21 CFR 73.1015 - Chromium-cobalt-aluminum oxide.

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

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

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  • 2014-04-11; vol. 79 # 70 - Friday, April 11, 2014
    1. 79 FR 20095 - Listing of Color Additives Exempt From Certification; Spirulina Extract
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.
      21 CFR Part 73

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.

  • 2014-04-11; vol. 79 # 70 - Friday, April 11, 2014
    1. 79 FR 20095 - Listing of Color Additives Exempt From Certification; Spirulina Extract
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.
      21 CFR Part 73