21 CFR 73.2120 - Disodium EDTA-copper.

§ 73.2120 Disodium EDTA-copper.

(a)Identity. The color additive disodium EDTA-copper is disodium [[N,N′- 1,2- ethanediylbis[N - (carboxymethyl) glycinato]] (4-)-N,N′,O,O′,ON,ON′] cuprate (2-).

(b)Specifications. Disodium EDTA-copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:

Total copper, not less than 13.5 percent.
Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent.
Free copper, not more than 100 parts per million.
Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent.
Moisture, not more than 15 percent.
Water insoluble matter, not more than 0.2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.

(c)Uses and restrictions. Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics.

(d)Labeling requirements. The labeling 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 batches thereof are exempt from the requirements of section 721(c) of the act.

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 09-Nov-2018 03:23

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

  • 2018-11-13; vol. 83 # 219 - Tuesday, November 13, 2018
    1. 83 FR 56258 - Sensient Colors, LLC; Filing of Color Additive Petition
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of petition.
      The color additive petition was filed on October 4, 2018.
      21 CFR Part 73