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.
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.
Code of Federal Regulations
(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.
(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.
(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.