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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2013]
[CITE: 21CFR82.1051]



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

PART 82 -- LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS

Subpart C--Drugs and Cosmetics

Sec. 82.1051 Lakes (D+C).

(a)(1)General. Any lake, other than those listed in subpart B, made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or any combination of two or more of these, (i) one of the straight colors (except lakes) listed in subpart B or hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium; or (ii) a salt prepared from one of the straight colors (except lakes) listed in subpart B, or 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, except that if such name contains the symbol "FD+C" such symbol shall be changed to "D+C";

(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 D+C Red No. 9 upon a substratum is "D+C Red No. 9--Barium Lake", and a lake prepared by extending the aluminum salt prepared from FD+C Green No. 1 upon a substratum other than alumina is "D+C Green No. 1--Aluminum Lake".)

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