part_subject: "LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION"
subpart_code: "C"
subpart_subject: "Cosmetics"
section_number: "73.2396"
section_subject: "Lead acetate."
cfr_reference: "21 CFR 73.2396"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identity. The color additive lead acetate is the trihydrate of lead (2+) salt of acetic acid. The color additive has the chemical formula Pb(OOCCH3)2·3H2O.
(b)Specifications. Lead acetate 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)Water-insoluble matter, not more than 0.02 percent.
(2)pH (30 percent solution weight to volume at 25 °C), not less than 4.7 and not more than 5.8.
(3)Arsenic (as As), not more than 3 parts per million.
(5)Mercury (as Hg), not more than 1 part per million.
(c)Uses and restrictions. The color additive lead acetate may be safely used in cosmetics intended for coloring hair on the scalp only, subject to the following restrictions:
(1)The amount of the lead acetate in the cosmetic shall be such that the lead content, calculated as Pb, shall not be in excess of 0.6 percent (weight to volume).
(2)The cosmetic is not to be used for coloring mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp.
(d)Labeling requirements. (1) The label of the color additive lead acetate shall conform to the requirements of § 70.25 of this chapter, and bear the following statement or equivalent:
Wash thoroughly if the product comes into contact with the skin.
(2)The label of the cosmetic containing the color additive lead acetate, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, shall bear the following cautionary statement, conspicuously displayed thereon:
(e)Exemption for 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 the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.