401 Part 73—Listing of Color Ad- Ditives Exempt From

Food and Drug Administration, HHS Pt. 73

the act, has notified the sponsor or in- 73.352 Paracoccus pigment. vestigator that the proposed disposi- 73.355 Phaffia yeast. tion for food is authorized. Any person 73.450 Riboflavin. 73.500 Saffron. who contests a refusal to grant such 73.530 Spirulina extract. authorization shall have an oppor- 73.575 Titanium dioxide. tunity for a regulatory hearing before 73.585 Tomato lycopene extract; tomato ly- the Food and Drug Administration pur- copene concentrate. suant to part 16 of this chapter. 73.600 Turmeric. (b) The person who introduced such 73.615 Turmeric oleoresin. shipment or who delivers the color additive or a food, drug, or cosmetic con- Subpart B—Drugs taining such an additive into interstate 73.1001 Diluents in color additive mixtures commerce shall maintain adequate for drug use exempt from certification. records showing the name and post-of- 73.1010 Alumina (dried aluminum hydrox- fice address of the expert to whom the ide). color additive is shipped, date, quan- 73.1015 Chromium-cobalt-aluminum oxide. tity, and batch or code mark of each 73.1025 Ferric ammonium citrate. 73.1030 Annatto extract. shipment and delivery for a period of 2 73.1070 Calcium carbonate. years after such shipment and delivery. 73.1075 Canthaxanthin. Upon the request of a properly author- 73.1085 Caramel. ized employee of the Department, at 73.1095 b-Carotene. reasonable times, he shall make such 73.1100 Cochineal extract; carmine. records available for inspection and 73.1125 Potassium sodium copper copying. chlorophyllin (chlorophyllin-copper complex). 73.1150 Dihydroxyacetone. PART 73—LISTING OF COLOR AD- 73.1162 Bismuth oxychloride. DITIVES EXEMPT FROM CERTIFI- 73.1200 Synthetic iron oxide. CATION 73.1298 Ferric ammonium ferrocyanide. 73.1299 Ferric ferrocyanide. 73.1326 Chromium hydroxide green. Subpart A—Foods 73.1327 Chromium oxide greens. Sec. 73.1329 Guanine. 73.1 Diluents in color additive mixtures for 73.1350 Mica-based pearlescent pigments. food use exempt from certification. 73.1375 Pyrogallol. 73.30 Annatto extract. 73.1400 Pyrophyllite. 73.35 Astaxanthin. 73.1410 Logwood extract. 73.37 Astaxanthin dimethyldisuccinate. 73.1496 Mica. 73.40 Dehydrated beets (beet powder). 73.1530 Spirulina extract. 73.50 Ultramarine blue. 73.1550 Talc. 73.75 Canthaxanthin. 73.1575 Titanium dioxide. 73.85 Caramel. 73.1645 Aluminum powder. 73.90 b-Apo-8′-carotenal. 73.1646 Bronze powder. 73.95 b-Carotene. 73.1647 Copper powder. 73.100 Cochineal extract; carmine. 73.1991 Zinc oxide. 73.125 Sodium copper chlorophyllin. 73.140 Toasted partially defatted cooked Subpart C—Cosmetics cottonseed flour. 73.160 Ferrous gluconate. 73.2030 Annatto. 73.165 Ferrous lactate. 73.2085 Caramel. 73.169 Grape color extract. 73.2087 Carmine. 73.170 Grape skin extract (enocianina). 73.2095 b-Carotene. 73.185 Haematococcus algae meal. 73.2110 Bismuth citrate. 73.200 Synthetic iron oxide. 73.2120 Disodium EDTA-copper. 73.250 Fruit juice. 73.2125 Potassium sodium copper 73.260 Vegetable juice. chlorophyllin (chlorophyllin-copper com- 73.275 Dried algae meal. plex). 73.295 Tagetes (Aztec marigold) meal and 73.2150 Dihydroxyacetone. extract. 73.2162 Bismuth oxychloride. 73.300 Carrot oil. 73.2180 Guaiazulene. 73.315 Corn endosperm oil. 73.2190 Henna. 73.340 Paprika. 73.2250 Iron oxides. 73.345 Paprika oleoresin. 73.2298 Ferric ammonium ferrocyanide. 73.350 Mica-based pearlescent pigments. 73.2299 Ferric ferrocyanide.

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73.2326 Chromium hydroxide green. 73.3124 Phthalocyanine green. 73.2327 Chromium oxide greens. 73.3125 Iron oxides. 73.2329 Guanine. 73.3126 Titanium dioxide. 73.2396 Lead acetate. 73.3127 Vinyl alcohol/methyl methacrylate- 73.2400 Pyrophyllite. dye reaction products. 73.2496 Mica. 73.3128 Mica-based pearlescent pigments. 73.2500 Silver. 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1- 73.2575 Titanium dioxide. oxoallyl)amino]-2- 73.2645 Aluminum powder. sulfonatophenyl]amino]-9,10-dihydro-9,10- 73.2646 Bronze powder. dioxoanthracene-2-sulfonate. 73.2647 Copper powder. 73.2725 Ultramarines. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, 73.2775 Manganese violet. 351, 352, 355, 361, 362, 371, 379e. 73.2991 Zinc oxide. SOURCE: 42 FR 15643, Mar. 22, 1977, unless 73.2995 Luminescent zinc sulfide. otherwise noted. Subpart D—Medical Devices EDITORIAL NOTE: Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001. 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10- anthracenedione bis(2-methyl-2-propenoic)ester copolymers. Subpart A—Foods 73.3105 1,4–Bis[(2-methylphenyl)amino]-9,10- anthracenedione. § 73.1 Diluents in color additive mix- 73.3106 1,4-Bis[4-(2-methacryloxyethyl) tures for food use exempt from cer- phenylamino]anthraquinone copolymers. tification. 73.3107 Carbazole violet. The following substances may be 73.3110 Chlorophyllin-copper complex, oil safely used as diluents in color additive soluble. mixtures for food use exempt from cer- 73.3110a Chromium-cobalt-aluminum oxide. tification, subject to the condition that 73.3111 Chromium oxide greens. 73.3112 C.I. Vat Orange 1. each straight color in the mixture has 73.3115 2-[[2,5-Diethoxy-4-[(4- been exempted from certification or, if methylphenyl)thiol]phenyl]azo]-1,3,5- not so exempted, is from a batch that benzenetriol. has previously been certified and has 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] not changed in composition since cer- naphth [2′,3′:6,7] indolo [2,3-c] carbazole- tification. If a specification for a par- 5,10,15,17,22,24-hexone. ticular diluent is not set forth in this 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5- anthracenediyl) bisbenzamide. part 73, the material shall be of a pu- 73.3119 7,16-Dichloro–6,15-dihydro-5,9,14,18- rity consistent with its intended use. anthrazinetetrone. (a) General use. (1) Substances that 73.3120 16,17-Dimethoxydinaphtho [1,2,3- are generally recognized as safe under cd:3′,2′,1′-lm] perylene-5,10-dione. the conditions set forth in section 73.3121 Poly(hydroxyethyl methacrylate)- 201(s) of the act. dye copolymers. (2) Substances meeting the defini- 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4- tions and specifications set forth under dihydro-5-methyl-2-phenyl-3H-pyrazol-3- one. subchapter B of this chapter, and 73.3123 6-Ethoxy-2-(6-ethoxy-3- which are used only as prescribed by oxobenzo[b]thien-2(3H)-ylidene) such regulations. benzo[b]thiophen-3 (2H)-one. (3) The following:

Substances Definitions and specifications Restrictions

Calcium disodium EDTA (calcium diso- Contains calcium disodium ethyl- May be used in aqueous solutions and dium ethyl- enediamine- tetraacetate). enediamine- tetraacetate dihydrate aqueous dispersions as a preservative (CAS Reg. No. 6766–87–6) as set and sequestrant in color additive mixtures forth in the Food Chemicals Codex, intended only for ingested use; the color 3d ed., p. 50, 1981. additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhy- drous calcium disodium ethyl- enediamine-tetraacetate). Castor oil ...... As set forth in U.S.P. XVI ...... 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.

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Substances Definitions and specifications Restrictions

Dioctylsodium sulfosuccinate ...... As set forth in sec. 172.810 of this Not more than 9 p.p.m. in the finished food. chapter. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. Disodium EDTA (disodium ethyl- Contains disodium ethyl- enediamine- May be used in aqueous solutions and enediamine- tetraacetate). tetraacetate dihydrate (CAS Reg. No. aqueous dispersions as a preservative 6381–92–6) as set forth in the Food and sequestrant in color additive mixtures Chemicals Codex, 3d ed., p. 104, intended only for ingested use; the color 1981. additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhy- drous disodium ethyl- enediamine- tetraacetate).

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

Substances Definitions and specifications Restrictions

Alcohol, SDA–3A ...... As set forth in 26 CFR pt. 212 ...... No residue. n-Butyl alcohol ...... Do. Cetyl alcohol ...... As set forth in N.F. XI ...... Do. Cyclohexane ...... Do. Ethyl cellulose ...... As set forth in sec. 172.868 of this chapter. Ethylene glycol monoethyl ether ...... Do. Isobutyl alcohol ...... Do. Isopropyl alcohol ...... Do. Polyoxyethylene sorbitan monooleate As set forth in sec. 172.840 of this (polysorbate 80). chapter. Polyvinyl acetate ...... Molecular weight, minimum 2,000. Polyvinylpyrrolidone ...... As set forth in sec. 173.55 of this chapter. Rosin and rosin derivatives ...... As set forth in sec. 172.615 of this chapter. Shellac, purified ...... Food grade.

(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following:

Substances Definitions and specifications Restrictions

Acetone ...... As set forth in N.F. XI ...... No residue. Alcohol, SDA–3A ...... As set forth in 26 CFR pt. 212 ...... Do. Benzoin ...... As set forth in U.S.P. XVI. Copal, Manila ...... Ethyl acetate ...... As set forth in N.F. XI ...... Do. Ethyl cellulose ...... As set forth in sec. 172.868 of this chapter. Methylene chloride ...... Do. Polyvinylpyrrolidone ...... As set forth in sec. 173.55 of this chapter. Rosin and rosin derivatives ...... As set forth in sec. 172.615 of this chapter. Silicon dioxide ...... As set forth in sec. 172.480 of this Not more than 2 pct of the ink solids. chapter. Terpene resins, natural ...... As set forth in sec. 172.615 of this chapter. Terpene resins, synthetic ...... Polymers of a- and b-pinene.

(2) Diluents in color additive mixtures there is no penetration of the color ad- for coloring shell eggs. Items listed in ditive mixture or any of its compo- paragraph (a) of this section and the nents through the eggshell into the following, subject to the condition that egg:

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Alcohol, denatured, formula 23A (26 CFR Pentaerythritol ester of fumaric acid-rosin part 212), Internal Revenue Service. adduct. Damar gum (resin). Polyethylene glycol 6000 (as identified in Diethylene glycol distearate. § 172.820 of this chapter). Dioctyl sodium sulfosuccinate. Polyvinyl alcohol. Ethyl cellulose (as identified in § 172.868 of Rosin and rosin derivatives (as identified in this chapter). § 172.615 of this chapter). Ethylene glycol distearate. Japan wax. (3) Miscellaneous special uses. Items Limed rosin. listed in paragraph (a) of this section Naphtha. and the following:

Substances Definitions and specifications Restrictions

Polyvinylpyrrolidone ...... As set forth in sec. 173.55 of this chap- In or as food-tablet coatings; limit, not more ter. 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; 69 FR 24511, May 4, 2004]

§ 73.30 Annatto extract. (1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more (a) Identity. (1) The color additive than 10 parts per million. annatto extract is an extract prepared from annatto seed, Bixa orellana L., (2) When solvents listed under para- using any one or an appropriate com- graph (a)(1)(ii) of this section are used, bination of the food-grade extractants annatto extract shall contain no more listed in paragraph (a)(1) (i) and (ii) of solvent residue than is permitted of the this section: corresponding solvents in spice (i) Alkaline aqueous solution, alka- oleoresins under applicable food addi- line propylene glycol, ethyl alcohol or tive regulations in parts 170 through alkaline solutions thereof, edible vege- 189 of this chapter. table oils or fats, mono- and (c) Uses and restrictions. Annatto ex- diglycerides from the glycerolysis of tract may be safely used for coloring edible vegetable oils or fats. The alka- foods generally, in amounts consistent line alcohol or aqueous extracts may with good manufacturing practice, ex- be treated with food-grade acids to pre- cept that it may not be used to color cipitate annatto pigments, which are foods for which standards of identity separated from the liquid and dried, have been promulgated under section with or without intermediate recrys- 401 of the act unless added color is au- tallization, using the solvents listed thorized by such standards. under paragraph (a)(1)(ii) of this sec- (d) Labeling. The label of the color ad- tion. Food-grade alkalis or carbonates ditive and any mixtures prepared may be added to adjust alkalinity. therefrom and intended solely or in (ii) Acetone, ethylene dichloride, part for coloring purposes shall con- hexane, isopropyl alcohol, methyl alco- form to the requirements of § 70.25 of hol, methylene chloride, trichloro- this chapter. Labels shall bear informa- ethylene. tion showing that the color is derived (2) Color additive mixtures for food from annatto seed. The requirements of use made with annatto extract may § 70.25(a) of this chapter that all ingre- contain only diluents that are suitable dients shall be listed by name shall not and that are listed in this subpart as be construed as requiring the declara- safe in color additive mixtures for tion of residues of solvents listed in coloring foods. paragraph (a)(1)(ii) of this section. (b) Specifications. Annatto extract, in- (e) Exemption from certification. Cer- cluding pigments precipitated there- tification of this color additive is not from, shall conform to the following necessary for the protection of the pub- specifications: lic health and therefore batches thereof

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are exempt from the certification re- (2) The presence of the color additive quirements of section 721(c) of the act. in finished fish feed prepared according to paragraph (c) of this section shall be § 73.35 Astaxanthin. declared in accordance with § 501.4 of (a) Identity. (1) The color additive this chapter. astaxanthin is 3, 3′-dihydroxy-b, b-caro- (3) The presence of the color additive tene-4, 4′-dione. in salmonid fish that have been fed (2) Astaxanthin may be added to the feeds containing astaxanthin shall be fish feed only as a component of a sta- declared in accordance with bilized color additive mixture. Color §§ 101.22(k)(2) and 101.100(a)(2) of this additive mixtures for fish feed use chapter. made with astaxanthin may contain (e) Exemption from certification. Cer- only those diluents that are suitable tification of this color additive is not and are listed in this subpart as safe necessary for the protection of the pub- for use in color additive mixtures for lic health, and therefore batches there- coloring foods. of are exempt from the certification re- (b) Specifications. Astaxanthin shall quirements of section 721(c) of the act. conform to the following specifications [60 FR 18738, Apr. 13, 1995] and shall be free from impurities other than those named to the extent that § 73.37 Astaxanthin dimethyl- such impurities may be avoided by disuccinate. good manufacturing practice: (a) Identity. (1) The color additive Physical state, solid. astaxanthin dimethyldisuccinate is 0.05 percent solution in chloroform, complete 3,3′-bis(4-methoxy-1,4-dioxobutoxy)-b,b- and clear. carotene–4,4′-dione. Absorption maximum wavelength 484–493 (2) Astaxanthin dimethyldisuccinate nanometers (in chloroform). may be added to the fish feed only as a Residue on ignition, not more than 0.1 per- component of a stabilized mixture. cent. Total carotenoids other than astaxanthin, Color additive mixtures for fish feed not more than 4 percent. use made with astaxanthin Lead, not more than 5 parts per million. dimethyldisuccinate may contain only Arsenic, not more than 2 parts per million. those diluents that are suitable and are Mercury, not more than 1 part per million. listed in this subpart as safe for use in Heavy metals, not more than 10 parts per color additive mixtures for coloring million. foods. Assay, minimum 96 percent. (b) Specifications. Astaxanthin (c) Uses and restrictions. Astaxanthin dimethyldisuccinate shall conform to may be safely used in the feed of the following specifications and shall salmonid fish in accordance with the be free from impurities other than following prescribed conditions: those named to the extent that such (1) The color additive is used to en- impurities may be avoided by good hance the pink to orange-red color of manufacturing practice: the flesh of salmonid fish. (1) Physical state, solid. (2) The quantity of color additive in (2) 0.05 percent solution in chloro- feed is such that the color additive form, complete and clear. shall not exceed 80 milligrams per kilo- (3) Absorption maximum wavelength gram (72 grams per ton) of finished 484–493 nanometers (in chloroform). feed. (4) Residue on ignition, not more (d) Labeling requirements. (1) The la- than 0.1 percent. beling of the color additive and any (5) Total carotenoids other than premixes prepared therefrom shall bear astaxanthin dimethyldisuccinate, not expiration dates for the sealed and more than 4 percent. open container (established through (6) Lead, not more than 5 milligrams generally accepted stability testing per kilogram (mg/kg) (5 parts per mil- methods), other information required lion). by § 70.25 of this chapter, and adequate (7) Arsenic, not more than 2 mg/kg (2 directions to prepare a final product parts per million). complying with the limitations pre- (8) Mercury, not more than 1 mg/kg (1 scribed in paragraph (c) of this section. part per million).

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(9) Heavy metals, not more than 10 (2) Color additive mixtures made mg/kg (10 parts per million). with dehydrated beets may contain as (10) Assay including astaxanthin diluents only those substances listed in dimethyldisuccinate, astaxanthin this subpart as safe and suitable for use monomethylsuccinate, and in color additive mixtures for coloring astaxanthin, minimum 96 percent. foods. (c) Uses and restrictions. Astaxanthin (b) Specifications. The color additive dimethyldisuccinate may be safely shall conform to the following speci- used in the feed of salmonid fish in ac- fications: cordance with the following prescribed Volatile matter, not more than 4 percent. conditions: Acid insoluble ash, not more than 0.5 per- (1) The color additive is used to en- cent. hance the pink to orange-red color of Lead (as Pb), not more than 10 parts per mil- the flesh of salmonid fish. lion. (2) The quantity of astaxanthin Arsenic (as As), not more than 1 part per million. dimethyldisuccinate in the finished Mercury (as Hg), not more than 1 part per feed, when used alone or in combina- million. tion with other astaxanthin color additive sources listed in this part 73, shall (c) Uses and restrictions. Dehydrated not exceed 110 milligrams per kilogram beets may be safely used for the color- (mg/kg), which is equivalent to 80 mg/ ing of foods generally in amounts con- kg astaxanthin (72 grams per ton). sistent with good manufacturing prac- (d) Labeling requirements. (1) The la- tice, except that it may not be used to beling of the color additive and any color foods for which standards of iden- premixes prepared therefrom shall bear tity have been promulgated under sec- expiration dates for the sealed and tion 401 of the act, unless the use of open container (established through added color is authorized by such generally accepted stability testing standards. methods), other information required (d) Labeling. The label of the color ad- by § 70.25 of this chapter, and adequate ditive and any mixtures prepared directions to prepare a final product therefrom intended solely or in part for complying with the limitations pre- coloring purposes shall conform to the scribed in paragraph (c) of this section. requirements of § 70.25 of this chapter. (e) Exemption from certification. Cer- (2) The presence of the color additive tification of this color additive is not in finished fish feed prepared according necessary for the protection of the pub- to paragraph (c) of this section shall be lic health, and therefore batches there- declared in accordance with § 501.4 of of are exempt from the certification re- this chapter. quirements of section 721(c) of the act. (3) The presence of the color additive in salmonid fish that have been fed § 73.50 Ultramarine blue. feeds containing astaxanthin (a) Identity. The color additive ultra- dimethyldisuccinate shall be declared marine blue is a blue pigment obtained in accordance with §§ 101.22(b), (c), and by calcining a mixture of kaolin, sul- (k)(2), and 101.100(a)(2) of this chapter. fur, sodium carbonate, and carbon at (e) Exemption from certification. Cer- temperatures above 700 °C. Sodium sul- tification of this color additive is not fate and silica may also be incor- necessary for the protection of the pub- porated in the mixture in order to vary lic health, and therefore batches there- the shade. The pigment is a complex of are exempt from the certification re- sodium aluminum sulfo-silicate having quirements of section 721(c) of the act. the approximate formula Na7Ai6Si6O24 [74 FR 57251, Nov. 5, 2009] S3. (b) Specifications. Ultramarine blue § 73.40 Dehydrated beets (beet pow- shall conform to the following speci- der). fications: (a) Identity. (1) The color additive de- Lead (as Pb), not more than 10 parts per mil- hydrated beets is a dark red powder lion. prepared by dehydrating sound, ma- Arsenic (as As), not more than 1 part per ture, good quality, edible beets. million.

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Mercury (as Hg), not more than 1 part per been promulgated under section 401 of million. the act unless added color is authorized (c) Uses and restrictions. The color ad- by such standards. ditive ultramarine blue may be safely (2) Canthaxanthin may be safely used used for coloring salt intended for ani- in broiler chicken feed to enhance the mal feed subject to the restriction that yellow color of broiler chicken skin in the quantity of ultramarine blue does accordance with the following condi- not exceed 0.5 percent by weight of the tions: The quantity of canthaxanthin salt. incorporated in the feed shall not ex- (d) Labeling requirements. The color ceed 4.41 milligrams per kilogam (4 additive shall be labeled in accordance grams per ton) of complete feed to sup- with the requirements of § 70.25 of this plement other known sources of xan- chapter. thophyll and associated carotenoids to (e) Exemption from certification. Cer- accomplish the intended effect. tification of this color additive is not (3) Canthaxanthin may be safely used necessary for the protection of the pub- in the feed of salmonid fish in accord- lic health, and therefore batches there- ance with the following prescribed con- of are exempt from the certification re- ditions: quirements of section 721(c) of the act. (i) Canthaxanthin may be added to the fish feed only in the form of a sta- § 73.75 Canthaxanthin. bilized color additive mixture; (a) Identity. (1) The color additive (ii) The color additive is used to en- canthaxanthin is b-carotene-4,4′-dione. hance the pink to orange-red color of (2) Color additive mixtures for food the flesh of salmonid fish; and use made with canthaxanthin may con- (iii) The quantity of color additive in tain only those diluents that are suit- feed shall not exceed 80 milligrams per able and that are listed in this subpart kilogram (72 grams per ton) of finished as safe for use in color additive mix- feed. tures for coloring foods. (d) Labeling requirements. (1) The la- (b) Specifications. Canthaxanthin beling of the color additive and any shall conform to the following speci- mixture prepared therefrom intended fications and shall be free from impuri- solely or in part for coloring purposes ties other than those named to the ex- shall conform to the requirements of tent that such other impurities may be § 70.25 of this chapter. avoided by good manufacturing prac- (2) For purposes of coloring fish, the tice: labeling of the color additive and any Physical state, solid. premixes prepared therefrom shall bear 1 percent solution in chloroform, complete expiration dates (established through and clear. generally accepted stability testing Melting range (decomposition), 207 °C. to 212 methods) for the sealed and open con- °C. (corrected). tainer, other information required by Loss on drying, not more than 0.2 percent. § 70.25 of this chapter, and adequate di- Residue on ignition, not more than 0.2 percent. rections to prepare a final product Total carotenoids other than trans- complying with the limitations pre- canthaxanthin, not more than 5 percent. scribed in paragraph (c)(3) of this sec- Lead, not more than 10 parts per million. tion. Arsenic, not more than 3 parts per million. (3) The presence of the color additive Mercury, not more than 1 part per million. in finished fish feed prepared according Assay, 96 to 101 percent. to paragraph (c)(3) of this section shall (c) Use and restrictions. (1) The color be declared in accordance with § 501.4 of additive canthaxanthin may be safely this chapter. used for coloring foods generally sub- (4) The presence of the color additive ject to the following restrictions: in salmonid fish that have been fed (i) The quantity of canthaxanthin feeds containing canthaxanthin shall does not exceed 30 milligrams per be declared in accordance with pound of solid or semisolid food or per §§ 101.22(b), (c), and (k)(2), and pint of liquid food; and 101.100(a)(2) of this chapter. (ii) It may not be used to color foods (e) Exemption from certification. Cer- for which standards of identity have tification of this color additive is not

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necessary for the protection of the pub- Arsenic (as As), not more than 3 parts per lic health, and therefore batches there- million. of are exempt from the certification re- Mercury (as Hg), not more than 0.1 part per quirements of section 721(c) of the act. million. (c) Uses and restrictions. Caramel may [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, be safely used for coloring foods gen- 1998] erally, in amounts consistent with good manufacturing practice, except § 73.85 Caramel. that it may not be used to color foods (a) Identity. (1) The color additive for which standards of identity have caramel is the dark-brown liquid or been promulgated under section 401 of solid material resulting from the care- the act unless added color is authorized fully controlled heat treatment of the by such standards. following food-grade carbohydrates: (d) Labeling. The label of the color additive and any mixtures prepared Dextrose. therefrom and intended solely or in Invert sugar. part for coloring purposes shall con- Lactose. form to the requirements of § 70.25 of Malt sirup. Molasses. this chapter. Starch hydrolysates and fractions thereof. (e) Exemption from certification. Cer- Sucrose. tification of this color additive is not necessary for the protection of the pub- (2) The food-grade acids, alkalis, and lic health and therefore batches thereof salts listed in this subparagraph may are exempt from the certification re- be employed to assist caramelization, quirements of section 721(c) of the act. in amounts consistent with good manufacturing practice. § 73.90 β-Apo-8′-carotenal. (i) Acids: (a) Identity. (1) The color additive is Acetic acid. b-apo-8′-carotenal. Citric acid. (2) Color additive mixtures for food Phosphoric acid. use made with b-apo-8′-carotenal may Sulfuric acid. Sulfurous acid. contain only diluents that are suitable and that are listed in this subpart as (ii) Alkalis: safe in color additive mixtures for Ammonium hydroxide. coloring foods. Calcium hydroxide U.S.P. (b) Specifications. b-Apo-8′-carotenal Potassium hydroxide. shall conform to the following speci- Sodium hydroxide. fications: (iii) Salts: Ammonium, sodium, or Physical state, solid. potassium carbonate, bicarbonate, 1 percent solution in chloroform, clear. phosphate (including dibasic phosphate Melting point (decomposition), 136 °C.–140 °C. and monobasic phosphate), sulfate, and (corrected). sulfite. Loss of weight on drying, not more than 0.2 (3) Polyglycerol esters of fatty acids, percent. Residue on ignition, not more than 0.2 per- identified in § 172.854 of this chapter, cent. may be used as antifoaming agents in Lead (as Pb), not more than 10 parts per mil- amounts not greater than that re- lion. quired to produce the intended effect. Arsenic (as As), not more than 1 part per (4) Color additive mixtures for food million. use made with caramel may contain Assay (spectrophotometric), 96–101 percent. only diluents that are suitable and (c) Uses and restrictions. The color ad- that are listed in this subpart as safe in ditive b-apo-8′-carotenal may be safely color additive mixtures for coloring used for coloring foods generally, sub- foods. ject to the following restrictions: (b) Specifications. Caramel shall con- (1) The quantity of b-apo-8′-carotenal form to the following specifications: does not exceed 15 milligrams per Lead (as Pb), not more than 10 parts per mil- pound of solid or semisolid food or 15 lion. milligrams per pint of liquid food.

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(2) It may not be used to color foods (e) Exemption from certification. Cer- for which standards of identity have tification of this color additive is not been promulgated under section 401 of necessary for the protection of the pub- the act unless added color is authorized lic health and therefore batches thereof by such standards. are exempt from the certification re- (d) Labeling. The label of the color ad- quirements of section 721(c) of the act. ditive and any mixtures prepared therefrom and intended solely or in § 73.100 Cochineal extract; carmine. part for coloring purposes shall con- (a) Identity. (1) The color additive form to the requirements of § 70.25 of cochineal extract is the concentrated this chapter. solution obtained after removing the (e) Exemption from certification. Cer- alcohol from an aqueous-alcoholic ex- tification of this color additive is not tract of cochineal (Dactylopius coccus necessary for the protection of the pub- costa (Coccus cacti L.)). The coloring lic health and therefore batches thereof principle is chiefly carminic acid. are exempt from the certification re- (2) The color additive carmine is the quirements of section 721(c) of the act. aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of § 73.95 β-Carotene. the coloring principles, chiefly car- (a) Identity. (1) The color additive is minic acid, obtained by an aqueous ex- b-carotene prepared synthetically or traction of cochineal (Dactylopius coc- obtained from natural sources. cus costa (Coccus cacti L.)). (2) Color additive mixtures for food (3) Color additive mixtures for food use made with cochineal extract or car- use made with b-carotene may contain only diluents that are suitable and mine may contain only diluents that that are listed in this subpart as safe in are suitable and that are listed in this color additive mixtures for coloring subpart as safe in color additive mix- foods. tures for coloring foods. (b) Specifications. (1) Cochineal ex- (b) Specifications. -carotene shall b tract shall conform to the following conform to the following specifica- specifications: tions: pH, not less than 5.0 and not more than 5.5 at Physical state, solid. 25 °C. 1 percent solution in chloroform, clear. Protein (N × 6.25), not more than 2.2 percent. Loss of weight on drying, not more than 0.2 Total solids, not less than 5.7 and not more percent. than 6.3 percent. Residue on ignition, not more than 0.2 per- Methyl alcohol, not more than 150 parts per cent. million. Lead (as Pb), not more than 10 parts per mil- Lead (as Pb), not more than 10 parts per million. lion. Arsenic (as As), not more than 3 parts per Arsenic (as As), not more than 1 part per million. million. Assay (spectrophotometric), 96–101 percent. Carminic acid, not less than 1.8 percent. (c) Uses and restrictions. The color ad- (2) Carmine shall conform to the fol- ditive b-carotene may be safely used lowing specifications: for coloring foods generally, in Volatile matter (at 135 °C. for 3 hours), not amounts consistent with good manu- more than 20.0 percent. facturing practice, except that it may Ash, not more than 12.0 percent. not be used to color those foods for Lead (as Pb), not more than 10 parts per mil- which standards of identity have been lion. promulgated under section 401 of the Arsenic (as As), not more than 1 part per million. act unless added color is authorized by Carminic acid, not less than 50.0 percent. such standards. (d) Labeling. The label of the color ad- Carmine and cochineal extract shall be ditive and any mixtures prepared pasteurized or otherwise treated to de- therefrom and intended solely or in stroy all viable Salmonella microorga- part for coloring purposes shall con- nisms. Pasteurization or such other form to the requirements of § 70.25 of treatment is deemed to permit the add- this chapter. ing of safe and suitable substances

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(other than chemical preservatives) (Medicago sativa) using any one or a that are essential to the method of pas- combination of the solvents acetone, teurization or other treatment used. ethanol, and hexane. For the purposes of this paragraph, (2) Color additive mixtures made safe and suitable substances are those with sodium copper chlorophyllin may substances that perform a useful func- contain only those diluents that are tion in the pasteurization or other suitable and are listed in this subpart treatment to render the carmine and as safe for use in color additive mix- cochineal extract free of viable Sal- tures for coloring foods. monella microorganisms, which substances are not food additives as de- (b) Specifications. Sodium copper fined in section 201(s) of the act or, if chlorophyllin shall conform to the fol- they are food additives as so defined, lowing specifications and shall be free are used in conformity with regula- from impurities other than those tions established pursuant to section named to the extent that such impuri- 409 of the act. ties may be avoided by good manufac- (c) Uses and restrictions. Carmine and turing practice: cochineal extract may be safely used (1) Moisture, not more than 5.0 per- for coloring foods generally in amounts cent. consistent with good manufacturing (2) Solvent residues (acetone, eth- practice, except that they may not be anol, and hexane), not more than 50 used to color foods for which standards parts per million, singly or, in com- of identity have been promulgated bination. under section 401 of the act unless (3) Total copper, not less than 4 per- added color is authorized by such cent and not more than 6 percent. standards. (d) Labeling requirements. (1) The label (4) Free copper, not more than 200 of the color additives and any mixtures parts per million. intended solely or in part for coloring (5) Lead (as Pb), not more than 10 purposes prepared therefrom shall con- parts per million. form to the requirements of § 70.25 of (6) Arsenic (as As), not more than 3 this chapter. parts per million. (2) The label of food products in- (7) Mercury (as Hg), not more than tended for human use, including but- 0.5 part per million. ter, cheese, and ice cream, that contain (8) Ratio of absorbance at 405 nano- cochineal extract or carmine shall spe- meters (nm) to absorbance at 630 nm, cifically declare the presence of the not less than 3.4 and not more than 3.9. color additive by listing its respective (9) Total copper chlorophyllins, not common or usual name, ‘‘cochineal ex- less than 95 percent of the sample dried tract’’ or ‘‘carmine,’’ in the statement at 100 °C for 1 hour. of ingredients in accordance with § 101.4 of this chapter. (c) Uses and restrictions. Sodium cop- (e) Exemption from certification. Cer- per chlorophyllin may be safely used to tification of these color additives is color citrus-based dry beverage mixes not necessary for the protection of the in an amount not exceeding 0.2 percent public health, and therefore batches in the dry mix. thereof are exempt from the certifi- (d) Labeling requirements. The label of cation requirements of section 721(c) of the color additive and any mixtures the act. prepared therefrom shall conform to the requirements of § 70.25 of this chap- [42 FR 15643, Mar. 22, 1977, as amended at 74 FR 216, Jan. 5, 2009] ter. (e) Exemption from certification. Cer- § 73.125 Sodium copper chlorophyllin. tification of this color additive is not (a) Identity. (1) The color additive so- necessary for the protection of the pub- dium copper chlorophyllin is a green to lic health, and therefore batches there- black powder prepared from chloro- of are exempt from the certification re- phyll by saponification and replace- quirements of section 721(c) of the act. ment of magnesium by copper. Chloro- [67 FR 35431, May 20, 2002] phyll is extracted from alfalfa

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§ 73.140 Toasted partially defatted § 73.160 Ferrous gluconate. cooked cottonseed flour. (a) Identity. The color additive fer- (a) Identity. (1) The color additive rous gluconate is the ferrous gluconate toasted partially defatted cooked cot- defined in the Food Chemicals Codex, tonseed flour is a product prepared as 3d Ed. (1981), pp. 122–123, which is incor- follows: Food quality cottonseed is porated by reference. Copies may be delinted and decorticated; the meats obtained from the National Academy are screened, aspirated, and rolled; Press, 2101 Constitution Ave. NW., moisture is adjusted, the meats heated, Washington, DC 20418, or at the Na- and the oil expressed; the cooked meats tional Archives and Records Adminis- are cooled, ground, and reheated to ob- tration (NARA). For information on tain a product varying in shade from the availability of this material at light to dark brown. NARA, call 202–741–6030, or go to: http:// (2) Color additive mixtures for food www.archives.gov/federallregister/ use made with toasted partially codeloflfederallregulations/ defatted cooked cottonseed flour may ibrllocations.html. contain only diluents that are suitable (b) Specifications. Ferrous gluconate and that are listed in this subpart as shall meet the specifications given in safe in color additive mixtures for the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by ref- coloring foods. erence. The availability of this incor- (b) Specifications. Toasted partially poration by reference is given in para- defatted cooked cottonseed flour shall graph (a) of this section. conform to the following specifica- (c) Uses and restrictions. Ferrous glu- tions: conate may be safely used in amounts Arsenic: It contains no added arsenic com- consistent with good manufacturing pound and therefore may not exceed a practice for the coloring of ripe olives. maximum natural background level of 0.2 (d) Labeling. The label of the color ad- part per million total arsenic, calculated ditive shall conform to the require- as As. ments of § 70.25 of this chapter. Lead (as Pb), not more than 10 parts per mil- (e) Exemption from certification. Cer- lion. tification of this color additive is not Free gossypol content, not more than 450 parts per million. necessary for the protection of the public health, and therefore batches there- (c) Uses and restrictions. The color ad- of are exempt from the certification re- ditive toasted partially defatted quirements of section 721(c) of the act. cooked cottonseed flour may be safely [42 FR 15643, Mar. 22, 1977, as amended at 47 used for coloring foods generally, in FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] amounts consistent with good manufacturing practice, except that it may § 73.165 Ferrous lactate. not be used to color foods for which (a) Identity. The color additive fer- standards of identity have been pro- rous lactate is the ferrous lactate de- mulgated under section 401 of the act, fined in § 184.1311 of this chapter. unless added color is authorized by (b) Specifications. Ferrous lactate such standards. shall meet the specifications given in (d) Labeling. The label of the color ad- the Food Chemicals Codex, 4th ed. ditive and any mixtures prepared (1996), pp. 154 to 155, which is incor- therefrom and intended solely or in porated by reference in accordance part for coloring purposes shall con- with 5 U.S.C. 552(a) and 1 CFR part 51. form to the requirements of § 70.25 of Copies are available from the National this chapter. Academy Press, 2101 Constitution Ave. (e) Exemption from certification. Cer- NW., Washington, DC 20418, or may be tification of this color additive is not examined at the Food and Drug Admin- necessary for the protection of the pub- istration’s Main Library, 10903 New lic health and therefore batches thereof Hampshire Ave., Bldg. 2, Third Floor, are exempt from the certification re- Silver Spring, MD 20993, 301–796–2039, or quirements of section 721(c) of the act. at the National Archives and Records

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Administration (NARA). For informa- 10 parts per million. Arsenic (as As), tion on the availability of this mate- not more than 1 part per million. rial at NARA, call 202–741–6030, or go (c) Uses and restrictions. Grape color to: http://www.archives.gov/ extract may be safely used for the federallregister/ coloring of nonbeverage food, except codeloflfederallregulations/ that it may not be used to color foods ibrllocations.html. for which standards of identity have (c) Uses and restrictions. Ferrous lac- been promulgated under section 401 of tate may be safely used in amounts the act, unless the use of added color is consistent with good manufacturing authorized by such standards. practice for the coloring of ripe olives. (d) Labeling. The color additive and (d) Labeling. The label of the color ad- any mixtures prepared therefrom in- ditive shall conform to the require- tended solely or in part for coloring ments of § 70.25 of this chapter. purposes shall bear, in addition to the other information required by the act, (e) Exemption from certification. Cer- labeling in accordance with the provi- tification of this color additive is not sions of § 70.25 of this chapter. necessary for the protection of the pub- (e) Exemption from certification. Cer- lic health, and therefore batches there- tification of this color additive is not of are exempt from the certification re- necessary for the protection of the pub- quirements of section 721(c) of the Fed- lic health, and therefore batches are eral Food, Drug, and Cosmetic Act (the exempt from the certification require- act). ments of section 721(c) of the Act. [61 FR 40319, Aug. 2, 1996, as amended at 66 [46 FR 47532, Sept. 29, 1981] FR 66742, Dec. 27, 2001; 81 FR 5590, Feb. 3, 2016] § 73.170 Grape skin extract (enocianina). § 73.169 Grape color extract. (a) Identity. (1) The color additive (a) Identity. (1) The color additive grape skin extract (enocianina) is a grape color extract is an aqueous solu- purplish-red liquid prepared by the tion of anthocyanin grape pigments aqueous extraction (steeping) of the made from Concord grapes or a dehy- fresh deseeded marc remaining after drated water soluble powder prepared grapes have been pressed to produce from the aqueous solution. The aque- grape juice or wine. It contains the ous solution is prepared by extracting common components of grape juice; the pigments from precipitated lees namely, anthocyanins, tartaric acid, produced during the storage of Concord tannins, sugars, minerals, etc., but not grape juice. It contains the common in the same proportions as found in components of grape juice, namely grape juice. During the steeping proc- anthocyanins, tartrates, malates, sug- ess, sulphur dioxide is added and most ars, and minerals, etc., but not in the of the extracted sugars are fermented same proportion as found in grape to alcohol. The extract is concentrated juice. The dehydrated water soluble by vacuum evaporation, during which powder is prepared by spray drying the practically all of the alcohol is re- aqueous solution containing added moved. A small amount of sulphur di- malto-dextrin. oxide may be present. (2) Color additive mixtures for food (2) Color additive mixtures for food use made with grape color extract may use made with grape skin extract contain only those diluents listed in (enocianina) may contain only those this subpart as safe and suitable in diluents listed in this subpart as safe color additive mixtures for coloring and suitable in color additive mixtures foods. for coloring foods. (b) Specifications. Grape color extract (b) Specifications. Grape skin extract shall conform to the following speci- (enocianina) shall conform to the fol- fications: Pesticide residues, not more lowing specifications: than permitted in or on grapes by regu- Pesticide residues, not more than permitted lations promulgated under section 408 in or on grapes by regulations promulgated of the Federal Food, Drug, and Cos- under section 408 of the Federal Food, metic Act. Lead (as Pb), not more than Drug, and Cosmetic Act.

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Lead (as Pb), not more than 10 parts per mil- Mercury, not more than 1 part per million. lion. Heavy metals (as Pb), not more than 10 parts Arsenic (as As), not more than 1 part per per million. million. Astaxanthin, not less than 1.5 percent. (c) Uses and restrictions. Grape skin (c) Uses and restrictions. extract (enocianina) may be safely Haematococcus algae meal may be used for the coloring of still and car- safely used in the feed of salmonid fish bonated drinks and ades, beverage in accordance with the following pre- bases, and alcoholic beverages subject scribed conditions: to the following restrictions: (1) The color additive is used to en- (1) It may not be used to color foods hance the pink to orange-red color of for which standards of identity have the flesh of salmonid fish. been promulgated under section 401 of (2) The quantity of astaxanthin in the act unless artificial color is author- finished feed, from haematococcus ized by such standards. algae meal when used alone or in com- (2) Its use in alcoholic beverages bination with other astaxanthin color shall be in accordance with the provi- additive sources listed in this part 73, sions of parts 4 and 5, title 27 CFR. shall not exceed 80 milligrams per kilo- (d) Labeling requirements. The label of gram (72 grams per ton) of finished the color additive and any mixtures feed. prepared therefrom intended solely or (d) Labeling requirements. (1) The la- in part for coloring purposes shall con- beling of the color additive and any form to the requirements of § 70.25 of premixes prepared therefrom shall bear this chapter. The common or usual expiration dates for the sealed and name of the color additive is ‘‘grape open container (established through skin extract’’ followed, if desired, by generally accepted stability testing ‘‘(enocianina)’’. methods), other information required (e) Exemption from certification. Cer- by § 70.25 of this chapter, and adequate tification of this color additive is not directions to prepare a final product necessary for the protection of the pub- complying with the limitations pre- lic health, and therefore batches there- scribed in paragraph (c) of this section. of are exempt from the certification re- (2) The presence of the color additive quirements of section 721(c) of the act. in finished fish feed prepared according to paragraph (c) of this section shall be § 73.185 Haematococcus algae meal. declared in accordance with § 501.4 of (a) Identity. (1) The color additive this chapter. haematococcus algae meal consists of (3) The presence of the color additive the comminuted and dried cells of the in salmonid fish that have been fed alga Haematococcus pluvialis. feeds containing haematococcus algae (2) Haematococcus algae meal may meal shall be declared in accordance be added to the fish feed only as a com- with §§ 101.22(b), (c), and (k)(2), and ponent of a stabilized color additive 101.100(a)(2) of this chapter. mixture. Color additive mixtures for (e) Exemption from certification. Cer- fish feed use made with haematococcus tification of this color additive is not algae meal may contain only those necessary for the protection of the pub- diluents that are suitable and are list- lic health, and therefore batches there- ed in this subpart as safe for use in of are exempt from the certification re- color additive mixtures for coloring quirements of section 721(c) of the act. foods. [65 FR 41584, July 6, 2000] (b) Specifications. Haematococcus algae meal shall conform to the fol- § 73.200 Synthetic iron oxide. lowing specifications and shall be free (a) Identity. (1) The color additive from impurities other than those synthetic iron oxide consists of any named to the extent that such impuri- one or any combination of syn- ties may be avoided by good manufac- thetically prepared iron oxides, includ- turing practice: ing the hydrated forms. It is free from Physical state, solid. admixture with other substances. Lead, not more than 5 parts per million. (2) Color additive mixtures for food Arsenic, not more than 2 parts per million. use made with synthetic iron oxide

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may contain only those diluents that § 73.250 Fruit juice. are suitable and that are listed in this (a) Identity. (1) The color additive subpart as safe for use in color additive fruit juice is prepared either by ex- mixtures for coloring foods. pressing the juice from mature vari- (b) Specifications. (1) Synthetic iron eties of fresh, edible fruits, or by the oxide for human food use shall conform water infusion of the dried fruit. The to the following specifications: color additive may be concentrated or Arsenic (as As), not more than 3 milligrams dried. The definition of fruit juice in per kilogram (mg/kg) (3 parts per million this paragraph is for the purpose of (ppm)). identity as a color additive only and Lead (as Pb), not more than 5 mg/kg (5 ppm). shall not be construed as a standard of Mercury (as Hg), not more than 1 mg/kg (1 identity under section 401 of the act. ppm). However, where a standard of identity (2) Synthetic iron oxide for dog and for a particular fruit juice has been cat food use shall conform to the fol- promulgated under section 401 of the lowing specifications: act, it shall conform to such standard. Arsenic (as As), not more than 5 parts per (2) Color additive mixtures made million. with fruit juice may contain as Lead (as Pb), not more than 20 parts per mil- diluents only those substances listed in lion. this subpart as safe and suitable in Mercury (as Hg), not more than 3 parts per color additive mixtures for coloring million. foods. (c) Uses and restrictions. (1) Synthetic (b) Uses and restrictions. Fruit juice iron oxide may be safely used for may be safely used for the coloring of human food use subject to the fol- foods generally, in amounts consistent lowing restrictions: with good manufacturing practice, ex- (i) In sausage casings intended for cept that it may not be used to color human consumption in an amount not foods for which standards of identity exceeding 0.10 percent by weight of the have been promulgated under section finished food. 401 of the act, unless the use of added (ii) In soft and hard candy, mints, color is authorized by such standards. and chewing gum at levels consistent (c) Labeling. The color additive and with good manufacturing practice, ex- any mixtures intended solely or in part cept that it may not be used to color for coloring purposes prepared there- foods for which standards of identity from shall bear, in addition to the have been issued under section 401 of other information required by the act, the Federal Food, Drug, and Cosmetic labeling in accordance with the provi- Act, unless the use of the added color is sions of § 70.25 of this chapter. authorized by such standards. (d) Exemption from certification. Cer- (2) Synthetic iron oxide may be safe- tification of this color additive is not ly used for the coloring of dog and cat necessary for the protection of the pub- foods in an amount not exceeding 0.25 lic health, and therefore batches there- percent by weight of the finished food. of are exempt from the certification re- (d) Labeling requirements. The label of quirements of section 721(c) of the act. the color additive and any mixture pre- [42 FR 15643, Mar. 22, 1977, as amended at 60 pared therefrom intended solely or in FR 52629, Oct. 10, 1995] part for coloring purposes shall conform to the requirements of § 70.25 of § 73.260 Vegetable juice. this chapter. (a) Identity. (1) The color additive (e) Exemption from certification. Cer- vegetable juice is prepared either by tification of this color additive is not expressing the juice from mature vari- necessary for the protection of the pub- eties of fresh, edible vegetables, or by lic health, and therefore batches there- the water infusion of the dried vege- of are exempt from the certification re- table. The color additive may be con- quirements of section 721(c) of the act. centrated or dried. The definition of [42 FR 15643, Mar. 22, 1977, as amended at 59 vegetable juice in this paragraph is for FR 10578, Mar. 7, 1994; 80 FR 14842, Mar. 20, the purpose of identity as a color addi- 2015] tive only, and shall not be construed as

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a standard of identity under section 401 (2) The quantity of the color additive of the act. However, where a standard incorporated in the feed is such that of identity for a particular vegetable the finished feed: juice has been promulgated under sec- (i) Is supplemented sufficiently with tion 401 of the act, it shall conform to xanthophyll and associated carotenoids such standard. so as to accomplish the intended effect (2) Color additive mixtures made described in paragraph (b)(1) of this with vegetable juice may contain as section; and diluents only those substances listed in (ii) Meets the tolerance limitation this subpart as safe and suitable in for ethoxyquin in animal feed pre- color additive mixtures for coloring scribed in § 573.380 of this chapter. foods. (c) Labeling. The label of the color ad- (b) Uses and restrictions. Vegetable ditives and any premixes prepared juice may be safely used for the color- therefrom shall bear in addition to the information required by § 70.25 of this ing of foods generally, in amounts con- chapter. sistent with good manufacturing prac- (1) A statement of the concentrations tice, except that it may not be used to of xanthophyll and ethoxyquin con- color foods for which standards of iden- tained therein. tity have been promulgated under sec- (2) Adequate directions to provide a tion 401 of the act, unless the use of final product complying with the limi- added color is authorized by such tations prescribed in paragraph (b) of standards. this section. (c) Labeling. The color additive and (d) Exemption from certification. Cer- any mixtures intended solely or in part tification of this color additive is not for coloring purposes prepared there- necessary for the protection of the pub- from shall bear, in addition to the lic health and therefore batches thereof other information required by the act, are exempt from the certification re- labeling in accordance with the provi- quirements of section 721(c) of the act. sions of § 70.25 of this chapter. (d) Exemption from certification. Cer- § 73.295 Tagetes (Aztec marigold) meal tification of this color additive is not and extract. necessary for the protection of the pub- (a) Identity. (1) The color additive lic health, and therefore batches there- tagetes (Aztec marigold) meal is the of are exempt from the certification re- dried, ground flower petals of the Aztec quirements of section 721(c) of the act. marigold (Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin. [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] (2) The color additive tagetes (Aztec marigold) extract is a hexane extract § 73.275 Dried algae meal. of the flower petals of the Aztec marigold (Tagetes erecta L.). It is mixed with (a) Identity. The color additive dried an edible vegetable oil, or with an edi- algae meal is a dried mixture of algae ble vegetable oil and a hydrogenated cells (genus Spongiococcum, separated edible vegetable oil, and not more than from its culture broth), molasses, 0.3 percent ethoxyquin. It may also be cornsteep liquor, and a maximum of 0.3 mixed with soy flour or corn meal as a percent ethoxyquin. The algae cells are carrier. produced by suitable fermentation, (b) Specifications. (1) Tagetes (Aztec under controlled conditions, from a marigold) meal is free from admixture pure culture of the genus with other plant material from Spongiococcum. Tageteserecta L. or from plant material (b) Uses and restrictions. The color ad- or flowers of any other species of ditive dried algae meal may be safely plants. used in chicken feed in accordance (2) Tagetes (Aztec marigold) extract with the following prescribed condi- shall be prepared from tagetes (Aztec tions: marigold) petals meeting the specifica- (1) The color additive is used to en- tions set forth in paragraph (b)(1) of hance the yellow color of chicken skin this section and shall conform to the and eggs. following additional specifications:

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Melting point ...... 53.5–55.0 °C. tion of edible carrots (Daucus carota L.) Iodine value ...... 132–145. with subsequent removal of the hexane Saponification value ...... 175–200. by vacuum distillation. The resultant Acid value ...... 0.60–1.20. Titer ...... 35.5–37.0 °C. mixture of solid and liquid extractives Unsaponifiable matter ...... 23.0 percent–27.0 percent. consists chiefly of oils, fats, waxes, and Hexane residue ...... Not more than 25 p.p.m. carrotenoids naturally occurring in All determinations, except the hexane carrots. The definition of carrot oil in residue, shall be made on the initial ex- this paragraph is for the purpose of tract of the flower petals (after drying identity as a color additive only and in a vacuum oven at 60 °C. for 24 hours) shall not be construed as setting forth prior to the addition of the oils and an official standard for carrot oil or ethoxyquin. The hexane determination carrot oleoresin under section 401 of shall be made on the color additive the act. after the addition of the vegetable oils, (2) Color additive mixtures for food hydrogenated vegetable oils, and use made with carrot oil may contain ethoxyquin. only those diluents listed in this sub- (c) Uses and restrictions. The color ad- part as safe and suitable in color addi- ditives tagetes (Aztec marigold) meal tive mixtures for coloring foods. and extract may be safely used in (b) Specifications. Carrot oil shall con- chicken feed in accordance with the tain no more than 25 parts per million following prescribed conditions: of hexane. (1) The color additives are used to en- (c) Uses and restrictions. Carrot oil hance the yellow color of chicken skin may be safely used for coloring foods and eggs. generally, in amounts consistent with (2) The quantity of the color addi- good manufacturing practice, except tives incorporated in the feed is such that it may not be used to color foods that the finished feed: for which standards of identity have (i) Is supplemented sufficiently with been promulgated under section 401 of xanthophyll and associated carotenoids the act unless the use of added color is so as to accomplish the intended effect authorized by such standards. described in paragraph (c)(1) of this (d) Labeling requirements. The label of section; and the color additive and any mixtures (ii) Meets the tolerance limitation prepared therefrom intended solely or for ethoxyquin in animal feed pre- in part for coloring purposes shall con- scribed in § 573.380 of this chapter. form to the requirements of § 70.25 of (d) Labeling requirements. The label of this chapter. the color additives and any premixes (e) Exemption from certification. Cer- prepared therefrom shall bear, in addi- tification of this color additive is not tion to the information required by necessary for the protection of the pub- § 70.25 of this chapter: lic health, and therefore batches there- (1) A statement of the concentrations of are exempt from the certification re- of xanthophyll and ethoxyquin con- quirements of section 721(c) of the act. tained therein. (2) Adequate directions to provide a § 73.315 Corn endosperm oil. final product complying with the limi- (a) Identity. (1) The color additive tations prescribed in paragraph (c) of corn endosperm oil is a reddish-brown this section. liquid composed chiefly of glycerides, (e) Exemption from certification. Cer- fatty acids, sitosterols, and carotenoid tification of this color additive is not pigments obtained by isopropyl alcohol necessary for the protection of the pub- and hexane extraction from the gluten lic health, and therefore batches there- fraction of yellow corn grain. The defi- of are exempt from the certification re- nition of corn endosperm oil in this quirements of section 721(c) of the act. paragraph is for the purpose of definition as a color additive only and shall § 73.300 Carrot oil. not be construed as a food standard of (a) Identity. (1) The color additive identity under section 401 of the act. carrot oil is the liquid or the solid por- (2) Color additive mixtures for food tion of the mixture or the mixture use made with corn endosperm oil may itself obtained by the hexane extrac- contain only those diluents listed in

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this subpart as safe and suitable in (b) Uses and restrictions. Paprika may color additive mixtures for coloring be safely used for the coloring of foods foods. generally, in amounts consistent with (b) Specifications. Corn endosperm oil good manufacturing practice, except conforms to the following specifica- that it may not be used to color foods tions: for which standards of identity have Total fatty acids, not less than 85 percent. been promulgated under section 401 of Iodine value, 118 to 134. the act, unless the use of added color is Saponification value, 165 to 185. authorized by such standards. Unsaponifiable matter, not more than 14 per- (c) Labeling. The color additive and cent. any mixtures intended solely or in part Hexane, not more than 25 narts per millimn. for coloring purposes prepared there- Isopropyl alcohol, not more than 100 parts from shall bear, in addition to the per million. other information required by the act, (c) Uses and restrictions. The color ad- labeling in accordance with the provi- ditive corn endosperm oil may be safe- sions of § 70.25 of this chapter. ly used in chicken feed in accordance (d) Exemption from certification. Cer- with the following prescribed condi- tification of this color additive is not tions: necessary for the protection of the pub- (1) The color additive is used to en- lic health, and therefore batches there- hance the yellow color of chicken skin of are exempt from the certification re- and eggs. quirements of section 721(c) of the act. (2) The quantity of the color additive incorporated in the feed is such that § 73.345 Paprika oleoresin. the finished feed is supplemented sufficiently with xanthophyll and associ- (a) Identity. (1) The color additive pa- ated carotenoids so as to accomplish prika oleoresin is the combination of the intended effect described in para- flavor and color principles obtained graph (c)(1) of this section. from paprika (Capsicum annuum L.) by (d) Labeling requirements. The label of extraction, using any one or a com- the color additive and any premixes bination of the following solvents: prepared therefrom shall bear, in addi- Acetone Isopropyl alcohol tion to the information required by Ethyl alcohol Methyl alcohol § 70.25 of this chapter, a statement of Ethylene dichloride Methylene chloride the concentration of xanthophyll con- Hexane Trichloroethylene tained therein. (e) Exemption from certification. Cer- The definition of paprika oleoresin in tification of this color additive is not this paragraph is for the purpose of necessary for the protection of the pub- identity as a color additive only, and lic health, and therefore batches there- shall not be construed as setting forth of are exempt from the certification re- an official standard for paprika oleo- quirements of section 721(c) of the act. resin under section 401 of the act. (2) Color additive mixtures made § 73.340 Paprika. with paprika oleoresin may contain as (a) Identity. (1) The color additive pa- diluents only those substances listed in prika is the ground dried pod of mild this subpart as safe and suitable in capsicum (Capsicum annuum L.). The color additive mixtures for coloring definition of paprika in this paragraph foods. is for the purpose of identity as a color (b) Specifications. Paprika oleoresin additive only and shall not be con- shall contain no more residue of the strued as setting forth an official solvents listed in paragraph (a)(1) of standard for paprika under section 401 this section than is permitted of the of the act. corresponding solvents in spice (2) Color additive mixtures made with paprika may contain as diluents oleoresins under applicable food addi- only those substances listed in this tive regulations in parts 170 through subpart as safe and suitable in color 189 of this chapter. additive mixtures for coloring foods.

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(c) Uses and restrictions. Paprika oleo- serts, hard and soft candies (including resin may be safely used for the color- lozenges), nutritional supplement tab- ing of foods generally in amounts con- lets and gelatin capsules, and chewing sistent with good manufacturing prac- gum. tice, except that it may not be used to (ii) In amounts up to 0.07 percent, by color foods for which standards of iden- weight, in the following: tity have been promulgated under sec- (A) Distilled spirits containing not tion 401 of the act, unless the use of less than 18 percent and not more than added color is authorized by such 25 percent alcohol by volume. standards. (B) Cordials, liqueurs, flavored alco- (d) Labeling. The color additive and holic malt beverages, wine coolers, and any mixtures intended solely or in part cocktails. for coloring purposes prepared there- (C) Non-alcoholic cocktail mixes and from shall bear, in addition to the mixers, such as margarita mix, Bloody other information required by the act, Mary mix, and daiquiri mix, but ex- labeling in accordance with the provi- cluding eggnog, tonic water, and bev- sions of § 70.25 of this chapter. erages that are typically consumed (e) Exemption from certification. Cer- without added alcohol (e.g., fruit tification of this color additive is not juices, fruit juice drinks, and soft necessary for the protection of the pub- drinks). lic health, and therefore batches there- (iii) In egg decorating kits used for of are exempt from the certification re- coloring the shells of eggs in amounts quirements of section 721(c) of the act. consistent with good manufacturing practice. § 73.350 Mica-based pearlescent pig- (2) The color additive may not be ments. used to color foods for which standards (a) Identity. (1) The color additive is of identity have been issued under sec- formed by depositing titanium salts tion 401 of the act, unless the use of the onto mica, followed by heating to added color is authorized by such produce titanium dioxide on mica. standards. Mica used to manufacture the color ad- (d) Labeling. The label of the color additive shall conform in identity to the ditive and of any mixture prepared requirements of § 73.1496(a)(1). therefrom intended solely or in part for (2) Color additive mixtures for food coloring purposes shall conform to the use made with mica-based pearlescent requirements of § 70.25 of this chapter. pigments may contain only those (e) Exemption from certification. Cer- diluents listed in this subpart as safe tification of this color additive is not and suitable for use in color additive necessary for the protection of the pub- mixtures for coloring food. lic health and therefore batches thereof (b) Specifications. Mica-based pearl- are exempt from the certification re- escent pigments shall conform to the quirements of section 721(c) of the act. following specifications and shall be [71 FR 31929, June 2, 2006, as amended at 78 free from impurities other than those FR 35117, June 12, 2013; 80 FR 32307, June 8, named to the extent that such other 2015; 80 FR 58602, Sept. 30, 2015] impurities may be avoided by good manufacturing practice: § 73.352 Paracoccus pigment. (1) Lead (as Pb), not more than 4 (a) Identity. (1) The color additive parts per million (ppm). paracoccus pigment consists of the (2) Arsenic (as As), not more than 3 heat-killed, dried cells of a nonpatho- ppm. genic and nontoxicogenic strain of the (3) Mercury (as Hg), not more than 1 bacterium Paracoccus carotinifaciens ppm. and may contain added calcium car- (c) Uses and restrictions. (1) The sub- bonate to adjust the astaxanthin level. stance listed in paragraph (a) of this (2) Color additive mixtures for fish section may be safely used as a color feed use made with paracoccus pigment additive in food as follows: may contain only those diluents that (i) In amounts up to 1.25 percent, by are suitable and are listed in this sub- weight, in the following foods: Cereals, part as safe for use in color additive confections and frostings, gelatin des- mixtures for coloring foods.

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(b) Specifications. Paracoccus pigment thereof are exempt from the certifi- shall conform to the following speci- cation requirements of section 721(c) of fications and shall be free from impuri- the act. ties, other than those named, to the ex- [74 FR 58845, Nov. 16, 2009] tent that such impurities may be avoided by good manufacturing prac- § 73.355 Phaffia yeast. tice: (1) Physical state, solid. (a) Identity. (1) The color additive (2) Lead, not more than 5 milligrams phaffia yeast consists of the killed, per kilogram (mg/kg) (5 parts per mil- dried cells of a nonpathogenic and lion (ppm)). nontoxicogenic strain of the yeast (3) Arsenic, not more than 2 mg/kg (2 Phaffia rhodozyma. ppm). (2) Phaffia yeast may be added to the (4) Mercury, not more than 1 mg/kg (1 fish feed only as a component of a sta- ppm). bilized color additive mixture. Color (5) Heavy metals (as Pb), not more additive mixtures for fish feed use than 10 mg/kg (10 ppm). made with phaffia yeast may contain (6) Astaxanthin, not less than 1.75 only those diluents that are suitable percent. and are listed in this subpart as safe (c) Uses and restrictions. Paracoccus for use in color additive mixtures for pigment may be safely used in the feed coloring foods. of salmonid fish in accordance with the (b) Specifications. Phaffia yeast shall following prescribed conditions: conform to the following specifications (1) The color additive is used to en- and shall be free from impurities other hance the pink to orange-red color of than those named to the extent that the flesh of salmonid fish. such impurities may be avoided by (2) The quantity of astaxanthin in good manufacturing practice: finished feed, from paracoccus pigment Physical state, solid. when used alone or in combination Lead, not more than 5 parts per million. with other astaxanthin color additive Arsenic, not more than 2 parts per million. sources listed in this part 73, shall not Mercury, not more than 1 part per million. exceed 80 mg/kg (72 grams per ton) of Heavy metals (as Pb), not more than 10 parts finished feed. per million. Astaxanthin, not less than 0.4 percent. (d) Labeling requirements. (1) The labeling of the color additive and any (c) Uses and restrictions. Phaffia yeast premixes prepared therefrom shall bear may be safely used in the feed of expiration dates for the sealed and salmonid fish in accordance with the open container (established through following prescribed conditions: generally accepted stability testing (1) The color additive is used to en- methods), other information required hance the pink to orange-red color of by § 70.25 of this chapter, and adequate the flesh of salmonid fish. directions to prepare a final product (2) The quantity of astaxanthin in complying with the limitations pre- finished feed, from phaffia yeast when scribed in paragraph (c) of this section. used alone or in combination with (2) The presence of the color additive other astaxanthin color additive in finished fish feed prepared according sources listed in this part 73, shall not to paragraph (c) of this section shall be exceed 80 milligrams per kilogram (72 declared in accordance with § 501.4 of grams per ton) of finished feed. this chapter. (d) Labeling requirements. (1) The la- (3) The presence of the color additive beling of the color additive and any in salmonid fish that have been fed premixes prepared therefrom shall bear feeds containing paracoccus pigment expiration dates for the sealed and shall be declared in accordance with open container (established through §§ 101.22(b), (c), and (k)(2), and generally accepted stability testing 101.100(a)(2) of this chapter. methods), other information required (e) Exemption from certification. Cer- by § 70.25 of this chapter, and adequate tification of this color additive is not directions to prepare a final product necessary for the protection of the pub- complying with the limitations pre- lic health, and therefore, batches scribed in paragraph (c) of this section.

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(2) The presence of the color additive (d) Labeling. The label of the color ad- in finished fish feed prepared according ditive shall conform to the require- to paragraph (c) of this section shall be ments of § 70.25 of this chapter. declared in accordance with § 501.4 of (e) Exemption from certification. Cer- this chapter. tification of this color additive is not (3) The presence of the color additive necessary for the protection of the pub- in salmonid fish that have been fed lic health, and therefore batches there- feeds containing phaffia yeast shall be of are exempt from the certification re- declared in accordance with §§ 101.22(b), quirements of section 721(c) of the Act. (c), and (k)(2) and 101.100(a)(2) of this [42 FR 15643, Mar. 22, 1977, as amended at 47 chapter. FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] (e) Exemption from certification. Cer- tification of this color additive is not § 73.500 Saffron. necessary for the protection of the pub- (a) Identity. (1) The color additive saf- lic health, and therefore batches there- fron is the dried stigma of Crocus of are exempt from the certification re- sativus L. The definition of saffron in quirements of section 721(c) of the act. this paragraph is for the purpose of identity as a color additive only, and [65 FR 41587, July 6, 2000] shall not be construed as setting forth an official standard for saffron under § 73.450 Riboflavin. section 401 of the act. (a) Identity. (1) The color additive ri- (2) Color additive mixtures made boflavin is the riboflavin defined in the with saffron may contain as diluents Food Chemicals Codex, 3d Ed. (1981), only those substances listed in this pp. 262–263, which is incorporated by subpart as safe and suitable in color reference. Copies may be obtained from additive mixtures for coloring foods. the National Academy Press, 2101 Con- (b) Uses and restrictions. Saffron may stitution Ave. NW., Washington, DC be safely used for the coloring of foods 20418, or at the National Archives and generally, in amounts consistent with Records Administration (NARA). For good manufacturing practice, except information on the availability of this that it may not be used to color foods material at NARA, call 202–741–6030, or for which standards of identity have been promulgated under section 401 of go to: http://www.archives.gov/ the act, unless the use of added color is federallregister/ authorized by such standards. codeloflfederallregulations/ (c) Labeling. The color additive and ibr locations.html. l any mixtures intended solely or in part (2) Color additive mixtures made for coloring purposes prepared there- with riboflavin may contain as diluents from shall bear, in addition to the only those substances listed in this other information required by the act, subpart as safe and suitable for use in labeling in accordance with the provi- color additive mixtures for coloring sions of § 70.25 of this chapter. foods. (d) Exemption from certification. Cer- (b) Specifications. Riboflavin shall tification of this color additive is not meet the specifications given in the necessary for the protection of the pub- Food Chemicals Codex, 3d Ed. (1981), lic health, and therefore batches there- which is incorporated by reference. The of are exempt from the certification re- availability of this incorporation by quirements of section 721(c) of the act. reference is given in paragraph (a)(1) of this section. § 73.530 Spirulina extract. (c) Uses and restrictions. Riboflavin (a) Identity. (1) The color additive may be safely used for the coloring of spirulina extract is prepared by the fil- foods generally, in amounts consistent tered aqueous extraction of the dried with good manufacturing practice; ex- biomass of Arthrospira platensis. The cept that it may not be used to color color additive contains phycocyanins foods for which standards of identity as the principal coloring components. have been promulgated under section (2) Color additive mixtures for food 401 of the act, unless the use of added use made with spirulina extract may color is authorized by such standards. contain only those diluents that are

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suitable and are listed in this subpart (2) Color additive mixtures for food as safe for use in color additive mix- use made with titanium dioxide may tures for coloring foods. contain only those diluents that are (b) Specifications. Spirulina extract suitable and that are listed in this sub- must conform to the following speci- part as safe in color additive mixtures fications and must be free from impuri- for coloring foods, and the following: ties, other than those named, to the ex- Silicon dioxide, SiO2 and/or aluminum tent that such other impurities may be oxide, Al2 O3, as dispersing aids—not avoided by good manufacturing prac- more than 2 percent total. tice: (b) Specifications. Titanium dioxide (1) Lead, not more than 2 milligrams shall conform to the following speci- per kilogram (mg/kg) (2 part per mil- fications: lion (ppm)); (2) Arsenic, not more than 2 mg/kg (2 Lead (as Pb), not more than 10 parts per mil- ppm); lion. (3) Mercury, not more than 1 mg/kg (1 Arsenic (as As), not more than 1 part per ppm); and million. (4) Negative for microcystin toxin. Antimony (as Sb), not more than 2 parts per million. (c) Uses and restrictions. Spirulina ex- Mercury (as Hg), not more than 1 part per tract may be safely used for coloring million. confections (including candy and chew- Loss on ignition at 800 °C. (after drying for 3 ing gum), frostings, ice cream and fro- hours at 105 °C.), not more than 0.5 percent. zen desserts, dessert coatings and top- Water soluble substances, not more than 0.3 pings, beverage mixes and powders, yo- percent. gurts, custards, puddings, cottage Acid soluble substances, not more than 0.5 cheese, gelatin, breadcrumbs, ready-to- percent.

eat cereals (excluding extruded cere- TiO2, not less than 99.0 percent after drying als), and coating formulations applied for 3 hours at 105 °C. to dietary supplement tablets and capsules, at levels consistent with good Lead, arsenic, and antimony shall be manufacturing practice, except that it determined in the solution obtained by may not be used to color foods for boiling 10 grams of the titanium diox- which standards of identity have been ide for 15 minutes in 50 milliliters of issued under section 401 of the Federal 0.5N hydrochloric acid. Food, Drug, and Cosmetic Act, unless (c) Uses and restrictions. The color ad- the use of the added color is authorized ditive titanium dioxide may be safely by such standards. used for coloring foods generally, sub- (d) Labeling requirements. The label of ject to the following restrictions: the color additive and of any mixture (1) The quantity of titanium dioxide prepared therefrom intended solely or does not exceed 1 percent by weight of in part for coloring purposes must con- the food. form to § 70.25 of this chapter. (2) It may not be used to color foods (e) Exemption from certification. Cer- for which standards of identity have tification of this color additive is not been promulgated under section 401 of necessary for the protection of the pub- the act unless added color is authorized lic health, and therefore batches there- by such standards. of are exempt from the certification requirements of section 721(c) of the Fed- (d) Labeling. The label of the color ad- eral Food, Drug, and Cosmetic Act. ditive and any mixtures intended solely or in part for coloring purposes pre- [78 FR 49120, Aug. 13, 2013, as amended at 79 pared therefrom shall conform to the FR 20098, May 13, 2014; 80 FR 50765, Aug. 21, requirements of § 70.25 of this chapter. 2015] (e) Exemption from certification. Cer- § 73.575 Titanium dioxide. tification of this color additive is not necessary for the protection of the pub- (a) Identity. (1) The color additive ti- lic health and therefore batches thereof tanium dioxide is synthetically pre- are exempt from the certification re- pared TiO , free from admixture with 2 quirements of section 721(c) of the act. other substances.

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§ 73.585 Tomato lycopene extract; to- codeloflfederallregulations/ mato lycopene concentrate. ibrllocations.html (a) Identity. (1) The color additive to- (2) Tomato lycopene concentrate mato lycopene extract is a red to dark shall conform to the following speci- brown viscous oleoresin extracted with fication: Lycopene, not less than 60 ethyl acetate from tomato pulp fol- percent of oleoresin as determined by lowed by removal of the solvent by the method identified in paragraph evaporation. The pulp is produced from (b)(1) of this section. fresh, edible varieties of the tomato by (c) Uses and restrictions. Tomato lyco- removing the liquid. The main coloring pene extract and tomato lycopene con- component is lycopene. centrate may be safely used for coloring foods generally in amounts con- (2) The color additive tomato lyco- sistent with good manufacturing prac- pene concentrate is a powder prepared tice, except that they may not be used from tomato lycopene extract by re- to color foods for which standards of moving most of the tomato lipids with identity have been issued under section ethyl acetate and then evaporating off 401 of the act, unless the use of added the solvent. color is authorized by such standards. (3) Color additive mixtures made (d) Labeling. The label of the color ad- with tomato lycopene extract or to- ditive shall conform to the require- mato lycopene concentrate may con- ments of § 70.25 of this chapter. tain only those diluents listed in this (e) Exemption from certification. Cer- subpart as safe and suitable for use in tification of this color additive is not color additive mixtures for coloring necessary for the protection of the pub- food. lic health, and therefore batches there- (b) Specifications. (1) Tomato lycopene of are exempt from the certification re- extract shall conform to the following quirements of section 721(c) of the act. specification: Lycopene, not less than 5.5 percent of oleoresin as determined [70 FR 43045, July 26, 2005, as amended at 81 by the method entitled ‘‘Qualitative FR 5590, Feb. 3, 2016] Analysis of Lycopene, Its Isomers and § 73.600 Turmeric. Other Carotenoids in Different Con- centrations of Lyc-O-Mato ® (Tomato (a) Identity. (1) The color additive Oleoresin) and in Tomato Pulp by High turmeric is the ground rhizome of Performance Liquid Chromatography Curcuma longa L. The definition of (HPLC),’’ S.O.P. number : Lab/119/01, turmeric in this paragraph is for the Revision 01, dated May 30, 2001, pub- purpose of identity as a color additive lished by LycoRed Natural Products only, and shall not be construed as set- Industries, which is incorporated by ting forth an official standard for tur- reference, or an equivalent method. meric under section 401 of the act. The Director of the Office of the Fed- (2) Color additive mixtures made eral Register approves this incorpora- with turmeric may contain as diluents tion by reference in accordance with 5 only those substances listed in this U.S.C. 552(a) and 1 CFR part 51. You subpart as safe and suitable in color may obtain a copy of the method from additive mixtures for coloring foods. the Center for Food Safety and Applied (b) Uses and restrictions. Turmeric Nutrition (HFS–200), Food and Drug may be safely used for the coloring of Administration, 5100 Paint Branch foods generally, in amounts consistent Pkwy., College Park, MD 20740. You with good manufacturing practice, ex- may inspect a copy at theFood and cept that it may not be used to color Drug Administration’s Main Library, foods for which standards of identity 10903 New Hampshire Ave., Bldg. 2, have been promulgated under section Third Floor, Silver Spring, MD 20993, 401 of the act, unless the use of added 301–796–2039, or at the National Ar- color is authorized by such standards. chives and Records Administration (c) Labeling. The color additive and (NARA). For information on the avail- any mixtures intended solely or in part ability of this material at NARA, call for coloring purposes prepared there- 202–741–6030, or go to: http:// from shall bear, in addition to the www.archives.gov/federallregister/ other information required by the act,

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labeling in accordance with the provi- color foods for which standards of iden- sions of § 70.25 of this chapter. tity have been promulgated under sec- (d) Exemption from certification. Cer- tion 401 of the act, unless the use of tification of this color additive is not added color is authorized by such necessary for the protection of the pub- standards. lic health, and therefore batches there- (d) Labeling. The color additive and of are exempt from the certification re- any mixtures intended solely or in part quirements of section 721(c) of the act. for coloring purposes prepared therefrom shall bear, in addition to the § 73.615 Turmeric oleoresin. other information required by the act, (a) Identity. (1) The color additive labeling in accordance with the provi- turmeric oleoresin is the combination sions of § 70.25 of this chapter. of flavor and color principles obtained (e) Exemption from certification. Cer- from turmeric (Curcuma longa L.) by tification of this color additive is not extraction using any one or a combina- necessary for the protection of the pub- tion of the following solvents: lic health, and therefore batches thereof are exempt from the certification re- Acetone Isopropyl alcohol quirements of section 721(c) of the act. Ethyl alcohol Methyl alcohol Ethylene dichloride Methylene chloride Hexane Trichloroethylene Subpart B—Drugs The definition of turmeric oleoresin in § 73.1001 Diluents in color additive this paragraph is for the purpose of mixtures for drug use exempt from identity as a color additive only, and certification. shall not be construed as setting forth The following diluents may be safely an official standard for turmeric oleo- used in color additive mixtures that resin under section 401 of the act. are exempt from certification and (2) Color additive mixtures made which are to be used for coloring drugs, with turmeric oleoresin may contain as subject to the condition that each diluents only those substances listed in straight color in the mixture has been this subpart as safe and suitable in exempted from certification or, if not color additive mixtures for coloring so exempted, is from a batch that has foods. previously been certified and has not (b) Specifications. Turmeric oleoresin changed in composition since certifi- shall contain no more residue of the cation. Such listing of diluents is not solvents listed under paragraph (a)(1) to be construed as superseding any of of this section than is permitted for the other requirements of the Federal the corresponding solvents in spice Food, Drug, and Cosmetic Act with re- oleoresins under applicable food addi- spect to drugs, including new drugs. If tive regulation in parts 170 through 189 a definition and specification for a par- of this chapter. ticular diluent is not set forth in this (c) Uses and restrictions. Turmeric ole- subpart, the material shall be of a pu- oresin may be safely used for the color- rity consistent with its intended use. ing of foods generally, in amounts con- (a) Ingested drugs—(1) General use. sistent with good manufacturing prac- Diluents listed in § 73.1(a) and the fol- tice, except that it may not be used to lowing:

Substances Definitions and specifications Restrictions

Alcohol, specially denatured ...... As set forth in 26 CFR, pt. 212 ...... As set forth in 26 CFR, pt. 211. Cetyl alcohol ...... As set forth in N.F. XI. Isopropyl alcohol ...... In color coatings for pharmaceutical forms, no residue. Polyoxyethylene (20) sorbitan monostearate As set forth in sec. 172.836 of this (Polysorbate 60). chapter. Polyoxyethylene (20) sorbitan tristearate (Poly- As set forth in sec. 172.838 of this sorbate 65). chapter. Polysorbate 80 ...... As set forth in sec. 172.840 of this chapter. Polyvinyl-pyrrolidone ...... As set forth in sec. 173.55 of this chapter. Sorbitan monooleate.

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Substances Definitions and specifications Restrictions

Sorbitan monostearate ...... As set forth in sec. 172.842 of this chapter. Sorbitan trioleate.

(2) Special use; inks for branding phar- (d) Labeling requirements. The label of maceutical forms. Items listed in para- the color additive and of any mixtures graph (a)(1) of this section, prepared therefrom intended solely or § 73.1(b)(1)(i), and the following: in part for coloring purposes shall conform to the requirements of § 70.25 of Ethyl lactate Polyoxyethylene sorbitan monolaurate (20) this chapter. (e) Exemption from certification. Cer- (b) Externally applied drugs. Diluents tification of this color additive is not listed in paragraph (a)(1) of this section necessary for the protection of the pub- and the following: lic health, and therefore batches there- Substances Definitions and specifications of are exempt from the certification requirements of section 721(c) of the act. Benzyl alcohol ...... As set forth in N.F. XI. Ethyl cellulose ...... As set forth in § 172.868 of this § 73.1015 Chromium-cobalt-aluminum chapter. Hydroxyethyl cellulose. oxide. Hydroxypropyl cellulose As set forth in § 172.870 of this (a) Identity. The color additive chro- chapter. mium-cobalt-aluminum oxide is a blue- green pigment obtained by calcining a § 73.1010 Alumina (dried aluminum hy- mixture of chromium oxide, cobalt car- droxide). bonate, and aluminum oxide. It may (a) Identity. (1) The color additive contain small amounts (less than 1 per- alumina (dried aluminum hydroxide) is cent each) of oxides of barium, boron, a white, odorless, tasteless, amorphous silicon, and nickel. powder consisting essentially of alu- (b) Specifications. Chromium-cobalt- minum hydroxide (Al2 O3· XH2 O). aluminum oxide shall conform to the (2) Color additive mixtures for drug following specifications: use made with alumina (dried aluminum hydroxide) may contain only Chromium, calculated as Cr2 O3, 34–37 percent. those diluents listed in this subpart as Cobalt, calculated as CoO, 29–34 percent. safe and suitable for use in color addi- Aluminum, calculated as AL2 O3, 29–35 per- tive mixtures for coloring drugs. cent. (b) Specifications. Alumina (dried alu- Lead (as Pb), not more than 30 parts per mil- minum hydroxide) shall conform to the lion. following specifications: Arsenic (as As), not more than 3 parts per million. Acidity or alkalinity: Agitate 1 gram of the Total oxides of aluminum, chromium, and color additive with 25 milliliters of water cobalt not less than 97 percent. and filter. The filtrate shall be neutral to litmus paper. Lead and arsenic shall be determined Matter insoluble in dilute hydrochloric acid, in the solution obtained by boiling 10 not more than 0.5 percent. Lead (as Pb), not more than 10 parts per mil- grams of the chromium-cobalt-alu- lion. minum oxide for 15 minutes in 50 milli- Arsenic (as As), not more than 1 part per liters of 0.5 N hydrochloric acid. million. (c) Uses and restrictions. The color ad- Mercury (as Hg), not more than 1 part per ditive chromium-cobalt-aluminum million. oxide may be safely used for coloring Aluminum oxide (Al2 O3), not less than 50 linear polyethylene surgical sutures, percent. United States Pharmacopeia (U.S.P.), (c) Uses and restrictions. Alumina for use in general surgery, subject to (dried aluminum hydroxide) may be the following restrictions: safely used in amounts consistent with (1) For coloring procedure, the color good manufacturing practice to color additive is blended with the poly- drugs generally. ethylene resin. The mixture is heated

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to a temperature of 500–550 °F. and ex- (1) The dyed suture shall conform in truded through a fixed orifice. The fila- all respects to the requirements of the ments are cooled, oriented by drawing, United States Pharmacopeia XX (1980). and set by annealing. (2) The level of the ferric ammonium (2) The quantity of the color additive citrate-pyrogallol complex shall not does not exceed 2 percent by weight of exceed 3 percent of the total weight of the suture material. the suture material. (3) The dyed suture shall conform in (3) When the sutures are used for the all respects to the requirements of the purposes specified in their labeling, U.S.P. XX (1980). there is no migration of the color addi- (4) When the sutures are used for the tive to the surrounding tissue. purpose specified in their labeling, (4) If the suture is a new drug, an ap- there is no migration of the color addi- proved new drug application, pursuant tive to the surrounding tissue. to section 505 of the act, is in effect for (5) If the suture is a new drug, an ap- it. proved new drug application, pursuant (d) Labeling. The labeling of the to section 505 of the Federal Food, color-additive shall conform to the re- Drug, and Cosmetic Act, is in effect for quirements of § 70.25 of this chapter. it. (e) Exemption from certification. Cer- (d) Labeling. The label of the color ad- tification of this color additive is not ditive shall conform to the require- necessary for the protection of the pub- ments of § 70.25 of this chapter. lic health and therefore batches thereof (e) Exemption from certification. Cer- are exempt from the requirements of tification of this color additive is not section 721(c) of the act. necessary for the protection of the public health, and batches thereof are ex- [42 FR 15643, Mar. 22, 1977, as amended at 49 empt from the certification require- FR 10089, Mar. 19, 1984] ments of section 721(c) of the act. § 73.1030 Annatto extract. [42 FR 15643, Mar. 22, 1977, as amended at 49 (a) Identity and specifications. (1) The FR 10089, Mar. 19, 1984] color additive annatto extract shall § 73.1025 Ferric ammonium citrate. conform in identity and specifications to the requirements of § 73.30(a)(1) and (a) Identity. The color additive ferric (b). ammonium citrate consists of complex (2) Color additive mixtures for drug chelates prepared by the interaction of use made with annatto extract may ferric hydroxide with citric acid in the contain only those diluents that are presence of ammonia. The complex suitable and that are listed in this sub- chelates occur in brown and green part as safe in color additive mixtures forms, are deliquescent in air, and are for coloring ingested drugs. reducible by light. (b) Uses and restrictions. Annatto ex- (b) Specifications. Ferric ammonium tract may be safely used for coloring citrate shall conform to the following drugs generally, including those in- specifications and shall be free from tended for use in the area of the eye, in impurities other than those named to amounts consistent with good manu- the extent that such impurities may be facturing practice. avoided by good manufacturing prac- (c) The label of the color ad- tice: Labeling. ditive and any mixtures prepared Iron (as Fe), not less than 14.5 percent and therefrom and intended solely or in not more than 18.5 percent. part for coloring purposes shall con- Lead (as Pb), not more than 20 p/m. form to the requirements of § 70.25 of Arsenic (as As), not more than 3 p/m. this chapter. Labels shall bear informa- (c) Uses and restrictions. Ferric ammo- tion showing that the color is derived nium citrate may be safely used in from annatto seed. The requirements of combination with pyrogallol (as listed § 70.25(a) of this chapter that all ingre- in § 73.1375), for coloring plain and chro- dients shall be listed by name shall not mic catgut sutures for use in general be construed as requiring the declara- and ophthalmic surgery subject to the tion of residues of solvents listed in following conditions: § 73.30(a)(1)(ii) of this chapter.

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(d) Exemption from certification. Cer- coloring ingested drugs generally in tification of this color additive is not amounts consistent with good manu- necessary for the protection of the pub- facturing practice. lic health and therefore batches thereof (c) Labeling requirements. The label of are evempt from the certification re- the color additive and of any mixtures quirements of section 721(c) of the act. prepared therefrom intended solely or in part for coloring purposes shall con- [42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977] form to the requirements of § 70.25 of this chapter. § 73.1070 Calcium carbonate. (d) Exemption from certification. Cer- tification of this color additive is not (a) Identity. (1) The color additive cal- necessary for the protection of the pub- cium carbonate is a fine, white, syn- lic health, and therefore batches there- thetically prepared powder consisting of are exempt from the certification re- essentially of precipitated calcium car- quirements of section 721(c) of the act. bonate (CaCO3). (2) Color additive mixtures for drug § 73.1085 Caramel. use made with calcium carbonate may (a) Identity and specifications. (1) The contain only those diluents listed in color additive caramel shall conform in this subpart as safe and suitable for use identity and specifications to the re- in color additive mixtures for coloring quirements of § 73.85(a) (1), (2), and (3) drugs. and (b). (b) Specifications. Calcium carbonate (2) The diluents in color additive shall meet the specifications for pre- mixtures for drug use containing car- cipitated calcium carbonate in the amel shall be limited to those listed in United States Pharmacopeia XX (1980). this subpart as safe and suitable in (c) Uses and restrictions. Calcium car- color additive mixtures for coloring bonate may be safely used in amounts drugs. consistent with good manudacturing (b) Uses and restrictions. Caramel may practice to color drugs generally. be used for coloring ingested and topi- (d) Labeling requirements. The label of cally applied drugs generally in the color additive and of any mixtures amounts consistent with good manu- prepared therefrom intended solely or facturing practice. in part for coloring purposes shall con- (c) Exemption from certification. Cer- form to the requirements of § 70.25 of tification of this color additive is not this chapter. necessary for the protection of the pub- (e) Exemption from certification. Cer- lic health and therefore batches thereof tification of this color additive is not are exempt from the certification re- necessary for the protection of the pub- quirement of section 721(c) of the act. lic health, and therefore batches thereof are exempt from the certification re- § 73.1095 β-Carotene. quirements of section 721(c) of the act. (a) Identity and specifications. (1) The [42 FR 15643, Mar. 22, 1977, as amended at 49 color additive b-carotene shall conform FR 10089, Mar. 19, 1984] in identity and specifications to the requirements of § 73.95(a)(1) and (b). § 73.1075 Canthaxanthin. (2) The diluents in color additive (a) Identity and specifications. (1) The mixtures for drug use containing b-car- color additive canthaxanthin shall con- otene are limited to those listed in this form in identity and specifications to subpart as safe and suitable in color the requirements of § 73.75(a)(1) and (b). additive mixtures for coloring ingested (2) Color additive mixtures for in- drugs. gested drug use made with (b) Uses and restrictions. The color ad- canthaxanthin may contain only those ditive b-carotene may be safely used in diluents that are suitable and that are coloring drugs generally, including listed in this subpart as safe in color those intended for use in the area of additive mixtures for coloring ingested the eye, in amounts consistent with drugs. good manufacturing practice. (b) Uses and restrictions. (c) Labeling requirements. The labeling Canthaxanthin may be safely used for of the color additive and any mixtures

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intended solely or in part for coloring that are listed in this subpart as safe purposes prepared therefrom shall con- for use in color additive mixtures for form to the requirements of § 70.25 of coloring drugs. this chapter. (b) Specifications. Potassium sodium (d) Exemption from certification. Cer- copper chlorophyllin shall conform to tification of this color additive is not the following specifications and shall necessary for the protection of the pub- be free from impurities other than lic health, and therefore batches there- those named to the extent that such of are exempt from the certification re- other impurities may be avoided by quirements of section 721(c) of the act. good manufacturing practice: [42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977] Moisture, not more than 5.0 percent. Nitrogen, not more than 5.0 percent. § 73.1100 Cochineal extract; carmine. pH of 1 percent solution, 9 to 11. (a) Identity and specifications. (1) The Total copper, not less than 4 percent and not color additives cochineal extract and more than 6 percent. carmine shall conform in identity and Free copper, not more than 0.25 percent. specifications to the requirements of Iron, not more than 0.5 percent. Lead (as Pb)), not more than 20 parts per § 73.100(a) (1) and (2) and (b). million. (2) Color additive mixtures for drug Arsenic (as As), not more than 5 parts per use made with carmine and cochineal million. extract may contain only those Ratio, absorbance at 405 mμ to absorbance at diluents that are suitable and that are 630 mμ, not less than 3.4 and not more than listed in this subpart as safe in color 3.9. additive mixtures for coloring drugs. Total color, not less than 75 percent. (b) Uses and restrictions. Cochineal extract and carmine may be safely used (c) Uses and restrictions. Potassium for coloring ingested and externally ap- sodium copper chlorophyllin may be plied drugs in amounts consistent with safely used for coloring dentifrices that good manufacturing practice. are drugs at a level not to exceed 0.1 (c) Labeling requirements. The label of percent. Authorization for this use the color additives and any mixtures shall not be construed as waiving any intended solely or in part for coloring of the requirements of section 505 of purposes prepared therefrom shall con- the act with respect to the drug in form to the requirements of § 70.25 of which it is used. this chapter. (d) Labeling. The label of the color ad- (d) Exemption from certification. Cer- ditive and any mixtures prepared tification of these color additives is therefrom intended solely or in part for not necessary for the protection of the coloring purposes shall conform to the public health, and therefore batches requirements of § 70.25 of this chapter. thereof are exempt from the certifi- (e) Exemption from certification. Cer- cation requirements of section 721(c) of the act. tification of this color additive is not necessary for the protection of the pub- § 73.1125 Potassium sodium copper lic health and therefore batches thereof chloropyhllin (chlorophyllin-copper are exempt from the certification re- complex). quirements of section 721(c) of the act. (a) Identity. (1) The color additive potassium sodium copper chlorophyllin is § 73.1150 Dihydroxyacetone. a green to black powder obtained from (a) Identity. (1) The color additive chlorophyll by replacing the methyl dihydroxyacetone is 1,3-dihydroxy-2- and phytyl ester groups with alkali and propanone. replacing the magnesium with copper. (2) Color additive mixtures for drug The source of the chlorophyll is dehy- use made with dihydroxyacetone may drated alfalfa. contain only those diluents that are (2) Color additive mixtures for drug listed in this subpart as safe and suit- use made with potassium sodium copper chlorophyllin may contain only able in color additive mixtures for those diluents that are suitable and coloring externally applied drugs.

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(b) Specifications. Dihydroxyacetone be free from impurities other than shall conform to the following speci- those named to the extent that such fications and shall be free from impuri- other impurities may be avoided by ties other than those named to the ex- good manufacturing practice: tent that such impurities may be avoided by good manufacturing prac- Volatile matter, not more than 0.5 percent. tice: Lead (as Pb), not more than 20 parts per million. Volatile matter (at 34.6 °C. for 3 hours at a Arsenic (as As), not more than 3 parts per pressure of not more than 30 mm. mer- million. cury), not more than 0.5 percent. Mercury (as Hg), not more than 1 part per Residue on ignition, not more than 0.4 per- million. cent. Bismuth oxychloride, not less than 98 per- Lead (as Pb), not more than 20 parts per mil- cent. lion. Arsenic (as As), not more than 3 parts per (c) Uses and restrictions. The color ad- million. ditive bismuth oxychloride may be Iron (as Fe), not more than 25 parts per mil- safely used in coloring externally ap- lion. 1,3-dihydroxy-2-propanone, not less than 98 plied drugs, including those intended percent. for use in the area of the eye, in amounts consistent with good manu- (c) Uses and restrictions. facturing practice. Dihydroxyacetone may be safely used (d) Labeling. The color additive and in amounts consistent with good manu- any mixture prepared therefrom in- facturing practice in externally applied tended solely or in part for coloring drugs intended solely or in part to impart a color to the human body. Au- purposes shall bear, in addition to any thorization for this use shall not be information required by law, labeling construed as waiving any of the re- in accordance with the provisions of quirements of section 505 of the act § 70.25 of this chapter. with respect to the drug in which it is (e) Exemption from certification. Cer- used. tification of this color additive is not (d) Labeling requirements. The label of necessary for the protection of the pub- the color additive and any mixtures lic health, and therefore batches there- prepared therefrom intended solely or of are exempt from certification pursu- in part for coloring purposes shall con- ant to section 721(c) of the act. form to the requirements of § 70.25 of [42 FR 52394, Sept. 30, 1977] this chapter. (e) Exemption from certification. Cer- § 73.1200 Synthetic iron oxide. tification of this color additive is not necessary for the protection of the pub- (a) Identity. (1) The color additive lic health and therefore batches thereof synthetic iron oxide consists of any are exempt from the certification re- one or any combination of syn- quirements of section 721(c) of the act. thetically prepared iron oxides, including the hydrated forms. It is free from § 73.1162 Bismuth oxychloride. admixture with other substances. (a) Identity. (1) The color additive bis- (2) Color additive mixtures for drug muth oxychloride is a synthetically use made with synthetic iron oxide prepared white or nearly white amor- may contain only those diluents listed phous or finely crystalline, odorless in this subpart as safe and suitable in powder consisting principally of BiOCl. color additive mixtures for coloring (2) Color additive mixtures for drug drugs. use made with bismuth oxychloride (b) Specifications. Synthetic iron may contain only those diluents that oxide shall conform to the following are suitable and that are listed in this specifications, all on an ‘‘as is’’ basis: subpart as safe in color additive mix- Arsenic (as As), not more than 3 parts per tures for coloring externally applied million. drugs. Lead (as Pb), not more than 10 parts per mil- (b) Specifications. The color additive lion. bismuth oxychloride shall conform to Mercury (as Hg), not more than 3 parts per the following specifications and shall million.

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(c) Uses and restrictions. The color ad- Lead (as Pb), not more than 20 parts per mil- ditive synthetic iron oxide may be lion. safely used to color ingested or topi- Arsenic (as As), not more than 3 parts per million. cally applied drugs generally subject to Nickel (as Ni), not more than 200 parts per the restriction that if the color addi- million. tive is used in drugs ingested by man Cobalt (as Co), not more than 200 parts per the amount consumed in accordance million. with labeled or prescribed dosages shall Mercury (as Hg), not more than 1 part per not exceed 5 milligrams, calculated as million. elemental iron, per day. Total iron (as Fe corrected for volatile matter), not less than 33 percent and not more (d) Labeling requirements. The label of than 39 percent. the color additive and any mixtures intended solely or in part for coloring (c) Uses and restrictions. Ferric ammo- purposes prepared therefrom shall con- nium ferrocyanide may be safely used form to the requirements of § 70.25 of in amounts consistent with good manu- this chapter. facturing practice to color externally (e) Exemption from certification. Cer- applied drugs, including those for use tification of this color additive is not in the area of the eye. necessary for the protection of the pub- (d) Labeling requirements. The label of lic health, and therefore batches there- the color additive and of any mixtures of are exempt from certification re- prepared therefrom intended solely or quirements of section 721(c) of the act. in part for coloring purposes shall conform to the requirements of § 70.25 of § 73.1298 Ferric ammonium ferrocya- this chapter. nide. (e) Exemption from certification. Cer- tification of this color additive is not (a) Identity. (1) The color additive fer- necessary for the protection of the pub- ric ammonium ferrocyanide is the blue lic health, and therfore batches thereof pigment obtained by oxidizing under are exempt from the certification re- acidic conditions with sodium dichro- quirements of section 721(c) of the act. mate the acid digested precipitate resulting from mixing solutions of fer- [42 FR 38562, July 29, 1977, as amended at 44 rous sulfate and sodium ferrocyanide in FR 28322, May 15, 1979] the presence of ammonium sulfate. The oxidized product is filtered, washed, § 73.1299 Ferric ferrocyanide. and dried. The pigment consists prin- (a) Identity. (1) The color additive fer- cipally of ferric ammonium ferrocya- ric ferrocyanide is a ferric nide with smaller amounts of ferric fer- hexacyanoferrate pigment character- rocyanide and ferric sodium ferrocya- ized by the structual formula nide. Fe4[Fe(CN)6]3·XH2O, which may contain (2) Color additive mixtures for drug small amounts of ferric sodium ferro- use made with ferric ammonium ferrocyanide and ferric potassium ferrocya- cyanide may contain only those nide. diluents listed in this subpart as safe (2) Color additive mixtures for drug and suitable for use in color additive use made with ferric ferrocyanide may mixtures for coloring drugs. contain only those diluents listed in (b) Specifications. Ferric ammonium this subpart as safe and suitable for use ferrocyanide shall conform to the fol- in color additive mixtures for coloring lowing specifications and shall be free drugs. of impurities other than those named (b) Specifications. Ferric ferrocyanide to the extent that the other impurities shall conform to the following speci- may be avoided by good manufacturing fications and shall be free from impuri- practice: ties other than those named to the extent that such impurities may be Oxalic acid or its salts, not more than 0.1 avoided by good manufacturing prac- percent. tice: Water soluble matter, not more than 3 percent. Water soluble cyanide, not more than 10 Water soluble cyanide, not more than 10 parts per million. parts per million. Lead (as Pb), not more than 20 parts per mil- Volatile matter, not more than 4 percent. lion.

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Arsenic (as As), not more than 3 parts per Cr2O3 not less than 75%. million. Lead (as Pb), not more than 20 parts per mil- Nickel (as Ni), not more than 200 parts per lion. million. Arsenic (as As), not more than 3 parts per Cobalt (as Co), not more than 200 parts per million. million. Mercury (as Hg), not more than 1 part per Mercury (as Hg), not more than 1 part per million. million. Oxalic acid, not more than 0.1 percent. (c) Uses and restrictions. Chromium Water soluble matter, not more than 3 per- hydroxide green may be safely used in cent. amounts consistent with good manu- Volatile matter, not more than 10 percent. facturing practice to color externally Total iron (as Fe corrected for volatile mat- applied drugs, including those for use ter), not less than 37 percent and not more in the area of the eye. than 45 percent. (d) Labeling requirements. The label of (c) Uses and restrictions. Ferric ferro- the color additive and of any mixtures cyanide may be safely used in amounts prepared therefrom lintended solely or consistent with good manufacturing in part for coloring purposes shall con- practice to color externally applied form to the requirements of § 70.25 of drugs including those intended for use this chapter. in the area of the eye. (e) Exemption from certification. Cer- (d) Labeling requirements. The label of tification of this color additive is not the color additive and of any mixtures necessary for the protection of the pub- prepared therefrom intended solely or lic health, and therefore batches therein part for coloring purposes shall con- of are exempt from the certification re- form to the requirements of § 70.25 of quirements of section 721(c) of the act. this chapter. [42 FR 36451, July 15, 1977, as amended at 42 (e) Exemption from certification. Cer- FR 59852, Nov. 22, 1977] tification of this color additive is not necessary for the protection of the pub- § 73.1327 Chromium oxide greens. lic health, and therefore batches there- (a) Identity. (1) The color additive of are exempt from certification re- chromium oxide greens is principally quirements of section 721(c) of the act. chromic sesquioxide (Cr2O3). [43 FR 54235, Nov. 21, 1978] (2) Color additive mixtures for drug use made with chromium oxide greens § 73.1326 Chromium hydroxide green. may contain only those diluents listed (a) Identity. (1) The color additive in this subpart as safe and suitable for chromium hydroxide green is prin- use in color additive mixtures for cipally hydrated chromic sesquioxide coloring drugs. (Cr2O3·XH2O). (b) Specifications. the color additive (2) Color additive mixtures for drug chormium oxide greens shall conform use made with chromium hydroxide to the following specifications and green may contain only those diluents shall be free from impurities other listed in this subpart as safe and suit- than those named to the extent that able for use in color additive mixtures such impurities may be avoided by for coloring drugs. good manufacturing practice: (b) Specifications. Chromium hydrox- Chromium in 2% NaOH extract, not more ide green shall conform to the fol- than 0.075% as Cr2O3 (based on sample lowing specifications and shall be free weight). from impurities other than those Arsenic (as As), not more than 3 parts per named to the extent that such impuri- million. ties may be avoided by good manufac- Lead (as Pb), not more than 20 parts per mil- turing practice: lion. Mercury (as Hg), not more than 1 part per Water soluble matter, not more than 2.5%. million. Chromium in 2% NaOH extract, not more Cr2O3, not less than 95%. than 0.1% as Cr2O3 (based on sample weight). (c) Uses and restrictions. Chromium oxide greens is safe for use in coloring Boron (as B2O3), not more than 8 percent. Total volatile matter at 1000 °C, not more externally applied drugs, including than 20%. those intended for use in the area of

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eye, in amounts consistent with good (d) Labeling. The color additive and manufacturing practice. any mixture prepared therefrom in- (d) Labeling. The color additive and tended solely or in part for coloring any mixture prepared therefrom in- purposes shall bear, in addition to any tended solely or in part for coloring information required by law, labeling purposes shall bear, in addition to any in accordance with § 70.25 of this chap- information required by law, labeling ter. in accordance with § 70.25 of this chap- (e) Exemption from certification. Cer- ter. tification of this color additive is not (e) Exemption from certification. Cer- necessary for the protection of the pub- tification of this color additive is not lic health, and therefore batches therof necessary for the protection of the pub- are exempt from certification pursuant lic health, and therefore batches therof to section 721(c) of the act. are exempt from certification pursuant [42 FR 37537, July 22, 1977] to section 721(c) of the act. [42 FR 36451, July 15, 1977] § 73.1350 Mica-based pearlescent pigments. § 73.1329 Guanine. (a) Identity. (1) The color additive is (a) Identity. (1) The color additive formed by depositing titanium and/or guanine is the crystalline material ob- iron salts onto mica, followed by heat- tained from fish scales and consists ing to produce one of the following principally of the two purines, guanine combinations: Titanium dioxide on and hypoxanthine. The guanine con- mica; iron oxide on mica; titanium di- tent will vary from 75 to 97 percent, oxide and iron oxide on mica. Mica and the hypoxanthine will vary from 3 used to manufacture the color additive to 25 percent, depending on the par- shall conform in identity to the re- ticular fish and tissue from which the quirements of § 73.1496(a)(1). crystals are derived. (2) Color additive mixtures for drug (2) Color additive mixtures for drug use made with mica-based pearlescent use made with guanine may contain pigments may contain only those only those diluents listed in this sub- diluents listed in this subpart as safe part as safe and suitable for use in and suitable for use in color additive color additive mixtures for coloring ex- mixtures for coloring ingested drugs. ternally applied drugs. (b) Specifications. Mica-based pearl- (b) Specifications. The color additive escent pigments shall conform to the guanine shall conform to the following following specifications and shall be specifications and shall be free from free from impurities other than those impurities other than those named to named to the extent that such other the extent that such other impurities impurities may be avoided by good may be avoided by good manufacturing manufacturing practice: practice: (1) Lead (as Pb), not more than 4 parts per million (ppm). Guanine, not less than 75 percent. (2) Arsenic (as As), not more than 3 Hypoxanthine, not more than 25 percent. Ash (ignition at 800 °C), not more than 2 per- ppm. cent. (3) Mercury (as Hg), not more than 1 Lead (as Pb), not more than 20 parts per mil- ppm. lion. (c) Uses and restrictions. Mica-based Arsenic (as As), not more than 3 parts per pearlescent pigments may be safely million. used to color ingested drugs in Assay, not less than 96 percent total purines. amounts up to 3 percent, by weight, of Mercury (as Hg), not more than 1 part per the final drug product. The maximum million. amount of iron oxide to be used in pro- (c) Uses and restrictions. Guanine is ducing said pigments is not to exceed safe for use in coloring externally ap- 55 percent, by weight, in the finished plied drugs, including those intended pigment. for use in the area of the eye, in (d) Labeling. The label of the color ad- amounts consistent with good manu- ditive and of any mixture prepared facturing practice. therefrom intended solely or in part for

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coloring purposes shall conform to the are exempt from the certification re- requirements of § 70.25 of this chapter. quirements of section 721(c) of the act. (e) Exemption from certification. Cer- [42 FR 15643, Mar. 22, 1977, as amended at 49 tification of this color additive is not FR 10089, Mar. 19, 1984] necessary for the protection of the public health, and therefore batches there- § 73.1400 Pyrophyllite. of are exempt from the certification re- (a) Identity. (1) The color additive quirements of section 721(c) of the Fed- pyrophyllite is a naturally occurring eral Food, Drug, and Cosmetic Act. mineral substance consisting predominantly of a hydrous aluminum silicate, [70 FR 42273, July 22, 2005. Redesignated at 72 FR 10357, Mar. 8, 2007] Al2O3·4SiO2·H2 O, intimately mixed with lesser amounts of finely divided § 73.1375 Pyrogallol. silica, SiO2. Small amounts, usually less than 3 percent, of other silicates, (a) Identity. The color additive pyro- such as potassium aluminum silicate, gallol is 1,2,3-trihydroxybenzene. may be present. Pyrophyllite may be (b) Specifications. Pyrogallol shall identified and semiquantitatively de- conform to the following specifications termined by its characteristic X-ray and shall be free from impurities other powder diffraction pattern and by its than those named to the extent that optical properties. such impurities may be avoided by (2) Color additive mixtures made good manufacturing practice: with pyrophyllite are limited to those listed in this subpart as safe and suit- Melting point, between 130° and 133 °C. Residue on ignition, not more than 0.1 per- able in color additive mixtures for cent. coloring externally applied drugs. Lead (as Pb), not more than 20 p/m (parts per (b) Specifications. Pyrophyllite shall million). conform to the following specifica- Arsenic (as As), not more than 3 p/m. tions: (c) Uses and restrictions. Pyrogallol Lead (as Pb), not more than 20 parts per mil- may be safely used in combination lion. Arsenic (as As), not more than 3 parts per with ferric ammonium citrate (as list- million. ed in § 73.1025), for coloring plain and chromic catgut sutures for use in gen- Lead and arsenic shall be determined eral and ophthalmic surgery, subject to in the solution obtained by boiling 10 the following restrictions: grams of the pyrophyllite for 15 min- (1) The dyed suture shall conform in utes in 50 milliliters of 0.5N hydro- all respects to the requirements of the chloric acid. United States Pharmacopeia XX (1980). (c) Uses and restrictions. Pyrophyllite (2) The level of the ferric ammonium may be safely used in amounts con- citrate-pyrogallol complex shall not sistent with good manufacturing prac- exceed 3 percent of the total weight of tice to color drugs that are to be externally applied. the suture material. (d) Labeling requirements. The labeling (3) When the sutures are used for the of the color additive and any mixtures purposes specified in their labeling, prepared therefrom intended solely or there is no migration of the color addi- in part for coloring purposes shall con- tive to the surrounding tissues. form to the requirements of § 70.25 of (4) If the suture is a new drug, an ap- this chapter. proved new drug application, pursuant (e) Exemption from certification. Cer- to section 505 of the act, is in effect for tification of this color additive is not it. necessary for the protection of the pub- (d) Labeling. The label of the color ad- lic health, and therefore batches there- ditive shall conform to the require- of are exempt from the certification re- ments of § 70.25 of this chapter. quirements of section 721(c) of the act. (e) Exemption from certification. Cer- tification of this color additive is not § 73.1410 Logwood extract. necessary for the protection of the pub- (a) Identity. The color additive lic health and therefore batches thereof logwood extract is a reddish brown-to-

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black solid material extracted from the § 73.1496 Mica. heartwood of the leguminous tree (a) Identity. (1) The color additive Haematoxylon campechianum. The ac- mica is a white powder obtained from tive colorant substance is principally the naturally occurring mineral, mus- hematein. The latent coloring material covite mica, consisting predominantly is the unoxidized or leuco form of he- of a potassium aluminum silicate, matein called hematoxylin. The leuco K Al (Al Si O )(OH) or, alternatively, form is oxidized by air. 2 4 2 6 20 4 H2KAl3 (SiO4)3. Mica may be identified (b) Specifications. Logwood extract and semiquantitatively determined by shall conform to the following speci- its characteristic X-ray diffraction pat- fications and shall be free from impuri- tern and by its optical properties. ties other than those named to the ex- (2) Color additive mixtures for drug tent that such imnurities may be use made with mica may contain only avoided by good manufacturing prac- those diluents listed in this subpart as tice: safe and suitable for use in color additive mixtures for coloring drugs. Volatile matter (at 110 °C), not more than 15 percent. (b) Specifications. Mica shall conform Sulfated ash, not more than 20 percent. to the following specifications and Hematein, not less than 5 percent and not shall be free from impurities other more than 20 percent. than those named to the extent that Lead (as Pb), not more than 70 parts per mil- such other impurities may be avoided lion. by good manufacturing practice: Arsenic (as As), not more than 4 parts per Fineness, 100 percent shall pass through a million. 100-mesh sieve. Mercury (as Hg), not more than 3 parts per Loss on ignition at 600–650 °C, not more than million. 2 percent. (c) Use and restrictions. Logwood ex- Lead (as Pb), not more than 20 parts per mil- tract may be safely used to color nylon lion. Arsenic (as As), not more than 3 parts per 66 (the copolymer of million. hexamethylenediamine and adipic Mercury (as Hg), not more than 1 part per acid), nylon 6 (the polymer of e- million. caprolactam), or silk non-absorable sutures for use in general and ophthalmic (c) Uses and restrictions. Mica may be surgery subject to the following re- safely used in amounts consistent with good manufacturing practice to color strictions: dentifrices and externally applied (1) The quantity of color additive drugs, including those for use in the does not exceed 1.0 percent by weight area of the eye. of the suture. (d) Labeling requirements. The label of (2) When the sutures are used for the the color additive and of any mixture purposes specified in their labeling, prepared therefrom intended solely or there is no migration of the color addi- in part for coloring purposes shall con- tive to the surrounding tissue. form to the requirements of § 70.25 of (3) If the suture is a new drug, an ap- this chapter. proved new drug application, pursuant (e) Exemption from certification. Cer- to section 505 of the act, is in effect for tification of this color additive is not it. necessary for the protection of the pub- (d) Labeling. The label of the color ad- lic health, and therefore batches therof ditive shall conform to the require- are exempt from the certification re- ments of § 70.25 of this chapter. quirements of section 721(c) of the act. (e) Exemption from certification. Cer- [42 FR 38561, July 29, 1977, as amended at 52 tification of this color additive is not FR 29665, Aug. 11, 1987] necessary for the protection of the public health, and therefore batches there- § 73.1530 Spirulina extract. of are exempt from the certification re- (a) Identity. (1) The color additive quirements of section 721(c) of the act. spirulina extract is prepared by the fil- [42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. tered aqueous extraction of the dried 10, 1978] biomass of Arthrospira platensis. The

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color additive contains phycocyanins Lead (as Pb), not more than 20 parts per mil- as the principal coloring components. lion. (2) Color additive mixtures for drug Arsenic (as As), not more than 3 parts per use made with spirulina extract may million. contain only those diluents that are Lead and arsenic shall be determined suitable and are listed in this subpart in the solution obtained by boiling 10 as safe for use in color additive mix- grams of the talc for 15 minutes in 50 tures for coloring ingested drugs. milliliters of 0.5N hydrochloric acid. (b) Specifications. Spirulina extract (c) Uses and restrictions. Talc may be must conform to the following speci- safely used in amounts consistent with fications and must be free from impuri- good manufacturing practice to color ties, other than those named, to the ex- drugs generally. tent that such other impurities may be (d) Labeling requirements. The label of avoided by good manufacturing prac- the color additive and of any mixtures tice: prepared therefrom intended solely or (1) Lead, not more than 2 milligrams in part for coloring purposes shall con- per kilogram (mg/kg) (2 parts per mil- form to the requirements of § 70.25 of lion (ppm)); this chapter. (2) Arsenic, not more than 2 mg/kg (2 (e) Exemption from certification. Cer- ppm); tification of this color additive is not (3) Mercury, not more than 1 mg/kg (1 necessary for the protection of the pub- ppm); and lic health, and therefore batches there- (4) Negative for microcystin toxin. of are exempt from the certification re- (c) Uses and restrictions. Spirulina ex- quirements of section 721(c) of the act. tract may be safely used for coloring coating formulations applied to drug [42 FR 15643, Mar. 22, 1977, as amended at 49 tablets and capsules, at levels con- FR 10089, Mar. 19, 1984] sistent with good manufacturing prac- § 73.1575 Titanium dioxide. tice. (d) Labeling requirements. The label of (a) Identity and specifications. (1) The the color additive and any mixture pre- color additive titanium dioxide shall pared therefrom intended solely or in conform in identity and specifications part for coloring purposes shall con- to the requirements of § 73.575(a)(1) and form to the requirements of § 70.25 of (b). this chapter. (2) Color additive mixtures for drug (e) Exemption from certification. Cer- use made with titanium dioxide may tification of this color additive is not contain only those diluents that are necessary for the protection of the pub- suitable and that are listed in this sub- lic health, and therefore batches there- part as safe in color additive mixtures of are exempt from the certification re- for coloring drugs, and the following: quirements of section 721(c) of the Fed- Silicon dioxide, SiO2, and/or aluminum eral Food, Drug, and Cosmetic Act. oxide, Al2O3, as dispersing aids—not more than 2 percent total. [80 FR 50765, Aug. 21, 2015] (b) Uses and restrictions. The color additive titanium dioxide may be used for § 73.1550 Talc. coloring ingested and externally ap- (a) Identity. (1) The color additive plied drugs generally, in amounts con- talc is a finely powdered, native, hy- sistent with good manufacturing prac- drous magnesium silicate sometimes tice. External application includes use containing a small proportion of alu- in the area of the eye. minum silicate. (c) Labeling. The label of the color ad- (2) Color additive mixtures for drug ditive and any mixtures prepared use made with talc may contain only therefrom and intended solely or in those diluents listed in this subpart as part for coloring purposes shall con- safe and suitable for use in color addi- form to the requirements of § 70.25 of tive mixtures for coloring drugs. the chapter. (b) Specifications. Talc shall meet the (d) Exemption from certification. Cer- specifications for talc in the United tification of this color additive is not States Pharmacopeia XX (1980) and the necessary for the protection of the pub- following: lic health and therefore batches thereof

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are exempt from the certification re- contains small amounts of stearic or quirements of section 721(c) of the act. oleic acid as lubricants. (2) Color additive mixtures for drug § 73.1645 Aluminum powder. use made with bronze powder may con- (a) Identity. (1) The color additive tain only those diluents listed in this aluminum powder shall be composed of subpart as safe and suitable for use in finely divided particles of aluminum color additive mixtures for coloring ex- prepared from virgin aluminum. It is ternally applied drugs. free from admixture with other sub- (b) Specifications. Bronze powder shall stances. conform to the following specifications (2) Color additive mixtures for exter- and shall be free from impurities other nal drug use made with aluminum pow- than those named to the extent that der may contain only those diluents such impurities may be avoided by listed in this subpart as safe and suit- good manufacturing practice: able in color additive mixtures for Stearic or oleic acid, not more than 5 per- coloring externally applied drugs. cent. (b) Specifications. Aluminum powder Cadmium (as Cd), not more than 15 parts per shall conform to the following speci- million. fications and shall be free from impuri- Lead (as Pb), not more than 20 parts per mil- ties other than those named to the ex- lion. tent that such impurities may be Arsenic (as As), not more than 3 parts per avoided by good manufacturing prac- million. Mercury (as Hg), not more than 1 part per tice: million Fineness, 100 percent shall pass through a Aluminum (as Al), not more than 0.5 percent. 200-mesh screen and 95 percent shall pass Tin (as Sn), not more than 0.5 percent. through a 325-mesh screen. Copper (as Cu), not more than 95 percent and Mercury, not more than 1 part per million. not less than 70 percent. Arsenic, not more than 3 parts per million. Zinc (as Zn), not more than 30 percent. Lead, not more than 20 parts per million. Maximum particle size 45μ (95 percent min- Aluminum, not less than 99 percent. imum). (c) Uses and restrictions. Aluminum Aluminum, zinc, tin, and copper con- powder is safe for use in externally ap- tent shall be based on the weight of the plied drugs, including those intended dried powder after being thoroughly for use in the area of the eye, in washed with ether. amounts consistent with good manu- (c) Uses and restrictions. Bronze pow- facturing practice. der may be safely used in color exter- (d) Labeling. The color additive and nally applied drugs, including those in- any mixture prepared therefrom intended for use in the area of the eye, in tended solely or in part for coloring amounts consistent with good manu- purposes shall bear, in addition to any facturing practice. information required by law, labeling (d) Labeling. The color additive and in accordance with § 70.25 of this chap- any mixture prepared therefrom in- ter. tended solely or in part for coloring (e) Exemption from certification. Cer- purposes shall conform to the require- tification of this color additive is not ments of § 70.25 of this chapter. necessary for the protection of the pub- (e) Exemption from certification. Cer- lic health, and therefore batches therof tification of the color additive is not are exempt from certification pursuant necessary for the protection of the pub- to section 721(c) of the act. lic health, and therefore batches thereof are exempt from the certification re- [42 FR 38563, July 29, 1977] quirements of section 721(c) of the act. § 73.1646 Bronze powder. [42 FR 33723, July 1, 1977] (a) Identity. (1) The color additive bronze powder is a very fine metallic § 73.1647 Copper powder. powder prepared from alloys consisting (a) Identity. (1) The color additive principally of virgin electrolytic cop- copper powder is a very fine free-flow- per and zinc with small amounts of the ing metallic powder prepared from vir- virgin metals aluminum and tin. It gin electrolytic copper. It contains

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small amounts of stearic or oleic acid tive mixtures for coloring externally as lubricants. applied drugs. (2) Color additive mixtures for drug (b) Specifications. Zinc oxide shall use made with copper powder may con- conform to the following specifications tain only those diluents listed in this and shall be free from impurities other subpart as safe and suitable for use in than those named to the extent that color additive mixtures for coloring ex- such impurities may be avoided by ternally applied drugs. good manufacturing practice: (b) Specifications. Copper powder shall Zinc oxide (as ZnO), not less than 99 percent. conform to the following specifications Loss on ignition at 800 °C, not more than 1 and shall be free from impurities other percent. than those named to the extent that Cadmium (as Cd), not more than 15 parts per such impurities may be avoided by million. good manufacturing practice: Mercury (as Hg), not more than 1 part per million. Stearic or oleic acid, not more than 5 per- Arsenic (as As), not more than 3 parts per cent. million. Cadmium (as Cd), not more than 15 parts per Lead (as Pb), not more than 20 parts per mil- million. lion. Lead (as Pb), not more than 20 parts per million. (c) Uses and restrictions. The color ad- Arsenic (as As), not more than 3 parts per ditive zinc oxide may be safely used for million. coloring externally applied drugs, in- Mercury (as Hg), not more than 1 part per cluding those used in the area of the million. eye, in amounts consistent with good Copper (as Cu), not less than 95 percent. manufacturing practice. Maximum particle size 45μ (95 percent min- (d) Labeling. The color additive and imum). any mixtues prepared therefrom in- (c) Uses and restrictions. Copper pow- tended solely or in part for coloring der may be safely used in coloring ex- purposes shall bear, in addition to any ternally applied drugs, including those information required by law, labeling intended for use in the area of the eye, in accordance with the provisions of in amounts consistent with good manu- § 70.25 of this chapter. facturing practice. (e) Exemption from certification. Cer- (d) Labeling. The color additive and tification of this color additive is not any mixture prepared therefrom in- necessary for the protection of the pub- tended solely or in part for coloring lic health, and therefore batches therof purposes shall conform to the require- are exempt from the certifiation pursu- ments of § 70.25 of this chapter. ant to section 721(c) of the act. (e) Exemption from certification. Cer- [42 FR 37537, July 22, 1977] tification of the color additive is not necessary for the protection of the public health, and therefore batches there- Subpart C—Cosmetics of are exempt from the certification re- § 73.2030 Annatto. quirements of section 721(c) of the act. (a) Identity and specification. The [42 FR 33723, July 1, 1977] color additive annatto shall conform in identify and specification to the re- § 73.1991 Zinc oxide. quirements for annatto extract in (a) Identity. (1) The color additive § 73.30(a) (1) and (b). zinc oxide is a white or yellow-white (b) Use and restriction. The color addi- amorphous powder manufactured by tive annatto may be safely used in the French process (described as the in- coloring cosmetics generally, including direct process whereby zinc metal iso- cosmetics intended for use in the area lated from the zinc-containing ore is of the eye, in amounts consistent with vaporized and then oxidized). It is prin- good manufacturing practice. cipally composed of Zn. (c) Labeling. The color additive and (2) Color additive mixtures for drug any mixture prepared therefrom in- use made with zinc oxide may contain tended solely or in part for coloring only those diluents listed in this sub- purposes shall bear, in addition to any part as safe and suitable in color addi- information required by law, labeling

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in accordance with the provisions of mine prominently and conspicuously at § 70.25 of this chapter. least once in the labeling. For example: (d) Exemption from certification. Cer- ‘‘Contains carmine as a color addi- tification of this color additive is not tive.’’ necessary for the protection of the pub- (d) Exemption from certification. Cer- lic health, and therefore batches there- tification of this color additive is not of are exempt from the certification re- necessary for the protection of the pub- quirements of section 721(c) of the act. lic health, and therefore batches thereof are exempt from the certification [42 FR 36994, July 19, 1977] pursuant to section 721(c) of the act. § 73.2085 Caramel. [42 FR 32228, June 24, 1977, as amended at 74 (a) Identity and specifications. The FR 216, Jan. 5, 2009] color additive caramel shall conform in § 73.2095 β-Carotene. identity and specifications to the requirements of § 73.85(a)(1), (2), and (3) (a) Identity and specifications. The and (b). color additive b-carotene shall conform (b) Uses and restrictions. Caramel is in identity and specifications to the re- safe for use in coloring cosmetics gen- quirements of § 73.95(a)(1) and (b). erally, including cosmetics applied to (b) Uses and restrictions. The color ad- the area of the eye, in amounts con- ditive b-carotene may be safely used in sistent with good manufacturing prac- coloring cosmetics generally, including tice. cosmetics intended for use in the area (c) Labeling requirements. The label of of the eye, in amounts consistent with the color additive and any mixtures in- good manufacturing practices. tended solely or in part for coloring (c) Labeling. The color additive and purposes prepared therefrom shall con- any mixture prepared therefrom in- form to the requirements of § 70.25 of tended solely or in part for coloring this chapter. purposes shall bear, in addition to any (d) Exemption from certification. Cer- information required by law, labeling tification of this color additive is not in accordance with the provisions of necessary for the protection of the pub- § 70.25 of this chapter. (d) Cer- lic health, and therefore batches there- Exemption from certification. tification of this color additive is not of are exempt from the certification re- necessary for the protection of the pub- quirement of section 721(c) of the act. lic health, and therefore batches therof [46 FR 38501, July 28, 1981] are exempt from the certification pursuant to section 721(c) of the act. § 73.2087 Carmine. [42 FR 33722, July 1, 1977] (a) Identity and specifications. The color additive carmine shall conform in § 73.2110 Bismuth citrate. identity and specifications to the re- (a) Identity. The color additive bis- quirements of § 73.100 (a)(2) and (b)(2). muth citrate is the synthetically pre- (b) Use and restrictions. Carmine may pared crystalline salt of bismuth and be safely used in cosmetics generally, citric acid, consisting principally of including cosmetics intended for use in BiC6H5O7. the area of the eye, in amounts con- (b) Specifications. The color additive sistent with good manufacturing prac- bismuth citrate shall conform to the tices. following specifications and shall be (c) Labeling. (1) The color additive free from impurities other than those and any mixture prepared therefrom named to the extent that those impuri- intended solely or in part for coloring ties may be avoided by good manufac- purposes shall bear, in addition to any turing practice: information required by law, labeling in accordance with the provisions of Bismuth citrate, not less than 97 percent. § 70.25 of this chapter. Mercury (as Hg), not more than 1 part per million. (2) Cosmetics containing carmine Arsenic (as As), not more than 3 parts per that are not subject to the require- million. ments of § 701.3 of this chapter shall Lead (as Pb), not more than 20 parts per mil- specifically declare the presence of car- lion.

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Volatile matter, not more than 1 percent. Moisture, not more than 15 percent. Water insoluble matter, not more than 0.2 (c) Uses and restrictions. The color ad- percent. ditive bismuth citrate may be safely Lead (as Pb), not more than 20 parts per mil- used in cosmetics intended for coloring lion. hair on the scalp, subject to the fol- Arsenic (as As), not more than 3 parts per lowing restrictions: million. (1) The amount of bismuth citrate in (c) Uses and restrictions. Disodium the cosmetic shall not be in excess of EDTA-copper may be safely used in 2.0 percent (w/v). amounts consistent with good manu- (2) The cosmetic may not be used for facturing practices in the coloring of coloring eyelashes, eyebrows, or hair shampoos which are cosmetics. on parts of the body other than the (d) Labeling requirements. The labeling scalp. of the color additive shall conform to (d) Labeling. (1) The label of the color the requirements of § 70.25 of this chap- additive bismuth citrate shall bear, in ter. addition to any information required (e) Exemption from certification. Cer- by law, labeling in accordance with the tification of this color additive is not provisions of § 70.25 of this chapter. necessary for the protection of the pub- (2) The label of a cosmetic containing lic health and therefore batches thereof the color additive bismuth citrate shall are exempt from the requirements of bear, in addition to other information section 721(c) of the act. required by law, the following statement, conspicuously displayed thereon: § 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper Keep this product out of children’s reach. complex). Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on (a) Identity and specifications. The parts of the body other than the scalp. Wash color additive potassium sodium cop- hands thoroughly after each use. per chlorophyllin shall conform in (e) Exemption from certification. Cer- identity and specifications to the re- tification of this color additive for the quirements of § 73.1125(a)(1) and (b). prescribed use is not necessary for the (b) Uses and restrictions. Potassium protection of the public health, and, sodium copper chlorophyllin may be therefore, batches thereof are exempt safely used for coloring dentifrices that from certification requirements of sec- are cosmetics subject to the following tion 721(c) of the act. conditions: (1) It shall not be used at a level in [43 FR 44831, Sept. 29, 1978, as amended at 75 excess of 0.1 percent. FR 14493, Mar. 26, 2010] (2) It may be used only in combination with the following substances: § 73.2120 Disodium EDTA-copper. Water. (a) Identity. The color additive diso- Glycerin. dium EDTA-copper is disodium [[N,N′- Sodium carboxymethylcellulose. 1,2- ethanediylbis[N - (carboxymethyl) Tetrasodium pyrophosphate. glycinato]] (4-)-N,N′,O,O′,ON,ON′] Sorbitol. cuprate (2-). Magnesium phosphate, tribasic. (b) Specifications. Disodium EDTA- Calcium carbonate. copper shall conform to the following Calcium phosphate, dibasic. Sodium N-lauroyl sarcosinate. specifications and shall be free from Artificial sweeteners that are generally rec- impurities other than those named to ognized as safe or that are authorized the extent that such impurities may be under subchapter B of this chapter. avoided by good manufacturing prac- Flavors that are generally recognized as safe tice: or that are authorized under subchapter B of this chapter. Total copper, not less than 13.5 percent. Preservatives that are generally recognized Total (ethylene-dinitrilo) tetracetic acid, as safe or that are authorized under sub- not less than 62.5 percent. chapter B of this chapter. Free copper, not more than 100 parts per million. (c) Labeling. The label of the color ad- Free disodium salt of (ethylene-dinitrilo) ditive shall conform to the require- tetraacetic acid, not more than 1.0 percent. ments of § 70.25 of this chapter.

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(d) Exemption from certification. Cer- information required by law, labeling tification of this color additive is not in accordance with the provisions of necessary for the protection of the pub- § 70.25 of this chapter. lic health and therefore batches thereof (d) Exemption from certification. Cer- are exempt from the certification re- tification of this color additive is not quirements of section 721(c) of the act. necessary for the protection of the public health, and therefore batches there- § 73.2150 Dihydroxyacetone. of are exempt from certification pursu- (a) Identity and specifications. The ant to section 721(c) of the act. color additive dihydroxyacetone shall [42 FR 52394, Sept. 30, 1977] conform in identity and specifications to the requirements of § 73.1150 (a)(1) § 73.2180 Guaiazulene. and (b). (a) Identity. (1) The color additive, (b) Uses and restrictions. guaiazulene, is principally 1,4-di- Dihydroxyacetone may be safely used methyl-7-isopropyl-azulene. in amounts consistent with good manu- (2) Color additive mixtures of facturing practice in externally applied guaiazulene for cosmetic use may con- cosmetics intended solely or in part to tain the following diluent: impart a color to the human body. (c) Labeling requirements. The labeling Polyethylene glycol-40 castor oil (PEG–40 of the color additive and any mixtures castor oil). prepared therefrom intended solely or Saponification No., 60 to 70. in part for coloring purposes shall con- Hydroxyl No., 63 to 78. Acid No., 2. form to the requirements of § 70.25 of Specific gravity, 1.05 to 1.07. this chapter. (d) Exemption from certification. Cer- (b) Specifications. Guaiazulene shall tification of this color additive is not conform to the following specifications necessary for the protection of the pub- and shall be free from impurities, other lic health and therefore batches thereof than those named, to the extent that are exempt from the requirements of such other impurities may be avoided section 721(c) of the act. by good manufacturing practice. Melting point, 30.5 °C to 31.5 °C. § 73.2162 Bismuth oxychloride. Lead (as Pb), not more than 20 parts per mil- (a) Identity and specifications. (1) The lion. color additive bismuth oxychloride Arsenic (as As), not more than 3 parts per shall conform in identity and specifica- million. tions to the requirements of Mercury (as Hg), not more than 1 part per million. § 73.1162(a)(1) and (b). Total color, not less than 99 percent. (2) Color additive mixtures of bismuth oxychloride may contain the fol- (c) Uses and restrictions. Guaiazulene lowing diluents: may be safely used in externally ap- (i) For coloring cosmetics generally, plied cosmetics in amounts consistent only those diluents listed under with good manufacturing practice. § 73.1001(a)(1); (d) Labeling. The label of the color ad- (ii) For coloring externally applied ditive and any mixtures prepared cosmetics, only those diluents listed in therefrom intended solely or in part for § 73.1001(b) and, in addition, nitrocellu- coloring purposes shall conform to the lose. requirements of § 70.25 of this chapter. (b) Uses and restrictions. The color ad- (e) Exemption from certification. Cer- ditive bismuth oxychloride may be tification of this color additive for the safely used in coloring cosmetics gen- prescribed use is not necessary for the erally, including cosmetics intended protection of the public health and for use in the area of the eye, in therefore batches thereof are exempt amounts consistent with good manu- from the certification requirements of facturing practice. section 721(c) of the act. (c) Labeling. The color additive and any mixture prepared therefrom in- § 73.2190 Henna. tended solely or in part for coloring (a) Identity. The color additive henna purposes shall bear, in addition to any is the dried leaf and petiole of Lawsonia

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alba Lam. (Lawsonia inermis L.). It may (d) Labeling. The color additive and be identified by its characteristic odor any mixture prepared therefrom in- and by characteristic plant histology. tended solely or in part for coloring (b) Specifications. Henna shall con- purposes shall bear, in addition to any form to the following specifications: information required by law, labeling in accordance with § 70.25 of this chap- It shall not contain more than 10 percent of plant material from Lawsonia alba Lam. ter. (Lawsonia inermis L.) other than the leaf (e) Exemption from certification. Cer- and petiole, and shall be free from admix- tification of this color additive is not ture with material from any other species necessary for the protection of the pub- of plant. lic health, and therefore batches there- Moisture, not more than 10 percent. of are exempt from certification pursu- Total ash, not more than 15 percent. ant to section 721(c) of the act. Acid-insoluble ash, not more than 5 percent. Lead (as Pb), not more than 20 parts per mil- § 73.2298 Ferric ammonium ferrocya- lion. nide. Arsenic (as As), not more than 3 parts per million. (a) Identity and specifications. The color additive ferric ammonium ferro- (c) Uses and restrictions. The color ad- cyanide shall conform in identify and ditive henna may be safely used for specifications to the requirements of coloring hair only. It may not be used § 73.1298 (a)(1) and (b). for coloring the eyelashes or eyebrows, (b) Uses and restrictions. Ferric ammo- or generally in the area of the eye. nium ferrocyanide is safe for use in (d) Labeling. The label for henna shall coloring externally applied cosmetics, bear the information required by § 70.25 including cosmetics applied to the area of this chapter and the following state- of the eye, in amounts consistent with ments or their equivalent: good manufacturing practice. ‘‘Do not use in the area of the eye.’’ (c) Labeling. The color additive and ‘‘Do not use on cut or abraded scalp.’’ any mixture prepared therefrom in- (e) Exemption from certification. Cer- tended solely or in part for coloring tification of this color additive for the purposes shall bear, in addition to any prescribed use is not necessary for the information required by law, labeling protection of the public health and in accordance with § 70.25 of this chap- therefore batches thereof are exempt ter. from the certification requirements of (d) Exemption from certification. Cer- section 721(c) of the act. tification of this color additive is not necessary for the protection of the pub- § 73.2250 Iron oxides. lic health, and therefore batches there- (a) Identity. The color additives iron of are exempt from the certification oxides consist of any one or any com- pursuant to section 721(c) of the act. bination of synthetically prepared iron [42 FR 38562, July 29, 1977, as amended at 43 oxides, including the hydrated forms. FR 6939, Feb. 17, 1978] It is free from admixture with other substances. § 73.2299 Ferric ferrocyanide. (b) Specifications. Iron oxides shall (a) Identity and specifications. The conform to the following specifica- color additive ferric ferrocyanide shall tions, all on an ‘‘as is’’ basis: conform in identity and specifications Arsenic (as As), not more than 3 parts per to the requirements of § 73.1299(a)(1) million. and (b). Lead (as Pb), not more than 10 parts per mil- (b) Uses and restrictions. Ferric ferro- lion. cyanide is safe for use in coloring ex- Mercury (as Hg), not more than 3 parts per ternally applied cosmetics, including million. cosmetics applied to the area of the (c) Uses and restrictions. Iron oxides eye, in amounts consistent with good are safe for use in coloring cosmetics manufacturing practice. generally, including cosmetics applied (c) Labeling. The color additive and to the area of the eye, in amounts con- any mixture prepared therefrom in- sistent with good manufacturing prac- tended solely or in part for coloring tice. purposes shall bear, in addition to any

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information required by law, labeling (d) Exemption from certification. Cer- in accordance with § 70.25 of this chap- tification of this color additive is not ter. necessary for the protection of the pub- (d) Exemption from certification. Cer- lic health, and therefore batches there- tification of this color additive is not of are exempt from the certification necessary for the protection of the pub- pursuant to section 721(c) of the act. lic health, and therefore batches there- [42 FR 36452, July 15, 1977] of are exempt from certification under section 721(c) of the act. § 73.2329 Guanine. [43 FR 54236, Nov. 21, 1978] (a) Identity and specifications. (1) The color additive guanine shall conform in § 73.2326 Chromium hydroxide green. identity and specifications to the re- (a) Identity and specifications. The quirements of § 73.1329 (a)(1) and (b). color additive chromium hydroxide (2) Color additive mixtures of gua- green shall conform in identity and nine may contain the following specifications to the requirements of diluents: § 73.1326 (a)(1) and (b). (i) For coloring cosmetics generally, (b) Uses and restrictions. Chromium only those diluents listed under hydroxide green is safe for use in color- § 73.1001(a)(1); ing externally applied cosmetics, in- (ii) For coloring externally applied cluding those intended for use in the cosmetics, only those diluents listed in area of the eye, in amounts consistent § 73.1001(b) and, in addition, nitrocellu- with good manufacturing practice. lose. (c) Labeling. The color additive and (b) Use and restrictions. The color ad- any mixture prepared therefrom in- ditive guanine may be safely used in tended solely or in part for coloring cosmetics generally, including cos- purposes shall bear, in addition to any metics intended for use in the area of information required by law, labeling the eye, in amounts consistent with in accordance with § 70.25 of this chap- good manufacturing practice. ter. (c) Labeling requirements. The color (d) Exemption from certification. Cer- additive and any mixtures prepared tification of this color additive is not therefrom intended solely or in part for necessary for the protection of the pub- coloring purposes shall bear, in addi- lic health, and therefore batches there- tion to any information required by of are exempt from certification pursu- law, labeling in accordance with the ant to section 721(c) of the act. provisions of § 70.25 of this chapter. (d) Exemption from certification. Cer- [42 FR 36452, July 15, 1977] tification of this color additive is not necessary for the protection of the pub- § 73.2327 Chromium oxide greens. lic health, and therefore batches there- (a) Identity and specifications. The of are exempt from the certification color additive chromium oxide greens pursuant to section 721(c) of the act. shall conform in identify and specifications to the requirements of § 73.1327 [42 FR 37537, July 22, 1977] (a)(1) and (b). § 73.2396 Lead acetate. (b) Uses and restrictions. The color additive chromium oxide greens may be (a) Identity. The color additive lead safely used in externally applied cos- acetate is the trihydrate of lead (2 + ) metics, including cosmetics intended salt of acetic acid. The color additive for use in the area of the eye, in has the chemical formula Pb amounts consistent with good manu- (OOCCH3)2·3H2O). facturing practice. (b) Specifications. Lead acetate shall (c) Labeling requirements. The color conform to the following specifications additive and any mixtures prepared and shall be free from impurities other therefrom intended solely or in part for than those named to the extent that coloring purposes shall bear, in addi- such impurities may be avoided by tion to any information required by good manufacturing practice: law, labeling in accordance with the Water-insoluble matter, not more than 0.02 provisions of § 70.25 of this chapter. percent.

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pH (30 percent solution weight to volume at the requirements of § 73.1400 (a)(1) and 25 °C), not less than 4.7 and not more than (b). 5.8. (b) Uses and restrictions. Pyrophyllite Arsenic (as As), not more than 3 parts per may be safely used for coloring exter- million. Lead acetate, not less than 99 percent. nally applied cosmetics, in amounts Mercury (as Hg), not more than 1 part per consistent with good manufacturing million. practice. (c) Labeling requirements. The labeling (c) Uses and restrictions. The color ad- of the color additive and any mixtures ditive lead acetate may be safely used prepared therefrom intended solely or in cosmetics intended for coloring hair in part for coloring purposes shall con- on the scalp only, subject to the fol- form to all applicable requirements of lowing restrictions: law, including the requirements of (1) The amount of the lead acetate in § 70.25 of this chapter. the cosmetic shall be such that the (d) Exemption from certification. Cer- lead content, calculated as Pb, shall tification of this color additive is not not be in excess of 0.6 percent (weight necessary for the protection of the pub- to volume). lic health and therefore batches thereof (2) The cosmetic is not to be used for are exempt from the certification re- coloring mustaches, eyelashes, eye- quirements of section 721(c) of the act. brows, or hair on parts of the body other than the scalp. § 73.2496 Mica. (d) Labeling requirements. (1) The label of the color additive lead acetate shall (a) Identity and specifications. The conform to the requirements of § 70.25 color additive mica shall conform in of this chapter, and bear the following identity and specifications to the re- statement or equivalent: quirements of § 73.1496(a)(1) and (b). (b) Uses and restrictions. Mica is safe Wash thoroughly if the product comes into for use in coloring cosmetics generally, contact with the skin. including cosmetics applied to the area (2) The label of the cosmetic con- of the eye, in amounts consistent with taining the color additive lead acetate, good manufacturing practice. in addition to other information re- (c) Labeling. The color additive and quired by the act, shall bear the fol- any mixture prepared therefrom in- lowing cautionary statement, con- tended solely or in part for coloring spicuously displayed thereon: purposes shall bear, in addition to any information required by law, labeling CAUTION: Contains lead acetate. For exter- in accordance with of § 70.25 of this nal use only. Keep this product out of children’s reach. Do not use on cut or abraded chapter. scalp. If skin irritation develops, discontinue (d) Exemption from certification. Cer- use. Do not use to color mustaches, eye- tification of this color additive is not lashes, eyebrows, or hair on parts of the body necessary for the protection of the pub- other than the scalp. Do not get in eyes. Fol- lic health, and therefore batches there- low instructions carefully and wash hands of are exempt from the certification thoroughly after each use. pursuant to section 721(c) of the act. (e) Exemption for certification. Certifi- [42 FR 38561, July 29, 1977] cation of this color additive for the prescribed use is not necessary for the § 73.2500 Silver. protection of the public health and (a) Identity. (1) The color additive, therefore batches thereof are exempt silver, is a crystalline powder of high from the certification requirements of purity silver prepared by the reaction section 721(c) of the act. of silver nitrate with ferrous sulfate in [45 FR 72117, Oct. 31, 1980, as amended at 72 the presence of nitric, phosphoric and FR 10357, Mar. 8, 2007] sulfuric acids. Polyvinyl alcohol is used to prevent the agglomeration of § 73.2400 Pyrophyllite. crystals and the formation of amor- (a) Identity and specifications. The phous silver. color additive pyrophyllite shall con- (2) Color additive mixtures of silver form in identity and specifications to may contain only those diluents listed

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in § 73.1001(b) and, in addition, nitro- § 73.2645 Aluminum powder. cellulose. (a) Identity and specifications. The (b) Specifications. Silver shall con- color additive aluminum powder shall form to the following specifications conform in identity and specifications and shall be free from impurities other to the requirements of § 73.1645 (a)(1) than those named to the extent that and (b). such other impurities may be avoided (b) Uses and restrictions. Aluminum by good manufacturing practice: powder may be safely used in coloring Lead (as Pb), not more than 10 parts per mil- externally applied cosmetics, including lion. cosmetics intended for use in the area Arsenic (as As), not more than 5 parts per of the eye, in amounts consistent with million. good manufacturing practice. Mercury (as Hg), not more than 1 part per (c) Labeling. The color additive and million. Silver (as Ag), not less than 99.9 percent. any mixture prepared therefrom intended solely or in part for coloring (c) Uses and restrictions. The color ad- purposes shall bear, in addition to any ditive silver may be safely used for information required by law, labeling coloring fingernail polish at a level not in accordance with the provisions of to exceed 1 percent of the final product. § 70.25 of this chapter. (d) Labeling. The color additive and (d) Exemption from certification. Cer- any mixtures prepared therefrom in- tification of this color additive is not tended solely or in part for coloring necessary for the protection of the pub- purposes shall bear, in addition to any lic health, and therefore batches there- other information required by law, la- of are exempt from the certification beling in accordance with the provi- pursuant to section 721(c) of the act. sions of § 70.25 of this chapter. (e) Exemption from certification. Cer- [42 FR 38563, July 29, 1977] tification of this color additive is not § 73.2646 Bronze powder. necessary for the protection of the public health and therefore batches thereof (a) Identity and specifications. The are exempt from the certification re- color additive bronze powder shall con- quirements of section 721(c) of the act. form in identity and specifications to the requirements of § 73.1646 (a)(1) and [44 FR 65974, Nov. 16, 1979] (b). (b) Uses and restrictions. Bronze pow- § 73.2575 Titanium dioxide. der may be safely used in coloring cos- (a) Identity and specifications. The metics generally, including cosmetics color additive titanium dioxide shall intended for use in the area of the eye, conform in identity and specifications in amounts consistent with good manu- to the requirements on § 73.575 (a)(1) facturing practice. and (b). (c) Labeling. The color additive and (b) Uses and restrictions. The color ad- any mixture prepared therefrom in- ditive titanium dioxide may be safely tended solely or in part for coloring used in cosmetics, including cosmetics purposes shall conform to the require- intended for use in the area of the eye, ments of § 70.25 of this chapter. in amounts consistent with good manu- (d) Exemption from certification. Cer- facturing practice. tification of the color additive is not (c) Labeling requirements. The color necessary for the protection of the pub- additive and any mixtures prepared lic health, and therefore batches there- therefrom intended solely or in part for of are exempt from the certification re- coloring purposes shall bear, in addi- quirements of section 721(c) of the act. tion to any other information required by law, labeling in accordance with the [42 FR 33724, July 1, 1977] provisions of § 70.25 of this chapter. (d) Exemption from certification. Cer- § 73.2647 Copper powder. tification of this color additive is not (a) Identity and specifications. The necessary for the protection of the pub- color additive copper powder shall con- lic health, and therefore batches there- form in identity and specifications to of are exempt from certification pursu- the requirements of § 73.1647 (a)(1) and ant to section 721(c) of the act. (b).

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(b) Uses and restrictions. Copper pow- tion to any other information required der may be safely used in coloring cos- by law, labeling in accordance with metics generally, including cosmetics § 70.25 of this chapter. intended for use in the area of the eye, (e) Exemption from certification. Cer- in amounts consistent with good manu- tification of this color additive is not facturing practice. necessary for the protection of the pub- (c) Labeling. The color additive and lic health, and therefore batches there- any mixture prepared therefrom in- of are exempt from certification pursu- tended solely or in part for coloring ant to section 721(c) of the act. purposes shall conform to the requirements of § 70.25 of this chapter. § 73.2775 Manganese violet. (d) Exemption from certification. Cer- (a) Identity. The color additive man- tification of the color additive is not ganese violet is a violet pigment ob- necessary for the protection of the pub- tained by reacting phosphoric acid, am- lic health, and therefore batches there- monium dihydrogen orthophosphate, of are exempt from the certification re- and manganese dioxide at tempera- quirements of section 721(c) of the act. tures above 450 °F. The pigment is a [42 FR 33724, July 1, 1977] manganese ammonium pyrophosphate complex having the approximate for- § 73.2725 Ultramarines. mula: Mn(III)NH4P2O7. (b) Specifications. Manganese violet (a) Identity. The color additives, shall conform to the following speci- ultramarines (blue, green, pink, red, fications and shall be free from impuri- and violet) are pigments obtained by ties other than those named, to the ex- calcining at temperatures above 700 °C. tent that such other impurities may be a mixture of kaolin, sulfur, sodium car- avoided by good manufacturing prac- bonate, silicious matter, sodium sul- tice: fate, and carbonaceous matter, but not necessarily all these substances, to Ash (at 600 °C), not less than 81 percent. produce a single color. The Volatile matter at 135 °C for 3 hours, not ultramarines are complex sodium alu- more than 1 percent. minum sulfosilicates having a typical Water soluble substances, not more than 6 percent. formula Na(AlSiO)S with proportions pH of filtrate of 10 grams color additive of each element varying with each (shaken occasionally for 2 hours with 100 color. milliliters of freshly boiled distilled (b) Specifications. The ultramarines water), not more than 4.7 and not less than shall conform to the following speci- 2.5. fications and shall be free from impuri- Lead (as Pb), not more than 20 parts per mil- ties other than those named, to the ex- lion. Arsenic (as As), not more than 3 parts per tent that such other impurities may be million. avoided by good manufacturing prac- Mercury (as Hg), not more than 1 part per tice. million. Total color, based on Mn content in ‘‘as is’’ Lead (as Pb), not more than 20 parts per mil- sample, not less than 93 percent. lion. Arsenic (as As), not more than 3 parts per (c) Uses and restrictions. Manganese million. violet is safe for use in coloring cos- Mercury (as Hg), not more than 1 part per metics generally, including cosmetics million. applied to the area of the eye, in (c) Uses and restrictions. The ultra- amounts consistent with good manu- marine pigments may be safely used facturing practice. for coloring externally applied cos- (d) Labeling. The color additive and metics, including cosmetics intended any mixture prepared therefrom infor use in the area of the eye, in tended solely or in part for coloring amounts consistent with good manu- purposes shall bear, in addition to any facturing practice. information required by law, labeling (d) Labeling requirements. The color in accordance with § 70.25 of this chap- additives and any mixtures prepared ter. therefrom intended solely or in part for (e) Exemption from certification. Cer- coloring purposes shall bear, in addi- tification of this color additive is not

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necessary for the protection of the pub- nail polish included under lic health, and therefore batches there- § 720.4(c)(7)(ix) and (c)(8)(v) of this chap- of are exempt from certification pursu- ter, respectively, to the following re- ant to section 721(c) of the act. strictions: (1) The amount of luminescent zinc § 73.2991 Zinc oxide. sulfide in facial makeup preparations (a) Identity and specifications. The shall not exceed 10 percent by weight of color additive zinc oxide shall conform the final product. in identity and specifications to the re- (2) Facial makeup preparations con- quirements of § 73.1991 (a)(1) and (b). taining luminescent zinc sulfide are in- (b) Uses and restrictions. Zinc oxide tended for use only on limited, infre- may be safely used in cosmetics, in- quent occasions, e.g., Halloween, and cluding cosmetics intended for use in not for regular or daily use. the area of the eye, in amounts con- (d) Labeling requirements. (1) The label sistent with good manufacturing prac- of the color additive and any mixtures tice. prepared therefrom shall bear expira- (c) Labeling. The color additive and tion dates for the sealed and open con- any mixture prepared therefrom in- tainer (established through generally tended solely or in part for coloring accepted stability testing methods), purposes shall bear, in addition to any other information required by § 70.25 of information required by law, labeling this chapter, and adequate directions in accordance with § 70.25 of this chap- to prepare a final product complying ter. with the limitations prescribed in para- (d) Exemption from certification. Cer- graph (c) of this section. tification of this color additive is not (2) The label of a facial makeup prep- necessary for the protection of the pub- aration containing the color additive lic health, and therefore batches there- shall bear, in addition to other infor- of are exempt from the certification mation required by the law, the fol- pursuant to section 721(c) of the act. lowing statement conspicuously dis- [42 FR 37538, July 22, 1977] played: Do not use in the area of the eye. § 73.2995 Luminescent zinc sulfide. (e) Exemption from certification. Cer- (a) Identity. The color additive lumi- tification of this color additive is not nescent zinc sulfide is zinc sulfide con- necessary for the protection of the pub- taining a copper activator. Following lic health, and therefore batches there- excitation by daylight or a suitable ar- of are exempt from the certification re- tificial light, luminescent zinc sulfide quirements of section 721(c) of the act. produces a yellow-green phosphores- [65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, cence with a maximum at 530 nano- 2000] meters. (b) Specifications. Luminescent zinc Subpart D—Medical Devices sulfide shall conform to the following specifications and shall be free from § 73.3100 1,4-Bis[(2-hydroxy- impurities other than those named to ethyl)amino]-9,10-anthracenedione the extent that such impurities may be bis(2-methyl-2-propenoic)ester co- avoided by good manufacturing prac- polymers. tice: (a) Identity. The color additives are Zinc sulfide, not less than 99.8 percent. the copolymers formed as the reaction Copper, 100±5 parts per million. product of 1,4-bis[(2-hydroxy- Lead, not more than 20 parts per million. ethyl)amino]-9,10-anthracenedione Arsenic, not more than 3 parts per million. bis(2-methyl-2-propenoic)ester (C.I. Re- Mercury, not more than 1 part per million. active Blue 247) (CAS Reg. No. 109561– Cadmium, not more than 15 parts per mil- 07–1) with one or more vinyl and/or lion. acrylic monomers to form the contact (c) Uses and restrictions. The color ad- lens material. ditive luminescent zinc sulfide may be (b) Uses and restrictions. (1) The sub- safely used for coloring externally ap- stances listed in paragraph (a) of this plied facial makeup preparations and section may be used in amounts not to

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exceed the minimum reasonably re- (d) Exemption from certification. Cer- quired to accomplish the intended tification of this color additive is not coloring effect. necessary for the protection of the pub- (2) Authorization and compliance lic health, and therefore the color addi- with these uses shall not be construed tive is exempt from the certification as waiving any of the requirements of requirements of section 721(c) of the sections 510(k), 515, and 520(g) of the act. Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact [49 FR 30066, July 26, 1984] lens made from the color additives. § 73.3106 1,4-Bis[4-(2- (c) Labeling. The label of the color ad- methacryloxyethyl) ditives shall conform to the require- phenylamino]anthraquinone co- ments of § 70.25 of this chapter. polymers. (d) Cer- Exemption from certification. (a) Identity. The color additives are tification of these color additives is the copolymers formed as the reaction not necessary for the protection of the product of 1,4-bis[4- (2- public health and therefore the color methacryloxyethyl )phenylamino] additives are exempt from the certifi- anthraquinone (C.I. Reactive Blue 246) cation requirements of section 721(c) of (CAS Reg. No. 121888–69–5) with one or the act. more vinyl and/or acrylic monomers to [61 FR 51586, Oct. 3, 1996, as amended at 78 FR form the contact lens material. 19415, Apr. 1, 2013]] (b) Uses and restrictions. (1) The substances listed in paragraph (a) of this § 73.3105 1,4-Bis[(2- section may be used in amounts not to methylphenyl)amino]-9,10- anthracenedione. exceed the minimum reasonably required to accomplish the intended (a) Identity. The color additive is 1,4- coloring effect. bis[(2-methylphenyl)amino]-9,10- (2) Authorization and compliance anthracenedione (CAS Reg. No. 6737–68– with these uses shall not be construed 4). as waiving any of the requirements of (b) Uses and restrictions. (1) The sub- sections 510(k), 515, and 520(g) of the stance listed in paragraph (a) of this Federal Food, Drug, and Cosmetic Act section may be used as a color additive (the act) with respect to contact lenses in contact lenses in amounts not to ex- made from the color additives. ceed the minimum reasonably required (c) Labeling. The label of the color ad- to accomplish the intended coloring ef- ditives shall conform to the require- fect. ments of § 70.25 of this chapter. (2) Authorization and compliance (d) Exemption from certification. Cer- with this use shall not be construed as tification of these color additives is waiving any of the requirements of sec- not necessary for the protection of the tions 510(k), 515, and 520(g) of the Fed- public health and, therefore, the color eral Food, Drug, and Cosmetic Act (the additives are exempt from the certifi- act). A person intending to introduce a cation requirements of section 721(c) of device containing 1,4-bis[(2- the act. methylphenyl)amino]-9,10- anthracenedione listed under this sec- [58 FR 17507, Apr. 5, 1993, as amended at 60 tion into commerce shall submit to the FR 10497, Feb. 27, 1995; 78 FR 19415, Apr. 1, Food and Drug Administration either a 2013] premarket notification in accordance with subpart E of part 807 of this chap- § 73.3107 Carbazole violet. ter, if the device is not subject to pre- (a) Identity. The color additive is car- market approval, or submit and receive bazole violet (Pigment Violet 23) (CAS approval of an original or supplemental Reg. No. 6358–30–1, Colour Index No. premarket approval application if the 51319). device is subject to premarket ap- (b) Uses and restrictions. (1) The sub- proval. stance listed in paragraph (a) of this (c) Labeling. The label of the color ad- section may be used as a color additive ditive shall conform to the require- in contact lenses in amounts not to ex- ments of § 70.25 of this chapter. ceed the minimum reasonably required

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to accomplish the intended coloring ef- oil soluble (5 percent in palm oil, pea- fect. nut oil, and hydrogenated peanut oil), (2) Authorization for this use shall may be safely used to color not be construed as waiving any of the polymethylmethacrylate bone cement. requirements of sections 510(k), 515, Chlorophyllin-copper complex may be and 520(g) of the Federal Food, Drug, used at levels that do not exceed 0.003 and Cosmetic Act (the act) with re- percent by weight of the bone cement. spect to the contact lens in which the (2) Authorization for this use shall color additive is used. not be construed as waiving any of the (c) Labeling. The label of the color ad- requirements of sections 510(k), 515, ditive shall conform to the require- and 520(g) of the Federal Food, Drug, ments of § 70.25 of this chapter. and Cosmetic Act with respect to the (d) Exemption from certification. Cer- polymethylmethacrylate bone cement tification of this color additive is not in which chlorophyllin-copper complex, necessary for the protection of the pub- oil soluble, is used. lic health, and therefore the color addi- (d) Labeling. The label of the color ad- tive is exempt from the certification ditive shall conform to the require- requirements of section 721(c) of the ments of § 70.25 of this chapter. act. (e) Exemption from certification. Cer- [53 FR 41324, Oct. 21, 1988] tification of this color additive is not necessary for the protection of the pub- § 73.3110 Chlorophyllin-copper com- lic health, and therefore the color addi- plex, oil soluble. tive is exempt from the certification (a) Identity. The color additve is requirements of section 721(c) of the chlorophyllin-copper complex, oil solu- act. ble. The chlorophyllin is obtained by extraction from a mixture of fescue [48 FR 56370, Dec. 21, 1983] and rye grasses. The chlorophyll is acid-treated to remove chelated mag- § 73.3110a Chromium-cobalt-aluminum nesium which is replaced with hydro- oxide. gen, which is turn is replaced with cop- (a) Identity. The color additive chro- per. This mixture is diluted to a 5 per- mium-cobalt-aluminum oxide (Pigment cent concentration with a mixture of Blue 36) (CAS Reg. No. 68187–11–1, Col- palm oil, peanut oil, and hydrogenated our Index No. 77343) shall conform in peanut oil. identity and specifications to the re- (b) Specifications. The color additive quirements of § 73.1015 (a) and (b). chlorophyllin-copper complex, oil solu- (b) Uses and restrictions. (1) The sub- ble (5 percent in palm oil, peanut oil, stance listed in paragraph (a) of this and hydrogenated peanut oil), shall section may be used as a color additive conform to the following specifications in contact lenses in amounts not to ex- and shall be free from impurities other ceed the minimum reasonably required than those named to the extent that to accomplish the intended coloring ef- such other impurities may be avoided fect. by current good manufacturing prac- (2) Authorization for this use shall tice: not be construed as waiving any of the Moisture, not more than 0.5 percent. requirements of sections 510(k), 515, Nitrogen, not less than 0.2 percent and not and 520(g) of the Federal Food, Drug, more than 0.3 percent. and Cosmetic Act (the act) with re- Total copper, not less than 0.2 percent and spect to the contact lens in which the not more than 0.4 percent. color additive is used. Free copper, not more than 200 parts per million. (c) Labeling. The label of the color ad- Lead, not more than 20 parts per million. ditive shall conform to the require- Arsenic, not more than 5 parts per million. ments of § 70.25 of this chapter. Sulfated ash, not more than 2.5 percent. (d) Exemption from certification. Cer- Total color, not less than 4.5 percent and not tification of this color additive is not more than 5.5 percent. necessary for the protection of the pub- (c) Uses and restrictions. (1) The color lic health, and therefore the color addi- additive chlorophyllin-copper complex, tive is exempt from the certification

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requirements of section 721(c) of the in accordance with subpart E of part act. 807 of this chapter, if the device is not [53 FR 41325, Oct. 21, 1988] subject to premarket approval, or submit and receive approval of an original § 73.3111 Chromium oxide greens. or supplemental premarket approval (a) Identity and specifications. The application if the device is subject to color additive chromium oxide greens premarket approval. (chromic oxide) (CAS Reg. No. 1308–38– (c) Labeling. The label of the color ad- 9), Color Index No. 77288, shall conform ditive shall conform to the require- in identity and specifications to the re- ments of § 70.25 of this chapter. quirements of § 73.1327 (a)(1) and (b). (d) Exemption from certification. Cer- (b) Uses and restrictions. (1) The sub- tification of this color additive is not stance listed in paragraph (a) of this necessary for the protection of the pub- section may be used as a color additive lic health, and therefore the color addi- in contact lenses in amounts not to ex- tive is exempt from the certification ceed the minimum reasonably required requirements of section 721(c) of the to accomplish the intended coloring ef- act. fect. (2) Authorization and compliance [50 FR 20407, May 16, 1985] with this use shall not be construed as § 73.3115 2-[[2,5-Diethoxy-4-[(4- waiving any of the requirements of sec- methylphenyl)thiol]phenyl]azo]- tions 510(k), 515, and 520(g) of the Fed- 1,3,5-benzenetriol. eral Food, Drug, and Cosmetic Act with respect to the contact lenses in (a) Identity. The color additive2-[[2,5- which the additive is used. diethoxy-4-[(4- (c) Labeling. The label of the color ad- methylphenyl)thio]phenyl]azo]-1,3,5- ditive shall conform to the require- benzenetriol is formed in situ in soft ments of § 70.25 of this chapter. (hydrophilic) contact lenses. (d) Exemption from certification. Cer- (b) Uses and restrictions. The color ad- tification of this color additive is not ditive 2-[[2,5-diethoxy-4-[(4- necessary for the protection of the pub- methylphenyl)thio]phenyl]azo]-1,3,5- lic health, and therefore the color addi- benzenetriol may be safely used to tive is exempt from the certification mark soft (hydrophilic) contact lenses requirements of section 721(c) of the with the letter R or the letter L for act. identification purposes subject to the following restrictions: [51 FR 24816, July 9, 1986] (1) The quantity of the color additive ¥ § 73.3112 C.I. Vat Orange 1. does not exceed 1.1 × 10 7 grams in a soft (hydrophilic) contact lens. (a) Identity. The color additive is C.I. Vat Orange 1, Colour Index No. 59105. (2) When used as specified in the la- (b) Uses and restrictions. (1) The sub- beling, there is no measurable migra- stance listed in paragraph (a) of this tion of the color additive from the con- section may be used as a color additive tact lens to the surrounding ocular tis- in contact lenses in amounts not to ex- sue. ceed the minimum reasonably required (3) Authorization for this use shall to accomplish the intended coloring ef- not be construed as waiving any of the fect. requirements of section 510(k) and 515 (2) Authorization for this use shall of the Federal Food, Drug, and Cos- not be construed as waiving any of the metic Act with respect to the contact requirements of sections 510(k), 515, lens in which the color additive is used. and 520(g) of the Federal Food, Drug, (c) Labeling. The label of the color ad- and Cosmetic Act (the act) with re- ditive shall conform to the require- spect to the contact lens in which the ments of § 70.25 of this chapter. color additive is used. A person intend- (d) Exemption from certification. Cer- ing to introduce a device containing tification of this color additive is not C.I. Vat Orange 1 into commerce shall necessary for the protection of the pub- submit to the Food and Drug Adminis- lic health, and therefore the color addi- tration either a premarket notification tive is exempt from the certification

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requirements of section 721(c) of the contact lens in which the color addi- act. tive is used. (c) Labeling. The label of the color ad- [48 FR 22706, May 20, 1983] ditive shall conform to the require- § 73.3117 16,23-Dihydrodinaphtho[2,3- ments of § 70.25 of this chapter. a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3- (d) Exemption from certification. Cer- c] carbazole-5,10,15,17,22,24-hexone. tification of this color additive is not (a) Identity. The color additive is necessary for the protection of the pub- 16,23-dihydrodinaphtho [2,3- a:2′,3′-i] lic health, and therefore the color addi- napth [2′,3′:6,7] indolo [2, 3-c] carbazole- tive is exempt from the certification 5,10, 15,17,22,24-hexone (CAS Reg. No. requirements of section 721(c) of the 2475–33–4), Colour Index No. 70800. act. (b) Uses and restrictions. (1) The sub- [48 FR 31375, July 8, 1983] stance listed in paragraph (a) of this section may be used as a color additive § 73.3119 7,16-Dichloro–6,15-dihydro- in contact lenses in amounts not to ex- 5,9,14,18-anthrazinetetrone. ceed the minimum reasonably required (a) Identity. The color additive is 7,16- to accomplish the intended coloring ef- dichloro-6,15-dihydro-5,9,14,18- fect. anthrazinetetrone (CAS Reg. No. 130– (2) Authorization for this use shall 20–1), Colour Index No. 69825. not be construed as waiving any of the (b) Uses and restrictions. (1) The sub- requirements of sections 510(k), 515, stance listed in paragraph (a) of this and 520(g) of the Federal Food, Drug, section may be used as a color additive and Cosmetic Act with respect to the in contact lenses in amounts not to ex- contact lens in which the color addi- ceed the minimum reasonably required tive is used. to accomplish the intended coloring ef- (c) Labeling. The label of the color ad- fect. ditive shall conform to the require- (2) Authorization for this use shall ments of § 70.25 of this chapter. not be construed as waiving any of the (d) Exemption from certification. Cer- requirements of sections 510(k), 515, tification of this color additive is not and 520(g) of the Federal Food, Drug, necessary for the protection of the pub- and Cosmetic Act with respect to the lic health, and therefore the color addi- contact lens in which the color additive is exempt from the certification tive is used. requirements of section 721(c) of the (c) Labeling. The label of the color ad- act. ditive shall conform to the requirements of § 70.25 of this chapter. [48 FR 31375, July 8, 1983] (d) Exemption from certification. Cer- § 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo- tification of this color additive is not 1,5-anthracenediyl) bisbenzamide. necessary for the protection of the public health, and therefore the color addi- (a) Identity. The color additive is tive is exempt from the certification N,N′-(9,10-dihydro-9,10-dioxo-1,5- requirements of section 721(c) of the anthracenediyl) bisbenzamide (CAS act. Reg. No. 82–18–8), Colour Index No. 61725. [48 FR 31376, July 8, 1983] (b) Uses and restrictions. (1) The substance listed in paragraph (a) of this § 73.3120 16,17-Dimethoxydinaphtho ′ ′ ′ section may be used as a color additive [1,2,3-cd:3 ,2 ,1 -lm] perylene-5,10- in contact lenses in amounts not to ex- dione. ceed the minimum reasonably required (a) Identity. The color additive is to accomplish the intended coloring ef- 16,17-dimethoydinaphtho[1,2,3,- fect. cd:3′,2′,1′-lm]perylene-5,10-dione (CAS (2) Authorization for this use shall Reg. No. 128–58–5), Colour Index No. not be construed as waiving any of the 59825. requirements of sections 510(k), 515, (b) Uses and restrictions. (1) The sub- and 520(g) of the Federal Food, Drug, stance listed in paragraph (a) of this and Cosmetic Act with respect to the section may be used as a color additive

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in contact lenses in amounts not to ex- (5) Reactive Blue No. 19 [2-anthra- ceed the minimum reasonably required cene-sulfonic acid, 1-amino-9,10- to accomplish the intended coloring ef- dihydro-9,10-dioxo-4-((3-((2- fect. (sulfooxy)ethyl)sulfonyl)phenyl)amino) (2) Authorization for this use shall -, disodium salt] (CAS Reg. No. 2580–78– not be construed as waiving any of the 1); requirements of sections 510(k), 515, (6) Reactive Blue No. 4 [2- and 520(g) of the Federal Food, Drug, anthracenesulfonic acid, 1-amino-4-(3- and Cosmetic Act with respect to the ((4,6-dichloro-s-triazin-2-yl)amino)-4- contact lens in which the color addi- sulfoanilino)-9,10-dihydro-9,10-dioxo, ditive is used. sodium salt] (CAS Reg. No. 4499–01–8); (c) Labeling. The label of the color ad- (7) C.I. Reactive Red 11 [5-((4,6- ditive shall conform to the require- dichloro-1,3,5-triazin-2-yl)amino)-4-hy- ments of § 70.25 of this chapter. droxy-3-((1-sulfo-2-naphthalenyl)azo)-2, (d) Exemption from certification. Cer- 7-naphthalenedisulfonic acid, tri- tification of this color additive is not sodium salt] (CAS Reg. No. 12226–08–3); necessary for the protection of the pub- (8) C.I. Reactive Yellow 86 [1,3- lic health, and therefore the color addi- benzenedisulfonic acid, 4-((5- tive is exempt from the certification aminocarbonyl-1-ethyl-1,6-dihydro-2- requirements of section 721(c) of the hydroxy-4-methyl-6-oxo-3- act. pyridinyl)azo)-6-(4,6-dichloro-1,3,5- triazin-2-yl)amino)-, disodium salt] [48 FR 31376, July 8, 1983] (CAS Reg. No. 61951–86–8); (9) C.I. Reactive Blue 163 § 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers. [triphenodioxazinedisulfonic acid, 6,13- dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5- (a) Identity. The color additives are triazin-2-yl)amino) sulfophenyl)amino)- formed by reacting one or more of the , tetrasodium salt] (CAS Reg. No. reactive dyes listed in this paragraph 72847–56–4); and with poly(hydroxyethyl methacrylate), (10) C.I. Reactive Red 180 [5- so that the sulfate group (or groups) or (benzoylamino)-4-hydroxy-3-((1-sulfo-6- chlorine substituent of the dye is re- ((2-(sulfooxy)ethyl)sulfonyl)-2- placed by an ether linkage to naphthalenyl)azo)-2,7- poly(hydroxyethyl methacrylate). The naphthalenedisulfonic acid, dyes that may be used alone or in com- tetrasodium salt] (CAS Reg. No. 98114– bination are 32–0). (1) Reactive Black 5 [2,7- (b) Uses and restrictions. (1) The sub- naphthalenedisulfonic acid, 4-amino-5- stances listed in paragraph (a) of this hydroxy-3,6-bis((4-((2- section may be used to color contact (sulfooxy)ethyl)sulfonyl)phenyl)azo)- lenses in amounts not to exceed the tetrasodium salt] (CAS Reg. No. 17095– minimum reasonably required to ac- 24–8); complish the intended coloring effect. (2) Reactive Blue 21 [copper, (29H,31H- (2) As part of the manufacturing phthalocyaninato(2-)-N29,N30,N31,N32)-, process, the lenses containing the color sulfo((4-((2- additives are thoroughly washed to re- sulfooxy)ethyl)sulfonyl)phenyl)amino) move unbound reactive dyes. sulfonyl derivs] (CAS Reg. No. 73049–92– (3) Authorization and compliance 0); with this use shall not be construed as (3) Reactive Orange 78 [2- waiving any of the requirements of sec- naphthalenesulfonic acid, 7- tions 510(k), 515, and 520(g) of the Fed- (acetylamino)-4-hydroxy-3-((4-((2- eral Food, Drug, and Cosmetic Act (the (sulfooxy)ethyl) sulfonyl)phenyl)azo)-] act). A person intending to introduce a CAS Reg. No. 68189–39–9); device containing a poly(hydroxyethyl (4) Reactive Yellow 15 methacrylate)-dye copolymer listed [benzensulfonic acid, 4-(4,5-dihydro-4- under this section into commerce shall ((2-methoxy-5-methyl-4-((2- submit to the Food and Drug Adminis- (sulfooxy)ethyl) sulfonyl)phenyl)azo)-3- tration either a premarket notification methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS in accordance with subpart E of part Reg. No. 60958–41–0); 807 of this chapter, if the device is not

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subject to premarket approval, or sub- 2(3H)-ylidene)benzo[b]thiophen-3(2H)- mit and receive approval of an original one (CAS Reg. No. 3263–31–8), Colour or supplemental premarket approval Index No. 73335. application if the device is subject to (b) Uses and restrictions. (1) The sub- premarket approval. stance listed in paragraph (a) of this (c) Labeling. The label of the color ad- section may be used as a color additive ditives shall conform to the require- in contact lenses in amounts not to ex- ments of § 70.25 of this chapter. ceed the minimum reasonably required (d) Exemption from certification. Cer- to accomplish the intended coloring ef- tification of these color additives is fect. not necessary for the protection of the (2) Authorization for this use shall public health, and therefore these color not be construed as waiving any of the additives are exempt from the certifi- requirements of sections 510(k), 515, cation requirements of section 721(c) of and 520(g) of the Federal Food, Drug, the act. and Cosmetic Act with respect to the [49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, contact lens in which the color addi- 1984, as amended at 50 FR 9425, Mar. 8, 1985; tive is used. 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. (c) Labeling. The label of the color ad- 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, ditive shall conform to the require- Feb. 22, 1993] ments of § 70.25 of this chapter. (d) Exemption from certification. Cer- § 73.3122 4-[(2,4-dimethylphenyl)azo]- tification of this color additive is not 2,4-dihydro-5-methyl-2-phenyl-3H- necessary for the protection of the pub- pyrazol-3-one. lic health, and therefore the color addi- (a) Identity. The color additive is 4- tive is exempt from the certification [(2,4-dimethylphenyl)azo]-2,4-dihydro-5- requirements of section 721(c) of the methyl-2-phenyl-3H- pyrazol-3-one act. (CAS Reg. No. 6407–78–9). (b) Uses and restrictions. (1) The sub- [51 FR 11436, Apr. 3, 1986] stances listed in paragraph (a) of this § 73.3124 Phthalocyanine green. section may be used as a color additive in contact lenses in amounts not to ex- (a) Identity. The color additive is ceed the minimum reasonably required phthalocyanine green (CAS Reg. No. to accomplish the intended coloring ef- 1328–53–6), Colour Index No. 74260. fect. (b) Uses and restrictions. (1) The sub- (2) Authorization for this use shall stance listed in paragraph (a) of this not be construed as waiving any of the section may be used as a color additive requirements of sections 510(k), 515, in contact lenses in amounts not to ex- and 520(g) of the Federal Food, Drug, ceed the minimum reasonably required and Cosmetic Act with respect to the to accomplish the intended coloring ef- contact lens in which the color addi- fect. tive is used. (2) Authorization for this use shall (c) Labeling. The label of the color ad- not be construed as waiving any of the ditive shall conform to the require- requirements of sections 510(k), 515, ments of § 70.25 of this chapter. and 520(g) of the Federal Food, Drug, (d) Exemption from certification. Cer- and Cosmetic Act with respect to the tification of this color additive is not contact lens in which the additive is necessary for the protection of the pub- used. lic health, and therefore the color addi- (c) Labeling. The label of the color ad- tive is exempt from the certification ditive shall conform to the require- requirements of section 721(c) of the ments of § 70.25 of this chapter. act. (d) Exemption from certification. Cer- tification of this color additive is not [51 FR 11432, Apr. 3, 1986] necessary for the protection of the pub- § 73.3123 6-Ethoxy-2-(6-ethoxy-3- lic health, and therefore the color addi- oxobenzo[b]thien-2(3H)-ylidene) tive is exempt from the certification benzo[b]thiophen-3 (2H)-one. requirements of section 721(c) of the act. (a) Identity. The color additive is 6- ethoxy-2-(6-ethoxy-3-oxobenzo [b]thien- [51 FR 11433, Apr. 3, 1986]

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§ 73.3125 Iron oxides. (d) Exemption from certification. Cer- tification of this color additive is not (a) Identity and specifications. The necessary for the protection of the pub- color additive iron oxides (CAS Reg. lic health, and therefore the color addi- No. 1332–37–2), Color Index No. 77491, tive is exempt from the certification shall conform in identity and specifica- requirements of section 721(c) of the tions to the requirements of § 73.2250 (a) act. and (b). (b) Uses and restrictions. (1) The sub- [51 FR 24816, July 9, 1986] stance listed in paragraph (a) of this section may be used as a color additive § 73.3127 Vinyl alcohol/methyl meth- in contact lenses in amounts not to ex- acrylate-dye reaction products. ceed the minimum reasonably required (a) Identity. The color additives are to accomplish the intended coloring ef- formed by reacting the dyes, either fect. alone or in combination, with a vinyl (2) Authorization and compliance alcohol/methyl methacrylate copoly- with this use shall not be construed as mer, so that the sulfate groups of the waiving any of the requirements of sec- dyes are replaced by ether linkages to tions 510(k), 515, and 520(g) of the Fed- the vinyl alcohol/methyl methacrylate eral Food, Drug, and Cosmetic Act copolymer. The dyes are: with respect to the contact lens in (1) C.I. Reactive Red 180 [5- which the additive is used. (benzoylamino)-4-hydroxy-3-((1-sulfo-6- (c) Labeling. The label of the color ad- ((2-(sulfooxy)ethyl)sulfonyl)-2- ditive shall conform to the require- naphthalenyl)azo)-2,7- ments of § 70.25 of this chapter. naphthalenedisulfonic acid, (d) Exemption from certification. Cer- tetrasodium salt] (CAS Reg. No. 98114– tification of this color additive is not 32–0). necessary for the protection of the pub- (2) C.I. Reactive Black 5 [2,7- lic health, and therefore the color addi- naphthalenedisulfonic acid, 4-amino-5- tive is exempt from the certification hydroxy-3,6-bis((4-((2- requirements of section 721(c) of the (sulfooxy)ethyl)sulfonyl)phenyl)azo)-, act. tetrasodium salt] (CAS Reg. No. 17095– [51 FR 24816, July 9, 1986, as amended at 69 24–8). FR 24511, May 4, 2004] (3) C.I. Reactive Orange 78 [2- naphthalenesulfonic acid, 7- § 73.3126 Titanium dioxide. (acetylamino)-4-hydroxy-3-((4-((2- (a) Identity and specifications. The (sulfooxy)ethyl)sulfonyl)phenyl)azo)-] color additive titanium dioxide (CAS (CAS Reg. No. 68189–39–9). Reg. No. 13463–67–7), Color Index No. (4) C.I. Reactive Yellow 15 77891, shall conform in identity and [benzenesulfonic acid, 4-(4,5-dihydro-4- specifications to the requirements of ((2-methoxy-5-methyl-4-((2- § 73.575(a)(1) and (b). (sulfooxy)ethyl)sulfonyl)phenyl)azo)-3- (b) Uses and restrictions. (1) The sub- methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS stance listed in paragraph (a) of this Reg. No. 60958–41–0). section may be used as a color additive (5) C.I. Reactive Blue No. 19 [2- in contact lenses in amounts not to ex- anthracenesulfonic acid, 1-amino-9,10- ceed the minimum reasonably required dihydro-9,10-dioxo-4-((3-((2- to accomplish the intended coloring ef- (sulfooxy)ethyl)sulfonyl)phenyl)amino) fect. -, disodium salt] (CAS Reg. No. 2580–78– (2) Authorization and compliance 1). with this use shall not be construed as (6) C.I. Reactive Blue 21 [copper, waiving any of the requirements of sec- (29H,31H-phthalocyaninato(2-)-N29, N30, tions 510(k), 515, and 520(g) of the Fed- N31, N32)-, sulfo((4-((2-(sulfooxy) eral Food, Drug, and Cosmetic Act ethyl)sulfonyl)phenyl)amino)sulfonyl with respect to the contact lenses in derivatives] (CAS Reg. No. 73049–92–0). which the additive is used. (b) Uses and restrictions. (1) The sub- (c) Labeling. The label of the color ad- stances listed in paragraph (a) of this ditive shall conform to the require- section may be used to color contact ments of § 70.25 of this chapter. lenses in amounts not to exceed the

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minimum reasonably required to ac- waiving any of the requirements of sec- complish the intended coloring effect. tions 510(k), 515, and 520(g) of the Fed- (2) As part of the manufacturing eral Food, Drug, and Cosmetic Act (the process, the lenses containing the color act) with respect to the contact lenses additives are thoroughly washed to re- in which the additive is used. move unbound reactive dye. (c) Labeling. The label of the color ad- (3) Authorization and compliance ditive shall conform to the require- with this use shall not be construed as ments in § 70.25 of this chapter. waiving any of the requirements of sections 510(k), 515, and 520(g) of the Fed- (d) Exemption from certification. Cer- eral Food, Drug, and Cosmetic Act (the tification of this color additive is not act). A person intending to introduce a necessary for the protection of the pub- device containing a vinyl alcohol/meth- lic health, and therefore batches there- yl methacrylate-dye reaction product of are exempt from the certification re- listed under this section into com- quirements of section 721(c) of the act. merce shall submit to the Food and [67 FR 65312, Oct. 24, 2002] Drug Administration either a premarket notification in accordance with § 73.3129 Disodium 1-amino-4-[[4-[(2- subpart E of part 807 of this chapter, if bromo-1-oxoallyl)amino]-2- the device is not subject to premarket sulfonatophenyl]amino]-9,10- approval, or submit and receive ap- dihydro-9,10-dioxoanthracene-2- proval of an original or supplemental sulfonate. premarket approval application if the (a) Identity. The color additive is di- device is subject to premarket ap- sodium 1-amino-4-[[4-[(2-bromo-1- proval. oxoallyl)amino]-2- (c) Labeling. The label of the color additive shall conform to the require- sulfonatophenyl]amino]-9,10-dihydro- ments of § 70.25 of this chapter. 9,10-dioxoanthracene-2-sulfonate (Reac- (d) Exemption from certification. Cer- tive Blue 69) (CAS Reg. No. 70209–99–3, tification of this color additive is not Colour Index No. 612037). necessary for the protection of the pub- (b) Uses and restrictions. (1) The sub- lic health, and therefore, this color ad- stance listed in paragraph (a) of this ditive is exempt from the certification section may be used as a color additive requirements of section 721(c) of the in contact lenses in amounts not to ex- act. ceed the minimum reasonably required [58 FR 3227, Jan. 8, 1993, as amended at 58 FR to accomplish the intended coloring ef- 17510, Apr. 5, 1993] fect. (2) Authorization and compliance § 73.3128 Mica-based pearlescent pig- with this use shall not be construed as ments. waiving any of the requirements of sec- (a) Identity and specifications. The tions 510(k), 515, and 520(g) of the Fed- color additive is formed by depositing eral Food, Drug, and Cosmetic Act titanium or iron salts from a basic so- with respect to the contact lenses in lution onto mica, followed by calci- which the additive is used. nation to produce titanium dioxide or (c) Labeling. The label of the color ad- iron oxides on mica. Mica used to man- ditive shall conform to the require- ufacture the color additive shall con- ments in § 70.25 of this chapter. form in identity and specifications to (d) Exemption from certification. Cer- the requirements of § 73.1496(a)(1) and tification of this color additive is not (b). necessary for the protection of the pub- (b) Uses and restrictions. (1) Mica- based pearlescent pigments listed in lic health, and therefore batches there- paragraph (a) of this section may be of are exempt from the certification re- used as a color additive in contact quirements of section 721(c) of the Fed- lenses in amounts not to exceed the eral Food, Drug, and Cosmetic Act. minimum reasonably required to ac- [76 FR 25235, May 4, 2011, as amended at 78 complish the intended coloring effect. FR 14664, Mar. 7, 2013] (2) Authorization and compliance with this use shall not be construed as

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PART 74—LISTING OF COLOR AD- 74.2208 D&C Green No. 8. 74.2254 D&C Orange No. 4. DITIVES SUBJECT TO CERTIFI- 74.2255 D&C Orange No. 5. CATION 74.2260 D&C Orange No. 10. 74.2261 D&C Orange No. 11. Subpart A—Foods 74.2304 FD&C Red No. 4. 74.2306 D&C Red No. 6. Sec. 74.2307 D&C Red No. 7. 74.101 FD&C Blue No. 1. 74.2317 D&C Red No. 17. 74.102 FD&C Blue No. 2. 74.2321 D&C Red No. 21. 74.203 FD&C Green No. 3. 74.2322 D&C Red No. 22. 74.250 Orange B. 74.2327 D&C Red No. 27. 74.302 Citrus Red No. 2. 74.2328 D&C Red No. 28. 74.303 FD&C Red No. 3. 74.2330 D&C Red No. 30. 74.340 FD&C Red No. 40. 74.2331 D&C Red No. 31. 74.705 FD&C Yellow No. 5. 74.2333 D&C Red No. 33. 74.706 FD&C Yellow No. 6. 74.2334 D&C Red No. 34. Subpart B—Drugs 74.2336 D&C Red No. 36. 74.2340 FD&C Red No. 40. 74.1101 FD&C Blue No. 1. 74.2602 D&C Violet No. 2. 74.1102 FD&C Blue No. 2. 74.2602a Ext. D&C Violet No. 2. 74.1104 D&C Blue No. 4. 74.2705 FD&C Yellow No. 5. 74.1109 D&C Blue No. 9. 74.2706 FD&C Yellow No. 6. 74.1203 FD&C Green No. 3. 74.2707 D&C Yellow No. 7. 74.1205 D&C Green No. 5. 74.2707a Ext. D&C Yellow No. 7. 74.1206 D&C Green No. 6. 74.2708 D&C Yellow No. 8. 74.1208 D&C Green No. 8. 74.2710 D&C Yellow No. 10. 74.1254 D&C Orange No. 4. 74.2711 D&C Yellow No. 11. 74.1255 D&C Orange No. 5. 74.1260 D&C Orange No. 10. Subpart D—Medical Devices 74.1261 D&C Orange No. 11. 74.1303 FD&C Red No. 3. 74.3045 [Phthalocyaninato(2-)] copper. 74.1304 FD&C Red No. 4. 74.3102 FD&C Blue No. 2. 74.1306 D&C Red No. 6. 74.3106 D&C Blue No. 6. 74.1307 D&C Red No. 7. 74.3206 D&C Green No. 6. 74.1317 D&C Red No. 17. 74.3230 D&C Red No. 17. 74.1321 D&C Red No. 21. 74.3602 D&C Violet No. 2. 74.1322 D&C Red No. 22. 74.3710 D&C Yellow No. 10. 74.1327 D&C Red No. 27. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, 74.1328 D&C Red No. 28. 351, 352, 355, 361, 362, 371, 379e. 74.1330 D&C Red No. 30. 74.1331 D&C Red No. 31. SOURCE: 42 FR 15654, Mar. 22, 1977, unless 74.1333 D&C Red No. 33. otherwise noted. 74.1334 D&C Red No. 34. 74.1336 D&C Red No. 36. Subpart A—Foods 74.1339 D&C Red No. 39. 74.1340 FD&C Red No. 40. § 74.101 FD&C Blue No. 1. 74.1602 D&C Violet No. 2. 74.1705 FD&C Yellow No. 5. (a) Identity. (1) The color additive 74.1706 FD&C Yellow No. 6. FD&C Blue No. 1 is principally the di- 74.1707 D&C Yellow No. 7. sodium salt of ethyl [4-[p-[ethyl (m- 74.1707a Ext. D&C Yellow No. 7. sulfobenzyl) amino]-a-(o-sulfophenyl) 74.1708 D&C Yellow No. 8. benzylidene] - 2,5 -cyclohexadien - 1 - 74.1710 D&C Yellow No. 10. ylidene] (m-sulfobenzyl) ammonium hy- 74.1711 D&C Yellow No. 11. droxide inner salt with smaller Subpart C—Cosmetics amounts of the isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) 74.2052 D&C Black No. 2. amino]-a-(o-sulfophenyl) benzylidene]- 74.2053 D&C Black No. 3. 2,5-cyclohexadien-1-ylidene] (p- 74.2101 FD&C Blue No. 1. sulfobenzyl) ammonium hydroxide 74.2104 D&C Blue No. 4. 74.2151 D&C Brown No. 1. inner salt and ethyl [4-[p-[ethyl (o- 74.2203 FD&C Green No. 3. sulfobenzyl) amino] - a - (o 74.2205 D&C Green No. 5. -sulfophenyl) benzylidene]-2,5- 74.2206 D&C Green No. 6. cyclohexadien-1-ylidene] (o-

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