(a)Identity. The color additive is 1,4-bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone (CAS Reg. No. 121888-69-5), copolymerized with hydroxyethyl methacrylate monomer, or a blend of hydroxyethyl methacrylate and N-vinyl pyrrolidone monomers, or a blend of 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate (CAS Reg. No. 134072-99-4) and N-vinyl pyrrolidone monomers to form the contact lens material.
(b)Uses and restrictions.
(1) The substances listed in paragraph (a) of this section may be used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with these uses 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 contact lenses made from the color additives.
(c)Labeling. The label of the color additives shall conform to the requirements of § 70.25 of this chapter.
(d)Exemption from certification. Certification of these color additives is not necessary for the protection of the public health and, therefore, the color additives are exempt from the certification requirements of section 721(c) of the act.
[58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995]
Effective Date Note:
At 78 FR 19415, April 1, 2013, § 73.3106 was amended by revising paragraph (a), effective May 2, 2013. For the convenience of the user, the revised text is set forth as follows:
(a) Identity. The color additives are the copolymers formed as the reaction product of 1,4-bis[4-(2-methacryloxyethyl)phenylamino] anthraquinone (C.I. Reactive Blue 246) (CAS Reg. No. 121888-69-5) with one or more vinyl and/or acrylic monomers to form the contact lens material.
Title 21 published on 2014-04-01
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