21 CFR 73.3110 - Chlorophyllin-copper complex, oil soluble.

§ 73.3110 Chlorophyllin-copper complex, oil soluble.

(a)Identity. The color additve is chlorophyllin-copper complex, oil soluble. The chlorophyllin is obtained by extraction from a mixture of fescue and rye grasses. The chlorophyll is acid-treated to remove chelated magnesium which is replaced with hydrogen, which is turn is replaced with copper. This mixture is diluted to a 5 percent concentration with a mixture of palm oil, peanut oil, and hydrogenated peanut oil.

(b)Specifications. The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:

Moisture, not more than 0.5 percent.
Nitrogen, not less than 0.2 percent and not more than 0.3 percent.
Total copper, not less than 0.2 percent and not more than 0.4 percent.
Free copper, not more than 200 parts per million.
Lead, not more than 20 parts per million.
Arsenic, not more than 5 parts per million.
Sulfated ash, not more than 2.5 percent.
Total color, not less than 4.5 percent and not more than 5.5 percent.

(c)Uses and restrictions.

(1) The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), may be safely used to color polymethylmethacrylate bone cement. Chlorophyllin-copper complex may be used at levels that do not exceed 0.003 percent by weight of the bone cement.

(2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the polymethylmethacrylate bone cement in which chlorophyllin-copper complex, oil soluble, is used.

(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 therefore the color additive is exempt from the certification requirements of section 721(c) of the act.

[ 48 FR 56370, Dec. 21, 1983]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 10-May-2017 03:43

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

  • 2017-04-04; vol. 82 # 63 - Tuesday, April 4, 2017
    1. 82 FR 16321 - Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke; Filing of Color Additive Petition
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of petition.
      The color additive petition was filed on February 24, 2017. Submit either electronic or written comments by June 5, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 5, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 5, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
      21 CFR Part 73