(a)Identity. (1) The color additive dihydroxyacetone is 1,3-dihydroxy-2-propanone.
(2) Color additive mixtures for drug use made with dihydroxyacetone may contain only those diluents that are listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b)Specifications. Dihydroxyacetone 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:
Volatile matter (at 34.6 °C. for 3 hours at a pressure of not more than 30 mm. mercury), not more than 0.5 percent.
Residue on ignition, not more than 0.4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Iron (as Fe), not more than 25 parts per million.
1,3-dihydroxy-2-propanone, not less than 98 percent.
(c)Uses and restrictions. Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied drugs intended solely or in part to impart a color to the human body. Authorization for this use shall not be construed as waiving any of the requirements of section 505 of the act with respect to the drug in which it is used.
(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.
Title 21 published on 2014-04-01
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