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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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[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 B - Foods, Drugs, and Cosmetics

Sec. 82.50 General.

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

Sec. 82.51 Lakes (FD&C).

(a)(1) General. Any lake made by extending on a substratum of alumina, a salt prepared from one of the certified water-soluble straight colors hereinbefore listed in this subpart by combining such color with the basic radical aluminum or calcium.

(2) Specifications. Prepared from previously certified colors listed in this subpart.

Soluble chlorides and sulfates (as sodium salts), not more than 2.0 percent.

Inorganic matter, insoluble HCl, not more than 0.5 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 aluminum salt prepared from FD&C Blue No. 1 upon the substratum would be FD&C Blue No. 1 - Aluminum Lake.)

Sec. 82.101 FD&C Blue No. 1.

The color additive FD&C Blue No. 1 shall conform in identity and specifications to the requirements of § 74.101(a)(1) and (b) of this chapter.

Sec. 82.102 FD&C Blue No. 2.

The color additive FD&C Blue No. 2 shall conform in identity and specifications to the requirements of § 74.102(a)(1) and (b) of this chapter.

[48 FR 5261, Feb. 4, 1983]

Sec. 82.203 FD&C Green No. 3.

The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of § 74.203(a)(1) and (b) of this chapter.

[47 FR 52144, Nov. 19, 1982]

Sec. 82.304 FD&C Red No. 4.

The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of § 74.1304(a)(1) and (b) of this chapter. FD&C Red No. 4 is restricted to use in externally applied drugs and cosmetics.

Sec. 82.705 FD&C Yellow No. 5.

The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of § 74.705 (a)(1) and (b) of this chapter.

[51 FR 24519, July 7, 1986]

Sec. 82.706 FD&C Yellow No. 6.

(a) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706 (a)(1) and (b) of this chapter.

(b) All lakes including current D&C external and D&C lakes of FD&C Yellow No. 6 shall be manufactured from previously certified batches of the straight color additive.

[52 FR 21509, June 8, 1987]

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

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