(a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317(a)(1) 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 lens 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 section 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.

(c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(d) Certification. All batches of D&C Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter.