21 CFR 73.1125 - Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).

Status message

There are 7 Updates appearing in the Federal Register for 21 CFR 73. View below or at eCFR (GPOAccess)
§ 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).
(a) Identity.
(1) The color additive potassium sodium copper chlorophyllin is a green to black powder obtained from chlorophyll by replacing the methyl and phytyl ester groups with alkali and replacing the magnesium with copper. The source of the chlorophyll is dehydrated alfalfa.
(2) Color additive mixtures for drug use made with potassium sodium copper chlorophyllin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring drugs.
(b) Specifications. Potassium sodium copper chlorophyllin 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 good manufacturing practice:
Moisture, not more than 5.0 percent.
Nitrogen, not more than 5.0 percent.
pH of 1 percent solution, 9 to 11.
Total copper, not less than 4 percent and not more than 6 percent.
Free copper, not more than 0.25 percent.
Iron, not more than 0.5 percent.
Lead (as Pb)), not more than 20 parts per million.
Arsenic (as As), not more than 5 parts per million.
Ratio, absorbance at 405 mμ to absorbance at 630 mμ, not less than 3.4 and not more than 3.9.
Total color, not less than 75 percent.
(c) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are drugs at a level not to exceed 0.1 percent. Authorization for this use shall not be construed as waiving any of the requirements of section 505 of the act with respect to the drug in which it is used.
(d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes 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 batches thereof are exempt from the certification requirements of section 721(c) of the act.

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.

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

  • 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

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.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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