---
kind: "section"
citation: "21 C.F.R. § 74.3206"
title: "21"
number: "74.3206"
heading: "D&C Green No. 6."
url: "https://uscodex.org/cfr/21/74.3206"
---

# §74.3206. D&C Green No. 6.

- (a) **Identity.** The color additive D&C Green No. 6 shall conform in identity to the requirements of [§ 74.1206(a)](/cfr/21/74.1206.md?p=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)](/cfr/21/74.1206.md?p=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)](/cfr/21/510.md?p=k), [515](/cfr/21/515.md), and [520(g)](/cfr/21/520.md?p=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](/cfr/21/70.25.md) of this chapter.
- (e) **Certification.** All batches of D&C Green No. 6 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

### Source

Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.

### Amendments

[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]