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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR73.2500]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 73 -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

Subpart C - Cosmetics

Sec. 73.2500 Silver.

(a) Identity. (1) The color additive, silver, is a crystalline powder of high purity silver prepared by the reaction of silver nitrate with ferrous sulfate in the presence of nitric, phosphoric and sulfuric acids. Polyvinyl alcohol is used to prevent the agglomeration of crystals and the formation of amorphous silver.

(2) Color additive mixtures of silver may contain only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose.

(b) Specifications. Silver 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:

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

Arsenic (as As), not more than 5 parts per million.

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

Silver (as Ag), not less than 99.9 percent.

(c) Uses and restrictions. The color additive silver may be safely used for coloring fingernail polish at a level not to exceed 1 percent of the final product.

(d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other 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 thereof are exempt from the certification requirements of section 721(c) of the act.

[44 FR 65974, Nov. 16, 1979]

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