21 C.F.R. § 73.2120 Disodium EDTA-copper.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Subpart C—Cosmetics
§ 73.2120 Disodium EDTA-copper.
