LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

• Citation: 21 CFR Part 73
• Sections: 129

§ 73.1 Diluents in color additive mixtures for food use exempt from certification.

The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use.

(a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201(s) of the act.

(2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations.

(3) The following:

Substances

Definitions and specifications

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

Substances

Definitions and specifications

Restrictions

Alcohol, SDA-3A

As set forth in 26 CFR pt. 212

No residue.

n -Butyl alcohol

Do.

Cetyl alcohol

As set forth in N.F. XI

Do.

Cyclohexane

Do.

Ethyl cellulose

As set forth in sec. 172.868 of this chapter

Ethylene glycol monoethyl ether

Do.

Isobutyl alcohol

Do.

Isopropyl alcohol

Do.

Polyoxyethylene sorbitan monooleate (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. Items listed in paragraph (a) of this section and the following:

Substances

Definitions and specifications

Restrictions

Acetone

As set forth in N.F. XI

No residue.

Alcohol, SDA-3A

As set forth in 26 CFR pt. 212

Do.

Benzoin

As set forth in U.S.P. XVI

Copal, Manila

Ethyl acetate

As set forth in N.F. XI

Do.

Ethyl cellulose

As set forth in sec. 172.868 of this chapter

Methylene chloride

Do.

Polyvinylpyrrolidone

As set forth in sec. 173.55 of this chapter

Rosin and rosin derivatives

As set forth in sec. 172.615 of this chapter

Silicon dioxide

As set forth in sec. 172.480 of this 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. Items listed in paragraph (a) of this section and the following, subject to the condition that there is no penetration of the color additive mixture or any of its components through the eggshell into the egg:

Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service.

Damar gum (resin).

Diethylene glycol distearate.

Dioctyl sodium sulfosuccinate.

Ethyl cellulose (as identified in § 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. Items listed in paragraph (a) of this section and the following:

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.

§ 73.30 Annatto extract.

(a) Identity. (1) The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., using any one or an appropriate combination of the food-grade extractants listed in paragraph (a)(1) (i) and (ii) of this section:

(i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity.

(ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene.

(2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.

(b) Specifications. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications:

(1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million.

(2) When solvents listed under paragraph (a)(1)(ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter.

(c) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. Labels shall bear information showing that the color is derived from annatto seed. The requirements of § 70.25(a) of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in paragraph (a)(1)(ii) of this section.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.32 Antarctic krill meal.

(a) Identity. (1) The color additive Antarctic krill meal consists of the cooked, dried, and ground biomass of whole Euphausia superba (Antarctic krill), with or without removal of the lipid fraction. The lipid fraction may be fully or partially extracted with ethanol, followed by removal of residual ethanol, to produce defatted Antarctic krill meal. Whole Antarctic krill meal, produced when the lipid fraction is not removed, may contain ethoxyquin as a preservative.

(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. Antarctic krill meal must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Antarctic krill meal may be safely used in salmonid feed in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish;

(2) The 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. (1) The labeling of the color additive and any premixes prepared therefrom must bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, a statement of the concentration of ethoxyquin contained therein (whole Antarctic krill meal only), and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section 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. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.35 Astaxanthin.

(a) Identity. (1) The color additive astaxanthin is 3, 3′-dihydroxy-β, β-carotene-4, 4′-dione.

(2) Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Astaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Physical state, solid.

0.05 percent solution in chloroform, complete and clear.

Absorption maximum wavelength 484-493 nanometers (in chloroform).

Residue on ignition, not more than 0.1 percent.

Total carotenoids other than astaxanthin, not more than 4 percent.

Lead, not more than 5 parts per million.

Arsenic, not more than 2 parts per million.

Mercury, not more than 1 part per million.

Heavy metals, not more than 10 parts per million.

Assay, minimum 96 percent.

(c) Uses and restrictions. Astaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.

(2) The quantity of color additive in feed is such that the color additive shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 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. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.37 Astaxanthin dimethyldisuccinate.

(a) Identity. (1) The color additive astaxanthin dimethyldisuccinate is 3,3′-bis(4-methoxy-1,4-dioxobutoxy)-β,β-carotene-4,4′-dione.

(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. Astaxanthin dimethyldisuccinate shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

(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. Astaxanthin dimethyldisuccinate may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.

(2) The quantity of astaxanthin 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. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 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. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.39 xxx

Link to an amendment published at 91 FR 5298, Feb. 6, 2026.

§ 73.40 Dehydrated beets (beet powder).

(a) Identity. (1) The color additive dehydrated beets is a dark red powder prepared by dehydrating sound, mature, good quality, edible beets.

(2) Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods.

(b) Specifications. The color additive shall conform to the following specifications:

Volatile matter, not more than 4 percent.

Acid insoluble ash, not more than 0.5 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Mercury (as Hg), not more than 1 part per million.

(c) Uses and restrictions. Dehydrated beets may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.50 Ultramarine blue.

(a) Identity. The color additive ultramarine blue is a blue pigment obtained by calcining a mixture of kaolin, sulfur, sodium carbonate, and carbon at temperatures above 700 °C. Sodium sulfate and silica may also be incorporated in the mixture in order to vary the shade. The pigment is a complex sodium aluminum sulfo-silicate having the approximate formula Na 7 Ai 6 Si 6 O 2 4 S 3 .

(b) Specifications. Ultramarine blue shall conform to the following specifications:

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Mercury (as Hg), not more than 1 part per million.

(c) Uses and restrictions. The color additive ultramarine blue may be safely used for coloring salt intended for animal feed subject to the restriction that the quantity of ultramarine blue does not exceed 0.5 percent by weight of the salt.

(d) Labeling requirements. The color additive shall be labeled in accordance with the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.69 Butterfly pea flower extract.

(a) Identity. (1) The color additive butterfly pea flower extract is a dark blue liquid prepared by the aqueous extraction of dried butterfly pea flowers from Clitoria ternatea. The extract is further processed by ultrafiltration to remove residues of plant products, followed by concentration and pasteurization. Citric acid may be used to control the pH. The color additive contains anthocyanins as the principal coloring component.

(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. Butterfly pea flower extract must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Butterfly pea flower extract may be safely used for coloring alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, soft candy, ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips. Amounts must be consistent with good manufacturing practice. Butterfly pea flower extract may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.70 Calcium carbonate.

(a) Identity. (1) The color additive calcium carbonate is a fine, white powder consisting essentially of calcium carbonate (CaCO 3 ) prepared either by grinding naturally occurring limestone or synthetically, by precipitation.

(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. Calcium carbonate must meet the specifications given in calcium carbonate (FCC 13) and limestone, ground (FCC 13).

(c) Uses and restrictions. Calcium carbonate may be safely used in amounts consistent with good manufacturing practice to color dietary supplement tablets and capsules (including coatings and printing inks), soft and hard candies and mints, and in inks used on the surface of chewing gum, except that it may not be used to color chocolate for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and, therefore, batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

(f) Incorporation by reference. Material listed in this paragraph (f) is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration and at the National Archives and Records Administration (NARA). Contact the Food and Drug Administration between 9 a.m. and 4 p.m., Monday through Friday at: Dockets Management Staff, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For information on the availability of this material at NARA, email: [email protected]; website: www.archives.gov/federal-register/cfr/ibr-locations.html. You may obtain the material from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; website: www.usp.org.

(1) Limestone, Ground, Food Chemicals Codex, 13th edition, effective June 1, 2022 (FCC 13).

(2) Calcium Carbonate, Food Chemicals Codex, 13th edition, effective June 1, 2022 (FCC 13).

§ 73.75 Canthaxanthin.

(a) Identity. (1) The color additive canthaxanthin is β-carotene-4,4′-dione.

(2) Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Canthaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

Physical state, solid.

1 percent solution in chloroform, complete and clear.

Melting range (decomposition), 207 °C. to 212 °C. (corrected).

Loss on drying, not more than 0.2 percent.

Residue on ignition, not more than 0.2 percent.

Total carotenoids other than trans-canthaxanthin, not more than 5 percent.

Lead, not more than 10 parts per million.

Arsenic, not more than 3 parts per million.

Mercury, not more than 1 part per million.

Assay, 96 to 101 percent.

(c) Use and restrictions. (1) The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions:

(i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and

(ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(2) Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of canthaxanthin incorporated in the feed shall not exceed 4.41 milligrams per kilogam (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect.

(3) Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

(i) Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture;

(ii) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and

(iii) The quantity of color additive in feed shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(d) Labeling requirements. (1) The labeling of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(2) For purposes of coloring fish, the labeling of the color additive and any premixes prepared therefrom shall bear expiration dates (established through generally accepted stability testing methods) for the sealed and open container, other information required by § 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. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.80 Calcium phosphate.

(a) Identity. (1) The color additive calcium phosphate is a white, synthetically prepared powder consisting predominantly of precipitated Ca 5 OH(PO 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. Calcium phosphate must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Calcium phosphate may be safely used for coloring foods intended for human consumption, subject to the following 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. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.85 Caramel.

(a) Identity. (1) The color additive caramel is the dark-brown liquid or solid material resulting from the carefully controlled heat treatment of the following food-grade carbohydrates:

Dextrose.

Invert sugar.

Lactose.

Malt sirup.

Molasses.

Starch hydrolysates and fractions thereof.

Sucrose.

(2) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practice.

(i) Acids:

Acetic acid.

Citric acid.

Phosphoric acid.

Sulfuric acid.

Sulfurous acid.

(ii) Alkalis:

Ammonium hydroxide.

Calcium hydroxide U.S.P.

Potassium hydroxide.

Sodium hydroxide.

(iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite.

(3) Polyglycerol esters of fatty acids, identified in § 172.854 of this chapter, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect.

(4) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.

(b) Specifications. Caramel shall conform to the following specifications:

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Mercury (as Hg), not more than 0.1 part per million.

(c) Uses and restrictions. Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.90 β-Apo-8′-carotenal.

(a) Identity. (1) The color additive is β-apo-8′-carotenal.

(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. β-Apo-8′-carotenal shall conform to the following specifications:

Physical state, solid.

1 percent solution in chloroform, clear.

Melting point (decomposition), 136 °C.-140 °C. (corrected).

Loss of weight on drying, not more than 0.2 percent.

Residue on ignition, not more than 0.2 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Assay (spectrophotometric), 96-101 percent.

(c) Uses and restrictions. The color additive β-apo-8′-carotenal may be safely used for coloring foods generally, subject to the following 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. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.95 β-Carotene.

(a) Identity. (1) The color additive is β-carotene prepared synthetically or obtained from natural sources.

(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. β-carotene shall conform to the following specifications:

Physical state, solid.

1 percent solution in chloroform, clear.

Loss of weight on drying, not more than 0.2 percent.

Residue on ignition, not more than 0.2 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Assay (spectrophotometric), 96-101 percent.

(c) Uses and restrictions. The color additive β-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color those foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.100 Cochineal extract; carmine.

(a) Identity. (1) The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of cochineal ( Dactylopius coccus costa ( Coccus cacti L.)). The coloring principle is chiefly carminic acid.

(2) The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal ( Dactylopius coccus costa ( Coccus cacti L.)).

(3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.

(b) Specifications. (1) Cochineal extract shall conform to the following specifications:

pH, not less than 5.0 and not more than 5.5 at 25 °C.

Protein (N × 6.25), not more than 2.2 percent.

Total solids, not less than 5.7 and not more than 6.3 percent.

Methyl alcohol, not more than 150 parts per million.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Carminic acid, not less than 1.8 percent.

(2) Carmine shall conform to the following specifications:

Volatile matter (at 135 °C. for 3 hours), not more than 20.0 percent.

Ash, not more than 12.0 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Carminic acid, not less than 50.0 percent.

Carmine and cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine and cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in section 201(s) of the act or, if they are food additives as so defined, are used in conformity with regulations established pursuant to section 409 of the act.

(c) Uses and restrictions. Carmine and cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling requirements. (1) The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 70.25 of this chapter.

(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. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.125 Sodium copper chlorophyllin.

(a) Identity. (1) The color additive sodium copper chlorophyllin is a green to black powder prepared from chlorophyll by saponification and replacement of magnesium by copper. Chlorophyll is extracted from alfalfa ( Medicago sativa ) using any one or a combination of the solvents acetone, ethanol, and hexane.

(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. Sodium copper chlorophyllin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

(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. Sodium copper chlorophyllin may be safely used to color citrus-based dry beverage mixes in an amount not exceeding 0.2 percent in the dry mix.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.140 Toasted partially defatted cooked cottonseed flour.

(a) Identity. (1) The color additive toasted partially defatted cooked cottonseed flour is a product prepared as follows: Food quality cottonseed is delinted and decorticated; the meats are screened, aspirated, and rolled; moisture is adjusted, the meats heated, and the oil expressed; the cooked meats are cooled, ground, and reheated to obtain a product varying in shade from light to dark brown.

(2) Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.

(b) Specifications. Toasted partially defatted cooked cottonseed flour shall conform to the following specifications:

Arsenic: It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As.

Lead (as Pb), not more than 10 parts per million.

Free gossypol content, not more than 450 parts per million.

(c) Uses and restrictions. The color additive toasted partially defatted cooked cottonseed flour may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.160 Ferrous gluconate.

(a) Identity. The color additive ferrous gluconate is the ferrous gluconate defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(b) Specifications. Ferrous gluconate shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section.

(c) Uses and restrictions. Ferrous gluconate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.165 Ferrous lactate.

(a) Identity. The color additive ferrous lactate is the ferrous lactate defined in § 184.1311 of this chapter.

(b) Specifications. Ferrous lactate shall meet the specifications given in the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) Uses and restrictions. Ferrous lactate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act (the act).

§ 73.167 Galdieria extract blue.

(a) Identity. (1) The color additive galdieria extract blue is a liquid or powder prepared by the filtered aqueous extraction of the dried biomass of a non-pathogenic and non-toxigenic strain of Galdieria sulphuraria. The biomass is prepared by heterotrophic fermentation of G. sulphuraria. The color additive contains C-phycocyanin as the principal coloring component.

(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. Galdieria extract blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Galdieria extract blue may be safely used for coloring non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives), 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.

(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.168 Gardenia (genipin) blue.

(a) Identity. (1) The color additive gardenia (genipin) blue is prepared by reacting genipin extracted from the fruit of Gardenia jasminoides Ellis with soy protein hydrolysate. The color additive contains a genipin-peptide polymer as the principal coloring component.

(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. Gardenia (genipin) blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Gardenia (genipin) blue may be safely used in amounts consistent with good manufacturing practice for coloring sport drinks, flavored or enhanced noncarbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter. The label of the powdered form of the additive must also declare any additional ingredients used in its manufacture.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches of the color additive are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.169 Grape color extract.

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

(2) Color additive mixtures for food use made with grape color extract may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Grape color extract shall conform to the following specifications: Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million.

(c) Uses and restrictions. Grape color extract may be safely used for the coloring of nonbeverage food, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches are exempt from the certification requirements of section 721(c) of the Act.

§ 73.170 Grape skin extract (enocianina).

(a) Identity. (1) The color additive grape skin extract (enocianina) is a purplish-red liquid prepared by the aqueous extraction (steeping) of the fresh deseeded marc remaining after grapes have been pressed to produce grape juice or wine. It contains the common components of grape juice; namely, anthocyanins, tartaric acid, tannins, sugars, minerals, etc., but not in the same proportions as found in grape juice. During the steeping process, sulphur dioxide is added and most of the extracted sugars are fermented to alcohol. The extract is concentrated by vacuum evaporation, during which practically all of the alcohol is removed. A small amount of sulphur dioxide may be present.

(2) Color additive mixtures for food use made with grape skin extract (enocianina) may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Grape skin extract (enocianina) shall conform to the following specifications:

Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

(c) Uses and restrictions. Grape skin extract (enocianina) may be safely used for the coloring of still and carbonated drinks and ades, beverage bases, and alcoholic beverages subject to the following restrictions:

(1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards.

(2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. The common or usual name of the color additive is “grape skin extract” followed, if desired, by “(enocianina)”.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.185 Haematococcus algae meal.

(a) Identity. (1) The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis.

(2) Haematococcus algae meal may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with haematococcus algae meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Haematococcus algae meal shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Physical state, solid.

Lead, not more than 5 parts per million.

Arsenic, not more than 2 parts per million.

Mercury, not more than 1 part per million.

Heavy metals (as Pb), not more than 10 parts per million.

Astaxanthin, not less than 1.5 percent.

(c) Uses and restrictions. Haematococcus algae meal may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.

(2) The quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 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. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.200 Synthetic iron oxide.

(a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances.

(2) Color additive mixtures for food use made with synthetic iron oxide may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. (1) Synthetic iron oxide for human food use shall conform to the following specifications:

Arsenic (as As), not more than 3 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. (1) Synthetic iron oxide may be safely used for human food use subject to the following 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. The label of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.225 Jagua (genipin-glycine) blue.

(a) Identity. (1) The color additive jagua (genipin-glycine) blue is a dark blue powder or liquid prepared from the juice of the unripe fruit of Genipa americana by reacting the genipin in the juice with glycine using mild heat. The color additive contains a polymer as the principal coloring component and three dimers as minor coloring components.

(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. Jagua (genipin-glycine) blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Jagua (genipin-glycine) blue may be safely used for coloring flavored milk; dairy drinks and substitutes; dairy and dairy alternative yogurt; ice cream, frozen dairy and dairy alternative desserts, puddings, gelatins, ices, sorbets; ready-to-eat multicolored cereals; flavored potato chips, tortilla, corn, and other chips; candy and chewing gum; non-alcoholic fruit based/flavored drinks, nutritional beverages and smoothies; flavored cream cheese-based spreads; and icings, frostings, jams, syrups, and fruit toppings and fillings at levels consistent with good manufacturing practice, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.250 Fruit juice.

(a) Identity. (1) The color additive fruit juice is prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. The color additive may be concentrated or dried. The definition of fruit juice in this paragraph is for the purpose of identity as a color additive only and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular fruit juice has been promulgated under section 401 of the act, it shall conform to such standard.

(2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.260 Vegetable juice.

(a) Identity. (1) The color additive vegetable juice is prepared either by expressing the juice from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable. The color additive may be concentrated or dried. The definition of vegetable juice in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular vegetable juice has been promulgated under section 401 of the act, it shall conform to such standard.

(2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.275 Dried algae meal.

(a) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, separated from its culture broth), molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. The algae cells are produced by suitable fermentation, under controlled conditions, from a pure culture of the genus Spongiococcum.

(b) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the yellow color of chicken skin and eggs.

(2) The quantity of the color additive incorporated in the feed is such that the finished feed:

(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (b)(1) of this section; and

(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter.

(c) Labeling. The label of the color additives and any premixes prepared therefrom shall bear in addition to the information required by § 70.25 of this chapter.

(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.

(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (b) of this section.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.295 Tagetes (Aztec marigold) meal and extract.

(a) Identity. (1) The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold ( Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin.

(2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold ( Tagetes erecta L.). It is mixed with an edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible vegetable oil, and not more than 0.3 percent ethoxyquin. It may also be mixed with soy flour or corn meal as a carrier.

(b) Specifications. (1) Tagetes (Aztec marigold) meal is free from admixture with other plant material from Tageteserecta L. or from plant material or flowers of any other species of plants.

(2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications:

Melting point

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. The color additives tagetes (Aztec marigold) meal and extract may be safely used in chicken feed in accordance with the following prescribed conditions:

(1) The color additives are used to enhance the yellow color of chicken skin and eggs.

(2) The quantity of the color additives incorporated in the feed is such that the finished feed:

(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section; and

(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter.

(d) Labeling requirements. The label of the color additives and any premixes prepared therefrom shall bear, in addition to the information required by § 70.25 of this chapter:

(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.

(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (c) of this section.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.297 Myoglobin.

(a) Identity. (1) The color additive myoglobin is a stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, Komagataella phaffii, genetically engineered to express the myoglobin protein from Bos taurus. Myoglobin protein is the principal coloring component of the color additive and imparts a red color.

(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. Myoglobin must conform to the following specifications and must be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice:

(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. Myoglobin may be safely used in ground meat and ground poultry analogue products ( i.e., plant-based ground meat- and poultry-like food products subject to FDA regulation) where the amount of myoglobin protein does not exceed 2 percent by weight of the uncooked analogue product.

(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore, batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.300 Carrot oil.

(a) Identity. (1) The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots ( Daucus carota L.) with subsequent removal of the hexane by vacuum distillation. The resultant mixture of solid and liquid extractives consists chiefly of oils, fats, waxes, and carrotenoids naturally occurring in carrots. The definition of carrot oil in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for carrot oil or carrot oleoresin under section 401 of the act.

(2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Carrot oil shall contain no more than 25 parts per million of hexane.

(c) Uses and restrictions. Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless the use of added color is authorized by such standards.

(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.315 Corn endosperm oil.

(a) Identity. (1) The color additive corn endosperm oil is a reddish-brown liquid composed chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments obtained by isopropyl alcohol and hexane extraction from the gluten fraction of yellow corn grain. The definition of corn endosperm oil in this paragraph is for the purpose of definition as a color additive only and shall not be construed as a food standard of identity under section 401 of the act.

(2) Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Corn endosperm oil conforms to the following specifications:

Total fatty acids, not less than 85 percent.

Iodine value, 118 to 134.

Saponification value, 165 to 185.

Unsaponifiable matter, not more than 14 percent.

Hexane, not more than 25 parts per million.

Isopropyl alcohol, not more than 100 parts per million.

(c) Uses and restrictions. The color additive corn endosperm oil may be safely used in chicken feed in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the yellow color of chicken skin and eggs.

(2) The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section.

(d) Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required by § 70.25 of this chapter, a statement of the concentration of xanthophyll contained therein.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.340 Paprika.

(a) Identity. (1) The color additive paprika is the ground dried pod of mild capsicum ( Capsicum annuum L.). The definition of paprika in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for paprika under section 401 of the act.

(2) Color additive mixtures made with paprika may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Paprika may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.345 Paprika oleoresin.

(a) Identity. (1) The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika ( Capsicum annuum L.) by extraction, using any one or a combination of the following solvents:

Acetone

Ethyl alcohol

Ethylene dichloride

Hexane

Isopropyl alcohol

Methyl alcohol

Methylene chloride

Trichloroethylene

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

(2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Paprika oleoresin shall contain no more residue of the solvents listed in paragraph (a)(1) of this section than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter.

(c) Uses and restrictions. Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.350 Mica-based pearlescent pigments.

(a) Identity. (1) The color additive is formed by depositing titanium salts onto mica, followed by heating to produce titanium dioxide on mica. Mica used to manufacture the color additive shall conform in identity to the requirements of § 73.1496(a)(1).

(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. Mica-based pearlescent pigments shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

(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. (1) The substance listed in paragraph (a) of this section may be safely used as a color additive in food as follows:

(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., fruit juices, fruit juice drinks, and soft drinks).

(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. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.352 Paracoccus pigment.

(a) Identity. (1) The color additive paracoccus pigment consists of the heat-killed, dried cells of a nonpathogenic and nontoxicogenic strain of the bacterium Paracoccus carotinifaciens and may contain added calcium carbonate to adjust the astaxanthin level.

(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. Paracoccus pigment shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice:

(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. Paracoccus pigment may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.

(2) The quantity of astaxanthin in finished feed, from 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. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 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. Certification of this color additive is not necessary for the protection of the public health, and therefore, batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.355 Phaffia yeast.

(a) Identity. (1) The color additive phaffia yeast consists of the killed, dried cells of a nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma.

(2) Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Phaffia yeast shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Physical state, solid.

Lead, not more than 5 parts per million.

Arsenic, not more than 2 parts per million.

Mercury, not more than 1 part per million.

Heavy metals (as Pb), not more than 10 parts per million.

Astaxanthin, not less than 0.4 percent.

(c) Uses and restrictions. Phaffia yeast may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.

(2) The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), 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) of this section.

(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with § 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. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.450 Riboflavin.

(a) Identity. (1) The color additive riboflavin is the riboflavin defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 262-263, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.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. Riboflavin shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a)(1) of this section.

(c) Uses and restrictions. Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice; except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Act.

§ 73.500 Saffron.

(a) Identity. (1) The color additive saffron is the dried stigma of Crocus sativus L. The definition of saffron in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for saffron under section 401 of the act.

(2) Color additive mixtures made with saffron may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Saffron may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.520 Soy leghemoglobin.

(a) Identity. (1) The color additive soy leghemoglobin is a stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, Pichia pastoris, genetically engineered to express soy leghemoglobin protein. Soy leghemoglobin protein is the principal coloring component of the color additive and imparts a reddish-brown color.

(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. Soy leghemoglobin shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice:

(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. Soy leghemoglobin may be safely used in ground beef analogue products such that the amount of soy leghemoglobin protein does not exceed 0.8 percent by weight of the uncooked ground beef analogue product.

(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.530 Spirulina extract.

Link to an amendment published at 91 FR 5295, Feb. 6, 2026.

(a) Identity. (1) The color additive spirulina extract is prepared by the filtered aqueous extraction of the dried biomass of Arthrospira platensis. The color additive contains phycocyanins as the principal coloring components.

(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. Spirulina extract must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:

(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. Spirulina extract may be safely used for coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts (including non-dairy frozen dessert), dessert coatings and toppings, beverage mixes and powders, yogurts (including non-dairy yogurt alternatives), custards, puddings (including non-dairy puddings), cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded cereals), alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, seasoning mixes (unheated), salad dressings, condiments and sauces, dips, coating formulations applied to dietary supplement tablets and capsules, at levels consistent with good manufacturing practice, and to seasonally color the shells of hard-boiled eggs, 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.

(d) Labeling requirements. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

§ 73.575 Titanium dioxide.

(a) Identity. (1) The color additive titanium dioxide is synthetically prepared TiO 2 , free from admixture with other substances.

(2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO 2 and/or aluminum oxide, Al 2 O 3 , as dispersing aids—not more than 2 percent total.

(b) Specifications. Titanium dioxide shall conform to the following specifications:

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Antimony (as Sb), not more than 2 parts per million.

Mercury (as Hg), not more than 1 part per million.

Loss on ignition at 800 °C. (after drying for 3 hours at 105 °C.), not more than 0.5 percent.

Water soluble substances, not more than 0.3 percent.

Acid soluble substances, not more than 0.5 percent.

TiO 2 , not less than 99.0 percent after drying for 3 hours at 105 °C.

Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5 N hydrochloric acid.

(c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions:

(1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food.

(2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.585 Tomato lycopene extract; tomato lycopene concentrate.

(a) Identity. (1) The color additive tomato lycopene extract is a red to dark brown viscous oleoresin extracted with ethyl acetate from tomato pulp followed by removal of the solvent by evaporation. The pulp is produced from fresh, edible varieties of the tomato by removing the liquid. The main coloring component is lycopene.

(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. (1) Tomato lycopene extract shall conform to the following specification: Lycopene, not less than 5.5 percent of oleoresin as determined by the method entitled “Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Concentrations of Lyc-O-Mato ® (Tomato Oleoresin) and in Tomato Pulp by High Performance Liquid Chromatography (HPLC),” S.O.P. number : Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed Natural Products Industries, which is incorporated by reference, or an equivalent method. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of the method from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. You may inspect a copy at theFood and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.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. Tomato lycopene extract and tomato lycopene concentrate may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been issued under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.600 Turmeric.

(a) Identity. (1) The color additive turmeric is the ground rhizome of Curcuma longa L. The definition of turmeric in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric under section 401 of the act.

(2) Color additive mixtures made with turmeric may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Turmeric may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.615 Turmeric oleoresin.

(a) Identity. (1) The color additive turmeric oleoresin is the combination of flavor and color principles obtained from turmeric (Curcuma longa L.) by extraction using any one or a combination of the following solvents:

Acetone

Ethyl alcohol

Ethylene dichloride

Hexane

Isopropyl alcohol

Methyl alcohol

Methylene chloride

Trichloroethylene

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

(2) Color additive mixtures made with turmeric oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Turmeric oleoresin shall contain no more residue of the solvents listed under paragraph (a)(1) of this section than is permitted for the corresponding solvents in spice oleoresins under applicable food additive regulation in parts 170 through 189 of this chapter.

(c) Uses and restrictions. Turmeric oleoresin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.1001 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 —(1) General use. Diluents listed in § 73.1(a) and the following:

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. Items listed in paragraph (a)(1) of this section, § 73.1(b)(1)(i), and the following:

Ethyl lactate

Polyoxyethylene sorbitan monolaurate (20)

(b) Externally applied drugs. Diluents listed in paragraph (a)(1) of this section and the following:

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. (1) The color additive alumina (dried aluminum hydroxide) is a white, odorless, tasteless, amorphous powder consisting essentially of aluminum hydroxide (Al 2 O 3 · XH 2 O).

(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. Alumina (dried aluminum hydroxide) shall conform to the following 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 O 3 ), not less than 50 percent.

(c) Uses and restrictions. Alumina (dried aluminum hydroxide) may be safely used in amounts consistent with good manufacturing practice to color drugs generally.

(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

§ 73.1015 Chromium-cobalt-aluminum oxide.

(a) Identity. The color additive chromium-cobalt-aluminum oxide is a blue-green pigment obtained by calcining a mixture of chromium oxide, cobalt carbonate, and aluminum oxide. It may contain small amounts (less than 1 percent each) of oxides of barium, boron, silicon, and nickel.

(b) Specifications. Chromium-cobalt-aluminum oxide shall conform to the following specifications:

Chromium, calculated as Cr 2 O 3 , 34-37 percent.

Cobalt, calculated as CoO, 29-34 percent.

Aluminum, calculated as AL 2 O 3 , 29-35 percent.

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 hydrochloric acid.

(c) Uses and restrictions. The color additive chromium-cobalt-aluminum oxide may be safely used for coloring linear polyethylene surgical sutures, United States Pharmacopeia (U.S.P.), for use in general surgery, subject to the following 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. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and batches thereof are exempt from the certification requirements of section 721(c) of the act.