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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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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).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR81.1]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 81 -- GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

Sec. 81.1 Provisional lists of color additives.

The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 379e note)). Except for color additives for which petitions have been filed, progress reports are required by January 1, 1968, and at 6-month intervals thereafter. Specifications for color additives listed in paragraphs (a), (b), and (c) of this section appear in the respective designated sections. The listing of color additives in this section is not to be construed as a listing for surgical suture use unless color additive petitions have been submitted for such use or the Commissioner has been notified of studies underway to establish the safety of the color additive for such use. The color additives listed in paragraphs (a), (b), and (c) of this section may not be used in products which are intended to be used in the area of the eye. The color additives listed in paragraphs (a), (b), and (c) of this section are provisionally listed until the closing dates set forth therein.

(a) Color additives previously and presently subject to certification and provisionally listed for food, drug, and cosmetic use.

Color additive Closing date Restrictions
Food use Drug and cosmetic use
Lakes (FD&C) (sec. 82.51 of this chapter)

(b) Color additives previously and presently subject to certification and provisionally listed for drug and cosmetic use.

Closing date Restrictions
Lakes (D&C) (Sec. 82.2051 of this chapter)

(c) Color additives previously and presently subject to certification and provisionally listed for use in externally applied drugs and cosmetics.

Closing date Restrictions
Lakes (Ext. D&C) (sec. 82.105(1) of this chapter)

[42 FR 15665, Mar. 22, 1977]

Editorial Note:

For Federal Register citations affecting § 81.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

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