21 CFR 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 of the Federal Food, Drug, and Cosmetic Act, is in effect for it.
(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.