21 CFR Part 73 — Listing of Color Additives Exempt from Certification

PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted. Editorial Note: Nomenclature changes to part 73 appear at 66 FR 66742, Dec. 27, 2001. Subpart A—Foods § 73.1 Diluents in color additive mixtures for food use exempt from certification. The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use. (a) General use. (2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations. (3) The following: Substances Definitions and specifications Restrictions Calcium disodium EDTA (calcium disodium ethyl- enediamine- tetraacetate) Contains calcium disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6766-87-6) as set forth in the Food Chemicals Codex, 3d ed., p. 50, 1981 May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous calcium disodium 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 chapter Not more than 9 p.p.m. in the finished food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction. Disodium EDTA (disodium ethyl- enediamine- tetraacetate) Contains disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6381-92-6) as set forth in the Food Chemicals Codex, 3d ed., p. 104, 1981 May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous disodium ethyl- enediamine- tetraacetate). (b) Special use Diluents in color additive mixtures for marking food Inks for marking food supplements in tablet form, gum, and confectionery. Substances Definitions and specifications Restrictions Alcohol, SDA-3A As set forth in 26 CFR pt. 212 No residue. n 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 (polysorbate 80) As set forth in sec. 172.840 of this 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. Substances Definitions and specifications Restrictions Acetone As set forth in N.F. XI No residue. Alcohol, SDA-3A As set forth in 26 CFR pt. 212 Do. Benzoin As set forth in U.S.P. XVI Copal, Manila Ethyl acetate As set forth in N.F. XI Do. Ethyl cellulose As set forth in sec. 172.868 of this chapter Methylene chloride Do. Polyvinylpyrrolidone As set forth in sec. 173.55 of this chapter Rosin and rosin derivatives As set forth in sec. 172.615 of this chapter Silicon dioxide As set forth in sec. 172.480 of this chapter Not more than 2 pct of the ink solids. Terpene resins, natural As set forth in sec. 172.615 of this chapter Terpene resins, synthetic Polymers of α- and β-pinene (2) Diluents in color additive mixtures for coloring shell eggs. Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service. Damar gum (resin). Diethylene glycol distearate. Dioctyl sodium sulfosuccinate. Ethyl cellulose (as identified in § 172.868 of this chapter). Ethylene glycol distearate. Japan wax. Limed rosin. Naphtha. Pentaerythritol ester of fumaric acid-rosin adduct. Polyethylene glycol 6000 (as identified in § 172.820 of this chapter). Polyvinyl alcohol. Rosin and rosin derivatives (as identified in § 172.615 of this chapter). (3) Miscellaneous special uses. Substances Definitions and specifications Restrictions Polyvinylpyrrolidone As set forth in sec. 173.55 of this chapter In or as food-tablet coatings; limit, not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidone shall bear adequate directions for use that will result in a food meeting this restriction. [42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004] § 73.30 Annatto extract. (a) Identity. Bixa orellana (i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity. (ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene. (2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. (1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million. (2) When solvents listed under paragraph (a)(1)(ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.32 Antarctic krill meal. (a) Identity. Euphausia superba (2) Color additive mixtures for fish feed use made with Antarctic krill meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Physical state, solid. (2) Ethoxyquin, not more than 250 milligrams per kilogram (mg/kg) (250 parts per million (ppm)) in whole Antarctic krill meal. (3) Lead, not more than 2 mg/kg (2 ppm). (4) Arsenic, not more than 5 mg/kg (5 ppm). (5) Mercury, not more than 1 mg/kg (1 ppm). (6) Cadmium, not more than 2 mg/kg (2 ppm). (7) Fluoride, not more than 2,500 mg/kg (2,500 ppm). (8) Astaxanthin, not more than 170 mg/kg (170 ppm) in whole Antarctic krill meal; not more than 90 mg/kg (90 ppm) in defatted Antarctic krill meal. (c) Uses and restrictions. (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; (2) The color additive may be used at levels not to exceed 4 percent by weight in freshwater salmonid feed and 12 percent by weight in marine salmonid feed; (3) The quantity of the color additive incorporated in the feed is such that the finished feed meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter; and (4) The quantity of astaxanthin in the finished feed, from Antarctic krill meal when used alone or in combination with other astaxanthin color additive sources listed in this part, must not exceed 80 mg/kg astaxanthin (72 grams per ton) in the finished feed. (d) Labeling requirements. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section must be declared in accordance with § 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing Antarctic krill meal must be declared in accordance with §§ 101.22(b), (c), and (k)(2) and 101.100(a)(2) of this chapter. (e) Exemption from certification. [87 FR 27935, May 10, 2022] § 73.35 Astaxanthin. (a) Identity. (2) Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Physical state, solid. 0.05 percent solution in chloroform, complete and clear. Absorption maximum wavelength 484-493 nanometers (in chloroform). Residue on ignition, not more than 0.1 percent. Total carotenoids other than astaxanthin, not more than 4 percent. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals, not more than 10 parts per million. Assay, minimum 96 percent. (c) Uses and restrictions. (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of color additive in feed is such that the color additive shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin shall be declared in accordance with §§ 101.22(k)(2) and 101.100(a)(2) of this chapter. (e) Exemption from certification. [60 FR 18738, Apr. 13, 1995] § 73.37 Astaxanthin dimethyldisuccinate. (a) Identity. (2) Astaxanthin dimethyldisuccinate may be added to the fish feed only as a component of a stabilized mixture. Color additive mixtures for fish feed use made with astaxanthin dimethyldisuccinate may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Physical state, solid. (2) 0.05 percent solution in chloroform, complete and clear. (3) Absorption maximum wavelength 484-493 nanometers (in chloroform). (4) Residue on ignition, not more than 0.1 percent. (5) Total carotenoids other than astaxanthin dimethyldisuccinate, not more than 4 percent. (6) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts per million). (7) Arsenic, not more than 2 mg/kg (2 parts per million). (8) Mercury, not more than 1 mg/kg (1 part per million). (9) Heavy metals, not more than 10 mg/kg (10 parts per million). (10) Assay including astaxanthin dimethyldisuccinate, astaxanthin monomethylsuccinate, and astaxanthin, minimum 96 percent. (c) Uses and restrictions. (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin dimethyldisuccinate in the finished feed, when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 110 milligrams per kilogram (mg/kg), which is equivalent to 80 mg/kg astaxanthin (72 grams per ton). (d) Labeling requirements. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin dimethyldisuccinate shall be declared in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter. (e) Exemption from certification. [74 FR 57251, Nov. 5, 2009] § 73.39 xxx Link to an amendment published at 91 FR 5298, Feb. 6, 2026. This amendment was delayed indefinitely at 91 FR 13951, Mar. 24, 2026. § 73.40 Dehydrated beets (beet powder). (a) Identity. (2) Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. Volatile matter, not more than 4 percent. Acid insoluble ash, not more than 0.5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.50 Ultramarine blue. (a) Identity. 7 6 6 2 4 3 (b) Specifications. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.69 Butterfly pea flower extract. (a) Identity. Clitoria ternatea. (2) Color additive mixtures for food use made with butterfly pea flower extract may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) pH, not less than 3.0 and not more than 4.5 at 25 °C. (2) Lead, not more than 1 milligram per kilogram (mg/kg) (1 part per million (ppm)). (3) Arsenic, not more than 1 mg/kg (1 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Cadmium, not more than 1 mg/kg (1 ppm). (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [86 FR 49233, Sept. 2, 2021, as amended at 90 FR 20104, May 12, 2025] § 73.70 Calcium carbonate. (a) Identity. 3 (2) Color additive mixtures for food use made with calcium carbonate may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. (f) Incorporation by reference. [email protected]; www.archives.gov/federal-register/cfr/ibr-locations.html. www.usp.org. (1) Limestone, Ground, Food Chemicals Codex, (2) Calcium Carbonate, Food Chemicals Codex, [82 FR 51557, Nov. 7, 2017, as amended at 87 FR 58448, Sept. 27, 2022] § 73.75 Canthaxanthin. (a) Identity. (2) Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Physical state, solid. 1 percent solution in chloroform, complete and clear. Melting range (decomposition), 207 °C. to 212 °C. (corrected). Loss on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Total carotenoids other than trans-canthaxanthin, not more than 5 percent. Lead, not more than 10 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Assay, 96 to 101 percent. (c) Use and restrictions. (i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and (ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (2) Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of canthaxanthin incorporated in the feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect. (3) Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (i) Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture; (ii) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and (iii) The quantity of color additive in feed shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (2) For purposes of coloring fish, the labeling of the color additive and any premixes prepared therefrom shall bear expiration dates (established through generally accepted stability testing methods) for the sealed and open container, other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c)(3) of this section. (3) The presence of the color additive in finished fish feed prepared according to paragraph (c)(3) of this section shall be declared in accordance with § 501.4 of this chapter. (4) The presence of the color additive in salmonid fish that have been fed feeds containing canthaxanthin shall be declared in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, 1998] § 73.80 Calcium phosphate. (a) Identity. 5 4 3. (2) Color additive mixtures for food use made with calcium phosphate may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Loss on ignition, not more than 10 percent. (2) Assay (Ca): 36.0-40.0 percent. (3) Fluoride, not more than 75 milligrams/kilogram (mg/kg) (75 parts per million (ppm)). (4) Lead, not more than 0.25 mg/kg (0.25 ppm). (5) Arsenic, not more than 3 mg/kg (3 ppm). (c) Uses and restrictions. (1) In ready-to-eat chicken products in an amount not exceeding 1.5 percent by weight of the finished food. (2) In white candy melts in an amount not exceeding 0.25 percent by weight of the finished food. (3) In doughnut sugar in an amount not exceeding 2.0 percent by weight of the finished food. (4) In sugar for coated candies in an amount not exceeding 5.25 percent by weight of the finished food. (d) Labeling requirements. (e) Exemption from certification. [90 FR 20100, May 12, 2025] § 73.85 Caramel. (a) Identity. Dextrose. Invert sugar. Lactose. Malt sirup. Molasses. Starch hydrolysates and fractions thereof. Sucrose. (2) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practice. (i) Acids: Acetic acid. Citric acid. Phosphoric acid. Sulfuric acid. Sulfurous acid. (ii) Alkalis: Ammonium hydroxide. Calcium hydroxide U.S.P. Potassium hydroxide. Sodium hydroxide. (iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite. (3) Polyglycerol esters of fatty acids, identified in § 172.854 of this chapter, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect. (4) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 0.1 part per million. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.90 β-Apo-8′-carotenal. (a) Identity. (2) Color additive mixtures for food use made with β-apo-8′-carotenal may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Physical state, solid. 1 percent solution in chloroform, clear. Melting point (decomposition), 136 °C.-140 °C. (corrected). Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Assay (spectrophotometric), 96-101 percent. (c) Uses and restrictions. (1) The quantity of β-apo-8′-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food. (2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. (e) Exemption from certification. § 73.95 β-Carotene. (a) Identity. (2) Color additive mixtures for food use made with β-carotene may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Physical state, solid. 1 percent solution in chloroform, clear. Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Assay (spectrophotometric), 96-101 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.100 Cochineal extract; carmine. (a) Identity. Dactylopius coccus costa Coccus cacti (2) The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal ( Dactylopius coccus costa Coccus cacti (3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. pH, not less than 5.0 and not more than 5.5 at 25 °C. Protein (N × 6.25), not more than 2.2 percent. Total solids, not less than 5.7 and not more than 6.3 percent. Methyl alcohol, not more than 150 parts per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 1.8 percent. (2) Carmine shall conform to the following specifications: Volatile matter (at 135 °C. for 3 hours), not more than 20.0 percent. Ash, not more than 12.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 50.0 percent. Carmine and cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine and cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in section 201(s) of the act or, if they are food additives as so defined, are used in conformity with regulations established pursuant to section 409 of the act. (c) Uses and restrictions. (d) Labeling requirements. (2) The label of food products intended for human use, including butter, cheese, and ice cream, that contain cochineal extract or carmine shall specifically declare the presence of the color additive by listing its respective common or usual name, “cochineal extract” or “carmine,” in the statement of ingredients in accordance with § 101.4 of this chapter. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 74 FR 216, Jan. 5, 2009] § 73.125 Sodium copper chlorophyllin. (a) Identity. Medicago sativa (2) Color additive mixtures made with sodium copper chlorophyllin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Moisture, not more than 5.0 percent. (2) Solvent residues (acetone, ethanol, and hexane), not more than 50 parts per million, singly or, in combination. (3) Total copper, not less than 4 percent and not more than 6 percent. (4) Free copper, not more than 200 parts per million. (5) Lead (as Pb), not more than 10 parts per million. (6) Arsenic (as As), not more than 3 parts per million. (7) Mercury (as Hg), not more than 0.5 part per million. (8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 nm, not less than 3.4 and not more than 3.9. (9) Total copper chlorophyllins, not less than 95 percent of the sample dried at 100 °C for 1 hour. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [67 FR 35431, May 20, 2002] § 73.140 Toasted partially defatted cooked cottonseed flour. (a) Identity. (2) Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Arsenic: It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As. Lead (as Pb), not more than 10 parts per million. Free gossypol content, not more than 450 parts per million. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.160 Ferrous gluconate. (a) Identity. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) Specifications. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] § 73.165 Ferrous lactate. (a) Identity. (b) Specifications. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001; 81 FR 5590, Feb. 3, 2016] § 73.167 Galdieria extract blue. (a) Identity. Galdieria sulphuraria. G. sulphuraria. (2) Color additive mixtures for food use made with galdieria extract blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5 parts per million (ppm)). (2) Arsenic, not more than 0.5 mg/kg (0.5 ppm). (3) Mercury, not more than 0.05 mg/kg (0.05 ppm). (4) Cadmium, not more than 0.5 mg/kg (0.5 ppm). (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [90 FR 20108, May 12, 2025] § 73.168 Gardenia (genipin) blue. (a) Identity. Gardenia jasminoides (2) Color additive mixtures for food use made with gardenia (genipin) blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Genipin, not more than 5 milligram per kilogram (mg/kg) (5 part per million (ppm)). (2) Geniposide, not more than 80 mg/kg (80 ppm). (3) Methanol, not more than 300 mg/kg (300 ppm) (4) Lead, not more than 2 mg/kg (2 ppm). (5) Arsenic, not more than 2 mg/kg (2 ppm). (6) Mercury, not more than 1 mg/kg (1 ppm). (7) Cadmium, not more than 1 mg/kg (1 ppm). (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [90 FR 31590, July 15, 2025, as amended at 90 FR 37793, Aug. 6, 2025] § 73.169 Grape color extract. (a) Identity. (2) Color additive mixtures for food use made with grape color extract may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [46 FR 47532, Sept. 29, 1981] § 73.170 Grape skin extract (enocianina). (a) Identity. (2) Color additive mixtures for food use made with grape skin extract (enocianina) may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. (c) Uses and restrictions. (1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards. (2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR. (d) Labeling requirements. (e) Exemption from certification. § 73.185 Haematococcus algae meal. (a) Identity. Haematococcus pluvialis. (2) Haematococcus algae meal may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with haematococcus algae meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 1.5 percent. (c) Uses and restrictions. (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing haematococcus algae meal shall be declared in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter. (e) Exemption from certification. [65 FR 41584, July 6, 2000] § 73.200 Synthetic iron oxide. (a) Identity. (2) Color additive mixtures for food use made with synthetic iron oxide may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Arsenic (as As), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million (ppm)). Lead (as Pb), not more than 5 mg/kg (5 ppm). Mercury (as Hg), not more than 1 mg/kg (1 ppm). (2) Synthetic iron oxide for dog and cat food use shall conform to the following specifications: Arsenic (as As), not more than 5 parts per million. Lead (as Pb), not more than 20 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Uses and restrictions. (i) In sausage casings intended for human consumption in an amount not exceeding 0.10 percent by weight of the finished food. (ii) In soft and hard candy, mints, and chewing gum at levels consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards. (iii) In dietary supplement tablets and capsules, including coatings and printing inks, such that the total amount of elemental iron per day for labeled dosages does not exceed 5 milligrams. (2) Synthetic iron oxide may be safely used for the coloring of dog and cat foods in an amount not exceeding 0.25 percent by weight of the finished food. (d) Labeling requirements. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994; 80 FR 14842, Mar. 20, 2015; 83 FR 54872, Nov. 1, 2018] § 73.225 Jagua (genipin-glycine) blue. (a) Identity. Genipa americana (2) Color additive mixtures for food use made with jagua (genipin-glycine) blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Arsenic, not more than 1 milligram/kilogram (mg/kg) (1 part per million (ppm)). (2) Cadmium, not more than 1 mg/kg (1 ppm). (3) Lead, not more than 1 mg/kg (1 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Genipin, not more than 20 mg/kg (20 ppm). (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [88 FR 75494, Nov. 3, 2023] § 73.250 Fruit juice. (a) Identity. (2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] § 73.260 Vegetable juice. (a) Identity. (2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] § 73.275 Dried algae meal. (a) Identity. Spongiococcum, Spongiococcum. (b) Uses and restrictions. (1) The color additive is used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (b)(1) of this section; and (ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter. (c) Labeling. (1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein. (2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (b) of this section. (d) Exemption from certification. § 73.295 Tagetes (Aztec marigold) meal and extract. (a) Identity. Tagetes erecta (2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold ( Tagetes erecta (b) Specifications. Tageteserecta (2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications: Melting point 53.5-55.0 °C. Iodine value 132-145. Saponification value 175-200. Acid value 0.60-1.20. Titer 35.5-37.0 °C. Unsaponifiable matter 23.0 percent-27.0 percent. Hexane residue Not more than 25 p.p.m. All determinations, except the hexane residue, shall be made on the initial extract of the flower petals (after drying in a vacuum oven at 60 °C. for 24 hours) prior to the addition of the oils and ethoxyquin. The hexane determination shall be made on the color additive after the addition of the vegetable oils, hydrogenated vegetable oils, and ethoxyquin. (c) Uses and restrictions. (1) The color additives are used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additives incorporated in the feed is such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section; and (ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter. (d) Labeling requirements. (1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein. (2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (c) of this section. (e) Exemption from certification. § 73.297 Myoglobin. (a) Identity. Komagataella phaffii, Bos taurus. (2) Color additive mixtures made with myoglobin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Myoglobin protein purity on protein basis (weight/weight), not less than 85 percent. (2) Lead, not more than 0.01 milligrams per kilogram (0.01 parts per million). (c) Uses and restrictions. i.e., (d) Labeling. (e) Exemption from certification. [90 FR 5594, Jan. 17, 2025] § 73.300 Carrot oil. (a) Identity. Daucus carota (2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.315 Corn endosperm oil. (a) Identity. (2) Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Total fatty acids, not less than 85 percent. Iodine value, 118 to 134. Saponification value, 165 to 185. Unsaponifiable matter, not more than 14 percent. Hexane, not more than 25 parts per million. Isopropyl alcohol, not more than 100 parts per million. (c) Uses and restrictions. (1) The color additive is used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section. (d) Labeling requirements. (e) Exemption from certification. § 73.340 Paprika. (a) Identity. Capsicum annuum (2) Color additive mixtures made with paprika may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. § 73.345 Paprika oleoresin. (a) Identity. Capsicum annuum Acetone Ethyl alcohol Ethylene dichloride Hexane Isopropyl alcohol Methyl alcohol Methylene chloride Trichloroethylene The definition of paprika oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for paprika oleoresin under section 401 of the act. (2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.350 Mica-based pearlescent pigments. (a) Identity. (2) Color additive mixtures for food use made with mica-based pearlescent pigments may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food. (b) Specifications. (1) Lead (as Pb), not more than 4 parts per million (ppm). (2) Arsenic (as As), not more than 3 ppm. (3) Mercury (as Hg), not more than 1 ppm. (c) Uses and restrictions. (i) In amounts up to 1.25 percent, by weight, in the following foods: Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. (ii) In amounts up to 0.07 percent, by weight, in the following: (A) Distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume. (B) Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, and cocktails. (C) Non-alcoholic cocktail mixes and mixers, such as margarita mix, Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, and beverages that are typically consumed without added alcohol ( e.g., (iii) In egg decorating kits used for coloring the shells of eggs in amounts consistent with good manufacturing practice. (2) The color additive may not be used to color foods for which standards of identity have been issued under section 401 of the act, unless the use of the added color is authorized by such standards. (d) Labeling. (e) Exemption from certification. [71 FR 31929, June 2, 2006, as amended at 78 FR 35117, June 12, 2013; 80 FR 32307, June 8, 2015; 80 FR 58602, Sept. 30, 2015] § 73.352 Paracoccus pigment. (a) Identity. Paracoccus carotinifaciens (2) Color additive mixtures for fish feed use made with paracoccus pigment may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Physical state, solid. (2) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts per million (ppm)). (3) Arsenic, not more than 2 mg/kg (2 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Heavy metals (as Pb), not more than 10 mg/kg (10 ppm). (6) Astaxanthin, not less than 1.75 percent. (c) Uses and restrictions. (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from paracoccus pigment when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 mg/kg (72 grams per ton) of finished feed. (d) Labeling requirements. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing paracoccus pigment shall be declared in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter. (e) Exemption from certification. [74 FR 58845, Nov. 16, 2009] § 73.355 Phaffia yeast. (a) Identity. Phaffia rhodozyma. (2) Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 0.4 percent. (c) Uses and restrictions. (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 501.4 of this chapter. (3) The presence of the color additive in salmonid fish that have been fed feeds containing phaffia yeast shall be declared in accordance with §§ 101.22(b), (c), and (k)(2) and 101.100(a)(2) of this chapter. (e) Exemption from certification. [65 FR 41587, July 6, 2000] § 73.450 Riboflavin. (a) Identity. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Color additive mixtures made with riboflavin may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] § 73.500 Saffron. (a) Identity. (2) Color additive mixtures made with saffron may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. § 73.520 Soy leghemoglobin. (a) Identity. Pichia pastoris, (2) Color additive mixtures made with soy leghemoglobin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Soy leghemoglobin protein purity on protein basis (weight/weight), not less than 65 percent, as determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis. (2) Lead, not more than 0.4 milligrams per kilogram (mg/kg) (0.4 parts per million (ppm)). (3) Arsenic, not more than 0.05 mg/kg (0.05 ppm). (4) Mercury, not more than 0.05 mg/kg (0.05 ppm). (5) Cadmium, not more than 0.2 mg/kg (0.2 ppm). (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [84 FR 37576, Aug. 1, 2019] § 73.530 Spirulina extract. Link to an amendment published at 91 FR 5295, Feb. 6, 2026. This amendment was delayed indefinitely at 91 FR 13951, Mar. 24, 2026. (a) Identity. Arthrospira platensis. (2) Color additive mixtures for food use made with spirulina extract may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 part per million (ppm)); (2) Arsenic, not more than 2 mg/kg (2 ppm); (3) Mercury, not more than 1 mg/kg (1 ppm); and (4) Negative for microcystin toxin. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [78 FR 49120, Aug. 13, 2013, as amended at 79 FR 20098, May 13, 2014; 80 FR 50765, Aug. 21, 2015; 82 FR 30734, July 3, 2017; 87 FR 67789, Nov. 10, 2022] § 73.575 Titanium dioxide. (a) Identity. 2 (2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO 2 2 3 (b) Specifications. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Antimony (as Sb), not more than 2 parts per million. Mercury (as Hg), not more than 1 part per million. Loss on ignition at 800 °C. (after drying for 3 hours at 105 °C.), not more than 0.5 percent. Water soluble substances, not more than 0.3 percent. Acid soluble substances, not more than 0.5 percent. TiO 2 Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5 N (c) Uses and restrictions. (1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food. (2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. (e) Exemption from certification. § 73.585 Tomato lycopene extract; tomato lycopene concentrate. (a) Identity. (2) The color additive tomato lycopene concentrate is a powder prepared from tomato lycopene extract by removing most of the tomato lipids with ethyl acetate and then evaporating off the solvent. (3) Color additive mixtures made with tomato lycopene extract or tomato lycopene concentrate may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food. (b) Specifications. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html (2) Tomato lycopene concentrate shall conform to the following specification: Lycopene, not less than 60 percent of oleoresin as determined by the method identified in paragraph (b)(1) of this section. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [70 FR 43045, July 26, 2005, as amended at 81 FR 5590, Feb. 3, 2016; 81 FR 49895, July 29, 2016] § 73.600 Turmeric. (a) Identity. (2) Color additive mixtures made with turmeric may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. § 73.615 Turmeric oleoresin. (a) Identity. Acetone Ethyl alcohol Ethylene dichloride Hexane Isopropyl alcohol Methyl alcohol Methylene chloride Trichloroethylene The definition of turmeric oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric oleoresin under section 401 of the act. (2) Color additive mixtures made with turmeric oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. Subpart B—Drugs § 73.1001 Diluents in color additive mixtures for drug use exempt from certification. The following diluents may be safely used in color additive mixtures that are exempt from certification and which are to be used for coloring drugs, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. Such listing of diluents is not to be construed as superseding any of the other requirements of the Federal Food, Drug, and Cosmetic Act with respect to drugs, including new drugs. If a definition and specification for a particular diluent is not set forth in this subpart, the material shall be of a purity consistent with its intended use. (a) Ingested drugs General use. 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 (Polysorbate 60) As set forth in sec. 172.836 of this chapter Polyoxyethylene (20) sorbitan tristearate (Polysorbate 65) As set forth in sec. 172.838 of this 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 pharmaceutical forms. Ethyl lactate Polyoxyethylene sorbitan monolaurate (20) (b) Externally applied drugs. Substances Definitions and specifications Benzyl alcohol As set forth in N.F. XI. Ethyl cellulose As set forth in § 172.868 of this chapter. Hydroxyethyl cellulose Hydroxypropyl cellulose As set forth in § 172.870 of this chapter. § 73.1010 Alumina (dried aluminum hydroxide). (a) Identity. 2 3 2 (2) Color additive mixtures for drug use made with alumina (dried aluminum hydroxide) may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Acidity or alkalinity: Agitate 1 gram of the color additive with 25 milliliters of water and filter. The filtrate shall be neutral to litmus paper. Matter insoluble in dilute hydrochloric acid, not more than 0.5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Mercury (as Hg), not more than 1 part per million. Aluminum oxide (Al 2 3 (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.1015 Chromium-cobalt-aluminum oxide. (a) Identity. (b) Specifications. Chromium, calculated as Cr 2 3 Cobalt, calculated as CoO, 29-34 percent. Aluminum, calculated as AL 2 3 Lead (as Pb), not more than 30 parts per million. Arsenic (as As), not more than 3 parts per million. Total oxides of aluminum, chromium, and cobalt not less than 97 percent. Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the chromium-cobalt-aluminum oxide for 15 minutes in 50 milliliters of 0.5 N (c) Uses and restrictions. (1) For coloring procedure, the color additive is blended with the polyethylene resin. The mixture is heated to a temperature of 500-550 °F. and extruded through a fixed orifice. The filaments are cooled, oriented by drawing, and set by annealing. (2) The quantity of the color additive does not exceed 2 percent by weight of the suture material. (3) The dyed suture shall conform in all respects to the requirements of the U.S.P. XX (1980). (4) When the sutures are used for the purpose specified in their labeling, there is no migration of the color additive to the surrounding tissue. (5) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act, is in effect for it. (d) Labeling. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984] § 73.1025 Ferric ammonium citrate. (a) Identity. (b) Specifications. Iron (as Fe), not less than 14.5 percent and not more than 18.5 percent. Lead (as Pb), not more than 20 p/m. Arsenic (as As), not more than 3 p/m. (c) Uses and restrictions. (1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980). (2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material. (3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue. (4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it. (d) Labeling. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984] § 73.1030 Annatto extract. (a) Identity and specifications. (2) Color additive mixtures for drug use made with annatto extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977] § 73.1070 Calcium carbonate. (a) Identity. 3 (2) Color additive mixtures for drug use made with calcium carbonate may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984] § 73.1075 Canthaxanthin. (a) Identity and specifications. (2) Color additive mixtures for ingested drug use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. § 73.1085 Caramel. (a) Identity and specifications. (2) The diluents in color additive mixtures for drug use containing caramel shall be limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring drugs. (b) Uses and restrictions. (c) Exemption from certification. § 73.1095 β-Carotene. (a) Identity and specifications. (2) The diluents in color additive mixtures for drug use containing β-carotene are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977] § 73.1100 Cochineal extract; carmine. (a) Identity and specifications. (2) Color additive mixtures for drug use made with carmine and cochineal extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. § 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex). (a) Identity. (2) Color additive mixtures for drug use made with potassium sodium copper chlorophyllin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Moisture, not more than 5.0 percent. Nitrogen, not more than 5.0 percent. pH of 1 percent solution, 9 to 11. Total copper, not less than 4 percent and not more than 6 percent. Free copper, not more than 0.25 percent. Iron, not more than 0.5 percent. Lead (as Pb)), not more than 20 parts per million. Arsenic (as As), not more than 5 parts per million. Ratio, absorbance at 405 mμ to absorbance at 630 mμ, not less than 3.4 and not more than 3.9. Total color, not less than 75 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.1150 Dihydroxyacetone. (a) Identity. (2) Color additive mixtures for drug use made with dihydroxyacetone may contain only those diluents that are listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs. (b) Specifications. Volatile matter (at 34.6 °C. for 3 hours at a pressure of not more than 30 mm. mercury), not more than 0.5 percent. Residue on ignition, not more than 0.4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Iron (as Fe), not more than 25 parts per million. 1,3-dihydroxy-2-propanone, not less than 98 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.1162 Bismuth oxychloride. (a) Identity. (2) Color additive mixtures for drug use made with bismuth oxychloride may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring externally applied drugs. (b) Specifications. Volatile matter, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Bismuth oxychloride, not less than 98 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 52394, Sept. 30, 1977] § 73.1200 Synthetic iron oxide. (a) Identity. (2) Color additive mixtures for drug use made with synthetic iron oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring drugs. (b) Specifications. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.1298 Ferric ammonium ferrocyanide. (a) Identity. (2) Color additive mixtures for drug use made with ferric ammonium ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Oxalic acid or its salts, not more than 0.1 percent. Water soluble matter, not more than 3 percent. Water soluble cyanide, not more than 10 parts per million. Volatile matter, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Nickel (as Ni), not more than 200 parts per million. Cobalt (as Co), not more than 200 parts per million. Mercury (as Hg), not more than 1 part per million. Total iron (as Fe corrected for volatile matter), not less than 33 percent and not more than 39 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979] § 73.1299 Ferric ferrocyanide. (a) Identity. 4 6 3 2 (2) Color additive mixtures for drug use made with ferric ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Water soluble cyanide, not more than 10 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Nickel (as Ni), not more than 200 parts per million. Cobalt (as Co), not more than 200 parts per million. Mercury (as Hg), not more than 1 part per million. Oxalic acid, not more than 0.1 percent. Water soluble matter, not more than 3 percent. Volatile matter, not more than 10 percent. Total iron (as Fe corrected for volatile matter), not less than 37 percent and not more than 45 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [43 FR 54235, Nov. 21, 1978] § 73.1326 Chromium hydroxide green. (a) Identity. 2 3 2 (2) Color additive mixtures for drug use made with chromium hydroxide green may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Water soluble matter, not more than 2.5%. Chromium in 2% NaOH extract, not more than 0.1% as Cr 2 3 Boron (as B 2 3 Total volatile matter at 1000 °C, not more than 20%. Cr 2 3 Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [42 FR 36451, July 15, 1977, as amended at 42 FR 59852, Nov. 22, 1977] § 73.1327 Chromium oxide greens. (a) Identity. 2 3 (2) Color additive mixtures for drug use made with chromium oxide greens may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Chromium in 2% NaOH extract, not more than 0.075% as Cr 2 3 Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 20 parts per million. Mercury (as Hg), not more than 1 part per million. Cr 2 3 (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 36451, July 15, 1977] § 73.1329 Guanine. (a) Identity. (2) Color additive mixtures for drug use made with guanine may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Guanine, not less than 75 percent. Hypoxanthine, not more than 25 percent. Ash (ignition at 800 °C), not more than 2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Assay, not less than 96 percent total purines. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 37537, July 22, 1977] § 73.1350 Mica-based pearlescent pigments. (a) Identity. (2) Color additive mixtures for drug use made with mica-based pearlescent pigments may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring ingested drugs. (b) Specifications. (1) Lead (as Pb), not more than 4 parts per million (ppm). (2) Arsenic (as As), not more than 3 ppm. (3) Mercury (as Hg), not more than 1 ppm. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [70 FR 42273, July 22, 2005. Redesignated at 72 FR 10357, Mar. 8, 2007] § 73.1375 Pyrogallol. (a) Identity. (b) Specifications. Melting point, between 130° and 133 °C. Residue on ignition, not more than 0.1 percent. Lead (as Pb), not more than 20 p/m (parts per million). Arsenic (as As), not more than 3 p/m. (c) Uses and restrictions. (1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980). (2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material. (3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissues. (4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it. (d) Labeling. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984] § 73.1400 Pyrophyllite. (a) Identity. 2 3 2 2 2 (2) Color additive mixtures made with pyrophyllite are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs. (b) Specifications. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the pyrophyllite for 15 minutes in 50 milliliters of 0.5 N (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.1410 Logwood extract. (a) Identity. Haematoxylon campechianum. (b) Specifications. Volatile matter (at 110 °C), not more than 15 percent. Sulfated ash, not more than 20 percent. Hematein, not less than 5 percent and not more than 20 percent. Lead (as Pb), not more than 70 parts per million. Arsenic (as As), not more than 4 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Use and restrictions. e (1) The quantity of color additive does not exceed 1.0 percent by weight of the suture. (2) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue. (3) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it. (d) Labeling. (e) Exemption from certification. [42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. 10, 1978] § 73.1496 Mica. (a) Identity. 2 4 2 6 20 4 2 3 4 3 (2) Color additive mixtures for drug use made with mica may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Fineness, 100 percent shall pass through a 100-mesh sieve. Loss on ignition at 600-650 °C, not more than 2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [42 FR 38561, July 29, 1977, as amended at 52 FR 29665, Aug. 11, 1987] § 73.1530 Spirulina extract. (a) Identity. Arthrospira platensis. (2) Color additive mixtures for drug use made with spirulina extract may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring ingested drugs. (b) Specifications. (1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 parts per million (ppm)); (2) Arsenic, not more than 2 mg/kg (2 ppm); (3) Mercury, not more than 1 mg/kg (1 ppm); and (4) Negative for microcystin toxin. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [80 FR 50765, Aug. 21, 2015] § 73.1550 Talc. (a) Identity. (2) Color additive mixtures for drug use made with talc may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the talc for 15 minutes in 50 milliliters of 0.5 N (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. [42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984] § 73.1575 Titanium dioxide. (a) Identity and specifications. (2) Color additive mixtures for drug use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs, and the following: Silicon dioxide, SiO 2 2 3 (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. § 73.1645 Aluminum powder. (a) Identity. (2) Color additive mixtures for external drug use made with aluminum powder may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs. (b) Specifications. Fineness, 100 percent shall pass through a 200-mesh screen and 95 percent shall pass through a 325-mesh screen. Mercury, not more than 1 part per million. Arsenic, not more than 3 parts per million. Lead, not more than 20 parts per million. Aluminum, not less than 99 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 38563, July 29, 1977] § 73.1646 Bronze powder. (a) Identity. (2) Color additive mixtures for drug use made with bronze powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Stearic or oleic acid, not more than 5 percent. Cadmium (as Cd), not more than 15 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million Aluminum (as Al), not more than 0.5 percent. Tin (as Sn), not more than 0.5 percent. Copper (as Cu), not more than 95 percent and not less than 70 percent. Zinc (as Zn), not more than 30 percent. Maximum particle size 45µ (95 percent minimum). Aluminum, zinc, tin, and copper content shall be based on the weight of the dried powder after being thoroughly washed with ether. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 33723, July 1, 1977] § 73.1647 Copper powder. (a) Identity. (2) Color additive mixtures for drug use made with copper powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Stearic or oleic acid, not more than 5 percent. Cadmium (as Cd), not more than 15 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Copper (as Cu), not less than 95 percent. Maximum particle size 45µ (95 percent minimum). (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 33723, July 1, 1977] § 73.1991 Zinc oxide. (a) Identity. (2) Color additive mixtures for drug use made with zinc oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs. (b) Specifications. Zinc oxide (as ZnO), not less than 99 percent. Loss on ignition at 800 °C, not more than 1 percent. Cadmium (as Cd), not more than 15 parts per million. Mercury (as Hg), not more than 1 part per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 20 parts per million. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [42 FR 37537, July 22, 1977] Subpart C—Cosmetics § 73.2030 Annatto. (a) Identity and specification. (b) Use and restriction. (c) Labeling. (d) Exemption from certification. [42 FR 36994, July 19, 1977] § 73.2085 Caramel. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. [46 FR 38501, July 28, 1981] § 73.2087 Carmine. (a) Identity and specifications. (b) Use and restrictions. (c) Labeling. (2) Cosmetics containing carmine that are not subject to the requirements of § 701.3 of this chapter shall specifically declare the presence of carmine prominently and conspicuously at least once in the labeling. For example: “Contains carmine as a color additive.” (d) Exemption from certification. [42 FR 32228, June 24, 1977, as amended at 74 FR 216, Jan. 5, 2009] § 73.2095 β-Carotene. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 33722, July 1, 1977] § 73.2110 Bismuth citrate. (a) Identity. 6 5 7 (b) Specifications. Bismuth citrate, not less than 97 percent. Mercury (as Hg), not more than 1 part per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 20 parts per million. Volatile matter, not more than 1 percent. (c) Uses and restrictions. (1) The amount of bismuth citrate in the cosmetic shall not be in excess of 2.0 percent (w/v). (2) The cosmetic may not be used for coloring eyelashes, eyebrows, or hair on parts of the body other than the scalp. (d) Labeling. (2) The label of a cosmetic containing the color additive bismuth citrate shall bear, in addition to other information required by law, the following statement, conspicuously displayed thereon: Keep this product out of children's reach. Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts of the body other than the scalp. Wash hands thoroughly after each use. (e) Exemption from certification. [43 FR 44831, Sept. 29, 1978, as amended at 75 FR 14493, Mar. 26, 2010] § 73.2120 Disodium EDTA-copper. (a) Identity. N,N′- N N,N′,O,O′,O N O N (b) Specifications. Total copper, not less than 13.5 percent. Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent. Free copper, not more than 100 parts per million. Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent. Moisture, not more than 15 percent. Water insoluble matter, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex). (a) Identity and specifications. (b) Uses and restrictions. (1) It shall not be used at a level in excess of 0.1 percent. (2) It may be used only in combination with the following substances: Water. Glycerin. Sodium carboxymethylcellulose. Tetrasodium pyrophosphate. Sorbitol. Magnesium phosphate, tribasic. Calcium carbonate. Calcium phosphate, dibasic. Sodium N Artificial sweeteners that are generally recognized as safe or that are authorized under subchapter B of this chapter. Flavors that are generally recognized as safe or that are authorized under subchapter B of this chapter. Preservatives that are generally recognized as safe or that are authorized under subchapter B of this chapter. (c) Labeling. (d) Exemption from certification. § 73.2150 Dihydroxyacetone. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. § 73.2162 Bismuth oxychloride. (a) Identity and specifications. (2) Color additive mixtures of bismuth oxychloride may contain the following diluents: (i) For coloring cosmetics generally, only those diluents listed under § 73.1001(a)(1); (ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 52394, Sept. 30, 1977] § 73.2180 Guaiazulene. (a) Identity. (2) Color additive mixtures of guaiazulene for cosmetic use may contain the following diluent: Polyethylene glycol-40 castor oil (PEG-40 castor oil). Saponification No., 60 to 70. Hydroxyl No., 63 to 78. Acid No., 2. Specific gravity, 1.05 to 1.07. (b) Specifications. Melting point, 30.5 °C to 31.5 °C. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 99 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.2190 Henna. (a) Identity. Lawsonia alba Lawsonia inermis (b) Specifications. It shall not contain more than 10 percent of plant material from Lawsonia alba Lawsonia inermis Moisture, not more than 10 percent. Total ash, not more than 15 percent. Acid-insoluble ash, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. (d) Labeling. “Do not use in the area of the eye.” “Do not use on cut or abraded scalp.” (e) Exemption from certification. § 73.2250 Iron oxides. (a) Identity. (b) Specifications. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.2298 Ferric ammonium ferrocyanide. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 38562, July 29, 1977, as amended at 43 FR 6939, Feb. 17, 1978] § 73.2299 Ferric ferrocyanide. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [43 FR 54236, Nov. 21, 1978] § 73.2326 Chromium hydroxide green. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 36452, July 15, 1977] § 73.2327 Chromium oxide greens. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. [42 FR 36452, July 15, 1977] § 73.2329 Guanine. (a) Identity and specifications. (2) Color additive mixtures of guanine may contain the following diluents: (i) For coloring cosmetics generally, only those diluents listed under § 73.1001(a)(1); (ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Use and restrictions. (c) Labeling requirements. (d) Exemption from certification. [42 FR 37537, July 22, 1977] § 73.2400 Pyrophyllite. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. § 73.2496 Mica. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 38561, July 29, 1977] § 73.2500 Silver. (a) Identity. (2) Color additive mixtures of silver may contain only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Specifications. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 5 parts per million. Mercury (as Hg), not more than 1 part per million. Silver (as Ag), not less than 99.9 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. [44 FR 65974, Nov. 16, 1979] § 73.2550 Silver nitrate. (a) Identity. 3. (b) Specifications. (1) Arsenic, not more than 3 milligrams/kilogram (mg/kg) (3 parts per million (ppm)). (2) Cadmium, not more than 5 mg/kg (5 ppm). (3) Lead, not more than 10 mg/kg (10 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Volatile matter, calculated as water, not more than 0.1 percent. (6) Total color, not less than 99.9 percent. (c) Uses and restrictions. (1) The amount of silver nitrate in the cosmetic product shall not be more than 4 percent by weight. (2) The viscosity of the cosmetic formulation shall be not less than 120 Pascal-seconds (Pa⋅s) and not more than 180 Pa⋅s at normal temperature and pressure. (3) The cosmetic containing silver nitrate is not intended for use on persons under the age of 16. (4) Application of the cosmetic containing silver nitrate is not intended to exceed 1 minute and is intended to be followed by immediate removal. (5) The cosmetic containing silver nitrate is applied by a professional. (6) The cosmetic containing silver nitrate is not distributed or directly sold to consumers. (d) Labeling requirements. (2) The label of any cosmetic containing the color additive silver nitrate, in addition to other information required by law, shall contain the following statements: Contains silver nitrate. Silver nitrate may permanently stain skin with which it comes into contact. Silver nitrate may irritate the eyes. For application by professionals only for dyeing eyebrows and eyelashes, in accordance with the directions for use. Not for use on persons under the age of 16. Apply to eyebrows and eyelashes for no more than 1 minute, followed by immediate removal. Rinse eyes immediately if product comes into contact with them. Consult a physician if any irritation persists. Not for distribution or direct sale to consumers. (e) Exemption from certification. [86 FR 55498, Oct. 6, 2021] § 73.2575 Titanium dioxide. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Exemption from certification. § 73.2645 Aluminum powder. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 38563, July 29, 1977] § 73.2646 Bronze powder. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 33724, July 1, 1977] § 73.2647 Copper powder. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 33724, July 1, 1977] § 73.2725 Ultramarines. (a) Identity. (b) Specifications. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling requirements. (e) Exemption from certification. § 73.2775 Manganese violet. (a) Identity. 4 2 7 (b) Specifications. Ash (at 600 °C), not less than 81 percent. Volatile matter at 135 °C for 3 hours, not more than 1 percent. Water soluble substances, not more than 6 percent. pH of filtrate of 10 grams color additive (shaken occasionally for 2 hours with 100 milliliters of freshly boiled distilled water), not more than 4.7 and not less than 2.5. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, based on Mn content in “as is” sample, not less than 93 percent. (c) Uses and restrictions. (d) Labeling. (e) Exemption from certification. § 73.2991 Zinc oxide. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Exemption from certification. [42 FR 37538, July 22, 1977] § 73.2995 Luminescent zinc sulfide. (a) Identity. (b) Specifications. Zinc sulfide, not less than 99.8 percent. Copper, 100 ± Lead, not more than 20 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Cadmium, not more than 15 parts per million. (c) Uses and restrictions. (1) The amount of luminescent zinc sulfide in facial makeup preparations shall not exceed 10 percent by weight of the final product. (2) Facial makeup preparations containing luminescent zinc sulfide are intended for use only on limited, infrequent occasions, e.g., Halloween, and not for regular or daily use. (d) Labeling requirements. (2) The label of a facial makeup preparation containing the color additive shall bear, in addition to other information required by the law, the following statement conspicuously displayed: Do not use in the area of the eye. (e) Exemption from certification. [65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000] Subpart D—Medical Devices § 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers. (a) Identity. (b) Uses and restrictions. (2) Authorization and compliance with these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens made from the color additives. (c) Labeling. (d) Exemption from certification. [61 FR 51586, Oct. 3, 1996, as amended at 78 FR 19415, Apr. 1, 2013]] § 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. (a) Identity. (b) Uses and restrictions. (2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A person intending to introduce a device containing 1,4-bis[(2-methylphenyl)amino]-9,10-anthracenedione listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval. (c) Labeling. (d) Exemption from certification. [49 FR 30066, July 26, 1984] § 73.3106 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers. (a) Identity. (b) Uses and restrictions. (2) Authorization and compliance with these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to contact lenses made from the color additives. (c) Labeling. (d) Exemption from certification. [58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995; 78 FR 19415, Apr. 1, 2013] § 73.3107 Carbazole violet. (a) Identity. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [53 FR 41324, Oct. 21, 1988] § 73.3110 Chlorophyllin-copper complex, oil soluble. (a) Identity. (b) Specifications. Moisture, not more than 0.5 percent. Nitrogen, not less than 0.2 percent and not more than 0.3 percent. Total copper, not less than 0.2 percent and not more than 0.4 percent. Free copper, not more than 200 parts per million. Lead, not more than 20 parts per million. Arsenic, not more than 5 parts per million. Sulfated ash, not more than 2.5 percent. Total color, not less than 4.5 percent and not more than 5.5 percent. (c) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the polymethylmethacrylate bone cement in which chlorophyllin-copper complex, oil soluble, is used. (d) Labeling. (e) Exemption from certification. [48 FR 56370, Dec. 21, 1983] § 73.3110a Chromium-cobalt-aluminum oxide. (a) Identity. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [53 FR 41325, Oct. 21, 1988] § 73.3111 Chromium oxide greens. (a) Identity and specifications. (b) Uses and restrictions. (2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lenses in which the additive is used. (c) Labeling. (d) Exemption from certification. [51 FR 24816, July 9, 1986] § 73.3112 C.I. Vat Orange 1. (a) Identity. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used. A person intending to introduce a device containing C.I. Vat Orange 1 into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval. (c) Labeling. (d) Exemption from certification. [50 FR 20407, May 16, 1985] § 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol. (a) Identity. (b) Uses and restrictions. (1) The quantity of the color additive does not exceed 1.1 × 10 −7 (2) When used as specified in the labeling, there is no measurable migration of the color additive from the contact lens to the surrounding ocular tissue. (3) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k) and 515 of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [48 FR 22706, May 20, 1983] § 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone. (a) Identity. a: i c (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [48 FR 31375, July 8, 1983] § 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide. (a) Identity. N N (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [48 FR 31375, July 8, 1983] § 73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. (a) Identity. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [48 FR 31376, July 8, 1983] § 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione. (a) Identity. cd: lm (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [48 FR 31376, July 8, 1983] § 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers. (a) Identity. (1) Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-tetrasodium salt] (CAS Reg. No. 17095-24-8); (2) Reactive Blue 21 [copper, (29 H H N 29 N 30 N 31 N 32 (3) Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-] CAS Reg. No. 68189-39-9); (4) Reactive Yellow 15 [benzensulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-3-methyl-5-oxo-1 H (5) Reactive Blue No. 19 [2-anthracene-sulfonic acid, 1-amino-9,10-dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580-78-1); (6) Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS Reg. No. 4499-01-8); (7) C.I. Reactive Red 11 [5-((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((1-sulfo-2-naphthalenyl)azo)-2, 7-naphthalenedisulfonic acid, trisodium salt] (CAS Reg. No. 12226-08-3); (8) C.I. Reactive Yellow 86 [1,3-benzenedisulfonic acid, 4-((5-aminocarbonyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl)azo)-6-(4,6-dichloro-1,3,5-triazin-2-yl)amino)-, disodium salt] (CAS Reg. No. 61951-86-8); (9) C.I. Reactive Blue 163 [triphenodioxazinedisulfonic acid, 6,13-dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5-triazin-2-yl)amino) sulfophenyl)amino)-, tetrasodium salt] (CAS Reg. No. 72847-56-4); and (10) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7- naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0). (b) Uses and restrictions. (2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dyes. (3) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A person intending to introduce a device containing a poly(hydroxyethyl methacrylate)-dye copolymer listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval. (c) Labeling. (d) Exemption from certification. [49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, 1984, as amended at 50 FR 9425, Mar. 8, 1985; 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, Feb. 22, 1993] § 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one. (a) Identity. H- (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [51 FR 11432, Apr. 3, 1986] § 73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one. (a) Identity. b H b H (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Exemption from certification. [51 FR 11436, Apr. 3, 1986] § 73.3124 Phthalocyanine green. (a) Identity. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the additive is used. (c) Labeling. (d) Exemption from certification. [51 FR 11433, Apr. 3, 1986] § 73.3125 Iron oxides. (a) Identity and specifications. (b) Uses and restrictions. (2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the additive is used. (c) Labeling. (d) Exemption from certification. [51 FR 24816, July 9, 1986, as amended at 69 FR 24511, May 4, 2004] § 73.3126 Titanium dioxide. (a) Identity and specifications. (b) Uses and restrictions. (2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lenses in which the additive is used. (c) Labeling. (d) Exemption from certification. [51 FR 24816, July 9, 1986, as amended at 81 FR 75692, Nov. 1, 2016] § 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products. (a) Identity. (1) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7-naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114-32-0). (2) C.I. Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-, tetrasodium salt] (CAS Reg. No. 17095-24-8). (3) C.I. Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-] (CAS Reg. No. 68189-39-9). (4) C.I. Reactive Yellow 15 [benzenesulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-methyl-5-oxo-1 H (5) C.I. Reactive Blue No. 19 [2-anthracenesulfonic acid, 1-amino-9,10-dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580-78-1). (6) C.I. Reactive Blue 21 [copper, (29 H H N 29 N 30 N 31 N 32 (b) Uses and restrictions. (2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dye. (3) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act). A person intending to introduce a device containing a vinyl alcohol/methyl methacrylate-dye reaction product listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval. (c) Labeling. (d) Exemption from certification. [58 FR 3227, Jan. 8, 1993, as amended at 58 FR 17510, Apr. 5, 1993] § 73.3128 Mica-based pearlescent pigments. (a) Identity and specifications. (b) Uses and restrictions. (2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lenses in which the additive is used. (c) Labeling. (d) Exemption from certification. [67 FR 65312, Oct. 24, 2002] § 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate. (a) Identity. (b) Uses and restrictions. (2) Authorization and compliance with this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lenses in which the additive is used. (c) Labeling. (d) Exemption from certification. [76 FR 25235, May 4, 2011, as amended at 78 FR 14664, Mar. 7, 2013]

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