Code of Federal Regulations Title 21. Food and Drugs § 21.73.1015 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:

Chromium, calculated as Cr₂ O₃, 34–37 percent.

Cobalt, calculated as CoO, 29–34 percent.

Aluminum, calculated as AL₂ O₃, 29–35 percent.

Lead (as Pb), not more than 30 parts per million.

Arsenic (as As), not more than 3 parts per million.

Total oxides of aluminum, chromium, and cobalt not less than 97 percent.

Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the chromium-cobalt-aluminum oxide for 15 minutes in 50 milliliters of 0.5 N hydrochloric acid.

(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:

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