CFR - Code of Federal Regulations Title 21

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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: 21CFR74.2340]

TITLE 21--FOOD AND DRUGS

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

SUBCHAPTER A - GENERAL

PART 74 -- LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

Subpart C - Cosmetics

Sec. 74.2340 FD&C Red No. 40.

(a) Identity and specifications. (1) The color additive FD&C red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b) of this chapter.

(2) The listing of this color additive includes lakes prepa red as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 or § 82.1051 of this chapter.

(b) Uses and restrictions. FD&C red No. 40 may be safely used in coloring cosmetics generally, except that only FD&C red No. 40 and FD&C red No. 40 Aluminum Lake may be safely used in coloring cosmetics intended for use in the area of the eye. These uses are subject to the following restrictions:

(1) The color additive may be used in amounts consistent with current good manufacturing practice.

(2) The color additive shall not be exposed to oxidizing or red ucing agents that may affect the integrity of the color additives or any other condition that may affect their integrity.

(c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(d) Certification. All batches of FD&C red No. 40 shall be certified in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]