(a)Identity. (1) The color additive chromium oxide greens is principally chromic sesquioxide (Cr2O3).
(2) Color additive mixtures for drug use made with chromium oxide greens may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b)Specifications. the color additive chormium oxide greens 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:
Chromium in 2% NaOH extract, not more than 0.075% as Cr2O3 (based on sample weight).
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 1 part per million.
Cr2O3, not less than 95%.
(c)Uses and restrictions. Chromium oxide greens is safe for use in coloring externally applied drugs, including those intended for use in the area of 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 721(c) of the act.
[42 FR 36451, July 15, 1977]
Title 21 published on 2014-04-01
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