CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR73.2120]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 73 -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

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 § 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.