PART 73—LISTING of COLOR AD- Plex)

Pt. 73 21 CFR Ch. I (4–1–18 Edition)

states prominently, ‘‘Caution—Con- 73.165 Ferrous lactate. tains new color additive—For inves- 73.169 Grape color extract. tigational use only.’’ No animals used 73.170 Grape skin extract (enocianina). 73.185 Haematococcus algae meal. in such investigations, or their prod- 73.200 Synthetic iron oxide. ucts, such as milk or eggs, shall be 73.250 Fruit juice. used for food purposes, unless the spon- 73.260 Vegetable juice. sor or the investigator has submitted 73.275 Dried algae meal. to the Commissioner data dem- 73.295 Tagetes (Aztec marigold) meal and onstrating that such use will be con- extract. sistent with the public health, and the 73.300 Carrot oil. Commissioner, proceeding as he would 73.315 Corn endosperm oil. 73.340 Paprika. in a matter involving section 409(i) of 73.345 Paprika oleoresin. the act, has notified the sponsor or in- 73.350 Mica-based pearlescent pigments. vestigator that the proposed disposi- 73.352 Paracoccus pigment. tion for food is authorized. Any person 73.355 Phaffia yeast. who contests a refusal to grant such 73.450 Riboflavin. authorization shall have an oppor- 73.500 Saffron. tunity for a regulatory hearing before 73.530 Spirulina extract. the Food and Drug Administration pur- 73.575 Titanium dioxide. 73.585 Tomato lycopene extract; tomato ly- suant to part 16 of this chapter. copene concentrate. (b) The person who introduced such 73.600 Turmeric. shipment or who delivers the color ad- 73.615 Turmeric oleoresin. ditive or a food, drug, or cosmetic containing such an additive into interstate Subpart B—Drugs commerce shall maintain adequate 73.1001 Diluents in color additive mixtures records showing the name and post-of- for drug use exempt from certification. fice address of the expert to whom the 73.1010 Alumina (dried aluminum hydrox- color additive is shipped, date, quan- ide). tity, and batch or code mark of each 73.1015 Chromium-cobalt-aluminum oxide. shipment and delivery for a period of 2 73.1025 Ferric ammonium citrate. years after such shipment and delivery. 73.1030 Annatto extract. Upon the request of a properly author- 73.1070 Calcium carbonate. ized employee of the Department, at 73.1075 Canthaxanthin. 73.1085 Caramel. reasonable times, he shall make such 73.1095 b-Carotene. records available for inspection and 73.1100 Cochineal extract; carmine. copying. 73.1125 Potassium sodium copper chlorophyllin (chlorophyllin-copper com- PART 73—LISTING OF COLOR AD- plex). 73.1150 Dihydroxyacetone. DITIVES EXEMPT FROM CERTIFI- 73.1162 Bismuth oxychloride. CATION 73.1200 Synthetic iron oxide. 73.1298 Ferric ammonium ferrocyanide. Subpart A—Foods 73.1299 Ferric ferrocyanide. 73.1326 Chromium hydroxide green. Sec. 73.1327 Chromium oxide greens. 73.1 Diluents in color additive mixtures for 73.1329 Guanine. food use exempt from certification. 73.1350 Mica-based pearlescent pigments. 73.30 Annatto extract. 73.1375 Pyrogallol. 73.35 Astaxanthin. 73.1400 Pyrophyllite. 73.37 Astaxanthin dimethyldisuccinate. 73.1410 Logwood extract. 73.40 Dehydrated beets (beet powder). 73.1496 Mica. 73.50 Ultramarine blue. 73.1530 Spirulina extract. 73.70 Calcium carbonate. 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.

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73.2085 Caramel. 73.3121 Poly(hydroxyethyl methacrylate)- 73.2087 Carmine. dye copolymers. 73.2095 b-Carotene. 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4- 73.2110 Bismuth citrate. dihydro-5-methyl-2-phenyl-3H-pyrazol-3- 73.2120 Disodium EDTA-copper. one. 73.2125 Potassium sodium copper 73.3123 6-Ethoxy-2-(6-ethoxy-3- chlorophyllin (chlorophyllin-copper com- oxobenzo[b]thien-2(3H)-ylidene) plex). benzo[b]thiophen-3 (2H)-one. 73.2150 Dihydroxyacetone. 73.3124 Phthalocyanine green. 73.2162 Bismuth oxychloride. 73.3125 Iron oxides. 73.2180 Guaiazulene. 73.3126 Titanium dioxide. 73.2190 Henna. 73.3127 Vinyl alcohol/methyl methacrylate- 73.2250 Iron oxides. dye reaction products. 73.2298 Ferric ammonium ferrocyanide. 73.3128 Mica-based pearlescent pigments. 73.2299 Ferric ferrocyanide. 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1- 73.2326 Chromium hydroxide green. oxoallyl)amino]-2- 73.2327 Chromium oxide greens. sulfonatophenyl]amino]-9,10-dihydro-9,10- 73.2329 Guanine. dioxoanthracene-2-sulfonate. 73.2396 Lead acetate. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, 73.2400 Pyrophyllite. 351, 352, 355, 361, 362, 371, 379e. 73.2496 Mica. 73.2500 Silver. SOURCE: 42 FR 15643, Mar. 22, 1977, unless 73.2575 Titanium dioxide. otherwise noted. 73.2645 Aluminum powder. EDITORIAL NOTE: Nomenclature changes to 73.2646 Bronze powder. part 73 appear at 66 FR 66742, Dec. 27, 2001. 73.2647 Copper powder. 73.2725 Ultramarines. 73.2775 Manganese violet. Subpart A—Foods 73.2991 Zinc oxide. 73.2995 Luminescent zinc sulfide. § 73.1 Diluents in color additive mixtures for food use exempt from cer- Subpart D—Medical Devices tification. The following substances may be 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10- safely used as diluents in color additive anthracenedione bis(2-methyl-2-propenoic)ester copolymers. mixtures for food use exempt from cer- 73.3105 1,4–Bis[(2-methylphenyl)amino]-9,10- tification, subject to the condition that anthracenedione. each straight color in the mixture has 73.3106 1,4-Bis[4-(2-methacryloxyethyl) been exempted from certification or, if phenylamino]anthraquinone copolymers. not so exempted, is from a batch that 73.3107 Carbazole violet. has previously been certified and has 73.3110 Chlorophyllin-copper complex, oil not changed in composition since cer- soluble. tification. If a specification for a par- 73.3110a Chromium-cobalt-aluminum oxide. 73.3111 Chromium oxide greens. ticular diluent is not set forth in this 73.3112 C.I. Vat Orange 1. part 73, the material shall be of a pu- 73.3115 2-[[2,5-Diethoxy-4-[(4- rity consistent with its intended use. methylphenyl)thiol]phenyl]azo]-1,3,5- (a) General use. (1) Substances that benzenetriol. are generally recognized as safe under 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] the conditions set forth in section naphth [2′,3′:6,7] indolo [2,3-c] carbazole- 201(s) of the act. 5,10,15,17,22,24-hexone. (2) Substances meeting the defini- ′ 73.3118 N,N -(9,10-Dihydro-9,10-dioxo-1,5- tions and specifications set forth under anthracenediyl) bisbenzamide. 73.3119 7,16-Dichloro–6,15-dihydro-5,9,14,18- subchapter B of this chapter, and anthrazinetetrone. which are used only as prescribed by 73.3120 16,17-Dimethoxydinaphtho [1,2,3- such regulations. cd:3′,2′,1′-lm] perylene-5,10-dione. (3) The following:

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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. 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.

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Substances Definitions and specifications Restrictions

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 Ethylene glycol distearate. for coloring shell eggs. Items listed in Japan wax. paragraph (a) of this section and the Limed rosin. following, subject to the condition that Naphtha. there is no penetration of the color ad- Pentaerythritol ester of fumaric acid-rosin ditive mixture or any of its compo- adduct. nents through the eggshell into the Polyethylene glycol 6000 (as identified in egg: § 172.820 of this chapter). Polyvinyl alcohol. Alcohol, denatured, formula 23A (26 CFR Rosin and rosin derivatives (as identified in part 212), Internal Revenue Service. § 172.615 of this chapter). Damar gum (resin). Diethylene glycol distearate. (3) Miscellaneous special uses. Items Dioctyl sodium sulfosuccinate. listed in paragraph (a) of this section Ethyl cellulose (as identified in § 172.868 of and the following: this chapter).

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. hol, methylene chloride, trichloro- (a) Identity. (1) The color additive ethylene. annatto extract is an extract prepared (2) Color additive mixtures for food from annatto seed, Bixa orellana L., use made with annatto extract may using any one or an appropriate com- contain only diluents that are suitable bination of the food-grade extractants and that are listed in this subpart as listed in paragraph (a)(1) (i) and (ii) of safe in color additive mixtures for this section: coloring foods. (i) Alkaline aqueous solution, alka- (b) Specifications. Annatto extract, in- line propylene glycol, ethyl alcohol or cluding pigments precipitated there- alkaline solutions thereof, edible vege- from, shall conform to the following table oils or fats, mono- and specifications: diglycerides from the glycerolysis of (1) Arsenic (as As), not more than 3 edible vegetable oils or fats. The alka- parts per million; lead as Pb, not more line alcohol or aqueous extracts may than 10 parts per million. be treated with food-grade acids to pre- (2) When solvents listed under para- cipitate annatto pigments, which are graph (a)(1)(ii) of this section are used, separated from the liquid and dried, annatto extract shall contain no more with or without intermediate recrys- solvent residue than is permitted of the tallization, using the solvents listed corresponding solvents in spice under paragraph (a)(1)(ii) of this sec- oleoresins under applicable food addition. Food-grade alkalis or carbonates tive regulations in parts 170 through may be added to adjust alkalinity. 189 of this chapter. (ii) Acetone, ethylene dichloride, (c) Uses and restrictions. Annatto ex- hexane, isopropyl alcohol, methyl alco- tract may be safely used for coloring

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foods generally, in amounts consistent Assay, minimum 96 percent. with good manufacturing practice, ex- (c) Uses and restrictions. Astaxanthin cept that it may not be used to color may be safely used in the feed of foods for which standards of identity salmonid fish in accordance with the have been promulgated under section following prescribed conditions: 401 of the act unless added color is au- (1) The color additive is used to en- thorized by such standards. (d) Labeling. The label of the color ad- hance the pink to orange-red color of ditive and any mixtures prepared the flesh of salmonid fish. therefrom and intended solely or in (2) The quantity of color additive in part for coloring purposes shall con- feed is such that the color additive form to the requirements of § 70.25 of shall not exceed 80 milligrams per kilo- this chapter. Labels shall bear informa- gram (72 grams per ton) of finished tion showing that the color is derived feed. from annatto seed. The requirements of (d) Labeling requirements. (1) The la- § 70.25(a) of this chapter that all ingre- beling of the color additive and any dients shall be listed by name shall not premixes prepared therefrom shall bear be construed as requiring the declara- expiration dates for the sealed and tion of residues of solvents listed in open container (established through paragraph (a)(1)(ii) of this section. generally accepted stability testing (e) Exemption from certification. Cer- methods), other information required tification of this color additive is not by § 70.25 of this chapter, and adequate necessary for the protection of the pub- directions to prepare a final product lic health and therefore batches thereof complying with the limitations pre- are exempt from the certification re- scribed in paragraph (c) of this section. quirements of section 721(c) of the act. (2) The presence of the color additive in finished fish feed prepared according § 73.35 Astaxanthin. to paragraph (c) of this section shall be (a) Identity. (1) The color additive declared in accordance with § 501.4 of astaxanthin is 3, 3′-dihydroxy-b, b-caro- this chapter. tene-4, 4′-dione. (3) The presence of the color additive (2) Astaxanthin may be added to the in salmonid fish that have been fed fish feed only as a component of a sta- feeds containing astaxanthin shall be bilized color additive mixture. Color declared in accordance with additive mixtures for fish feed use §§ 101.22(k)(2) and 101.100(a)(2) of this made with astaxanthin may contain chapter. only those diluents that are suitable (e) Exemption from certification. Cer- and are listed in this subpart as safe tification of this color additive is not for use in color additive mixtures for necessary for the protection of the pub- coloring foods. lic health, and therefore batches there- (b) Specifications. Astaxanthin shall of are exempt from the certification re- conform to the following specifications quirements of section 721(c) of the act. and shall be free from impurities other than those named to the extent that [60 FR 18738, Apr. 13, 1995] such impurities may be avoided by good manufacturing practice: § 73.37 Astaxanthin dimethyldisuccinate. Physical state, solid. (a) Identity. (1) The color additive 0.05 percent solution in chloroform, complete and clear. astaxanthin dimethyldisuccinate is Absorption maximum wavelength 484–493 3,3′-bis(4-methoxy-1,4-dioxobutoxy)-b,b- nanometers (in chloroform). carotene–4,4′-dione. Residue on ignition, not more than 0.1 per- (2) Astaxanthin dimethyldisuccinate cent. may be added to the fish feed only as a Total carotenoids other than astaxanthin, component of a stabilized mixture. not more than 4 percent. Color additive mixtures for fish feed Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. use made with astaxanthin Mercury, not more than 1 part per million. dimethyldisuccinate may contain only Heavy metals, not more than 10 parts per those diluents that are suitable and are million. listed in this subpart as safe for use in

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color additive mixtures for coloring (2) The presence of the color additive foods. in finished fish feed prepared according (b) Specifications. Astaxanthin to paragraph (c) of this section shall be dimethyldisuccinate shall conform to declared in accordance with § 501.4 of the following specifications and shall this chapter. be free from impurities other than (3) The presence of the color additive those named to the extent that such in salmonid fish that have been fed impurities may be avoided by good feeds containing astaxanthin manufacturing practice: dimethyldisuccinate shall be declared (1) Physical state, solid. in accordance with §§ 101.22(b), (c), and (2) 0.05 percent solution in chloro- (k)(2), and 101.100(a)(2) of this chapter. form, complete and clear. (e) Exemption from certification. Cer- (3) Absorption maximum wavelength tification of this color additive is not 484–493 nanometers (in chloroform). necessary for the protection of the pub- (4) Residue on ignition, not more lic health, and therefore batches there- than 0.1 percent. of are exempt from the certification re- (5) Total carotenoids other than quirements of section 721(c) of the act. astaxanthin dimethyldisuccinate, not more than 4 percent. [74 FR 57251, Nov. 5, 2009] (6) Lead, not more than 5 milligrams § 73.40 Dehydrated beets (beet pow- per kilogram (mg/kg) (5 parts per mil- der). lion). (7) Arsenic, not more than 2 mg/kg (2 (a) Identity. (1) The color additive de- parts per million). hydrated beets is a dark red powder (8) Mercury, not more than 1 mg/kg (1 prepared by dehydrating sound, ma- part per million). ture, good quality, edible beets. (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 dimethyldisuccinate in the finished million. feed, when used alone or in combina- Mercury (as Hg), not more than 1 part per 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.

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(e) Exemption from certification. Cer- (b) Specifications. The color additive tification of this color additive is not meets the specifications of the Food necessary for the protection of the pub- Chemicals Codex, 10th ed. (2016), pp. lic health, and therefore batches there- 213–214 (calcium carbonate) and p. 754 of are exempt from the certification re- (limestone, ground), which is incor- quirements of section 721(c) of the act. porated by reference. The Director of the Office of the Federal Register ap- § 73.50 Ultramarine blue. proves this incorporation by reference (a) Identity. The color additive ultra- in accordance with 5 U.S.C. 552(a) and 1 marine blue is a blue pigment obtained CFR part 51. You may obtain copies by calcining a mixture of kaolin, sul- from the United States Pharmacopeial fur, sodium carbonate, and carbon at Convention, 12601 Twinbrook Pkwy., temperatures above 700 °C. Sodium sul- Rockville, MD 20852 (internet address fate and silica may also be incor- http://www.usp.org). Copies may be ex- porated in the mixture in order to vary amined at the Food and Drug Adminis- the shade. The pigment is a complex tration’s Main Library, 10903 New sodium aluminum sulfo-silicate having Hampshire Ave., Bldg. 2, Third Floor, the approximate formula Na Ai Si O 7 6 6 24 Silver Spring, MD 20993, 301–796–2039, or S . 3 at the National Archives and Records (b) Specifications. Ultramarine blue Administration (NARA). For informa- shall conform to the following specifications: tion on the availability of this material at NARA, call 202–741–6030, or go Lead (as Pb), not more than 10 parts per mil- to: http://www.archives.gov/ lion. federallregister/ Arsenic (as As), not more than 1 part per million. codeloflfederallregulations/cfr/ Mercury (as Hg), not more than 1 part per ibrllocations.html. million. (c) Uses and restrictions. Calcium car- (c) Uses and restrictions. The color ad- bonate may be safely used in amounts ditive ultramarine blue may be safely consistent with good manufacturing used for coloring salt intended for ani- practice to color soft and hard candies mal feed subject to the restriction that and mints, and in inks used on the sur- the quantity of ultramarine blue does face of chewing gum, except that it not exceed 0.5 percent by weight of the may not be used to color chocolate for salt. which standards of identity have been (d) Labeling requirements. The color promulgated under section 401 of the additive shall be labeled in accordance Federal Food, Drug, and Cosmetic Act with the requirements of § 70.25 of this unless added color is authorized by chapter. such standards. (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 must 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. (e) Exemption from certification. Cer- § 73.70 Calcium carbonate. 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 powder lic health, and, therefore, batches consisting essentially of calcium car- thereof are exempt from the certifi- bonate (CaCO3) prepared either by cation requirements of section 721(c) of grinding naturally occurring limestone the Federal Food, Drug, and Cosmetic or synthetically, by precipitation. Act. (2) Color additive mixtures for food use made with calcium carbonate may [82 FR 51557, Nov. 7, 2017] contain only those diluents that are suitable and that are listed in this sub- § 73.75 Canthaxanthin. part as safe for use in color additive (a) Identity. (1) The color additive mixtures for coloring foods. canthaxanthin is b-carotene-4,4′-dione. 432

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(2) Color additive mixtures for food (ii) The color additive is used to en- use made with canthaxanthin may con- hance the pink to orange-red color of tain only those diluents that are suit- the flesh of salmonid fish; and able and that are listed in this subpart (iii) The quantity of color additive in as safe for use in color additive mix- feed shall not exceed 80 milligrams per tures for coloring foods. kilogram (72 grams per ton) of finished (b) Specifications. Canthaxanthin feed. shall conform to the following speci- (d) Labeling requirements. (1) The la- fications and shall be free from impuri- beling of the color additive and any ties other than those named to the ex- mixture prepared therefrom intended tent that such other impurities may be solely or in part for coloring purposes avoided by good manufacturing prac- shall conform to the requirements of tice: § 70.25 of this chapter. (2) For purposes of coloring fish, the Physical state, solid. labeling of the color additive and any 1 percent solution in chloroform, complete premixes prepared therefrom shall bear and clear. expiration dates (established through ° Melting range (decomposition), 207 C. to 212 generally accepted stability testing °C. (corrected). methods) for the sealed and open con- Loss on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 per- tainer, other information required by cent. § 70.25 of this chapter, and adequate di- Total carotenoids other than trans- rections to prepare a final product canthaxanthin, not more than 5 percent. complying with the limitations pre- Lead, not more than 10 parts per million. scribed in paragraph (c)(3) of this sec- Arsenic, not more than 3 parts per million. tion. Mercury, not more than 1 part per million. (3) The presence of the color additive Assay, 96 to 101 percent. in finished fish feed prepared according 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 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 re- (2) Canthaxanthin may be safely used quirements of section 721(c) of the act. in broiler chicken feed to enhance the yellow color of broiler chicken skin in [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, accordance with the following condi- 1998] tions: The quantity of canthaxanthin incorporated in the feed shall not ex- § 73.85 Caramel. ceed 4.41 milligrams per kilogam (4 (a) Identity. (1) The color additive grams per ton) of complete feed to sup- caramel is the dark-brown liquid or plement other known sources of xan- solid material resulting from the care- thophyll and associated carotenoids to fully controlled heat treatment of the accomplish the intended effect. following food-grade carbohydrates: (3) Canthaxanthin may be safely used in the feed of salmonid fish in accord- Dextrose. ance with the following prescribed con- Invert sugar. ditions: Lactose. Malt sirup. (i) Canthaxanthin may be added to Molasses. the fish feed only in the form of a sta- Starch hydrolysates and fractions thereof. bilized color additive mixture; Sucrose.

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(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. contain only diluents that are suitable Sulfurous acid. and that are listed in this subpart as (ii) Alkalis: safe in color additive mixtures for coloring foods. Ammonium hydroxide. (b) Specifications. -Apo-8′-carotenal Calcium hydroxide U.S.P. b 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). Loss of weight on drying, not more than 0.2 sulfite. percent. (3) Polyglycerol esters of fatty acids, 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. Arsenic (as As), not more than 3 parts per (2) It may not be used to color foods million. for which standards of identity have Mercury (as Hg), not more than 0.1 part per been promulgated under section 401 of million. the act unless added color is authorized (c) Uses and restrictions. Caramel may by such standards. be safely used for coloring foods gen- (d) Labeling. The label of the color ad- erally, in amounts consistent with ditive and any mixtures prepared good manufacturing practice, except therefrom and intended solely or in that it may not be used to color foods part for coloring purposes shall con- for which standards of identity have form to the requirements of § 70.25 of been promulgated under section 401 of this chapter. the act unless added color is authorized (e) Exemption from certification. Cer- by such standards. tification of this color additive is not (d) Labeling. The label of the color ad- necessary for the protection of the pub- ditive and any mixtures prepared lic health and therefore batches thereof therefrom and intended solely or in are exempt from the certification re- part for coloring purposes shall con- quirements of section 721(c) of the act. form to the requirements of § 70.25 of β this chapter. § 73.95 -Carotene. (e) Exemption from certification. Cer- (a) Identity. (1) The color additive is tification of this color additive is not b-carotene prepared synthetically or necessary for the protection of the pub- obtained from natural sources.

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(2) Color additive mixtures for food (3) Color additive mixtures for food use made with b-carotene may contain use made with cochineal extract or car- 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. b-carotene shall (b) Specifications. (1) Cochineal ex- conform to the following specifica- tract shall conform to the following tions: specifications: Physical state, solid. pH, not less than 5.0 and not more than 5.5 at 1 percent solution in chloroform, clear. 25 °C. × Loss of weight on drying, not more than 0.2 Protein (N 6.25), not more than 2.2 percent. percent. Total solids, not less than 5.7 and not more 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 ° amounts consistent with good manu- Volatile matter (at 135 C. for 3 hours), not 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 act unless added color is authorized by million. such standards. Carminic acid, not less than 50.0 percent. (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 (e) Exemption from certification. Cer- (other than chemical preservatives) tification of this color additive is not that are essential to the method of pas- necessary for the protection of the pub- teurization or other treatment used. lic health and therefore batches thereof For the purposes of this paragraph, are exempt from the certification re- safe and suitable substances are those quirements of section 721(c) of the act. substances that perform a useful func- tion in the pasteurization or other § 73.100 Cochineal extract; carmine. treatment to render the carmine and (a) Identity. (1) The color additive cochineal extract free of viable Sal- cochineal extract is the concentrated monella microorganisms, which sub- solution obtained after removing the stances are not food additives as de- alcohol from an aqueous-alcoholic ex- fined in section 201(s) of the act or, if tract of cochineal (Dactylopius coccus they are food additives as so defined, costa (Coccus cacti L.)). The coloring are used in conformity with regula- principle is chiefly carminic acid. tions established pursuant to section (2) The color additive carmine is the 409 of the act. aluminum or calcium-aluminum lake (c) Uses and restrictions. Carmine and on an aluminum hydroxide substrate of cochineal extract may be safely used the coloring principles, chiefly car- for coloring foods generally in amounts minic acid, obtained by an aqueous ex- consistent with good manufacturing traction of cochineal (Dactylopius coc- practice, except that they may not be cus costa (Coccus cacti L.)). used to color foods for which standards

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of identity have been promulgated (3) Total copper, not less than 4 per- under section 401 of the act unless cent and not more than 6 percent. added color is authorized by such (4) Free copper, not more than 200 standards. parts per million. (d) Labeling requirements. (1) The label (5) Lead (as Pb), not more than 10 of the color additives and any mixtures parts per million. intended solely or in part for coloring (6) Arsenic (as As), not more than 3 purposes prepared therefrom shall con- parts per million. form to the requirements of § 70.25 of (7) Mercury (as Hg), not more than this chapter. 0.5 part per million. (2) The label of food products in- (8) Ratio of absorbance at 405 nano- tended for human use, including but- meters (nm) to absorbance at 630 nm, ter, cheese, and ice cream, that contain not less than 3.4 and not more than 3.9. cochineal extract or carmine shall spe- (9) Total copper chlorophyllins, not cifically declare the presence of the less than 95 percent of the sample dried color additive by listing its respective at 100 °C for 1 hour. common or usual name, ‘‘cochineal ex- (c) Uses and restrictions. Sodium cop- tract’’ or ‘‘carmine,’’ in the statement per chlorophyllin may be safely used to of ingredients in accordance with § 101.4 color citrus-based dry beverage mixes of this chapter. (e) Exemption from certification. Cer- in an amount not exceeding 0.2 percent tification of these color additives is in the dry mix. not necessary for the protection of the (d) Labeling requirements. The label of public health, and therefore batches the color additive and any mixtures thereof are exempt from the certifi- prepared therefrom shall conform to cation requirements of section 721(c) of the requirements of § 70.25 of this chap- the act. ter. (e) Exemption from certification. Cer- [42 FR 15643, Mar. 22, 1977, as amended at 74 tification of this color additive is not FR 216, Jan. 5, 2009] necessary for the protection of the pub- § 73.125 Sodium copper chlorophyllin. lic health, and therefore batches thereof are exempt from the certification re- (a) Identity. (1) The color additive so- quirements of section 721(c) of the act. dium copper chlorophyllin is a green to black powder prepared from chloro- [67 FR 35431, May 20, 2002] phyll by saponification and replace- ment of magnesium by copper. Chloro- § 73.140 Toasted partially defatted cooked cottonseed flour. phyll is extracted from alfalfa (Medicago sativa) using any one or a (a) Identity. (1) The color additive combination of the solvents acetone, toasted partially defatted cooked cot- ethanol, and hexane. tonseed flour is a product prepared as (2) Color additive mixtures made follows: Food quality cottonseed is with sodium copper chlorophyllin may delinted and decorticated; the meats contain only those diluents that are are screened, aspirated, and rolled; suitable and are listed in this subpart moisture is adjusted, the meats heated, as safe for use in color additive mix- and the oil expressed; the cooked meats tures for coloring foods. are cooled, ground, and reheated to ob- (b) Specifications. Sodium copper tain a product varying in shade from chlorophyllin shall conform to the fol- light to dark brown. lowing specifications and shall be free (2) Color additive mixtures for food from impurities other than those use made with toasted partially named to the extent that such impuri- defatted cooked cottonseed flour may ties may be avoided by good manufac- contain only diluents that are suitable turing practice: and that are listed in this subpart as (1) Moisture, not more than 5.0 per- safe in color additive mixtures for cent. coloring foods. (2) Solvent residues (acetone, eth- (b) Specifications. Toasted partially anol, and hexane), not more than 50 defatted cooked cottonseed flour shall parts per million, singly or, in com- conform to the following specifica- bination. tions:

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Arsenic: It contains no added arsenic com- (d) Labeling. The label of the color ad- pound and therefore may not exceed a ditive shall conform to the require- maximum natural background level of 0.2 ments of § 70.25 of this chapter. part per million total arsenic, calculated as As. (e) Exemption from certification. Cer- Lead (as Pb), not more than 10 parts per mil- tification of this color additive is not lion. necessary for the protection of the pub- Free gossypol content, not more than 450 lic health, and therefore batches there- parts per million. of are exempt from the certification re- (c) Uses and restrictions. The color ad- quirements of section 721(c) of the act. ditive toasted partially defatted 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 manu- § 73.165 Ferrous lactate. facturing practice, except that it may 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- tification of this color additive is not NW., Washington, DC 20418, or may be necessary for the protection of the pub- examined at the Food and Drug Admin- lic health and therefore batches thereof istration’s Main Library, 10903 New are exempt from the certification re- Hampshire Ave., Bldg. 2, Third Floor, quirements of section 721(c) of the act. Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records § 73.160 Ferrous gluconate. Administration (NARA). For informa- (a) Identity. The color additive fer- tion on the availability of this mate- rous gluconate is the ferrous gluconate rial at NARA, call 202–741–6030, or go defined in the Food Chemicals Codex, to: http://www.archives.gov/ 3d Ed. (1981), pp. 122–123, which is incor- federallregister/ porated by reference. Copies may be codeloflfederallregulations/ obtained from the National Academy ibrllocations.html. Press, 2101 Constitution Ave. NW., (c) Uses and restrictions. Ferrous lac- Washington, DC 20418, or at the Na- tate may be safely used in amounts tional Archives and Records Adminis- consistent with good manufacturing tration (NARA). For information on practice for the coloring of ripe olives. the availability of this material at (d) Labeling. The label of the color ad- NARA, call 202–741–6030, or go to: http:// ditive shall conform to the require- www.archives.gov/federallregister/ codeloflfederallregulations/ ments of § 70.25 of this chapter. ibrllocations.html. (e) Exemption from certification. Cer- (b) Specifications. Ferrous gluconate tification of this color additive is not shall meet the specifications given in necessary for the protection of the pub- the Food Chemicals Codex, 3d Ed. lic health, and therefore batches there- (1981), which is incorporated by ref- of are exempt from the certification re- erence. The availability of this incor- quirements of section 721(c) of the Fed- poration by reference is given in para- eral Food, Drug, and Cosmetic Act (the graph (a) of this section. act). (c) Uses and restrictions. Ferrous gluconate may be safely used in amounts [61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001; 81 FR 5590, Feb. 3, consistent with good manufacturing 2016] practice for the coloring of ripe olives.

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§ 73.169 Grape color extract. § 73.170 Grape skin extract (enocianina). (a) Identity. (1) The color additive grape color extract is an aqueous solu- (a) Identity. (1) The color additive tion of anthocyanin grape pigments grape skin extract (enocianina) is a made from Concord grapes or a dehy- purplish-red liquid prepared by the drated water soluble powder prepared aqueous extraction (steeping) of the fresh deseeded marc remaining after from the aqueous solution. The aque- grapes have been pressed to produce ous solution is prepared by extracting grape juice or wine. It contains the the pigments from precipitated lees common components of grape juice; produced during the storage of Concord namely, anthocyanins, tartaric acid, grape juice. It contains the common tannins, sugars, minerals, etc., but not components of grape juice, namely in the same proportions as found in anthocyanins, tartrates, malates, sug- grape juice. During the steeping proc- ars, and minerals, etc., but not in the ess, sulphur dioxide is added and most same proportion as found in grape of the extracted sugars are fermented juice. The dehydrated water soluble to alcohol. The extract is concentrated powder is prepared by spray drying the by vacuum evaporation, during which aqueous solution containing added practically all of the alcohol is re- malto-dextrin. moved. A small amount of sulphur di- (2) Color additive mixtures for food oxide may be present. use made with grape color extract may (2) Color additive mixtures for food contain only those diluents listed in use made with grape skin extract this subpart as safe and suitable in (enocianina) may contain only those color additive mixtures for coloring diluents listed in this subpart as safe foods. and suitable in color additive mixtures (b) Specifications. Grape color extract for coloring foods. shall conform to the following speci- (b) Specifications. Grape skin extract (enocianina) shall conform to the fol- fications: Pesticide residues, not more lowing specifications: than permitted in or on grapes by regulations promulgated under section 408 Pesticide residues, not more than permitted of the Federal Food, Drug, and Cos- in or on grapes by regulations promulgated metic Act. Lead (as Pb), not more than under section 408 of the Federal Food, Drug, and Cosmetic Act. 10 parts per million. Arsenic (as As), Lead (as Pb), not more than 10 parts per mil- not more than 1 part per million. lion. (c) Uses and restrictions. Grape color Arsenic (as As), not more than 1 part per extract may be safely used for the million. coloring of nonbeverage food, except (c) Uses and restrictions. Grape skin that it may not be used to color foods extract (enocianina) may be safely for which standards of identity have used for the coloring of still and car- been promulgated under section 401 of bonated drinks and ades, beverage the act, unless the use of added color is bases, and alcoholic beverages subject authorized by such standards. to the following restrictions: (d) Labeling. The color additive and (1) It may not be used to color foods any mixtures prepared therefrom infor which standards of identity have tended solely or in part for coloring been promulgated under section 401 of purposes shall bear, in addition to the the act unless artificial color is author- other information required by the act, ized by such standards. labeling in accordance with the provi- (2) Its use in alcoholic beverages sions of § 70.25 of this chapter. shall be in accordance with the provi- (e) Exemption from certification. Cer- sions of parts 4 and 5, title 27 CFR. 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 are prepared therefrom intended solely or in part for coloring purposes shall con- exempt from the certification require- form to the requirements of § 70.25 of ments of section 721(c) of the Act. this chapter. The common or usual [46 FR 47532, Sept. 29, 1981] name of the color additive is ‘‘grape

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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 Mercury, not more than 1 part per million. may contain only those diluents that Heavy metals (as Pb), not more than 10 parts per million. are suitable and that are listed in this Astaxanthin, not less than 1.5 percent. subpart as safe for use in color additive mixtures for coloring foods. (c) Uses and restrictions. (b) Specifications. (1) Synthetic iron Haematococcus algae meal may be oxide for human food use shall conform safely used in the feed of salmonid fish to the following specifications: in accordance with the following prescribed conditions: Arsenic (as As), not more than 3 milligrams (1) The color additive is used to en- per kilogram (mg/kg) (3 parts per million hance the pink to orange-red color of (ppm)). Lead (as Pb), not more than 5 mg/kg (5 ppm). the flesh of salmonid fish. Mercury (as Hg), not more than 1 mg/kg (1 (2) The quantity of astaxanthin in ppm). finished feed, from haematococcus algae meal when used alone or in com- (2) Synthetic iron oxide for dog and bination with other astaxanthin color cat food use shall conform to the fol- additive sources listed in this part 73, lowing specifications: shall not exceed 80 milligrams per kilo- Arsenic (as As), not more than 5 parts per gram (72 grams per ton) of finished million. feed. Lead (as Pb), not more than 20 parts per mil- (d) Labeling requirements. (1) The la- lion. beling of the color additive and any Mercury (as Hg), not more than 3 parts per premixes prepared therefrom shall bear million. expiration dates for the sealed and (c) Uses and restrictions. (1) Synthetic open container (established through iron oxide may be safely used for

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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 prepared therefrom intended solely or in [42 FR 15643, Mar. 22, 1977, as amended at 60 part for coloring purposes shall con- FR 52629, Oct. 10, 1995] form to the requirements of § 70.25 of this chapter. § 73.260 Vegetable juice. (e) Exemption from certification. Cer- (a) Identity. (1) The color additive tification of this color additive is not vegetable juice is prepared either by necessary for the protection of the pub- expressing the juice from mature vari- lic health, and therefore batches there- eties of fresh, edible vegetables, or by of are exempt from the certification re- the water infusion of the dried vege- quirements of section 721(c) of the act. table. The color additive may be con- [42 FR 15643, Mar. 22, 1977, as amended at 59 centrated or dried. The definition of FR 10578, Mar. 7, 1994; 80 FR 14842, Mar. 20, vegetable juice in this paragraph is for 2015] the purpose of identity as a color additive only, and shall not be construed as § 73.250 Fruit juice. a standard of identity under section 401 (a) Identity. (1) The color additive of the act. However, where a standard fruit juice is prepared either by ex- of identity for a particular vegetable pressing the juice from mature vari- juice has been promulgated under sec- eties of fresh, edible fruits, or by the tion 401 of the act, it shall conform to water infusion of the dried fruit. The such standard. color additive may be concentrated or (2) Color additive mixtures made dried. The definition of fruit juice in with vegetable juice may contain as this paragraph is for the purpose of diluents only those substances listed in identity as a color additive only and this subpart as safe and suitable in shall not be construed as a standard of color additive mixtures for coloring identity under section 401 of the act. foods. However, where a standard of identity (b) Uses and restrictions. Vegetable for a particular fruit juice has been juice may be safely used for the color- promulgated under section 401 of the ing of foods generally, in amounts con- act, it shall conform to such standard. sistent with good manufacturing prac- (2) Color additive mixtures made tice, except that it may not be used to with fruit juice may contain as color foods for which standards of iden- diluents only those substances listed in tity have been promulgated under sec- this subpart as safe and suitable in tion 401 of the act, unless the use of color additive mixtures for coloring added color is authorized by such foods. standards. (b) Uses and restrictions. Fruit juice (c) Labeling. The color additive and may be safely used for the coloring of any mixtures intended solely or in part

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for coloring purposes prepared there- lic health and therefore batches thereof from shall bear, in addition to the are exempt from the certification re- other information required by the act, quirements of section 721(c) of the act. labeling in accordance with the provisions of § 70.25 of this chapter. § 73.295 Tagetes (Aztec marigold) meal (d) Exemption from certification. Cer- and extract. tification of this color additive is not (a) Identity. (1) The color additive necessary for the protection of the pub- tagetes (Aztec marigold) meal is the lic health, and therefore batches there- dried, ground flower petals of the Aztec of are exempt from the certification re- marigold (Tagetes erecta L.) mixed with quirements of section 721(c) of the act. not more than 0.3 percent ethoxyquin. [42 FR 15643, Mar. 22, 1977, as amended at 60 (2) The color additive tagetes (Aztec FR 52629, Oct. 10, 1995] marigold) extract is a hexane extract of the flower petals of the Aztec mari- § 73.275 Dried algae meal. gold (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 enhance the yellow color of chicken skin tions set forth in paragraph (b)(1) of and eggs. this section and shall conform to the (2) The quantity of the color additive following additional specifications: incorporated in the feed is such that Melting point ...... 53.5–55.0 °C. the finished feed: Iodine value ...... 132–145. Saponification value ...... 175–200. (i) Is supplemented sufficiently with Acid value ...... 0.60–1.20. xanthophyll and associated carotenoids Titer ...... 35.5–37.0 °C. so as to accomplish the intended effect Unsaponifiable matter ...... 23.0 percent–27.0 percent. described in paragraph (b)(1) of this Hexane residue ...... Not more than 25 p.p.m. section; and (ii) Meets the tolerance limitation All determinations, except the hexane for ethoxyquin in animal feed pre- residue, shall be made on the initial ex- scribed in § 573.380 of this chapter. tract of the flower petals (after drying (c) Labeling. The label of the color ad- in a vacuum oven at 60 °C. for 24 hours) ditives and any premixes prepared prior to the addition of the oils and therefrom shall bear in addition to the ethoxyquin. The hexane determination information required by § 70.25 of this shall be made on the color additive chapter. after the addition of the vegetable oils, (1) A statement of the concentrations hydrogenated vegetable oils, and of xanthophyll and ethoxyquin con- ethoxyquin. tained therein. (c) Uses and restrictions. The color ad- (2) Adequate directions to provide a ditives tagetes (Aztec marigold) meal final product complying with the limi- and extract may be safely used in tations prescribed in paragraph (b) of chicken feed in accordance with the this section. following prescribed conditions: (d) Exemption from certification. Cer- (1) The color additives are used to en- tification of this color additive is not hance the yellow color of chicken skin necessary for the protection of the pub- and eggs.

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(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 tion of edible carrots (Daucus carota L.) this subpart as safe and suitable in with subsequent removal of the hexane color additive mixtures for coloring by vacuum distillation. The resultant foods. mixture of solid and liquid extractives (b) Specifications. Corn endosperm oil consists chiefly of oils, fats, waxes, and conforms to the following specifica- carrotenoids naturally occurring in tions: carrots. The definition of carrot oil in Total fatty acids, not less than 85 percent. this paragraph is for the purpose of Iodine value, 118 to 134. identity as a color additive only and Saponification value, 165 to 185. shall not be construed as setting forth Unsaponifiable matter, not more than 14 per- an official standard for carrot oil or cent. carrot oleoresin under section 401 of Hexane, not more than 25 parts per million. the act. Isopropyl alcohol, not more than 100 parts (2) Color additive mixtures for food per million. use made with carrot oil may contain (c) Uses and restrictions. The color ad- only those diluents listed in this sub- ditive corn endosperm oil may be safe- part as safe and suitable in color addi- ly used in chicken feed in accordance tive mixtures for coloring foods. with the following prescribed condi- (b) Specifications. Carrot oil shall con- tions: tain no more than 25 parts per million (1) The color additive is used to en- of hexane. hance the yellow color of chicken skin (c) Uses and restrictions. Carrot oil and eggs. may be safely used for coloring foods (2) The quantity of the color additive generally, in amounts consistent with incorporated in the feed is such that

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the finished feed is supplemented suffi- § 73.345 Paprika oleoresin. ciently 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 addition to the information required by Acetone Isopropyl alcohol § 70.25 of this chapter, a statement of Ethyl alcohol Methyl alcohol the concentration of xanthophyll con- Ethylene dichloride Methylene chloride tained therein. Hexane Trichloroethylene (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 oleoresins under applicable food addi- with paprika may contain as diluents tive regulations in parts 170 through only those substances listed in this 189 of this chapter. subpart as safe and suitable in color (c) Uses and restrictions. Paprika oleo- additive mixtures for coloring foods. resin may be safely used for the color- (b) Uses and restrictions. Paprika may ing of foods generally in amounts con- be safely used for the coloring of foods sistent with good manufacturing prac- generally, in amounts consistent with tice, except that it may not be used to good manufacturing practice, except color foods for which standards of iden- that it may not be used to color foods tity have been promulgated under sec- for which standards of identity have tion 401 of the act, unless the use of been promulgated under section 401 of added color is authorized by such the act, unless the use of added color is standards. authorized by such standards. (d) Labeling. The color additive and (c) Labeling. The color additive and any mixtures intended solely or in part any mixtures intended solely or in part for coloring purposes prepared there- for coloring purposes prepared therefrom shall bear, in addition to the from shall bear, in addition to the other information required by the act, other information required by the act, labeling in accordance with the provi- labeling in accordance with the provisions of § 70.25 of this chapter. sions of § 70.25 of this chapter. (e) Exemption from certification. Cer- (d) Exemption from certification. Cer- tification of this color additive is not tification of this color additive is not necessary for the protection of the pub- necessary for the protection of the public health, and therefore batches there- lic health, and therefore batches thereof are exempt from the certification re- of are exempt from the certification requirements of section 721(c) of the act. quirements of section 721(c) of the act.

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§ 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. serts, hard and soft candies (including lozenges), nutritional supplement tab- (b) Specifications. Paracoccus pigment lets and gelatin capsules, and chewing shall conform to the following speci- gum. fications and shall be free from impuri- (ii) In amounts up to 0.07 percent, by ties, other than those named, to the ex- weight, in the following: tent that such impurities may be (A) Distilled spirits containing not avoided by good manufacturing prac- less than 18 percent and not more than tice: 25 percent alcohol by volume. (1) Physical state, solid. (B) Cordials, liqueurs, flavored alco- (2) Lead, not more than 5 milligrams holic malt beverages, wine coolers, and per kilogram (mg/kg) (5 parts per mil- cocktails. lion (ppm)). (C) Non-alcoholic cocktail mixes and (3) Arsenic, not more than 2 mg/kg (2 mixers, such as margarita mix, Bloody ppm). Mary mix, and daiquiri mix, but ex- (4) Mercury, not more than 1 mg/kg (1 cluding eggnog, tonic water, and bev- ppm). erages that are typically consumed (5) Heavy metals (as Pb), not more without added alcohol (e.g., fruit than 10 mg/kg (10 ppm). juices, fruit juice drinks, and soft (6) Astaxanthin, not less than 1.75 drinks). percent. (iii) In egg decorating kits used for (c) Uses and restrictions. Paracoccus coloring the shells of eggs in amounts pigment may be safely used in the feed consistent with good manufacturing of salmonid fish in accordance with the practice. following prescribed conditions:

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(1) The color additive is used to en- than those named to the extent that hance the pink to orange-red color of such impurities may be avoided by the flesh of salmonid fish. good manufacturing practice: (2) The quantity of astaxanthin in Physical state, solid. finished feed, from paracoccus pigment Lead, not more than 5 parts per million. when used alone or in combination Arsenic, not more than 2 parts per million. with other astaxanthin color additive Mercury, not more than 1 part per million. sources listed in this part 73, shall not Heavy metals (as Pb), not more than 10 parts exceed 80 mg/kg (72 grams per ton) of per million. finished feed. Astaxanthin, not less than 0.4 percent. (d) Labeling requirements. (1) The la- (c) Uses and restrictions. Phaffia yeast beling of the color additive and any may be safely used in the feed of premixes prepared therefrom shall bear salmonid fish in accordance with the expiration dates for the sealed and following prescribed conditions: open container (established through (1) The color additive is used to en- generally accepted stability testing hance the pink to orange-red color of methods), other information required the flesh of salmonid fish. by § 70.25 of this chapter, and adequate (2) The quantity of astaxanthin in directions to prepare a final product finished feed, from phaffia yeast when complying with the limitations pre- used alone or in combination with scribed in paragraph (c) of this section. other astaxanthin color additive (2) The presence of the color additive sources listed in this part 73, shall not in finished fish feed prepared according exceed 80 milligrams per kilogram (72 to paragraph (c) of this section shall be grams per ton) of finished feed. declared in accordance with § 501.4 of (d) Labeling requirements. (1) The la- this chapter. beling of the color additive and any (3) The presence of the color additive premixes prepared therefrom shall bear in salmonid fish that have been fed expiration dates for the sealed and feeds containing paracoccus pigment open container (established through shall be declared in accordance with generally accepted stability testing §§ 101.22(b), (c), and (k)(2), and methods), other information required 101.100(a)(2) of this chapter. by § 70.25 of this chapter, and adequate (e) Exemption from certification. Cer- directions to prepare a final product tification of this color additive is not complying with the limitations pre- necessary for the protection of the pub- scribed in paragraph (c) of this section. lic health, and therefore, batches (2) The presence of the color additive thereof are exempt from the certifi- in finished fish feed prepared according cation requirements of section 721(c) of to paragraph (c) of this section shall be the act. declared in accordance with § 501.4 of [74 FR 58845, Nov. 16, 2009] this chapter. (3) The presence of the color additive § 73.355 Phaffia yeast. in salmonid fish that have been fed (a) Identity. (1) The color additive feeds containing phaffia yeast shall be phaffia yeast consists of the killed, declared in accordance with §§ 101.22(b), dried cells of a nonpathogenic and (c), and (k)(2) and 101.100(a)(2) of this chapter. nontoxicogenic strain of the yeast (e) Exemption from certification. Cer- Phaffia rhodozyma. tification of this color additive is not (2) Phaffia yeast may be added to the necessary for the protection of the pub- fish feed only as a component of a sta- lic health, and therefore batches there- bilized color additive mixture. Color of are exempt from the certification re- additive mixtures for fish feed use quirements of section 721(c) of the act. made with phaffia yeast may contain only those diluents that are suitable [65 FR 41587, July 6, 2000] and are listed in this subpart as safe for use in color additive mixtures for § 73.450 Riboflavin. coloring foods. (a) Identity. (1) The color additive ri- (b) Specifications. Phaffia yeast shall boflavin is the riboflavin defined in the conform to the following specifications Food Chemicals Codex, 3d Ed. (1981), and shall be free from impurities other pp. 262–263, which is incorporated by

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reference. Copies may be obtained from (b) Uses and restrictions. Saffron may the National Academy Press, 2101 Con- be safely used for the coloring of foods stitution Ave. NW., Washington, DC generally, in amounts consistent with 20418, or at the National Archives and good manufacturing practice, except Records Administration (NARA). For that it may not be used to color foods information on the availability of this for which standards of identity have material at NARA, call 202–741–6030, or 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 ibrllocations.html. 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 (d) Labeling. The label of the color ad- suitable and are listed in this subpart ditive shall conform to the require- as safe for use in color additive mix- ments of § 70.25 of this chapter. tures for coloring foods. (e) Exemption from certification. Cer- (b) Specifications. Spirulina extract tification of this color additive is not must conform to the following speci- necessary for the protection of the pub- fications and must be free from impuri- lic health, and therefore batches there- ties, other than those named, to the ex- of are exempt from the certification re- tent that such other impurities may be quirements of section 721(c) of the Act. avoided by good manufacturing prac- [42 FR 15643, Mar. 22, 1977, as amended at 47 tice: FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] (1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 part per mil- § 73.500 Saffron. lion (ppm)); (a) Identity. (1) The color additive saf- (2) Arsenic, not more than 2 mg/kg (2 fron is the dried stigma of Crocus ppm); sativus L. The definition of saffron in (3) Mercury, not more than 1 mg/kg (1 this paragraph is for the purpose of ppm); and identity as a color additive only, and (4) Negative for microcystin toxin. shall not be construed as setting forth (c) Uses and restrictions. Spirulina ex- an official standard for saffron under tract may be safely used for coloring section 401 of the act. confections (including candy and chew- (2) Color additive mixtures made ing gum), frostings, ice cream and fro- with saffron may contain as diluents zen desserts, dessert coatings and top- only those substances listed in this pings, beverage mixes and powders, yo- subpart as safe and suitable in color gurts, custards, puddings, cottage additive mixtures for coloring foods. cheese, gelatin, breadcrumbs, ready-to-

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eat cereals (excluding extruded cere- TiO2, not less than 99.0 percent after drying als), coating formulations applied to for 3 hours at 105 °C. dietary supplement tablets and cap- Lead, arsenic, and antimony shall be sules, at levels consistent with good determined in the solution obtained by manufacturing practice, and to season- boiling 10 grams of the titanium diox- ally color the shells of hard-boiled ide for 15 minutes in 50 milliliters of eggs, except that it may not be used to 0.5N hydrochloric acid. color foods for which standards of iden- (c) Uses and restrictions. The color ad- tity have been issued under section 401 ditive titanium dioxide may be safely of the Federal Food, Drug, and Cos- used for coloring foods generally, sub- metic Act, unless the use of the added ject to the following restrictions: color is authorized by such standards. (1) The quantity of titanium dioxide (d) Labeling requirements. The label of does not exceed 1 percent by weight of the color additive and of any mixture the food. prepared therefrom intended solely or (2) It may not be used to color foods in part for coloring purposes must con- for which standards of identity have form to § 70.25 of this chapter. been promulgated under section 401 of (e) Exemption from certification. Cer- the act unless added color is authorized tification of this color additive is not by such standards. necessary for the protection of the pub- (d) Labeling. The label of the color ad- lic health, and therefore batches there- ditive and any mixtures intended sole- of are exempt from the certification re- ly or in part for coloring purposes pre- quirements of section 721(c) of the Fed- pared therefrom shall conform to the eral Food, Drug, and Cosmetic Act. requirements of § 70.25 of this chapter. (e) Exemption from certification. Cer- [78 FR 49120, Aug. 13, 2013, as amended at 79 FR 20098, May 13, 2014; 80 FR 50765, Aug. 21, tification of this color additive is not 2015; 82 FR 30734, July 3, 2017] necessary for the protection of the public health and therefore batches thereof § 73.575 Titanium dioxide. are exempt from the certification requirements of section 721(c) of the act. (a) Identity. (1) The color additive titanium dioxide is synthetically pre- § 73.585 Tomato lycopene extract; to- pared TiO2, free from admixture with mato lycopene concentrate. other substances. (a) Identity. (1) The color additive to- (2) Color additive mixtures for food mato lycopene extract is a red to dark use made with titanium dioxide may brown viscous oleoresin extracted with contain only those diluents that are ethyl acetate from tomato pulp fol- suitable and that are listed in this sub- lowed by removal of the solvent by part as safe in color additive mixtures evaporation. The pulp is produced from for coloring foods, and the following: fresh, edible varieties of the tomato by Silicon dioxide, SiO2 and/or aluminum removing the liquid. The main coloring oxide, Al2 O3, as dispersing aids—not component is lycopene. more than 2 percent total. (2) The color additive tomato lyco- (b) Specifications. Titanium dioxide pene concentrate is a powder prepared shall conform to the following speci- from tomato lycopene extract by re- fications: moving most of the tomato lipids with Lead (as Pb), not more than 10 parts per mil- ethyl acetate and then evaporating off lion. the solvent. Arsenic (as As), not more than 1 part per (3) Color additive mixtures made million. with tomato lycopene extract or to- Antimony (as Sb), not more than 2 parts per mato lycopene concentrate may con- million. tain only those diluents listed in this Mercury (as Hg), not more than 1 part per subpart as safe and suitable for use in million. color additive mixtures for coloring Loss on ignition at 800 °C. (after drying for 3 hours at 105 °C.), not more than 0.5 percent. food. Water soluble substances, not more than 0.3 (b) Specifications. (1) Tomato lycopene percent. extract shall conform to the following Acid soluble substances, not more than 0.5 specification: Lycopene, not less than percent. 5.5 percent of oleoresin as determined

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by the method entitled ‘‘Qualitative § 73.600 Turmeric. Analysis of Lycopene, Its Isomers and (a) Identity. (1) The color additive Other Carotenoids in Different Con- ® turmeric is the ground rhizome of centrations of Lyc-O-Mato (Tomato Curcuma longa L. The definition of Oleoresin) and in Tomato Pulp by High turmeric in this paragraph is for the Performance Liquid Chromatography purpose of identity as a color additive (HPLC),’’ S.O.P. number : Lab/119/01, only, and shall not be construed as set- Revision 01, dated May 30, 2001, pub- ting forth an official standard for tur- lished by LycoRed Natural Products meric under section 401 of the act. Industries, which is incorporated by (2) Color additive mixtures made reference, or an equivalent method. with turmeric may contain as diluents The Director of the Office of the Fed- only those substances listed in this eral Register approves this incorpora- subpart as safe and suitable in color tion by reference in accordance with 5 additive mixtures for coloring foods. U.S.C. 552(a) and 1 CFR part 51. You (b) Uses and restrictions. Turmeric may obtain a copy of the method from may be safely used for the coloring of the Center for Food Safety and Applied foods generally, in amounts consistent Nutrition (HFS–200), Food and Drug with good manufacturing practice, ex- Administration, 5001 Campus Dr., Col- cept that it may not be used to color lege Park, MD 20740. You may inspect a foods for which standards of identity copy at theFood and Drug Administra- have been promulgated under section tion’s Main Library, 10903 New Hamp- 401 of the act, unless the use of added shire Ave., Bldg. 2, Third Floor, Silver color is authorized by such standards. Spring, MD 20993, 301–796–2039, or at the (c) Labeling. The color additive and National Archives and Records Admin- any mixtures intended solely or in part istration (NARA). For information on for coloring purposes prepared there- the availability of this material at from shall bear, in addition to the NARA, call 202–741–6030, or go to: http:// other information required by the act, www.archives.gov/federallregister/ labeling in accordance with the provi- codeloflfederallregulations/ sions of § 70.25 of this chapter. ibrllocations.html (d) Exemption from certification. Cer- (2) Tomato lycopene concentrate tification of this color additive is not shall conform to the following speci- necessary for the protection of the pub- fication: Lycopene, not less than 60 lic health, and therefore batches there- percent of oleoresin as determined by of are exempt from the certification re- the method identified in paragraph quirements of section 721(c) of the act. (b)(1) of this section. (c) Uses and restrictions. Tomato lyco- § 73.615 Turmeric oleoresin. pene extract and tomato lycopene con- (a) Identity. (1) The color additive centrate may be safely used for color- turmeric oleoresin is the combination ing foods generally in amounts con- of flavor and color principles obtained sistent with good manufacturing prac- from turmeric (Curcuma longa L.) by tice, except that they may not be used extraction using any one or a combina- to color foods for which standards of tion of the following solvents: identity have been issued under section 401 of the act, unless the use of added Acetone Isopropyl alcohol color is authorized by such standards. Ethyl alcohol Methyl alcohol (d) Labeling. The label of the color ad- Ethylene dichloride Methylene chloride ditive shall conform to the require- Hexane Trichloroethylene ments of § 70.25 of this chapter. The definition of turmeric oleoresin in (e) Exemption from certification. Cer- this paragraph is for the purpose of tification of this color additive is not identity as a color additive only, and necessary for the protection of the pub- shall not be construed as setting forth lic health, and therefore batches there- an official standard for turmeric oleo- of are exempt from the certification re- resin under section 401 of the act. quirements of section 721(c) of the act. (2) Color additive mixtures made [70 FR 43045, July 26, 2005, as amended at 81 with turmeric oleoresin may contain as FR 5590, Feb. 3, 2016; 81 FR 49895, July 29, diluents only those substances listed in 2016] this subpart as safe and suitable in

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color additive mixtures for coloring of are exempt from the certification re- foods. quirements of section 721(c) of the act. (b) Specifications. Turmeric oleoresin shall contain no more residue of the Subpart B—Drugs solvents listed under paragraph (a)(1) of this section than is permitted for § 73.1001 Diluents in color additive the corresponding solvents in spice mixtures for drug use exempt from oleoresins under applicable food addi- certification. tive regulation in parts 170 through 189 The following diluents may be safely of this chapter. used in color additive mixtures that (c) Uses and restrictions. Turmeric oleoresin may be safely used for the color- are exempt from certification and ing of foods generally, in amounts con- which are to be used for coloring drugs, sistent with good manufacturing prac- subject to the condition that each tice, except that it may not be used to straight color in the mixture has been color foods for which standards of iden- exempted from certification or, if not tity have been promulgated under sec- so exempted, is from a batch that has tion 401 of the act, unless the use of previously been certified and has not added color is authorized by such changed in composition since certifi- standards. cation. Such listing of diluents is not (d) Labeling. The color additive and to be construed as superseding any of any mixtures intended solely or in part the other requirements of the Federal for coloring purposes prepared there- Food, Drug, and Cosmetic Act with re- from shall bear, in addition to the spect to drugs, including new drugs. If other information required by the act, a definition and specification for a par- labeling in accordance with the provi- ticular diluent is not set forth in this sions of § 70.25 of this chapter. subpart, the material shall be of a pu- (e) Exemption from certification. Cer- rity consistent with its intended use. tification of this color additive is not (a) Ingested drugs—(1) General use. necessary for the protection of the pub- Diluents listed in § 73.1(a) and the fol- lic health, and therefore batches there- 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. Sorbitan monostearate ...... As set forth in sec. 172.842 of this chapter. Sorbitan trioleate.

(2) Special use; inks for branding phar- Substances Definitions and specifications maceutical forms. Items listed in paragraph (a)(1) of this section, Benzyl alcohol ...... As set forth in N.F. XI. Ethyl cellulose ...... As set forth in § 172.868 of this § 73.1(b)(1)(i), and the following: chapter. Hydroxyethyl cellulose. Ethyl lactate Hydroxypropyl cellulose As set forth in § 172.870 of this Polyoxyethylene sorbitan monolaurate (20) chapter. (b) Externally applied drugs. Diluents listed in paragraph (a)(1) of this section and the following:

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§ 73.1010 Alumina (dried aluminum hy- (b) Specifications. Chromium-cobalt- droxide). aluminum oxide shall conform to the (a) Identity. (1) The color additive following specifications:

alumina (dried aluminum hydroxide) is Chromium, calculated as Cr2 O3, 34–37 per- a white, odorless, tasteless, amorphous cent. powder consisting essentially of alu- Cobalt, calculated as CoO, 29–34 percent. minum hydroxide (Al O · XH O). Aluminum, calculated as AL2 O3, 29–35 per- 2 3 2 cent. (2) Color additive mixtures for drug Lead (as Pb), not more than 30 parts per mil- use made with alumina (dried alu- lion. minum hydroxide) may contain only Arsenic (as As), not more than 3 parts per those diluents listed in this subpart as million. safe and suitable for use in color addi- Total oxides of aluminum, chromium, and tive mixtures for coloring drugs. cobalt not less than 97 percent. (b) Specifications. Alumina (dried alu- Lead and arsenic shall be determined minum hydroxide) shall conform to the in the solution obtained by boiling 10 following specifications: grams of the chromium-cobalt-alu- Acidity or alkalinity: Agitate 1 gram of the minum oxide for 15 minutes in 50 milli- color additive with 25 milliliters of water liters of 0.5 N hydrochloric acid. and filter. The filtrate shall be neutral to (c) Uses and restrictions. The color ad- litmus paper. ditive chromium-cobalt-aluminum Matter insoluble in dilute hydrochloric acid, oxide may be safely used for coloring not more than 0.5 percent. linear polyethylene surgical sutures, Lead (as Pb), not more than 10 parts per mil- United States Pharmacopeia (U.S.P.), lion. for use in general surgery, subject to Arsenic (as As), not more than 1 part per the following restrictions: million. (1) For coloring procedure, the color Mercury (as Hg), not more than 1 part per additive is blended with the poly- million. ethylene resin. The mixture is heated Aluminum oxide (Al2 O3), not less than 50 ° percent. to a temperature of 500–550 F. and extruded through a fixed orifice. The fila- (c) Uses and restrictions. Alumina ments are cooled, oriented by drawing, (dried aluminum hydroxide) may be and set by annealing. safely used in amounts consistent with (2) The quantity of the color additive good manufacturing practice to color does not exceed 2 percent by weight of drugs generally. the suture material. (d) Labeling requirements. The label of (3) The dyed suture shall conform in the color additive and of any mixtures all respects to the requirements of the prepared therefrom intended solely or U.S.P. XX (1980). in part for coloring purposes shall con- (4) When the sutures are used for the form to the requirements of § 70.25 of purpose specified in their labeling, this chapter. there is no migration of the color addi- (e) Exemption from certification. Cer- tive to the surrounding tissue. tification of this color additive is not (5) If the suture is a new drug, an ap- necessary for the protection of the pub- proved new drug application, pursuant lic health, and therefore batches there- to section 505 of the Federal Food, of are exempt from the certification re- Drug, and Cosmetic Act, is in effect for quirements of section 721(c) of the act. it. (d) Labeling. The label of the color ad- § 73.1015 Chromium-cobalt-aluminum ditive shall conform to the require- oxide. ments of § 70.25 of this chapter. (a) Identity. The color additive chro- (e) Exemption from certification. Cer- mium-cobalt-aluminum oxide is a blue- tification of this color additive is not green pigment obtained by calcining a necessary for the protection of the pub- mixture of chromium oxide, cobalt car- lic health, and batches thereof are ex- bonate, and aluminum oxide. It may empt from the certification require- contain small amounts (less than 1 per- ments of section 721(c) of the act. cent each) of oxides of barium, boron, [42 FR 15643, Mar. 22, 1977, as amended at 49 silicon, and nickel. FR 10089, Mar. 19, 1984]

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§ 73.1025 Ferric ammonium citrate. 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. (b) Uses and restrictions. Annatto ex- reducible by light. tract may be safely used for coloring (b) Specifications. Ferric ammonium 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 manufacturing practice. the extent that such impurities may be (c) Labeling. The label of the color ad- avoided by good manufacturing prac- ditive and any mixtures prepared tice: therefrom and intended solely or in Iron (as Fe), not less than 14.5 percent and part for coloring purposes shall con- not more than 18.5 percent. form to the requirements of § 70.25 of Lead (as Pb), not more than 20 p/m. this chapter. Labels shall bear informa- Arsenic (as As), not more than 3 p/m. tion showing that the color is derived (c) Uses and restrictions. Ferric ammo- from annatto seed. The requirements of nium citrate may be safely used in § 70.25(a) of this chapter that all ingre- combination with pyrogallol (as listed dients shall be listed by name shall not in § 73.1375), for coloring plain and chro- be construed as requiring the declara- mic catgut sutures for use in general tion of residues of solvents listed in and ophthalmic surgery subject to the § 73.30(a)(1)(ii) of this chapter. following conditions: (d) Exemption from certification. Cer- (1) The dyed suture shall conform in tification of this color additive is not all respects to the requirements of the necessary for the protection of the pub- United States Pharmacopeia XX (1980). lic health and therefore batches thereof (2) The level of the ferric ammonium are evempt from the certification re- citrate-pyrogallol complex shall not quirements of section 721(c) of the act. exceed 3 percent of the total weight of [42 FR 15643, Mar. 22, 1977, as amended at 42 the suture material. FR 36994, July 19, 1977] (3) When the sutures are used for the purposes specified in their labeling, § 73.1070 Calcium carbonate. there is no migration of the color addi- (a) Identity. (1) The color additive cal- tive to the surrounding tissue. cium carbonate is a fine, white, syn- (4) If the suture is a new drug, an ap- thetically prepared powder consisting proved new drug application, pursuant essentially of precipitated calcium car- to section 505 of the act, is in effect for bonate (CaCO3). it. (2) Color additive mixtures for drug (d) Labeling. The labeling of the use made with calcium carbonate may color-additive shall conform to the re- contain only those diluents listed in quirements of § 70.25 of this chapter. this subpart as safe and suitable for use (e) Exemption from certification. Cer- in color additive mixtures for coloring tification of this color additive is not drugs. necessary for the protection of the pub- (b) Specifications. Calcium carbonate lic health and therefore batches thereof shall meet the specifications for pre- are exempt from the requirements of cipitated calcium carbonate in the section 721(c) of the act. United States Pharmacopeia XX (1980). [42 FR 15643, Mar. 22, 1977, as amended at 49 (c) Uses and restrictions. Calcium car- FR 10089, Mar. 19, 1984] bonate may be safely used in amounts consistent with good manudacturing § 73.1030 Annatto extract. practice to color drugs generally. (a) Identity and specifications. (1) The (d) Labeling requirements. The label of color additive annatto extract shall the color additive and of any mixtures conform in identity and specifications prepared therefrom intended solely or

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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 coloring ingested drugs generally in intended solely or in part for coloring amounts consistent with good manu- purposes prepared therefrom shall con- facturing practice. form to the requirements of § 70.25 of (c) Labeling requirements. The label of this chapter. the color additive and of any mixtures (d) Exemption from certification. Cer- prepared therefrom intended solely or tification of this color additive is not in part for coloring purposes shall con- necessary for the protection of the pub- form to the requirements of § 70.25 of lic health, and therefore batches there- this chapter. of are exempt from the certification re- (d) Exemption from certification. Cer- quirements of section 721(c) of the act. tification of this color additive is not [42 FR 15643, Mar. 22, 1977, as amended at 42 necessary for the protection of the pub- FR 33722, July 1, 1977] lic health, and therefore batches thereof are exempt from the certification re- § 73.1100 Cochineal extract; carmine. quirements of section 721(c) of the act. (a) Identity and specifications. (1) The color additives cochineal extract and § 73.1085 Caramel. carmine shall conform in identity and (a) Identity and specifications. (1) The specifications to the requirements of color additive caramel shall conform in § 73.100(a) (1) and (2) and (b). identity and specifications to the re- (2) Color additive mixtures for drug quirements of § 73.85(a) (1), (2), and (3) use made with carmine and cochineal and (b). extract may contain only those (2) The diluents in color additive diluents that are suitable and that are mixtures for drug use containing car- listed in this subpart as safe in color amel shall be limited to those listed in additive mixtures for coloring drugs. this subpart as safe and suitable in (b) Uses and restrictions. Cochineal ex- color additive mixtures for coloring tract and carmine may be safely used drugs. for coloring ingested and externally ap- (b) Uses and restrictions. Caramel may plied drugs in amounts consistent with be used for coloring ingested and topi- good manufacturing practice. cally applied drugs generally in (c) Labeling requirements. The label of amounts consistent with good manu- the color additives and any mixtures facturing practice. intended solely or in part for coloring

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purposes prepared therefrom shall con- (d) Labeling. The label of the color ad- form to the requirements of § 70.25 of ditive and any mixtures prepared this chapter. therefrom intended solely or in part for (d) Exemption from certification. Cer- coloring purposes shall conform to the tification of these color additives is requirements of § 70.25 of this chapter. not necessary for the protection of the (e) Exemption from certification. Cer- public health, and therefore batches tification of this color additive is not thereof are exempt from the certifi- necessary for the protection of the pub- cation requirements of section 721(c) of lic health and therefore batches thereof the act. are exempt from the certification requirements of section 721(c) of the act. § 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper § 73.1150 Dihydroxyacetone. complex). (a) Identity. (1) The color additive (a) Identity. (1) The color additive po- dihydroxyacetone is 1,3-dihydroxy-2- tassium sodium copper chlorophyllin is propanone. a green to black powder obtained from (2) Color additive mixtures for drug chlorophyll by replacing the methyl use made with dihydroxyacetone may and phytyl ester groups with alkali and contain only those diluents that are replacing the magnesium with copper. listed in this subpart as safe and suit- The source of the chlorophyll is dehy- able in color additive mixtures for drated alfalfa. coloring externally applied drugs. (2) Color additive mixtures for drug (b) Specifications. Dihydroxyacetone use made with potassium sodium cop- shall conform to the following speci- per chlorophyllin may contain only fications and shall be free from impuri- those diluents that are suitable and ties other than those named to the ex- that are listed in this subpart as safe tent that such impurities may be for use in color additive mixtures for avoided by good manufacturing prac- coloring drugs. tice: (b) Specifications. Potassium sodium copper chlorophyllin shall conform to Volatile matter (at 34.6 °C. for 3 hours at a the following specifications and shall pressure of not more than 30 mm. mer- be free from impurities other than cury), not more than 0.5 percent. those named to the extent that such Residue on ignition, not more than 0.4 per- other impurities may be avoided by cent. Lead (as Pb), not more than 20 parts per mil- good manufacturing practice: lion. Moisture, not more than 5.0 percent. Arsenic (as As), not more than 3 parts per Nitrogen, not more than 5.0 percent. million. pH of 1 percent solution, 9 to 11. Iron (as Fe), not more than 25 parts per mil- Total copper, not less than 4 percent and not lion. more than 6 percent. 1,3-dihydroxy-2-propanone, not less than 98 Free copper, not more than 0.25 percent. percent. Iron, not more than 0.5 percent. Lead (as Pb)), not more than 20 parts per (c) Uses and restrictions. million. Dihydroxyacetone may be safely used Arsenic (as As), not more than 5 parts per in amounts consistent with good manu- million. facturing practice in externally applied Ratio, absorbance at 405 mμ to absorbance at drugs intended solely or in part to im- 630 mμ, not less than 3.4 and not more than part a color to the human body. Au- 3.9. thorization for this use shall not be Total color, not less than 75 percent. construed as waiving any of the re- (c) Uses and restrictions. Potassium quirements of section 505 of the act sodium copper chlorophyllin may be with respect to the drug in which it is safely used for coloring dentifrices that used. are drugs at a level not to exceed 0.1 (d) Labeling requirements. The label of percent. Authorization for this use the color additive and any mixtures shall not be construed as waiving any prepared therefrom intended solely or of the requirements of section 505 of in part for coloring purposes shall con- the act with respect to the drug in form to the requirements of § 70.25 of which it is used. this chapter.

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(e) Exemption from certification. Cer- § 73.1200 Synthetic iron oxide. tification of this color additive is not (a) Identity. (1) The color additive necessary for the protection of the pub- synthetic iron oxide consists of any lic health and therefore batches thereof one or any combination of syn- are exempt from the certification requirements 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. (2) Color additive mixtures for drug (a) Identity. (1) The color additive bis- use made with synthetic iron oxide muth oxychloride is a synthetically may contain only those diluents listed prepared white or nearly white amor- in this subpart as safe and suitable in phous or finely crystalline, odorless color additive mixtures for coloring powder consisting principally of BiOCl. drugs. (2) Color additive mixtures for drug (b) Synthetic iron use made with bismuth oxychloride Specifications. 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. be free from impurities other than (c) Uses and restrictions. The color ad- those named to the extent that such ditive synthetic iron oxide may be other impurities may be avoided by safely used to color ingested or topi- good manufacturing practice: cally applied drugs generally subject to Volatile matter, not more than 0.5 percent. the restriction that if the color addi- Lead (as Pb), not more than 20 parts per mil- tive is used in drugs ingested by man lion. the amount consumed in accordance Arsenic (as As), not more than 3 parts per with labeled or prescribed dosages shall million. not exceed 5 milligrams, calculated as Mercury (as Hg), not more than 1 part per elemental iron, per day. million. (d) Labeling requirements. The label of Bismuth oxychloride, not less than 98 per- the color additive and any mixtures in- cent. tended solely or in part for coloring (c) Uses and restrictions. The color ad- purposes prepared therefrom shall con- ditive bismuth oxychloride may be form to the requirements of § 70.25 of safely used in coloring externally ap- this chapter. plied drugs, including those intended (e) Exemption from certification. Cer- for use in the area of the eye, 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 there- (d) Labeling. The color additive and of are exempt from certification re- any mixture prepared therefrom in- quirements of section 721(c) of the act. tended solely or in part for coloring purposes shall bear, in addition to any § 73.1298 Ferric ammonium ferrocya- information required by law, labeling nide. in accordance with the provisions of (a) Identity. (1) The color additive fer- § 70.25 of this chapter. ric ammonium ferrocyanide is the blue (e) Exemption from certification. Cer- pigment obtained by oxidizing under tification of this color additive is not acidic conditions with sodium dichro- necessary for the protection of the pub- mate the acid digested precipitate re- lic health, and therefore batches there- sulting from mixing solutions of fer- of are exempt from certification pursu- rous sulfate and sodium ferrocyanide in ant to section 721(c) of the act. the presence of ammonium sulfate. The [42 FR 52394, Sept. 30, 1977] oxidized product is filtered, washed,

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and dried. The pigment consists prin- § 73.1299 Ferric ferrocyanide. cipally of ferric ammonium ferrocya- (a) Identity. (1) The color additive fer- nide with smaller amounts of ferric ferric ferrocyanide is a ferric rocyanide and ferric sodium ferrocya- hexacyanoferrate pigment character- nide. ized by the structual formula (2) Color additive mixtures for drug Fe4[Fe(CN)6]3·XH2O, which may contain use made with ferric ammonium ferro- small amounts of ferric sodium ferrocyanide may contain only those cyanide and ferric potassium ferrocya- diluents listed in this subpart as safe nide. and suitable for use in color additive (2) Color additive mixtures for drug mixtures for coloring drugs. use made with ferric ferrocyanide may (b) Specifications. Ferric ammonium contain only those diluents listed in ferrocyanide shall conform to the fol- this subpart as safe and suitable for use lowing specifications and shall be free in color additive mixtures for coloring of impurities other than those named drugs. to the extent that the other impurities (b) Specifications. Ferric ferrocyanide may be avoided by good manufacturing shall conform to the following speci- practice: fications and shall be free from impurities other than those named to the ex- Oxalic acid or its salts, not more than 0.1 tent that such impurities may be percent. avoided by good manufacturing prac- Water soluble matter, not more than 3 per- tice: cent. Water soluble cyanide, not more than 10 Water soluble cyanide, not more than 10 parts per million. parts per million. Volatile matter, not more than 4 percent. Lead (as Pb), not more than 20 parts per mil- Lead (as Pb), not more than 20 parts per million. lion. Arsenic (as As), not more than 3 parts per million. Arsenic (as As), not more than 3 parts per Nickel (as Ni), not more than 200 parts per million. million. Nickel (as Ni), not more than 200 parts per Cobalt (as Co), not more than 200 parts per million. million. Cobalt (as Co), not more than 200 parts per Mercury (as Hg), not more than 1 part per million. million. Mercury (as Hg), not more than 1 part per Oxalic acid, not more than 0.1 percent. million. Water soluble matter, not more than 3 per- Total iron (as Fe corrected for volatile mat- cent. ter), not less than 33 percent and not more Volatile matter, not more than 10 percent. than 39 percent. Total iron (as Fe corrected for volatile matter), not less than 37 percent and not more (c) Uses and restrictions. Ferric ammo- than 45 percent. nium ferrocyanide may be safely used (c) Uses and restrictions. Ferric ferro- in amounts consistent with good manu- cyanide may be safely used in amounts facturing practice to color externally consistent with good manufacturing applied drugs, including those for use practice to color externally applied in the area of the eye. drugs including those intended for use (d) Labeling requirements. The label of in the area of the eye. the color additive and of any mixtures (d) Labeling requirements. The label of prepared therefrom intended solely or the color additive and of any mixtures in part for coloring purposes shall con- prepared therefrom intended solely or form to the requirements of § 70.25 of in part for coloring purposes shall con- this chapter. form to the requirements of § 70.25 of (e) Exemption from certification. Cer- this chapter. 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 therfore batches thereof necessary for the protection of the pub- are exempt from the certification re- lic health, and therefore batches there- quirements of section 721(c) of the act. of are exempt from certification requirements of section 721(c) of the act. [42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979] [43 FR 54235, Nov. 21, 1978]

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§ 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 use in color additive mixtures for chromium hydroxide green is prin- coloring drugs. cipally hydrated chromic sesquioxide (b) Specifications. the color additive (Cr O ·XH O). 2 3 2 chormium oxide greens shall conform (2) Color additive mixtures for drug to the following specifications and use made with chromium hydroxide shall be free from impurities other green may contain only those diluents than those named to the extent that listed in this subpart as safe and suit- such impurities may be avoided by able for use in color additive mixtures good manufacturing practice: for coloring drugs. (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 million. named to the extent that such impuri- Lead (as Pb), not more than 20 parts per mil- ties may be avoided by good manufac- lion. turing practice: Mercury (as Hg), not more than 1 part per million. Water soluble matter, not more than 2.5%. Cr O , not less than 95%. Chromium in 2% NaOH extract, not more 2 3 than 0.1% as Cr2O3 (based on sample (c) Uses and restrictions. Chromium weight). oxide greens is safe for use in coloring Boron (as B2O3), not more than 8 percent. externally applied drugs, including ° Total volatile matter at 1000 C, not more those intended for use in the area of than 20%. eye, in amounts consistent with good Cr2O3 not less than 75%. Lead (as Pb), not more than 20 parts per mil- manufacturing practice. lion. (d) Labeling. The color additive and Arsenic (as As), not more than 3 parts per any mixture prepared therefrom in- million. tended solely or in part for coloring Mercury (as Hg), not more than 1 part per purposes shall bear, in addition to any million. information required by law, labeling (c) Uses and restrictions. Chromium in accordance with § 70.25 of this chap- hydroxide green may be safely used in ter. amounts consistent with good manu- (e) Exemption from certification. Cer- facturing practice to color externally tification of this color additive is not applied drugs, including those for use necessary for the protection of the pub- in the area of the eye. lic health, and therefore batches therof (d) Labeling requirements. The label of are exempt from certification pursuant the color additive and of any mixtures to section 721(c) of the act. prepared therefrom lintended solely or [42 FR 36451, July 15, 1977] in part for coloring purposes shall conform to the requirements of § 70.25 of § 73.1329 Guanine. this chapter. (a) Identity. (1) The color additive (e) Exemption from certification. Cer- guanine is the crystalline material ob- tification of this color additive is not tained from fish scales and consists necessary for the protection of the pub- principally of the two purines, guanine lic health, and therefore batches there- and hypoxanthine. The guanine con- of are exempt from the certification re- tent will vary from 75 to 97 percent, quirements of section 721(c) of the act. and the hypoxanthine will vary from 3 [42 FR 36451, July 15, 1977, as amended at 42 to 25 percent, depending on the par- FR 59852, Nov. 22, 1977] ticular fish and tissue from which the crystals are derived. § 73.1327 Chromium oxide greens. (2) Color additive mixtures for drug (a) Identity. (1) The color additive use made with guanine may contain chromium oxide greens is principally only those diluents listed in this sub- chromic sesquioxide (Cr2O3). part as safe and suitable for use in (2) Color additive mixtures for drug color additive mixtures for coloring ex- use made with chromium oxide greens ternally applied drugs.

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(b) Specifications. The color additive following specifications and shall be guanine shall conform to the following free from impurities other than those specifications and shall be free from named to the extent that such other impurities other than those named to impurities may be avoided by good the extent that such other impurities manufacturing practice: may be avoided by good manufacturing (1) Lead (as Pb), not more than 4 practice: parts per million (ppm). Guanine, not less than 75 percent. (2) Arsenic (as As), not more than 3 Hypoxanthine, not more than 25 percent. ppm. Ash (ignition at 800 °C), not more than 2 per- (3) Mercury (as Hg), not more than 1 cent. ppm. Lead (as Pb), not more than 20 parts per mil- (c) Uses and restrictions. Mica-based lion. 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 (d) Labeling. The color additive and coloring purposes shall conform to the any mixture prepared therefrom in- requirements of § 70.25 of this chapter. tended solely or in part for coloring (e) Exemption from certification. Cer- purposes shall bear, in addition to any tification of this color additive is not information required by law, labeling necessary for the protection of the pub- in accordance with § 70.25 of this chap- lic health, and therefore batches there- ter. of are exempt from the certification re- (e) Exemption from certification. Cer- quirements of section 721(c) of the Fed- tification of this color additive is not eral Food, Drug, and Cosmetic Act. necessary for the protection of the pub- [70 FR 42273, July 22, 2005. Redesignated at 72 lic health, and therefore batches therof FR 10357, Mar. 8, 2007] are exempt from certification pursuant to section 721(c) of the act. § 73.1375 Pyrogallol. [42 FR 37537, July 22, 1977] (a) Identity. The color additive pyrogallol is 1,2,3-trihydroxybenzene. § 73.1350 Mica-based pearlescent pig- (b) Specifications. Pyrogallol shall ments. conform to the following specifications (a) Identity. (1) The color additive is and shall be free from impurities other formed by depositing titanium and/or than those named to the extent that iron salts onto mica, followed by heat- such impurities may be avoided by ing to produce one of the following good manufacturing practice: combinations: Titanium dioxide on mica; iron oxide on mica; titanium di- Melting point, between 130° and 133 °C. oxide and iron oxide on mica. Mica Residue on ignition, not more than 0.1 per- used to manufacture the color additive cent. shall conform in identity to the re- Lead (as Pb), not more than 20 p/m (parts per million). quirements of § 73.1496(a)(1). Arsenic (as As), not more than 3 p/m. (2) Color additive mixtures for drug use made with mica-based pearlescent (c) Uses and restrictions. Pyrogallol pigments may contain only those may be safely used in combination diluents listed in this subpart as safe with ferric ammonium citrate (as list- and suitable for use in color additive ed in § 73.1025), for coloring plain and mixtures for coloring ingested drugs. chromic catgut sutures for use in gen- (b) Specifications. Mica-based pearl- eral and ophthalmic surgery, subject to escent pigments shall conform to the the following restrictions:

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(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 exter- the suture material. nally applied. (3) When the sutures are used for the (d) Labeling requirements. The labeling purposes specified in their labeling, of the color additive and any mixtures there is no migration of the color addi- prepared therefrom intended solely or tive to the surrounding tissues. in part for coloring purposes shall con- (4) If the suture is a new drug, an ap- form to the requirements of § 70.25 of proved new drug application, pursuant this chapter. to section 505 of the act, is in effect for (e) Exemption from certification. Cer- it. tification of this color additive is not (d) Labeling. The label of the color ad- necessary for the protection of the pub- ditive shall conform to the require- lic health, and therefore batches there- ments of § 70.25 of this chapter. of are exempt from the certification re- (e) Exemption from certification. Cer- quirements of section 721(c) of the act. tification of this color additive is not necessary for the protection of the pub- § 73.1410 Logwood extract. lic health and therefore batches thereof (a) Identity. The color additive are exempt from the certification re- logwood extract is a reddish brown-to- quirements of section 721(c) of the act. black solid material extracted from the [42 FR 15643, Mar. 22, 1977, as amended at 49 heartwood of the leguminous tree FR 10089, Mar. 19, 1984] Haematoxylon campechianum. The active colorant substance is principally § 73.1400 Pyrophyllite. hematein. The latent coloring material (a) Identity. (1) The color additive is the unoxidized or leuco form of he- pyrophyllite is a naturally occurring matein called hematoxylin. The leuco mineral substance consisting predomi- form is oxidized by air. nantly of a hydrous aluminum silicate, (b) Specifications. Logwood extract shall conform to the following speci- Al2O3·4SiO2·H2 O, intimately mixed with lesser amounts of finely divided fications and shall be free from impurities other than those named to the ex- silica, SiO2. Small amounts, usually less than 3 percent, of other silicates, tent that such imnurities may be such as potassium aluminum silicate, avoided by good manufacturing prac- may be present. Pyrophyllite may be tice: identified and semiquantitatively de- Volatile matter (at 110 °C), not more than 15 termined by its characteristic X-ray percent. powder diffraction pattern and by its Sulfated ash, not more than 20 percent. optical properties. Hematein, not less than 5 percent and not (2) Color additive mixtures made more than 20 percent. with pyrophyllite are limited to those Lead (as Pb), not more than 70 parts per mil- listed in this subpart as safe and suit- lion. able in color additive mixtures for Arsenic (as As), not more than 4 parts per coloring externally applied drugs. million. (b) Specifications. Pyrophyllite shall Mercury (as Hg), not more than 3 parts per million. conform to the following specifications: (c) Use and restrictions. Logwood extract may be safely used to color nylon Lead (as Pb), not more than 20 parts per mil- 66 (the copolymer of lion. Arsenic (as As), not more than 3 parts per hexamethylenediamine and adipic million. acid), nylon 6 (the polymer of e- caprolactam), or silk non-absorable su- Lead and arsenic shall be determined tures for use in general and ophthalmic in the solution obtained by boiling 10 surgery subject to the following re- grams of the pyrophyllite for 15 min- strictions:

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(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 color additive contains phycocyanins § 73.1496 Mica. as the principal coloring components. (a) Identity. (1) The color additive (2) Color additive mixtures for drug mica is a white powder obtained from use made with spirulina extract may the naturally occurring mineral, mus- contain only those diluents that are covite mica, consisting predominantly suitable and are listed in this subpart of a potassium aluminum silicate, as safe for use in color additive mix- K2Al4(Al2Si6O20)(OH)4 or, alternatively, tures for coloring ingested drugs. H2KAl3 (SiO4)3. Mica may be identified (b) Specifications. Spirulina extract and semiquantitatively determined by must conform to the following speci- its characteristic X-ray diffraction pat- fications and must 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 other impurities 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 addi- (1) Lead, not more than 2 milligrams tive mixtures for coloring drugs. per kilogram (mg/kg) (2 parts per mil- (b) Specifications. Mica shall conform lion (ppm)); to the following specifications and (2) Arsenic, not more than 2 mg/kg (2 shall be free from impurities other ppm); than those named to the extent that (3) Mercury, not more than 1 mg/kg (1 such other impurities may be avoided ppm); and by good manufacturing practice: (4) Negative for microcystin toxin. (c) Uses and restrictions. Spirulina ex- Fineness, 100 percent shall pass through a tract may be safely used for coloring 100-mesh sieve. Loss on ignition at 600–650 °C, not more than coating formulations applied to drug 2 percent. tablets and capsules, at levels con- Lead (as Pb), not more than 20 parts per mil- sistent with good manufacturing prac- lion. tice. Arsenic (as As), not more than 3 parts per (d) Labeling requirements. The label of million. the color additive and any mixture pre- Mercury (as Hg), not more than 1 part per pared therefrom intended solely or in million. part for coloring purposes shall con- (c) Uses and restrictions. Mica may be form to the requirements of § 70.25 of safely used in amounts consistent with this chapter. good manufacturing practice to color (e) Exemption from certification. Cer- dentifrices and externally applied tification of this color additive is not

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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 ad- § 73.1550 Talc. ditive titanium dioxide may be used for 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 those diluents listed in this subpart as therefrom and intended solely or in safe and suitable for use in color addi- part for coloring purposes shall con- tive mixtures for coloring drugs. form to the requirements of § 70.25 of (b) Specifications. Talc shall meet the the chapter. specifications for talc in the United (d) Exemption from certification. Cer- States Pharmacopeia XX (1980) and the tification of this color additive is not following: necessary for the protection of the public health and therefore batches thereof Lead (as Pb), not more than 20 parts per mil- are exempt from the certification re- lion. quirements of section 721(c) of the act. Arsenic (as As), not more than 3 parts per million. § 73.1645 Aluminum powder. Lead and arsenic shall be determined (a) Identity. (1) The color additive in the solution obtained by boiling 10 aluminum powder shall be composed of grams of the talc for 15 minutes in 50 finely divided particles of aluminum milliliters of 0.5N hydrochloric acid. prepared from virgin aluminum. It is (c) Uses and restrictions. Talc may be free from admixture with other sub- safely used in amounts consistent with stances. good manufacturing practice to color (2) Color additive mixtures for exter- drugs generally. nal drug use made with aluminum pow- (d) Labeling requirements. The label of der may contain only those diluents the color additive and of any mixtures listed in this subpart as safe and suit- prepared therefrom intended solely or able in color additive mixtures for in part for coloring purposes shall con- coloring externally applied drugs. form to the requirements of § 70.25 of (b) Specifications. Aluminum powder this chapter. shall conform to the following speci- (e) Exemption from certification. Cer- fications and shall be free from impuri- tification of this color additive is not ties other than those named to the ex- necessary for the protection of the pub- tent that such impurities may be lic health, and therefore batches there- avoided by good manufacturing prac- of are exempt from the certification re- tice: quirements of section 721(c) of the act. Fineness, 100 percent shall pass through a [42 FR 15643, Mar. 22, 1977, as amended at 49 200-mesh screen and 95 percent shall pass FR 10089, Mar. 19, 1984] through a 325-mesh screen. Mercury, not more than 1 part per million. § 73.1575 Titanium dioxide. Arsenic, not more than 3 parts per million. (a) Identity and specifications. (1) The Lead, not more than 20 parts per million. Aluminum, not less than 99 percent. color additive titanium dioxide shall conform in identity and specifications (c) Uses and restrictions. Aluminum to the requirements of § 73.575(a)(1) and powder is safe for use in externally ap- (b). plied drugs, including those intended (2) Color additive mixtures for drug for use in the area of the eye, in use made with titanium dioxide may amounts consistent with good manu- contain only those diluents that are facturing practice.

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(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 there- [42 FR 38563, July 29, 1977] of are exempt from the certification requirements 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 contains small amounts of stearic or small amounts of stearic or oleic acid oleic acid as lubricants. as lubricants. (2) Color additive mixtures for drug (2) Color additive mixtures for drug use made with bronze powder may con- use made with copper powder may contain only those diluents listed in this tain only those diluents listed in this subpart as safe and suitable for use in subpart as safe and suitable for use in color additive mixtures for coloring ex- color additive mixtures for coloring externally applied drugs. ternally applied drugs. (b) Specifications. Bronze powder shall (b) Specifications. Copper powder shall conform to the following specifications conform to the following specifications and shall be free from impurities other and shall be free from impurities other than those named to the extent that than those named to the extent that such impurities may be avoided by such impurities may be avoided by good manufacturing practice: good manufacturing practice: Stearic or oleic acid, not more than 5 per- Stearic or oleic acid, not more than 5 percent. cent. Cadmium (as Cd), not more than 15 parts per Cadmium (as Cd), not more than 15 parts per million. million. Lead (as Pb), not more than 20 parts per mil- Lead (as Pb), not more than 20 parts per million. lion. Arsenic (as As), not more than 3 parts per million. Arsenic (as As), not more than 3 parts per Mercury (as Hg), not more than 1 part per million. million Mercury (as Hg), not more than 1 part per Aluminum (as Al), not more than 0.5 percent. million. Tin (as Sn), not more than 0.5 percent. Copper (as Cu), not less than 95 percent. Copper (as Cu), not more than 95 percent and Maximum particle size 45μ (95 percent min- not less than 70 percent. imum). Zinc (as Zn), not more than 30 percent. (c) Uses and restrictions. Copper pow- Maximum particle size 45μ (95 percent minimum). der may be safely used in coloring externally applied drugs, including those Aluminum, zinc, tin, and copper con- intended for use in the area of the eye, tent shall be based on the weight of the in amounts consistent with good manu- dried powder after being thoroughly facturing practice. washed with ether. (d) Labeling. The color additive and (c) Uses and restrictions. Bronze pow- any mixture prepared therefrom in- der may be safely used in color exter- tended solely or in part for coloring

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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- tification of the color additive is not [42 FR 37537, July 22, 1977] necessary for the protection of the public health, and therefore batches there- Subpart C—Cosmetics of are exempt from the certification requirements of section 721(c) of the act. § 73.2030 Annatto. [42 FR 33723, July 1, 1977] (a) Identity and specification. The color additive annatto shall conform in § 73.1991 Zinc oxide. identify and specification to the re- (a) Identity. (1) The color additive quirements for annatto extract in zinc oxide is a white or yellow-white § 73.30(a) (1) and (b). amorphous powder manufactured by (b) Use and restriction. The color addi- the French process (described as the in- tive annatto may be safely used in direct process whereby zinc metal iso- coloring cosmetics generally, including lated from the zinc-containing ore is cosmetics intended for use in the area vaporized and then oxidized). It is prin- of the eye, in amounts consistent with cipally composed of Zn. good manufacturing practice. (2) Color additive mixtures for drug (c) Labeling. The color additive and use made with zinc oxide may contain any mixture prepared therefrom in- only those diluents listed in this sub- tended solely or in part for coloring part as safe and suitable in color addi- purposes shall bear, in addition to any tive mixtures for coloring externally information required by law, labeling applied drugs. in accordance with the provisions of (b) Specifications. Zinc oxide shall conform to the following specifications § 70.25 of this chapter. and shall be free from impurities other (d) Exemption from certification. Cer- than those named to the extent that tification of this color additive is not such impurities may be avoided by necessary for the protection of the pub- good manufacturing practice: lic health, and therefore batches thereof are exempt from the certification re- Zinc oxide (as ZnO), not less than 99 percent. Loss on ignition at 800 °C, not more than 1 quirements of section 721(c) of the act. percent. [42 FR 36994, July 19, 1977] Cadmium (as Cd), not more than 15 parts per million. § 73.2085 Caramel. Mercury (as Hg), not more than 1 part per million. (a) Identity and specifications. The Arsenic (as As), not more than 3 parts per color additive caramel shall conform in million. identity and specifications to the re- Lead (as Pb), not more than 20 parts per million. quirements of § 73.85(a)(1), (2), and (3) and (b). (c) Uses and restrictions. The color ad- (b) Uses and restrictions. Caramel is ditive zinc oxide may be safely used for safe for use in coloring cosmetics gen- coloring externally applied drugs, in- erally, including cosmetics applied to cluding those used in the area of the the area of the eye, in amounts con- eye, in amounts consistent with good sistent with good manufacturing prac- manufacturing practice. (d) Labeling. The color additive and tice. any mixtues prepared therefrom in- (c) Labeling requirements. The label of tended solely or in part for coloring the color additive and any mixtures in- purposes shall bear, in addition to any tended solely or in part for coloring information required by law, labeling purposes prepared therefrom shall con- in accordance with the provisions of form to the requirements of § 70.25 of § 70.25 of this chapter. this chapter. (e) Exemption from certification. Cer- (d) Exemption from certification. Cer- tification of this color additive is not tification of this color additive is not necessary for the protection of the public health, and therefore batches therof

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necessary for the protection of the pub- in accordance with the provisions of lic health, and therefore batches there- § 70.25 of this chapter. of are exempt from the certification re- (d) Exemption from certification. Cer- quirement of section 721(c) of the act. tification of this color additive is not necessary for the protection of the pub- [46 FR 38501, July 28, 1981] lic health, and therefore batches therof § 73.2087 Carmine. are exempt from the certification pursuant to section 721(c) of the act. (a) Identity and specifications. The color additive carmine shall conform in [42 FR 33722, July 1, 1977] identity and specifications to the re- § 73.2110 Bismuth citrate. quirements of § 73.100 (a)(2) and (b)(2). (b) Use and restrictions. Carmine may (a) Identity. The color additive bis- be safely used in cosmetics generally, muth citrate is the synthetically pre- including cosmetics intended for use in pared crystalline salt of bismuth and the area of the eye, in amounts con- citric acid, consisting principally of sistent with good manufacturing prac- BiC6H5O7. tices. (b) Specifications. The color additive (c) Labeling. (1) The color additive bismuth citrate shall conform to the and any mixture prepared therefrom following specifications and shall be intended solely or in part for coloring free from impurities other than those purposes shall bear, in addition to any named to the extent that those impuri- information required by law, labeling ties may be avoided by good manufac- in accordance with the provisions of turing practice: § 70.25 of this chapter. Bismuth citrate, not less than 97 percent. (2) Cosmetics containing carmine Mercury (as Hg), not more than 1 part per that are not subject to the require- million. ments of § 701.3 of this chapter shall Arsenic (as As), not more than 3 parts per specifically declare the presence of car- million. mine prominently and conspicuously at Lead (as Pb), not more than 20 parts per million. least once in the labeling. For example: Volatile matter, not more than 1 percent. ‘‘Contains carmine as a color additive.’’ (c) Uses and restrictions. The color ad- (d) Exemption from certification. Cer- ditive bismuth citrate may be safely tification of this color additive is not used in cosmetics intended for coloring necessary for the protection of the pub- hair on the scalp, subject to the fol- lic health, and therefore batches there- lowing restrictions: of are exempt from the certification (1) The amount of bismuth citrate in pursuant to section 721(c) of the act. the cosmetic shall not be in excess of 2.0 percent (w/v). [42 FR 32228, June 24, 1977, as amended at 74 (2) The cosmetic may not be used for FR 216, Jan. 5, 2009] coloring eyelashes, eyebrows, or hair on parts of the body other than the § 73.2095 β-Carotene. scalp. (a) Identity and specifications. The (d) Labeling. (1) The label of the color color additive b-carotene shall conform additive bismuth citrate shall bear, in in identity and specifications to the re- addition to any information required quirements of § 73.95(a)(1) and (b). by law, labeling in accordance with the (b) Uses and restrictions. The color ad- provisions of § 70.25 of this chapter. ditive b-carotene may be safely used in (2) The label of a cosmetic containing coloring cosmetics generally, including the color additive bismuth citrate shall cosmetics intended for use in the area bear, in addition to other information of the eye, in amounts consistent with required by law, the following state- good manufacturing practices. ment, conspicuously displayed thereon: (c) Labeling. The color additive and Keep this product out of children’s reach. any mixture prepared therefrom in- Do not use on cut or abraded scalp. Do not tended solely or in part for coloring use to color eyelashes, eyebrows, or hair on purposes shall bear, in addition to any parts of the body other than the scalp. Wash information required by law, labeling hands thoroughly after each use.

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(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: [43 FR 44831, Sept. 29, 1978, as amended at 75 (1) It shall not be used at a level in FR 14493, Mar. 26, 2010] excess of 0.1 percent. (2) It may be used only in combina- § 73.2120 Disodium EDTA-copper. tion with the following substances: (a) Identity. The color additive diso- Water. dium EDTA-copper is disodium [[N,N′- Glycerin. 1,2- ethanediylbis[N - (carboxymethyl) Sodium carboxymethylcellulose. glycinato]] (4-)-N,N′,O,O′,ON,ON′] Tetrasodium pyrophosphate. cuprate (2-). Sorbitol. (b) Specifications. Disodium EDTA- Magnesium phosphate, tribasic. copper shall conform to the following Calcium carbonate. specifications and shall be free from Calcium phosphate, dibasic. impurities other than those named to Sodium N-lauroyl sarcosinate. Artificial sweeteners that are generally rec- the extent that such impurities may be ognized as safe or that are authorized avoided by good manufacturing prac- under subchapter B of this chapter. tice: Flavors that are generally recognized as safe Total copper, not less than 13.5 percent. or that are authorized under subchapter B Total (ethylene-dinitrilo) tetracetic acid, of this chapter. not less than 62.5 percent. Preservatives that are generally recognized Free copper, not more than 100 parts per mil- as safe or that are authorized under sub- lion. chapter B of this chapter. Free disodium salt of (ethylene-dinitrilo) (c) Labeling. The label of the color ad- tetraacetic acid, not more than 1.0 percent. ditive shall conform to the require- Moisture, not more than 15 percent. ments of § 70.25 of this chapter. Water insoluble matter, not more than 0.2 percent. (d) Exemption from certification. Cer- Lead (as Pb), not more than 20 parts per mil- tification of this color additive is not lion. necessary for the protection of the pub- Arsenic (as As), not more than 3 parts per lic health and therefore batches thereof million. are exempt from the certification re- (c) Uses and restrictions. Disodium quirements of section 721(c) of the act. EDTA-copper may be safely used in § 73.2150 Dihydroxyacetone. amounts consistent with good manufacturing practices in the coloring of (a) Identity and specifications. The shampoos which are cosmetics. color additive dihydroxyacetone shall (d) Labeling requirements. The labeling conform in identity and specifications of the color additive shall conform to to the requirements of § 73.1150 (a)(1) the requirements of § 70.25 of this chap- and (b). ter. (b) Uses and restrictions. (e) Exemption from certification. Cer- Dihydroxyacetone may be safely used tification of this color additive is not in amounts consistent with good manu- necessary for the protection of the pub- facturing practice in externally applied lic health and therefore batches thereof cosmetics intended solely or in part to are exempt from the requirements of impart a color to the human body. section 721(c) of the act. (c) Labeling requirements. The labeling of the color additive and any mixtures § 73.2125 Potassium sodium copper prepared therefrom intended solely or chlorophyllin (chlorophyllin-copper in part for coloring purposes shall con- complex). form to the requirements of § 70.25 of (a) Identity and specifications. The this chapter. color additive potassium sodium cop- (d) Exemption from certification. Cer- per chlorophyllin shall conform in tification of this color additive is not

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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.

§ 73.2162 Bismuth oxychloride. Melting point, 30.5 °C to 31.5 °C. 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 § 73.1162(a)(1) and (b). million. (2) Color additive mixtures of bis- Total color, not less than 99 percent. muth 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 information required by law, labeling alba Lam. (Lawsonia inermis L.). It may in accordance with the provisions of be identified by its characteristic odor § 70.25 of this chapter. and by characteristic plant histology. (d) Exemption from certification. Cer- (b) Specifications. Henna shall con- tification of this color additive is not form to the following specifications: necessary for the protection of the public health, and therefore batches there- It shall not contain more than 10 percent of of are exempt from certification pursu- plant material from Lawsonia alba Lam. (Lawsonia inermis L.) other than the leaf ant to section 721(c) of the act. and petiole, and shall be free from admix- [42 FR 52394, Sept. 30, 1977] ture with material from any other species of plant. § 73.2180 Guaiazulene. Moisture, not more than 10 percent. Total ash, not more than 15 percent. (a) Identity. (1) The color additive, Acid-insoluble ash, not more than 5 percent. guaiazulene, is principally 1,4-di- Lead (as Pb), not more than 20 parts per mil- methyl-7-isopropyl-azulene. lion. (2) Color additive mixtures of Arsenic (as As), not more than 3 parts per guaiazulene for cosmetic use may con- million. tain the following diluent: (c) Uses and restrictions. The color ad- Polyethylene glycol-40 castor oil (PEG–40 ditive henna may be safely used for castor oil). coloring hair only. It may not be used Saponification No., 60 to 70. for coloring the eyelashes or eyebrows, Hydroxyl No., 63 to 78. or generally in the area of the eye. Acid No., 2. (d) Labeling. The label for henna shall Specific gravity, 1.05 to 1.07. bear the information required by § 70.25 (b) Specifications. Guaiazulene shall of this chapter and the following state- conform to the following specifications ments or their equivalent:

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‘‘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 (d) Labeling. The color additive and information required by law, labeling any mixture prepared therefrom in- in accordance with § 70.25 of this chap- tended solely or in part for coloring ter. 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 § 70.25 of this chap- necessary for the protection of the pub- ter. lic health, and therefore batches there- (e) Exemption from certification. Cer- of are exempt from certification under tification of this color additive is not section 721(c) of the act. necessary for the protection of the public health, and therefore batches there- [43 FR 54236, Nov. 21, 1978] of are exempt from certification pursuant to section 721(c) of the act. § 73.2326 Chromium hydroxide green. (a) Identity and specifications. The § 73.2298 Ferric ammonium ferrocya- color additive chromium hydroxide nide. green shall conform in identity and (a) Identity and specifications. The specifications to the requirements of color additive ferric ammonium ferro- § 73.1326 (a)(1) and (b). cyanide shall conform in identify and (b) Uses and restrictions. Chromium specifications to the requirements of hydroxide green is safe for use in color- § 73.1298 (a)(1) and (b). ing externally applied cosmetics, in- (b) Uses and restrictions. Ferric ammo- cluding those intended for use in the nium ferrocyanide is safe for use in area of the eye, in amounts consistent coloring externally applied cosmetics, with good manufacturing practice. including cosmetics applied to the area (c) Labeling. The color additive and of the eye, in amounts consistent with any mixture prepared therefrom in- good manufacturing practice. tended solely or in part for coloring

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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 § 73.2327 Chromium oxide greens. necessary for the protection of the public 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). (b) Uses and restrictions. The color ad- § 73.2396 Lead acetate. ditive 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. (d) Exemption from certification. Cer- pH (30 percent solution weight to volume at tification of this color additive is not 25 °C), not less than 4.7 and not more than necessary for the protection of the pub- 5.8. lic health, and therefore batches there- Arsenic (as As), not more than 3 parts per of are exempt from the certification million. Lead acetate, not less than 99 percent. pursuant to section 721(c) of the act. Mercury (as Hg), not more than 1 part per [42 FR 36452, July 15, 1977] million. (c) Uses and restrictions. The color ad- § 73.2329 Guanine. ditive lead acetate may be safely used (a) Identity and specifications. (1) The in cosmetics intended for coloring hair color additive guanine shall conform in on the scalp only, subject to the fol- identity and specifications to the re- lowing restrictions: quirements of § 73.1329 (a)(1) and (b). (1) The amount of the lead acetate in (2) Color additive mixtures of gua- the cosmetic shall be such that the nine may contain the following lead content, calculated as Pb, shall diluents: not be in excess of 0.6 percent (weight (i) For coloring cosmetics generally, to volume). only those diluents listed under (2) The cosmetic is not to be used for § 73.1001(a)(1); coloring mustaches, eyelashes, eye- (ii) For coloring externally applied brows, or hair on parts of the body cosmetics, only those diluents listed in other than the scalp. § 73.1001(b) and, in addition, nitrocellu- (d) Labeling requirements. (1) The label lose. of the color additive lead acetate shall (b) Use and restrictions. The color ad- conform to the requirements of § 70.25 ditive guanine may be safely used in of this chapter, and bear the following cosmetics generally, including cos- statement or equivalent:

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Wash thoroughly if the product comes into (b) Uses and restrictions. Mica is safe contact with the skin. for use in coloring cosmetics generally, (2) The label of the cosmetic con- including cosmetics applied to the area taining the color additive lead acetate, of the eye, in amounts consistent with in addition to other information re- good manufacturing practice. quired by the act, shall bear the fol- (c) Labeling. The color additive and lowing cautionary statement, con- any mixture prepared therefrom in- spicuously displayed thereon: tended solely or in part for coloring purposes shall bear, in addition to any CAUTION: Contains lead acetate. For exter- information required by law, labeling nal use only. Keep this product out of chil- in accordance with of § 70.25 of this dren’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, eyelashes, eyebrows, or hair on parts of the body tification of this color additive is not other than the scalp. Do not get in eyes. Fol- necessary for the protection of the pub- low instructions carefully and wash hands lic health, and therefore batches there- thoroughly after each use. of are exempt from the certification pursuant to section 721(c) of the act. (e) Exemption for certification. Certifi- cation of this color additive for the [42 FR 38561, July 29, 1977] prescribed use is not necessary for the protection of the public health and § 73.2500 Silver. therefore batches thereof are exempt (a) Identity. (1) The color additive, from the certification requirements of silver, is a crystalline powder of high section 721(c) of the act. purity silver prepared by the reaction 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 § 73.2400 Pyrophyllite. used to prevent the agglomeration of 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 the requirements of § 73.1400 (a)(1) and in § 73.1001(b) and, in addition, nitro- (b). cellulose. (b) Uses and restrictions. Pyrophyllite (b) Specifications. Silver shall con- may be safely used for coloring exter- form to the following specifications nally applied cosmetics, in amounts and shall be free from impurities other consistent with good manufacturing than those named to the extent that practice. such other impurities may be avoided (c) Labeling requirements. The labeling by good manufacturing practice: of the color additive and any mixtures prepared therefrom intended solely or Lead (as Pb), not more than 10 parts per million. in part for coloring purposes shall con- Arsenic (as As), not more than 5 parts per form to all applicable requirements of million. law, including the requirements of Mercury (as Hg), not more than 1 part per § 70.25 of this chapter. million. (d) Exemption from certification. Cer- Silver (as Ag), not less than 99.9 percent. tification of this color additive is not (c) Uses and restrictions. The color ad- necessary for the protection of the pub- ditive silver may be safely used for lic health and therefore batches thereof coloring fingernail polish at a level not are exempt from the certification re- to exceed 1 percent of the final product. quirements of section 721(c) of the act. (d) Labeling. The color additive and any mixtures prepared therefrom in- § 73.2496 Mica. tended solely or in part for coloring (a) Identity and specifications. The purposes shall bear, in addition to any color additive mica shall conform in other information required by law, la- identity and specifications to the re- beling in accordance with the provi- quirements of § 73.1496(a)(1) and (b). sions of § 70.25 of this chapter.

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(e) Exemption from certification. Cer- of are exempt from the certification tification of this color additive is not pursuant to section 721(c) of the act. necessary for the protection of the pub- [42 FR 38563, July 29, 1977] lic health and therefore batches thereof are exempt from the certification re- § 73.2646 Bronze powder. quirements of section 721(c) of the act. (a) Identity and specifications. The [44 FR 65974, Nov. 16, 1979] color additive bronze powder shall conform in identity and specifications to § 73.2575 Titanium dioxide. the requirements of § 73.1646 (a)(1) and (b). (a) Identity and specifications. The (b) Uses and restrictions. Bronze pow- color additive titanium dioxide shall der may be safely used in coloring cos- conform in identity and specifications metics generally, including cosmetics to the requirements on § 73.575 (a)(1) intended for use in the area of the eye, and (b). in amounts consistent with good manu- (b) Uses and restrictions. The color ad- facturing practice. ditive titanium dioxide may be safely (c) Labeling. The color additive and used in cosmetics, including cosmetics any mixture prepared therefrom in- intended for use in the area of the eye, tended solely or in part for coloring in amounts consistent with good manu- purposes shall conform to the require- facturing practice. ments of § 70.25 of this chapter. (c) Labeling requirements. The color (d) Exemption from certification. Cer- additive and any mixtures prepared tification of the 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 other information required of are exempt from the certification re- by law, labeling in accordance with the quirements of section 721(c) of the act. provisions of § 70.25 of this chapter. [42 FR 33724, July 1, 1977] (d) Exemption from certification. Cer- tification of this color additive is not § 73.2647 Copper powder. necessary for the protection of the pub- (a) Identity and specifications. The lic health, and therefore batches there- color additive copper powder shall con- of are exempt from certification pursu- form in identity and specifications to ant to section 721(c) of the act. the requirements of § 73.1647 (a)(1) and (b). § 73.2645 Aluminum powder. (b) Uses and restrictions. Copper pow- (a) Identity and specifications. The der may be safely used in coloring cos- color additive aluminum powder shall metics generally, including cosmetics conform in identity and specifications intended for use in the area of the eye, to the requirements of § 73.1645 (a)(1) in amounts consistent with good manu- and (b). facturing practice. (b) Uses and restrictions. Aluminum (c) Labeling. The color additive and powder may be safely used in coloring any mixture prepared therefrom in- externally applied cosmetics, including tended solely or in part for coloring cosmetics intended for use in the area purposes shall conform to the require- of the eye, in amounts consistent with ments of § 70.25 of this chapter. good manufacturing practice. (d) Exemption from certification. Cer- (c) Labeling. The color additive and tification of the 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 there- purposes shall bear, in addition to any of are exempt from the certification re- information required by law, labeling quirements of section 721(c) of the act. in accordance with the provisions of [42 FR 33724, July 1, 1977] § 70.25 of this chapter. (d) Exemption from certification. Cer- § 73.2725 Ultramarines. tification of this color additive is not (a) Identity. The color additives, necessary for the protection of the pub- ultramarines (blue, green, pink, red, lic health, and therefore batches there- and violet) are pigments obtained by

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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 Ash (at 600 °C), not less than 81 percent. necessarily all these substances, to ° produce a single color. The Volatile matter at 135 C for 3 hours, not more than 1 percent. ultramarines are complex sodium alu- Water soluble substances, not more than 6 minum sulfosilicates having a typical 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. tent that such other impurities may be Arsenic (as As), not more than 3 parts per avoided by good manufacturing prac- million. tice. Mercury (as Hg), not more than 1 part per million. Lead (as Pb), not more than 20 parts per mil- Total color, based on Mn content in ‘‘as is’’ lion. sample, not less than 93 percent. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. Manganese Mercury (as Hg), not more than 1 part per violet is safe for use in coloring cos- million. metics generally, including cosmetics applied to the area of the eye, in (c) Uses and restrictions. The ultramarine pigments may be safely used amounts consistent with good manu- for coloring externally applied cos- facturing practice. metics, including cosmetics intended (d) Labeling. The color additive and for use in the area of the eye, in any mixture prepared therefrom in- amounts consistent with good manu- tended solely or in part for coloring facturing practice. purposes shall bear, in addition to any (d) Labeling requirements. The color information required by law, labeling additives and any mixtures prepared in accordance with § 70.25 of this chap- therefrom intended solely or in part for ter. coloring purposes shall bear, in addi- (e) Exemption from certification. Cer- tion to any other information required tification of this color additive is not by law, labeling in accordance with necessary for the protection of the pub- § 70.25 of this chapter. lic health, and therefore batches there- (e) Exemption from certification. Cer- of are exempt from certification pursu- tification of this color additive is not ant to section 721(c) of the act. necessary for the protection of the public health, and therefore batches there- § 73.2991 Zinc oxide. of are exempt from certification pursu- (a) Identity and specifications. The ant to section 721(c) of the act. color additive zinc oxide shall conform in identity and specifications to the re- § 73.2775 Manganese violet. quirements of § 73.1991 (a)(1) and (b). (a) Identity. The color additive man- (b) Uses and restrictions. Zinc oxide ganese violet is a violet pigment ob- may be safely used in cosmetics, in- tained by reacting phosphoric acid, am- cluding cosmetics intended for use in monium dihydrogen orthophosphate, the area of the eye, in amounts con- and manganese dioxide at tempera- sistent with good manufacturing prac- tures above 450 °F. The pigment is a tice. manganese ammonium pyrophosphate (c) Labeling. The color additive and complex having the approximate for- any mixture prepared therefrom in- mula: Mn(III)NH4P2O7. tended solely or in part for coloring (b) Specifications. Manganese violet purposes shall bear, in addition to any shall conform to the following speci- information required by law, labeling fications and shall be free from impuri- in accordance with § 70.25 of this chap- ties other than those named, to the exter.

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(d) Exemption from certification. Cer- (2) The label of a facial makeup prep- tification of this color additive is not aration containing the color additive necessary for the protection of the pub- shall bear, in addition to other infor- lic health, and therefore batches there- mation required by the law, the fol- of are exempt from the certification lowing statement conspicuously dis- pursuant to section 721(c) of the act. played: [42 FR 37538, July 22, 1977] Do not use in the area of the eye. (e) Exemption from certification. Cer- § 73.2995 Luminescent zinc sulfide. tification of this color additive is not (a) Identity. The color additive lumi- necessary for the protection of the pub- nescent zinc sulfide is zinc sulfide con- lic health, and therefore batches there- taining a copper activator. Following of are exempt from the certification re- excitation by daylight or a suitable ar- quirements of section 721(c) of the act. tificial light, luminescent zinc sulfide 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 million. 07–1) with one or more vinyl and/or 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 nail polish included under exceed the minimum reasonably re- § 720.4(c)(7)(ix) and (c)(8)(v) of this chapter, respectively, to the following required to accomplish the intended strictions: coloring effect. (1) The amount of luminescent zinc (2) Authorization and compliance sulfide in facial makeup preparations with these uses shall not be construed shall not exceed 10 percent by weight of as waiving any of the requirements of the final product. sections 510(k), 515, and 520(g) of the (2) Facial makeup preparations con- Federal Food, Drug, and Cosmetic Act taining luminescent zinc sulfide are in- (the act) with respect to the contact tended for use only on limited, infre- lens made from the color additives. quent occasions, e.g., Halloween, and (c) Labeling. The label of the color ad- not for regular or daily use. ditives shall conform to the require- (d) Labeling requirements. (1) The label ments of § 70.25 of this chapter. of the color additive and any mixtures (d) Exemption from certification. Cer- prepared therefrom shall bear expira- tification of these color additives is tion dates for the sealed and open con- not necessary for the protection of the tainer (established through generally public health and therefore the color accepted stability testing methods), additives are exempt from the certifi- other information required by § 70.25 of cation requirements of section 721(c) of this chapter, and adequate directions the act. to prepare a final product complying with the limitations prescribed in para- [61 FR 51586, Oct. 3, 1996, as amended at 78 FR graph (c) of this section. 19415, Apr. 1, 2013]]

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§ 73.3105 1,4-Bis[(2- section may be used in amounts not to methylphenyl)amino]-9,10- exceed the minimum reasonably re- anthracenedione. quired 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 effect. ditives shall conform to the require- (2) Authorization and compliance ments of § 70.25 of this chapter. with this use shall not be construed as (d) Exemption from certification. Cer- waiving any of the requirements of sec- tification of these color additives is tions 510(k), 515, and 520(g) of the Fed- not necessary for the protection of the eral Food, Drug, and Cosmetic Act (the public health and, therefore, the color act). A person intending to introduce a additives are exempt from the certifi- device containing 1,4-bis[(2- cation requirements of section 721(c) of methylphenyl)amino]-9,10- the act. anthracenedione listed under this section into commerce shall submit to the [58 FR 17507, Apr. 5, 1993, as amended at 60 Food and Drug Administration either a FR 10497, Feb. 27, 1995; 78 FR 19415, Apr. 1, 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 premarket approval, or submit and receive (a) Identity. The color additive is car- approval of an original or supplemental bazole violet (Pigment Violet 23) (CAS premarket approval application if the Reg. No. 6358–30–1, Colour Index No. device is subject to premarket ap- 51319). proval. (b) Uses and restrictions. (1) The sub- (c) Labeling. The label of the color ad- stance listed in paragraph (a) of this ditive shall conform to the require- section may be used as a color additive ments of § 70.25 of this chapter. in contact lenses in amounts not to ex- (d) Exemption from certification. Cer- ceed the minimum reasonably required tification of this color additive is not to accomplish the intended coloring ef- necessary for the protection of the pub- fect. lic health, and therefore the color addi- (2) Authorization for this use shall tive is exempt from the certification not be construed as waiving any of the requirements of section 721(c) of the requirements of sections 510(k), 515, act. and 520(g) of the Federal Food, Drug, [49 FR 30066, July 26, 1984] and Cosmetic Act (the act) with respect to the contact lens in which the § 73.3106 1,4-Bis[4-(2- methacryloxyethyl) color additive is used. phenylamino]anthraquinone co- (c) Labeling. The label of the color ad- polymers. ditive shall conform to the require- (a) Identity. The color additives are ments of § 70.25 of this chapter. the copolymers formed as the reaction (d) Exemption from certification. Cer- product of 1,4-bis[4-(2- tification of this color additive is not methacryloxyethyl)phenylamino]- necessary for the protection of the pub- anthraquinone (C.I. Reactive Blue 246) lic health, and therefore the color addi- (CAS Reg. No. 121888–69–5) with one or tive is exempt from the certification more vinyl and/or acrylic monomers to requirements of section 721(c) of the form the contact lens material. act. (b) Uses and restrictions. (1) The substances listed in paragraph (a) of this [53 FR 41324, Oct. 21, 1988]

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§ 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 [48 FR 56370, Dec. 21, 1983] extraction from a mixture of fescue and rye grasses. The chlorophyll is § 73.3110a Chromium-cobalt-aluminum acid-treated to remove chelated mag- oxide. nesium which is replaced with hydro- (a) Identity. The color additive chro- gen, which is turn is replaced with cop- mium-cobalt-aluminum oxide (Pigment per. This mixture is diluted to a 5 per- Blue 36) (CAS Reg. No. 68187–11–1, Col- cent concentration with a mixture of our Index No. 77343) shall conform in palm oil, peanut oil, and hydrogenated 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 requirements of sections 510(k), 515, Moisture, not more than 0.5 percent. 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 mil- (c) Labeling. The label of the color ad- lion. ditive shall conform to the require- Lead, not more than 20 parts per million. 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 oil soluble (5 percent in palm oil, pea- requirements of section 721(c) of the nut oil, and hydrogenated peanut oil), act. may be safely used to color [53 FR 41325, Oct. 21, 1988] polymethylmethacrylate bone cement. Chlorophyllin-copper complex may be § 73.3111 Chromium oxide greens. used at levels that do not exceed 0.003 (a) The percent by weight of the bone cement. Identity and specifications. (2) Authorization for this use shall color additive chromium oxide greens not be construed as waiving any of the (chromic oxide) (CAS Reg. No. 1308–38– requirements of sections 510(k), 515, 9), Color Index No. 77288, shall conform and 520(g) of the Federal Food, Drug, in identity and specifications to the re- and Cosmetic Act with respect to the quirements of § 73.1327 (a)(1) and (b). polymethylmethacrylate bone cement (b) Uses and restrictions. (1) The sub- in which chlorophyllin-copper complex, stance listed in paragraph (a) of this oil soluble, is used. section may be used as a color additive (d) Labeling. The label of the color ad- in contact lenses in amounts not to ex- ditive shall conform to the require- ceed the minimum reasonably required ments of § 70.25 of this chapter. to accomplish the intended coloring ef- (e) Exemption from certification. Cer- fect. tification of this color additive is not (2) Authorization and compliance necessary for the protection of the pub- with this use shall not be construed as

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waiving any of the requirements of sec- § 73.3115 2-[[2,5-Diethoxy-4-[(4- tions 510(k), 515, and 520(g) of the Fed- methylphenyl)thiol]phenyl]azo]- eral Food, Drug, and Cosmetic Act 1,3,5-benzenetriol. 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 mark soft (hydrophilic) contact lenses tive is exempt from the certification with the letter R or the letter L for requirements of section 721(c) of the identification purposes subject to the act. following restrictions: [51 FR 24816, July 9, 1986] (1) The quantity of the color additive does not exceed 1.1 × 10¥7 grams in a § 73.3112 C.I. Vat Orange 1. soft (hydrophilic) contact lens. (a) Identity. The color additive is C.I. (2) When used as specified in the labeling, there is no measurable migra- Vat Orange 1, Colour Index No. 59105. tion of the color additive from the con- (b) Uses and restrictions. (1) The sub- tact lens to the surrounding ocular tis- stance listed in paragraph (a) of this sue. section may be used as a color additive (3) Authorization for this use shall in contact lenses in amounts not to ex- not be construed as waiving any of the ceed the minimum reasonably required requirements of section 510(k) and 515 to accomplish the intended coloring ef- of the Federal Food, Drug, and Cos- fect. metic Act with respect to the contact (2) Authorization for this use shall lens in which the 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 (the act) with re- (d) Exemption from certification. Cer- spect to the contact lens in which the tification of this color additive is not color additive is used. A person intend- necessary for the protection of the pub- ing to introduce a device containing lic health, and therefore the color addi- C.I. Vat Orange 1 into commerce shall tive is exempt from the certification submit to the Food and Drug Adminis- requirements of section 721(c) of the tration either a premarket notification act. in accordance with subpart E of part [48 FR 22706, May 20, 1983] 807 of this chapter, if the device is not subject to premarket approval, or sub- § 73.3117 16,23-Dihydrodinaphtho[2,3- mit and receive approval of an original a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3- or supplemental premarket approval c] carbazole-5,10,15,17,22,24-hexone. application if the device is subject to (a) Identity. The color additive is premarket approval. 16,23-dihydrodinaphtho [2,3- a:2′,3′-i] (c) Labeling. The label of the color ad- napth [2′,3′:6,7] indolo [2, 3-c] carbazole- ditive shall conform to the require- 5,10, 15,17,22,24-hexone (CAS Reg. No. ments of § 70.25 of this chapter. 2475–33–4), Colour Index No. 70800. (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 effect. act. (2) Authorization for this use shall [50 FR 20407, May 16, 1985] not be construed as waiving any of the

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

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§ 73.3121 Poly(hydroxyethyl methacry- (9) C.I. Reactive Blue 163 late)-dye copolymers. [triphenodioxazinedisulfonic acid, 6,13- (a) Identity. The color additives are dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5- formed by reacting one or more of the triazin-2-yl)amino) sulfophenyl)amino)- reactive dyes listed in this paragraph , tetrasodium salt] (CAS Reg. No. with poly(hydroxyethyl methacrylate), 72847–56–4); and so that the sulfate group (or groups) or (10) C.I. Reactive Red 180 [5- chlorine substituent of the dye is re- (benzoylamino)-4-hydroxy-3-((1-sulfo-6- placed by an ether linkage to ((2-(sulfooxy)ethyl)sulfonyl)-2- poly(hydroxyethyl methacrylate). The naphthalenyl)azo)-2,7- dyes that may be used alone or in com- naphthalenedisulfonic acid, bination are tetrasodium salt] (CAS Reg. No. 98114– (1) Reactive Black 5 [2,7- 32–0). naphthalenedisulfonic acid, 4-amino-5- (b) Uses and restrictions. (1) The sub- hydroxy-3,6-bis((4-((2- stances listed in paragraph (a) of this (sulfooxy)ethyl)sulfonyl)phenyl)azo)- section may be used to color contact tetrasodium salt] (CAS Reg. No. 17095– lenses in amounts not to exceed the 24–8); minimum reasonably required to ac- (2) Reactive Blue 21 [copper, (29H,31H- complish the intended coloring effect. 29 30 31 32 phthalocyaninato(2-)-N ,N ,N ,N )-, (2) As part of the manufacturing sulfo((4-((2- process, the lenses containing the color sulfooxy)ethyl)sulfonyl)phenyl)amino) additives are thoroughly washed to re- sulfonyl derivs] (CAS Reg. No. 73049–92– move unbound reactive dyes. 0); (3) Authorization and compliance (3) Reactive Orange 78 [2- naphthalenesulfonic acid, 7- with this use shall not be construed as (acetylamino)-4-hydroxy-3-((4-((2- waiving any of the requirements of sec- (sulfooxy)ethyl) sulfonyl)phenyl)azo)-] tions 510(k), 515, and 520(g) of the Fed- CAS Reg. No. 68189–39–9); eral Food, Drug, and Cosmetic Act (the (4) Reactive Yellow 15 act). A person intending to introduce a [benzensulfonic acid, 4-(4,5-dihydro-4- device containing a poly(hydroxyethyl ((2-methoxy-5-methyl-4-((2- methacrylate)-dye copolymer listed (sulfooxy)ethyl) sulfonyl)phenyl)azo)-3- under this section into commerce shall methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS submit to the Food and Drug Adminis- Reg. No. 60958–41–0); tration either a premarket notification (5) Reactive Blue No. 19 [2-anthra- in accordance with subpart E of part cene-sulfonic acid, 1-amino-9,10- 807 of this chapter, if the device is not dihydro-9,10-dioxo-4-((3-((2- subject to premarket approval, or sub- (sulfooxy)ethyl)sulfonyl)phenyl)amino) mit and receive approval of an original -, disodium salt] (CAS Reg. No. 2580–78– or supplemental premarket approval 1); application if the device is subject to (6) Reactive Blue No. 4 [2- premarket approval. anthracenesulfonic acid, 1-amino-4-(3- (c) Labeling. The label of the color ad- ((4,6-dichloro-s-triazin-2-yl)amino)-4- ditives shall conform to the require- sulfoanilino)-9,10-dihydro-9,10-dioxo, di- ments of § 70.25 of this chapter. sodium salt] (CAS Reg. No. 4499–01–8); (d) Exemption from certification. Cer- (7) C.I. Reactive Red 11 [5-((4,6- tification of these color additives is dichloro-1,3,5-triazin-2-yl)amino)-4-hy- not necessary for the protection of the droxy-3-((1-sulfo-2-naphthalenyl)azo)-2, public health, and therefore these color 7-naphthalenedisulfonic acid, tri- additives are exempt from the certifi- sodium salt] (CAS Reg. No. 12226–08–3); cation requirements of section 721(c) of (8) C.I. Reactive Yellow 86 [1,3- the act. benzenedisulfonic acid, 4-((5- aminocarbonyl-1-ethyl-1,6-dihydro-2- [49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, hydroxy-4-methyl-6-oxo-3- 1984, as amended at 50 FR 9425, Mar. 8, 1985; pyridinyl)azo)-6-(4,6-dichloro-1,3,5- 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. triazin-2-yl)amino)-, disodium salt] 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, (CAS Reg. No. 61951–86–8); Feb. 22, 1993]

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§ 73.3122 4-[(2,4-dimethylphenyl)azo]- (d) Exemption from certification. Cer- 2,4-dihydro-5-methyl-2-phenyl-3H- tification of this color additive is not pyrazol-3-one. necessary for the protection of the pub- (a) Identity. The color additive is 4- lic health, and therefore the color addi- [(2,4-dimethylphenyl)azo]-2,4-dihydro-5- tive is exempt from the certification methyl-2-phenyl-3H- pyrazol-3-one requirements of section 721(c) of the (CAS Reg. No. 6407–78–9). act. (b) Uses and restrictions. (1) The sub- [51 FR 11436, Apr. 3, 1986] stances listed in paragraph (a) of this section may be used as a color additive § 73.3124 Phthalocyanine green. 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 (a) Identity. The color additive is 6- act. ethoxy-2-(6-ethoxy-3-oxobenzo [b]thien- [51 FR 11433, Apr. 3, 1986] 2(3H)-ylidene)benzo[b]thiophen-3(2H)- one (CAS Reg. No. 3263–31–8), Colour § 73.3125 Iron oxides. Index No. 73335. (a) Identity and specifications. The (b) Uses and restrictions. (1) The sub- color additive iron oxides (CAS Reg. stance listed in paragraph (a) of this No. 1332–37–2), Color Index No. 77491, section may be used as a color additive shall conform in identity and specifica- in contact lenses in amounts not to ex- tions to the requirements of § 73.2250 (a) ceed the minimum reasonably required and (b). to accomplish the intended coloring ef- (b) Uses and restrictions. (1) The sub- fect. stance listed in paragraph (a) of this (2) Authorization for this use shall section may be used as a color additive not be construed as waiving any of the in contact lenses in amounts not to ex- requirements of sections 510(k), 515, ceed the minimum reasonably required and 520(g) of the Federal Food, Drug, to accomplish the intended coloring ef- and Cosmetic Act with respect to the fect. contact lens in which the color addi- (2) Authorization and compliance tive is used. with this use shall not be construed as (c) Labeling. The label of the color ad- waiving any of the requirements of sec- ditive shall conform to the require- tions 510(k), 515, and 520(g) of the Fed- ments of § 70.25 of this chapter. eral Food, Drug, and Cosmetic Act

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with respect to the contact lens in the vinyl alcohol/methyl methacrylate which the additive is used. copolymer. The dyes are: (c) Labeling. The label of the color ad- (1) C.I. Reactive Red 180 [5- ditive shall conform to the require- (benzoylamino)-4-hydroxy-3-((1-sulfo-6- ments of § 70.25 of this chapter. ((2-(sulfooxy)ethyl)sulfonyl)-2- (d) Exemption from certification. Cer- naphthalenyl)azo)-2,7- tification of this color additive is not naphthalenedisulfonic acid, necessary for the protection of the pub- tetrasodium salt] (CAS Reg. No. 98114– lic health, and therefore the color addi- 32–0). tive is exempt from the certification (2) C.I. Reactive Black 5 [2,7- requirements of section 721(c) of the naphthalenedisulfonic acid, 4-amino-5- act. hydroxy-3,6-bis((4-((2- (sulfooxy)ethyl)sulfonyl)phenyl)azo)-, [51 FR 24816, July 9, 1986, as amended at 69 FR 24511, May 4, 2004] tetrasodium salt] (CAS Reg. No. 17095– 24–8). § 73.3126 Titanium dioxide. (3) C.I. Reactive Orange 78 [2- naphthalenesulfonic acid, 7- (a) The Identity and specifications. (acetylamino)-4-hydroxy-3-((4-((2- color additive titanium dioxide (CAS (sulfooxy)ethyl)sulfonyl)phenyl)azo)-] Reg. No. 13463–67–7), Color Index No. (CAS Reg. No. 68189–39–9). 77891, shall conform in identity and (4) C.I. Reactive Yellow 15 specifications to the requirements of [benzenesulfonic acid, 4-(4,5-dihydro-4- § 73.575(a)(1) and (b). ((2-methoxy-5-methyl-4-((2- (b) Uses and restrictions. (1) The sub- (sulfooxy)ethyl)sulfonyl)phenyl)azo)-3- stance listed in paragraph (a) of this methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS section may be used as a color additive Reg. No. 60958–41–0). in contact lenses and intraocular lens (5) C.I. Reactive Blue No. 19 [2- orientation marks in amounts not to anthracenesulfonic acid, 1-amino-9,10- exceed the minimum reasonably re- dihydro-9,10-dioxo-4-((3-((2- quired to accomplish the intended (sulfooxy)ethyl)sulfonyl)phenyl)amino) coloring effect. -, 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 (d) Exemption from certification. Cer- minimum reasonably required to ac- tification of this color additive is not complish the intended coloring effect. necessary for the protection of the pub- (2) As part of the manufacturing lic health, and therefore the color addi- process, the lenses containing the color tive is exempt from the certification additives are thoroughly washed to re- requirements of section 721(c) of the move unbound reactive dye. act. (3) Authorization and compliance [51 FR 24816, July 9, 1986, as amended at 81 with this use shall not be construed as FR 75692, Nov. 1, 2016] waiving any of the requirements of sections 510(k), 515, and 520(g) of the Fed- § 73.3127 Vinyl alcohol/methyl meth- eral Food, Drug, and Cosmetic Act (the acrylate-dye reaction products. act). A person intending to introduce a (a) Identity. The color additives are device containing a vinyl alcohol/meth- formed by reacting the dyes, either yl methacrylate-dye reaction product alone or in combination, with a vinyl listed under this section into com- alcohol/methyl methacrylate copoly- merce shall submit to the Food and mer, so that the sulfate groups of the Drug Administration either a pre- dyes are replaced by ether linkages to market notification in accordance with

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subpart E of part 807 of this chapter, if § 73.3129 Disodium 1-amino-4-[[4-[(2- the device is not subject to premarket bromo-1-oxoallyl)amino]-2- approval, or submit and receive ap- sulfonatophenyl]amino]-9,10- proval of an original or supplemental dihydro-9,10-dioxoanthracene-2- premarket approval application if the sulfonate. device is subject to premarket ap- (a) Identity. The color additive is di- proval. sodium 1-amino-4-[[4-[(2-bromo-1- (c) Labeling. The label of the color ad- oxoallyl)amino]-2- ditive shall conform to the require- sulfonatophenyl]amino]-9,10-dihydro- ments of § 70.25 of this chapter. 9,10-dioxoanthracene-2-sulfonate (Reac- tive Blue 69) (CAS Reg. No. 70209–99–3, (d) Exemption from certification. Cer- Colour Index No. 612037). tification of this color additive is not (b) Uses and restrictions. (1) The sub- necessary for the protection of the pub- stance listed in paragraph (a) of this lic health, and therefore, this color ad- section may be used as a color additive ditive is exempt from the certification in contact lenses in amounts not to ex- requirements of section 721(c) of the ceed the minimum reasonably required act. to accomplish the intended coloring ef- [58 FR 3227, Jan. 8, 1993, as amended at 58 FR fect. 17510, Apr. 5, 1993] (2) Authorization and compliance with this use shall not be construed as § 73.3128 Mica-based pearlescent pig- waiving any of the requirements of sec- ments. tions 510(k), 515, and 520(g) of the Fed- (a) Identity and specifications. The eral Food, Drug, and Cosmetic Act color additive is formed by depositing with respect to the contact lenses in which the additive is used. titanium or iron salts from a basic so- (c) Labeling. The label of the color ad- lution onto mica, followed by calci- ditive shall conform to the require- nation to produce titanium dioxide or ments in § 70.25 of this chapter. iron oxides on mica. Mica used to man- (d) Exemption from certification. Cer- ufacture the color additive shall con- tification of this color additive is not form in identity and specifications to necessary for the protection of the pub- the requirements of § 73.1496(a)(1) and lic health, and therefore batches there- (b). of are exempt from the certification re- (b) Uses and restrictions. (1) Mica- quirements of section 721(c) of the Fed- based pearlescent pigments listed in eral Food, Drug, and Cosmetic Act. paragraph (a) of this section may be [76 FR 25235, May 4, 2011, as amended at 78 used as a color additive in contact FR 14664, Mar. 7, 2013] lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. PART 74—LISTING OF COLOR AD- (2) Authorization and compliance DITIVES SUBJECT TO CERTIFI- with this use shall not be construed as CATION waiving any of the requirements of sections 510(k), 515, and 520(g) of the Fed- Subpart A—Foods eral Food, Drug, and Cosmetic Act (the Sec. act) with respect to the contact lenses 74.101 FD&C Blue No. 1. in which the additive is used. 74.102 FD&C Blue No. 2. 74.203 FD&C Green No. 3. (c) Labeling. The label of the color ad- 74.250 Orange B. ditive shall conform to the require- 74.302 Citrus Red No. 2. ments in § 70.25 of this chapter. 74.303 FD&C Red No. 3. (d) Exemption from certification. Cer- 74.340 FD&C Red No. 40. tification of this color additive is not 74.705 FD&C Yellow No. 5. necessary for the protection of the pub- 74.706 FD&C Yellow No. 6. lic health, and therefore batches there- Subpart B—Drugs of are exempt from the certification requirements of section 721(c) of the act. 74.1101 FD&C Blue No. 1. 74.1102 FD&C Blue No. 2. [67 FR 65312, Oct. 24, 2002] 74.1104 D&C Blue No. 4.

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