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[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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