of the new dietary ingredient notification, the agency will review all submissions pertaining to that notification, including responses made to inquiries from the agency, to determine whether they are substantive and whether they require that the 75-day period be reset. If the agency determines that the new submission is a substantive amendment, FDA will assign a new filing date. FDA will acknowledge receipt of the additional information and, when applicable, notify the manufacturer of the new filing date, which is the date of receipt by FDA of the information that constitutes the substantive amendment. (e) FDA will not disclose the existence of, or the information contained in, the new dietary ingredient notification for 90 days after the filing date of the notification. After the 90th day, all information in the notification will be placed on public display, except for any information that is trade secret or otherwise confidential commercial information. (f) Failure of the agency to respond to a notification does not constitute a finding by the agency that the new dietary ingredient or the dietary supplement that contains the new dietary ingredient is safe or is not adulterated under section 402 of the act. [62 FR 49891, Sept. 23, 1997, as amended at 66 FR 17359, Mar. 30, 2001]

PARTS 191-199 [RESERVED]

PART 1210—REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT Subpart A—General Provisions Sec. 1210.1 Authority. 1210.2 Scope of act. 1210.3 Definitions. Subpart B—Inspection and Testing 1210.10 Availability for examination and inspection. 1210.11 Sanitary inspection of dairy farms. 1210.12 Physical examination of cows. 1210.13 Tuberculin test. 1210.14 Sanitary inspection of plants. 1210.15 Pasteurization; equipment and methods. 1210.16 Method of bacterial count. 1199

§ 1210.1

1210.17 Authority to sample and inspect. 1210.18 Scoring. Subpart C—Permit Control 1210.20 Application for permit. 1210.21 Permit number. 1210.22 Form of tag. 1210.23 Permits granted on certificates. 1210.24 Temporary permits. 1210.25 Permits for pasteurized milk or cream. 1210.26 Permits for raw milk or cream. 1210.27 Permits waiving clauses 2 and 5, section 2 of the Federal Import Milk Act. 1210.28 Permits waiving clause 4, section 2 of the Federal Import Milk Act. Subpart D—Hearings 1210.30 Hearing procedure for permit denial, suspension, and revocation. 1210.31 Hearing before prosecution. AUTHORITY: 21 U.S.C. 141-149. CROSS REFERENCES: For Animal and Plant Health Inspection Service regulations concerning tubercular cattle, see 9 CFR parts 50 and 77. For Animal and Plant Health Inspection Service regulations concerning tubercular cattle, see 9 CFR chapter I. For customs regulations concerning importation of milk and cream, see 19 CFR 12.7. For regulations of the Agricultural Marketing Service (Marketing Agreements and Orders) covering marketing areas for milk, see 7 CFR chapter X. SOURCE: 38 FR 32104, Nov. 20, 1973, unless otherwise noted.

Subpart A—General Provisions § 1210.1 Authority. For the purposes of the regulations in this part the act (44 Stat. 1101; 21 U.S.C. 141-149) ``To regulate the importation of milk and cream into the United States for the purpose of promoting the dairy industry of the United States and protecting the public health’’ shall be known and referred to as ``the Federal Import Milk Act.’’ § 1210.2 Scope of act. The provisions of the act apply to all milk and cream offered for import into the continental United States. § 1210.3 Definitions. (a) Secretary. Secretary means the Secretary of Health and Human Services. (b) Commissioner. Commissioner means the Commissioner of Food and Drugs. (c) Milk. For the purposes of the act and of the regulations in this part: Milk is the whole, fresh, clean, lacteal secretion obtained by the complete milking of one or more healthy cows, properly fed and kept, excluding that obtained within 15 days before and 5 days after calving, or such longer period as may be necessary to render the milk practically colostrum free. (d) Condensed milk. Condensed milk, as the term is used in section 3, paragraph 2, of the Federal Import Milk Act, includes evaporated milk in the manufacture of which sterilization of the milk and cream is a necessary and usual process; it includes sweetened condensed milk only if it is prepared by a process which insures sterilization of the milk and cream. Condensed milk, as the term is used in section 3, paragraph 3, of the Federal Import Milk Act, means sweetened condensed milk. 1200

§ 1210.13

(e) Sweetened condensed milk. Sweetened condensed milk conforms to the definition and standard of identity for such food as set out in Sec. 131.120 of this chapter. (f) Evaporated milk. Evaporated milk conforms to the definition and standard of identity for such food as set out in Sec. 131.130 of this chapter. (g) Cream. Cream is that portion of the milk, rich in milk fat, which rises to the surface of milk on standing or is separated from it by centrifugal force. (See Secs. 131.150 through 131.157 of this chapter). (h) Pasteurization. Pasteurization is the process of heating every particle of milk or cream to at least 143 [deg]F., and holding it at such temperature continuously for at least 30 minutes, or to at least 161 [deg]F., and holding it at such temperature continuously for at least 15 seconds. (i) Shipper. A shipper is anyone, other than a common carrier, who ships, transports, or causes to be shipped or transported into the United States milk or cream owned by him. [38 FR 32104, Nov. 20, 1973, as amended at 42 FR 14091, Mar. 15, 1977]

Subpart B—Inspection and Testing § 1210.10 Availability for examination and inspection. Dairy farms and plants from which milk or cream is shipped or transported into the United States shall be open at all reasonable times to authorized agents for necessary examinations and inspections. Failure to permit such examinations and inspections may be considered cause for the suspension or revocation of the permit. § 1210.11 Sanitary inspection of dairy farms. The sanitary conditions of any dairy farm producing milk or cream to be shipped or transported into the United States or to a plant from which milk or cream is to be shipped or transported into the United States must score at least 50 points out of 100 points, according to the methods for scoring as provided by the score card for sanitary inspection of dairy farms in the form prescribed by the Secretary. § 1210.12 Physical examination of cows. (a) Physical examination of any and all cows in herds producing milk or cream which is to be shipped or transported into the United States shall be made by an authorized veterinarian of the United States or of any State or municipality thereof or of the country in which such milk or cream is produced to determine whether such cow or cows are in a healthy condition. Such examination shall be made as often as the Secretary may deem necessary and, in any event, shall have been made within one year previous to the time of the importation. (b) The result of the physical examination shall be set forth in the form prescribed by the Secretary. § 1210.13 Tuberculin test. (a) Except as provided in Sec. 1210.27 any and all animals in herds producing milk or cream which is to be shipped or transported raw into the United States shall be free from tuberculosis, as determined by a tuberculin test applied by an official veterinarian of the United States or of any State or municipality thereof or of the country in which such milk or cream is produced. Such test shall be made as often as the Secretary may deem necessary and, in any event, shall have been made within 1 year previous to the time of the importation. All animals showing positive or suspicious reactions to the tuberculin test must be permanently removed from the herd. (b) The results of the tuberculin test and all facts concerning the disposal of reacting or suspected animals shall be set forth in the form prescribed by the Secretary.

1201

§ 1210.14

§ 1210.14 Sanitary inspection of plants. The sanitary conditions of any plant handling milk or cream any part of which is to be shipped or transported into the United States shall score at least 50 points out of 100 points according to the methods for scoring as provided by the score card for sanitary inspection of such plants in the form prescribed by the Secretary. § 1210.15 Pasteurization; equipment and methods. All dairy farms and plants at which any milk or cream is pasteurized for shipment or transportation into the United States shall employ adequate pasteurization machinery of a type easily cleaned and of sanitary construction capable of holding every portion of the milk or cream at the required temperature for the required time. Such pasteurizing machinery shall be properly equipped with accurate time and temperature recording devices, which shall be kept at all times in good working order. The temperature at the time of heating and holding must invariably be recorded on thermograph charts, initialed, numbered, and dated by the official having jurisdiction over such farms and plants. All thermograph charts shall be held for a period of 2 years unless within that period they have been examined and released by such authorized agents as are designated by the Secretary. § 1210.16 Method of bacterial count. The bacterial count of milk and cream refers to the number of viable bacteria as determined by the standard plate method of the American Public Health Association in use at the time of the examination. § 1210.17 Authority to sample and inspect. Inspectors engaged in the enforcement of the Federal Import Milk Act are empowered to test for temperature, to take samples of milk or cream, and to use such means as may be necessary for these purposes. § 1210.18 Scoring. Scoring of sanitary conditions required by Secs. 1210.11, 1210.14 shall be done by an official inspector of the United States or of any State or municipality thereof or of the country in which the dairy farm or plant is located.

Subpart C—Permit Control § 1210.20 Application for permit. Application for a permit to ship or transport milk or cream into the United States shall be made by the actual shipper upon forms prescribed by the Secretary. The request for forms of applications for permits should be addressed to Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857. § 1210.21 Permit number. Each permit issued under the Federal Import Milk Act, including each temporary permit, shall bear an individual number. The right to the use of such number is restricted solely to the permittee. § 1210.22 Form of tag. Each container of milk or cream shipped or transported into the United States by such permittee shall have firmly attached thereto a tag in the following form, bearing the required information in clear and legible type:

1202

§ 1210.28

Product_________________________________________________________________ (State whether raw milk, pasteurized milk, raw cream, or pasteurized cream.) Permit number___________________________________________________________ Federal Import Milk Act, Department of Health and Human Services. Shipper_________________________________________________________________ Address of shipper________________________________________________________ Provided, That in case of unit shipments consisting of milk only or cream only under one permit number, in lieu of each container being so marked, the vehicle of transportation, if sealed, may be tagged with the above tag, which should, in addition, show the number of containers and quantity of contents of each. § 1210.23 Permits granted on certificates. In the discretion of the Secretary, a permit may be granted on a duly certified statement signed by a duly accredited official of an authorized department of any foreign government or of any State of the United States or any municipality thereof. Such statement shall be in the form of a certificate prescribed by the Secretary, and shall have attached thereto, as a part thereof, signed copies of reports prescribed by Secs. 1210.12, 1230.13, and also by Secs. 1210.11, 1210.14, as applicable. The necessary inspections and examinations upon which the reports are based shall be made by persons who are acting under the direct supervision of the certifying official. § 1210.24 Temporary permits. A temporary permit will be granted only upon a satisfactory showing that the applicant therefor has been unable to obtain the necessary inspections required by the applicable provisions of section 2 of the Federal Import Milk Act. Temporary permits shall be valid until the Secretary shall provide for inspection to ascertain that clauses 1, 2, and 3 of section 2 of the Federal Import Milk Act have been complied with. § 1210.25 Permits for pasteurized milk or cream. Permits to ship or transport pasteurized milk or cream into the United States will be granted only upon compliance with the requirements of clauses 1 and 3 of section 2 of the Federal Import Milk Act, Secs. 1210.11, 1210.12, 1210.14, as applicable. § 1210.26 Permits for raw milk or cream. Except as provided in Sec. 1210.27, permits to ship or transport raw milk or cream into the United States will be granted only when the milk or cream comes from dairy farms or plants where pasteurization is not carried on and then only upon compliance with the requirements of clauses 1, 2, and 3 of section 2 of the Federal Import Milk Act, Secs. 1210.11 to 1210.14 as applicable. § 1210.27 Permits waiving clauses 2 and 5, section 2 of the Federal Import Milk Act. A permit to ship or transport raw milk into the United States will contain a waiver of clauses 2 and 5 of section 2 of the Federal Import Milk Act when the shipper is an operator of a creamery or condensery, or is a producer shipping or transporting to a creamery or condensery and the creamery or condensery is located in the United States within a radius of 20 miles of the point of production of such milk, and the milk, prior to its sale, use, or disposal, is pasteurized, condensed, or evaporated. § 1210.28 Permits waiving clause 4, section 2 of the Federal Import Milk Act. The Secretary, in his discretion, will issue to a shipper who is an operator of a condensery a permit waiving the requirements of clause 4, of section 2 of the Federal Import Milk Act and allowing milk and cream containing not to 1203

§ 1210.30

exceed 1,200,000 bacteria per cubic centimeter to be shipped or transported into the United States if the condensery is located within a radius of 15 miles of the point of production of the milk and cream and such milk and cream are to be sterilized in the manufacture of condensed milk.

Subpart D—Hearings § 1210.30 Hearing procedure for permit denial, suspension, and revocation. Any person who contests denial, suspension, or revocation of a permit shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to subpart F of part 16 of this chapter. [41 FR 48269, Nov. 2, 1976, as amended at 42 FR 15676, Mar. 22, 1977]

§ 1210.31 Hearing before prosecution. Before violation of the act is referred to the Department of Justice for prosecution under section 5 of the Federal Import Milk Act, an opportunity to be heard will be given to the party against whom prosecution is under consideration. The hearing will be private and confined to questions of fact. The party notified may present evidence, either oral or written, in person or by attorney, to show cause why he should not be prosecuted. After a hearing is held, if it appears that the law has been violated, the facts will be reported to the Department of Justice. [41 FR 48269, Nov. 2, 1976]

PART 1240—CONTROL OF COMMUNICABLE DISEASES Subpart A—General Provisions Sec. 1240.3 1240.10

General definitions. Effective bactericidal treatment.

Subpart B—Administrative Procedures 1240.20 1240.30 1240.45

Issuance and posting of certificates following inspections. Measures in the event of inadequate local control. Report of disease.

Subpart C [Reserved] Subpart D—Specific Administrative Decisions Regarding Interstate Shipments 1240.60 1240.61 1240.62 1240.65 1240.75

Molluscan shellfish. Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption. Turtles intrastate and interstate requirements. Psittacine birds. Garbage.

Subpart E—Source and Use of Potable Water 1240.80 1240.83

General requirements for water for drinking and culinary purposes. Approval of watering points. 1204

§ 1240.3

1240.86 1240.90 1240.95

Protection of pier water system. Approval of treatment aboard conveyances. Sanitation of water boats.

AUTHORITY: 42 U.S.C. 216, 243, 264, 271. CROSS REFERENCES: For Department of Health and Human Services regulations relating to foreign quarantine, sanitation measures, and control of communicable diseases, see Centers for Disease Control’s requirements as set forth in 42 CFR parts 71 and 72. SOURCE: 40 FR 5620, Feb. 6, 1975, unless otherwise noted.

Subpart A—General Provisions § 1240.3 General definitions. As used in this part, terms shall have the following meaning: (a) Bactericidal treatment. The application of a method or substance for the destruction of pathogens and other organisms as set forth in Sec. 1240.10. (b) Communicable diseases. Illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment. (c) Communicable period. The period or periods during which the etiologic agent may be transferred directly or indirectly from the body of the infected person or animal to the body of another. (d) Contamination. The presence of a certain amount of undesirable substance or material, which may contain pathogenic microorganisms. (e) Conveyance. Conveyance means any land or air carrier, or any vessel as defined in paragraph (n) of this section. (f) Garbage. (1) The solid animal and vegetable waste, together with the natural moisture content, resulting from the handling, preparation, or consumption of foods in houses, restaurants, hotels, kitchens, and similar establishments, or (2) any other food waste containing pork. (g) Incubation period. The period between the implanting of disease organisms in a susceptible person and the appearance of clinical manifestation of the disease. (h) Interstate traffic. (1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation which is entirely within a State or possession, (i) From a point of origin in any State or possession to a point of destination in any other State or possession, or (ii) Between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country. (2) Interstate traffic does not include the following: (i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country. (ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage. (i) Milk. Milk is the product defined in Sec. 131.110 of this chapter. (j) Milk products. Food products made exclusively or principally from the lacteal secretion obtained from one or more healthy milk-producing animals, e.g., cows, goats, sheep, and water buffalo, including, but not limited to, the following: lowfat milk, skim milk, cream, half and half, dry milk, nonfat dry milk, dry cream, condensed or concentrated milk products, cultured or acidified milk or milk products, kefir, eggnog, yogurt, butter, cheese (where not specifically exempted by regulation), whey, condensed or dry whey or whey products, ice cream, ice milk, other frozen dairy desserts and products obtained by modifying the chemical or physical characteristics of milk, cream, or whey by using enzymes, solvents, heat, pressure, cooling, vacuum, genetic engineering, fractionation, or other similar processes, and any such product made by the addition or subtraction of milkfat or the addition of safe and suitable optional ingredients for the protein, vitamin, or mineral fortification of the product. (k) Minimum heat treatment. The causing of all particles in garbage to be heated to a boiling temperature and held at that temperature for a period of not less than 30 minutes. (l) Possession. Any of the possessions of the United States, including Puerto Rico and the Virgin Islands. 1205

§ 1240.10

(m) Potable water. Water which meets the standards prescribed in the Environmental Protection Agency’s Primary Drinking Water Regulations as set forth in 40 CFR part 141 and the Food and Drug Administration’s sanitation requirements as set forth in this part and part 1250 of this chapter. (n) State. Any State, the District of Columbia, Puerto Rico and the Virgin Islands. (o) Utensil. Includes any kitchenware, tableware, glassware, cutlery, containers, or equipment with which food or drink comes in contact during storage, preparation, or serving. (p) Vessel. Any passenger-carrying, cargo, or towing vessel exclusive of: (1) Fishing boats including those used for shell-fishing; (2) Tugs which operate only locally in specific harbors and adjacent waters; (3) Barges without means of self-propulsion; (4) Construction-equipment boats and dredges; and (5) Sand and gravel dredging and handling boats. (q) Watering point. The specific place or water boat from which potable water is loaded on a conveyance. (r) Molluscan shellfish. Any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the product consists entirely of the shucked adductor muscle. (s) Certification number means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish processor. (t) Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal government, legally responsible for the administration of a program that includes activities such as classification of molluscan shellfish growing areas, enforcement of molluscan shellfish harvesting controls, and certification of molluscan shellfish processors. (u) Tag means a record of harvesting information attached to a container of shellstock by the harvester or processor. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983; 57 FR 57344, Dec. 4, 1992; 60 FR 65201, Dec. 18, 1995]

§ 1240.10 Effective bactericidal treatment. Whenever, under the provisions of this part, bactericidal treatment is required, it shall be accomplished by one or more of the following methods: (a) By immersion of the utensil or equipment for at least 2 minutes in clean hot water at a temperature of at least 170 °F or for one-half minute in boiling water; (b) By immersion of the utensil or equipment for at least 2 minutes in a lukewarm chlorine bath containing at least 50 ppm of available chlorine if hypochlorites are used or a concentration of equal bactericidal strength if chloramines are used; (c) By exposure of the utensil or equipment in a steam cabinet at a temperature of at least 170 °F for at least 15 minutes or at a temperature of 200 °F for at least 5 minutes; (d) By exposure of the utensil or equipment in an oven or hot air cabinet at a temperature of at least 180 °F for at least 20 minutes; (e) In the case of utensils or equipment so designed or installed as to make immersion or exposure impractical, the equipment may be treated for the prescribed periods of time either at the temperatures or with chlorine solutions as specified above, (1) with live steam from a hose if the steam can be confined, (2) with boiling rinse water, or (3) by spraying or swabbing with chlorine solution; (f) Any other method determined by the Commissioner of Food and Drugs, upon application of an owner or operator of a conveyance, to be effective to prevent the spread of communicable disease. [40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989]

Subpart B—Administrative Procedures § 1240.20 Issuance and posting of certificates following inspections. The Commissioner of Food and Drugs may issue certificates based upon inspections provided for in this part and part 1250. Such certificates shall be prominently posted on conveyances. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

1206

§ 1240.61

§ 1240.30 Measures in the event of inadequate local control. Whenever the Commissioner of Food and Drugs determines that the measures taken by health authorities of any State or possession (including political subdivisions thereof) are insufficient to prevent the spread of any of the communicable diseases from such State or possession to any other State or possession, he may take such measures to prevent such spread of the diseases as he deems reasonably necessary, including inspection, fumigation, disinfection, sanitation, pest extermination, and destruction of animals or articles believed to be sources of infection. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

§ 1240.45 Report of disease. The master of any vessel or person in charge of any conveyance engaged in interstate traffic, on which a case or suspected case of a communicable disease develops shall, as soon as practicable, notify the local health authority at the next port of call, station, or stop, and shall take such measures to prevent the spread of the disease as the local health authority directs.

Subpart C [Reserved]

Subpart D—Specific Administrative Decisions Regarding Interstate Shipments § 1240.60 Molluscan shellfish. (a) A person shall not offer for transportation, or transport, in interstate traffic any molluscan shellfish handled or stored in such an insanitary manner, or grown in an area so contaminated, as to render such molluscan shellfish likely to become agents in, and their transportation likely to contribute to the spread of communicable disease from one State or possession to another. (b) All shellstock shall bear a tag that discloses the date and place they were harvested (by State and site), type and quantity of shellfish, and by whom they were harvested (i.e., the identification number assigned to the harvester by the shellfish control authority, where applicable or, if such identification numbers are not assigned, the name of the harvester or the name or registration number of the harvester’s vessel). In place of the tag, bulk shellstock shipments may be accompanied by a bill of lading or similar shipping document that contains the same information. (c) All containers of shucked molluscan shellfish shall bear a label that identifies the name, address, and certification number of the packer or repacker of the molluscan shellfish. (d) Any molluscan shellfish without such a tag, shipping document, or label, or with a tag, shipping document, or label that does not bear all the information required by paragraphs (b) and (c) of this section, shall be subject to seizure or refusal of entry, and destruction. [40 FR 5620, Feb. 6, 1975, as amended at 60 FR 65202, Dec. 18, 1995]

§ 1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption. (a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized or is made from dairy ingredients (milk or milk products) that have all been pasteurized, except where alternative procedures to pasteurization are provided for by regulation, such as in part 133 of this chapter for curing of certain cheese varieties. (b) Except as provided in paragraphs (c) and (d) of this section, the terms ``pasteurization,’’ ``pasteurized,’’ and similar terms shall mean the process of heating every particle of milk and milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time: 1207

§ 1240.62

———————————————————————————————— Temperature Time ———————————————————————————————— 1 145 °F (63 °C) .............. 30 minutes. 161 °F (72 °C)1.............. 15 seconds. 191 °F (89 °C).................. 1 second. ———————————————————————————————— 1If the fat content of the milk product is 10 percent or more, or if it contains added sweeteners, the specified temperature shall be increased by 5 °F (3 °C).

———————————————————————————————— Temperature Time ———————————————————————————————— 194 °F (90 °C).................. 0.5 second. 201 °F (94 °C).................. 0.1 second. 204 °F (96 °C).................. 0.05 second. 212 °F (100 °C)................. 0.01 second. ————————————————————————————————

(c) Eggnog shall be heated to at least the following temperature and time specification: ———————————————————————————————— Temperature Time ———————————————————————————————— 155 °F (69 °C).................. 30 minutes. 175 °F (80 °C).................. 25 seconds. 180 °F (83 °C).................. 15 seconds. ————————————————————————————————

(d) Neither paragraph (b) nor (c) of this section shall be construed as barring any other pasteurization process that has been recognized by the Food and Drug Administration to be equally efficient in the destruction of microbial organisms of public health significance. [52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992]

§ 1240.62 Turtles intrastate and interstate requirements. (a) Definition. As used in this section the term ``turtles’’ includes all animals commonly known as turtles, tortoises, terrapins, and all other animals of the order Testudinata, class Reptilia, except marine species (families Dermachelidae and Chelonidae). (b) Sales; general prohibition. Except as otherwise provided in this section, viable turtle eggs and live turtles with a carapace length of less than 4 inches shall not be sold, held for sale, or offered for any other type of commercial or public distribution. (c) Destruction of turtles or turtle eggs; criminal penalties. (1) Any viable turtle eggs or live turtles with a carapace length of less than 4 inches which are held for sale or offered for any other type of commercial or public distribution shall be subject to destruction in a humane manner by or under the supervision of an officer or employee of the Food and Drug Administration in accordance with the following procedures: (i) Any District Office of the Food and Drug Administration, upon detecting viable turtle eggs or live turtles with a carapace length of less than 4 inches which are held for sale or offered for any other type of commercial or public distribution, shall serve upon the person in whose possession such turtles or turtle eggs are found a written demand that such turtles or turtle eggs be destroyed in a humane manner under the supervision of said District Office, within 10 working days from the date of promulgation of the demand. The demand shall recite with particularity the facts which justify the demand. After service of the demand, the person in possession of the turtles or turtle eggs shall not sell, distribute, or otherwise dispose of any of the turtles or turtle eggs except to destroy them under the supervision of the District Office, unless and until the Director of the Center for Food Safety and Applied Nutrition withdraws the demand for destruction after an appeal pursuant to paragraph (c)(1)(ii) of this section. (ii) The person on whom the demand for destruction is served may either comply with the demand or, within 10 working days from the date of its promulgation, appeal the demand for destruction to the Director of the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. The demand for destruction may also be appealed within the same period of 10 working days by any other person having a pecuniary interest in such turtles or turtle eggs. In the event of such an appeal, the Center Director shall provide an opportunity for hearing by written notice to the appellant(s) specifying a time and place for the 1208

§ 1240.65

hearing, to be held within 14 days from the date of the notice but not within less than 7 days unless by agreement with the appellant(s). (iii) Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The hearing shall be conducted by the Center Director or his designee, and a written summary of the proceedings shall be prepared by the person presiding. Any appellant shall have the right to hear and to question the evidence on which the demand for destruction is based, including the right to cross-examine witnesses, and he may present oral or written evidence in response to the demand. (iv) If, based on the evidence presented at the hearing, the Center Director finds that the turtles or turtle eggs were held for sale or offered for any other type of commercial or public distribution in violation of this section, he shall affirm the demand that they be destroyed under the supervision of an officer or employee of the Food and Drug Administration; otherwise, the Center Director shall issue a written notice that the prior demand by the District Office is withdrawn. If the Center Director affirms the demand for destruction he shall order that the destruction be accomplished in a humane manner within 10 working days from the date of the promulgation of his decision. The Center Director’s decision shall be accompanied by a statement of the reasons for the decision. The decision of the Center Director shall constitute final agency action, reviewable in the courts. (v) If there is no appeal to the Director of the Center for Food Safety and Applied Nutrition from the demand by the Food and Drug Administration District Office and the person in possession of the turtles or turtle eggs fails to destroy them within 10 working days, or if the demand is affirmed by the Director of the Center for Food Safety and Applied Nutrition after an appeal and the person in possession of the turtles or turtle eggs fails to destroy them within 10 working days, the District Office shall designate an officer or employee to destroy the turtles or turtle eggs. It shall be unlawful to prevent or to attempt to prevent such destruction of turtles or turtle eggs by the officer or employee designated by the District Office. Such destruction will be stayed if so ordered by a court pursuant to an action for review in the courts as provided in paragraph (c)(1)(iv) of this section. (2) Any person who violates any provision of this section, including but not limited to any person who sells, offers for sale, or offers for any other type of commercial or public distribution viable turtle eggs or live turtles with a carapace length of less than 4 inches, or who refuses to comply with a valid final demand for destruction of turtles or turtle eggs (either an unappealed demand by an FDA District Office or a demand which has been affirmed by the Director of the Center for Food Safety and Applied Nutrition pursuant to appeal), or who fails to comply with the requirement in such a demand that the manner of destruction be humane, shall be subject to a fine of not more than $1,000 or imprisonment for not more than 1 year, or both, for each violation, in accordance with section 368 of the Public Health Service Act (42 U.S.C. 271). (d) Exceptions. The provisions of this section are not applicable to: (1) The sale, holding for sale, and distribution of live turtles and viable turtle eggs for bona fide scientific, educational, or exhibitional purposes, other than use as pets. (2) The sale, holding for sale, and distribution of live turtles and viable turtle eggs not in connection with a business. (3) The sale, holding for sale, and distribution of live turtles and viable turtle eggs intended for export only, provided that the outside of the shipping package is conspicuously labeled ``For Export Only.’’ (4) Marine turtles excluded from this regulation under the provisions of paragraph (a) of this section and eggs of such turtles. (e) Petitions. The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to amend this regulation. Any such petition shall include an adequate factual basis to support the petition, and will be published for comment if it contains reasonable grounds for the proposed regulation. A petition requesting such a regulation, which would amend this regulation, shall be submitted to the Dockets Management Branch, Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. [40 FR 22545, May 23, 1975, as amended at 46 FR 8461, Jan. 27, 1981; 48 FR 11431, Mar. 18, 1983; 54 FR 24900, June 12, 1989; 59 FR 14366, Mar. 28, 1994; 66 FR 56035, Nov. 6, 2001]

§ 1240.65 Psittacine birds. (a) The term psittacine birds shall include all birds commonly known as parrots, Amazons, Mexican double heads, African grays, cocatoos, macaws, parakeets, love birds, lories, lorikeets, and all other birds of the psittacine family. 1209

§ 1240.75

(b) No person shall transport, or offer for transportation, in interstate traffic any psittacine bird unless the shipment is accompanied by a permit from the State health department of the State of destination where required by such department. (c) Whenever the Surgeon General finds that psittacine birds or human beings in any area are infected with psittacosis and there is such danger of transmission of psittacosis from such area as to endanger the public health, he may declare it an area of infection. No person shall thereafter transport, or offer for transportation, in interstate traffic any psittacine bird from such area, except shipments authorized by the Surgeon General for purposes of medical research and accompanied by a permit issued by him, until the Surgeon General finds that there is no longer any danger of transmission of psittacosis from such area. As used in this paragraph, the term ``area’’ includes, but is not limited to, specific premises or buildings. § 1240.75 Garbage. (a) A person shall not transport, receive, or cause to be transported or received, garbage in interstate traffic and feed such garbage to swine unless, prior to the feeding, such garbage has received minimum heat treatment. (b) A person transporting garbage in interstate traffic shall not make, or agree to make, delivery thereof to any person with knowledge of the intent or customary practice of such person to feed to swine garbage which has not been subjected to minimum heat treatment.

Subpart E—Source and Use of Potable Water § 1240.80 General requirements for water for drinking and culinary purposes. Only potable water shall be provided for drinking and culinary purposes by any operator of a conveyance engaged in interstate traffic, except as provided in Sec. 1250.84(b) of this chapter. Such water shall either have been obtained from watering points approved by the Commissioner of Food and Drugs, or, if treated aboard a conveyance, shall have been subjected to treatment approved by the Commissioner of Food and Drugs. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

§ 1240.83 Approval of watering points. (a) The Commissioner of Food and Drugs shall approve any watering point if (1) the water supply thereat meets the standards prescribed in the Environmental Protection Agency’s Primary Drinking Water Regulations as set forth in 40 CFR part 141, and (2) the methods of and facilities for delivery of such water to the conveyance and the sanitary conditions surrounding such delivery prevent the introduction, transmission, or spread of communicable diseases. (b) The Commissioner of Food and Drugs may base his approval or disapproval of a watering point upon investigations made by representatives of State departments of health or of the health authorities of contiguous foreign nations. (c) If a watering point has not been approved, the Commissioner of Food and Drugs may permit its temporary use under such conditions as, in his judgment, are necessary to prevent the introduction, transmission, or spread of communicable diseases. (d) Upon request of the Commissioner of Food and Drugs, operators of conveyances shall provide information as to watering points used by them. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983; 48 FR 13978, Apr. 1, 1983]

§ 1240.83 Approval of watering points. (a) The Commissioner of Food and Drugs shall approve any watering point if (1) the water supply thereat meets the standards prescribed in the Environmental Protection Agency’s Primary Drinking Water Regulations as set forth in 40 CFR part 141, and (2) the methods of and facilities for delivery of such water to the conveyance and the sanitary conditions surrounding such delivery prevent the introduction, transmission, or spread of communicable diseases. 1210

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(b) The Commissioner of Food and Drugs may base his approval or disapproval of a watering point upon investigations made by representatives of State departments of health or of the health authorities of contiguous foreign nations. (c) If a watering point has not been approved, the Commissioner of Food and Drugs may permit its temporary use under such conditions as, in his judgment, are necessary to prevent the introduction, transmission, or spread of communicable diseases. (d) Upon request of the Commissioner of Food and Drugs, operators of conveyances shall provide information as to watering points used by them. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983; 48 FR 13978, Apr. 1, 1983]

§ 1240.86 Protection of pier water system. No vessel engaged in interstate traffic shall make a connection between its nonpotable water system and any pier potable water system unless provisions are made to prevent backflow from the vessel to the pier. § 1240.90 Approval of treatment aboard conveyances. (a) The treatment of water aboard conveyances shall be approved by the Commissioner of Food and Drugs if the apparatus used is of such design and is so operated as to be capable of producing and in fact does produce, potable water. (b) The Commissioner of Food and Drugs may base his approval or disapproval of the treatment of water upon investigations made by representatives of State departments of health or of the health authorities of contiguous foreign nations. (c) Overboard water treated on vessels shall be from areas relatively free of contamination and pollution. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

§ 1240.95 Sanitation of water boats. No vessel engaged in interstate traffic shall obtain water for drinking and culinary purposes from any water boat unless the tanks, piping, and other appurtenances used by the water boat in the loading, transportation, and delivery of such drinking and culinary water, have been approved by the Commissioner of Food and Drugs. [40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]

PART 1250—INTERSTATE CONVEYANCE SANITATION Subpart A—General Provisions Sec. 1250.3

Definitions.

Subpart B—Food Service Sanitation on Land and Air Conveyances, and Vessels 1250.20 1250.21 1250.22 1250.25 1250.26 1250.27 1250.28 1250.30

Applicability. Inspection. General requirements. Source identification and inspection of food and drink. Special food requirements. Storage of perishables. Source and handling of ice. Construction, maintenance and use of places where food is prepared, served, or stored. 1211

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1250.32 1250.33 1250.34 1250.35 1250.38 1250.39

Food-handling operations. Utensils and equipment. Refrigeration equipment. Health of persons handling food. Toilet and lavatory facilities for use of food-handling employees. Garbage equipment and disposition.

Subpart C—Equipment and Operation of Land and Air Conveyances 1250.40 1250.41 1250.42 1250.43 1250.44 1250.45 1250.49 1250.50 1250.51 1250.52 1250.53

Applicability. Submittal of construction plans. Water systems; constant temperature bottles. Ice. Drinking utensils and toilet articles. Food handling facilities on railroad conveyances. Cleanliness of conveyances. Toilet and lavatory facilities. Railroad conveyances; discharge of wastes. Discharge of wastes on highway conveyances. Discharge of wastes on air conveyances.

Subpart D—Servicing Areas for Land and Air Conveyances 1250.60 1250.61 1250.62 1250.63 1250.65 1250.67 1250.70 1250.75 1250.79

Applicability. Inspection and approval. Submittal of construction plans. General requirements. Drainage. Watering equipment. Employee conveniences. Disposal of human wastes. Garbage disposal.

Subpart E—Sanitation Facilities and Conditions on Vessels 1250.80 1250.81 1250.82 1250.83 1250.84 1250.85 1250.86 1250.87 1250.89 1250.90 1250.93 1250.95 1250.96

Applicability. Inspection. Potable water systems. Storage of water prior to treatment. Water in galleys and medical care spaces. Drinking fountains and coolers; ice; constant temperature bottles. Water for making ice. Wash water. Swimming pools. Toilets and lavatories. Discharge of wastes. Insect control. Rodent control.

Authority: 42 U.S.C 216, 243, 264, 271. Cross References: For Department of Health and Human Services regulations relating to foreign quarantine and control of communicable diseases, see Centers for Disease Control’s requirements as set forth in 42 CFR parts 71 and 72. Source: 40 FR 5624, Feb. 6, 1975, unless otherwise noted.

1212

§ 1250.3

Subpart A—General Provisions § 1250.3 Definitions. As used in this part, terms shall have the following meaning: (a) Bactericidal treatment. The application of a method or substance for the destruction of pathogens and other organisms as set forth in Sec. 1240.10 of this chapter. (b) Communicable diseases. Illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment. (c) Communicable period. The period or periods during which the etiologic agent may be transferred directly or indirectly from the body of the infected person or animal to the body of another. (d) Contamination. The presence of a certain amount of undesirable substance or material, which may contain pathogenic microorganisms. (e) Conveyance. Conveyance means any land or air carrier, or any vessel as defined in paragraph (m) of this section. (f) Existing vessel. Any vessel the construction of which was started prior to the effective date of the regulations in this part. (g) Garbage. (1) The solid animal and vegetable waste, together with the natural moisture content, resulting from the handling, preparation, or consumption of foods in houses, restaurants, hotels, kitchens, and similar establishments, or (2) any other food waste containing pork. (h) Interstate traffic. (1) The movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation which is entirely within a State or possession, (i) from a point of origin in any State or possession to a point of destination in any other State or possession, or (ii) between a point of origin and a point of destination in the same State or possession but through any other State, possession, or contiguous foreign country. (2) Interstate traffic does not include the following: (i) The movement of any conveyance which is solely for the purpose of unloading persons or property transported from a foreign country, or loading persons or property for transportation to a foreign country. (ii) The movement of any conveyance which is solely for the purpose of effecting its repair, reconstruction, rehabilitation, or storage. (i) Possession. Any of the possessions of the United States, including Puerto Rico and the Virgin Islands. (j) Potable water. Water which meets the standards prescribed in the Environmental Protection Agency’s Primary Drinking Water Regulations as set forth in 40 CFR part 141 and the Food and Drug Administration’s sanitation regulations as set forth in this part and part 1240 of this chapter. (k) State. Any State, the District of Columbia, Puerto Rico and the Virgin Islands. (l) Utensil. Includes any kitchenware, tableware, glassware, cutlery, containers, or equipment with which food or drink comes in contact during storage, preparation, or serving. (m) Vessel. Any passenger-carrying, cargo, or towing vessel exclusive of: (1) Fishing boats including those used for shell-fishing; (2) Tugs which operate only locally in specific harbors and adjacent waters; (3) Barges without means of self-propulsion; (4) Construction-equipment boats and dredges; and (5) Sand and gravel dredging and handling boats. (n) Wash water. Water suitable for domestic uses other than for drinking and culinary purposes, and medical care purposes excluding hydrotherapy. (o) Shellfish. Any fresh, frozen, or incompletely cooked oysters, clams, or mussels, either shucked or in the shell, and any fresh, frozen, or incompletely cooked edible products thereof. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

1213

§ 1250.20

Subpart B—Food Service Sanitation on Land and Air Conveyances, and Vessels § 1250.20 Applicability. All conveyances engaged in interstate traffic shall comply with the requirements prescribed in this subpart and Sec. 1240.20 of this chapter. § 1250.21 Inspection. The Commissioner of Food and Drugs may inspect such conveyance to determine compliance with the requirements of this subpart and Sec. 1240.20 of this chapter. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.22 General requirements. All food and drink served on conveyances shall be clean, wholesome, and free from spoilage, and shall be prepared, stored, handled, and served in accordance with the requirements prescribed in this subpart and Sec. 1240.20 of this chapter. § 1250.25 Source identification and inspection of food and drink. (a) Operators of conveyances shall identify, when requested by the Commissioner of Food and Drugs, the vendors, distributors or dealers from whom they have acquired or are acquiring their food supply, including milk, fluid milk products, ice cream and other frozen desserts, butter, cheese, bottled water, sandwiches and box lunches. (b) The Commissioner of Food and Drugs may inspect any source of such food supply in order to determine whether the requirements of the regulations in this subpart and in Sec. 1240.20 of this chapter are being met, and may utilize the results of inspections of such sources made by representatives of State health departments or of the health authorities of contiguous foreign nations. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.26 Special food requirements. Milk, fluid milk products, ice cream and other frozen desserts, butter, cheese, and shellfish served or sold on conveyances shall conform to the following requirements: (a) Milk and fluid milk products, including cream, buttermilk, skim milk, milk beverages, and reconstituted milk, shall be pasteurized and obtained from a source of supply approved by the Commissioner of Food and Drugs. The Commissioner of Food and Drugs shall approve any source of supply at or from which milk or fluid milk products are produced, processed, and distributed so as to prevent the introduction, transmission, or spread of communicable diseases. If a source of supply of milk or fluid milk products has not been approved, the Commissioner of Food and Drugs may permit its temporary use under such conditions as, in his judgment, are necessary to prevent the introduction, transmission, or spread of communicable diseases. Containers of milk and fluid milk products shall be plainly labeled to show the contents, the word ``pasteurized’’, and the identity of the plant at which the contents were packaged by name and address, provided that a code may be used in lieu of address. (b) Ice cream, other frozen desserts, and butter shall be manufactured from milk or milk products that have been pasteurized or subjected to equivalent heat treatment. (c) Cheese shall be (1) pasteurized or subjected to equivalent heat treatment, (2) made from pasteurized milk products or from milk products which have been subjected to equivalent heat treatment, or (3) cured for not less than 60 days at a temperature not less than 35 °F. (d) Milk, buttermilk, and milk beverages shall be served in or from the original individual containers in which received from the distributor, or from a bulk container equipped with a dispensing device so designed, constructed, installed, and maintained as to prevent the transmission of communicable diseases. 1214

§ 1250.33

(e) Shellfish purchased for consumption on any conveyance shall originate from a dealer currently listed by the Public Health Service as holding an unexpired and unrevoked certificate issued by a State authority. (f) Shucked shellfish shall be purchased in the containers in which they are placed at the shucking plant and shall be kept therein until used. The State abbreviation and the certificate number of the packers shall be permanently recorded on the container. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.27 Storage of perishables. All perishable food or drink shall be kept at or below 50 °F, except when being prepared or kept hot for serving. § 1250.28 Source and handling of ice. Ice coming in contact with food or drink and not manufactured on the conveyance shall be obtained from sources approved by competent health authorities. All ice coming in contact with food or drink shall be stored and handled in such manner as to avoid contamination. § 1250.30 Construction, maintenance and use of places where food is prepared, served, or stored. (a) All kitchens, galleys, pantries, and other places where food is prepared, served, or stored shall be adequately lighted and ventilated: Provided, however, That ventilation of cold storage rooms shall not be required. All such places where food is prepared, served, or stored shall be so constructed and maintained as to be clean and free from flies, rodents, and other vermin. (b) Such places shall not be used for sleeping or living quarters. (c) Water of satisfactory sanitary quality, under head or pressure, and adequate in amount and temperature, shall be easily accessible to all rooms in which food is prepared and utensils are cleaned. (d) All plumbing shall be so designed, installed, and maintained as to prevent contamination of the water supply, food, and food utensils. § 1250.32 Food-handling operations. (a) All food-handling operations shall be accomplished so as to minimize the possibility of contaminating food, drink, or utensils. (b) The hands of all persons shall be kept clean while engaged in handling food, drink, utensils, or equipment. § 1250.33 Utensils and equipment. (a) All utensils and working surfaces used in connection with the preparation, storage, and serving of food or beverages, and the cleaning of food utensils, shall be so constructed as to be easily cleaned and self-draining and shall be maintained in good repair. Adequate facilities shall be provided for the cleaning and bactericidal treatment of all multiuse eating and drinking utensils and equipment used in the preparation of food and beverages. An indicating thermometer, suitably located, shall be provided to permit the determination of the hot water temperature when and where hot water is used as the bactericidal agent. (b) All multiuse eating and drinking utensils shall be thoroughly cleaned in warm water and subjected to an effective bactericidal treatment after each use. All other utensils that come in contact with food and drink shall be similarly treated immediately following the day’s operation. All equipment shall be kept clean. (c) After bactericidal treatment, utensils shall be stored and handled in such manner as to prevent contamination before reuse.

1215

§ 1250.34

§ 1250.34 Refrigeration equipment. Each refrigerator shall be equipped with a thermometer located in the warmest portion thereof. Waste water drains from ice boxes, refrigerating equipment, and refrigerated spaces shall be so installed as to prevent backflow of contaminating liquids. § 1250.35 Health of persons handling food. (a) Any person who is known or suspected to be in a communicable period or a carrier of any communicable disease shall not be permitted to engage in the preparation, handling, or serving of water, other beverages, or food.

(b) Any person known or suspected to be suffering from gastrointestinal disturbance or who has on the exposed portion of the body an open lesion or an infected wound shall not be permitted to engage in the preparation, handling, or serving of food or beverages. § 1250.38 Toilet and lavatory facilities for use of food-handling employees. (a) Toilet and lavatory facilities of suitable design and construction shall be provided for use of food-handling employees. Railroad dining car crew lavatory facilities are regulated under Sec. 1250.45. (b) Signs directing food-handling employees to wash their hands after each use of toilet facilities shall be posted so as to be readily observable by such employees. Hand washing facilities shall include soap, sanitary towels and hot and cold running water or warm running water in lieu of hot and cold running water. (c) All toilet rooms shall be maintained in a clean condition. § 1250.39 Garbage equipment and disposition. Watertight, readily cleanable nonabsorbent containers with close-fitting covers shall be used to receive and store garbage. Garbage and refuse shall be disposed of as frequently as is necessary and practicable.

Subpart C—Equipment and Operation of Land and Air Conveyances § 1250.40 Applicability. The sanitary equipment and facilities on land and air conveyances engaged in interstate traffic and the use of such equipment and facilities shall comply with the requirements prescribed in this subpart. § 1250.41 Submittal of construction plans. Plans for the construction or major reconstruction of sanitary equipment or facilities for such conveyances shall be submitted to the Commissioner of Food and Drugs for review of the conformity of such plans with the requirements of this subpart, except that submittal of plans shall not be required for any conveyance under reconstruction if the owner or operator thereof has made arrangements satisfactory to the Commissioner of Food and Drugs for inspections of such conveyances while under reconstruction for the purpose of determining conformity with those requirements. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.42 Water systems; constant temperature bottles. (a) The water system, whether of the pressure or gravity type, shall be complete and closed from the filling ends to the discharge taps, except for protected vent openings. The water system shall be protected against backflow. 1216

§ 1250.51

(b) Filling pipes or connections through which water tanks are supplied shall be provided on both sides of all new railway conveyances and on existing conveyances when they undergo heavy repairs. All filling connections shall be easily cleanable and so located and protected as to minimize the hazard of contamination of the water supply. (c) On all new or reconstructed conveyances, water coolers shall be an integral part of the closed system. (d) Water filters if used on dining cars and other conveyances will be permitted only if they are so operated and maintained at all times as to prevent contamination of the water. (e) Constant temperature bottles and other containers used for storing or dispensing potable water shall be kept clean at all times and shall be subjected to effective bactericidal treatment as often as may be necessary to prevent the contamination of water so stored and dispensed. § 1250.43 Ice. Ice shall not be permitted to come in contact with water in coolers or constant temperature bottles. § 1250.44 Drinking utensils and toilet articles. (a) No cup, glass, or other drinking utensil which may be used by more than one person shall be provided on any conveyance unless such cup, glass, or drinking utensil shall have been thoroughly cleaned and subjected to effective bactericidal treatment after each individual use. (b) Towels, combs, or brushes for common use shall not be provided. § 1250.45 Food handling facilities on railroad conveyances. (a) Both kitchens and pantries of cars hereafter constructed or reconstructed shall be equipped with double sinks, one of which shall be of sufficient size and depth to permit complete immersion of a basket of dishes during bactericidal treatment; in the pantry a dishwashing machine may be substituted for the double sinks. If chemicals are used for bactericidal treatment, 3-compartment sinks shall be provided. (b) A sink shall be provided for washing and handling cracked ice used in food or drink and shall be used for no other purpose. (c) Lavatory facilities for the use of the dining car crew shall be provided on each dining car. Such facilities shall be conveniently located and used for hand and face washing only: Provided, however, That where the kitchen and pantry on a dining car hereafter constructed or reconstructed are so partitioned or separated as to impede free passage between them lavatory facilities shall be provided in both the kitchen and the pantry. (d) Wherever toilet and lavatory facilities required by paragraph (c) of this section are not on the dining car, a lavatory shall be provided on the dining car for the use of employees. The lavatory shall be conveniently located and used only for the purpose for which it is installed. § 1250.49 Cleanliness of conveyances. Conveyances while in transit shall be kept clean and free of flies and mosquitoes. A conveyance which becomes infected with vermin shall be placed out of service until such time as it shall have been effectively treated for the destruction of the vermin. § 1250.50 Toilet and lavatory facilities. Where toilet and lavatory facilities are provided on conveyances they shall be so designed as to permit ready cleaning. On conveyances not equipped with retention facilities, toilet hoppers shall be of such design and so located as to prevent spattering of water filling pipes or hydrants. § 1250.51 Railroad conveyances; discharge of wastes. (a) New railroad conveyances. Human wastes, garbage, waste water, or other polluting materials shall not be discharged from any new railroad conveyance except at servicing areas approved by the Commissioner of Food and Drugs. In lieu of retention pending discharge at approved servicing areas, human wastes, garbage, waste water, or 1217

§ 1250.51

other polluting materials that have been suitably treated to prevent the spread of communicable diseases may be discharged from such conveyances, except at stations. For the purposes of this section, ``new railroad conveyance’’ means any such conveyance placed into service for the first time after July 1, 1972, and the terms ``waste water or other polluting materials’’ do not include drainage of drinking water taps or lavatory facilities. (b) Nonnew railroad conveyances. Human wastes, garbage, waste water, or other polluting materials shall not be discharged from any railroad conveyance, other than passenger conveyances for which an extension has been granted pursuant to paragraph (f) of this section, after December 31, 1977, except at servicing areas approved by the Commissioner of Food and Drugs. In lieu of retention pending discharge at approved servicing areas, human wastes, garbage, waste water, or other polluting materials that have been suitably treated to prevent the spread of communicable diseases may be discharged from such conveyances, except at stations. The terms ``waste water or other polluting materials’’ do not include drainage of drinking water taps or lavatory facilities. (c) Toilets. When railroad conveyances, occupied or open to occupancy by travelers, are at a station or servicing area, toilets shall be kept locked unless means are provided to prevent contamination of the area or station. (d) Submission of annual report. Each railroad company shall submit to the Center for Food Safety and Applied Nutrition (HFS-627), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, an annual report of accomplishments made in modifying conveyances to achieve compliance with paragraph (b) of this section. Annual reports shall be required until a report is submitted showing that 100 percent of the company’s conveyances can comply with the requirements of paragraph (b) of this section; annual reports shall be required subsequent to such report if conveyances not capable of complying with the requirements of paragraph (b) of this section are acquired. Every railroad company shall have not less than 10 percent of its nonpassenger conveyances that are in operation capable of complying with the requirements of paragraph (b) of this section by December 31, 1974, not less than 40 percent by December 31, 1975, and not less than 70 percent by December 31, 1976. All conveyances, other than passenger conveyances for which an extension has been granted pursuant to paragraph (f) of this section, in operation after December 31, 1977, shall be capable of complying with paragraph (b) of this section. (e) Requirements of annual report. Annual reports required by paragraph (d) of this section shall be submitted within 60 days of the end of each calendar year. Each report shall contain at least the following information: (1) Company name and address. (2) Name, title, and address of the company’s chief operating official. (3) Name, title, address, and telephone number of the person designated by the company to be directly responsible for compliance with this section. (4) A statement that all new railroad conveyances placed into service after July 1, 1972 meet the requirements of this section. (5) A complete, factual, narrative statement explaining why retrofitting of noncomplying nonnew conveyances is incomplete, if it is incomplete. (6) A statement of the percentage of conveyances retrofitted with waste discharge facilities in compliance with this section as of the reporting date and the percentage expected to be completed by December 31st of the following year. (7) A tabular report with the following vertical columns: equipment type, e.g., locomotive, caboose, passenger car, and any others having toilets; number of toilets per conveyance; number of each equipment type in operation; and number of each to be retrofitted by December 31st of each year until 100 percent compliance with this section is achieved. (f) Variances and extensions—(1) Variances. Upon application by a railroad company, the Director, Center for Food Safety and Applied Nutrition, may grant a variance from the compliance schedule prescribed in paragraph (d) of this section for nonpassenger conveyances when the requested variance is required to prevent substantial disruption of the railroad company’s operations. Such variance shall not affect the final deadline of compliance established in paragraph (d) of this section. (2) Extensions. Upon application by a railroad company, the Director, Center for Food Safety and Applied Nutrition, may grant an extension of time for compliance with the requirements of paragraph (b) of this section beyond December 31, 1977, for passenger conveyances operated by railroad companies when compliance cannot be achieved without substantial disruption of the railroad company’s operations. (3) Application for variance or extension. Application for variances or extensions shall be submitted to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Manager, Interstate Travel Sanitation SubProgram, HFF-312, 5100 Paint Branch Pkwy., College Park, MD 20740, and shall include the following information: (i) A detailed description of the proposed deviation from the requirements of paragraphs (b) or (d) of this section. 1218

§ 1250.61

(ii) A report, current to the date of the request for a variance or extension, containing the information required by paragraph (e) of this section. (4) Administration of variances and extensions. (i) Written notification of the granting or refusal of a variance or extension will be provided to the applying railroad company by the Director, Center for Food Safety and Applied Nutrition. The notification of a granted variance will state the approved deviation from the compliance schedule provided for in paragraph (d) of this section. The notification of a granted extension will state the final date for compliance with the provisions of paragraph (b) of this section. (ii) A public file of requested variances and extensions, their disposition, and information relating to pending actions will be maintained in the Dockets Management Branch, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. (iii) After notice to the railroad company and opportunity for hearing in accordance with part 16 of this chapter, a variance or extension may be withdrawn prior to its scheduled termination if the Director, Center for Food Safety and Applied Nutrition, determines that such withdrawal is necessary to protect the public health. CROSS REFERENCe: For statutory exemptions for ``intercity rail passenger service,’’ see section 306(i) of 45 U.S.C. 546(i). [40 FR 5624, Feb. 6, 1975, as amended at 40 FR 30110, July 17, 1975; 46 FR 8461, Jan. 27, 1981; 48 FR 11432, Mar. 18, 1983; 54 FR 24900, June 12, 1989; 59 FR 14366, Mar. 28, 1994; 61 FR 14481, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] EFFECTIVE DATE NOTE: For a document staying the effectiveness of Sec. 1250.51 (b) and (d), see 42 FR 57122, Nov. 1, 1977.

§ 1250.52 Discharge of wastes on highway conveyances. There shall be no discharge of excrement, garbage, or waste water from a highway conveyance except at servicing areas approved by the Commissioner of Food and Drugs. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.53 Discharge of wastes on air conveyances. There shall be no discharge of excrement or garbage from any air conveyance except at servicing areas approved by the Commissioner of Food and Drugs. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

Subpart D—Servicing Areas for Land and Air Conveyances § 1250.60 Applicability. Land and air conveyances engaged in interstate traffic shall use only such servicing areas within the United States as have been approved by the Commissioner of Food and Drugs as being in compliance with the requirements prescribed in this subpart. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.61 Inspection and approval. The Commissioner of Food and Drugs may inspect any such areas to determine whether they shall be approved. He may base his approval or disapproval on investigations made by representatives of State departments of health. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

1219

§ 1250.62

§ 1250.62 Submittal of construction plans. Plans for construction or major reconstruction of sanitation facilities at servicing areas shall be submitted to the Commissioner of Food and Drugs for review of the conformity of the proposed facilities with the requirements of this subpart. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.63 General requirements. Servicing areas shall be provided with all necessary sanitary facilities so operated and maintained as to prevent the spread of communicable diseases. § 1250.65 Drainage. All platforms and other places at which water or food supplies are loaded onto or removed from conveyances shall be adequately drained so as to prevent pooling. § 1250.67 Watering equipment. (a) General requirements. All servicing area piping systems, hydrants, taps, faucets, hoses, buckets, and other appurtenances necessary for delivery of drinking and culinary water to a conveyance shall be designed, constructed, maintained and operated in such a manner as to prevent contamination of the water. (b) Outlets for nonpotable water. Outlets for nonpotable water shall be provided with fittings different from those provided for outlets for potable water and each nonpotable water outlet shall be posted with permanent signs warning that the water is unfit for drinking. (c) Ice. If bulk ice is used for the cooling of drinking water or other beverages, or for food preservation purposes, equipment constructed so as not to become a factor in the transmission of communicable diseases shall be provided for the storage, washing, handling, and delivery to conveyances of such bulk ice, and such equipment shall be used for no other purposes. § 1250.70 Employee conveniences. (a) There shall be adequate toilet, washroom, locker, and other essential sanitary facilities readily accessible for use of employees adjacent to places or areas where land and air conveyances are serviced, maintained, and cleaned. These facilities shall be maintained in a clean and sanitary condition at all times. (b) In the case of diners not in a train but with a crew on board, adequate toilet facilities shall be available to the crew within a reasonable distance but not exceeding 500 feet of such diners. (c) Drinking fountains and coolers shall be constructed of impervious, nonoxidizing material, and shall be so designed and constructed as to be easily cleaned. The jet of a drinking fountain shall be slanting and the orifice of the jet shall be protected by a guard in such a manner as to prevent contamination thereof by droppings from the mouth. The orifice of such a jet shall be located a sufficient distance above the rim of the basin to prevent backflow. § 1250.75 Disposal of human wastes. (a) At servicing areas and at stations where land and air conveyances are occupied by passengers the operations shall be so conducted as to avoid contamination of such areas and stations by human wastes. (b) Toilet wastes shall be disposed of through sanitary sewers or by other methods assuring sanitary disposal of such wastes. All soil cans and removable containers shall be thoroughly cleaned before being returned to use. Equipment for cleaning such containers and for flushing nonremovable containers and waste carts shall be so designed as to prevent backflow into the water line, and such equipment shall be used for no purpose connected with the handling of food, water or ice. (c) All persons who have handled soil cans or other containers which have come in contact with human wastes shall be required to wash their hands thoroughly with soap and warm water and to remove any garments which have 1220

§ 1250.82

become soiled with such wastes before engaging in any work connected with the loading, unloading, transporting or other handling of food, water or ice. § 1250.79 Garbage disposal. (a) Water-tight, readily cleanable, nonabsorbent containers with close-fitting covers shall be used to receive and store garbage. (b) Can washing and draining facilities shall be provided. (c) Garbage cans shall be emptied daily and shall be thoroughly washed before being returned for use.

Subpart E—Sanitation Facilities and Conditions on Vessels § 1250.80 Applicability. The sanitation facilities and the sanitary conditions on vessels engaged in interstate traffic shall comply with the requirements prescribed in this subpart, provided that no major structural change will be required on existing vessels. § 1250.81 Inspection. The Commissioner of Food and Drugs may inspect such vessels to determine compliance with the requirements of this subpart. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.82 Potable water systems. The following conditions must be met by vessel water systems used for the storage and distribution of water which has met the requirements of Sec. 1240.80 of this chapter. (a) The potable water system, including filling hose and lines, pumps, tanks, and distributing pipes, shall be separate and distinct from other water systems and shall be used for no other purposes. (b) All potable water tanks shall be independent of any tanks holding nonpotable water or other liquid. All potable water tanks shall be independent of the shell of the ship unless (1) the bottom of the tank is at least 2 feet above the maximum load water line, (2) the seams in the shell are continuously welded, and (3) there are no rivets in that part of the shell which forms a side of a tank. A deck may be used as the top of a tank provided there are no access or inspection openings or rivets therein, and the seams are continuously welded. No toilet or urinal shall be installed immediately above that part of the deck which forms the top of a tank. All potable water tanks shall be located at a sufficient height above the bilge to allow for draining and to prevent submergence in bilge water. (c) Each potable water tank shall be provided with a means of drainage and, if it is equipped with a manhole, overflow, vent, or a device for measuring depth of water, provision shall be made to prevent entrance into the tank of any contaminating substance. No deck or sanitary drain or pipe carrying any nonpotable water or liquid shall be permitted to pass through the tank. (d) Tanks and piping shall bear clear marks of identification. (e) There shall be no backflow or cross connection between potable water systems and any other systems. Pipes and fittings conveying potable water to any fixture, apparatus, or equipment shall be installed in such way that backflow will be prevented. Waste pipes from any part of the potable water system, including treatment devices, discharging to a drain, shall be suitably protected against backflow. (f) Water systems shall be cleaned, disinfected, and flushed whenever the Commissioner of Food and Drugs shall find such treatment necessary to prevent the introduction, transmission, or spread of communicable diseases. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

1221

§ 1250.83

§ 1250.83 Storage of water prior to treatment. The following requirements with respect to the storage of water on vessels prior to treatment must be met in order to obtain approval of treatment facilities under Sec. 1240.90 of this chapter. (a) The tank, whether independent or formed by the skin of the ship, deck, tank top, or partitions common with other tanks, shall be free of apparent leakage. (b) No sanitary drain shall pass through the tank. (c) The tank shall be adequately protected against both the backflow and discharge into it of bilge or highly contaminated water. § 1250.84 Water in galleys and medical care spaces. (a) Potable water, hot and cold, shall be available in the galley and pantry except that, when potable water storage is inadequate, nonpotable water may be piped to the galley for deck washing and in connection with garbage disposal. Any tap discharging nonpotable water which is installed for deck washing purposes shall not be more than 18 inches above the deck and shall be distinctly marked ``For deck washing only’’. (b) In the case of existing vessels on which heat treated wash water has been used for the washing of utensils prior to the effective date of the regulations in this part, such water may continue to be so used provided controls are employed to insure the heating of all water to at least 170 °F before discharge from the heater. (c) Potable water, hot and cold, shall be available in medical care spaces for hand-washing and for medical care purposes excluding hydrotherapy. § 1250.85 Drinking fountains and coolers; ice; constant temperature bottles. (a) Drinking fountains and coolers shall be constructed of impervious, nonoxidizing material, and shall be so designed and constructed as to be easily cleaned. The jet of a drinking fountain shall be slanting and the orifice of the jet shall be protected by a guard in such a manner as to prevent contamination thereof by droppings from the mouth. The orifice of such a jet shall be located a sufficient distance above the rim of the basin to prevent backflow. (b) Ice shall not be permitted to come in contact with water in coolers or constant temperature bottles. (c) Constant temperature bottles and other containers used for storing or dispensing potable water shall be kept clean at all times and shall be subjected to effective bactericidal treatment after each occupancy of the space served and at intervals not exceeding one week. § 1250.86 Water for making ice. Only potable water shall be piped into a freezer for making ice for drinking and culinary purposes. § 1250.87 Wash water. Where systems installed on vessels for wash water, as defined in Sec. 1250.3(n), do not comply with the requirements of a potable water system, prescribed in Sec. 1250.82, they shall be constructed so as to minimize the possibility of the water therein being contaminated. The storage tanks shall comply with the requirements of Sec. 1250.83, and the distribution system shall not be cross connected to a system carrying water of a lower sanitary quality. All faucets shall be labeled ``Unfit for drinking’’. § 1250.89 Swimming pools. (a) Fill and draw swimming pools shall not be installed or used. (b) Swimming pools of the recirculation type shall be equipped so as to provide complete circulation, replacement, and filtration of the water in the pool every six hours or less. Suitable means of chlorination and, if necessary, other treatment of the water shall be provided to maintain the residual chlorine in the pool water at not less than 0.4 part per million and the pH (a measure of the hydrogen ion concentration) not less than 7.0. (c) Flowing-through types of salt water pools shall be so operated that complete circulation and replacement of the water in the pool will be effected every 6 hours or less. The water delivery pipe to the pool shall be independent of 1222

§ 1250.96

all other pipes and shall originate at a point where maximum flushing of the pump and pipe line is effected after leaving polluted waters. § 1250.90 Toilets and lavatories. Toilet and lavatory equipment and spaces shall be maintained in a clean condition. § 1250.93 Discharge of wastes. Vessels operating on fresh water lakes or rivers shall not discharge sewage, or ballast or bilge water, within such areas adjacent to domestic water intakes as are designated by the Commissioner of Food and Drugs. CROSS REFERENCE: For Environmental Protection Agency’s regulations for vessel sanitary discharges as related to authority under the Federal Water Pollution Control Act, as amended (33 U.S.C. 1314 et seq.), see 40 CFR part 140. [40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

§ 1250.95 Insect control. Vessels shall be maintained free of infestation by flies, mosquitoes, fleas, lice, and other insects known to be vectors in the transmission of communicable diseases, through the use of screening, insecticides, and other generally accepted methods of insect control. § 1250.96 Rodent control. Vessels shall be maintained free of rodent infestation through the use of traps, poisons, and other generally accepted methods of rodent control.

1223

1224

Index

90-day limit, 71.4, 71.20

acrylonitrile/butadiene/styrene copolymer, 177.1020, 181.32(a)(1) acrylonitrile/butadiene/styrene/methyl methacrylate copolymer, 177.1030 acrylonitrile copolymers, 175.125(c), 180.22, 181.32 acrylonitrile-methyl acrylate copolymers, 177.1480 acrylonitrile resins, 181.32 acrylonitrile/styrene copolymer, 177.1040, 177.1050, 181.32(a) acrylonitrile-vinyl chloride copolymer, 177.2910(a)(1), 181.32(a) Actinoplanes missouriensis, 184.1372(a) action levels defect, 110 Subpart G, 110.110 emergency, 180.1(f), 181.1(c) added (claims), 101.13(j)(1)(i)(B), 101.54(e)(1-2) additives. See color additives; food additives adequate (definition of), 110.3(b) adhesives, 175 Subpart B, 175.105 components of, 178.3650(c), 189.155(a), 189.280(a) pressure-sensitive, 175.125 adipic acid, 184.1009 adjuvants, 173 Subpart A, 178 Subpart D acrylamide-acrylic acid resins, 176.110 azodicarbonamide, 178.3010 calcium carbonate/glyceryl tri-(12-acetoxystearate), 178.3505 1,1-difluoroethane, 178.3010 disodium inosinate, 172.535 esters of stearic and palmitic acids, 178.3450 for flavorings, 182.60 for food treatment, 173 Subpart A in herbicide dilutions, 172.840(c)(12) isopentane, 178.3010 in manufacture of foamed plastics, 178.3010 natural, 172.510 n-pentane, 178.3010 pesticide chemicals/dilutions, 172.710, 182.99 polyethylene glycol, 172.820(c)(2-3) polymaleic acid, 173.45 polysorbate 80, 172.840(c)(12) propylene glycol alginate, 172.858 in slimicide preparation, 176.300(d) sorbitan monooleate, 173.75

acacia (gum arabic), 184.1330 acceptance number, 158.3(f) acesulfame potassium, 172.800 acetic acid, 184.1005 in sanitizing solutions, 178.1010(b) See also contents of specific cheeses Acetobacter suboxydans, 186.1839(a) Acetobacter xylinum, 186.1839(a) alpha-acetolactate decarboxylase, 173.115 acetone, 73.1(b)(1)(ii), 173.210 acetone peroxides, 137.105(a)(6), 172.802 acetylated monoglycerides, 172.828 acid foods, 110.80(b)(3)(iv), 110.80(b)(15) definition of, 110.3(a), 114.3(a) ultrafiltration membranes for, 177.2910(e) See also low-acid foods; nonacid foods acidified foods, 108.25, 110.80(b)(15), Part 114 acidification procedures, 114.80(a)(3) coding, 114.80(b) definition of, 110.3(a), 114.3(b) methodology, 114.90 personnel, 114.10 production and process controls, 114 Subpart E, 114.80 records, 114.100 acidified milk, 131.111 acidified sodium chlorite solutions, 173.325 acidified sour cream, 131.162 acidity (instruments for), 110.40(f) acidophilus cultured milk, 131.112(f) aconitic acid, 184.1007 acrylamide-acrylic acid resins, 176.110 acrylamide copolymer, 172.710 acrylamide resins, 173.5, 176.110 See also polyacrylamide resin acrylate-acrylamide resins, 173.5 acrylate ester copolymer coating, 175.210 acrylic acid-acrylamide resins, 176.110 acrylic acid copolymers, 177.1310 acrylic copolymers, 177.1060 acrylic plastics, 177.1010

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Index

synthetic, 172.515 1,1,2,2-tetra-chloroethylene, 178.3010 toluene, 178.3010 See also contents of specific polymers and copolymers administrative procedures, 1240 Subpart B administrative rulings and decisions, Part 2, 100 Subpart G, 1240 Subpart D adulterated articles, 2.10(c) adulterated fish, 123.6(g), 123.12(d) adulterated food, 2.25, 2.35(c), 81.30 criteria for, 110.5(a), 184.1(e), 186.1(e) disposal of, 110.80(b)(9) prior sanction violations, 181.5(b), 181.5(d), 184.1(e), 186.1(e) prohibited substance use, 189.1(a), 189 Subparts B & C adulterated infant formula, 106.120(b), 107.200, 107.210(b) adulterated juice, 120.9, 120.14(d) adverse reaction reports, 71.15(a)(3) adverse reactions, 1.21(c)(1) aerated foods, 101.12(e) aerating agents n-butane, 184.1165(c)(1) carbon dioxide, 184.1240(c)(1) iso-butane, 184.1165(c)(1) methyl ethyl cellulose, 172.872(c) nitrogen, 184.1540(c)(1) nitrous oxide, 184.1545(c)(1) propane, 184.1655(c)(1) affirmative disclosure, 1.21(b) aflatoxin, 110.80(a)(3) agar-agar, 184.1115 air-blowing equipment, 110.20(b)(6) air conveyances, 1250.3(e), 1250.53 sanitation on, 1250 Subparts B-D air flow, 110.20(b)(2) air-flow systems, positive, 110.37(d)(4) DL-alanine, 172.540 See also amino acids albumen. See egg whites Alcaligenes faecalis, 172.809(a) alcohol denatured (formula 23A), 73.1(b)(2) SDA-3A, 73.1(b)(1)(i-ii) See also specific alcohols by name alcoholic beverages, 73.170(c), 73.170(c)(2), 135.140(e)(4) α-ALDC enzyme preparation, 173.115 algae brown, 184.1001(a), 184.1120, 184.1133(a), 184.1610(a), 184.1724(a) Latin names for, 101.4(h) meal, 73.185, 73.275 red, 184.1115(a), 184.1121 See also seaweed algin (sodium alginate). See contents of specific dairy products alginic acid, 172.858(c)(1), 184.1011

n-alkyl amine acetate, 172.710 n-alkyl benzyl dimethyl ammonium chloride, 178.1010(b) di-n-alkyl dimethyl ammonium chloride, 172.710, 178.1010(b)(22) n-alkyl dimethyl ethyl benzyl ammonium chloride, 178.1010(b)(11) alpha-alkyl-omega-hydroxy[poly(oxyethylene) poly(oxypropylene)], 178.1010(b)(24) alpha-alkyl-omegahydroxypoly(oxyethylene)poly(oxypropylene), 178.1010(b)(31) alkyl ketene dimers, 176.120 alkyl (C12-C15) monoether, 178.1010(b)(13) n-alkylglutarimide/acrylic copolymers, 177.1060 allergens, 120.7(c)(8) alligator, 123.3(d) alumina, 82.3(g) aluminum ammonium sulfate, 182.1127 aluminum calcium silicate, 182.2122 aluminum hydroxide, 82.3(i) aluminum nicotinate, 172.310 aluminum oxide, 177.2910(a)(3) aluminum potassium sulfate, 182.1129 aluminum silicate, 184.1155(a) aluminum sodium sulfate, 182.1131 aluminum sulfate, 182.1125 ambergris, 182.50 amendments color additive, 71.6(b), 80.32(h) food additive petitions, 171.6 prior sanction regulation, 181.1(b), 181.5(c) prohibited substances regulation, 189.1(c) American cheese, 133.123(f), 133.133(h), 133.146(d)(2), 133.169(g), 133.173(h), 133.179(i) amino acids, 172.320 DL-alanine, 172.540 L-cysteine, 184.1271, 184.1272 aminoacetic acid, 170.50 4-aminoazobenzene, 74.705(b), 74.706(b) 4-aminobenzenesulfonic acid, 74.705(b), 74.706(b) 4-aminobiphenyl, 74.705(b), 74.706(b), 81.10(i) aminoglycoside 3’-phosphotransferase II, 173.170 aminopeptidase, 184.1985 ammonium alginate, 178.3900, 184.1133 ammonium bicarbonate, 184.1135 ammonium carbonate, 184.1137 ammonium chloride, 172.165, 184.1138 ammonium citrate, dibasic, 184.1140 ammonium hydroxide, 74.101(a), 184.1139 ammonium phosphate, dibasic, 184.1141b ammonium phosphate, monobasic, 184.1141a ammonium saccharin, 180.37 ammonium sulfate, 184.1143 amount per serving, 101.36(b)(2)(i)(A) α-amylase, 137.105(a), 137.105(b)(2), 137.200(b)(2), 184.1012 amyloglucosidase, 173.110 analysis, methods of, 2.19 analytical methods. See specific foods and additives

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Index

analytical unit, 165.3(c) anchovy, 172.385(a) anencephaly, 101.79(a)(1) aniline, 74.705(b), 74.706(b) animal glue, 178.3120 animal lipase, 184.1415 annatto extract, 73.30 annual report, 1250.51(d-e) anoxomer, 172.105 anti-offset substances, 176.130 antibiotic activity (absent), 184.1148(b), 184.1150(b), 184.1372(a), 184.1538(a) See also antimicrobial agents anticaking agents, 100.155(c), 172 Subpart E, 182 Subpart C aluminum calcium silicate, 182.2122 calcium chloride, 184.1193(c) calcium silicate, 172.410, 182.2227 calcium sulfate, 184.1230(c) carnauba wax, 184.1978(c)(1) fatty acid salts, 172.863(b) iron ammonium citrate, 172.430 magnesium carbonate, 184.1425(c)(1) magnesium oxide, 184.1431(c)(1) magnesium silicate, 182.2437 mannitol, 180.25 potassium acid tartrate, 184.1077(c)(1) propylene glycol, 184.1666(c) silicon dioxide, 172.480 sodium aluminosilicate, 182.2727 sodium calcium aluminosilicate, 182.2729 sodium naphthalene sulfonates, 172.824(b)(2) sorbitol, 184.1835(c) tricalcium silicate, 182.2906 yellow prussiate of soda, 172.490 anticancer clause, 70.51 See also cancer clause anticorrosive agents, 178.3125 antidusting agent, 172.878(c)(13) antifoaming agent, 182.1711 antifogging agents, 178.3130 antimicrobial agents benzoic acid, 184.1021(c) calcium chloride, 184.1193(c) calcium propionate, 184.1221(c)(1) ethyl alcohol, 184.1293(c) hydrogen peroxide, 184.1366(c) lactic acid, 184.1061(c) methylparaben, 184.1490(c) nisin, 184.1538(c) ozone, 184.1563(c) potassium acid tartrate, 184.1077(c)(1) propionic acid, 184.1081(c)(1) propylparaben, 184.1670(c) quaternary ammonium chloride combination, 172.165 slimicides, 176.300(a)(1) sodium benzoate, 184.1733(c) sodium diacetate, 184.1754(c) sodium propionate, 184.1784(c)(1) antimony, 73.575

antimycotics, 181.23 calcium propionate, 181.23 methylparaben, 181.23 natamycin (pimaricin), 172.155 prior-sanctioned, 181.23 prohibited if added, thiourea, 189.190(a-b) propylparaben, 181.23 sodium benzoate, 181.23 sodium propionate, 181.23 sorbic acid, 181.23 See also contents of specific cheeses antioxidant (claims), 101.54(g) antioxidants, 178 Subpart C, 181.24 anoxomer, 172.105 butylated hydroxyanisole (BHA), 172.110, 181.24, 182.3169 butylated hydroxytoluene (BHT), 172.115, 181.24, 182.3173 dilauryl thiodipropionate, 181.24, 182.3280 distearyl thiodipropionate, 181.24 ethoxyquin, 172.140 gum guaiac, 181.24 4-hydroxymethyl-2,6-di-tert-butylphenol, 172.150, 178.2550 isopropyl citrate, 184.1386(c)(1) monoglyceride citrate, 172.832 nordihydroguaiaretic acid, 181.24, 189.165 for polymers, 178.2010 prior-sanctioned, 181.24 prohibited if added 4,4’-isopropylidene-diphenolphosphite ester resins, 189.300(a-b) nordihydroguaiaretic acid, 189.165(a-b) propyl gallate, 181.24, 184.1660(c) propylene glycol, 184.1666(c) sodium carbonate, 184.1742(c)(1) stannous chloride, 184.1845(c) stearyl citrate, 184.1851(c)(1) tertiary butylhydroquinone (TBHQ), 172.185 thiodipropionic acid, 181.24, 182.3109 2,4,5-trihydroxy butyrophenone (THBP), 172.190, 181.24 See also contents of specific foods and additives antistatic agents, 178.3130 AOAC methods, 2.19, 133.5 apple butter, 150.110(b)(1) applesauce, 145.110 applications (food additive), 171 Subpart B approval. See prior sanction approved source (of water), 129.3(a) apricot butter, 150.110(b)(1) apricot kernal, 182.40 apricots, 145.115 aqueous foods, 176.170, 178.3280(b)(2) arabinoagalactan, 172.610 Aroclor, 109.15(a) arrest warrants, 5.31(b)(1)(ii) arrests, 5.31(b)(1)(iv) arsenic, 82.5(b)(1)(ii), 82.5(b)(2)(ii) See also specific color additives

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Index

artesian water, 165.110(a)(2)(i) arthropod pests, 179.26(b)(4) artificial color/coloring, 101.22(c), 101.22(k)(2) definition of, 101.22(a)(4) in sherbet, 135.140(f), 135.140(i) artificial flavor/flavoring, 101.22(c), 101.22(h)(1), 101.22(h)(7)(i)(1)(ii), 101.22(h)(7)(i)(2-4) certification of no artificial flavor, 101.22(h)(7)(i)(4) definition of, 101.22(a)(1) in ice cream, 135.110(f) in sherbet, 135.140(f), 135.140(i) artificial smoke flavors, 101.22(h)(6) artificial sweeteners, 105.3(a)(2) prohibited cyclamate, 189.135(a-b) dulcin, 189.145(a-b) P-4000, 189.175(a-b) See also sweeteners ascorbic acid, 182.3013, 182.8013 nicotinamide complex, 172.315 See also vitamin C ascorbyl palmitate, 182.3149 aseptic processing, 5.304(a), 108.35(g), 113.3(a), 113.40(g), 113.100(a)(4) ash, 137.105(c) See also specific food additives asiago cheeses, 133.102, 133.103, 133.104 asparagus, 172.180 aspartame, 172.804 Aspergillus niger, 173.120, 173.280 Aspergillus oryzae, 137.105(a), 137.105(b)(2), 137.200(b)(2), 173.150(a)(5) Association of Official Analytical Chemists (AOAC) methods, 2.19, 133.5 astaxanthin, 73.35, 73.185(b), 73.185(c)(2), 73.355(b), 73.355(c)(2) audits, 106.100(j) authority citations, 1.4 delegations of, Part 5 redelegations of, 5 Subpart B azobenzene, 74.705(b), 74.706(b) azodicarbonamide, 136.110(c)(14)(ii), 137.105(a)(7), 172.806, 178.3010 Aztec marigold (Tagetes) meal and extract, 73.295

bacteria. See microorganisms bacterial count, 1210.16 bacterial cultures, 101.4(b)(5) bactericidal treatment, 1240.10, 1250.45(a) definition of, 1240.3(a), 1250.3(a) of utensils, 1250.33(a-c), 1250.44(a) of water containers, 1250.42(e), 1250.85(c) See also antimicrobial agents bagels, 101.12(b) bags (components of), 178.3730 baked goods, 170.3(n)(1), 172.894(a)(3) bakers yeast extract, 184.1983 glycan, 172.898 protein, 172.325 bakery products, 101.12(b), Part 136 baking powder, 101.12(b) calcium silicate in, 172.410(b) safe for intended use, 182.1(a) baking soda, 101.12(b) bananas, 101.100(i) barbecue sauce, 101.12(b) barges, 1240.3(p)(3), 1250.3(m)(3) barium, 82.5(b)(3) See also heavy metals barium sulfate, 82.3(i) barley (color identification of seed), 2.25(a) batch, 70.3(p) certification, 71.20(b), 80.37, 80.38, 82.6, 82.50 in-process, 106.3(b) number, 70.3(q) batter, 110.3(c), 110.80(b)(12) batter mixes, 101.12(b) bean cake, 101.12(b) beans, 101.12(b) carob, 184.1434 green, 155.120 soybean oil, 172.723 soybeans, 136.110(c)(12) tonka, 189.130(a) vanilla, 169.3(b) wax, 155.120 beard covers, 110.10(b)(6) beef fat, 184.1287(a) beer, 172.560(a), 173.55(b) See also malt beverages beeswax, 184.1973 beet powder, 73.40 beet sugar juice, 173.45(b), 173.73(b) beet-sugar mills, 173.320 beets, dehydrated, 73.40 bentonite, 184.1155 benzenecarboxylic acid, 184.1021(a) benzenesulfonic acids, 74.203(a-b), 74.705(b), 74.706(b) benzidine, 74.705(b), 74.706(b), 81.10(i) benzoic acid, 74.303(b), 184.1021 benzoin, 73.1(b)(1)(ii) benzoyl peroxide, 184.1157 See also contents of specific cheeses ortho-benzyl-para-chlorophenol, 178.1010(b)(20)

Bacillus amyloliquefaciens, 184.1148(a), 184.1150(a) Bacillus brevis, 173.115(a) Bacillus cereus, 173.150(a)(2) Bacillus coagulans, 184.1372(a) Bacillus stearothermophilus, 184.1012 Bacillus subtilis, 173.115, 184.1148(a), 184.1150(a) backflow in drinking fountains, 1250.70(c), 1250.85(a) in refrigeration equipment, 1250.34 of wastes, 1250.75(b) in water storage tanks, 1250.83(c) in water systems, 1240.86, 1250.42(a), 1250.82(e) bacon, 184.1890(c)(1) See also curing agents

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Index

berries, 145.120 β-apo-8’-carotenal, 73.90 beta-carotene, 73.95, 101.36(b)(2)(i)(B)(3), 184.1245 See also astaxanthin; canthaxanthin; vitamin A β-glucan, 101.81(c)(2)(i)(G)(1), 101.81(c)(2)(ii)(A) beverage containers (sanitizing solutions), 178.1010(b) beverages, Part 165 alcoholic, 73.170(c), 73.170(c)(2), 135.140(e)(4) beer, 172.560(a), 173.55(b) bottled water (see bottled water) clarifying agent for, 173.50(c) coffee, 135.140(e)(1) decaffeination of, 173.228(b), 173.255(d), 173.290 juice (see fruit juice; juices; vegetable juice) malt, 172.725(b), 172.730(c), 172.770 reference amounts, 101.12(b) tea, 135.140(e)(1), 173.228(b), 189.180(b) BHA. See butylated hydroxyanisole BHT. See butylated hydroxytoluene binders arabinoagalactan, 172.610(b) ethyl cellulose, 172.868(b)(1) fatty acid salts, 172.863(b) fatty acids, 172.860(d)(1) hydroxypropyl cellulose, 172.870(b)(2) oleic acid, 172.862(c) polyethylene glycol, 172.820(c)(1) white mineral oil, 172.878(c) binomial nomenclature. See Latin names biotin, 182.8159 See also contents of specific foods biphenyls. See polychlorinated biphenyls (PCB’s) birds, 110.3(j) biscuits, 101.12(b) Black No. 1 (D&C), 81.30(d) blanc fixe, 82.3(h) blanching, 110.3(d), 114.80(a)(3)(i) heat, 110.80(b)(11), 113.81(b) bleached flours, 137.105(b)(2), 137.200(b)(2) bleaching agents acetone peroxides, 172.802(c) benzoyl peroxide, 184.1157(c)(1) hydrogen peroxide, 184.1366(c) bleeders, 113.3(b), 113.40(a)(8), 113.40(f)(7), 113.87(g) blended cheese, 133.167, 133.168 blue cheese, 133.106 blue-mold cheese, 133.184 Blue No. 1 (Ext. D&C), 81.30(d) Blue No. 1 (FD&C), 74.101, 82.101 Blue No. 2 (FD&C), 74.102, 82.102 Blue No. 4 (Ext. D&C), 81.30(d) Blue No. 6 (D&C), 81.10(n), 81.30(o)(1) Blue No. 7 (D&C), 81.30(d) blue, ultramarine, 73.50 bluefish, 123.3(m) boats. See vessels bodying agents, 172.610(b), 172.695(e) boiler water additives, 173.310, 184.1005(c) boils (on personnel), 110.10(a) bonito, 102.47

botanical names, 101.4(h) bottle washers, 129.40(a)(1) bottled water, Part 129, 165.110 buildings and facilities, 129 Subpart B, 129.20 equipment, 129.40 fluoridation of, 170.45 production and process controls, 129.80 records, 129.80(h) source identification, 1250.25 See also drinking water; potable water bottles component of, 177.1050 constant temperature, 1250.42, 1250.43, 1250.85 glass, 178.1010(b) rigid vinyl chloride polymer, 189.300(a) sanitizing solutions for, 178.1010(b) wine, 189.301 box lunches, 1250.25 bran, 101.12(b) brand name health claims, 101.14(a)(1) nutrient content claims, 101.13(q)(6), 101.69(b)(3) breading, 110.80(b)(12) breads, 136.3(a), 136.110 egg, 136.110(e)(1), 136.115(b) enriched, 136.115 entire wheat, 136.180 graham, 136.180 milk, 136.115(b), 136.130 raisin, 136.160 reference amounts, 101.12(b) white, 136.110(a) whole wheat, 136.180 breakfast cereals, 101.12(b) brewer’s malt, 172.725(d)(2), 172.730(c) brick cheese, 101.100(f)(3), 133.108, 133.109 Brix levels, 101.30(h)(1) bromated flour, 101.4(b)(15) bromelain, 184.1024 brominated vegetable oil, 180.30 brown algae, 184.1001(a), 184.1120, 184.1133(a), 184.1610(a), 184.1724(a) brownies, 101.12(b) buildings, 110.3(k) bottled drinking water, 129 Subpart B current good manufacturing practice, 110 Subpart B, 110.20 bulk containers, 1.24(a)(1), 1250.26(d) bulk ice, 1250.67(c) bulk quantities of food, 177.2250, 177.2550, 177.2910(c) bulking agent, 172.841(c) buns, 136.3(b), 136.110 egg, 136.110(e)(1), 136.115(b) enriched, 136.115 entire wheat, 136.180 graham, 136.180 milk, 136.115(b), 136.130 raisin, 136.160 white, 136.110(a) whole wheat, 136.180

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Index

burritos, 101.12(b) butadiene. See under polymers (indirect food additives) butadiene/styrene elastomer, 177.1050 n-butane, 184.1165 1,4-butanedicarboxylic acid, 184.1009(a) 1,4-butanedioic acid, 184.1091(a) butene copolymers, 177.1430, 177.1570 butoxy monoether, 178.1010(b) butter, 1240.3(j) cocoa butter, 172.861, 184.1259 coloring of, 74.705(d)(2), 101.22(k), 101.22(k)(3) fruit butters, Part 150, 150.110 labeling exemptions, 1.24(a)(10) nutrient content claims, 101.67 reference amounts, 101.12(b) sale/service on conveyances, 1250.25, 1250.26 butter starter distillate, 184.1848 butterfat, 101.4(b)(9), 184.1287(a) buttermilk, 101.4(b)(5-6), 131.112(f) chocolate, 163.135 sale/service on conveyances, 1250.25, 1250.26 butteroil, 101.4(b)(9) n-butyl alcohol, 73.1(b)(1)(i) butylated hydroxyanisole (BHA), 172.110, 181.24, 182.3169 butylated hydroxytoluene (BHT), 172.115, 181.24, 182.3173 1,3-butylene glycol, 172.712, 173.220 butyrin, 184.1903

calcium hypochlorite, 178.1010(b)(1) calcium iodate, 136.110(c)(14)(i), 184.1206 calcium lactate, 184.1207 calcium lactobionate, 172.720 calcium lignosulfonate, 172.715 calcium oxide, 184.1210 calcium pantothenate, 184.1212 calcium peroxide, 136.110(c)(14)(i) calcium phosphate, 182.1217, 182.8217 calcium phosphate, monobasic, 182.6215 calcium propionate, 181.23, 184.1221 calcium pyrophosphate, 182.8223 calcium saccharin, 180.37 calcium silicate, 172.410, 177.2355(a), 182.2227 calcium sorbate, 182.3225 calcium stearate, 178.1010(b)(41), 184.1229 calcium stearoyl-2-lactylate, 172.844 calcium sulfate, 184.1230 calorie content claims, 101.60 free, 101.13(b)(5) low, 101.12(d), 101.13(b)(5), 101.60(a)(4), 101.60(b)(2), 105.66 reduced, 101.56(b)(2)(i), 105.66(d-e) calories, 101.36(b)(2)(i)(B)(1), 101.36(b)(2)(ii) cancer clause, 70.50 See also anticancer clause cancer (health claims) dietary lipids, 101.73 fiber-containing foods, 101.76 fruits and vegetables, 101.76, 101.78 candelilla wax, 184.1976 Candida guilliermondii, 173.160 Candida lipolytica, 173.165 Candida pseudotropicalis, 184.1387 Candida utilis, 172.896 candies additives, 172.894(a)(3-4) individually wrapped, 1.24(a)(4) reference amounts, 101.12(b) release agent for, 172.876(b) cane sirup, 168.130 cane-sugar mills, 173.320 canned fruit juices. See fruit juices, canned canned fruits. See fruits, canned canned vegetables. See vegetables, canned canola oil, 184.1555(c) cans. See container closures canthaxanthin, 73.75 caprino romano cheese, 133.183(e) caprylic acid, 184.1025 caps on containers, 129.37(c-d) for employees, 110.10(b)(6) capsicum, 73.340(a), 73.345(a) capsules (gelatin), 172.255, 172.280(b) caramel, 73.85, 182.1235 caraway seed, 133.127(b)(3)(iv) carbamide, 184.1923 carbohydrase, 173.120, 173.130, 184.1148

cacao products, Part 163, 163.5 cacao nibs, 163.110 chocolate, 163.123, 163.130, 163.135, 163.140, 163.145 chocolate liquor, 163.111 cocoa, 163.112, 163.113, 163.114, 163.117 caciocavallo siciliano cheese, 133.111 caffeine, 182.1180 cakes, 101.12(b) calamus, 189.110 calcium, 101.72 See also contents of specific foods calcium acetate, 184.1185 calcium alginate, 184.1187 calcium ascorbate, 182.3189 calcium bromate, 136.110(c)(14)(i) calcium bromide, 178.1010(b)(1-2) calcium carbonate, 137.105(a)(5), 184.1191 calcium carbonate/glyceryl tri-(12-acetoxystearate), 178.3505 calcium chloride, 178.1010(b)(40), 184.1193 calcium citrate, 184.1195 See also contents of specific cheeses calcium diacetate, 182.6197 calcium disodium EDTA, 73.1(a)(3), 172.120, 172.135(b)(2) calcium gluconate, 184.1199 calcium glycerophosphate, 184.1201 calcium hexametaphosphate, 182.6203 calcium hydroxide, 184.1205

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Index

carbohydrase and protease enzyme product, 184.1027 carbohydrate (percent of daily value), 101.36(b)(2)(iii)(D) See also contents of specific foods carbon black, 81.10(g) carbon dioxide, 184.1240 carbon monoxide copolymers, 177.1312 carbonated drinks, 73.170(c), 102.33(a) carbonation, 129.80(a) carboxylates, 74.705(b) carboxylic acids, 74.705(a-b), 178.1010(b)(39) carboxymethylcellulose, 182.1745 cardiovascular disease, 101.71(a) See also coronary heart disease (CHD) caries (dental), 101.80 carmine, 73.100 carnauba wax, 184.1978 carob bean gum, 184.1434 β-apo-8’-carotenal, 73.90 beta-carotene, 73.95, 101.36(b)(2)(i)(B)(3), 184.1245 See also astaxanthin; canthaxanthin; vitamin A carrageenan, 136.110(c)(6), 172.620, 172.623, 172.626, 182.7255 carrot oil, 73.300 caseinate, 101.4(d) casseroles, 101.12(b) castor oil, 73.1(a)(3), 172.876 dehydrated, 181.26 hydrogenated, 178.3280 castoreum, 182.50 cat food, 73.200(b)(2), 73.200(c)(2) catalase, 173.135, 184.1034 See also contents of specific cheeses catalyst, 184.1537(c)(1) catsup, 155.194 cautions, 71.37(a), 101.100(d)(3) investigational use, 170.17(a-b) nitrates/nitrites, 172.170(b)(3), 172.175(b)(3) olestra, 172.867(e)(1) See also precautions; warnings ceilings, 110.20(b)(4) cellophane, 177.1200, 178.3280(b)(2), 179.45(b)(1) cellulase, 173.120, 184.1250 cellulose, hydroxypropyl, 172.870 Center for Food Safety and Applied Nutrition (CFSAN), 5.33(a)(3)(i), 70.3(e), 107.250, 190.6(a) Centers (list of), 5.1100 ceramicware, 109.16 cereal flours and products, 101.12(b), Part 137 See also flours certifiable mixtures, 82.6 certificates color additive certification, 80.32, 81.30, 81.32 communicable diseases, 1240.20 permits for (Federal Import Milk Act), 1210.23 of sanitation, 5.32, 1250.26(e-f) certification, 5.32, 5.35 batch, 71.20(b), 80.37, 80.38, 82.6, 82.50 color additive (see color additive certification) no artificial flavor, 101.22(h)(7)(i)(4) number, 123.3(a), 1240.3(s)

See also specific color additives, exemption from certification certified provisionally listed colors, Part 82 cetyl alcohol, 73.1(b)(1)(i) CFSAN. See Center for Food Safety and Applied Nutrition CHD. See coronary heart disease (CHD) cheddar cheese, 101.100(f)(3), 133.113, 133.114, 133.116 cheese, Part 133, 1240.3(j) coloring of, 74.705(d)(2), 101.22(k), 101.22(k)(3) labeling, 1.24(a)(2), 101.100(f)(1-3) methods of analysis, 133.5 milk used in (see contents of specific cheeses) notice to manufacturers/packers/distributors, 133.10 packaging materials, 178.3850(e)(2) protective coating, 172.888(e) reference amounts, 101.12(b) sale/service on conveyances, 1250.25, 1250.26 cheese and related products, specific standardized, 133 Subpart B American cheese, 133.123(f), 133.133(h), 133.146(d)(2), 133.169(g), 133.173(h), 133.179(i) American cheese food, 133.147 asiago cheeses, 133.102, 133.103, 133.104 blended cheese, 133.167, 133.168 blue cheese, 133.106 blue-mold cheese, 133.184 brick cheese, 101.100(f)(3), 133.108, 133.109 caciocavallo siciliano cheese, 133.111 cheddar cheese, 101.100(f)(3), 133.113, 133.114, 133.116 cheese spread, 133.175, 133.176 chipped cheese, 133.146(d)(4)(ii) chopped cheese, 133.146(d)(4)(ii) club cheese, 133.123 colby cheese, 101.100(f)(3), 133.118, 133.119, 133.121 cold-pack cheese, 133.123 cold-pack cheese food, 133.124, 133.125 cook cheese/koch kaese, 133.127 cottage cheese, 133.128, 133.129 cream cheese, 133.133, 133.134, 133.167(c) curd cheese, 101.100(f)(3), 133.136, 133.137, 133.144 edam cheese, 133.138 emmentaler cheese, 133.195 gammelost cheese, 133.140 gorgonzola cheese, 133.141 gouda cheese, 133.142 granular cheese, 101.100(f)(3), 133.144, 133.145 grated cheeses, 133.146, 133.147 grating cheeses, hard, 133.148 gruyere cheese, 133.149 hard cheeses, 133.150 koch kaese, 133.127 limburger cheese, 133.152 monterey/monterey jack cheese, 133.153, 133.154 mozzarella cheese, 133.155, 133.156, 133.157, 133.158 muenster/munster cheese, 133.160, 133.161

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Index

neufchatel cheese, 133.162, 133.167(c) neufchatel cheese spread, 133.178 nuworld cheese, 133.164 parmesan cheese, 133.146(d)(3), 133.165 pimento cheese, 133.171 pimento cheese food, 133.174 process cheese, 133.169, 133.170, 133.171 process cheese food, 133.173, 133.174 process cheese spread, 133.179, 133.180 provolone cheese, 133.181 reggiano cheese, 133.146(d)(3)(ii), 133.165 ripened cheeses, 133.182 romano cheese, 133.146(d)(3), 133.183 roquefort cheese, 133.184 samsoe cheese, 133.185 sap sago cheese, 133.186 scamorza cheese, 133.155, 133.156, 133.157, 133.158 semisoft cheeses, 133.187, 133.188 sheep’s milk blue-mold cheese, 133.184 skim milk cheese, 133.189 soft ripened cheeses, 133.182 spiced cheeses, 133.190, 133.191, 133.193 swiss cheese, 133.195, 133.196 cheese food, 133.124, 133.125, 133.173, 133.174 cheese spreads, 133.175, 133.176, 133.178, 133.179, 133.180 chelating agents, 176.150 chemical contamination, 120.7(c)(3), 123.6(c)(1)(iii) chemical preservatives, 101.22(f), 182 Subpart D definition of, 101.22(a)(5) GRAS substances, 182 Subpart D labeling of, 101.4(b)(1), 101.22, 101.22(j) See also preservatives cherries (canned), 145.125 cherry pie, 152.126 chewing gum, 110.10(b)(8) additives, 172.866(d), 172.888(e), 172.890(b) bases, 110.10(b)(8), 172 Subpart G, 172.615 arabinoagalactan, 172.610 carrageenan, 172.620, 172.623, 172.626 furcelleran, 172.655, 172.660 gellan gum, 172.665 xanthan gum, 172.695 chick-edema factor, 172.860(b)(2), 172.860(c)(2) chicken fat, 184.1287(a) feed, 73.75(c)(2), 73.275(b), 73.295(c), 73.315(c) See also poultry Chief Counsel, 5.1105 chili pepper, 101.12(b) chinawood oil, 181.26 chipped cheese, 133.146(d)(4)(ii) chips, 101.12(b) chloride. See contents of specific foods chlorine, 137.105(a)(2) chlorine dioxide, 137.105(a)(4), 173.300, 178.1010(b) chloroacetic acid, 178.1010(b)(40), 189.155 chlorofluorocarbon, 101.17(c) chlorofluorocarbon 133, 173.342 chlorofluorocarbon propellants, 189.191

chloromethylated aminated styrene-divinylbenzene resin, 173.70 chloropentafluoroethane, 173.345 chocolate, 135.140(e)(2), 163.123, 163.145 buttermilk, 163.135 liquor, 163.111, 163.150(a)(1) milk chocolate, 163.130, 163.135, 163.140 and vegetable fat coating, 163.153, 163.155 See also cacao products cholecalciferol, 107.10(b)(1) cholesterol and coronary heart disease, 101.75, 101.77, 101.81, 101.82, 101.83(a)(1-2) disqualifying nutrient levels, 101.14(a)(4) low density lipoprotein (LDL), 101.75(a)(1-2), 101.77(a)(1-2), 101.81-101.83(a)(1-2) nutrient content claims, 101.62, 101.62(d) choline, 172.370 choline bitartrate, 182.8250 choline chloride, 182.8252 chondrus extract, 182.7255 chopped cheese, 133.146(d)(4)(ii) chromic chloride complexes, 178.3290 chromium, 74.101(b), 74.203(b) chromium complex, 176.160 chub, smoked, 172.177 chymosin preparation, 184.1685 cinnamyl anthranilate, 189.113 citrate complex, 172.370 citric acid, 184.1033 fermentation production of, 173.160, 173.165 in sanitizing solutions, 178.1010(b)(44) solvent extraction process, 173.280 citrus fruit coatings, 172.210, 172.215, 172.250, 172.260 Citrus Red No. 2, 74.302 civet, 182.50 claims. See health claims; nutrient content claims; specific product claims clams, 102.49, 123.3(h), 172.120(d)(1), 1240.3(r), 1250.3(o) clarifying agents, 173.50, 173.55, 173.60, 173.70 for polymers, 178.3295 clay (kaolin), 186.1256 cleaned (definition), 120.3(a) cleaning compounds, 110.35(b)(1-2), 123.11(b)(5) cleaning solutions, 129.80(c) See also sanitizers; sanitizing solutions cleanliness (of personnel), 110.10(b) Clostridium botulinum, 184.1538(c) negative for, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) toxin, 123.6(e), 123.16, 172.177 Clostridium perfringens, negative for, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) closures. See container closures clotting enzymes, 173.150 See also contents of specific cheeses cloud inhibitor, 172.854(c) clove, 184.1257 clover, 133.186(a)(2)

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Index

club cheese, 133.123 coal tar color, 82.6(a)(i) hair dyes, 70.3(u) coatings, 172 Subpart C, Part 175, 175 Subpart C acrylate ester copolymer, 175.210 acrylonitrile copolymers, 181.32(a)(2) chocolate/cocoa and vegetable fat, 163.150, 163.153, 163.155 cocoa butter substitute, 172.861(c), 184.1259(c) coumarone-indene resin, 172.215 ethyl cellulose, 172.868(b)(2) on fresh citrus fruit, 172.210, 172.215, 172.250, 172.260, 172.275 hot-melt, 172.878(c)(9), 175.230 morpholine, 172.235 oxidized polyethylene, 172.260 paper/paperboard, 176.170, 176.200, 176.230, 179.45(b)(3) paraffin, synthetic, 172.275, 175.250 partial phosphoric acid esters of polyester resins, 175.260 petroleum hydrocarbons, 172.882(c)(4), 172.884(c) petroleum naphtha, 172.250 petroleum wax, 172.886(d), 172.888(e), 178.3720 polyethylene glycol, 172.820(c)(1), 172.820(c)(4) poly(vinyl fluoride) resins, 175.270 protective, 172.260(b), 172.859(c)(3), 172.880(c), 172.886(d), 172.888(e) petrolatum, 178.3700(c) white mineral oil, 172.878, 178.3620(a-b) release, 177.1430(b)(5) repeated use, 177.1500(b)(9b) resinous and polymeric, 175.300, 175.320, 178.3280(b)(3) rice bran wax, 172.890(b) vinyl acetate/crotonic acid copolymer, 175.350 vinylidene chloride copolymer, 175.360, 175.365 wax, 101.4(b)(22), 101.95(c)(1)(i), 176.170, 179.45(b)(3) white mineral oil, 172.878(c), 178.3620(a) xylene-formaldehyde resins, 175.380 zinc-silicon dioxide matrix, 175.390 cobalt caprylate, 181.25 cobalt linoleate, 181.25 cobalt naphthenate, 181.25 cobalt tallate, 181.25 cobaltous salts, 189.120 cobblers, 101.12(b) cochineal extract, 73.100 cocktail, 102.33 seafood, 102.54 cocoa, 135.140(e)(2), 163.113 breakfast, 163.112 with dioctyl sodium sulfosuccinate, 163.117, 172.520 lowfat, 163.114 for manufacturing, 163.117, 172.520 reference amounts, 101.12(b) and vegetable fat coating, 163.150 See also cacao products

cocoa butter substitute, 172.861, 184.1259 coconut oil, 172.861 ester, 172.816, 178.3600 Codex Alimentarius food standards, 130.6 coding acidified foods, 114.80(b) hermetically sealed containers, 113.60(c) infant formula, 106.90 milk and milk products, 1250.26(a) unit package production, 129.80(e) coffee, 135.140(e)(1) decaffeination of, 173.228(b), 173.255(d), 173.290 reference amounts, 101.12(b) cognac oil, 182.50 colby cheese, 101.100(f)(3), 133.118, 133.119, 133.121 cold-pack cheese, 133.123, 133.124, 133.125 cold storage compartment, 110.40(e) rooms, 1250.30(a) color adjunct, 184.1230(c) certified, Part 82 Color Certification Branch, 70.3(e) colorants for polymers, 178.3297 fixatives, 181.34, 184.1311(c) identification of seed, 2.25 labeling of, 101.4(b)(1), 101.22, 101.22(k) lakes (see lakes) mixtures, 70.3(k), 73.1, 82.6 provisionally listed, Part 82 pure, 70.3(o) straight, 70.3(j), 70.20, 70.25(a)(1), 73.1, 82.51 certification of, 80.10(a), 82.50 specifications for, 82.5 tolerance for, 70.45 See also color additives; pigment dispersants; specific colors by name color additive advisory committee, 70.51 color additive certification, Part 74, Part 80, 80.31 batch certification, 71.20(b), 71.25(a-b) condition for, 71.25 exemption from, 71.18, 71.26, 71.27, Part 73, 80.35 fees for, 80.10, 80.21(f) form (example form), 80.21(j) records of distribution, 80.39 refusal of, 80.34 revocation or amendment, 80.32(h) samples for, 80.21(g), 80.22, 80.32(b) See also color additive petitions color additive listings additives exempt from certification, Part 73 additives subject to certification, Part 74 provisional, 81.1, 81.10 color additive petitions, Part 71 administrative action on, 71 Subpart B amendments, 71.6(b) confidentiality of data, 71.15 deception and, 71.22 exemption for investigational use, 71.37 exemption from certification, 71.18, 71.26, 71.27

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Index

extension of time, 71.6(a) form (example form), 71.1(c) notice of filing, 71.2 objections to regulations, 71.30 public disclosure, 71.15(a) regulation concerning, 71.20, 71.22, 71.27, 71.30 samples, 71.4 scientific studies for, 71.1(g), 71.1(i) withdrawal without prejudice, 71.6(c) color additives, Part 70 allocation of, 70.45 anticancer clause, 70.51 cancer clause, 70.50 criteria for safety, 70.42 definition of, 70.3(f) delegations of authority, 5.10(a)(25), 5.300 diluents, 73.1, 80.35(c) exempt from certification, Part 73, 80.35 exemption from color additive status, 70.3(g-h) expiration date, 70.25(a)(4) in feed, 70.50(c) chicken feed, 73.75(c)(2), 73.275(b), 73.295(c), 73.315(c) fish feed, 73.185(a)(2), 73.185(c)(1-3), 73.355(a)(2), 73.355(d)(2) salmonid fish feed, 73.35(c), 73.75(c)(3), 73.355(c), 73.355(d)(3) fees, 70.19, 80.10 labeling requirements, 70.25, 101.22(k)(1-2) (see also specific color additives) in meat, 71.1(j)(1), 71.20(a)(3) mixtures, 70.3(k), 73.1, 80.10(b), 80.35 packaging requirements, 70.20 patent term extensions, 5.27 in polymers, 178.3297(d) in poultry, 71.1(j)(1), 73.275(b) provisional, Part 81 restrictions on use, 70.5 safety evaluation, 70 Subpart C, 70.40, 71.37(a) samples of, 71.4, 80.21(g), 80.22, 80.32(b) scientific studies, 70.55 in standardized foods, 70.10 tolerances for, 70.11(d), 70.25(b), 70.45 unapproved use of, 120.7(c)(7), 123.6(c)(1)(viii) See also specific colors and color additives Colphen, 109.15(a) combustion product gas, 173.350 come-up-time, 113.3(c) commercial processor, 113.3(d) commercial sterility, 113.3(d), 113.3(j), 178.1005(e)(2) common or usual name, 101.4(b)(2), Part 102, 102.5 botanical names of dietary supplements, 101.4(h) labeling requirements, 101.3(b)(2), 101.4(b)(2)(i) in nutrient content claims, 101.13(q)(6) petitions, 102.19 for specific nonstandardized foods, 102 Subpart B common use in food, 170.3(f), 170.30(a), 170.30(c) communicable diseases, Part 1240, 1250.26(a), 1250.26(d) administrative procedures, 1240 Subpart B carriers of, 1250.35(a), 1250.95

certificates, 1240.20 definition of, 1240.3(b), 1250.3(b) inspections, 1240.20 and interstate shipments, 1240 Subpart D local control, 1240.30 potable water source/use, 1240 Subpart E preventing transmission of, 1250.51(a-b), 1250.67(c), 1250.82(f) psittacosis, 1240.65(c) sanitary facilities and, 1250.63 See also disease communicable period, 1240.3(c), 1250.3(c) complaints consumer, 123.8(a)(2)(i) infant formula, 106.100(k), 106.100(n) compliance, 5.31(a)(1) substantial, 101.42(c-f), 101.43 variances from, 1250.51(f) See also specific regulations compressed air, 110.40(g) concentrate (food), 177.2550 concentrate (juice), 102.33(g)(1), 146.120, 146.121, 146.126, 146.145 concentrated milk, 1.24(a)(7), 101.4(b)(4), 131.115, 133.3(a) concentrated orange juice, 146.146, 146.148, 146.150, 146.153, 146.154 Concord grapes, 73.169(a) condensary, 1210.27, 1210.28 condensate, 110.20(b)(4), 123.11(b)(5) condensed milk, 131.120, 1210.3(d-e), 1210.27, 1210.28 condiments, 101.12(b) conditioning agents, 172.826(b)(2), 172.826(b)(4-5), 172.844(c)(3) conditions of use, 176.170(c) Table 2, Part 182, Part 184, Part 186, 186.1(b)(1) limited, 184.1(b)(1-2), 184.1(f)(2-3), 186.1(b)(2) safe use conditions, 172.5(b), 181.1(b), 181.5(c), 186.1(b)(1) See also specific foods and additives confidential commercial information, 190.6(e) constant temperature bottles, 1250.42, 1250.43, 1250.85 construction food preparation/service/storage areas, 1250.30, 1250.62 plant, 110.20(b), 129.20 container closures, 113.60(a) inspections of, 5.304(a), 108.35(g), 113.60(a), 113.100(c) with sealing gaskets, 177.1210, 178.3280(b)(5) vacuum, 113.60(a)(2) containers, 129.80(b), 1240.3(o), 1250.3(l) bulk, 1.24(a)(1), 1250.26(d) components of, 177.1320 fill of, 130.12, 130.14 filling/capping/sealing, 129.80(f) hermetically sealed (see hermetically sealed containers) misleading, 100.100 multiservice, 129.3(d), 129.37(a-b), 129.80(b)(1)

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Index

primary, 129.3(g) rigid and semirigid, 181.32(a)(3) sanitizing solutions, 178.1010(b) secondhand, 2.35 self-pressurized, 101.17(a-b) shipping, 1.20(a-b), 2.35 shipping cases, 129.3(j), 129.80(b)(2) single-serving, 101.9(b)(2)(i), 101.9(b)(3), 101.9(b)(5), 129.3(k), 129.37(c), 1250.26(d) sterilization of, 113.40(g)(2) See also food-packaging materials contaminants, unavoidable, Part 109 contamination, 1240.3(d), 1250.3(d) chemical, 120.7(c)(3), 123.6(c)(1)(iii) by cosmetics, 110.10(b)(9) by drug residues, 123.6(c)(1)(v) of food and utensils, 1250.30(d), 1250.32, 1250.33(c) by fuel, 110.40(a), 123.11(b)(5) with hair, 110.10(b)(9) by human wastes, 1250.75(a) of ice, 1250.28 lead, 109.16(a) with lubricants, 110.40(a), 123.11(b)(5) with medicines applied to skin, 110.10(b)(9) microbial, 120.7(c)(1) PCB’s in food-packaging paper, 109.15 permissible level, 109.7(a) with pesticide chemicals, 123.6(c)(1)(iv), 123.11(b)(5) of utensils, 1250.30(d), 1250.32 of water, 1250.42(b), 1250.42(d) of water supply, 1250.30(d), 1250.42(b), 1250.82, 1250.83(c) contents. See net quantity of contents contracts, 2.19 contraindications, 1.21(c)(1) control (definition of), 120.3(b) control measure, 120.3(c) conveyances, 1240.3(e), 1250.3(e) interstate (see under sanitation) See also communicable diseases cook cheese/koch kaese, 133.127 cookies, 101.12(b) cooking utensils, 5.10(a)(21) cooking wine, 101.12(b) coolers, water, 1250.42(c), 1250.43, 1250.70(c), 1250.85 copal, Manila, 73.1(b)(1)(ii) copolymer coatings, 175.210, 175.350, 175.360, 175.365, 179.45(b), 181.32(a)(2) copolymer condensates, 172.808 copolymer films, 179.45(b)(9), 179.45(d)(2)(iv), 181.32(a)(1) copolymer resins, 177.1340 copolymers acrylamide, 172.710 acrylic, 177.1060 acrylic acid, 177.1310 acrylonitrile, 175.125(c), 177.2910(a)(1), 180.22, 181.32

acrylonitrile/butadiene/styrene, 177.1020, 181.32(a)(1) acrylonitrile/butadiene/styrene/methyl methacrylate, 177.1030 acrylonitrile-methyl acrylate, 177.1480 acrylonitrile/styrene, 177.1040, 177.1050, 181.32(a) acrylonitrile-vinyl chloride, 177.2910(a)(1), 181.32(a) n-alkylglutarimide/acrylic, 177.1060 butene/ethylene, 177.1570 dimethylamine-epichlorohydrin, 173.60 divinylbenzene, 172.775, 173.65 ethyl acrylate, 177.1320 ethylene-acrylic acid, 177.1310 ethylene-carbon monoxide, 177.1312 ethylene-1,4-cyclohexylene dimethylene terephthalate, 177.1315 ethylene-ethyl acrylate, 177.1320 ethylene-methacrylic acid, 177.1330 ethylene-methyl acrylate, 177.1340 ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate, 177.1345 ethylene-vinyl acetate, 177.1350, 179.45(c) ethylene-vinyl acetate-vinyl alcohol, 177.1360 ethylene-vinyl chloride, 177.1950 hexene-1-vinyl chloride, 177.1960 isobutylene-butene, 177.1430 lauryl vinyl ether-vinyl chloride, 177.1970 methacrylic acid, 172.775, 177.1330 methyl acrylate, 177.1340, 177.1480, 177.1990, 177.2000 methyl methacrylate, 177.1030, 177.1830, 177.2000 α-methylstyrene-vinyltoluene resins, 178.3610 polyacrylate, 177.1211 polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate, 177.2465 polyoxymethylene, 177.2470 propylene-vinyl chloride, 177.1980 styrene-maleic anhydride, 177.1820 styrene-methyl methacrylate, 177.1830 vinyl acetate, 177.1350, 177.1360, 179.45(c) vinyl acetate/crotonic acid copolymer, 175.350 vinyl alcohol, 177.1360 vinyl chloride-acrylonitrile, 177.2910(a)(1), 181.32(a) vinyl chloride-ethylene, 177.1950 vinyl chloride-hexene-1, 177.1960 vinyl chloride-lauryl vinyl ether, 177.1970 vinyl chloride-propylene, 177.1980 vinylidene chloride/methyl acrylate, 177.1990 vinylidene chloride-vinyl chloride, 179.45(b)(9) See also polymers copper. See contents of specific foods copper gluconate, 184.1260 copper sulfate, 184.1261 corn, 155.130, 155.131 bread, 101.12(b) color identification of seed, 2.25(a) endosperm oil, 73.315 flour, 1.24(a)(12), 137.211, 137.215 gluten, 184.1321 grits, 172.345(f)

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Index

silk, 184.1262 sirup, 145.3(a), 146.3(a), 184.1865, 184.1866 sugar, 184.1857 corn meal, 137.260, 137.270, 137.290 white, 137.250, 137.255, 137.265, 137.270 yellow, 137.275, 137.280, 137.285, 137.290 cornstarch, 101.12(b) coronary heart disease (CHD) and dietary saturated fat/cholesterol, 101.75 and fruits/vegetables/grains, 101.77 and plant sterol/stanol esters, 101.83 and psyllium fiber, 101.17(f), 101.81(c)(2)(ii)(B) and soluble fiber, 101.77, 101.80 corporate name, 101.5(b) corrective actions definition of, 113.60(a) fish and fishery products, 123.7 hazard analysis and critical control point (HACCP) systems, 120.10, 120.11(a)(1)(iv)(B), 123.6(c)(5) See also verification corrosion inhibitors, 178.3300 See also anticorrosive agents cosmetics, 110.10(b)(9) cottage cheese, 133.128, 133.129 cotton/cotton fabrics (for packaging), 182.70 constituents of fish oil, 186.1551(c) Japan wax, 186.1555(b)(1) sodium sulfate, 186.1797(b) sorbose, 186.1839(b) tall oil, 186.1557(b)(1) cottonseed delinting of, 173.322 flour, 73.140 products, 172.894 coumarin, 189.130 coumarone-indene resin, 172.215 Counsel, Chief, 5.1105 cow’s milk. See contents of specific cheeses cows (physical examination of), 1210.12 crabmeat, 102.50, 102.54 cracked wheat, 137.190 cranberry sauce, 101.12(b) cream, Part 131 definition of, 131.3(a), 133.3(c), 1210.3(g) dry, 131.149, 1240.3(j) heavy/heavy whipping, 131.150 labeling of, 1.24(a)(7), 101.4(b)(8) light, 131.155 light whipping, 131.157 permits for, 1210 Subpart C plastic, 101.4(b)(8) reference amounts, 101.12(b) sour, 131.160, 131.162 whipped, 131.25 whipping, 131.150, 131.157 See also Federal Import Milk Act cream cheese, 133.133, 133.134, 133.167(c) creamery, 1210.27 criminal proceedings, 5.10(b)

critical control points, 120.8(b)(2), 120.11(a)(1)(iv)(A), 123.6(c)(2) definition of, 110.3(d), 120.3(d), 120.7(a)(5), 123.3(b) See also hazard analysis and critical control point (HACCP) systems; verification critical factors, 113.83 definition of, 113.3(f) deviations in, 113.89 records, 113.100(a)(6-7) in thermal processing, 113.40(a)(13), 113.40(b)(14), 113.40(c)(10), 113.40(d)(8), 113.40(e)(7), 113.40(f)(9), 113.40(h)(2) critical limits, 120.8(b)(3), 123.6(c)(3) definition of, 120.3(e), 123.3(c) deviations from, 123.7(a) croissants, 101.12(b) crotonic acid copolymer, 175.350 croutons, 101.12(b) crushed wheat, 137.195 crust (pie/pizza), 101.12(b) crustaceans, 123.3(d) crystallization aids glyceryl tristearate, 172.811(c) methyl glucoside-coconut oil ester, 172.816(b)(1) sodium naphthalene sulfonates, 172.824(b)(1) crystallization inhibitor, 172.818(b) culinary water, 1240.83, 1240.95, 1250.67(a), 1250.86 culled, 120.3(f) cultured buttermilk, 131.112(f) cultured milk, 101.4(b)(5), 131.112 cultured sour cream, 131.160 cup (drinking), 1250.44(a) cup (measure), 101.9(b)(5) cuprous iodide, 184.1265 curd cheese, 101.100(f)(3), 133.136, 133.137, 133.144 curdlan, 172.809 curing agents acetic acid, 184.1005(c) calcium chloride, 184.1193(c) glucono delta-lactone, 184.1318(c)(1) lactic acid, 184.1061(c) nitrites/nitrates, 170.60 potassium nitrate, 172.150, 181.33 potassium nitrite, 181.34 sodium carbonate, 184.1742(c)(1) sodium nitrate, 172.170, 181.33 sodium nitrite, 172.175, 172.177, 181.34 sorbitol, 184.1835(c) curing premixes, 170.60 current good manufacturing practice, Part 110, 110.5 buildings and facilities, 110 Subpart B, 110.20 defect action levels, 110 Subpart G, 110.110 equipment, 110.40 exclusions, 110.19 hazard analysis and critical control point (HACCP) systems, 120.5 irradiation of food, 179.25 personnel, 110.10 production and process controls, 110 Subpart E, 110.80

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Index

sanitary facilities and controls, 110.37 sanitary operations, 110.35 unavoidable contaminants, 109.7(b) utensils, 110.40 warehousing and distribution, 110.93 See also good manufacturing practice; specific foods and additives current good manufacturing practice: specific products acidified foods, Part 114, 114.5 bottled drinking water, Part 129, 129.1 dietary supplements, Part 111 fish and fishery products, Part 123, 123.5 food-packaging materials, 181.22 GRAS substances, Part 182, 182.1(b), Part 184, 184.1(b), Part 186, 186.1(b) thermally processed low-acid foods, 113.5 custards frozen, 135.110 reference amounts, 101.12(b) cutlery, 1240.3(o), 1250.3(l) cyclamate, 189.135 cyclohexane, 73.1(b)(1)(i) 1,4-cyclohexylene dimethylene isophthalate, 177.1240 1,4-cyclohexylene dimethylene terephthalate, 177.1240, 177.1315 L-cysteine, 184.1271 monohydrochloride, 184.1272 See also amino acids

Daily Value (percent of), 101.36(b)(2)(iii), 101.36(b)(2)(iii)(D) dairy farms. See Federal Import Milk Act dairy-processing equipment, 178.1010(b) damar gum, 73.1(b)(2) data bases (nutrient values), 101.45(b)(1), 101.45(c) DATEM, 184.1101(a) debarment, 5.34 decaffeination, 173.228(b), 173.255(d), 173.290 decanoic acid, 178.1010(b) deception and color additives, 71.22 in use of GRAS substances, 184.1(c), 186.1(d) declaration of ingredients (exemptions from), 1.23 declaration of net quantity of contents, 101.105 exemptions from, 1.23, 1.24(a)(1) defect action levels, 110 Subpart G, 110.110 defects (closure), 113.60 defoaming agents, 173.340 copolymer condensates of ethylene and propolyene oxides, 172.808(b)(3)(i) fatty acids, 172.860(d)(1) oleic acid, 172.862(c) petrolatum, 172.880(c) petroleum hydrocarbons, 172.884(c), 178.3650(c) petroleum wax, 172.886(d), 172.888(e) polysorbate 80, 172.840(c)(2), 172.840(c)(13) used in manufacture of paper/paperboard, 176.200 used in paper/paperboard coatings, 176.200 white mineral oil, 172.878(c)(4) dehydrated beets, 73.40 dehydrated food, 110.80(b)(14) dehydrating agents, 172.225, 172.270 dehydroacetic acid, 172.130 deionized water, 165.110(a)(2)(iv) delegations of authority, Part 5 deleterious substances. See poisonous or deleterious substances delinting cottonseed, 173.322 demineralized water, 165.110(a)(2)(iv) dental caries, 101.80 dentifrices, 81.10(t), 81.30(s)(1) DEPC (diethylpyrocarbonate), 189.140 design. See plant construction and design designation of ingredients, 101.4, 130.11 desserts frozen, 1.24(a)(6), Part 135 reference amounts, 101.12(b) destruction of samples, 2.10(e) detention of eggs, 5.302 of meat, 5.10(a)(10), 5.302 of poultry, 5.10(a)(11), 5.302 dextrans, 186.1275 dextrin, 184.1277 in sanitizing solutions, 178.1010(b)(41) dextrose (definition of), 145.3(b), 146.3(b) dextrose anhydrous, 168.110 dextrose monohydrate, 168.111 diacetyl, 184.1278, 184.1848(a)

D&C Black No. 1, 81.30(d) D&C Blue No. 6, 81.10(n), 81.30(o)(1) D&C Blue No. 7, 81.30(d) D&C Green No. 6, 81.10(o), 81.30(p)(1) D&C Green No. 7, 81.30(d) D&C lakes, 81.1(b) D&C Orange No. 3, 81.30(d) D&C Orange No. 4, 81.30(g) D&C Orange No. 8, 81.30(d) D&C Orange No. 10, 81.10(m), 81.30(n)(1) D&C Orange No. 11, 81.10(m), 81.30(n)(1) D&C Orange No. 14, 81.30(d) D&C Orange No. 15, 81.30(d) D&C Orange No. 16, 81.30(d) D&C Orange No. 17, 81.10(s), 81.30(t)(1) D&C Red No. 5, 81.30(d) D&C Red No. 8, 81.10(t), 81.30(s)(1) D&C Red No. 10, 81.10(h), 81.30(k)(1) D&C Red No. 11, 81.10(h), 81.30(k)(1) D&C Red No. 12, 81.10(h), 81.30(k)(1) D&C Red No. 13, 81.10(h), 81.30(k)(1) D&C Red No. 14, 81.30(d) D&C Red No. 18, 81.30(d) D&C Red No. 19, 81.10(q)(1), 81.30(r)(1) D&C Red No. 24, 81.30(d) D&C Red No. 29, 81.30(d) D&C Red No. 35, 81.30(d) D&C Red No. 37, 81.10(q), 81.30(r)(1) D&C Red No. 38, 81.30(d) Daily Reference Value (DRV), 101.36(b)(2), 101.54(a)

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Index

diacetyl tartaric acid esters, 136.110(c)(5)(ii), 184.1101 diary farms. See Federal Import Milk Act dicalcium phosphate, 137.105(a)(5), 137.185(e) dichlorodifluoromethane, 173.355 dichloroisocyanuric acid, 178.1010(b)(2) dickite, 186.1256(a) dicyclohexylamine, 178.3300(b)(1) diet/dietary label statements, 105.66 diet soft drink, 101.13(q)(2) dietary additives. See special dietary and nutritional \ additives dietary fiber health claims, 101.71(a), 101.77(c)(2)(i)(D), 101.78(a-b)(2) percent of daily value, 101.36(b)(2)(iii)(D) dietary lipids, 101.73 dietary saturated fat. See saturated fat dietary sugar alcohols, 101.80 dietary supplements, Part 190 botanical names, 101.4(h) current good manufacturing practice, Part 111 disease claims, 101.93(g) exemptions, 101.36(h), 111.50(b) health claims, 101.14(d)(3), 101.14(e), 101.71, 101.93 ingredient list, 101.4(g) iron-containing, 111.50 labeling of, 101.3(g), 101.4(a)(1), 101.36, 101.93(b-f) misbranding, 101.36(j) new ingredients, 190.6 nutrient content claims, 101.13(b)(5), 101.13(q)(3)(i-ii), 101.62(a)(4) premarket notification, 190.6 reference amounts, 101.12(b) warnings, 101.17(e) See also nutrient supplements dietary use, special, Part 105, 105.3 diethanolamine, 172.710 diethylene glycol distearate, 73.1(b)(2) diethylpyrocarbonate (DEPC), 189.140 diets high in/low in (see specific health claims) special, Part 105, 105.3 1,1-difluoroethane, 178.3010 dihydrosafrole, 189.180(a-b) dilauryl thiodipropionate, 181.24 dill, 184.1282 diluents, 70.3(m) in color additive mixtures, 73.1, 82.6(a)(2-3) for herbicides, 172.840(c)(12) for pesticides, 172.710 See also specific color additives dimethyl dicarbonate, 172.133 dimethylamine-epichlorohydrin copolymer, 173.60 dimethyldialkylammonium chloride, 173.400 2-(1,1-dimethylethyl)-1,4-benzenediol (TBHQ), 172.185 N,N-dimethyloctanamine, 178.1010(b)(39) 3,5-dimethyl-1,2,3,2H-tetrahydrothiadiazine-2-thione, 176.230 dining car (railroad), 1250.45(b), 1250.45(d)

dinitrogen monoxide, 184.1545(a) dinners, 101.12(b), 102.28 frozen heat and serve, 102.26, 104.47 dioctyl sodium sulfosuccinate, 73.1(a)(3), 73.1(b)(2), 163.117, 172.520, 172.810 See also contents of specific dairy products 1,3-diphenyltriazene, 74.705(b), 74.706(b) dipotassium phosphate, 133.169(c), 182.6285 dips, 101.12(b) direct food additives. See food additives, direct directions for use, 184.1(f)(3) disclosure affirmative, 1.21(b) public, 71.15(a) disease, 101.14(a)(5), 101.14(b)(1) control, 110.10(a) organisms in secondhand containers, 2.35(a) report of, 1240.45 See also communicable diseases disinfection by radiation, 179.26(b)(4-5) disintegrator (in tablets), 172.870(b)(1) disodium EDTA, 73.1(a)(3), 172.120(b)(2), 172.135, 178.1010(b)(44) disodium guanylate, 172.530 disodium inosinate, 172.535 disodium phosphate, 133.169(c), 182.6290 dispersing agents calcium lignosulfonate, 172.715(b) dioctyl sodium sulfosuccinate, 172.810(e) polysorbate 60, 172.836(c)(13) polysorbate 80, 172.840(c)(3-4), 172.840(c)(7), 172.840(c)(11) display panel. See principal display panel disqualifying nutrient levels, 101.14(a)(4), 101.14(e)(3) distearyl thiodipropionate, 181.24 distillates, 101.22(a)(3) natural, 182.20 distillation, 129.80(a) distilled water, 165.110(a)(2)(iv) distribution, 110.93 distribution records, 80.39, 106.100(g), 106.100(n) distributors, 101.5, 133.10 District of Columbia, 1240.3(l), 1250.3(k) divinylbenzene copolymer, 172.775, 173.65 divinylbenzene-styrene resins, 173.70, 177.2710 Divisions (list of), 5.1100 dodecylbenzenesulfonic acid, 178.1010(b) dodecyldiphenyloxidedisulfonic acid, 178.1010(b)(29) α-(p-dodecylphenyl)-omega-hydroxypoly (oxyethylene), 172.710 dog food, 73.200(b)(2), 73.200(c)(2) dogs, guide/guard, 110.35(c) doors, self-closing, 129.35(c) dosage unit, 111.50(a) dough conditioners, 101.4(b)(18), 136.110(c)(15), 137.105(a), 137.200(b)(2) acetone peroxides, 172.802(c) azodicarbonamide, 172.806(a)(2) calcium stearoyl-2-lactylate, 172.844(c)(1) polysorbate 60, 172.836(c)(11)

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Index

sodium stearyl fumarate, 172.826(b)(1) succinylated monoglycerides, 172.830(c)(2) dough strengtheners ammonium bicarbonate, 184.1135(c)(1) ammonium chloride, 184.1138(c) ammonium phosphate, dibasic, 184.1141b ammonium phosphate, monobasic, 184.1141a ammonium sulfate, 184.1143(c) calcium iodate, 184.1206(c) calcium sulfate, 184.1230(c) L-cysteine, 184.1271(c) L-cysteine monohydrochloride, 184.1272(c) mono- and diglycerides, 184.1505(c)(1) potassium iodate, 184.1635(c) propylene glycol, 184.1666(c) sodium stearoyl lactylate, 172.846(c)(1) wheat gluten, 184.1322(c)(1) doughnuts, 101.12(b) drainage, 1250.65 drained weight, 145.3(n), 145.3(o)(4), 155.3(a) dressing rooms, 110.20(b)(5) dressings contamination of, 110.80(b)(12) salad, 101.12(b), 101.83(c)(2)(iii)(D), Part 169 dried algae meal, 73.275 dried cream, 101.4(b)(8) dried egg whites, 101.4(b)(11) dried whole eggs, 101.4(b)(10) driers (prior-sanctioned), 181.25 drink mixers, 101.12(b) drinking fountains, 1250.70(c), 1250.85 drinking utensils, 5.10(a)(21), 1250.44 drinking water, 1240.80, 1240.95, 1250.67(a-c) bottled, Part 129 EPA Primary Drinking Water Regulations, 1240.3(m), 1240.83(a), 1250.3(j) See also bottled water; potable water drug residues, 123.6(c)(1)(v) DRV (Daily Reference Value), 101.36(b)(2), 101.54(a) dry cream, 131.149, 1240.3(j) dry foods labels for, 175.125(a) packaging, 176 Subpart B, 182.70 dry milk, 131.125, 131.127, 131.147 dry mixes, 110.80(b)(14) drying agents agar-agar, 184.1115(c) calcium sulfate, 184.1230(c) sorbitol, 184.1835(c) drying oils, 181.26 ducts and pipes, 110.20(b)(4) due diligence determinations, 5.10(a)(25), 5.27 dulcin, 189.145, 189.145(a) durum flour, 101.4(b)(15), 137.220, 137.225, 139.110(a) dust control agent, 172.878(c)(15-16)

edam cheese, 133.138 edible fats and oils, 172.225, 184.1472(b)(3), 184.1555(c)(4) edible organic acid/salt, 145.3(g) EDTA (ethylenediamine tetraacetate) calcium disodium, 73.1(a)(3), 172.120, 172.135(b)(2) disodium, 73.1(a)(3), 172.120(b)(2), 172.135, 178.1010(b)(44) tetrasodium, 178.1010(b) education. See training effective date (of regulations), 5.301 egg products, 101.100(d)(3), Part 160 bread, 136.110(e)(1), 136.115(b) buns, 136.110(e)(1), 136.115(b) Egg Products Inspection Act, 5.10(a)(12), 5.302(c) egg rolls, 101.12(b), 136.110(e)(1), 136.115(b) eggnog, 101.12(b), 131.170, 1240.3(j), 1240.61(c) noodles, 139.150, 139.155, 139.160, 139.165, 139.180 egg whites, 101.4(b)(11), 139.110(a)(5), 160.140, 160.145, 160.150 egg yolks, 101.4(b)(12), 131.170(a), 131.170(c), 160.180, 160.185, 160.190 eggs, Part 160, 160.100 color additives in, 73.275(b)(1), 73.295(c)(1), 73.315(c)(1) detention of, 5.302 dried, 101.4(b)(10), 160.105 egg substitutes, 101.12(b) frozen, 101.4(b)(10), 160.110 liquid, 101.4(b)(10), 160.115 reference amounts, 101.12(b) shell (see shell eggs) whole, 101.4(b)(10) elastomers, perfluorocarbon cured, 177.2400 electrodes (pH), 114.90(a)(3) emergency action level, 180.1(f), 181.1(c) emergency health functions, 5.10(a)(15) emergency permit, 5.301, Part 108, 108.3 activities without/in violation of, 108.12 exemption from compliance with, 108.19, 108 Subpart B issuance or denial, 108.7 need for, 108.5, 108.6 suspension and reinstatement, 108.10 emergency stops (for retorts), 113.40(c)(8) emmentaler cheese, 133.195 employees conveniences for, 1250.70 food-handling, 1250.38 health conditions, 123.11(b)(7) standards of conduct, 5.10(a)(26)(ii) See also personnel emulsifiers, 173.75, 178.3400 acacia (gum arabic), 184.1330(c) alginic acid, 184.1011(c) arabinoagalactan, 172.610(b) bakers yeast glycan, 172.898(d) carrageenan, 172.620(c), 172.626(b)

E. coli, 120.25(c-e) negative test for, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) eating utensils. See utensils

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Index

diacetyl tartaric acid esters of mono- and diglycerides, 184.1101(c)(1) dioctyl sodium sulfosuccinate, 172.810(d) ethoxylated mono- and diglycerides, 172.834(c) fatty acid salts, 172.863(b) furcelleran, 172.655(c), 172.660(b) glyceryl-lacto esters of fatty acids, 172.852(b) guar gum, 184.1339(c) gum ghatti, 184.1333(c) gum tragacanth, 184.1351(c) hydroxylated lecithin, 172.814(b) hydroxypropyl cellulose, 172.870(b)(1) hydroxypropyl methylcellulose, 172.874(b) karaya gum, 184.1349(c) lactylated fatty acid esters of glycerol and propylene glycol, 172.850(c) lactylic esters of fatty acids, 172.848(b) lecithin (enzyme-modified), 184.1063(c)(1) methyl ethyl cellulose, 172.872(c) mono- and diglycerides, 184.1505(c)(1), 184.1521(c)(1) pectins, 184.1588(c)(1) polyglycerol esters of fatty acids, 172.854(b), 172.854(d) polysorbate 60, 172.836(c) polysorbate 65, 172.838(c) polysorbate 80, 172.840(c) propylene glycol, 184.1666(c) propylene glycol alginate, 172.858 rapeseed oil, 184.1555(b)(3) sodium alginate, 184.1724(c) sodium hypophosphite, 184.1764(c)(1) sodium lauryl sulfate, 172.822(b)(1) sodium potassium tartrate, 184.1804(c)(1) sodium stearoyl lactylate, 172.846(c) sodium tartrate, 184.1801(c)(1) sorbitan monostearate, 172.842(c) sorbitol, 184.1835(c) stearyl citrate, 184.1851(c)(1) succinylated monoglycerides, 172.830(c)(1) succistearin, 172.765(c) sucrose fatty acid esters, 172.859(c)(1) xanthan gum, 172.695(e) emulsion stabilizer, 172.755(c) enchiladas, 101.12(b) end-product testing, 120.11(a)(1)(iii), 120.11(a)(1)(iv)(C) Endothia parasitica, 173.150(a)(1) enforcement activities/procedures, 5.31, 115.50(d-e) regulations, Part 1 State/civil, 100.2 enocianina, 73.170 enriched bread/rolls/buns, 136.115 enriched (claims), 101.13(j)(1)(i)(B), 101.54(e)(1-2) enriched corn meal, 137.260 enriched flours, 136.115(a)(5), 137.160, 137.165, 137.185 enriched macaroni, 139.115, 139.117, 139.122, 139.135 enriched noodles, 139.155 enriched rice, 137.350 environmental impact (exclusion from), 100.1(d)(3)(D)

Environmental Protection Agency (EPA), 1240.3(m), 1240.83(a), 1250.3(j) enzyme preparations, 173 Subpart B alpha-acetolactate decarboxylase, 173.115 aminoglycoside 3’-phosphotransferase II, 173.170 aminopeptidase, 184.1985 α-amylase, 137.105(a), 137.105(b)(2), 137.200(b)(2), 184.1012 amyloglucosidase, 173.110 bromelain, 184.1024 carbohydrase, 173.120, 173.130 carbohydrase and protease enzyme product, 184.1027 carbohydrase (bacterially-derived), 184.1148 catalase, 173.135, 184.1034 cellulase, 173.120, 184.1250 chymosin, 184.1685 disinfection by radiation, 179.26(b)(4) esterase-lipase, 173.140 ficin, 184.1316 fixing agents, 173.357 alpha-galactosidase, 173.145 glucose isomerase, 184.1372 lactase from Candida pseudotropicalis, 184.1387 lactase from Kluyveromyces lactis, 184.1388 lipase, animal, 184.1415 lipase from Rhizopus niveus, 184.1420 malt, 184.1443a milk-clotting enzymes, 173.150 pancreatin, 184.1583 papain, 184.1585 pepsin, 184.1595 protease and carbohydrase enzyme product, 184.1027 protease (bacterially-derived), 184.1150 rennet, 184.1685 trypsin, 184.1914 urease, 184.1924 EPA Primary Drinking Water Regulations, 1240.3(m), 1240.83(a), 1250.3(j) epichlorohydrin, 177.2550 dimethylamine copolymer, 173.60 epoxy resins, 175.380, 177.2280 epoxidized soybean oil, 172.723 epoxy resins, 175.380 thermosetting, 177.2280 equipment, 110.40, 110.80(b), 129.37(a), 1240.3(o), 1250.3(l), 1250.33 bactericidal treatment of, 1240.10 bottled drinking water, 129.40 dairy-processing, 178.1010(b) food-processing, 170.39(a), 171.8, 174.6, 177.1320 garbage, 1250.39 pasteurization, 1210.15 refrigeration, 1250.34 sanitary, 1250.40 sanitizing solutions for, 178.1010(b) watering, 1250.67 See also current good manufacturing practice Eremothecium ashbyii, 184.1695(a) ergocalciferol. See vitamin D erythorbic acid, 182.3041

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Index

erythritol, 101.80(c)(2)(ii)(B) Escherichia coli, 120.25(c-e) negative test for, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) essence, 101.22(a)(3) essential nutrient, 101.3(e)(4) essential oils, 101.22(a)(3) from clove, 184.1257(a) from dill, 184.1282(a) from garlic, 184.1317(a) generally recognized as safe (GRAS), 182.20, 182.50 esterase-lipase, 173.140 esters of stearic and palmitic acids, 178.3450 ethanoic acid. See acetic acid ethoxylated mono- and diglycerides, 172.834 ethoxyquin, 172.140 in specific products, 73.275(a), 73.275(c)(1), 73.295(a)(2), 73.295(c)(2)(ii), 73.295(d)(1) ethyl acetate, 73.1(b)(1)(ii), 173.228 ethyl acrylate copolymers, 177.1320 ethyl alcohol, 73.1(b)(1)(i), 178.1010(b)(16), 184.1293 ethyl cellulose, 73.1(b)(1)(i-ii), 73.1(b)(2), 172.868 ethyl formate, 184.1295 ethyl methanoate, 184.1295(a) N-ethyl,N-(m-sulfobenzyl) sulfanilic acid, 74.101(b) ethylene-acrylic acid copolymers, 177.1310 ethylene-carbon monoxide copolymers, 177.1312 ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers, 177.1315 ethylene dichloride, 172.710, 173.230 ethylene-ethyl acrylate copolymers, 177.1320 ethylene glycol distearate, 73.1(b)(1)(ii), 73.1(b)(2) ethylene glycol monoethyl ether, 73.1(b)(1)(i) ethylene-methacrylic acid copolymers, 177.1330 ethylene-methyl acrylate copolymer resins, 177.1340 ethylene oxide copolymer condensates, 172.808 ethylene oxide polymer, 172.770 ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer, 177.1345 ethylene polymer, chlorosulfonated, 177.2210 ethylene-vinyl acetate copolymers, 177.1350, 179.45(c) ethylene-vinyl acetate-vinyl alcohol copolymers, 177.1360 ethylene-vinyl chloride copolymers, 177.1950 ethylenediamine, 178.1010(b)(36) ethylenediamine tetraacetate. See EDTA (ethylenediamine tetraacetate) 4-ethyoxyphenylurea, 189.145(a) eucric acid, 184.1555(c) evaporated milk, 131.130, 1210.6(d), 1210.6(f), 1210.27 examination samples, 2.10 examinations, 5.31(a-b) of cows, 1210.12 Federal Import Milk Act, 1210.10 excluded use of GRAS substances, 184.1(e), 186.1(e) exclusions (current good manufacturing practice), 110.19 excrement, 1250.52, 1250.53 exemptions color additive certification, 71.18, 71.26, 71.27, Part 73 color additive status, 70.3(g-h)

declaration of ingredients, 1.23 declaration of net quantity of contents, 1.23, 1.24(a)(1) dietary supplements, 101.36(h), 111.50(b) emergency permit compliance, 108.19, 108 Subpart B food additive tolerances, 171.130 hair dye, 70.3(u) health claims, 101.14(f) infant formulas, 107.3, 107 Subpart C, 107.50 for investigational use, 71.37, 170.17 juice processors, 120.24(a) label statements, 1.23, 1.24 labeling, 101.17(d)(2), 101.22(d-f), 101 Subpart G, 101.100, 101.108 soft drink, 1.24(a)(5), 101.2(c)(1) nutrient content claims, 101.13(q) percentage juice declaration, 101.30(d) pesticide chemical adjuvants, 182.99 prior-sanctioned ingredients, 181.1(a), 181.5(b) revocation of, 71.26 shell eggs, 115.50(c) from State or local requirements, 100.1 See also specific color additives, exemption from certification experimental animals, 170.17 experimental packs of food, 130.17 expiration date (color additive), 70.25(a)(4) Ext. D&C Blue No. 1, 81.30(d) Ext. D&C Blue No. 4, 81.30(d) Ext. D&C Green No. 1, 81.10(k), 81.30(m)(1) Ext. D&C Orange No. 1, 81.30(d) Ext. D&C Orange No. 4, 81.30(d) Ext. D&C Red No. 1, 81.30(d) Ext. D&C Red No. 2, 81.30(d) Ext. D&C Red No. 3, 81.30(d) Ext. D&C Red No. 10, 81.30(d) Ext. D&C Red No. 11, 81.30(d) Ext. D&C Red No. 13, 81.30(d) Ext. D&C Red No. 14, 81.30(d) Ext. D&C Red No. 15, 81.30(d) Ext. D&C Yellow No. 1, 81.10(i), 81.30(l)(1) Ext. D&C Yellow No. 5, 81.30(d) Ext. D&C Yellow No. 6, 81.30(d) Ext. D&C Yellow No. 9, 81.10(a) Ext. D&C Yellow No. 10, 81.10(a) extensions, 1250.51(f) extra (claims), 101.13(j)(1)(i)(B), 101.54(e)(1-2) extractability conditions, 176.170(d), 177.1010(c) extractives, 101.22(a)(3) natural, 182.20, 182.40, 182.50 from clove, 184.1257(a) from dill, 184.1282(a) from garlic, 184.1317(a) time/temperature conditions, 176.170(c)Table 2, 177.1210(c)Table 4 tolerances, 177.1210(b)(5)Table 2 See also specific food additives fabrics cotton, 182.70

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Index

polyethylene phthalate, 177.1630 See also cotton/cotton fabrics facilities, 110 Subpart B, 110.3(k), 110.20 Fair Packaging and Labeling Act, 5.10(a)(1), 5.31(a)(1) falsified records, 80.34(a)(2) fans, 110.20(b)(6) farina, 137.300, 137.305, 139.110(a) fat analogs, 130.10(c)(5) calories from, 101.36(b)(2), 101.36(b)(2)(iii)(G) free, 101.62(b), 101.62(b)(6) low, 101.62(b)(2), 101.62(c)(4), 131.203, 163.114 nutrient content claims, 101.62 See also contents of specific foods fats beef, 184.1287(a) butterfat, 101.4(b)(9), 184.1287(a) and cancer, 101.73(a) chicken, 184.1287(a) dietary lipids, 101.73 disqualifying nutrient levels, 101.14(a)(4) edible fats and oils, 172.225, 172.867(a), 184.1472(b)(3), 184.1555(c)(4) enzyme-modified, 184.1287 labeling of, 101.4(b)(14) mixtures with olive oil, 102.37 olestra as substitute for, 172.867(c) percent of daily value, 101.36(b)(2)(iii)(D) propylene glycol mono- and diesters, 172.856 reference amounts, 101.12(b) See also milkfat; saturated fat fatty acids, 172.860 fat-forming, 136.110(c)(5)(ii) glyceryl-lacto esters, 172.852 lactylated fatty acid esters, 172.850 lactylic esters, 172.848 methyl and ethyl esters, 172.225 nutrient content claims, 101.62, 101.62(c) polyglycerol esters, 172.854 propylene glycol mono- and diesters, 172.856 salts of, 172.863 sucrose fatty acid esters, 172.859 tall oil, 172.862 See also olestra fatty alcohols, synthetic, 172.864, 172.864(c)(1), 178.3480 fatty foods, 176.170, 178.3280(b)(2) faucets, 1250.67(a), 1250.87 FD&C Blue No. 1, 74.101, 82.101 FD&C Blue No. 2, 74.102, 82.102 FD&C Green No. 1, 81.30(d) FD&C Green No. 2, 81.30(d) FD&C Green No. 3, 74.203, 82.203 FD&C lakes, 81.1(a), 82.51 FD&C Red No. 1, 81.10(c), 81.30(b)(1) FD&C Red No. 2, 81.10(f), 81.30(j)(1) FD&C Red No. 3, 74.303, 81.10(u), 81.30(u)(1) FD&C Red No. 4, 81.10(d), 81.30(c), 82.304 FD&C Red No. 40, 74.340 FD&C Violet No. 1, 81.10(e), 81.30(h)(1) FD&C Yellow No. 5, 74.705, 82.705

FD&C Yellow No. 6, 74.706, 82.706 FDA recall (infant formula), 107.200 See also infant formula recalls Federal Caustic Poison Act, 5.10(a)(1), 5.10(b), 5.31(a)(1) Federal Food, Drug, and Cosmetic Act, 5.10(a)(1), 5.10(b), 5.31(a)(1) Federal Import Milk Act, 5.10(a)(1), 5.10(b), 5.31(a)(1), Part 1210 hearings, 1210 Subpart D inspection and testing, 1210 Subpart B permits, 1210.10, 1210 Subpart C, 1250.10 Federal Insecticide, Fungicide, and Rodenticide Act, 178.1010(d) Federal Meat Inspection Act, 5.302(a), 101.4(b)(2) feed chicken, 73.75(c)(2), 73.275(b), 73.295(c), 73.315(c) fish, 73.185(a)(2), 73.185(c)(1-3), 73.355(a)(2), 73.355(d)(2) salmonid fish, 73.35(c), 73.75(c)(3), 73.355(c), 73.355(d)(3) fees color additive certification, 80.10, 80.21(f) color additive listing, 70.19 fermentation, 173.160, 173.165 aid, 184.1923(c)(1) vessels (outdoor bulk), 110.20(b)(3) ferric ammonium citrate, 184.1296 ferric chloride, 184.1297 ferric citrate, 184.1298 ferric hydroxide, 172.370 ferric oxide, 186.1300 ferric phosphate, 184.1301 ferric pyrophosphate, 184.1304 ferric sulfate, 184.1307 ferrous ascorbate, 184.1307a ferrous carbonate, 184.1307b ferrous citrate, 184.1307c ferrous fumarate, 172.350(c), 184.1307d ferrous gluconate, 73.160, 184.1308 ferrous lactate, 73.165, 184.1311 ferrous sulfate, 184.1315 fewer (claims), 101.13(j) fiber health claims, 101.54(d), 101.71(a), 101.76, 101.77, 101.77(c)(2)(i)(D), 101.78(a-b)(2) percent of daily value, 101.36(b)(2)(iii)(D) reclaimed, 176.260 soluble, 101.77, 101.81 fibryls, 177.1850(a-c) ficin, 184.1316 field corn, 155.131 field structure, 5.1115 filing date (new dietary supplements), 190.6(c-e) fill of containers, 130.12, 130.14, 145.3(o)(3), 146.3(g)(2), 164.120(c) See also specific food products Filled Milk Act. See Federal Import Milk Act fillers (ethyl cellulose), 172.868(b)(1) film formers, 172.870(b)(1), 172.874(b)

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Index

films, 172 Subpart C acrylonitrile copolymers, 181.32(a)(1) food-contact, 177.1350(d)(2-3), 177.1350(e), 177.1500(b) hydroxyethyl cellulose, 177.1400 multilayer, 177.1500(b)(10.3) nylon, 175.360 nylon 6, 179.45(d)(2)(iii) polyacrylamide, 172.255 polycarbonate, 175.365 polyethylene, 179.45(d)(2) polyethylene phthalate, 177.1630 polyethylene terephthalate, 179.45(b)(6), 179.45(d)(2)(ii) polymeric, 177.1390(c)(1) polyolefin, 175.320, 178.3610, 179.45(b)(4) polypropylene film, 178.3930 polystyrene, 179.45(b)(7) polyvinyl alcohol, 177.1670 rubber hydrochloride, 179.45(b)(8) solvents for, 178.3950 terpene resin, 172.280 vinyl chloride-vinyl acetate copolymer, 179.45(d)(2)(iv) vinylidene chloride-vinyl chloride copolymer, 179.45(b)(9) filters membrane, 177.1500(b)(15) microporous polymeric, 177.2250 resin-bonded, 177.2260 ultra-filtration membranes, 177.2910 water, 1250.42(d) filtration, 129.80(a), 177.2510(a)(4), 177.2910 firm-initiated recalls (infant formula), 107.210 See also infant formula recalls firming agents, 101.4(b)(19) ammonium phosphate, dibasic, 184.1141b ammonium sulfate, 184.1143(c) calcium acetate, 184.1185(c) calcium chloride, 184.1193(c) calcium gluconate, 184.1199(c) calcium lactate, 184.1207(c)(1) calcium lactobionate, 172.720(b) calcium sulfate, 184.1230(c) guar gum, 184.1339(c) magnesium oxide, 184.1431(c)(1) sodium alginate, 184.1724(c) sorbitol, 184.1835(c) tartaric acid, 184.1099(c)(1) fish, Part 161 definition of, 123.3(d) feed, 73.185(a)(2), 73.185(c)(1-3), 73.355(a)(2), 73.355(d)(2) salmonid fish feed, 73.35(c), 73.75(c)(3), 73.355(c), 73.355(d)(3) fillets, wrapped, 101.100(h) nutrition facts, 101 Appendix D oil, 186.1551 protein concentrate, 172.385 protein ingredients, 101.4(b)(23)

protein isolate, 172.340 raw, 101.42, 101.43, 101.44, 101.45 sticks, 102.45 substitutes, 101.12(b) top 20, 101.44 See also names of specific fish fish and fishery products, Part 123 current good manufacturing practice, 123.5 hazard analysis critical control point (HACCP) plan, 123.6 records, 123.9 smoked and smoke-flavored, 123.3(s), 123.15, 123.16 fishing boats, 1240.3(p)(1), 1250.3(m)(1) fixing agents, 173.357 color fixatives, 181.34 ethyl cellulose, 172.868(b)(3) flame sterilizer, 113.3(f), 113.40(h), 113.100(a)(5) flavor/flavorings, 101.4(b)(1), 101.22, Part 169, 172 Subpart F artificial (see artificial flavor/flavoring) generally recognized as safe (GRAS), 182.10, 182.40, 182.60 microcapsules for, 172.230 natural, 101.22(a)(3), 101.22(h)(1), 101.22(h)(7), 172.510 smoke, 101.22(h), 123.3(s) solvent for, 173.220(c) synthetic, 172.515, 182.60 See also flavoring agents and adjuvants flavor enhancers, 173.140(d) acetic acid, 184.1005(c) DL-alanine, 172.540 ammonium chloride, 184.1138(c)(1) ammonium citrate, dibasic, 184.1140(c)(1) aspartame, 172.804 brown algae, 184.1120(c) calcium chloride, 184.1193(c) calcium lactate, 184.1207(c)(1) disodium guanylate, 172.530 disodium inosinate, 172.535 lactic acid, 184.1061(c) licorice, 184.1408(c) magnesium sulfate, 184.1443(c)(1) malic acid, 184.1069(c) polyethylene glycol, 172.820(c)(2) potassium chloride, 184.1622(c)(1) potassium lactate, 184.1639(c)(1) red algae, 184.1121(c) sodium alginate, 184.1724(c) sodium lactate, 184.1768(c)(1) succinic acid, 184.1091(c) tannic acid, 184.1097(c)(1) tartaric acid, 184.1099(c)(1) yeast-malt sprout extract, 172.590(b) flavoring agents and adjuvants, 172 Subpart F, 172.510, 172.515, 172.858 acacia (gum arabic), 184.1330(c) acetic acid, 184.1005(c) aconitic acid, 184.1007(c) adipic acid, 184.1009(c)

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Index

agar-agar, 184.1115(c) DL-alanine, 172.540 bakers yeast extract, 184.1983(d) beeswax, 184.1973(c) benzoic acid, 184.1021(c) brown algae, 184.1120(c) calcium lactate, 184.1207(c)(1) calcium stearate, 184.1229(c)(1) caprylic acid, 184.1025(c) clove and its derivatives, 184.1257(c) cocoa with dioctyl sodium sulfosuccinate, 163.117, 172.520 corn silk and corn silk extract, 184.1262(c) diacetyl, 184.1278(c)(1) diacetyl tartaric acid esters of mono- and diglycerides, 184.1101(c)(1) dill and its derivatives, 184.1282(c) disodium guanylate, 172.530 disodium inosinate, 172.535 ethyl formate, 184.1295(c) fats, enzyme-modified, 184.1287(c)(1) ferric chloride, 184.1297(c) ferric sulfate, 184.1307(c) garlic and its derivatives, 184.1317(c) glyceryl monooleate, 184.1323(c)(1) glyceryl tributyrate, 184.1903(c)(1) hop extract, 172.560 lactic acid, 184.1061(c) licorice, 184.1408(c) linoleic acid, 184.1065(c)(1) magnesium chloride, 184.1426(c)(1) malic acid, 184.1069(c) malt syrup, 184.1445(c)(1) mono- and diglycerides, 184.1505(c)(1) oil of rue, 184.1699(c) potassium carbonate, 184.1619(c)(1) potassium chloride, 184.1622(c)(1) potassium lactate, 184.1639(c)(1) potassium sulfate, 184.1643(c) prohibited substances calamus, 189.110(a-b) cinnamyl anthranilate, 189.113(a-b) coumarin, 189.130(a-b) safrole, 189.180(a-b) propionic acid, 184.1081(c)(1) propylene glycol, 184.1666(c) propylene glycol alginate, 172.858 quinine, 172.575 red algae, 184.1121(c) sassafras extract, 172.580 sodium acetate, 184.1721(c) sodium alginate, 184.1724(c) sodium benzoate, 184.1733(c) sodium carbonate, 184.1742(c)(1) sodium diacetate, 184.1754(c) sodium lactate, 184.1768(c)(1) sodium propionate, 184.1784(c)(1) sorbitol, 184.1835(c) starter distillate, 184.1848(c)(1) stearic acid, 184.1090(c)(1)

sugar beet extract flavor base, 172.585 tannic acid, 184.1097(c)(1) tartaric acid, 184.1099(c)(1) thiamine hydrochloride, 184.1875(c)(1) triethyl citrate, 184.1911(c)(1) vanilla, 135.110(f), 169.3(a-b), 169.175, 169.178, 169.179 vanilla-vanillin, 169.180, 169.181, 169.182 vanillin, 182.60 yeast-malt sprout extract, 172.590 fleas, 1250.95 Flectol H, 189.220 flies, 110.3(j), 1250.30(a), 1250.49, 1250.95 float (protective), 172.878(c)(3), 172.878(c)(10), 172.882(c)(5), 172.884(c) floor drainage, 110.37(b)(4) floors, 110.20(b)(4) flounders, 102.57 flours, 136.110(c)(1), Part 137, 137.105 bleached, 137.105(b)(2), 137.200(b)(2) bleaching agents, 172.802(c) bromated, 136.110(c)(1), 136.180(a)(1), 137.155, 137.160, 137.205 corn, 1.24(a)(12), 137.211, 137.215 durum, 101.4(b)(15), 137.220, 137.225, 139.110(a) enriched, 136.115(a)(5), 137.160, 137.165, 137.185 graham, 101.4(b)(15), 137.200(a) ingredient labeling, 101.4(b)(15) instantized, 137.170 malted barley, 137.105(a) malted wheat, 137.105(a) nonwheat, 136.110(c)(11) phosphated, 136.110(c)(1), 137.175 plain, 137.105(a) reference amounts, 101.12(b) self-rising, 137.180, 137.185 treating agents, 184.1230(c), 184.1425(c)(1) wheat, 137.105(a) entire wheat, 137.200(a) whole wheat, 136.180(a)(1), 137.105(a), 137.200, 137.205 white, 101.4(b)(15), 137.105(a) fluid ounce (fl oz), 101.9(b)(5) fluorescent whiteners, 178.3297(a) fluoridation, 170.45 fluoride added, 101.13(q)(8), 165.110(b)(4)(ii)(A-D) fluorine-containing compounds, 170.45 fluorocarbon resins, 177.1380 foam enhancer, 172.695(e) See also foaming agents foam stabilizers, 172.770 prohibited, 189.120(a) See also defoaming agents foamed plastics, 178.3010 foaming agents, 172.836(c)(10), 172.872(c) folacin. See folic acid folate, 101.79 See also contents of specific foods folic acid, 172.345 See also contents of specific foods

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Index

food (definition of), 110.3(f) food additive petitions, Part 171, 171.1 administrative actions, 171 Subpart B amendment, 171.6 regulation, 171.100, 171.102 withdrawal without prejudice, 171.7 food additives, Part 170 administrative rulings and decisions, 170 Subpart C definition of, 170.3(e) delegations of authority, 5.10(a)(25), 5.300 exemptions, 170.17, 181.1(a), 181.5(b) food additive status, 170.6, 170.38 investigational use, 170.17 patent term extensions, 5.27 poisonous or deleterious substances, 109.6(a) prior sanction, 181.1(a), 181.5(d) regulation, 170.15, 170.39, 182.1(d) safety, 170 Subpart B, 170.20, 170.22 in standardized foods, 130 Subpart B standards of identity, 130.20 unapproved use of, 120.7(c)(7), 123.6(c)(1)(viii) See also specific additives by name and function food additives, direct, Part 172, 172.5 anticaking agents, 172 Subpart E coatings, films, and related substances, 172 Subpart C flavoring agents and related substances, 172 Subpart F gums, chewing gum bases and related substances, 172 Subpart G multipurpose additives, 172 Subpart I preservatives, 172 Subpart B prior sanction, 181.5(d) special dietary and nutritional additives, 172 Subpart D specific usage additives, 172 Subpart H See also detailed listings under subheading titles food additives, secondary direct, Part 173 enzyme preparations and microorganisms, 173 Subpart B polymer substances and adjuvants, 173 Subpart A solvents, lubricants, and release agents, 173 Subpart C specific usage additives, 173 Subpart D See also detailed listings under subheading titles food additives, indirect, Part 174, Part 175, Part 176, Part 177, Part 178 adhesives, 175 Subpart B adjuvants, 178 Subpart D antioxidants, 178 Subpart C coatings, 175 Subpart C microorganism control, 178 Subpart B paper and paperboard components, Part 176 polymers, Part 177 repeated use articles (components of), 177 Subpart C single & repeated use food contact surface components, 177 Subpart B production aids, 178 Subpart D sanitizers, 178 Subpart B stabilizers, 178 Subpart C See also detailed listings under subheading titles

food additives, interim basis, Part 180, 180.1 acrylonitrile copolymers, 180.22 brominated vegetable oil, 180.30 mannitol, 180.25 saccharins, 180.37 food additives, multipurpose, 172 Subpart I acesulfame potassium, 172.800 acetone peroxides, 172.802 acetylated monoglycerides, 172.828 aspartame, 172.804 azodicarbonamide, 172.806 bakers yeast glycan, 172.898 calcium stearoyl-2-lactylate, 172.844 castor oil, 172.876 cocoa butter substitute, 172.861 copolymer condensates of ethylene and propolyene oxides, 172.808 cottonseed products, modified, 172.894 curdlan, 172.809 dioctyl sodium sulfosuccinate, 172.810 ethoxylated mono- and diglycerides, 172.834 ethyl cellulose, 172.868 fatty acid salts, 172.863 fatty acids, 172.860 fatty alcohols (synthetic), 172.864 glycerin (synthetic), 172.866 glyceryl-lacto esters of fatty acids, 172.852 glyceryl tristearate, 172.811 glycine, 172.812 hydroxylated lecithin, 172.814 hydroxypropyl cellulose, 172.870 hydroxypropyl methylcellulose, 172.874 lactylated fatty acid esters of glycerol and propylene glycol, 172.850 lactylic esters of fatty acids, 172.848 methyl ethyl cellulose, 172.872 methyl glucoside-coconut oil ester, 172.816 monoglyceride citrate, 172.832 oleic acid, 172.862 olestra, 172.867 oxystearin, 172.818 petrolatum, 172.880 petroleum hydrocarbons, 172.882, 172.884 petroleum wax, 172.886, 172.888 polydextrose, 172.841 polyethylene glycol, 172.820 polyglycerol esters of fatty acids, 172.854 polysorbate 60, 172.836 polysorbate 65, 172.838 polysorbate 80, 172.840 propylene glycol alginate, 172.858 propylene glycol mono- and diesters of fats and fatty acids, 172.856 rice bran wax, 172.890 sodium lauryl sulfate, 172.822 sodium naphthalene sulfonates, 172.824 sodium stearoyl lactylate, 172.846 sodium stearyl fumarate, 172.826 sorbitan monostearate, 172.842 succinylated monoglycerides, 172.830

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Index

sucralose, 172.831 sucrose acetate isobutyrate (SAIB), 172.833 sucrose fatty acid esters, 172.859 white mineral oil, 172.878 yeast glycan, bakers, 172.898 yeasts, dried, 172.896 food additives, specific usage, 172 Subpart H, 173 Subpart D acidified sodium chlorite solutions, 173.325 adjuvants for pesticide dilutions, 172.710 boiler water additives, 173.310 1,3-butylene glycol, 172.712 calcium lactobionate, 172.720 calcium lignosulfonate, 172.715 chlorine dioxide, 137.105(a)(4), 173.300 chlorofluorocarbon 133, 173.342 chloropentafluoroethane, 173.345 combustion product gas, 173.350 cotton delinting chemicals, 172.322 defoaming agents (see defoaming agents) dichlorodifluoromethane, 173.355 dimethyldialkylammonium chloride, 173.400 epoxidized soybean oil, 172.723 ethylene oxide polymer, 172.770 fixing agents for enzyme preparations, 173.357 fruit/vegetable washing and peeling chemicals, 173.315 gibberellic acid, 172.725 glycerol ester of wood rosin, 172.735 methacrylic acid-divinylbenzene copolymer, 172.775 microorganism control at cane- and beet-sugar mills, 172.320 octafluorocyclobutane, 173.360 ozone, 173.368 peroxyacids, 173.370 potassium bromate, 172.730 sodium methyl sulfate, 173.385 stearyl monoglyceridyl citrate, 172.755 succistearin, 172.765 trifluoromethane sulfonic acid, 173.395 Food and Drug Administration recalls, 107.200 See also infant formula recalls food-contact articles, 109.3(e), 174.5, 174.6, 186.1(b) components of, 174.5, 178.3480, 178.3750 regulation of, 170.39, 171.8, 174.5(c) repeated use, 177 Subpart C sanitizing solutions for, 178.1010 food-contact surfaces, 110.3(g), 177 Subpart B, 186.1275 adhesives used with, 175 Subpart B coatings used in, 175 Subpart C construction of, 110.40(a-b) food additives permitted pending study, Part 180 indirect food ingredients used in, 186.1 of labels, 175.125 paper and paperboard in contact with, 176.170, 176.320 prior sanction of substances, 181.5(d) sanitation of, 110.35(d), 123.11(b)(1-3) sanitizing solutions, 178.1005, 178.1010 See also current good manufacturing practice

Food, Drug, and Cosmetic Act. See Federal Food, Drug, and Cosmetic Act food freezant 12, 173.355 food-grade products. See specific foods and additives food handling employees, 1250.32, 1250.35, 1250.38 facilities, 1250.45 irradiation in, Part 179 food irradiation. See irradiation food-packaging equipment, 170.39(a), 171.8, 174.6, 177.1320 food-packaging materials, Part 109, 109.15, 178.3500, 181.22 adhesives, 175.105 adjuvants, 178.3450 antistatic/antifogging agents, 178.3130 cellophane, 177.1200, 178.3280(b)(2), 179.45(b)(1) components of, 177.1040, 177.1320, 177.1400, 177.1500 corrosion inhibitors, 178.3300(b)(1) cotton/cotton fabrics, 182.70, 186 Subpart B glassine, 176.320(b), 179.45(b)(2) for irradiated foods, 179.25(c), 179.45 kraft paper, 179.45(b)(5) manufacture of, 181.22, 181.30 nylon resins, 177.1500 paper and paperboard products, 176 Subpart B, 186 Subpart B prior sanctions, 181.1, 181.22-181.29 See also packaging; polymers (indirect food additives) food poisoning, 110.80(a)(2) food-processing equipment, 170.39(a), 171.8, 174.6, 177.1320 corrosion inhibitors, 178.3300 sanitizing solutions, 178.1010 food-processing instruction schools, 5.304 food safety. See safety food service sanitation, 1250 Subpart B food standards, Part 130, 130.5 Codex Alimentarius, 130.6 redelegations of authority, 5.300 standards of identity, 130.8, 130.10(c) food treatment. See treatment of food foreign agency, 123.3(o) foreign commercial processor, 108.25(j)(1), 108.35(k)(1), 123.12(a)(2)(ii)(A-E) formaldehyde, polymerized, 177.2480(a) formaldehyde resins, 175.380, 177.1460, 177.1900 formic acid, 186.1316 formula. See infant formula formulation aids acacia (gum arabic), 184.1330(c) agar-agar, 184.1115(c) 1,3-butylene glycol, 172.712(c) calcium gluconate, 184.1199(c) calcium sulfate, 184.1230(c) carnauba wax, 184.1978(c)(1) curdlan, 172.809(c) dextrin, 184.1277(c)(1)

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Index

glyceryl behenate, 184.1328(c)(1) glyceryl palmitostearate, 184.1329(c)(1) glyceryl tristearate, 172.811(c) guar gum, 184.1339(c) gum tragacanth, 184.1351(c) karaya gum, 184.1349(c) mono- and diglycerides, 184.1505(c)(1) polydextrose, 172.841(c) potassium acid tartrate, 184.1077(c)(1) potassium bicarbonate, 184.1613(c)(1) potassium hydroxide, 184.1631(c)(1) propylene glycol, 184.1666(c) propylene glycol alginate, 172.858 sodium stearoyl lactylate, 172.846(c)(4) sodium thiosulfate, 184.1807(c) sorbitol, 184.1835(c) triacetin, 184.1901(c)(1) urea, 184.1923(c)(1) wheat gluten, 184.1322(c)(1) formylbenzenesulfonic acids, 74.203(b) fortification of nutrients, 104 Subpart B, 104.20, 105.3(a)(1)(iii) fortified (claims), 101.13(j)(1)(i)(B), 101.54(e)(1-2) fraction, 101.9(b)(5) fractionation aid, 172.811(c) frankfurter casings, 74.250(c) free (claims), 101.13(e) calorie free, 101.13(b)(5) fat free, 101.62(b), 101.62(b)(6) sodium (salt) free, 101.61(c)(1) sugar free, 105.66(f) free-flow agents magnesium carbonate, 184.1425(c)(1) magnesium oxide, 184.1431(c)(1) sorbitol, 184.1835(c) freezer, 110.40(e) freezing, 110.80(b)(4) freezing agents, 173.355 French dressing, 169.115 French fries, 101.12(b) french ice cream, 135.110(f)(1), 135.115(c)(1) French toast, 101.12(b) fresh (claims), 101.94 fresh frozen (claims), 101.94 frog, 123.3(d) frozen desserts, Part 135, 1240.3(j) frozen custard, 135.110 ice cream, 135.110 labeling exemptions, 1.24(a)(6) mellorine, 135.130 sale/service on conveyances, 1250.25, 1250.26 sherbet, 135.140 water ices, 1.24(a)(6), 135.160 frozen eggs, 101.4(b)(10), 160.110 frozen fresh (claims), 101.94 frozen heat and serve dinners, 102.26, 104.47 frozen peas, 158.170 fruit juice, 1.24(a)(13), 73.250 Brix levels, 101.30(h)(1) common or usual name, 102.33

definition of, 145.3(i-j) percentage juice declaration, 101.30 reference amounts, 101.12(b) See also juices fruit juices, canned, Part 146 grapefruit, 146.132 lemon, 146.114 lemonade (concentrate for), 146.120, 146.121, 146.126 orange, 146.135, 146.137, 146.140, 146.141, 146.145 concentrated, 146.146, 146.148, 146.150, 146.153, 146.154 for manufacturing, 146.151, 146.153 with preservative, 146.152, 146.154 reduced acid, 146.148 pineapple, 146.185 prune, 146.187 fruit products, 101.12(b) butters, Part 150, 150.110 cocktail, 145.135, 145.136 jams, 150.160, 150.161 jellies, Part 150, 150.140, 150.141 pies, Part 152, 152.126 preserves, Part 150, 150.160, 150.161 sherbets, 1.24(a)(6) fruits coatings, 172.235(a), 172.882(c)(3), 172.890(b) on fresh citrus, 172.210, 172.250(d) protective coatings, 172.215(c), 172.260(b), 172.275(c), 172.859(c)(3), 172.878(c)(8), 172.880(c), 172.886(d), 172.888(e) exemption from compliance, 101.22(f) health claims, 101.76, 101.77, 101.78 labels for, 175.125(a-b) raw, 101.42, 101.43, 101.44, 101.45, 101 Appendix C reference amounts, 101.12(b) top 20, 101.44 washing or peeling of, 173.315 fruits, canned, Part 145 applesauce, 145.110 apricots, 145.115, 145.116 berries, 145.120 cherries, 145.125, 145.126 figs, 145.130, 145.131, 145.134 fruit cocktail, 145.135, 145.136 grapefruit, 145.145 grapes, 145.140 peaches, 145.170, 145.171 pears, 145.176 pineapple, 145.180, 145.181 plums, 145.185 prunes, 145.190 fuel, 110.40(a), 123.11(b)(5) fumaric acid, 172.350 pentaerythritol ester, 73.1(b)(2) fungi (in dietary supplements), 101.4(h) fungicide, 2.25(a) Federal Insecticide, Fungicide, and Rodenticide Act, 178.1010(d) furcelleran, 172.655, 172.660

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Index

alpha-galactosidase, 173.145 galleys, 1250.30(a-d), 1250.84 game meats, 101.12(b) gamma rays, 179.26(a)(1) See also irradiation gammelost cheese, 133.140 garbage, 1240.75 definition of, 1240.3(f), 1250.3(g) disposal, 1250.51(a-b), 1250.52, 1250.53, 1250.79 equipment, 1250.39 garlic, 184.1317 garlic oil, 184.1317(b) gases n-butane, 184.1165 carbon dioxide, 184.1240(c)(1) helium, 184.1355 iso-butane, 184.1165 nitrogen, 184.1540 nitrous oxide, 184.1545 ozone, 184.1563 propane, 184.1655 gastrointestinal disturbance, 1250.35(b) gelatin capsules, 172.255, 172.280(b) reference amounts, 101.12(b) See also contents of specific dairy products gelatinized starch, 173.110(d-e) gellan gum, 172.665 general enforcement regulations, Part 1 generally recognized as safe (GRAS), 5.300, 73.1(a)(1), 182.1, 184.1, 186.1 affirmation of GRAS status, 170.35, 181.5(d), 182.1(d), 184.1 classification list, 170.3(n) eligibility for GRAS classification, 170.30 independent determination of GRAS status, 184.1(b)(1), 186.1(b)(1) generally recognized as safe (GRAS) substances, Part 182, Part 184, Part 186 adjuvants, 182.60, 182.99 anticaking agents, 182 Subpart C chemical preservatives, 182 Subpart D direct food substances, Part 184, 184.1 essential oils, 182.20, 182.50 extractives, natural, 182.20, 182.40, 182.50 flavorings, 182.10, 182.40, 182.60 indirect food substances, Part 186, 186.1 migrating from cotton/paper products, 182.70, 182.90 multiple purpose GRAS food substances, 182 Subpart B nutrients, 182 Subpart I oleoresins, 182.20, 182.50 sequestrants, 182 Subpart G spices and seasonings, 182.10, 182.40, 182.50 stabilizers, 182 Subpart H substances migrating from cotton/paper products, 182.70, 182.90 See also detailed listings under subheading titles generally recognized as safe food substances, multiple purpose, 182 Subpart B

aluminum ammonium sulfate, 182.1127 aluminum potassium sulfate, 182.1129 aluminum sodium sulfate, 182.1131 aluminum sulfate, 182.1125 caffeine, 182.1180 calcium phosphate, 182.1217 caramel, 182.1235 glutamic acid, 182.1045, 182.1047 glycerin, 182.1320 hydrochloric acid, 182.1057 methylcellulose, 182.1480 monoammonium glutamate, 182.1500 monopotassium glutamate, 182.1516 phosphoric acid, 182.1073 silica aerogel, 182.1711 sodium acid pyrophosphate, 182.1087 sodium aluminum phosphate, 182.1781 sodium carboxymethylcellulose, 182.1745 sodium caseinate, 182.1748 sodium phosphate, 182.1778 sodium tripolyphosphate, 182.1810 Gersthofen process, 178.3770 gibberellic acid, 172.725 gift product, 100.100(a)(5) glass bottles, 178.1010(b) glass, drinking, 1250.44(a) glassine (paper), 176.320(b), 179.45(b)(2) glassware, 1240.3(o), 1250.3(l) Glauber’s salt, 186.1797(a) gloss white, 82.3(i) gloves, 110.10(b)(5) β-glucan soluble fiber, 101.81(c)(2)(i)(G)(1), 101.81(c)(2)(ii)(A) glucono delta-lactone, 133.129(b)(1)(iii), 184.1318 glucose isomerase, 184.1372 glucose sirups, 101.80(c)(2)(ii)(B), 145.3(c-d), 146.3(c-d), 168.120, 168.121, 184.1865 glutamic acid, 182.1045 glutamic acid hydrochloride, 182.1047 gluten corn, 184.1321 wheat, 184.1322 glycerin, 182.1320 esters of, 184.1101(a) synthetic, 172.866, 178.3500 glycerol esters, 172.735, 172.850, 178.3870(a)(3) glyceryl behenate, 184.1328 glyceryl-lacto esters of fatty acids, 172.852 glyceryl monooleate, 184.1323 glyceryl monostearate, 139.110(a)(6), 184.1324 glyceryl palmitostearate, 184.1329 glyceryl triacetate, 184.1901(a) glyceryl tri-(12-acetoxystearate), 178.3505 glyceryl tributyrate, 184.1903(a) glyceryl tristearate, 172.811 glycine, 170.50, 172.812 chromium complex of, 176.160 goat’s milk in cheeses, 133.111(c)(1), 133.148(c), 133.150(c)(1), 133.187(c)(1), 133.188(c)(1)

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Index

ice cream, 135.115 good manufacturing practice, 174.5(d), 181.22 GRAS substances, Part 182, 182.1(b) See also current good manufacturing practice good source (claims), 101.54(c) gorgonzola cheese, 133.141 gossypol, 73.140(b), 172.894(b)(1) gouda cheese, 133.142 graham bread, 136.180 graham flour, 101.4(b)(15), 137.200(a) grain-based bars, 101.12(b) grain products health claims for, 101.76, 101.77 reference amounts, 101.12(b) grain seed, 2.25 granular cheese, 101.100(f)(3), 133.144, 133.145 grape butter, 150.110(b)(1) grape color extract, 73.169 grape skin extract, 73.170 grapefruit juice, 146.132 grapes, canned, 145.140 graphite, 81.10(j) GRAS substances. See generally recognized as safe (GRAS) substances grated cheeses, 133.146, 133.147 grating cheeses, 133.148 gravies, 101.12(b), 110.80(b)(12) grease-resistant papers, 176.160(b)(2) greaseproof paper, 176.320(b) green beans, 155.120 Green No. 1 (Ext. D&C), 81.10(k), 81.30(m)(1) Green No. 1 (FD&C), 81.30(d) Green No. 2 (FD&C), 81.30(d) Green No. 3 (FD&C), 74.203, 82.203 Green No. 6 (D&C), 81.10(o), 81.30(p)(1) Green No. 7 (D&C), 81.30(d) green onion, 101.12(b) Greenland turbot, 102.57 grits, 101.12(b) corn, 172.345(f) hominy, 101.12(b) nonwheat, 136.110(c)(11) See also meal products ground water, 165.110(a)(2)(ii) grounds, 110.20(a) gruyere cheese, 133.149 guar gum, 184.1339 guard dogs, 110.35(c) guidance documents, 170.39(h) guide dogs, 110.35(c) gums, 172 Subpart G acacia (gum arabic), 184.1330 carob bean gum, 184.1434 cellulose gum (carboxymethylcellulose) damar gum, 73.1(b)(2) gellan gum, 172.665 guar gum, 184.1339 gum ghatti, 184.1333 gum gluten, 139.110(a)(5), 139.150(a)(3) gum guaiac, 181.24

gum rosin, 178.3870(a)(1)(i) gum tragacanth, 184.1351 karaya gum (sterculia gum), 184.1349 locust (carob) bean gum, 184.1434 xanthan gum, 172.695 See also chewing gum HACCP. See hazard analysis and critical control point (HACCP) systems Haematococcus algae meal, 73.185 hair (contamination with), 110.10(b)(9) hair dye exemption, 70.3(u) hair nets, 110.10(b)(6) hake, 172.385(a) half-and-half, 131.180, 1240.3(j) labeling exemptions, 1.24(a)(7) reference amounts, 101.12(b) halibut, 102.57 hand washing before food handling, 1250.75(c) facilities, 110.10(b)(3), 110.20(b)(5), 110.37(e), 123.11(b)(4), 1250.38(b) railroad conveyance facilities, 1250.45(c) handling food. See food handling hard cheeses, 133.150 hash, 101.12(b) hash browns, 101.12(b) hazard analysis, 120.7, 123.6(a) hazard analysis and critical control point (HACCP) systems, Part 120 corrective actions, 120.10 current good manufacturing practice, 120.5 fish and fishery products, 123.6 HACCP plan, 120.8, 120.11(b-c) fish and fishery products, 123.6 process controls, 120.20, 120.24, 120.25 records, 120.12 sanitation standard operating procedures (SSOP’s), 120.6 See also verification hazards definition of, 120.3(g) disclosure of facts concerning, 1.21(c)(1) of fungicidal treatments, 2.25(a) to public health, 2.5, 108.5(a)(2) safety, 123.3(f), 123.6(a), 123.16 headbands, 110.10(b)(6) headquarters, 5.1100 headspace, 113.3(h), 113.83 health emergency functions, 5.10(a)(15) information, 5.10(a)(18) injurious to, 181.1(b-c) See also public health health claims, 101.14, 101 Subpart E calcium and osteoporosis, 101.72 coronary heart disease and plant sterol/stanol esters, 101.83 and saturated fat/cholesterol, 101.75 and soluble fiber, 101.77, 101.81

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Index

and soy protein, 101.82 dietary lipids and cancer, 101.73 dietary sugar alcohols and dental caries, 101.80 dietary supplements, 101.14(d)(3), 101.14(e), 101.71, 101.93 fiber, 101.17(f), 101.71(a) fiber-containing foods and cancer, 101.76 folate and neural tube defects, 101.79 fruits/vegetables and cancer, 101.78 implied, 101.14(a)(1) not authorized, 101.71 petitions for, 101.70 prohibited, 101.14(e) redelegations of authority, 5.300 and reference amounts, 101.12(g) for restaurant foods, 101.10, 101.14(d)(2)(vii)(B), 101.14(d)(3) sodium and hypertension, 101.74 validity requirement, 101.14(c) health-related condition, 101.14(a)(5), 101.14(b)(1) healthy (claims), 101.65(d)(1-2) hearings emergency permit, 108.5(b-c) Federal Import Milk Act permits, 1210.30, 1210.31 food additive regulation, 171.110 informal, 5.27, 115.50(e)(2) heat and serve dinners, 102.26, 104.47 heat blanching, 110.80(b)(11), 113.81(b) heat sterilization, 113.83, 177.1390(b) heat treatment, 1240.3(k), 1250.26(b-c) minimum, 1240.75(a-b) See also pasteurization; pressure processing heating food (by radiofrequency radiation), 179.30 heavy cream, 131.149, 1240.3(j) heavy metals, 73.185(b), 73.355, 82.5(b)(1)(iii), 82.5(b)(2)(iii) See also contents of specific foods and additives helium, 184.1355 hematite, 186.1300(a) heptylparaben, 172.145 herbicide dilutions, 172.840(c)(12) herbs, 101.4(h), 190.6(b)(2) health claims, 101.71 reference amounts, 101.12(b) herds producing milk. See Federal Import Milk Act hermetically sealed containers, 106.90, 108.35, Part 113, 113.60 and Clostridium botulinum toxin, 123.6(e) coding, 113.60(c) definition of, 113.3(j) inspections, 113.100(c) herring, 172.385(a), 186.1551(a) hexane, 173.270 hexane-dioic acid, 184.1009(a) hexene-1 copolymers, 177.1960 hi. See high (claims) high blood pressure, 101.74 high (claims), 101.13(b)(4), 101.14(d)(2)(vii), 101.54 high potency (claims), 101.54(f) high temperature laminates, 177.1390

histamine, 123.3(m) holding food adhesives used in, 175.105(a) coatings used in, 175.210, 175.250, 175.300, 175.320 containers used in, 177.1210, 177.1320 current good manufacturing practice, Part 110 paper and paperboard products used in, 176 Subpart B See also polymers (indirect food additives); production aids hollandaise sauce, 101.12(b) hominy grits, 101.12(b) homogenized. See specific dairy products honey, 101.12(b) hops extract, 172.560 tolerances of extraction chemicals, 173.240(c), 173.250(b), 173.255(b), 173.270(b) hot-melt strippable food coatings, 175.230 household measures, 101.9(b)(5) humectants acacia (gum arabic), 184.1330(c) agar-agar, 184.1115(c) ammonium alginate, 184.1133(c) calcium chloride, 184.1193(c) polydextrose, 172.841(c) potassium acid tartrate, 184.1077(c)(1) potassium lactate, 184.1639(c)(1) propylene glycol, 184.1666(c) sodium lactate, 184.1768(c)(1) sorbitol, 184.1835(c) tartaric acid, 184.1099(c)(1) triacetin, 184.1901(c)(1) hush puppies, 101.12(b) hydriodic acid, 178.1010(b) hydrochloric acid, 182.1057 See also contents of specific cheeses hydrogen carboxylic acid, 186.1316(a) hydrogen peroxide, 184.1366 solution, 178.1005, 178.1010(b) See also contents of specific cheeses hydrogenated fish oil, 186.1551 hydrogenated sperm oil, 173.275 hydrolysates. See protein hydrolysates 1-hydroxy-1,2-ethanedicarboxylic acid, 184.1069(a) hydroxybenzenesulfonic acid, 74.203(b) hydroxyethyl cellulose film, 177.1400 1-hydroxyethylidene-1,1-diphosphonic acid, 178.1010(b) hydroxylated lecithin, 172.814 4-hydroxymethyl-2,6-di-tert-butylphenol, 172.150, 178.2550 2-hydroxypropanoic acid, 184.1061(a) hydroxypropyl cellulose, 172.870 hydroxypropyl methylcellulose, 172.874 hydroxypyrazole, 74.250(a-b) hydroxytoluene, 137.350(a)(4) hypertension, 101.74 hypoallergenic foods, 105.62 hypochlorous acid, 178.1010(b)(43) ice, 1250.43, 1250.67(c), 1250.85, 1250.86

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Index

in contact with food/drink, 110.80(b)(16), 123.11(b)(1), 1250.45(b) source/handling of, 1250.28 ice boxes, 1250.34 ice cream, 135.110, 1240.3(j) coloring of, 74.705(d)(2), 101.22(k), 101.22(k)(3) french ice cream, 135.110(f)(1), 135.115(c)(1) goat’s milk, 135.115 labeling exemptions, 1.24(a)(6) mellorine, 135.130 Neapolitan, 135.110(f)(6) reference amounts, 101.12(b) sale/service on conveyances, 1250.25, 1250.26 ice milk, 1.24(a)(6), 101.12(b), 1240.3(j) ices, water, 1.24(a)(6), 135.160 identity labeling, 101.3 identity standards. See standards of identity illnesses (of personnel), 110.10(a) imitation food, 101.3(e), 101.12(d), 101.13(d) imminent hazard, 2.5, 108.5(a)(2) immune function (health claim not authorized), 101.71(b) implied claims, 101.13(b)(2), 101.14(a)(1), 101.65, 101.69(a), 101.69(b)(3) Import Milk Act. See Federal Import Milk Act importation of milk/cream. See Federal Import Milk Act imported products, 120.14, 123.12 importer, 120.3(h), 123.3(g) of juice, 120.14(a) verification of, 123.12(a) imports (acidified foods), 108.25(j), 108.35(k) impurities. See specific color additives in-process batch, 106.3(b) control, 106.25 testing, 120.11(a)(1)(iii), 120.11(a)(1)(iv)(C) incubation, 113.3(k) incubation period, 1240.3(g) Indian gum, 184.1333(a) indicator nutrient, 106.3(a) indigo, 74.102(a) indirect food additives. See food additives, indirect indirect food substances affirmed as GRAS, Part 186, 186.1 individual serving-size packages labeling exemptions, 1.24(a)(3), 101.2(c)(2) of salt, 100.155(d) individual single-serving containers, 101.9(b)(2)(i), 101.9(b)(3), 101.9(b)(5), 1250.26(d) individually wrapped candy, 1.24(a)(4) industrial starch-modified, 178.3250 infant and toddler foods, 105.64 labeling, 101.36(i)(1) nutrient content claims, 101.13(b)(3) reference amounts, 101.12(b) infant formula, Part 107 coding, 106.90 directions for use, 107.20 exempt formulas, 107.3, 107 Subpart C, 107.50 exemptions, 101.14(f)(1), 107.30 finished product evaluation, 106.30

folic acid in, 172.345(f) new formulations/reformulations, 106.120 notification requirements, 107.240 nutrient requirements, 107 Subpart D quality control procedures, Part 106, 106.1, 106.3 records, 106.100 infant formula recalls, 107 Subpart E, 107 Subpart E, 107.220, 107.230 compliance with, 107.270 FDA-required, 107.200 firm-initiated, 107.210 notification requirements, 107.240 records retention, 107.280 revision of, 107.260 termination of, 107.250 infected wounds (in personnel), 110.10(a) infectious agents, 1250.3(b) See also communicable diseases; microorganisms informal hearings, 5.27, 115.50(e)(2) See also hearings information panel, 101.2, 101.4(a)(1) See also labeling; principal display panel ingredients characterizing, 102.5(c) combination of, 184.1(d), 184.1(f) declaration of, 1.23 designation of, 101.4, 130.11 direct/indirect, 184.1(a) GRAS status, Part 184, 184.1, Part 186, 186.1 eligibility for, 170.30(e-k) new dietary, 190.6(a) nonnutritive, 105.66(b) not provided for, 130.10(f)(2) optional, 101.4(b)(2)(i) percentage of, 101.4(e), 102.5(b) prior-sanctioned, Part 181, 181.1, 181.5 raw, 110.3(f) source, 101.36(d) for standardized foods, 130.11 undeclared, 120.7(c)(8) See also labeling initial temperature, 113.3(l) injurious to health, 181.1(b-c) inks for marking, 73.1(b)(1) inositol, 184.1370 See also contents of specific foods insect control, 178.3730, 1250.95 insecticides, 110.35(c), 172.882(c)(2), 172.884(c) Federal Insecticide, Fungicide, and Rodenticide Act, 178.1010(d) inspections, 5.31(a-b) authority for, 1210.17 certification following, 5.32 communicable diseases, 1240.20 container closure, 5.304(a), 108.35(g), 113.60(a), 113.100(c) of dairy farms, 1210.10, 1210.11 Egg Products Inspection Act, 5.10(a)(12), 5.302(c) Federal Import Milk Act, 1210 Subpart B, 1210.10, 1210.11

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Index

Federal Meat Inspection Act, 5.302(a), 101.4(b)(2) food service sanitation, 1250.21, 1250.25, 1250.61, 1250.81 irradiation sources for food inspection, 179 Subpart B, 179.21 of plants handling milk/cream, 1210.14 Poultry Products Inspection Act, 5.302(b), 101.4(b)(2) records, 106.100(l) sanitary, 1210.11, 1210.18 scoring, 1210.18 shell eggs, 115.50(f) instant blending flours, 137.170(c) instantized flours, 137.170 intended use, 170.30(d), 172.5(a)(2), Part 182, 182.1, Part 184, 184.1(a), Part 186, 186.1(b) See also conditions of use; specific additives and substances interim food additives. See food additives, interim basis interstate commerce, 2.10(a)(1) dietary supplements, 190.6(a), 190.6(c) exemption from State or local requirements, 100.1(a)(2), 100.1(d)(3)(C)(3) milk/milk products, 1240.61(a) permits, 108.12(b), 130.17 interstate conveyance sanitation. See under sanitation interstate shipments, 1240 Subpart D interstate traffic, 1240.60, 1250.20, 1250.40, 1250.60, 1250.80 definition of, 1240.3(h), 1250.3(h) and garbage, 1240.75(a-b) and potable water, 1240.80, 1240.95 report of disease, 1240.45 interstate travel sanitation, 5.10(a)(3) invert sugar, 184.1859 sirup, 145.3(e), 146.3(e) investigation samples, 2.10 investigations, 5.31(a-b) iodide, 100.155(a-b) iodine in sanitizing solutions, 178.1010(b) source of, 172.365, 172.375, 184.1265(c), 184.1634(d) See also contents of specific foods iodized salt, 100.155 ion exchange, 129.80(a) membranes, 173.20, 173.21 resins, 173.25 ionizing radiation, 101.95(c)(1)(iv) See also irradiation ionomeric resins, 177.1330 iron, 111.50(a) elemental, 184.1375 See also contents of specific foods iron ammonium citrate, 172.430 iron caprylate, 181.25 iron-choline complex, 172.370 iron-containing dietary supplements, 111.50 iron linoleate, 181.25 iron naphthenate, 181.25

iron oxide, 73.200 iron oxides, 186.1374, 186.1374(b)(1) iron tallate, 181.25 irradiation, 110.80(b)(4), Part 179, 179.21 of food-contact films, 177.1350(d-e) food inspection uses, 179.21 food irradiation processor, 179.25(d-e) food treatment by, 101.95(c)(1)(iv), 179.25, 179.26, 179.39, 179.41 packaging materials for irradiated foods, 179.25(c), 179.45 sources of, 179 Subpart B, 179.21, 179.26(a) pulsed light, 179.41 radiofrequency/microwave, 179.30 ultraviolet, 179.39 iso-butane, 184.1165 isobutyl alcohol, 73.1(b)(1)(i) isobutylene-butene copolymers, 177.1430 isobutylene polymers, 177.1420 isomalt, 101.80(c)(2)(ii)(B) isoparaffinic petroleum hydrocarbons, 172.882, 178.3530 isopentane, 178.3010 isophthalate. See under polymers (indirect food additives) isopropyl alcohol, 73.1(b)(1)(i), 173.240, 178.1010(b) isopropyl citrate, 184.1386 4,4’-isopropylidene-diphenol-epichlorohydrin resins, 175.380, 177.1440, 177.2280 4,4’-isopropylidene-diphenolphosphite ester resins, 189.300 isosafrole, 189.180(a-b) jams, 101.12(b), 150.160, 150.161 Japan wax, 73.1(b)(2), 186.1555 jellies, fruit, Part 150, 150.140, 150.141 jellyfish, 123.3(d) jewelry, 110.10(b)(4) juices adulterated, 120.9, 120.14(d) Brix levels, 101.30(h)(1) clarified, 145.3(k) percentage juice declaration, 101.30 radiation treatment of, 179.39(b) reference amounts, 101.12(b) warning statements, 101.17(g) See also fruit juice; hazard analysis and critical control point (HACCP) systems; vegetable juice Kanaclor, 109.15(a) kaolin, 186.1256 kaolinite, 186.1256(a) karaya gum, 184.1349 kefir cultured milk, 131.112(f) kelp, 172.365 ketchup. See catsup kitchens, 1250.30(a-d), 1250.45(a) kitchenware, 1240.3(o), 1250.3(l) Kjeldahl methods, 137.105(b)(2) Kluyveromyces lactis, 184.1388 koch kaese, 133.127 kraft paper, 179.45(b)(5)

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Index

label, 1.3(a) alternative method, 101.2(f) for food-contact surfaces, 175.125 for GRAS food ingredients, 184.1(f) information, mandatory, 1.20 statements designation of ingredients, 101.4, 130.11 exemptions from, 1.23, 1.24 implied claims, 101.65(b) special dietary foods, 105 Subpart B labeling, Part 101 cheese products, 133.10(b-d) definition of, 1.3(a) exemptions, 1.23, 1.24, 101.2(c)(1), 101.17(d)(2), 101.22(d-f), 101 Subpart G, 101.100, 101.108 experiments, 101.108 Fair Packaging and Labeling Act, 5.10(a)(1), 5.31(a)(1) GRAS food ingredients, 184.1(f) health claims (see health claims) identity, 101.3 infant formula, 107 Subpart B irradiated food, 179.26(c) misleading, 1.21(a) nutrient content claims (see nutrient content claims) nutrient fortification claims, 104.20(h-i) nutrition (see nutrition labeling) nutritional quality guidelines, 104.5(b-d) prominence of required statements, 101.15 requirements, 1 Subpart B, 70.25, 101 Subparts B-G warning statements (see warnings) See also specific foods and additives lactase enzyme preparation, 184.1387, 184.1388 lactic acid, 178.1010(b)(35), 184.1061 See also contents of specific cheeses lactitol, 101.80(c)(2)(ii)(B) Lactobacillus bulgaricus, 131.170(a), 131.203(a) Lactobacillus fermentum, 184.1924 Lactococcus lactis, 184.1985 lactose, 168.122 lactylated fatty acid esters, 172.850 lakes, 70.3(l) D&C, 81.1(b) FD&C, 81.1(a), 82.51 fees for certification, 80.10(a) labeling, 101.22(k)(1) See also color; color additives laminate structures, 177.1395 high temperature, 177.1390 non-food-contact layers, 177.1345, 177.1395(a) land and air conveyances, 1240.3(e), 1250.3(e) sanitation on, 1250 Subparts B-D See also communicable diseases larvae (insect), 110.3(j) Latin names for algae, 101.4(h) for herbs/supplements, 101.4(h), 190.6(b)(2) See also microorganisms, specific laughing gas, 184.1545(a) lauryl vinyl ether copolymers, 177.1970

lavatory facilities. See toilet facilities LDL. See low density lipoprotein (LDL) lead, 82.5(b)(1)(i), 82.5(b)(2)(i) contamination of ceramicware, 109.16(a) foil capsules, 189.301 solders, 189.240 See also specific color additives Lead-Based Paint Poisoning Prevention Act, 5.10(a)(21) leavening agents, 101.4(b)(16) adipic acid, 184.1009(c) ammonium bicarbonate, 184.1135(c) ammonium carbonate, 184.1137(c)(1) ammonium chloride, 184.1138(c)(1) ammonium hydroxide, 184.1139(c)(1) ammonium phosphate, dibasic, 184.1141b calcium lactate, 184.1207(c)(1) calcium sulfate, 184.1230(c) carbon dioxide, 184.1240(c)(1) glucono delta-lactone, 184.1318(c)(1) potassium acid tartrate, 184.1077(c)(1) lecithin, 136.110(c)(5)(i), 184.1400 enzyme-modified, 184.1063 hydroxylated, 172.814 legumes, 101.12(b), 101.82(c)(2)(ii)(A) lemon juice, 146.114 lemon oil, 173.240(b) lemonade, 146.120, 146.121, 146.126 lesions (in personnel), 110.10(a), 1250.35(b) less (claims), 101.13(j) Leuconostoc citrovorum, 184.1848(a) Leuconostoc dextranicum, 184.1848(a) Leuconostoc mesenteroides, 186.1275(a) libel proceedings, 5.31(b)(1)(v) lice, 1250.95 licorice, 184.1408 light (claims), 101.13(j), 101.56 light cream, 131.155, 131.157 lighting, 110.20(b)(5) limburger cheese, 133.152 limed rosin, 73.1(b)(2) See also rosins limestone (ground), 184.1409 limited conditions of use, 184.1(b)(1-2), 184.1(f)(2-3), 186.1(b)(2) (see also individual food ingredients) linoleic acid, 184.1065 See also contents of specific foods linseed oil, 181.26 lipase, 173.140 animal, 184.1415 from Rhizopus niveus, 184.1420 lipids. See fats liqueurs, 135.140(e)(4) liquid food, 177.2250 lite (claims), 101.56 lite fare (claims), 101.13(q)(5)(iii) lithium hypochlorite, 178.1010(b)(15) lo. See low (claims) local control (of communicable diseases), 1240.30 local requirements, 100 Subpart A, 1240.30 petitions for exemption from, 100.1

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Index

locker rooms, 110.20(b)(5), 129.35(c), 1250.70(a) locust (carob) bean gum, 184.1434 lot (definition of), 110.3(h), 113.3(m), 114.3(c), 129.3(c), 158.3(a), 165.3(a) lot number, 70.3(r) lot size, 158.3(b) low-acid foods, 113.3(n), 114.3(d) thermally processed, 106.90, 108.35, Part 113 See also acid foods; nonacid foods low calorie, 101.12(d), 101.13(b)(5), 101.60(a)(4), 101.60(b)(2) label statements, 105.66(c), 105.66(e) See also calorie content claims; light (claims) low (claims), 101.13(b)(4), 101.13(e), 101.14(d)(2) low density lipoprotein (LDL) cholesterol, 101.75(a)(1-2), 101.77(a)(1-2), 101.81-101.83(a)(1-2) low fat claims, 101.62(b)(2) low saturated fat, 101.62(c)(4) low sodium, 101.12(g), 101.13(b)(1) cheeses, 133.116, 133.121 See also sodium lowfat cocoa, 163.114 lowfat yogurt, 131.203 lubricants, 173 Subpart C beeswax, 184.1973(c) calcium stearate, 184.1229(c)(1) candelilla wax, 184.1976(c)(1) carnauba wax, 184.1978(c)(1) castor oil, hydrogenated, 178.3280(b)(1) contamination with, 110.40(a), 123.11(b)(5) fatty acids, 172.860(d)(1) hydrogenated sperm oil, 173.275 with incidental food contact, 178.3570 magnesium carbonate, 184.1425(c)(1) magnesium oxide, 184.1431(c)(1) magnesium stearate, 184.1440(c)(1) in metallic article manufacture, 178.3910 mono- and diglycerides, 184.1505(c)(1), 184.1521(c)(1) oleic acid, 172.862(c) pentaerythritol adipate-stearate, 178.3690 petrolatum, 172.880(c), 178.3700 petroleum hydrocarbons, odorless light, 178.3650(c) polyethylene glycol, 172.820(c)(1) polyhydric alcohol esters, 178.3770, 178.3780 sodium oleate, 186.1770(b) sorbitol, 184.1835(c) white mineral oil, 172.878(c) See also food additives, indirect lunch rooms, 129.35(c)

magnesium carbonate, 184.1425 magnesium chloride, 184.1426 magnesium hydroxide, 184.1428 magnesium oxide, 184.1431 magnesium phosphate, 184.1434 magnesium silicate, 182.2437 magnesium stearate, 184.1440 magnesium sulfate, 184.1443 mahi mahi, 123.3(m) main dishes, 101.13(l), 102.28 maintenance (of food areas), 1250.30 maleic anhydride copolymers, 177.1820 malic acid, 184.1069 malt, 184.1443a beverages, 172.725(b), 172.730(c), 172.770 brewer’s, 172.725(d)(2), 172.730(c) syrup, 184.1445 maltitol, 101.80(c)(2)(ii)(B) maltrodextrin, 184.1444 manganese, 74.101(b) See also contents of specific foods manganese caprylate, 181.25 manganese chloride, 184.1446 manganese citrate, 184.1449 manganese gluconate, 184.1452 manganese linoleate, 181.25 manganese naphthenate, 181.25 manganese sulfate, 184.1461 manganese tallate, 181.25 mannitol, 101.80(c)(2)(ii)(B), 180.25 manufacturers, 106.3(c), 107.3 name and place of business, 101.5 notice to, 133.10 manufacturing food, 108.3(e), Part 110 coatings used in, 175.250, 175.300, 175.320 containers used in, 177.1210, 177.1320 paper and paperboard products used in, 176 Subpart B without/in violation of emergency permit, 108.12 See also polymers (indirect food additives); production aids maple sirup, 168.140 margarine, Part 166, 166.40, 166.110 labeling exemptions, 1.24(a)(11) reference amounts, 101.12(b) marigold, Aztec, 73.295 marking inks, 73.1(b)(1) marking of shell eggs, 115.50(e)(1)(iv) masking agent, 172.812(b) material facts, 1.21, 80.31(a)(1) mayonnaise, 101.12(b), 169.140 meal products, 101.13(l) algae meal, 73.185, 73.275 Aztec marigold (Tagetes) meal, 73.295 corn meal enriched, 137.260 self-rising, 137.270, 137.290 white, 137.250, 137.255, 137.265, 137.270 yellow, 137.275, 137.280, 137.285, 137.290 meal-replacement products, 172.345(h)

macaroni products, Part 139, 139.110 enriched macaroni, 139.115, 139.117, 139.122, 139.135 macaroni and cheese, 101.12(b) milk macaroni, 139.120, 139.121, 139.122 vegetable macaroni, 139.125, 139.135 wheat and soy macaroni, 139.140 whole wheat macaroni, 139.138 magnesium. See contents of specific foods

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Index

measures, household, 101.9(b)(5) meat color additives in, 71.1(j)(1), 71.20(a)(3) detention of, 5.10(a)(10), 5.302 Meat Inspection Act, 5.302(a), 101.4(b)(2) for NASA, 179.26(b)(7) processing chemicals, 173.368 radiation treatment, 179.26(b) twine for, 178.3760, 178.3940 See also curing agents medical foods exemption from health claim regulations, 101.14(f)(1) folic acid in, 172.345(f) medicines (contamination with), 110.10(b)(9) melamine-formaldehyde resins, 177.1460 mellorine, 135.130 membrane filters, 177.1500(b)(15) membranes ion exchange, 173.20, 173.21 ultra-filtration, 177.2510(a)(4), 177.2910 menhaden, 172.385(a) menhaden oil, 184.1472, 186.1551(a) mercaptoimidazoline, 189.250 mercury. See specific color additives mercury lamps, 179.39(a) metal fragments, 110.40(a), 110.80(b)(8) metallic article manufacture, 178.3910 methacrylic acid copolymers, 172.775, 177.1330 methanoic acid, 186.1316(a) n-acetyl-l-methionine, 172.372 methods of analysis, 2.19, 133.5 bacterial count, 1210.16 pasteurization, 1210.15 methyl acrylate copolymer resins, 177.1340 methyl acrylate copolymers, 177.1480, 177.1990, 177.2000 methyl alcohol, 173.250 methyl ethyl cellulose, 172.872 methyl glucoside-coconut oil ester, 172.816, 178.3600 methyl methacrylate copolymers, 177.1030, 177.1830, 177.2000 methylcellulose, 172.874, 182.1480 methylene chloride, 73.1(b)(1)(ii), 173.255 4,4’-methylenebis (2-chloroanaline), 189.280 methylparaben, 181.23, 184.1490 α-methylstyrene-vinyltoluene resins, 178.3610 microcapsules, 172.230, 172.886(d) Micrococcus lysodeikticus, 173.135 microfiche, 106.100(m) microfilm, 106.100(m) microorganisms control of, 173.320, 178 Subpart B, 178.1005, 178.1010 definition of, 110.3(i) and enzyme preparations, 173 Subpart B pathogenic, 2.35(b)(1), 179.26(b)(6), 1250.3(d) pertinent, 120.24(a) undesirable, 110.3(i), 110.3(n-o), 110.80(b)(4), 110.80(b)(14-15)

See also antimicrobial agents; irradiation; sanitizers microorganisms, specific Acetobacter suboxydans, 186.1839(a) Acetobacter xylinum, 186.1839(a) Actinoplanes missouriensis, 184.1372(a) Alcaligenes faecalis, 172.809(a) Aspergillus niger, 173.120, 173.280 Aspergillus oryzae, 137.105(a), 137.105(b)(2), 137.200(b)(2), 173.150(a)(5) Bacillus amyloliquefaciens, 184.1148(a), 184.1150(a) Bacillus brevis, 173.115(a) Bacillus cereus, 173.150(a)(2) Bacillus coagulans, 184.1372(a) Bacillus stearothermophilus, 184.1012 Bacillus subtilis, 173.115, 184.1148(a), 184.1150(a) Candida guilliermondii, 173.160 Candida lipolytica, 173.165 Candida pseudotropicalis, 184.1387 Candida utilis, 172.896 Clostridium botulinum (see Clostridium botulinum) Clostridium perfringens, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) Endothia parasitica, 173.150(a)(1) Eremothecium ashbyii, 184.1695(a) Escherichia coli (E. coli), 120.25(c-e), 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) Kluyveromyces lactis, 184.1388 Lactobacillus bulgaricus, 131.170(a), 131.203(a) Lactobacillus fermentum, 184.1924 Lactococcus lactis, 184.1985 Leuconostoc citrovorum, 184.1848(a) Leuconostoc dextranicum, 184.1848(a) Leuconostoc mesenteroides, 186.1275(a) Micrococcus lysodeikticus, 173.135 Mortierella vinaceae, 173.145 Mucor miehei, 173.140, 173.150(a)(4) Mucor pusillus, 173.150(a)(3) Penicillium roquefortii, 133.141(a)(1-2), 133.164(a)(1-2), 133.184(a)(1-2) Phaffia rhodozyma, 73.355(a) Pseudomonas elodea, 172.665(a) Rhizopus niveus, 173.110, 184.1420 Rhizopus oryzae, 173.130 Saccharomyces cerevisiae, 172.325(a), 172.896, 172.898(a) Saccharomyces fragilis, 172.896 Salmonella (see Salmonella) Staphylococci, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) Streptococcus cremoris, 184.1848(a) Streptococcus lactis, 184.1538(a), 184.1848(a) Streptococcus thermophilus, 131.170(a), 131.203(a) Streptomyces griseus, 184.1945(a) Streptomyces olivaceus, 184.1372(a) Streptomyces olivochromogenes, 184.1372(a) Streptomyces rubiginosus, 184.1372(a) Trichinella spiralis, 179.26(b)(1) Trichoderma longibrachiatum, 184.1250 Xanthomonas campestris, 172.695(a) Zygosaccharomyces rouxii, 180.25(a)(2)

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Index

microparticulated protein powder, 184.1498 microwave radiation, 179.30 See also irradiation mildew, 178.3800(a) milk, 101.4(b)(4), Part 131, 131.110 acidified, 131.111 buttermilk, 101.4(b)(5-6), 131.112(f), 163.135, 1250.25, 1250.26 concentrated, 101.4(b)(4), 131.115, 133.3(a) condensed, sweetened, 131.120, 1210.3(d-e), 1210.27, 1210.28 containers (sanitizing solutions for), 178.1010(b) cultured, 101.4(b)(5), 131.112 definition of, 133.3(a), 1210.3(c) evaporated, 131.130, 1210.6(d), 1210.6(f), 1210.27 ice, 1.24(a)(6), 101.12(b), 1240.3(j) labeling, 1.24(a)(7), 101.4(b)(4) nonfat dry, 101.4(b)(3), 131.125, 131.127 pasteurization, mandatory, 1240.61 permits for, 1210 Subpart C reconstituted, 101.4(b)(2), 133.3(a) reference amounts, 101.12(b) sale/service on conveyances, 1250.25, 1250.26 skim, 101.4(b)(3), 101.62(b) source of, 1250.25 cow’s milk (see contents of specific cheeses) goat’s milk, 133.111(c)(1), 133.148(c), 133.150(c)(1), 133.187(c)(1), 133.188(c)(1) sheep’s milk (see contents of specific cheeses) water buffalo milk, 133.155(b)(1), 133.156(b)(1) unpasteurized, 101.100(f)(1-3) whole (dry), 101.4(b)(4), 131.147, 133.3(a) Milk Act. See Federal Import Milk Act milk-clotting enzymes, 173.150 milk products, 1240.3(j), 1240.61 bread/rolls/buns, 136.115(b), 136.130 chocolate, 163.130, 163.135, 163.140 macaroni, 139.120, 139.121, 139.122 milk sugar. See lactose milkfat content, 133.5, 133.5(b), 133.5(d) See also contents of specific dairy products mineral oil, 178.3620 white, 172.878, 178.3620(a-b) mineral reinforced nylon resins, 177.2355 mineral water, 165.110(a)(2)(iii) minerals, 101.9(a)(4) addition to product water, 129.80(a) health claims, 101.71 order on label, 101.36(b)(2)(i)(B) See also contents of specific foods minimum heat treatment, 1240.3(k), 1240.75(a-b) minimum thermal process, 113.3(o) minor violations, 5.33 misbranded articles, 2.10(c) misbranded food, 101.3(e), 181.5(b) misbranded infant formula, 106.120(b), 107.200, 107.210(b) misbranding in food labeling, 101.18, 101.36(j) reasons other than labeling, 100 Subpart F

misleading containers, 100.100 misleading labeling, 1.21(a) mixed oxides, 82.3(j) mixtures, 70.3(k), 73.1, 80.10(b), 82.6 modified (claims), 101.13(k) moisture barrier, 172.280(b) moisture content, 133.5, 133.5(a) molasses, 101.12(b) mold-inhibiting ingredients. See antimycotics molded articles, 177.1460, 177.1900, 177.2410 molds, 110.3(i) Penicillium roquefortii, 133.141(a)(1-2), 133.164(a)(1-2), 133.184(a)(1-2) See also contents of specific cheeses molecular sieve resins, 173.40 molluscan shellfish, 123.3(p), 123.3(r), 123.20, 123.28, 1240.60 certification number, 1240.3(s) definition of, 123.3(h), 1240.3(r) shellfish control authority, 1240.3(t) See also shellfish mollusks, 123.3(d) Monier-Williams procedure, 101 Appendix A, 130.9(a) monitor (definition of), 120.3(i) mono- and diglycerides, 136.110(c)(5)(ii), 184.1505 monosodium phosphate derivatives of, 184.1521 tartaric acid esters of, 184.1101 monoammonium glutamate, 182.1500 monochloroacetic acid, 189.155 monoglyceride citrate, 172.832 monoiodofluoresceins, 74.303(b) monopotassium glutamate, 182.1516 monosodium glutamate, 182.1(a) monosodium phosphate, 133.169(c), 178.1010(b)(44) monostearin, 184.1324 montan wax acids, 178.3770 monterey/monterey jack cheese, 133.153, 133.154 more (claims), 101.13(j), 101.54(e)(1-2) morpholine, 172.235, 178.3300(b)(1) Mortierella vinaceae, 173.145 mosquitoes, 1250.49, 1250.95 mouthwash, 81.10(t), 81.30(s)(1) mozzarella cheese, 133.155, 133.156, 133.157, 133.158 Mucor miehei, 173.140, 173.150(a)(4) Mucor pusillus, 173.150(a)(3) muenster/munster cheese, 133.160, 133.161 muffins, 101.12(b) multiple purpose GRAS food substances, 182 Subpart B multipurpose food additives. See food additives, multipurpose multiservice containers, 129.3(d), 129.37(a-b), 129.80(b)(1) multiservice shipping cases, 129.80(b)(2) multiunit food package, 1.24(a)(14), 107.30 multiuse utensils, 1250.33(a-b) multiwall bag, 176.160(b)(2) Munsell color discs, 155.3(d), 155.190(b)(2)(ii), 156.3(a) munster cheese, 133.160, 133.161 mushrooms, 155.201 musk, 182.50

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Index

mussels, 123.3(h), 1240.3(r), 1250.3(o) myristo chromic chloride complex, 178.3290

nontoxic materials, 129.3(e), 129.40(a)(2) α-(p-nonylphenyl)-omega-hydroxypoly-(oxyethylene), 178.1010(b) noodle products, Part 139, 139.150 egg noodles, 139.150, 139.155, 139.160, 139.165, 139.180 enriched noodles, 139.155 vegetable noodles, 139.160, 139.165 wheat and soy noodles, 139.180 nordihydroguaiaretic acid (NDGA), 181.24, 189.165 notice statements, 101.17 notification dietary supplements, 190.6 infant formula, 106 Subpart D, 107.240 of State/civil proceedings, 100.2(d-i) nutrient addition, 130.10(b) content of infant formulas, 106 Subpart B definition of, 106.3(d) fortification, 104 Subpart B, 104.20, 105.3(a)(1)(iii) indicator, 106.3(a) information (infant formula), 107.10 levels (disqualifying), 101.14(a)(4) premixes, 106.3(e), 106.20(b)(2), 106.100(c-d) requirements (infant formula), 107 Subpart D, 107.100 values, 101.45(b)(1), 101.45(c) See also nutrition facts nutrient content claims, 101.13, 101 Subpart D, 130.10 for butter, 101.67 calorie content, 101.60 exemptions to, 101.13(q) expressed, 101.13(b)(1), 101.69(a) fat, fatty acid, and cholesterol content, 101.62 implied, 101.13(b)(2), 101.65, 101.69(a), 101.69(b)(3) petitions for, 101.69 redelegations of authority, 5.300 and reference amounts, 101.12(g) for restaurant foods, 101.10, 101.13(q)(5) sodium content, 101.61 specific words used as claims, 101.54, 101.56, 101.60 nutrient supplements calcium chloride, 184.1193(c) calcium glycerophosphate, 184.1201(c)(1) calcium lactate, 184.1207(c)(1) calcium pantothenate, 184.1212(c)(1) calcium sulfate, 184.1230(c) beta-carotene, 184.1245(c)(1) copper gluconate, 184.1260(c)(1) copper sulfate, 184.1261(c)(1) corn gluten, 184.1321(c)(1) cuprous iodide, 184.1265(c) ferric ammonium citrate, 184.1296(c) ferric citrate, 184.1298(c) ferric phosphate, 184.1301(c) ferric pyrophosphate, 184.1304(c) ferrous ascorbate, 184.1307a ferrous carbonate, 184.1307b ferrous citrate, 184.1307c

nacrite, 186.1256(a) names botanical, 101.4(h) brand, 101.13(q)(6), 101.14(a)(1), 101.69(b)(3) common or usual (see common or usual name) corporate, 101.5(b) Latin, 101.4(h), 190.6(b)(2) and place of business, 101.5 naphtha, 73.1(b)(2) naphthalenesulfonic acid, 74.340(a-b), 74.706(a-b), 178.1010(b)(35) 1-(phenylazo)-2-naphthalenol, 74.706(b) naphthionic acid, 74.250(b) 1-(2,5-dimethoxyphenylazo)-2-naphthol, 74.302(a) β-naphthylamine, 81.10(a), 81.10(h) NASA (National Aeronautics and Space Administration), 179.26(b)(7) natamycin (pimaricin), 172.155 natural extractives. See under extractives natural flavor/flavoring, 101.22(a)(3), 101.22(h)(1), 101.22(h)(7), 172.510 natural toxins, 110.80(a)(3), 120.7(c)(6), 123.6(c)(1)(i) NDGA (nordihydroguaiaretic acid), 181.24, 189.165 neo-decanoic acid, 178.1010(b)(29) net quantity of contents, 1.23, 1.24(a)(1), 101.105 net weight, 1.24(a)(2), 101.105(j)(3), 101.105(t) neufchatel cheese, 133.162, 133.167(c) neufchatel cheese spread, 133.178 neural tube defects, 101.79 niacin, 184.1530 source of, 172.310 See also contents of specific foods; nicotinamide niacinamide, 184.1535 nickel, 184.1537 nicotinamide, 172.315, 184.1535(a) nicotinic acid. See niacin nisin, 133.179(f)(11), 184.1538 nitrates. See curing agents; preservatives nitrile rubber modified copolymers, 177.1480 nitrites. See curing agents; preservatives nitrocellulose-coated cellophane, 179.45(b)(1) nitrogen, 184.1540 nitrogen oxide, 137.105(a)(1) nitrosamine inhibitors, 184.1890(c)(1) nitrosyl chloride, 137.105(a)(3) nitrous oxide, 184.1545 nonacid foods, 177.2355, 177.2400, 177.2410 nonanoic acid, 178.1010(b)(42) noncarbonated drinks, 102.33(a) nonfat milk, 101.4(b)(3), 131.125, 131.127, 133.3(b) macaroni, 139.121, 139.122 nonfat yogurt, 131.206 nonnutritive ingredients, 105.66(b) nonnutritive sweeteners, 105.66(b)(2), 172.820(c)(2) nonperishable processed food, 170.3(j) nonpotable water, 1240.86, 1250.67(b), 1250.84(a) nonstandardized foods, Part 102

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Index

ferrous fumarate, 184.1307d ferrous gluconate, 184.1308(c) ferrous lactate, 184.1311(c) ferrous sulfate, 184.1315(c) inositol, 184.1370(c)(1) iron, elemental, 184.1375(c) linoleic acid, 184.1065(c)(1) magnesium carbonate, 184.1425(c)(1) magnesium chloride, 184.1426(c)(1) magnesium hydroxide, 184.1428(c)(1) magnesium oxide, 184.1431(c)(1) magnesium phosphate, 184.1434(c)(1) magnesium stearate, 184.1440(c)(1) magnesium sulfate, 184.1443(c)(1) manganese chloride, 184.1446(c)(1) manganese citrate, 184.1449(c)(1) manganese gluconate, 184.1452(c)(1) manganese sulfate, 184.1461(c)(1) niacin, 184.1530(c)(1) niacinamide, 184.1535(c)(1) peptones, 184.1553(c)(1) potassium bicarbonate, 184.1613(c)(1) potassium carbonate, 184.1619(c)(1) potassium chloride, 184.1622(c)(1) potassium iodide, 184.1634(c) pyridoxine hydrochloride, 184.1676(c)(1) riboflavin, 184.1695(c)(1) riboflavin-5’-phosphate (sodium), 184.1697(c)(1) thiamine hydrochloride, 184.1875(c)(1) thiamine mononitrate, 184.1878(c)(1) vitamin A, 184.1930(c)(1) vitamin B12, 184.1945(c)(1) vitamin D, 184.1950(c)(1) wheat gluten, 184.1322(c)(1) See also dietary supplements nutrients, specific GRAS, 182 Subpart I ascorbic acid, 182.8013 biotin, 182.8159 calcium phosphate, 182.8217 calcium pyrophosphate, 182.8223 choline bitartrate, 182.8250 choline chloride, 182.8252 sodium phosphate, 182.8778 α-tocopherol acetate, 182.8892 tocopherols, 182.8890 zinc chloride, 182.8985 zinc gluconate, 182.8988 zinc oxide, 182.8991 zinc stearate, 182.8994 zinc sulfate, 182.8997 nutrition facts, 101 Appendix C nutrition labeling, 101.2(c)(1)(ii)(B)(1), 101.2(d)(2), 101.9, 101.13(n) data bases, 101.45(b)(1), 101.45(c) dietary supplements, 101.36 raw fruit, vegetables, and fish, 101.42, 101.43, 101.45 reference amount consumed, 101.13(p)(1) of restaurant foods, 101.10, 101.14(d)(3) specific requirements, 101 Subpart C See also nutrient content claims

nutritional additives. See special dietary and nutritional additives nutritional inferiority, 101.3(e)(4), 101.13(d) nutritional quality guidelines, Part 104, 104.5, 104 Subpart C nutritive value, 101.14(a)(3) nuts, Part 164 mixed nuts, 164.110 protective coating for, 172.260(b) reference amounts, 101.12(b) shelled nuts, 164.120 undesirable microorganisms in, 110.80(b)(14) nuworld cheese, 133.164 nylon 6/12 resins, 177.1390(f) nylon 6 films, 179.45(d)(2)(iii) nylon 11, 179.45(b)(10) nylon film, 175.360 nylon MXD-6, 177.1390(e), 177.1500(b)(10) nylon resins, 177.1500 mineral reinforced, 177.2355 in twine for meat, 178.3760, 178.3940 oats color identification of seed, 2.25(a) whole, 101.81(c)(2)(i)(G)(1), 101.81(c)(2)(ii)(A) objections (food additive regulations), 171.110 (Z,Z)-9,12-octadecadienoic acid, 184.1065(a) octafluorocyclobutane, 173.360 octanesulfonic acid, 178.1010(b)(36) octanoic acid, 178.1010(b), 178.1010(b)(45), 184.1025(a) octenyl succinic acid, 178.1010(b)(39) odors, 110.20(b)(6) Offices (list of), 5.1100, 5.1115 official inspector, 1210.18 officials, 5.300, 5.301 oil of rue, 184.1699 oil of vitriol (sulfuric acid), 184.1095(a) oils edible fats and, 172.225, 184.1472(b)(3), 184.1555(c)(4) essential (see essential oils) labeling of, 101.4(b)(14) mixtures with olive oil, 102.37 olestra as substitute for, 172.867(c) reference amounts, 101.12(b) oils, specific butteroil, 101.4(b)(9) calamus, 189.110(a-b) canola, 184.1555(c) carrot, 73.300 castor, 73.1(a)(3), 172.876, 178.3280, 181.26 chinawood, 181.26 coconut, 172.816, 172.861, 178.3600 cognac, 182.50 corn endosperm, 73.315 drying, 181.26 fish, 186.1551 garlic, 184.1317(b) lemon, 173.240(b) linseed, 181.26

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Index

menhaden, 184.1472, 186.1551(a) mineral, 172.878, 178.3620 oil of rue, 184.1699 olive, 102.37 palm, 184.1259(a) palm kernal, 172.861 persic, 182.40 rapeseed, 184.1555 safflower, 184.1259(a) sassafras, 189.180(a-b) sheanut, 184.1702 soybean, 172.723 sperm, 173.275 sunflower, 184.1259(a) tall, 172.862, 178.1010(b)(29), 181.26, 186.1557 tung, 181.26 vegetable, 180.30 oilseed rape, 173.170 olefin polymers, 175.320(a), 177.1520, 178.3280(b)(7) oleic acid, 172.862 oleomargarine. See margarine oleoresins, 101.22(a)(3) from clove, 184.1257(a) from dill, 184.1282(a) from garlic, 184.1317(a) generally recognized as safe (GRAS), 182.20, 182.50 tolerance for acetone in, 173.210 See also spice oleoresins olestra, 172.867 olive oil, 102.37 olives, 101.12(b) coloring of, 73.160(c), 73.165(c), 184.1311(c) onion, green, 101.12(b) onion rings, 102.39 operating process, 113.3(p) operations water, 129.3(f), 129.35(a) opinion letters, 170.6 optical brighteners, 178.3297(a) Orange B, 74.250 orange juice. See under fruit juices, canned Orange No. 1 (Ext. D&C), 81.30(d) Orange No. 3 (D&C), 81.30(d) Orange No. 4 (D&C), 81.30(g) Orange No. 4 (Ext. D&C), 81.30(d) Orange No. 8 (D&C), 81.30(d) Orange No. 10 (D&C), 81.10(m), 81.30(n)(1) Orange No. 11 (D&C), 81.10(m), 81.30(n)(1) Orange No. 14 (D&C), 81.30(d) Orange No. 15 (D&C), 81.30(d) Orange No. 16 (D&C), 81.30(d) Orange No. 17 (D&C), 81.10(s), 81.30(t)(1) oranges (coloring of), 74.302(c) organization, 5 Subpart M original record, 5.10(a)(38) osmosis, reverse, 129.80(a), 165.110(a)(2)(iv), 177.2550 osteoporosis, 101.72 ounce (oz), 101.9(b)(5) ox bile extract, 184.1560 oxides, mixed, 82.3(j) oxidized polyethylene, 172.260

oxidizing and reducing agents, 184.1366(c) oxystearin, 172.818 oysters, 123.3(h), 161.30, 161.130, 161.136, 161.145, 1240.3(r), 1250.3(o) ozone, 173.368, 184.1563 water solution, 129.80(d)(4) See also antiozonant components of polymers ozone-depleting substance, 101.17(c) P-4000, 189.175 Pacific whiting, 102.46 package, 1.1(c), 1.20, 70.3(t) commemorative/promotional, 100.100(a)(5) form food, 101.1, 101.2, 101.3, 101.9(a)(a), 1240.61 unit, 129.3(l), 129.80(e) packaging aseptic, 113.40(g), 113.100(a)(4) for cheese, 178.3850(e)(2) coatings used in, 175.210, 175.250, 175.300, 175.320 of commercially sterile foods, 178.1005(e)(2) containers used in, 177.1210, 177.1320, 178.3300 Fair Packaging and Labeling Act, 5.10(a)(1), 5.31(a)(1) requirements, 70.20 system operations, 5.304(a) unit-dose, 111.50(a) vacuum, 113.3(u) See also food-packaging materials; production aids packers, 101.5, 133.10 packing food coatings used in, 175.250, 175.300, 175.320 containers used in, 177.1210 current good manufacturing practice, Part 110 paper and paperboard products used in, 176 Subpart B without/in violation of emergency permit, 108.12 See also polymers (indirect food additives); production aids packing medium (density), 145.3(m), 145.3(o)(1) packs of food, experimental, 130.17 palm kernal oil, 172.861 palm oil, 184.1259(a) palmitic acid esters, 178.3450 pancake sirup, 168.180(c) pancakes, 101.12(b) pancreatin, 184.1063(a), 184.1583 pantothenic acid. See contents of specific foods pantries, 1250.30(a-d), 1250.45(a) papain, 184.1585 paper contaminated by PCBs, 109.15 cups/towels, 110.35(d)(4) glassine, 176.320(b), 179.45(b)(2) grease-resistant, 176.160(b)(2) greaseproof, 176.320(b) kraft, 179.45(b)(5) substances migrating from, 182.90 ultra-filtration membranes, 177.2910(a)(1) waterleaf, 179.45(d)(1)

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Index

paper and paperboard components, Part 176, 176 Subpart B acrylamide-acrylic acid resins, 176.110 alkyl ketene dimers, 176.120 anti-offset substances, 176.130 chelating agents, 176.150 chromium complex of N-ethyl-N-heptadecylfluorooctane sulfonyl glycine, 176.160 clay (kaolin), 186.1256(b)(1) coatings for paper/paperboard, 176.200, 176.230 in contact with aqueous and fatty foods, 176.170, 178.3280(b)(4), 179.45(b)(3) in contact with dry foods, 176.180 defoaming agents, 176.200 3,5-dimethyl-1,2,3,2H-tetrahydrothiadiazine-2-thione, 176.230 ferric oxide, 186.1300(b)(1) formic acid, 186.1316(b) iron oxides, 186.1374(b)(1) poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane, 176.250 preservatives, 176.230 prior-sanctioned, 181.30 pulp, 186.1673(b-c) pulp from reclaimed fiber, 176.260 retention aid, 176.250 slimicides, 176.300, 186.1750(b) sodium chlorite, 186.1750(b) sodium formate, 186.1756(b) sodium nitrate-urea complex, 176.320 sodium oleate, 186.1770(b) sodium palmitate, 186.1771(b) sodium sulfate, 186.1797(b) sorbose, 186.1839(b) sulfamic acid, 186.1093(b) tamarind seed kernel powder, 176.350 time/temperature conditions for extractives, 176.170(c)Table 2 paprika, 73.340, 101.22(a)(2) paprika oleoresin, 73.345 paraffin, synthetic, 172.275, 175.250 parasites, 120.7(c)(2), 123.6(c)(1)(vii) parchments, vegetable, 179.45(d)(1) parmesan cheese, 133.146(d)(3), 133.165 parsley, 101.12(b) partial phosphoric acid esters, 175.260 partition, 110.20(b)(2) pastas, 101.12(b) pasteurization, 110.80(b)(4), 1210.3(h), 1240.61(b) for additives, 73.100(b)(2) equipment and methods, 1210.15 mandatory, 1240.61 pasteurized, 131.3(b), 133.3(d), 1240.61(b) cheese, 133.10, 1250.26(c) milk and cream, 1210.25, 1250.26(a) mix, 135.3 ultrapasteurized, 131.3(c), 133.3(e) See also specific dairy products pastries, 101.12(b) patent term extensions, 5.27

pathogenic microorganisms, 2.35(b)(1), 179.26(b)(6), 1250.3(d) See also microorganisms PCB’s (polychlorinated biphenyls), 109.15, 109.30 peach butter, 150.110(b)(1) peach kernal, 182.40 peaches, 145.170, 145.171 peanut products, Part 164 peanut butter, 101.12(f)(1), 102.23(b), 164.150 peanut spreads, 102.23 peanut stearine, 182.40 peanuts, 164.110(a-b) pear butter, 150.110(b)(1) pears, 145.176 peas, 155.170, 155.172, 158.170 pecorino romano cheese, 133.183(e) pectins, 101.12(b), 184.1588 peeling of fruits and vegetables, 173.315 Penicillium roquefortii, 133.141(a)(1-2), 133.164(a)(1-2), 133.184(a)(1-2) pentaerythritol adipate-stearate, 178.3690 pentaerythritol esters, 73.1(b)(2), 178.3870(a)(3)(vii-xiii) n-pentane, 178.3010 pepper, 182.1(a) pepsin, 184.1595 peptones, 184.1553 peracetic acid, 178.1010(b)(30) percent daily value, 101.36(b)(2)(iii), 101.36(b)(2)(iii)(D) percentage of ingredients, 101.4(e), 102.5(b) juice declaration, 101.30 of nutrient, 101.13(i), 101.13(q)(3)(i-ii) perfluorinated ion exchange membranes, 173.21 perfluorocarbon cured elastomers, 177.2400 perfluorocarbon resins, 177.1550 perfluorohexane, 173.342 perishables, 1250.27 permits acting without, 108.12 emergency, 5.301, Part 108 milk and cream, 1210.10, 1210 Subpart C, 1250.10 temporary, 5.300(b)(2), 130.17, 1210.21, 1210.24 violation of, 108.12 peroxyacetic acids, 178.1010(b) peroxyacids, 173.370 peroxyoctanoic acid, 178.1010(b)(45) persic oil, 182.40 personnel acidified foods, 114.10 manufacturing/packing/holding human food, 110.10 thermally processed low-acid foods, 113.10 See also employees perspiration, 110.10(b)(9) pertinent microorganism, 120.24(a) pest, 110.3(j), 110.20(a)(1) control, 110.35(c), 123.11(b)(8), 179.26(b)(3) pesticide chemicals, 70.11(c), 101.22(f), 101.95(c)(1)(ii) adjuvants for, 172.710, 182.99 in bottled water, 165.110(b)(4)(iii)(C) dispersing agent, 172.715(b)

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Index

food contamination with, 123.6(c)(1)(iv), 123.11(b)(5) in processed foods, 170.19 residues of, 120.7(c)(4) tolerance for, 109.6(a) Pesticide Monitoring Improvements Act, 5.10(a)(27) pesticide-treated seed, 2.35(b)(2) petitions color additive (see color additive petitions) common or usual name, 102.19 exemption from State or local requirements, 100.1 food additive, Part 171 food standards, 130.5(b-c) GRAS status, 184.1(b)(1), 186.1(b)(1) health claims, 101.70 nutrient content claims, 101.69 prohibited substances, 189.1(c) reference amounts, 101.12(h) regulation of food production, 108.19(a) petrolatum, 172.880, 178.3700 petroleum hydrocarbons isoparaffinic, 172.882, 178.3530 odorless light, 172.884, 178.3650 petroleum naphtha, 172.250 petroleum wax, 172.886, 178.3710, 178.3850(a) release agents in, 178.3860 synthetic, 172.888, 178.3720 pH colorimetric methods, 114.90(b) controlling, 110.80(b)(4), 110.80(b)(15), 114.80(a)(2) electrodes, 114.90(a)(3) instruments, 110.40(f) potentiometric method, 114.90(a) titrable acidity, 114.90(c) See also acid foods; acidified foods; low-acid foods; nonacid foods pH control agents acetic acid, 184.1005(c) adipic acid, 184.1009(c) ammonium bicarbonate, 184.1135(c) ammonium carbonate, 184.1137(c)(1) ammonium citrate, dibasic, 184.1140(c)(1) ammonium hydroxide, 184.1139(c)(1) ammonium phosphate, dibasic, 184.1141b ammonium phosphate, monobasic, 184.1141a calcium acetate, 184.1185(c) calcium chloride, 184.1193(c) calcium sulfate, 184.1230(c) glucono delta-lactone, 184.1318(c)(1) lactic acid, 184.1061(c) magnesium carbonate, 184.1425(c)(1) magnesium hydroxide, 184.1428(c)(1) magnesium oxide, 184.1431(c)(1) magnesium phosphate, 184.1434(c)(1) malic acid, 184.1069(c) potassium acid tartrate, 184.1077(c)(1) potassium bicarbonate, 184.1613(c)(1) potassium carbonate, 184.1619(c)(1) potassium chloride, 184.1622(c)(1) potassium hydroxide, 184.1631(c)(1)

potassium lactate, 184.1639(c)(1) sodium acetate, 184.1721(c) sodium carbonate, 184.1742(c)(1) sodium diacetate, 184.1754(c) sodium hydroxide, 184.1763(c)(1) sodium lactate, 184.1768(c)(1) sodium potassium tartrate, 184.1804(c)(1) sodium sesquicarbonate, 184.1792(c)(1) sodium tartrate, 184.1801(c)(1) succinic acid, 184.1091(c) sulfuric acid, 184.1095(c) tartaric acid, 184.1099(c)(1) Phaffia rhodozyma, 73.355(a) Phaffia yeast, 73.355 Phenoclor, 109.15(a) phenol content. See specific food additives phenol equivalent value, 133.5(c) See also contents of specific cheeses phenolic resins, 177.2410 phenylalanine, 172.804(d)(2) 1,3-phenylene oxyethylene isophthalate copolymer, 177.1345 phenylketonurics, 172.804(d)(2) ortho-phenylphenol, 178.1010(b)(20) phosphatase levels (in cheeses), 133.5 phosphated flours, 136.110(c)(1), 137.175 phospholipase, 184.1063(a) phosphoric acid, 178.1010(b), 182.1073 See also contents of specific cheeses phosphoric acid esters of polyester resins, 175.260 phosphorus. See contents of specific foods phosphotransferase II, 173.170 photocopies, 106.100(m) phylloquinone, 107.100(c) pickles, 101.12(b), 101.105(r) pickling agents acetic acid, 184.1005(c) calcium chloride, 184.1193(c) glucono delta-lactone, 184.1318(c)(1) lactic acid, 184.1061(c) sodium carbonate, 184.1742(c)(1) sorbitol, 184.1835(c) pickling mixtures, 172.540 piece, 101.9(b)(5), 101.12(b) pier water system, 1240.86 pies, 101.12(b) pigment dispersants, 178.3725 pimaricin, 172.155 pimento, 101.12(b) pimento cheese, 133.171 pimento cheese food, 133.174 pineapple, 145.180, 145.181 pineapple juice, 146.185 beta-pinene, 73.1(b)(1)(ii), 178.3930(b) piperazine, 177.2550 piperonyl butoxide, 178.3730 pipes, 129.37(a) pizza, 101.12(b) plain flour, 101.4(b)(15)

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Index

plant, 110.20 construction and design, 110.20(b), 129.20 definition of, 110.3(k) milk/cream handling, 1210.14 plant-growth regulator, 172.840(c)(12) plastic cream, 101.4(b)(8) plasticizers glyceryl-lacto esters of fatty acids, 172.852(b) isobutylene-butene copolymers, 177.1430(b)(2) lactylated fatty acid esters of glycerol and propylene glycol, 172.850(c) lactylic esters of fatty acids, 172.848(b) migrating from food-packaging material, 181.27 petroleum hydrocarbons, 178.3650(c) polyethylene glycol, 172.820(c)(1) in polymeric substances, 178.3740 prior-sanctioned, 181.27 sodium nitrate-urea complex, 176.320 See also polymers (indirect food additives) plastics acrylic, 177.1010 foamed, 178.3010 plum butter, 150.110(b)(1) plumbing, 110.37(b), 1250.30(d) plums, 145.185 plus (claims), 101.13(j)(1)(i)(B), 101.54(e)(1-2) PNA’s. See polynuclear aromatic hydrocarbons (PNA’s) poisoning food, 110.80(a)(2) Lead-Based Paint Poisoning Prevention Act, 5.10(a)(21) poisonous or deleterious substances, 2.35(a), 2.35(b)(2) action levels, 109.4(c), 109.6(d-e), 109.7(a) added, 109.3(d), 109.4(a-c), 109.6 Federal Caustic Poison Act, 5.10(a)(1), 5.10(b), 5.31(a)(1) naturally occurring, 109.3(c), 109.4(d) in paper/paperboard, 176.260(b) poisonous treated seeds, 2.25 regulatory limits, 109.4(b), 109.6(c), 109.7(b) tolerances for, 109.4(a), 109.6(a-b), 109.6(e), 109.7(a), 109.30 poly-1-butene resins, 177.1570 poly(2,6-dimethyl-1,4,-phenylene) oxide resins, 177.2460 poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane, 176.250 poly (phenyleneterephthalamide) resins, 177.1632 polyacrylamide film, 172.255 polyacrylamide resin, 173.10 polyacrylate, 173.73 polyacrylate copolymers, 177.1211 polyamide, 177.2550 polyamide-imide resins, 177.2450 polyaramide, 177.2550 polyarylate resins, 177.1555 polyaryletherketone resins, 177.1556, 177.2415 polyarylsulfone resins, 177.1560 polycarbonate film, 175.365 polycarbonate resins, 177.1580 polychlorinated biphenyls (PCB’s), 109.15, 109.30

polydextrose, 172.841 polyepoxy resins, 177.1650 polyester elastomers, 177.1590 polyester resins, 175.260 cross-linked, 177.2420, 178.3280(b)(6) polyestercarbonate resins, 177.1585 polyether resins, 177.2430 polyetheramine, 177.2550 polyetherimide resin, 177.1595 polyethersulfone resins, 177.2440 polyethylene (chlorinated), 177.1610 polyethylene (fluorinated), 177.1615 polyethylene (oxidized), 172.260, 177.1620 polyethylene films, 179.45(d)(2) polyethylene glycol, 172.820, 178.3750 polyethylene glycol (400) monolaurate, 178.3760 polyethylene glycol 6000, 73.1(b)(2) polyethylene phthalate polymers, 177.1630 polyethylene resins, carboxyl modified, 177.1600 polyethylene terephthalate film, 179.45(b)(6), 179.45(d)(2)(ii) polyglycerate 60, 172.834(d) polyglycerol esters of fatty acids, 172.854 polygylceryl phthalate ester, 172.710, 173.230 polyhydric alcohol esters, 178.3770, 178.3780 polymaleic acid, 173.45 polymeric coatings, 175.300, 175.320, 178.3280(b)(3) polymers antioxidants/stabilizers for, 178.2010 block, 178.1010(b) clarifying agents for, 178.3295 colorants for, 178.3297 food-contact, 178.3297(d) modifiers, 178.3790 plasticizers, 178.3740 polyvinyl chloride emulsion polymers, 178.3900 See also adjuvants polymers (indirect food additives), Part 177 repeated use articles (components of), 177 Subpart C ethylene polymer, chlorosulfonated, 177.2210 filters, microporous polymeric, 177.2250 filters, resin-bonded, 177.2260 4,4’-isopropylidenediphenol-epichlorohydrin thermosetting epoxy resins, 177.2280 nylon resins, mineral reinforced, 177.2355 perfluorocarbon cured elastomers, 177.2400 phenolic resins in molded articles, 177.2410 poly(2,6-dimethyl-1,4,-phenylene) oxide resins, 177.2460 polyamide-imide resins, 177.2450 polyaryletherketone resins, 177.1556, 177.2415 polyester resins, cross-linked, 177.2420 polyether resins, chlorinated, 177.2430 polyethersulfone resins, 177.2440 polymethylmethacrylate/poly (trimethoxysilylpropyl) methacrylate copolymers, 177.2465 polyoxymethylene copolymer, 177.2470 polyoxymethylene homopolymer, 177.2480 polyphenylene sulfide resins, 177.2490

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Index

polyphenylene sulfone resins, 177.2500 polyvinylidene fluoride resins, 177.2510 reverse osmosis membranes, 177.2550 rubber articles for repeated use, 177.2600 silicone polymers, 177.2465 styrene-divinylbenzene resins, cross-linked, 177.2710 textiles and textile fibers, 177.2800 ultra-filtration membranes, 177.2910 single & repeated use food contact surface components, 177 Subpart B acrylic plastics, 177.1010 acrylonitrile/butadiene/styrene copolymer, 177.1020 acrylonitrile/butadiene/styrene/methyl methacrylate copolymer, 177.1030 acrylonitrile/styrene copolymer, 177.1040, 177.1050 n-alkylglutarimide/acrylic copolymers, 177.1060 butene/ethylene copolymers, 177.1570 cellophane, 177.1200 closures with sealing gaskets, 177.1210 1,4-cyclohexylene dimethylene isophthalate, 177.1240 1,4-cyclohexylene dimethylene terephthalate, 177.1240 ethylene-acrylic acid copolymers, 177.1310 ethylene-carbon monoxide copolymers, 177.1312 ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers, 177.1315 ethylene-ethyl acrylate copolymers, 177.1320 ethylene-methacrylic acid copolymers, 177.1330 ethylene-methyl acrylate copolymer resins, 177.1340 ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer, 177.1345 ethylene-vinyl acetate copolymers, 177.1350 ethylene-vinyl acetate-vinyl alcohol copolymers, 177.1360 fluorocarbon resins, 177.1380 hydroxyethyl cellulose film, 177.1400 ionomeric resins, 177.1330 isobutylene-butene copolymers, 177.1430 isobutylene polymers, 177.1420 4,4’-isopropylidenediphenol-epichlorohydrin resins, 177.1440 laminate structures, 177.1390, 177.1395 melamine-formaldehyde resins, 177.1460 methacrylic acid polymers, 177.1330 nitrile rubber modified acrylonitrile-methyl acrylate copolymers, 177.1480 nylon resins, 177.1500 olefin polymers, 177.1520 perfluorocarbon resins, 177.1550 poly-1-butene resins, 177.1570 poly (phenyleneterephthalamide) resins, 177.1632 polyacrylate copolymers, cross-linked, 177.1211 polyarylate resins, 177.1555 polyaryletherketone resins, 177.1556 polyarylsulfone resins, 177.1560

polycarbonate resins, 177.1580 polyester elastomers, 177.1590 polyestercarbonate resins, 177.1585 polyetherimide resin, 177.1595 polyethylene, chlorinated, 177.1610 polyethylene, fluorinated, 177.1615 polyethylene, oxidized, 177.1620 polyethylene phthalate polymers, 177.1630 polyethylene resins, carboxyl modified, 177.1600 poly(oxy-1,2-ethanediyloxycarbonyl-2,6naphthalenediylcarbonyl) resins, 177.1637 poly(p-methylstyrene), 177.1635 polystyrene and rubber-modified polystyrene, 177.1640 polysulfide polymer-polyepoxy resins, 177.1650 polysulfone resins, 177.1655 poly(tetramethylene terephthalate), 177.1660 polyurethane resins, 177.1680 polyvinyl alcohol film, 177.1670 styrene block polymers, 177.1810 styrene-maleic anhydride copolymers, 177.1820 styrene-methyl methacrylate copolymers, 177.1830 textryls, 177.1850 urea-formaldehyde resins, 177.1900 vinyl chloride-ethylene copolymers, 177.1950 vinyl chloride-hexene-1 copolymers, 177.1960 vinyl chloride-lauryl vinyl ether copolymers, 177.1970 vinyl chloride polymer resins, 189.300(a-b) vinyl chloride-propylene copolymers, 177.1980 vinyl chloride stabilizers, 178.2650 vinylidene chloride/methyl acrylate copolymers, 177.1990 vinylidene chloride/methyl acrylate/methyl methacrylate polymers, 177.2000 polymers (secondary direct food additives), 173 Subpart A acrylate-acrylamide resins, 173.5 dimethylamine-epichlorohydrin copolymer, 173.60 divinylbenzene copolymer, 173.65 ethylene oxide polymer, 172.770 ion exchange membranes, 173.20, 173.21 ion exchange resins, 173.25 molecular sieve resins, 173.40 polyacrylamide resin, modified, 173.10 polymaleic acid, 173.45 polyvinylpolypyrrolidone, 173.50 polyvinylpyrrolidone, 73.1(b)(1)(i-ii), 73.1(b)(3), 173.55 sodium polyacrylate, 173.73 sorbitan monooleate, 173.75 styrene-divinylbenzene resin, 173.70 polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate copolymers, 177.2465 polynuclear aromatic hydrocarbons (PNA’s), 81.10(j) polyolefin films, 175.320, 178.3610, 179.45(b)(4) poly(oxy-1,2-ethanediyloxycarbonyl-2,6naphthalenediylcarbonyl) resins, 177.1637 polyoxyethylene-polyoxypropylene block polymers, 178.1010(b)

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Index

polyoxyethylene sorbitan monooleate (polysorbate 80), 73.1(b)(1)(i), 172.623, 172.840 polyoxymethylene copolymer, 177.2470 polyoxymethylene homopolymer, 177.2480 poly(p-methylstyrene), 177.1635 polyphenylene sulfide resins, 177.2490 polyphenylene sulfone resins, 177.2500 polypropylene film, 178.3930 polysorbate 60, 172.836 polysorbate 65, 172.838 polysorbate 80, 73.1(b)(1)(i), 172.623, 172.840 polystyrene, 177.1640 polystyrene articles, 177.1430(b)(4) polystyrene film, 179.45(b)(7) polysulfide polymer-polyepoxy resins, 177.1650 polysulfone resins, 177.1655 poly(tetramethylene terephthalate), 177.1660 poly(trimethoxysilylpropyl) methacrylate copolymers, 177.2465 polyurethane resins, 177.1680 polyvinyl acetate, 73.1(b)(1)(i) polyvinyl alcohol, 73.1(b)(2) polyvinyl alcohol film, 177.1670 polyvinyl chloride emulsion polymers, 178.3900 poly(vinyl fluoride) resins, 175.270 poly(vinylidene fluoride) membrane, 177.2510(a)(4) polyvinylidene fluoride resins, 177.2510 polyvinylpolypyrrolidone, 173.50 polyvinylpyrrolidone, 73.1(b)(1)(i-ii), 73.1(b)(3), 173.55 popcorns, 101.12(b) pork, 179.26(b)(1) positive air-flow systems, 110.37(d)(4) possessions (of the U.S.), 1240.3(l), 1240.30, 1250.3(i) pot pies, 101.12(b) potable water, 1250.67(b), 1250.84 containers for, 1250.42(e), 1250.85(c) definition of, 1240.3(m), 1250.3(j) radiation treatment of, 179.39(b) source/use, 1240 Subpart E systems, 1240.86, 1250.82 potassium. See contents of specific foods potassium acid tartrate, 184.1077 potassium alginate, 184.1610 potassium bicarbonate, 184.1613 potassium bisulfite, 101.100(a)(4), 182.3616 potassium bromate, 172.730 potassium bromide, 178.1010(b)(1-2) potassium carbonate, 184.1619 potassium chloride, 184.1622 potassium citrate, 133.169(c), 184.1625 potassium dichloroisocyanurate, 178.1010(b)(2) potassium gibberellate, 172.725(a)(4-6) potassium hydroxide, 184.1631 potassium hydroxide phthalate method, 114.90(c) potassium hypochlorite, 178.1010(b)(1) potassium iodate, 136.110(c)(14)(i), 184.1635 potassium iodide, 172.375, 178.1010(b), 184.1634 potassium lactate, 184.1639 potassium metabisulfite, 101.100(a)(4), 182.3637 potassium nitrate, 172.150, 181.33

potassium permanganate, 178.1010(b)(37) potassium sorbate, 182.3640 See also contents of specific cheeses potassium sulfate, 184.1643 potato chips, 102.41 potato starch, 101.12(b) potatoes, 101.12(b) poultry color additives in, 71.1(j)(1), 73.275(b) detention of, 5.10(a)(11), 5.302 labels for, 175.125(a) Poultry Products Inspection Act, 5.302(b), 101.4(b)(2) processing chemicals, 172.808(b)(3)(i), 173.325, 173.342, 173.368, 173.370(b) radiation treatment of, 179.26(b)(6) substitutes, 101.12(b) See also curing agents prawns, 161.173(a)(5) See also shrimp precautions, 1.21(c)(1) See also cautions; warnings preemption, 115.50(g) exemption from, 100.1 premarket notification, 190.6 premixes, curing, 170.60 prepackaged foods, 179.25(c), 179.45 preservation of samples, 2.10(b)(3) preservatives, 114.80(a)(1), 170.60, 172 Subpart B anoxomer, 172.105 ascorbic acid, 182.3013 ascorbyl palmitate, 182.3149 butylated hydroxyanisole (BHA), 172.110, 181.24, 182.3169 butylated hydroxytoluene (BHT), 172.115, 181.24, 182.3173 calcium ascorbate, 182.3189 calcium disodium EDTA, 73.1(a)(3), 172.120, 172.135(b)(2) calcium sorbate, 182.3225 chemical, 101.22(c), 101.22(f), 182 Subpart D definition of, 101.22(a)(5) GRAS substances, 182 Subpart D labeling of, 101.4(b)(1), 101.22, 101.22(j) dehydroacetic acid, 172.130 dilauryl thiodipropionate, 181.24 dimethyl dicarbonate, 172.133 3,5-dimethyl-1,2,3,2H-tetrahydrothiadiazine-2-thione, 176.230 disodium EDTA, 73.1(a)(3), 172.120(b)(2), 172.135 erythorbic acid, 182.3041 ethoxyquin, 172.140 heptylparaben, 172.145 4-hydroxymethyl-2,6-di-tert-butylphenol, 172.150 monochloroacetic acid (prohibited if added), 189.155(a) natamycin (pimaricin), 172.155 in paper/paperboard manufacture, 176.230 potassium bisulfite, 101.100(a)(4), 182.3616 potassium metabisulfite, 101.100(a)(4), 182.3637

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Index

potassium nitrate, 172.150, 181.33 potassium nitrite, 181.34 potassium sorbate, 182.3640 quaternary ammonium chloride combination, 172.165 sodium ascorbate, 182.3731 sodium bisulfite, 182.3739 sodium metabisulfite, 101.100(a)(4), 182.3766 sodium nitrate, 172.170, 181.33 sodium nitrite, 172.175, 172.177, 181.34 sodium pentachlorophenate, 178.3900 sodium sorbate, 182.3795 sodium sulfite, 101.100(a)(4), 182.3798 sorbic acid, 182.3089 stannous chloride, 172.180 sulfur dioxide, 101.100(a)(4), 182.3862 TBHQ, 172.185 THBP, 172.190 thiodipropionic acid, 182.3109 tocopherols, 182.3890 for wood, 178.3800 preserves (fruit), Part 150, 150.160, 150.161 pressure processing, 113.40 See also retorts pressure-sensitive adhesives, 175.125 pretzels, 101.12(b) preventive measure (definition of), 123.3(i) primary containers, 129.3(g), 129.80(b)(1) principal display panel, 1.24(a)(2), 101.1 definition of, 1.1(c) identity labeling, 101.3(a), 101.3(d), 101.4(a)(1) net quantity of contents, 101.105(a), 101.105(e-f) See also information panel; labeling prior sanction, 181.1, 181.5 definition of, 170.3(l) and GRAS status, 170.35(c)(7), 181.5(d), 184.1(e) GRAS substances, Part 184, 184.1(e), Part 186, 186.1(e) indirect food additives, 174.5(d)(3) sanitizing solutions, 178.1010(b) See also specific foods, additives, and ingredients prior-sanctioned food ingredients, Part 181, 181.1, 181.5, 184.1(e) acrylonitrile copolymers and resins, 181.32 antimycotics, 181.23 antioxidants, 181.24 driers, 181.25 drying oils, 181.26 exemptions for, 181.1(a), 181.5(b) food-packaging materials, 181.22, 181.23-181.29 paper/paperboard substances, 181.30 plasticizers, 181.27 release agents, 181.28 sodium nitrate and potassium nitrate, 181.33 sodium nitrite and potassium nitrite, 181.34 stabilizers, 181.29 See also prohibited substances process cheese, 133.169, 133.170, 133.171 process cheese food, 133.173, 133.174 process-monitoring instrument, 123.3(j) process water, 176.300(a)(3)

processed foods exemptions from labeling, 101.100(f) paper and paperboard in contact with, 176.170(c)Table 1 processing, 120.3(j), 123.3(k)(1) containers used in, 177.1210, 177.1320 irradiation in, Part 179, 179.21 paper and paperboard products used in, 176 Subpart B without or in violation of emergency permit, 108.12 See also polymers (indirect food additives); production aids processing aids ammonium chloride, 184.1138(c)(1) ammonium phosphate, dibasic, 184.1141b ammonium sulfate, 184.1143(c) bentonite, 184.1155(c)(1) 1,3-butylene glycol, 172.712(c) calcium acetate, 184.1185(c) calcium chloride, 184.1193(c) calcium sulfate, 184.1230(c) carbon dioxide, 184.1240(c)(1) copper sulfate, 184.1261(c)(1) curdlan, 172.809(c) dextrin, 184.1277(c)(1) dioctyl sodium sulfosuccinate, 172.810(a), 172.810(f) ferrous sulfate, 184.1315(c) helium, 184.1355(c)(1) magnesium carbonate, 184.1425(c)(1) magnesium hydroxide, 184.1428(c)(1) magnesium stearate, 184.1440(c)(1) magnesium sulfate, 184.1443(c)(1) methyl glucoside-coconut oil ester, 178.3600 papain, 184.1585(c)(1) peptones, 184.1553(c)(1) potassium acid tartrate, 184.1077(c)(1) potassium bicarbonate, 184.1613(c)(1) potassium carbonate, 184.1619(c)(1) potassium hydroxide, 184.1631(c)(1) propylene glycol, 184.1666(c) rennet, 184.1685(c)(1) sodium alginate, 184.1724(c) sodium carbonate, 184.1742(c)(1) sodium hydroxide, 184.1763(c)(1) sodium metasilicate, 184.1769a sodium pentachlorophenate, 178.3900 sodium stearoyl lactylate, 172.846(c)(1), 172.846(c)(4) sulfuric acid, 184.1095(c) wheat gluten, 184.1322(c)(1) processing system operations, 5.304(a) processor, 120.3(k), 123.3(l) producing food coatings used in, 175.250, 175.300, 175.320 containers used in, 177.1210, 177.1320 irradiation in, Part 179 paper and paperboard products used in, 176 Subpart B product water, 129.3(h), 129.35(a-b), 129.80(a)

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Index

production aids, 178 Subpart D animal glue, 178.3120 anticorrosive agents, 178.3125 antistatic/antifogging agents, 178.3130 castor oil, hydrogenated, 178.3280 chromic chloride complexes, 178.3290 clarifying agents for polymers, 178.3295 colorants for polymers, 178.3297 corrosion inhibitors for steel/tinplate, 178.3300 emulsifiers/surface-active agents, 178.3400 esters of stearic and palmitic acids, 178.3450 fatty alcohols, synthetic, 178.3480 glycerin, synthetic, 178.3500 glyceryl tri-(12-acetoxystearate), 178.3505 industrial starch-modified, 178.3250 isobutylene-butene copolymers, 177.1430 lubricants in metallic article manufacture, 178.3910 lubricants with incidental food contact, 178.3570 methyl glucoside-coconut oil ester, 178.3600 α-methylstyrene-vinyltoluene resins, hydrogenated, 178.3610 mineral oil, 178.3620 pentaerythritol adipate-stearate, 178.3690 petrolatum, 178.3700 petroleum hydrocarbons, isoparaffinic, 178.3530 petroleum hydrocarbons, odorless light, 178.3650 petroleum wax, 178.3710 pigment dispersants, 178.3725 piperonyl butoxide and pyrethrins, 178.3730 plasticizers in polymeric substances, 178.3740 polyethylene glycol, 178.3750 polyethylene glycol (400) monolaurate, 178.3760 polyhydric alcohol esters, 178.3770, 178.3780 polymer modifiers, 178.3790 preservatives for wood, 178.3800 reinforced wax, 178.3850 release agents, 178.3860 rosins and rosin derivatives, 178.3870 sodium pentachlorophenate, 178.3900 terpene resins, 178.3930 tetraethylene glycol di-(2-ethylhexoate), 178.3940 tetrahydrofuran, 178.3950 See also emulsifiers; lubricants; processing aids; release agents prohibited health claims, 101.14(e) prohibited substances, 181.1(b-c), Part 189, 189.1 prohibited from direct addition, 189 Subpart B prohibited from indirect addition, 189 Subpart C regulation concerning, 182.1(d), 189.1(c) prohibition of introduction of foods, 5.10(a)(20) prominence of required labeling statements, 101.15 propane, 184.1655 1,2-propanediol, 184.1666(a) propellants n-butane, 184.1165(c)(1) carbon dioxide, 184.1240(c)(1) chlorofluorocarbon (prohibited), 189.191 iso-butane, 184.1165(c)(1) nitrogen, 184.1540(c)(1) nitrous oxide, 184.1545(c)(1)

propane, 184.1655(c)(1) propionic acid, 184.1081 in sanitizing solutions, 178.1010(b)(42) See also contents of specific cheeses proprietary blend, 101.36(c) propyl gallate, 181.24, 184.1660 propylene glycol, 184.1666 propylene glycol alginate, 172.858 propylene glycol esters, 136.110(c)(5)(ii), 172.850, 172.856 propylene oxide copolymer condensates, 172.808 propylene-vinyl chloride copolymers, 177.1980 propylparaben, 181.23, 184.1670 protease enzyme preparation, 184.1150 protease enzyme product, 184.1027 protective colloids, 172.870(b)(1), 172.874(b) protective float, 172.878(c)(3), 172.878(c)(10), 172.882(c)(5), 172.884(c) protective garments, 110.10(b)(1) protein bakers yeast, 172.325 concentrate, 184.1979c determination of, 137.105(b)(2) fish, 101.4(b)(23), 172.340, 172.385 hydrolysates, 101.22(a)(3), 101.22(h)(7), 102.22 percent of daily value, 101.36(b)(2)(iii)(D) powder, 184.1498 products (labeling), 101.17(d) soy, 101.82 See also contents of specific foods provisional color additives, Part 81 cancellation of certificates, 81.30 limitation of certificates, 81.32 termination of provisional listings, 81.10 provisionally listed colors, Part 82 provolone cheese, 133.181 prune butter, 150.110(b)(1) prune juice, 146.187 prunes, 145.190 Pseudomonas elodea, 172.665(a) psittacosis, 1240.65(c) psyllium husk, 101.81(c)(2)(ii)(B) labeling, 101.81(c)(1) warnings, 101.17(f) public disclosure color additive petitions, 71.15(a) exemption from State or local requirements, 100.1(e) new dietary ingredient notification, 190.6(e) public eating places (sanitizing solutions), 178.1010(b) public health evaluation of infant formula, 106.100(o) imminent hazard to, 2.5, 108.5(a)(2) interim food additives, 180.1(b) potential risk to, 189.1(a) protection of, 1210.1 Public Information Offices, 5.1110 pudding, 101.12(b) Puerto Rico, 1240.3(l), 1240.3(n), 1250.3(i), 1250.3(k) pulp, 186.1673 from reclaimed fiber, 176.260

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Index

pulsed light radiation, 179.41 pure color, 70.3(o) purified water, 165.110(a)(2)(iv) pyrethrins, 178.3730 pyridinedicarboxylic acid, 178.1010(b)(38) pyridoxine hydrochloride, 184.1676 pyroligneous acid, 101.22(h)(6)

original, 5.10(a)(38) sanitation standard operating procedures (SSOP’s), 120.6 thermal processing, 113.83, 113.100 thermographic charts, 1210.15 red algae, 184.1115(a), 184.1121 Red No. 1 (Ext. D&C), 81.30(d) Red No. 1 (FD&C), 81.10(c), 81.30(b)(1) Red No. 2 (Citrus), 74.302 Red No. 2 (Ext. D&C), 81.30(d) Red No. 2 (FD&C), 81.10(f), 81.30(j)(1) Red No. 3 (Ext. D&C), 81.30(d) Red No. 3 (FD&C), 74.303, 81.10(u), 81.30(u)(1) Red No. 4 (FD&C), 81.10(d), 81.30(c), 82.304 Red No. 5 (D&C), 81.30(d) Red No. 8 (D&C), 81.10(t), 81.30(s)(1) Red No. 10 (D&C), 81.10(h), 81.30(k)(1) Red No. 10 (Ext. D&C), 81.30(d) Red No. 11 (D&C), 81.10(h), 81.30(k)(1) Red No. 11 (Ext. D&C), 81.30(d) Red No. 12 (D&C), 81.10(h), 81.30(k)(1) Red No. 13 (D&C), 81.10(h), 81.30(k)(1) Red No. 13 (Ext. D&C), 81.30(d) Red No. 14 (D&C), 81.30(d) Red No. 14 (Ext. D&C), 81.30(d) Red No. 15 (Ext. D&C), 81.30(d) Red No. 18 (D&C), 81.30(d) Red No. 19 (D&C), 81.10(q)(1), 81.30(r)(1) Red No. 24 (D&C), 81.30(d) Red No. 29 (D&C), 81.30(d) Red No. 35 (D&C), 81.30(d) Red No. 37 (D&C), 81.10(q), 81.30(r)(1) Red No. 38 (D&C), 81.30(d) Red No. 40 (FD&C), 74.340 redelegations of authority, 5 Subpart B reduced calorie, 101.56(b)(2)(i), 105.66(d-e) reduced (claims), 101.13(j) reduced fat (claims), 101.62(b)(4), 101.62(c)(4) reducing agent, 184.1807(c) reducing/maintaining body weight, 105.66 reference amounts customarily consumed, 101.12, 101.13(p)(1) Reference Daily Intake (RDI), 101.9(a)(4), 101.36(b)(2), 101.54(a) refrigerating, 110.80(b)(4) refrigeration equipment, 1250.34 refunds, 80.10(e) refuse, 110.37(e)(6), 1250.39 reggiano cheese, 133.146(d)(3)(ii), 133.165 Regional Field Offices, 5.1115 regulations color additive petitions, 71.20, 71.22, 71.27, 71.30 drinking water, 1240.3(m), 1240.83(a), 1250.3(j) effective date, 5.301 food additive, 170.15, 170.39, 171.100, 171.102, 172.5(a) GRAS substances, 182.1(d), 186.1(b)(1-2) interim basis pending study, 182.1(d) objections to, 171.110 food-contact articles, 170.39, 171.8, 174.5(c)

quality control, 2.19, 110.3(l) acidified foods, 114 Subpart E infant formula, Part 106, 106.1, 106.3 thermally processed low-acid foods, 113 Subpart E unavoidable contaminants, 109.7(b) See also current good manufacturing practice quality guidelines (nutritional), Part 104, 104.5, 104 Subpart C quiche, 101.12(b) quick-mixing flours, 137.170(c) quince butter, 150.110(b)(1) quince seed, 182.40 quinine, 172.575 radiation. See irradiation railroad conveyances, 1250.45, 1250.51 See also land and air conveyances raisin bread, 136.160 raisins, 172.225(b), 172.270(b) random food packages, 1.24(a)(2) rapeseed oil, 184.1555 raw agricultural ingredients, 110.19(a), 120.1(a), 120.3(j)(2) raw agricultural products, 178.3800, 182.99 raw fish, 101.42, 101.43, 101.44, 101.45 raw foods, 101.95(c)(1)(iv) paper and paperboard in contact with, 176.170(c)Table 1 raw fruits/vegetables nutrition facts, 101 Appendix C nutrition labeling, 101.42, 101.43, 101.44, 101.45 raw materials, 110.3(f), 110.80(a) raw molluscan shellfish, 123.3(p), 123.20, 123.28 RDI (Reference Daily Intake), 101.9(a)(4), 101.36(b)(2), 101.54(a) recalls. See infant formula recalls reclaimed fiber, 176.260 reconstituted juice, 102.33(g)(1) reconstituted milk, 1.24(a)(7), 101.4(b)(2), 133.3(a) recordkeeping, 120.8(b)(7), 123.8(d) records acidified foods, 114.100 aseptic packaging, 113.40(g)(1)(ii)(e), 113.40(g)(2)(ii)(c) bottled drinking water, 129.80(h) distribution, 80.39, 106.100(g), 106.100(n) falsified, 80.34(a)(2) fish and fishery products, 123.9 food irradiation, 179.25(e) hazard analysis and critical control point (HACCP) systems, 120.12, 120.14(c) infant formula, 106.100, 107.280

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Index

GRAS status, 181.5(d), 182.1(d), 184.1, 186.1 indirect food additive, 174.5 interim food additives, 180.1(c-e), 182.1(d) prior sanction, 181.1(b), 181.5(c-d) prior-sanctioned ingredients, 181.5(d) prohibited substance, 189.1(c) repeal of, 189.1(c) sanitation, 1250.3(j) See also specific substances and Federal Acts Regulatory Flexibility Act, 5.35(a) rehydration aid, 172.842(c)(6) reinforced wax, 178.3850 Reinhardtius hippoglossoides, 102.57 relative claims, 101.13(j), 101.54(e)(1-2) release agents, 173 Subpart C calcium stearate, 184.1229(c)(1) castor oil, 172.876(b) chromic chloride complexes, 178.3290 hydrogenated sperm oil, 173.275 isobutylene-butene copolymers, 177.1430(b)(1) magnesium oxide, 184.1431(c)(1) magnesium stearate, 184.1440(c)(1) migrating from food-packaging material, 181.28 mono- and diglycerides, 184.1505(c)(1), 184.1521(c)(1) oxystearin, 172.818(b) petrolatum, 172.880(c) in petroleum wax, 178.3860 prior-sanctioned, 181.28 sorbitol, 184.1835(c) white mineral oil, 172.878(c), 178.3620(a) release coatings, 177.1430(b)(5) relishes, 101.12(b), 101.105(r) rennet, 184.1685 See also contents of specific dairy products repacks, 80.10(b) repeal of regulation, 189.1(c) repeated use articles, 180.22(a)(3) repeated use food contact surfaces. See under polymers (indirect food additives) reports adverse reaction, 71.15(a)(3) annual, 1250.51(d-e) of disease, 1240.45 infant formula recall, 107.240(c) of minor violations, 5.33 request for certification, 80.21 resin-bonded filters, 177.2260 resinous coatings, 175.300, 175.320, 178.3280(b)(3) resins ingredients on produce, 101.4(b)(22) ion exchange, 173.25 ionomeric, 177.1330 molecular sieve, 173.40 See also specific resin substances restaurant foods health claims, 101.10, 101.14(d)(2)(vii)(B), 101.14(d)(3) nutrient content claims, 101.10, 101.13(q)(5) nutrition labeling, 101.10, 101.14(d)(3)

restrictions (provisional color additives), Part 81 See also conditions of use; intended use retail establishment, 120.3(l) retailers, 101.42(c-f), 101.43 retention aid, 176.250 retinol. See vitamin A retinyl acetate, 184.1930(a)(2) retinyl palmitate, 184.1930(a)(3) retorts, 113.3(q) operations, 5.304(a), 108.35(g) retort room, 113.87(a-b) specific retorts continuous agitating, 113.40(c), 113.89, 113.100(a)(2) discontinuous agitating, 113.40(d-e), 113.100(a)(2) hydrostatic, 113.40(f), 113.100(a)(3) still, 113.40(a-b), 113.100(a)(1) still horizontal, 113.40(a)(7), 113.40(b)(13) still vertical, 113.40(a)(8), 113.40(b)(2), 113.40(b)(13) reverse osmosis, 129.80(a) membranes, 177.2550 water, 165.110(a)(2)(iv) revocation of color additive listing, 80.32(h) of exemption, 71.26 rework, 110.3(m), 110.80(a)(4-5) Rhizopus niveus, 173.110, 184.1420 Rhizopus oryzae, 173.130 riboflavin, 73.450, 184.1695 See also contents of specific foods riboflavin-5’-phosphate (sodium), 184.1697 rice bran wax, 172.890 rice, enriched, 137.350 rich in (claims), 101.54(b) ripe olives, 73.160(c), 73.165(c) ripened cheeses, 133.182 Rochelle salt, 184.1804(a) rodent control, 1250.96 rodenticides, 110.35(c) Federal Insecticide, Fungicide, and Rodenticide Act, 178.1010(d) rodents, 110.3(j), 1250.30(a) roe, 123.3(d) rolls, 136.3(b), 136.110 enriched, 136.115 entire wheat, 136.180 graham, 136.180 milk, 136.115(b), 136.130 raisin, 136.160 reference amounts, 101.12(b) white, 136.110(a) whole wheat, 136.180 romano cheese, 133.146(d)(3), 133.183 roquefort cheese, 133.184 rosins, 73.1(b)(1)(i-ii), 73.1(b)(2), 178.3870 rubber articles, 189.250(a-b) for repeated use, 177.2600 rubber hydrochloride film, 179.45(b)(8)

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Index

rubber-modified substances acrylonitrile-methyl acrylate copolymers, 177.1480 poly(p-methylstyrene), 177.1635 polystyrene, 177.1640 rubbish and offal disposal, 110.37(f) rue, 184.1698, 184.1699 rye (color identification of seed), 2.25(a)

samples of beverages, 165.3(b) of color additives, 71.4, 80.21(g), 80.22, 80.32(b) destruction of, 2.10(e) examination and investigation, 2.10 obtaining, 5.31(a)(1) of shell eggs, 115.50(f) sampling procedure, 145.3(p), 146.3(h), 155.3(c) samsoe cheese, 133.185 sanction. See prior sanction sandwiches reference amounts, 101.12(b) source identification, 1250.25 sanitary equipment, 1250.40, 1250.41 sanitary facilities, 110.37, 129.35, 1250.40, 1250.62, 1250.63, 1250.70(a) sanitary inspections, 1210.11, 1210.18 sanitary operations, 110.35, 129.37, 129.80(d) sanitation certificates, 5.32, 1250.26(e-f) controls, 120.8(c), 123.6(f), 123.11 food service, 1250 Subpart B interstate conveyance, Part 1250 interstate travel, 5.10(a)(3) regulations (FDA), 1250.3(j) standard operating procedures (SSOP’s), 120.6, 123.11(a) of water boats, 1240.95 sanitize (definition of), 110.3(o) sanitizers, 110.35(b)(1-2), 110.35(d)(5), 123.11(b)(5), 129.80(d), Part 178 sanitizing solutions, 129.80(c), 178.1005, 178.1010 sap sago cheese, 133.186 sassafras extract, 172.580 sassafras oil, 189.180(a-b) saturated fat calories from, 101.36(b)(2), 101.36(b)(2)(iii)(G) and coronary heart disease, 101.75, 101.77, 101.81, 101.82 disqualifying nutrient levels, 101.14(a)(4) nutrient content claims, 101.62(a)(4), 101.62(c)(1), 101.62(c)(4) percent of daily value, 101.36(b)(2)(iii)(D) See also fats sauces, 101.12(b), 110.80(b)(12) sausage casings, 73.200(c)(1), 74.250(c), 172.712(c) scallops, 123.3(h), 1240.3(r) scamorza cheese, 133.155, 133.156, 133.157, 133.158 scheduled processes, 113.3(r), 113.83, 114.3(e), 114.83 deviations from, 114.89 schools (food-processing instruction), 5.304 scientific procedures, 170.3(h) scombroid toxin-forming species, 123.3(m), 123.6(c)(1)(vi) screening, 110.20(b)(7) sea cucumber, 123.3(d) sea urchin, 123.3(d) seafood cocktails, 102.54 sealing and polishing agent, 172.878(c)(14) sealing gaskets, 177.1210, 178.3280(b)(5)

Saccharomyces cerevisiae, 172.325(a), 172.896, 172.898(a) Saccharomyces fragilis, 172.896 Saccharomyces lactis. See Kluyveromyces lactis safe, 130.3(d), 170.3(i), 189.1(a) handling statements, 101.17 moisture level, 110.3(m), 110.80(b)(14) safe-for-use principle, 70.42(a) use conditions, 172.5(b), 181.1(b), 181.5(c), 186.1(b)(1) See also generally recognized as safe (GRAS) safety, 170.3(i), 170.3(k) color additive, 70 Subpart C, 70.40, 71.37(a) food additive, 170 Subpart B, 170.20, 170.22 food ingredient, 186.1(b)(1) hazard, 123.3(f), 123.6(a), 123.16 interim food additive, 180.1(a) new dietary ingredients, 190.6(a-b), 190.6(f) safflower oil, 184.1259(a) saffron, 73.500, 101.22(a)(2) safrole, 189.180 salad dressings, 169.150 acidic, 101.100(d)(3)(i-ii) French, 169.115 health claim labeling, 101.83(c)(2)(iii)(D) mayonnaise, 169.140 reference amounts, 101.12(b) salads, 101.12(b) salmon, 161.170 Salmonella, 2.35(b)(1), 73.100(b)(2), 101.100(d)(3) negative test for, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) and shell eggs, 101.17(h)(4), 115.50(c), 179.26(b)(9) salmonid fish feed, 73.35(c), 73.75(c)(3), 73.355(c), 73.355(d)(3) See also fish feed salsa, 101.12(b) salt, 100.155, 101.22(h)(4), 101.61(c) free, 101.61(c)(1) lightly salted, 101.56(g) reference amounts, 101.12(b) safe for intended use, 182.1(a) substitutes, 133.116, 133.121(a) glutamic acid, 182.1045(c), 182.1047(c) reference amounts, 101.12(b) table salt, 100.155(c), 100.155(e) See also sodium sample authority to, 1210.17 size, 158.3(c) unit, 158.3(d-f)

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Index

seals, 129.37(c-d) search warrants, 5.31(b)(1)(ii) seasonings, 182.10 See also flavor/flavorings seaweed kelp, 172.365 red, 172.620 See also algae secondary direct food additives. See food additives, secondary direct secondhand containers, 2.35 seeds poisonous treated, 2.25 reference amounts, 101.12(b) seizures of items, 5.31(a-b) of molluscan shellfish, 1240.60(d) self-closing doors, 129.35(c) self-pressurized containers, 101.17(a-b), 189.191 self-rising corn meal, 137.270, 137.290 self-rising flour, 137.180, 137.185 semisoft cheeses, 133.187, 133.188 semolina, 137.320, 139.110(a) sequestrants, 182 Subpart G calcium acetate, 184.1185(c) calcium diacetate, 182.6197 calcium gluconate, 184.1199(c) calcium hexametaphosphate, 182.6203 calcium phosphate, monobasic, 182.6215 dipotassium phosphate, 182.6285 disodium EDTA, 172.135(b)(3) disodium phosphate, 182.6290 glucono delta-lactone, 184.1318(c)(1) isopropyl citrate, 184.1386(c)(1) sodium acid phosphate, 182.6085 sodium gluconate, 182.6757 sodium hexametaphosphate, 182.6760 sodium metaphosphate, 182.6769 sodium phosphate, 182.6778 sodium pyrophosphate, 182.6787 sodium tripolyphosphate, 182.6810 sorbitol, 184.1835(c) stearyl citrate, 184.1851(c)(1) tetra sodium pyrophosphate, 182.6789 servicing areas, 1250 Subpart D serving, 101.9(b)(1) serving size, 101.9(b)(1), 101.12(a)(5), 101.36(b)(1) servings per container, 101.36(b)(1)(ii) sewage disposal, 110.37(b)(2), 110.37(c) sheanut oil, 184.1702 sheep’s milk. See contents of specific cheeses sheep’s milk blue-mold cheese, 133.184 shelf-stable product, 120.3(n) shell eggs, 1.24(a)(9), 73.1(b)(2), Part 115 coatings, 172.882(c)(4), 172.884(c) coloring of, 82.6(a)(3) enforcement procedures, 115.50(d-e) exemptions, 115.50(c) inspection, 115.50(f) labeling/marking of, 115.50(e)(1)(iv)

order for diversion/destruction of, 115.50(e)(1-2) refrigeration of, 115.50 and Salmonella, 101.17(h)(4), 115.50(c), 179.26(b)(9) warning statements, 101.17(h) See also eggs shellac, 73.1(b)(1)(i) shellfish, Part 161, 1240.3(r), 1250.3(o) certification number, 1240.3(s) clams, 102.49, 123.3(h), 172.120(d)(1), 1240.3(r), 1250.3(o) control authority, 123.3(o) mussels, 123.3(h), 1240.3(r), 1250.3(o) oysters, 123.3(h), 161.30, 161.130, 161.136, 161.145, 1240.3(r), 1250.3(o) sale/service on conveyances, 1250.26 scallops, 1240.3(r) shellfish control authority, 1240.3(t) shellstock, 123.3(p), 123.28(c), 1240.60(b) shucked, 123.3(r), 123.28(d), 1240.60(c), 1250.3(o), 1250.26 substitutes, 101.12(b) tag, 1240.3(u) See also molluscan shellfish shellstock, 123.3(p), 123.28(c), 1240.60(b) sherbets, 1.24(a)(6), 101.12(b), 135.140 shipper, 1210.3(i), 1210.27 shipping cases, 129.3(j), 129.80(b)(2) shipping containers, 1.20(a-b), 2.35 shortening, 136.110(c)(5) shredded cheese, 133.146(d)(4)(i) shrimp canned, 161.173 cocktail, 102.54 frozen raw, 161.175, 161.176 processing, 173.120(d)(2) units (breaded), 102.55 shucked shellfish, 123.3(r), 123.28(d), 1240.60(c), 1250.3(o), 1250.26 side-seam cements, 177.1500(b)(5.2b) signs for employees, 110.37(e)(5), 1250.38(b) silica aerogel, 182.1711 silicon dioxide, 73.1(b)(1)(ii), 172.480 silicon dioxide matrix coatings, 175.390 silicone polymers, 177.2465 single & repeated use food contact surfaces. See under polymers (indirect food additives) single-serving containers, 101.9(b)(2)(i), 101.9(b)(3), 101.9(b)(5), 129.3(k), 129.37(c), 1250.26(d) single-use articles, 110.35(d)(4), 180.22(a)(1-2) sinks, 1250.45(a-b) sirups, Part 168 cane, 168.130 corn, 145.3(a), 146.3(a), 184.1865, 184.1866 glucose, 101.80(c)(2)(ii)(B), 145.3(c-d), 146.3(c-d), 168.120, 168.121, 184.1865 invert sugar, 145.3(e), 146.3(e) maple, 168.140 pancake, 168.180(c) reference amounts, 101.12(b) sorghum, 168.150

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Index

table, 168 Subpart B, 168.180 waffle, 168.180(c) See also sweeteners skim milk, 101.4(b)(3), 101.62(b) cheese, 133.189 chocolate, 163.140 skylights, 110.20(b)(5) slack-fill, 100.100(a) slice, 101.9(b)(5) slime-control substances, 176.300(c) slimicides, 176.300, 186.1750(b) small businesses, 120.1(b) smoke, artifical, 101.22(h)(6) smoked cheeses, 133.118(e)(1), 133.173(b), 133.181(c)(2)(i) smoked fishery products, 123.3(s), 123.15, 123.16, 161.190(a)(8)(v), 172.170(a)(1) chub, 172.177 cured tuna, 172.175(a)(1) snack food, 101.12(b), 172.894(a)(3) soap, 1250.38(b), 1250.75(c) sodium, 101.74(a)(1) disqualifying nutrient levels, 101.14(a)(4) free, 101.61(c)(1) and hypertension, 101.74 light in (claims), 101.56(c)(1)(ii)(B), 101.56(c)(2)(i-iii), 101.56(d)(1-2) low (see low sodium) See also salt; sodium chloride; contents of specific foods sodium acetate, 184.1721 sodium acid phosphate, 182.6085 sodium acid pyrophosphate, 161.190(a)(8)(vii), 182.1087 sodium acrylate copolymer, 172.710 sodium alginate, 184.1724 See also contents of specific dairy products sodium-alpha-alkyl-omega-hydroxypoly (oxyethylene) sulfate, 178.1010(b)(20) sodium aluminosilicate, 182.2727 sodium aluminum phosphate, 182.1781 See also contents of specific flours sodium aluminum sulfate, 137.105(a)(5) sodium ascorbate, 182.3731 sodium benzoate, 181.23, 184.1733 sodium bicarbonate, 184.1736 in sanitizing solutions, 178.1010(b)(41) in self-rising flours, 137.180(a), 137.270(a) sodium bisulfite, 182.3739 sodium bromide, 178.1010(b)(1-2) sodium calcium aluminosilicate, 182.2729 sodium carbonate, 184.1742 sodium carboxymethylcellulose, 182.1745 See also contents of specific dairy products sodium caseinate, 182.1748 sodium chloride, 101.22(h)(4), 101.61(c) distinguished from sodium, 101.74(a)(1) See also salt sodium chlorite, 186.1750 acidified, 173.325

sodium citrate, 184.1751 See also contents of specific dairy products sodium N-cyclohexyl-N-palmitoyl taurate, 178.1010(b)(40) sodium diacetate, 184.1754 sodium dichloroisocyanurate, 178.1010(b) sodium dioctylsulfosuccinate, 178.1010(b)(6) sodium dodecylbenzenesulfonate, 178.1010(b)(21) sodium ferrocyanide decahydrate, 172.490 sodium formate, 186.1756 sodium gluconate, 182.6757 sodium hexametaphosphate, 133.169(c), 182.6760 sodium hydroxide, 184.1763 pH standard solution, 114.90(c) in sanitizing solutions, 178.1010(b)(40) sodium hypochlorite, 178.1010(b) sodium hypophosphite, 184.1764 sodium hyposulfite, 184.1807(a) sodium iodide, 74.303(b), 178.1010(b)(6) sodium lactate, 184.1768 sodium lauryl sulfate, 172.822, 178.1010(b) sodium metabisulfite, 101.100(a)(4), 182.3766 sodium metaborate, 178.1010(b)(18) sodium metaphosphate, 133.169(c), 182.6769 sodium metasilicate, 184.1769a sodium methyl sulfate, 173.385 sodium naphthalene sulfonate, 172.824, 178.1010(b)(35) sodium nitrate, 172.170, 181.33 sodium nitrate-urea complex, 176.320 sodium nitrite, 172.175, 172.177, 172.820(c)(4), 181.34 sodium 1-octanesulfonate, 178.1010(b) sodium oleate, 186.1770 sodium palmitate, 186.1771 sodium pentachlorophenate, 178.3900 sodium phosphate, 182.1778, 182.6778, 182.8778 sodium polyacrylate, 173.73 sodium polymethacrylate, 173.73 sodium potassium tartrate, 133.169(c), 184.1804 sodium propionate, 181.23, 184.1784 See also contents of specific cheeses sodium pyrophosphate, 182.6787 sodium pyrophosphate, tetra, 182.6789 sodium saccharin, 180.37 sodium sesquicarbonate, 184.1792 sodium sorbate, 182.3795 See also contents of specific cheeses sodium stearoyl lactylate, 172.846 sodium stearyl fumarate, 172.826 sodium sulfate, 186.1797 sodium sulfite, 101.100(a)(4), 182.3798 sodium tartrate, 133.169(c), 184.1801 sodium thiosulfate, 184.1807 sodium p-toluenesulfonchloroamide, 178.1010(b)(3) sodium tripolyphosphate, 182.1810, 182.6810 sodium xylenesulfonate, 178.1010(b)(28) soft drinks, 1.24(a)(5), 101.2(c)(1), 101.13(q)(12) soft ripened cheeses, 133.182 solder, lead, 189.240 solid pack, 145.3(l) solids. See contents of specific foods

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Index

solubilizing agents copolymer condensates of ethylene and propolyene oxides, 172.808(b)(1) dioctyl sodium sulfosuccinate, 172.810(c) polysorbate 80, 172.840(c)(3-4), 172.840(c)(7) soluble fiber, 101.77, 101.81 β-glucan, 101.81(c)(2)(i)(G)(1), 101.81(c)(2)(ii)(A) solvent extraction process, 173.280 solvents, 173 Subpart C acetic acid, 184.1005 acetone, 73.1(b)(1)(ii), 173.210 1,3-butylene glycol, 173.220 in dietary ingredients, 101.36(b)(3)(ii)(B-C) ethyl acetate, 73.1(b)(1)(ii), 173.228 ethylene dichloride, 173.230 glyceryl monooleate, 184.1323(c)(1) hexane, 173.270 isopropyl alcohol, 73.1(b)(1)(i), 173.240 isopropyl citrate, 184.1386(c)(1) lactic acid, 184.1061(c) methylene chloride, 73.1(b)(1)(ii), 173.255 propylene glycol, 184.1666(c) solvent extraction process for citric acid, 173.280 tetrahydrofuran, 178.3950 trichloroethylene, 173.290 triethyl citrate, 184.1911(c)(1) sorbic acid, 181.23, 182.3089 See also contents of specific cheeses sorbitan monooleate, 173.75 sorbitan monostearate, 172.842 sorbitol, 101.80(c)(2)(ii)(B), 184.1835 sorbitol anhydrides. See polysorbates sorbose, 186.1839 sores (in personnel), 110.10(a) sorghum (color identification of seed), 2.25(a) sorghum sirup, 168.150 soups, 101.12(b) sour cream acidified, 131.162 cultured, 131.160 labeling exemptions, 1.24(a)(7) reference amounts, 101.12(b) source ingredient, 101.36(d) source of food supply, 1250.25 soy macaroni, 139.140 soy noodle products, 139.180 soy protein, 101.82 soybean oil, 172.723 soybeans, 136.110(c)(12) spaghetti, 101.12(b) See also specific macaroni and noodle products spaghetti sauce, 101.12(b) sparkling water, 165.110(a)(2)(v) special dietary and nutritional additives, 172 Subpart D aluminum nicotinate, 172.310 amino acids, 172.320 bakers yeast protein, 172.325 fish protein concentrate, 172.385 fish protein isolate, 172.340 folic acid, 172.345

fumaric acid, 172.350 iron-choline complex, 172.370 kelp, 172.365 n-acetyl-l-methionine, 172.372 nicotinamide-ascorbic acid complex, 172.315 potassium iodide, 172.375 xylitol, 172.395 zinc methionine sulfate, 172.399 special dietary use, Part 105, 105.3 specific usage food additives. See food additives, specific usage specifications methods of analysis, 2.19 for provisional color additives, Part 81 for provisionally listed colors, Part 82 for straight colors, 82.5 sperm oil, 173.275 spice oleoresins, 173.210, 173.230, 173.240(a), 173.250(a), 173.255(a), 173.270(a), 173.290 spiced cheeses, 133.190, 133.191, 133.193 spices, 101.4(b)(1), 101.22(a)(2) generally recognized as safe (GRAS), 182.10 irradiation of, 179.26(b)(5) labeling, 101.22, 101.22(h)(1) reference amounts, 101.12(b) See also contents of specific foods spina bifida, 101.79(a)(1) spring water, 165.110(a)(2)(vi) stability analysis, 106.30(b)(3) stabilizers, 178 Subpart C, 182 Subpart H emulsion, 172.755(c) foam, 172.770 migrating from food-packaging material, 181.29 in pesticides, 172.715(b) for polymers, 178.2010 prior-sanctioned, 181.29 for soybean oil, 172.723(c) stabilizers, specific acacia (gum arabic), 184.1330(c) agar-agar, 184.1115(c) alginic acid, 184.1011(c) ammonium alginate, 184.1133(c) arabinoagalactan, 172.610(b) bakers yeast glycan, 172.898(d) brominated vegetable oil, 180.30 calcium acetate, 184.1185(c) calcium alginate, 184.1187(c) calcium chloride, 184.1193(c) calcium gluconate, 184.1199(c) calcium lactate, 184.1207(c)(1) calcium lignosulfonate, 172.715(b) calcium stearate, 184.1229(c)(1) calcium sulfate, 184.1230(c) carrageenan, 172.620(c), 172.626(b), 182.7255 chondrus extract, 182.7255 copolymer condensates of ethylene and propolyene oxides, 172.808(b)(1) curdlan, 172.809(c) dextrin, 184.1277(c)(1) epoxidized soybean oil, 172.723(c)

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Index

ethylene oxide polymer, 172.770 furcelleran, 172.655(c), 172.660(b) gellan gum, 172.665(e) glycine, 172.812(b) guar gum, 184.1339(c) gum tragacanth, 184.1351(c) hydroxypropyl cellulose, 172.870(b)(1) hydroxypropyl methylcellulose, 172.874(b) karaya gum, 184.1349(c) locust (carob) bean gum, 184.1434(c) mono- and diglycerides, 184.1505(c)(1) organotin, 178.2650 pectins, 184.1588(c)(1) potassium acid tartrate, 184.1077(c)(1) potassium alginate, 184.1610(c) potassium chloride, 184.1622(c)(1) potassium hydroxide, 184.1631(c)(1) prohibited if added, 189.300(a-b) propylene glycol, 184.1666(c) propylene glycol alginate, 172.858 rennet, 184.1685(c)(1) sodium alginate, 184.1724(c) sodium hypophosphite, 184.1764(c)(1) sodium stearoyl lactylate, 172.846(c)(2-3), 172.846(c)(5-9) sodium stearyl fumarate, 172.826(b)(3) sorbitol, 184.1835(c) stearyl monoglyceridyl citrate, 172.755(c) sucrose acetate isobutyrate (SAIB), 172.833(b) wheat gluten, 184.1322(c)(1) xanthan gum, 172.695(e) stacking equipment, 113.40(a)(9), 113.40(b)(7) standard plate method, 1210.16 standardized foods, 130.11, 170.10 bakery products, 136 Subpart B beverages, 165 Subpart B cacao products, 163 Subpart B canned fruit juices and beverages, 146 Subpart B canned fruits, 145 Subpart B canned vegetables, 155 Subpart B cereal flours and related products, 137 Subpart B, 137.105 cheese and related products, 133 Subpart B color additives in, 70.10 eggs and egg products, 160 Subpart B fish and shellfish, 161 Subpart B food additives in, 130.9, 130 Subpart B, 130.20 food dressings and flavorings, 169 Subpart B frozen desserts, 135 Subpart B frozen vegetables, 158 Subpart B fruit butters, jellies, preserves, and related products, 150 Subpart B fruit pies, 152 Subpart B macaroni and noodle products, 139 Subpart B margarine, 166 Subpart B milk and cream, 131 Subpart B sweeteners and table sirups, 168 Subpart B tree nut and peanut products, 164 Subpart B vegetable juices, 156 Subpart B See also food standards

standards of identity, 101.1(c)(4), 101.4(a)(1), 130.8 cheese products, 133.10 deviations from, 130.10(c), 130.17 food additives, 130.20 labeling, 101.3, 101.4(f) stannous chloride, 172.180, 184.1845 Staphylococci, coagulase positive, 172.325(c)(3), 172.898(c)(3), 184.1983(c)(3) starch gelatinized, 173.110(d-e) hydrolysates, 101.80(c)(2)(ii)(B) industrial starch-modified, 178.3250 manufacture of, 178.3600 nonwheat, 136.110(c)(11) potato, 101.12(b) reference amounts, 101.12(b) in sanitizing solutions, 178.1010(b)(41) See also contents of specific foods starter distillate, 184.1848 State definition of, 100.1(b)(4), 1240.3(n), 1250.3(k) enforcement of federal regulations, 100.2 and local requirements, 100 Subpart A, 1240.30 petitions for exemption from, 100.1 requirement, 100.1(b)(5) statement of identity, 101.3(a-d) steam. See pressure processing stearato chromic chloride complex, 178.3290 stearic acid, 184.1090 stearic acid esters, 178.3450 stearoyl propylene glycol hydrogen succinate, 172.765 stearyl citrate, 184.1851 stearyl monoglyceridyl citrate, 172.755 steel (corrosion inhibitors), 178.3300 sterculia gum, 184.1349 sterility, commercial, 113.3(d), 113.3(j), 178.1005(e)(2) sterilization, 107.20(a)(3), 110.80(b)(4), 113.40(g) heat, 113.83, 177.1390(b) of meats for NASA, 179.26(b)(7) See also sanitizers sterilized water, 165.110(a)(2)(vii) sterilizer, flame, 113.3(f), 113.40(h), 113.100(a)(5) sterol/stanol esters, 101.83 stews, 101.12(b) storage construction of areas, 1250.30 containers, 2.35 of perishables, 1250.27 of water, 1250.83 straight color, 70.3(j), 70.20, 70.25(a)(1), 73.1, 82.51 certification of, 80.10(a), 82.50 specifications for, 82.5 tolerance for, 70.45 Streptococcus cremoris, 184.1848(a) Streptococcus lactis, 184.1538(a), 184.1848(a) See also Lactococcus lactis Streptococcus thermophilus, 131.170(a), 131.203(a) Streptomyces griseus, 184.1945(a) Streptomyces olivaceus, 184.1372(a) Streptomyces olivochromogenes, 184.1372(a)

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Index

Streptomyces rubiginosus, 184.1372(a) stuffing, 101.12(b) styrene-divinylbenzene resins, 173.70, 177.2710 styrene-maleic anhydride copolymers, 177.1820 styrene-methyl methacrylate copolymers, 177.1830 styrene polymers, 177.1810 See also under polymers (indirect food additives) substance (definition of), 101.14(a)(2), 170.3(g) substances anti-offset, 176.130 GRAS (see generally recognized as safe (GRAS) substances) prohibited (see prohibited substances) substandard fill and quality, 130.14 substantial compliance, 101.42(c-f), 101.43 substitutes, 101.13(d) salt, 133.116, 133.121(a), 182.1045(c), 182.1047(c) sugar, 101.12(b), 172.800(c)(1), 172.804(c)(1) See also synthetic forms of substances substratum, 70.3(n) succinic acid, 184.1091 succinic acid derivatives, 172.275(a) succinic anhydride, 172.275(a) succinylated monoglycerides, 172.830 succistearin, 172.765 sucralose, 172.831 sucrose, 101.4(b)(20), 145.3(f), 146.3(f), 184.1854 sucrose acetate isobutyrate (SAIB), 172.833 sucrose fatty acid esters, 172.859 sugar, 145.3(f) alcohols, 101.80 in canned foods, 145.3(f), 146.3(f) content claims, 101.60(c) corn, 184.1857 free, 105.66(f) ingredient labeling, 101.4(b)(20) invert, 184.1859 reference amounts, 101.12(b) substitutes, 101.12(b), 172.800(c)(1), 172.804(c)(1) See also sugar beet; sweeteners sugar beet flavor base, 172.585 juice, 173.45(b), 173.73(b) mills, 173.320 processing, 173.145(c), 173.315(a)(4) sulfamic acid, 186.1093 N-ethyl,N-(m-sulfobenzyl) sulfanilic acid, 74.101(b) sulfate turpentine, 178.3930(a) sulfated butyl oleate, 172.270 sulfites in standardized foods, 130.9 sulfiting agents, 101.100(a)(4), 130.9(a-b) See also curing agents 5-sulfoanthranilic acid, 74.102(b) sulfobenzaldehydes, 74.101(b) sulfonated 9-octadecenoic acid, 178.1010(b)(28) sulfonated oleic acid, 178.1010(b)(12) sulfonated tall oil fatty acid, 178.1010(b)(29) sulfonic acids, 74.102(a-b), 74.250(b)

sulfur dioxide, 101.100(a)(4), 182.3862 removers of, 184.1366(c) sulfuric acid, 178.1010(b), 184.1095 sulfurous acid, 130.9(a) sumac wax, 186.1555(a) sunflower oil, 184.1259(a) supervision of personnel, 110.10(d) supplements. See dietary supplements; nutrient supplements surface-active agents, 178.3400 calcium chloride, 184.1193(c) lactylated fatty acid esters of glycerol and propylene glycol, 172.850(c) lactylic esters of fatty acids, 172.848(b) licorice, 184.1408(c) mono- and diglycerides, 184.1505(c)(1), 184.1521(c)(1) peptones, 184.1553(c)(1) potassium acid tartrate, 184.1077(c)(1) propylene glycol, 184.1666(c) sodium alginate, 184.1724(c) sodium stearoyl lactylate, 172.846(c)(2), 172.846(c)(4) stearyl citrate, 184.1851(c)(1) triethyl citrate, 184.1911(c)(1) surface-finishing agents acacia (gum arabic), 184.1330(c) agar-agar, 184.1115(c) ammonium hydroxide, 184.1139(c)(1) beeswax, 184.1973(c) candelilla wax, 184.1976(c)(1) carnauba wax, 184.1978(c)(1) dextrin, 184.1277(c)(1) mono- and diglycerides, 184.1505(c)(1) sorbitol, 184.1835(c) wheat gluten, 184.1322(c)(1) zein, 184.1984(c)(1) surface primers, 177.2465 surfactants copolymer condensates of ethylene and propolyene oxides, 172.808, 172.808(b)(3)(i) methyl glucoside-coconut oil ester, 172.816(b)(1) ox bile extract, 184.1560(c) for pesticide dilutions, 172.710 polysorbate 60, 172.836(c)(15) polysorbate 80, 172.840(c)(5), 172.840(c)(14) propylene glycol alginate, 172.858 sodium lauryl sulfate, 172.822(b)(3) surveys, 2.19 suspending agents hydroxypropyl cellulose, 172.870(b)(1) hydroxypropyl methylcellulose, 172.874(b) xanthan gum, 172.695(e) sweet potatoes, 101.12(b) sweeteners, Part 168 acesulfame potassium, 172.800 artificial, 105.3(a)(2) aspartame, 172.804 cane sirup, 168.130 dextrose anhydrous, 168.110

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Index

dextrose monohydrate, 168.111 glucose sirup, dried, 168.121 lactose, 168.122 maple sirup, 168.140 nonnutritive, 105.66(b)(2) in pickling mixtures, 172.540 prohibited cyclamate, 189.135(a-b) dulcin, 189.145(a-b) P-4000, 189.175(a-b) saccharins, 180.37 sorbitol, 184.1835(c) sorghum sirup, 168.160 sucralose, 172.831(c) sucrose, 184.1854 table sirup, 168.180 See also sirups; sugar sweets, 101.12(b) See also candies swiss cheese, 133.195, 133.196 symbols in health claims, 101.14(a)(1) in nutrient content claims, 101.13(q)(5)(iii) synergists calcium chloride, 184.1193(c) calcium sulfate, 184.1230(c) copper gluconate, 184.1260(c)(1) magnesium carbonate, 184.1425(c)(1) synonymous term, petitions for, 101.69(b)(2) synthetic substances adjuvants, 172.515 fatty alcohols, 172.864, 172.864(c)(1), 178.3480 flavorings, 172.515, 182.60 glycerin, 172.866, 178.3500 paraffin, 172.275, 175.250 petroleum hydrocarbons, 178.3530 petroleum wax, 172.888, 178.3720 syrups. See sirups

TBHQ (tertiary butylhydroquinone), 172.185 tea, 135.140(e)(1) decaffeination of, 173.228(b) reference amounts, 101.12(b) sassafras, 189.180(b) teaspoon, 101.9(b)(5) teething biscuits, 101.12(b) temperature conditions for extractives, 176.170(c)Table 2 initial, 113.3(l) measuring/recording/controlling instruments, 110.40(f), 113.40(a-g) temporary exemptions, 101.108 temporary permits, 5.300(b)(2), 130.17, 1210.21, 1210.24 terephthalate. See under copolymers; polymers (indirect food additives) terpene resins, 73.1(b)(1)(ii), 172.280, 178.3930 alpha-terpineol, 178.1010(b)(18) tertiary butylhydroquinone (TBHQ), 172.185 para-tertiaryamylphenol, 178.1010(b)(20) testing (Federal Import Milk Act), 1210 Subpart B 1,1,2,2-tetra-chloroethylene, 178.3010 tetra sodium pyrophosphate, 182.6789 tetraethylene glycol di-(2-ethylhexoate), 178.3940 tetrahydrofuran, 178.3950 α-[p-(1,1,3,3-tetramethylbutyl) phenyl]-omegahydroxypoly (oxyethylene), 172.710, 178.1010(b)(18) tetrasodium ethylenediamine tetraacetate, 178.1010(b) tetrasodium phosphate, 133.169(c) textiles and textile fibers, 177.2800 textryls, 177.1850 texturizers ammonium bicarbonate, 184.1135(c) bakers yeast glycan, 172.898(d) calcium acetate, 184.1185(c) calcium chloride, 184.1193(c) calcium gluconate, 184.1199(c) calcium sulfate, 184.1230(c) corn gluten, 184.1321(c)(1) curdlan, 172.809(c) mono- and diglycerides, 184.1505(c)(1) papain, 184.1585(c)(1) polydextrose, 172.841(c) propylene glycol, 184.1666(c) protein powder, microparticulated, 184.1498(b)(1) sodium alginate, 184.1724(c) sodium stearoyl lactylate, 172.846(c)(5-9) sorbitol, 184.1835(c) sucrose fatty acid esters, 172.859(c)(2) wheat gluten, 184.1322(c)(1) THBP (2,4,5-trihydroxy butyrophenone), 172.190, 181.24 thermal processing of acidified foods, 114.80(a)(1) deviations in processing/venting/critical factor control, 113.89 equipment, 113.40 minimum, 113.3(o) room, 113.87 See also pasteurization; retorts

table salt, 100.155(c), 100.155(e) See also anticaking agents; salt table sirups, 168 Subpart B, 168.180 See also sirups tablespoon, 101.9(b)(5) tableware, 1240.3(o), 1250.3(l) Tagetes meal and extract, 73.295 tags, 123.3(t), 123.8(e) Federal Import Milk Act, 1210.22 molluscan shellfish, 1240.3(u), 1240.60(b-d) tall oil, 181.26, 186.1557 fatty acids, 172.862, 178.1010(b)(29) rosin, 178.3870(a)(1)(iii-iv) tamarind seed kernel powder, 176.350 tannic acid, 184.1097 tapes (food-contact surface), 175.125 tapioca, 101.12(b) taps (water), 1250.67(a), 1250.84(a) tartar sauce, 101.12(b) tartaric acid, 184.1099 esters, 184.1101

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Index

thermally processed low-acid foods, 106.90, 108.35, Part 113 containers for, 113.60 equipment, 113.40 personnel, 113.10 production and process controls, 113 Subpart E, 113.81 records, 113.100 thermographic charts, 1210.15 thermometer, 1250.33(a), 1250.34 thermosetting epoxy resins, 177.2280 thiamine. See vitamin B1 (thiamine) thiamine hydrochloride, 184.1875 thiamine mononitrate, 184.1878 thickeners acacia (gum arabic), 184.1330(c) agar-agar, 184.1115(c) alginic acid, 184.1011(c) ammonium alginate, 184.1133(c) bakers yeast glycan, 172.898(d) calcium acetate, 184.1185(c) calcium alginate, 184.1187(c) calcium chloride, 184.1193(c) calcium gluconate, 184.1199(c) calcium lactate, 184.1207(c)(1) calcium stearate, 184.1229(c)(1) calcium sulfate, 184.1230(c) carrageenan, 172.620(c), 172.626(b) curdlan, 172.809(c) dextrin, 184.1277(c)(1) furcelleran, 172.655(c), 172.660(b) gellan gum, 172.665(e) guar gum, 184.1339(c) gum tragacanth, 184.1351(c) hydroxypropyl cellulose, 172.870(b)(1) hydroxypropyl methylcellulose, 172.874(b) karaya gum, 184.1349(c) locust (carob) bean gum, 184.1434(c) mono- and diglycerides, 184.1505(c)(1) pectins, 184.1588(c)(1) potassium acid tartrate, 184.1077(c)(1) potassium alginate, 184.1610(c) potassium chloride, 184.1622(c)(1) potassium hydroxide, 184.1631(c)(1) propylene glycol, 184.1666(c) propylene glycol alginate, 172.858 protein powder, microparticulated, 184.1498(b)(1) rennet, 184.1685(c)(1) sodium alginate, 184.1724(c) wheat gluten, 184.1322(c)(1) xanthan gum, 172.695(e) thiocarbamide, 189.190 thiodipropionic acid, 181.24, 182.3109 thiourea, 189.190 time/temperature conditions for extractives, 176.170(c)Table 2, 177.1210(c)Table 4 tin-coated lead foil capsules, 189.301 tinplate (corrosion inhibitors), 178.3300 titanium dioxide, 73.575, 177.2355(b)

toasted cottonseed flour, 73.140 toasts, 101.12(b) tobacco, 110.10(b)(8-9) α-tocopherol acetate, 182.8892 tocopherols, 182.3890, 182.8890, 184.1890 tofu, 101.12(b) toilet facilities, 110.20(b)(5), 110.37(d), 123.11(b)(4) in land and air conveyances, 1250.38, 1250.45(c-d), 1250.50, 1250.51, 1250.70(a-b) on vessels, 1250.90 toilet wastes, 1250.75(b) tolerances acetone, 173.210 color additives70.11(d), 70.25(b), 70.45 exemptions from, 171.130 extractives, 177.1210(b)(5)Table 2 food additive, 170.3(n), 170.18, 171.130 food categories, 170.3(n) poisonous or deleterious substances, 109.4(a), 109.6(a-b), 109.6(e), 109.7, 109.30 toluene, 178.3010 toluenesulfonic acid, 74.340(b) tomato concentrates, 155.191 juice, 156.145 products, 113.3(n) soluble solids, 155.3(e), 156.3(b) tomatoes, 113.3(n) canned, 155.190 chemicals used in processing, 173.315(a)(3) genetically modified, 173.170 tonka beans, 189.130(a) tooth decay. See dental caries top 20 raw fruit/vegetables/fish, 101.44 tortillas, 101.12(b) towel service, 110.37(e)(3) towels paper, 110.35(d)(4) sanitary, 1250.38(b) toxic cleaning compounds, 110.35(b)(2), 123.11(b)(5) toxins aflatoxin, 110.80(a)(3) Clostridium botulinum, 123.6(e), 123.16, 172.177 and communicable diseases, 1250.3(b) natural, 110.80(a)(3), 120.7(c)(6), 123.6(c)(1)(i) scombroid toxin-forming species, 123.3(m), 123.6(c)(1)(vi) trade secret, 190.6(e) trademark, 101.18(c)(2), 101.22(h)(7)(i)(3)(i) training, 110.10(c), 113.10, 120.13 fish and fishery products, 123.7(c)(2), 123.10 transporting food adhesives used in, 175.105(a) coatings used in, 175.250, 175.300, 175.320 containers used in, 177.1210, 177.1320 paper and paperboard products used in, 176 Subpart B See also polymers (indirect food additives); production aids

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Index

treatment of food adjuvants for, 173 Subpart A containers used in, 177.1210, 177.1320 by irradiation, 101.95(c)(1)(iv), 179.25, 179.26, 179.39, 179.41 See also polymers (indirect food additives); production aids tree nut products, Part 164 triacetin, 184.1901 tribal government, 123.3(o) tributyrin, 184.1903 tricalcium phosphate, 137.105(a)(5) tricalcium silicate, 182.2906 Trichinella spiralis, 179.26(b)(1) trichloroethylene, 173.290 trichloroisocyanuric acid, 178.1010(b)(2) trichloromelamine, 178.1010(b)(10) Trichoderma longibrachiatum, 184.1250 3-(triethoxysilyl) propylamine, 177.2355(a) triethyl citrate, 184.1911 trifluoromethane sulfonic acid, 173.395 2,4,5-trihydroxy butyrophenone, 172.190, 181.24 triiodoresorcinol, 74.303(b) trisodium phosphate, 133.169(c), 178.1010(b)(37) true copies, 5.10(a)(38), 106.100(m) trypsin, 184.1914 tuberculosis/tuberculin test, 1210.13 tug boats, 1240.3(p)(2), 1250.3(m)(2) tuna, 123.3(m), 161.190, 186.1551(a) tung oil, 181.26 turbot, 102.57 turmeric, 73.600, 101.22(a)(2) turmeric oleoresin, 73.615 turnovers, 101.12(b) turpentine, 178.3930(a) turtles, 123.3(d), 1240.62 twine (for tying meat), 178.3760, 178.3940

utensils, 5.10(a)(21), 110.40, 110.80(b), 129.37(a-b), 1250.33 bactericidal treatment of, 1240.10 contamination of, 1250.30(d), 1250.32 definition of, 1240.3(o), 1250.3(l) drinking, 5.10(a)(21), 1250.44 multiuse, 1250.33(a-b) sanitizing solutions, 178.1010 See also current good manufacturing practice vaccino romano cheese, 133.183(e) vacuum closures, 113.60(a)(2) vacuum-packed, 113.3(u), 155.120(c) validation, 120.3(p), 120.8(b)(6), 120.11 vanilla, 135.110(f), 169.3(a-b), 169.175, 169.178, 169.179 vanilla-vanillin, 169.180, 169.181, 169.182 vanillin, 182.60 variances, 1250.51(f) variations. See exemptions variety pack, 101.9(b)(4) vegetable fat coatings, 163.150, 163.153, 163.155 vegetable juice, 73.260, Part 156 Brix levels, 101.30(h)(1) common or usual name, 102.33 percentage juice declaration, 101.30 reference amounts, 101.12(b) tomato juice, 156.145 See also juices vegetable oil, brominated, 180.30 vegetable products macaroni, 139.125, 139.135 noodle products, 139.160, 139.165 sauces/purees/pastes, 101.12(b) vegetables coatings, 172.235(a), 172.882(c)(3), 172.890(b) protective coatings, 172.260(b), 172.275(c), 172.878(c)(8), 172.880(c), 172.886(d), 172.888(e) exemption from compliance, 101.22(f) froth-flotation cleaning, 172.882(c)(1), 172.884(c) frozen, Part 158 health claims, 101.76, 101.77, 101.78 labels for, 175.125(a-b) raw, 101.42, 101.43, 101.44, 101.45, 101 Appendix C reference amounts, 101.12(b) top 20, 101.44 washing or peeling of, 173.315 vegetables, canned, Part 155, 155.200 catsup, 155.194 corn, 155.130, 155.131 green beans, 155.120 mushrooms, 155.201 peas, 155.170, 155.172 tomato concentrates, 155.191 tomatoes, 155.190 wax beans, 155.120 vehicles acetic acid, 184.1005 glyceryl monooleate, 184.1323(c)(1) isopropyl citrate, 184.1386(c)(1)

ultra-filtration membranes, 177.2510(a)(4), 177.2910 ultramarine blue, 73.50 ultrapasteurized, 131.3(c), 133.3(e) ultraviolet irradiation of foods and water, 179.39 ultraviolet treatment of product water, 129.80(a) unavoidability, 109.7 unavoidable contaminants, Part 109 undesirable microorganisms, 110.3(i), 110.3(n-o), 110.80(b)(4), 110.80(b)(14-15) unit containers, 1.24(a)(14) unit-dose packaging, 111.50(a) unit package, 129.3(l), 129.80(e) unit (vanilla constituent), 169.3(c) unit weight, 169.3(b) United States possessions, 1240.3(l), 1250.3(i) unpasteurized milk, 101.100(f)(1-3) unsalted, 101.61(c), 101.61(c)(2) urea, 184.1923 urea complex with sodium nitrate, 176.320 urea-formaldehyde resins, 177.1900 urease, 184.1924 use by (date), 107.20(c)

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Index

lactic acid, 184.1061(c) propylene glycol, 184.1666(c) triethyl citrate, 184.1911(c)(1) vending machine (labeling on), 101.2(c)(1)(ii)(B)(1) ventilation, 110.20(b)(6), 1250.30(a) vents, 113.3(v), 113.40(a)(12), 113.87(g) verification, 120.8(b)(6), 120.10(b)(5), 120.11, 120.25 definition of, 120.3(q) fish and fishery products, 123.6(c)(6), 123.6(d), 123.8 vermicelli. See specific macaroni and noodle products vermin, 1250.30(a), 1250.49 vessels, 1240.3(p), 1250.3(m) existing, 1250.3(f) sanitation on, 1240.95, 1250 Subparts B & E See also communicable diseases veterinarian, 1210.12, 1210.13 vinegar as clarifying agent, 173.50(c), 173.55(b) safe for intended use, 182.1(a) vinyl acetate/crotonic acid copolymer, 175.350 vinyl acetate-ethylene copolymers, 177.1350, 179.45(c) vinyl acetate-ethylene-vinyl alcohol copolymers, 177.1360 vinyl acetate-vinyl chloride copolymer film, 179.45(d)(2)(iv) vinyl alcohol copolymers, 177.1360 vinyl chloride-acrylonitrile copolymer, 177.2910(a)(1) vinyl chloride-ethylene copolymers, 177.1950 vinyl chloride-hexene-1 copolymers, 177.1960 vinyl chloride-lauryl vinyl ether copolymers, 177.1970 vinyl chloride plastic stabilizers, 178.2650 vinyl chloride plastics, 178.3790 vinyl chloride polymer resins, 189.300(a-b) vinyl chloride-propylene copolymers, 177.1980 vinyl chloride-vinyl acetate copolymer film, 179.45(d)(2)(iv) vinyl chloride-vinylidene chloride copolymer film, 179.45(b)(9) vinylidene chloride copolymer coatings, 175.360, 175.365, 179.45(b) vinylidene chloride/methyl acrylate copolymers, 177.1990 vinylidene chloride/methyl acrylate/methyl methacrylate polymers, 177.2000 vinylidene chloride-vinyl chloride copolymer film, 179.45(b)(9) vinyltoluene resins, 178.3610 violations, 5.10(b) emergency permit, 108.12 Federal Import Milk Act, 1210.31 GRAS substances deception in use of, 184.1(c), 186.1(d) excluded use of, 184.1(e), 186.1(e) minor, 5.33 prior sanction, 181.1(b), 181.5(d), 184.1(e), 186.1(e) prohibited substances, use of, 189.1(a), 189 Subparts B & C rendering food unlawful, 109.7(b) Violet No. 1 (FD&C), 81.10(e), 81.30(h)(1) Virgin Islands, 1240.3(l), 1240.3(n), 1250.3(i), 1250.3(k) viruses, 110.3(i) viscosity number, 177.1500(c)(5)

vitamin A (retinol), 101.78(a-b)(2), 107.10(b)(1), 131.127, 184.1930 See also contents of specific foods vitamin B1 (thiamine), 182.3616, 182.3637, 182.3739, 182.3766, 182.3798, 182.3862 vitamin B2 (riboflavin), 73.450, 184.1695 vitamin B12, 172.775(c), 184.1945 vitamin B complex. See niacin vitamin C, 101.78(a-b)(2) See also ascorbic acid; contents of specific foods vitamin D, 131.127, 184.1950 See also contents of specific foods vitamin E. See contents of specific foods vitamin K. See contents of specific foods vitamins, 101.9(a)(4) health claims, 101.71 order on label, 101.36(b)(2)(i)(B) See also contents of specific foods and enriched food products waffle sirup, 168.180(c) waivers Federal Import Milk Act clauses, 1210.27, 1210.28 of right to food sanction, 2.10(d), 184.1(e), 186.1(e) walls, 110.20(b)(4) warehousing and distribution, 110.93 warnings, 1.21(c)(1), 5.33(a), 101.17, 109.16(b) infant formula, 107.20(e) investigational use, 170.17(a-b) phenylketonurics, 172.804(d)(2) psyllium husk, 101.17(f) See also cautions warrants arrest, 5.31(b)(1)(ii) search, 5.31(b)(1)(ii) wash water, 1250.3(n), 1250.87 washing of fruits and vegetables, 173.315 hands (see hand washing) washroom, 1250.70(a) waste, 1240.3(f), 1250.3(g) discharge of, 1250.51, 1250.52, 1250.93 human, 1250.51(a-b), 1250.75 treatment and disposal, 110.20(a)(4), 1250.75 water added to reconstitute ingredients, 101.4(c) bottled (see bottled water) contamination of, 1250.42(b), 1250.42(d) coolers, 1250.42(c), 1250.43, 1250.70(c), 1250.85 culinary, 1240.83, 1240.95, 1250.67(a), 1250.86 distilled, 165.110(a)(2)(iv) drinking (see drinking water) filters, 1250.42(d) for food manufacturing, 177.2550 nonpotable, 1240.86, 1250.67(b), 1250.84(a) operations, 129.3(f), 129.35(a) potable (see potable water) process, 176.300(a)(3) product, 129.3(h), 129.35(a-b), 129.80(a)

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Index

purified, 165.110(a)(2)(iv) quality in food preparation/service areas, 1250.30(c) safety, 123.11(b)(1) source, 129.3(a), 129.35(a)(4) spring, 165.110(a)(2)(vi) sterilized, 165.110(a)(2)(vii) storage of, 1250.83 treatment, 1240.90 wash, 1250.3(n), 1250.87 waste, 1250.51(a-b), 1250.52 See also ice water activity (aw), 110.3(n), 110.80(b)(4), 110.80(b)(14), 113.83 definition of, 110.3(r), 113.3(w), 114.3(h) measuring/recording/controlling instruments, 110.40(f) water buffalo milk, 133.155(b)(1), 133.156(b)(1) water capacity, 130.12 water ices, 1.24(a)(6), 135.160 water supply, 110.37(a), 1240.83(a) contamination of, 1250.30(d), 1250.42(b), 1250.82, 1250.83(c) water systems, 1240.86, 1250.42, 1250.82 watering equipment, 1250.67 watering points, 1240.3(q), 1240.80, 1240.83 waterleaf paper, 179.45(d)(1) wax beans, 155.120 wax-coated paperboard, 176.170, 179.45(b)(3) wax ingredients/coatings, 101.4(b)(22), 101.95(c)(1)(i) waxes beeswax, 184.1973 candelilla wax, 184.1976 carnauba wax, 184.1978 Japan wax, 73.1(b)(2), 186.1555 montan wax acids, 178.3770 petroleum wax, 172.886, 178.3710, 178.3850(a), 178.3860 synthetic, 172.888, 178.3720 reinforced, 178.3850 rice bran wax, 172.890 sumac wax, 186.1555(a) weight body, 105.66 drained, 145.3(n), 145.3(o)(4), 155.3(a) net, 1.24(a)(2), 101.105(j)(3), 101.105(t) unit, 169.3(b) well water, 165.110(a)(2)(viii) wet pack shrimp, 161.173 wet processing, 110.35(d)(2) wetting agents dioctyl sodium sulfosuccinate, 172.810(a), 172.810(f) polysorbate 80, 172.840(c)(10), 172.840(c)(14) sodium lauryl sulfate, 172.822(b)(4) wheat color identification of seed, 2.25(a) cracked, 137.190 crushed, 137.195 See also specific wheat products

wheat flour, 137.105(a), 137.200(a) labeling, 1.24(a)(8), 101.4(b)(15) malted wheat, 137.105(a) whole wheat, 136.180(a)(1), 137.105(a), 137.200, 137.205 wheat germ, 101.12(b) wheat gluten, 184.1322 whey, 101.4(b)(7), 184.1979, 1240.3(j) protein concentrate, 184.1979c purification of, 173.40(c) reduced lactose, 184.1979a reduced minerals, 184.1979b See also contents of specific dairy products whipped cream, 131.25 whipping agents calcium stearoyl-2-lactylate, 172.844(c)(2) sodium lauryl sulfate, 172.822(b)(2) whipping cream, 1.24(a)(7), 131.157 See also whipped cream white bread/rolls/buns, 136.110(a) white corn flour, 137.211 meal, 137.250, 137.255, 137.265, 137.270 white flour, 101.4(b)(15), 137.105(a) white mineral oil, 172.878, 178.3620(a-b) whiteners, fluorescent, 178.3297(a) whiting, Pacific, 102.46 whole eggs, 101.4(b)(10) whole milk, 101.4(b)(4), 131.147, 133.3(a) whole oats, 101.81(c)(2)(i)(G)(1), 101.81(c)(2)(ii)(A) whole wheat. See specific whole wheat products wine, 135.140(e)(4) bottles (lead foil capsules), 189.301 cooking, 101.12(b) coolers, 101.12(b) winterization aid, 172.811(c) wood (preservatives for), 178.3800 wood rosin, 172.735, 178.3870(a)(1)(ii), 178.3870(a)(1)(v) woodpulp, 177.1460(b) wounds (in personnel), 110.10(a), 1250.35(b) wrapped food, 101.100(h-i) wrappings, 1.20 written notices, 5.33(a) x-radiation, 179.21(a-b), 179.26(a)(3), 179.45(b) See also irradiation xanthan gum, 172.695 Xanthomonas campestris, 172.695(a) xanthophyll, 73.275(b)(2)(i), 73.275(c)(1), 73.295(c)(2)(i), 73.295(d)(1), 73.315(d) xenon flashlamps, 179.41(a) xylene-formaldehyde resins, 175.380 xylitol, 101.80(c)(2)(ii)(B), 172.395 yams, 101.12(b) yeast, 110.3(i), 136.110(c)(3) bakers, 172.325, 172.898, 184.1983 dried, 172.896 nutrients, 101.4(b)(17), 136.110(c)(13) Phaffia, 73.355

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Index

See also microorganisms yeast-malt sprout extract, 172.590 Yellow No. 1 (Ext. D&C), 81.10(i), 81.30(l)(1) Yellow No. 5 (Ext. D&C), 81.30(d) Yellow No. 5 (FD&C), 74.705, 82.705 Yellow No. 6 (Ext. D&C), 81.30(d) Yellow No. 6 (FD&C), 74.706, 82.706 Yellow No. 9 (Ext. D&C), 81.10(a) Yellow No. 10 (Ext. D&C), 81.10(a) yellow prussiate of soda, 172.490 yogurt, 131.200, 1240.3(j) lowfat, 131.203 nonfat, 131.206 reference amounts, 101.12(b) zein, 184.1984 zinc health claim not authorized, 101.71(b) source of, 172.399 See also contents of specific foods zinc chloride, 182.8985 zinc gluconate, 182.8988 zinc hydroxy phosphite, 178.3125 zinc methionine sulfate, 172.399 zinc oxide, 182.8991 zinc-silicon dioxide matrix coatings, 175.390 zinc stearate, 182.8994 zinc sulfate, 182.8997 zirconium oxide, 177.2910(a)(2-3) Zygosaccharomyces rouxii, 180.25(a)(2)

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