21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.
(a)Identity. The color additive chromium-cobalt-aluminum oxide (Pigment Blue 36) (CAS Reg. No. 68187-11-1, Colour Index No. 77343) shall conform in identity and specifications to the requirements of § 73.1015 (a) and (b).
(b)Uses and restrictions.
(1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the contact lens in which the color additive is used.
(d)Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.