21 C.F.R. Subpart C—Drugs and Cosmetics
Title 21 - Food and Drugs
A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in 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. (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”.) The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of §74.1104(a)(1) and (b) of this chapter. D&C Blue No. 4 is restricted to use in externally applied drugs and cosmetics. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of §74.1205(a)(1) and (b)(2) of this chapter. [47 FR 24285, June 4, 1982] The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of §74.1206 (a) and (b) of this chapter. D&C Green No. 6 is restricted to use in externally applied drugs and cosmetics. [47 FR 14147, Apr. 2, 1982, as amended at 51 FR 9785, Mar. 21, 1986] The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of §74.1254(a)(1) and (b) of this chapter. D&C Orange No. 4 is restricted to use in externally applied drugs and cosmetics. [42 FR 52396, Sept. 30, 1977] (a) The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of §74.1255(a)(1) and (b) of this chapter. D&C Orange No. 5 is restricted to the uses described in this section. (b) The color additive D&C Orange No. 5. may be safely used for coloring externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. The color additive D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products, and for coloring mouthwashes, dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice. [49 FR 13343, Apr. 4, 1984] The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements to §74.1260(a)(1) and (b) of this chapter. D&C Orange No. 10 is restricted to use in externally applied drugs and cosmetics. [46 FR 18954, Mar. 27, 1981] The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of §74.1261(a)(1) and (b) of this chapter. D&C Orange No. 11 is restricted to use in externally applied drugs and cosmetics. [46 FR 18954, Mar. 27, 1981] (a) The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of §74.1306 (a)(1) and (b) of this chapter. (b) The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. [47 FR 57691, Dec. 28, 1982] (a) The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of §74.1307 (a)(1) and (b) of this chapter. (b) The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. [47 FR 57691, Dec. 28, 1982] The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of §74.1317 (a)(1) and (b) of this chapter. D&C Red No. 17 is restricted to use in externally applied drugs and cosmetics. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of §74.1321 (a)(1) and (b) of this chapter. [47 FR 53847, Nov. 30, 1982] The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of §74.1322 (a)(1) and (b) of this chapter. [47 FR 53847, Nov. 30, 1982] The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of §74.1327 (a)(1) and (b) of this chapter. [47 FR 42568, Sept. 28, 1982] The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of §74.1328 (a)(1) and (b) of this chapter. [47 FR 42568, Sept. 28, 1982] The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of §74.1330 (a)(1) and (b) of this chapter. [47 FR 22511, May 25, 1982] The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of §74.1331(a)(1) and (b) of this chapter. D&C Red No. 31 is restricted to use in externally applied drugs and cosmetics. (a) The color additive D&C Red. No. 33 shall conform in identity and specifications to the requirements of §74.1333(a) (1) and (b) of this chapter. (b) All lakes of D&C Red. No. 33 shall be manufactured from previously certified batches of the straight color additive. [53 FR 33121, Aug. 30, 1988] Calcium salt of 3-hydroxy-4-[(1-sulfo-2 -naphthalenyl)azol-2-naphthalenecarboxylic acid.
Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent. Subsidiary colors, not more than 4 percent. Total color not less than 85 percent. (a) The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of §74.1336 (a)(1) and (b) of this chapter. (b) All lakes of D&C Red No. 36 shall be manufactured from previously certified batches of the straight color additive. [53 FR 29031, Aug. 2, 1988] The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of §74.1602(a)(1) and (b) of this chapter. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of §74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 7 is restricted to use in externally applied drugs and cosmetics. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of §74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 8 is restricted to use in externally applied drugs and cosmetics. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of §74.1710(a)(1) and (b) of this chapter. [48 FR 39220, Aug. 30, 1983]
Title 21: Food and Drugs
PART 82—LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
Subpart C—Drugs and Cosmetics
§ 82.1050 General.
§ 82.1051 Lakes (D&C).
§ 82.1104 D&C Blue No. 4.
§ 82.1205 D&C Green No. 5.
§ 82.1206 D&C Green No. 6.
§ 82.1254 D&C Orange No. 4.
§ 82.1255 D&C Orange No. 5.
§ 82.1260 D&C Orange No. 10.
§ 82.1261 D&C Orange No. 11.
§ 82.1306 D&C Red No. 6.
§ 82.1307 D&C Red No. 7.
§ 82.1317 D&C Red No. 17.
§ 82.1321 D&C Red No. 21.
§ 82.1322 D&C Red No. 22.
§ 82.1327 D&C Red No. 27.
§ 82.1328 D&C Red No. 28.
§ 82.1330 D&C Red No. 30.
§ 82.1331 D&C Red No. 31.
§ 82.1333 D&C Red No. 33.
§ 82.1334 D&C Red No. 34.
§ 82.1336 D&C Red No. 36.
§ 82.1602 D&C Violet No. 2.
§ 82.1707 D&C Yellow No. 7.
§ 82.1708 D&C Yellow No. 8.
§ 82.1710 D&C Yellow No. 10.
