thereof are exempt from the certification requirements of section 706(c) of the act.

§ 73.1645 Aluminum powder.

(a) Identity. (1) The color additive aluminum powder shall be composed of finely divided particles of aluminum prepared from virgin aluminum. It is free from admixture with other substances.

(2) Color additive mixtures for external drug use made with aluminum powder may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.

(b) Specifications. Aluminum powder 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:

Fineness, 100 percent shall pass through a 200-mesh screen and 95 percent shall pass through a 325-mesh screen.

Mercury, not more than 1 part per million. Arsenic, not more than 3 parts per million. Lead, not more than 20 parts per million. Aluminum, not less than 99 percent.

(c) Uses and restrictions. Aluminum powder is safe for use in externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 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 therof are exempt from certification pursuant to section 706(c) of the act. [42 FR 38563, July 29, 1977]

§ 73.1646 Bronze powder.

(a) Identity. (1) The color additive bronze powder is a very fine metallic powder prepared from alloys consisting principally of virgin electrolytic copper and zinc with small amounts of

the virgin metals aluminum and tin. It contains small amounts of stearic or oleic acid as lubricants.

(2) Color additive mixtures for drug use made with bronze powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.

(b) Specifications. Bronze powder 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:

Stearic or oleic acid, not more than 5 percent.

Cadmium (as Cd), not more than 15 parts per million.

Lead (as Pb), not more than 20 parts per million.

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

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

Aluminum (as Al), not more than 0.5 percent.

Tin (as Sn), not more than 0.5 percent. Copper (as Cu), not more than 95 percent and not less than 70 percent.

Zinc (as Zn), not more than 30 percent.

Maximum particle size 45μ (95 percent minimum). Aluminum, zinc, tin, and copper content shall be based on the weight of the dried powder after being thoroughly washed with ether.

(c) Uses and restrictions. Bronze powder may be safely used in color externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

(d) Labeling. 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 the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act.

[42 FR 33723, July 1, 1977]

§ 73.1647 Copper powder.

(a) Identity. (1) The color additive copper powder is a very fine free-flowing metallic powder prepared from virgin electrolytic copper. It contains small amounts of stearic or oleic acid as lubricants.

(2) Color additive mixtures for drug use made with copper powder may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.

(b) Specifications. Copper powder 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:

Stearic or oleic acid, not more than 5 percent.

Cadmium (as Cd), not more than 15 parts per million.

Lead (as Pb), not more than 20 parts per million.

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

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

Copper (as Cu), not less than 95 percent. Maximum particle size 45μ (95 percent minimum).

(c) Uses and restrictions. Copper powder may be safely used in coloring externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

(d) Labeling. 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 the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act.

[42 FR 33723, July 1, 1977]

§ 73.1991 Zinc oxide.

(a) Identity. (1) The color additive zinc oxide is a white or yellow-white amorphous powder manufactured by the French process (described as the indirect process whereby zinc metal

isolated from the zinc-containing ore is vaporized and then oxidized). It is principally composed of Zn.

(2) Color additive mixtures for drug use made with zinc oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.

(b) Specifications. Zinc oxide 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:

Zinc oxide (as ZnO), not less than 99 percent.

Loss on ignition at 800° C, not more than 1 percent.

Cadmium (as Cd), not more than 15 parts per million.

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

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

Lead (as Pb), not more than 20 parts per million.

(c) Uses and restrictions. The color additive zinc oxide may be safely used for coloring externally applied drugs, including those used in the area of the eye, in amounts consistent with good manufacturing practice.

(d) Labeling. The color additive and any mixtues prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, 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 therof are exempt from the certifiation pursuant to section 706(c) of the act.

[42 FR 37537, July 22, 1977]

(b) Use and restriction. The color additive annatto may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, 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 706(c) of the act.

[42 FR 36994, July 19, 1977]

§ 73.2085 Caramel.

(a) Identity and specifications. The color additive caramel shall conform in identity and specifications to the requirements of § 73.85(a)(1), (2), and (3) and (b).

(b) Uses and restrictions. Caramel is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.

(c) Labeling requirements. 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.

(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 requirement of section 706(c) of the act.

[46 FR 38501, July 28, 1981]

§ 73.2087 Carmine.

(a) Identity and specifications. The color additive carmine shall conform in identity and specifications to the requirements of § 73.100 (a)(2) and (b)(2).

(b) Use and restrictions. Carmine may be safely used in cosmetics generally, including cosmetics intended for

use in the area of the eye, in amounts consistent with good manufacturing practices.

(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, 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 pursuant to section 706(c) of the act.

[42 FR 32228, June 24, 1977]

873.2095 B-Carotene.

(a) Identity and specifications. The color additive B-carotene shall conform in identity and specifications to the requirements of § 73.95(a)(1) and (b).

(b) Uses and restrictions. The color additive ẞ-carotene may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices.

(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, 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 therof are exempt from the certification pursuant to section 706(c) of the act.

[42 FR 33722, July 1, 1977]

named to the extent that those impurities may be avoided by good manufacturing practice:

Bismuth citrate, not less than 97 percent. Mercury (as Hg), not more than 1 part per million.

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

Lead (as Pb), not more than 20 parts per million.

Volatile matter, not more than 1 percent.

(c) Uses and restrictions. The color additive bismuth citrate may be safely used in cosmetics intended for coloring hair on the scalp, subject to the following restrictions:

(1) The amount of bismuth citrate in the cosmetic shall not be in excess of 0.5 percent (w/v).

(2) The cosmetic may not be used for coloring eyelashes, eyebrows, or hair on parts of the body other than the scalp.

(d) Labeling. (1) The label of the color additive bismuth citrate shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter.

(2) The label of a cosmetic containing the color additive bismuth citrate shall bear, in addition to other information required by law, the following statement, conspicuously displayed there n:

Keep this product out of children's reach. Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts of the body other than the scalp. Wash hands thoroughly after each use.

(e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health, and, therefore, batches thereof are exempt from certification requirements of section 706(c) of the act.

(Sec. 706(b), (c), and (d), 74 Stat. 399-403 (21 U.S.C. 376 (b), (c), and (d), and title II, Pub. L. 86-618, sec. 203, 74 Stat. 404-407 (21 U.S.C. 376 note))

[43 FR 44831, Sept. 29, 1978]

§ 73.2120 Disodium EDTA-copper.

(a) Identity. The color additive disodium EDTA-copper is disodium [[N,N'1,2-ethanediylbis[N-(carboxymethyl)

glycinatol] (4-)-N,N',O,O', ON, ON'] prate (2-).

cu

(b) Specifications. Disodium EDTAcopper 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:

Total copper, not less than 13.5 percent. Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent.

Free copper, not more than 100 parts per million.

Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent. Moisture, not more than 15 percent. Water insoluble matter, not more than 0.2 percent.

Lead (as Pb), not more than 20 parts per million.

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

(c) Uses and restrictions. Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics.

(d) Labeling requirements. The labeling 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 requirements of section 706(c) of the act.

§ 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).

(a) Identity and specifications. The color additive potassium sodium copper chlorophyliin shall conform in identity and specifications to the requirements of § 73.1125(a)(1) and (b).

(b) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are cosmetics subject to the following conditions:

(1) It shall not be used at a level in excess of 0.1 percent.

(2) It may be used only in combination with the following substances:

Water. Glycerin.

Sodium carboxymethylcellulose.

Tetrasodium pyrophosphate.

Sorbitol.

Magnesium phosphate, tribasic.

Calcium carbonate.

Calcium phosphate, dibasic.
Sodium N-lauroyl sarcosinate.

Artificial sweeteners that are generally recognized as safe or that are authorized under Subchapter B of this chapter. Flavors that are generally recognized as safe or that are authorized under Subchapter B of this chapter.

Preservatives that are generally recognized as safe or that are authorized under Subchapter B of this chapter.

(c) Labeling. The label of the color additive shall conform to the requirements 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 706(c) of the act.

§ 73.2150 Dihydroxyacetone.

(a) Identity and specifications. The color additive dihydroxyacetone shall conform in identity and specifications to the requirements of § 73.1150 (a)(1) and (b).

(b) Uses and restrictions. Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied cosmetics intended solely or in part to impart a color to the human body.

(c) Labeling requirements. The labeling 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.

(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 requirements of section 706(c) of the act.

§ 73.2162 Bismuth oxychloride.

(a) Identity and specifications. (1) The color additive bismuth oxychloride shall conform in identity and specifications to the requirements of § 73.1162(a)(1) and (b).

(2) Color additive mixtures of bismuth oxychloride may contain the following diluents:

(i) For coloring cosmetics generally, only those diluents listed under

§ 73.1001(a)(1);

(ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose.

(b) Uses and restrictions. The color additive bismuth oxychloride may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.

(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, 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 certification pursuant to section 706(c) of the act. [42 FR 52394, Sept. 30, 1977]

(a) Identity. (1) The color additive, guaiazulene, is principally 1,4-dimethyl-7-isopropyl-azulene.

(2) Color additive mixtures of guaiazulene for cosmetic use may contain the following diluent:

Polyethylene glycol-40 castor oil (PEG-40 castor oil).

Saponification No., 60 to 70.
Hydroxyl No., 63 to 78.
Acid No., 2.

Specific gravity, 1.05 to 1.07.

(b) Specifications. Guaiazulene 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.

Melting point, 30.5° C to 31.5° C.

Lead (as Pb), not more than 20 parts per million.

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