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

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There are 2 Updates appearing in the Federal Register for 21 CFR 73. View below or at eCFR (GPOAccess)
§ 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]

Title 21 published on 2014-04-01

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

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-11; vol. 79 # 112 - Wednesday, June 11, 2014
    1. 79 FR 33431 - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.
      21 CFR Part 73

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-10-22; vol. 79 # 204 - Wednesday, October 22, 2014
    1. 79 FR 63062 - Colorcon, Inc.; Filing of Color Additive Petition
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of petition.
      The color additive petition was filed on September 22, 2014.
      21 CFR Part 73