[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.1015]
 
 [Page 362-363]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                             Subpart B--Drugs
 
 Sec. 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 Cr<INF>2</INF> O<INF>3,</INF> 34-37 percent.
 Cobalt, calculated as CoO, 29-34 percent.
 Aluminum, calculated as AL<INF>2</INF> O<INF>3,</INF> 29-35 percent.
 Lead (as Pb), not more than 30 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 
 [[Page 363]]
 
 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:
     (1) For coloring procedure, the color additive is blended with the
 polyethylene resin. The mixture is heated to a temperature of 500[deg]-
 550 [deg]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.
     (d) Labeling. The label of the color additive shall conform to the
 requirements of Sec. 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.
 
 [42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]