(a)Identity. The color additives are 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester (CAS Reg. No. 109561-07-1) copolymerized either with glyceryl methacrylate, methyl methacrylate, and ethylene glycol dimethacrylate monomers, or with N, N-dimethyl acrylamide, methyl methacrylate, and ethylene glycol dimethacrylate 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 the contact lens 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.
At 78 FR 19415, April 1, 2013, § 73.3100 was amended by revising the section heading and 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[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) (CAS Reg. No. 109561-07-1) 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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