21 C.F.R. § 178.3297 Colorants for polymers.
Title 21 - Food and Drugs
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 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: [48 FR 46775, Oct. 14, 1983] Editorial Note: For
Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart D—Certain Adjuvants and Production Aids
§ 178.3297 Colorants for polymers.
------------------------------------------------------------------------ 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)-3- polymers. 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 § 176.170(c) of this chapter.N-[4-(Aminocarbonyl)phenyl]-4-[[1- For use at levels not to exceed [[(2,3-dihydro-2-oxo-1H-benzimidazol-5- 1 percent by weight of yl)amino]carbonyl]-2- polymers. 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 § 176.170(c) of this chapter.Anthra(2,1,9-def:(6,5,10- For use at levels not to exceed d[prime]e[prime]f)diisoquinoline- 1% by weight of polymers. The 1,3,8,10(2H,9H)-tetrone (C.I. Pigment finished articles are to Violet 29; CAS Reg. No. 81-33-4). contact food only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter.Barium sulfate.........................Bentonite..............................Bentonite, modified with 3- dimethyldioctadecylammonium ion.1,4-Bis[(2,4,6-trimethylphenyl)amino]- For use at levels not to exceed 9,10-anthracenedione (CAS Reg. No. 116- 0.0004 percent by weight of 75-6). polyethylene phthalate polymers complying with § 177.1630 of this chapter.3,6-Bis(4-chlorophenyl)-2,5-dihydro- For 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. 84632-65- polymers. The finished 5). articles are to contact food only under conditions of use B through H, described in table 2 of § 176.170(c) of this chapter.4,4[prime]-Bis(4-anilino-6- For use only in the textile diethanolamine-α-triazin-2- fibers specified in § ylamino)-2,2[prime]-stilbene 177.2800 of this chapter. disulfonic acid, disodium salt.4,4[prime]-Bis(4-anilino-6- Do. methylethanolamine-α-triazin-2- ylamino)-2,2[prime]-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).4-Chloro-2-[[5-hydroxy-3-methyl-1-(3- For use at levels not to exceed sulfophenyl)-1H-pyrazol-4-yl]azo]-5- 1.0 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 § 176.170(c) of this chapter. 4-Chloro-2-[[5-hydroxy-3-methyl-1-(3- For use at levels not to exceed sulfophenyl)-1H-pyrazol-4-yl]azo]-5- 0.5 percent by weight of methylbenzenesulfonic acid, diammonium 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 § 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 § 176.170(c) of this chapter.Chromium oxide green, Cr2O3 (C.I. For use only: 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 § 177.1520 of this chapter. 3. In repeat-use rubber articles complying with § 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 § 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4- 4[prime]isopropylidenediphenol- epichlorohydrin epoxy resins complying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 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 § 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. 68186- 5 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 § 176.170(c) of this chapter.D&C Red No. 7 and its lakes........Diatomaceous earth.....................4,4[prime]-Diamino-[1,1[prime]- For use at levels not to exceed bianthracene]-9,9[prime],10,10[prime]- 1 percent by weight of tetrone (CAS Reg. No. 4051-63-2). polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.2,9-Dichloro-5,12-dihydroquinone[2,3- For 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-1- For use only: (3-sulfophenyl)-1H-pyrazol-4- 1. 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 § 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 § 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 § 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 § 176.170(c) of this chapter.5-[(2,3-Dihydro-6-methyl-2-oxo-1H- For 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 § 176.170(c) of this chapter.2,9-Dimethylanthra(2,1,9-def:6,5,10- For use at levels not to exceed d[prime]e[prime]f[prime])diisoquinolin 1 percent by weight of e-1,3,8,10(2H,9H)-tetrone (C.I. polymers. The finished Pigment Red 179, CAS Reg. No. 5521-31- articles are to contact food 3). only under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter.3,3[prime]-[(2,5-Dimethyl-1,4- For use at levels not to exceed phenylene)bis[imino(1-acetyl-2-oxo-2,1- 1 percent by weight of ethanediyl)azo]]bis[4-chloro-N-(5- polymers. 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 § 176.170(c) of this chapter.3,3[prime]-[(2,5-Dimethyl-1,4- For use at levels not to exceed phenylene)bis[imino-carbonyl(2-hydroxy- 1 percent by weight of 3,1-naphthalenediyl) azo]] bis(4- polymers. The finished methylbenzoic acid), bis(2- articles are to contact food chloroethyl) ester (CAS Reg. No. 68259- only under conditions of use B 05-2). through H described in table 2 of § 176.170(c) of this chapter.2,2[prime]-[1,2-Ethanediylbis(oxy-2,1- For use at levels not to exceed phenyleneazo)]bis[N-(2,3-dihydro-2-oxo- 1.0 percent by weight of 1H-benzimidazol-5-yl)]-3-oxo- polymers. 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 § 176.170(c) of this chapter.2,2[prime]-(1,2-Ethenediyldi-4,1- For use as an optical phenylene) bis(benzoxazole) (CAS Reg. brightener for all polymers at No. 1533-45-5). a level not to exceed 0.025 percent by weight of polymer. The finished polymer shall contact foods only of the types identified in table 1 of § 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.php..Iron oxides............................Kaolin-modified, produced by treating For use only in olefin polymers kaolin with a reaction product of complying with § 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 § 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. 10101-66- 2 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 § 176.170(c) of this chapter.Mixed methylated 4,4[prime]-bis(2- For use as an optical benzoxazolyl)stilbenes with the major brightener only at levels not portion consisting of 4-(2- to exceed 0.05 percent by benzoxazolyl)-4[prime]-(5-methyl-2- weight 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[prime]-bis(5-methyl- in all other polymers. The 2-benzoxazolyl)stilbene (CAS Registry finished food-contact articles No. 2397-00-4) and 4,4[prime]-bis(2- shall 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 § 176.170(c) of this chapter.7-(2H-Naphtho[1,2-d]triazol-2-yl)-3- For use as an optical phenylcoumarin (CAS Reg. No. 3333-62- brightener only in: 8) having a melting point of 250 1. Olefin polymers complying °C to 251 °C and a nitrogen with § 177.1520 of this content of 10.7 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 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 § 177.1520(c) of this chapter. The polymer may be used under the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use E, F, and G. 2. Polyethylene terephthalate specified in § 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 § 176.170(c) of this chapter.1,1[prime]-[(6-Phenyl-1,3,5-triazine- For use at levels not to exceed 2,4-diyl)diimino]bis-9,10- 0.25 percent by weight of anthracenedione (CAS Reg. No. 4118-16- polyethylene phthalate 5). polymers that comply with § 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, § 176.170(c) of this chapter, except, when such articles are used with food types III, IV- A, and V, described in table 1, § 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 § 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 § 176.170(c) of this chapter.4,5,6,7-Tetrachloro-2-[2-(4,5,6,7- For use only at levels not to tetrachloro-2,3-dihydro-1,3-dioxo-1H- exceed 1 percent by weight of inden-2-yl)-8-quinolinyl]-1H-isoindole- polymers. 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 § 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[prime]-(2,5-Thiophenediyl)-bis(5- For use as an optical tert-butylbenzoxazole) (CAS Reg. No. brightener: 7128-64-5). 1. In all polymers at levels not to exceed 0.015 percent by weight of the polymer. The finished articles are to contact food only under conditions of use A through H described in table 2 of § 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 § 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 § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter and in pressure-sensitive adhesives complying with § 175.125 of this chapter.Titanium dioxide.......................Titanium dioxide-barium sulfate........Titanium dioxide-magnesium silicate....Ultramarines........................... As identified in § 73.2725 of this chapter.Zinc carbonate......................... For use only: 1. In resinous and polymeric coatings complying with § 175.300 of this chapter. 2. Melamineformaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4[prime]- isopropylidene diphenol- epichlorohydrin epoxy resins complying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter.Zinc chromate.......................... For use only in rubber articles for repeated use complying with § 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 § 175.300 of this chapter. 2. Melamine-formaldehyde resins in molded articles complying with § 177.1460 of this chapter. 3. Xylene-formaldehyde resins condensed with 4-4[prime]- isopropylidene-diphenol- epichlorohydrin epoxy resins complying with § 175.380 of this chapter. 4. Ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter. 5. Urea-formaldehyde resins in molded articles complying with § 177.1900 of this chapter.Zinc sulfide........................... For use at levels not to exceed 10 percent by weight.------------------------------------------------------------------------
