---
kind: "section"
citation: "21 C.F.R. § 73.1015"
title: "21"
number: "73.1015"
heading: "Chromium-cobalt-aluminum oxide."
url: "https://uscodex.org/cfr/21/73.1015"
---

# §73.1015. Chromium-cobalt-aluminum oxide.

- (a) **Identity.** The color additive chromium-cobalt-aluminum oxide is a blue-green pigment obtained by calcining a mixture of chromium oxide, cobalt carbonate, and aluminum oxide. It may contain small amounts (less than 1 percent each) of oxides of barium, boron, silicon, and nickel.
- (b) **Specifications.** Chromium-cobalt-aluminum oxide shall conform to the following specifications:
- (c) **Uses and restrictions.** The color additive chromium-cobalt-aluminum oxide may be safely used for coloring linear polyethylene surgical sutures, United States Pharmacopeia (U.S.P.), for use in general surgery, subject to the following restrictions:
  - (1) **For coloring procedure, the color additive is blended with the polyethylene resin.** The mixture is heated to a temperature of 500-550 °F. and extruded through a fixed orifice. The filaments are cooled, oriented by drawing, and set by annealing.
  - (2) **The quantity of the color additive does not exceed 2 percent by weight of the suture material.**
  - (3) The dyed suture shall conform in all respects to the requirements of the U.S.P. XX (1980).
  - (4) When the sutures are used for the purpose specified in their labeling, there is no migration of the color additive to the surrounding tissue.
  - (5) If the suture is a new drug, an approved new drug application, pursuant to [section 505](/cfr/21/505.md) of the Federal Food, Drug, and Cosmetic Act, is in effect for it.
- (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) **Exemption from certification.** Certification of this color additive is not necessary for the protection of the public health, and batches thereof are exempt from the certification requirements of [section 721(c)](/cfr/21/721.md?p=c) of the act.

## Notes

### Amendments

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]

### Authority

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

### Source

Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.

### Amendments

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]