(a) Identity. The color additive D&C Green No. 6 shall conform in identity to the requirements of §74.1206(a).

(b) Specifications. The color additive D&C Green No. 6 for use in medical devices shall conform to the specifications of §74.1206(b).

(c) Uses and restrictions.

(1) The color additive D&C Green No. 6 may be safely used at a level

(i) Not to exceed 0.03 percent by weight of the lens material for coloring contact lenses;

(ii) Not to exceed 0.75 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures, including sutures for ophthalmic use;

(iii) Not to exceed 0.1 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter greater than U.S.P. size 8-0, including sutures for ophthalmic use;

(iv) Not to exceed 0.5 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter not greater than U.S.P. size 8-0, including sutures for ophthalmic use;

(v) Not to exceed 0.21 percent by weight of the suture material for coloring poly(glycolic acid-co-trimethylene carbonate) sutures (also referred to as 1,4-dioxan-2,5-dione polymer with 1,3-dioxan-2-one) for general surgical use; and

(vi) Not to exceed 0.10 percent by weight of the haptic material for coloring polymethylmethacrylate support haptics of intraocular lenses.

(2) Authorization for 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 with respect to the medical device in which D&C Green No. 6 is used.

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

(e) Certification. All batches of D&C Green No. 6 shall be certified in accordance with regulations in part 80 of this chapter.

[48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27, 1986; 58 FR 21542, Apr. 22, 1993]