[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.2120]
[Page 372]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of
Subpart C Cosmetics
Sec. 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',O\N\,O\N\'] 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 Sec. 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.
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