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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 Jul 20, 2022.

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: 21CFR82]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL
 
PART 82LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
 

Subpart D - Externally Applied Drugs and Cosmetics

Sec. 82.2050 General.

A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use in externally applied drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.

Sec. 82.2051 Lakes (Ext. D&C).

(a)(1) General. Any lake made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or on any combination of two or more of these (i) one of the straight colors hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, barium, or calcium; or (ii) a salt prepared from one of the straight colors hereinbefore listed in this subpart by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium.

(2) Specifications.

Ether extracts, not more than 0.5 percent.

Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent.

Intermediates, not more than 0.2 percent.

(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:

(1) The listed name of the color from which the lake is prepared;

(2) The name of the basic radical combined in such color; and

(3) The word "Lake." (For example, the name of a lake prepared by extending the color Ext. D&C Yellow No. 2 upon a substratum is "Ext. D&C Yellow No. 2 - Calcium Lake," and a lake prepared by extending the barium salt prepared from Ext. D&C Red No. 2 upon the substratum is "Ext. D&C Red No. 2 - Barium Lake.")

Sec. 82.2707a Ext. D&C Yellow No. 7.

The color additive Ext. D&C Yellow No. 7 shall conform in identity with specifications to the requirements of § 74.1707a(a)(1) and (b) of this chapter. Ext. D&C Yellow No. 7 is restricted to use in externally applied drugs and cosmetics.

Authority: 21 U.S.C. 371, 379e, 379e note.
Source: 42 FR 15669, Mar. 22, 1977, unless otherwise noted.

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