PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted. Subpart A—Foods § 74.101 FD&C Blue No. 1. (a) Identity. p m o m p p o p p o o o (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o m p N N m Subsidiary colors, not more than 6.0 percent. Chromium (as Cr), not more than 50 parts per million. Manganese (as Mn), not more than 100 parts per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Total color, not less than 85.0 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993] § 74.102 FD&C Blue No. 2. (a) Identity. H H H H H H N (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water insoluble matter, not more than 0.4 percent. Isatin-5-sulfonic acid, not more than 0.4 percent. 5-Sulfoanthranilic acid, not more than 0.2 percent. Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2 H H Sodium salt of 2-(1,3-dihydro-3-oxo-2 H H Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [48 FR 5260, Feb. 4, 1983] § 74.203 FD&C Green No. 3. (a) Identity. N N- N N- N N- N N- benzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid or with dichromate and acid to form the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acid is prepared by the potassium permanganate oxidation of 2,2′-(1,2-ethenediyl)-bis(5-aminobenzenesulfonic acid) to sodium 5-amino-2-formylbenzenesulfonate. This amine is diazotized and the resulting diazonium salt is hydrolyzed to the desired 2-formyl-5-hydroxybenzenesulfonic acid. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring food. (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than 0.5 percent. Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic acid, disodium salts, not more than 0.3 percent. 2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 percent. Subsidiary colors, not more than 6 percent. Chromium (as Cr), not more than 50 parts per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982] § 74.302 Citrus Red No. 2. (a) Identity. (2) The following diluents may be used in aqueous suspension, in the percentages specified, to facilitate application to oranges in accordance with paragraph (c)(1) of this section: (i) Suitable diluents used in accordance with § 73.1(a) of this chapter. (ii) Volatile solvents that leave no residue after application to the orange. (iii) Salts of fatty acids meeting the requirements of § 172.863 of this chapter. (iv) Sodium tripolyphosphate, not more than 0.05 percent. (b) Specifications. Volatile matter (at 100 °C.), not more than 0.5 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 0.5 percent. Uncombined intermediates, not more than 0.05 percent. Subsidiary dyes, not more than 2.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 98 percent. (c) Uses and restrictions. Packinghouse elimination (2) Oranges colored with Citrus Red No. 2 shall bear not more than 2.0 parts per million of such color additive, calculated on the basis of the weight of the whole fruit. (d) Labeling. (1) The statement (or its equivalent) “To be used only for coloring skins of oranges.” (2) Directions for use to limit the amount of the color additive to not more than 2.0 parts per million, calculated on the basis of the weight of the whole fruit. (e) Certification. § 74.303 FD&C Red No. 3. Link to an amendment published at 90 FR 4634, Jan. 16, 2025. (a) Identity. o- (2) Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. Volatile matter (at 135 °C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. Unhalogenated intermediates, total not more than 0.1 percent. Sodium iodide, not more than 0.4 percent. Triiodoresorcinol, not more than 0.2 percent. 2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic acid, not more than 0.2 percent. Monoiodofluoresceins not more than 1.0 percent. Other lower iodinated fluoresceins, not more than 9.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 87.0 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.340 FD&C Red No. 40. (a) Identity. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (3) The listing of this color additive includes lakes prepared as described in § 82.51 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 of this chapter. (b) Specifications. Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent. Water-insoluble matter, not more than 0.2 percent. Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent. Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent. Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not more than 1.0 percent. Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent. 4-Amino-5-methoxy- o- Disodium salt of 6,6′-oxybis (2-naphthalene-sulfonic acid), not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 85.0 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.705 FD&C Yellow No. 5. (a) Identity. H H (2) Color additive mixtures for food use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H H 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. (d) Labeling requirements. (2) Foods for human use that contain FD&C Yellow No. 5, including butter, cheese, and ice cream, shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5 among the list of ingredients. (e) Certification. [42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at 44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986] § 74.706 FD&C Yellow No. 6. (a) Identity. (2) Color additive mixtures for food use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water insoluble matter, not more than 0.2 percent. Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent. Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 percent. Disodium salt of 6,6′-oxybis[2-naphthalenesulfonic acid], not more than 1 percent. Disodium salt of 4,4′-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not more than 0.1 percent. Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic acid and the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent. Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not more than 5 percent. 4-Aminoazobenzene, not more than 50 parts per billion. 4-Aminobiphenyl, not more than 15 parts per billion. Aniline, not more than 250 parts per billion. Azobenzene, not more than 200 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. 1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. (d) Labeling requirements. (2) [Reserved] (e) Certification. [51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988] Subpart B—Drugs § 74.1101 FD&C Blue No. 1 (a) Identity. (2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of § 74.2101(a). (3) Color additive mixtures for drug use made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice, subject to the restrictions on the use of color additives in § 70.5(b) and (c) of this chapter. (d) Labeling. (e) Certification. [47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994] § 74.1102 FD&C Blue No. 2. (a) Identity. (2) Color additive mixtures for use in ingested drugs made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) The color additive FD&C Blue No. 2 for use in coloring ingested drugs shall conform to the specifications in § 74.102(b). (c) The color additive FD&C Blue No. 2 may be safely used for coloring ingested drugs in amounts consistent with current good manufacturing practice. (d) Labeling. (e) Certification. [48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999] § 74.1104 D&C Blue No. 4. (a) Identity. p m- o- m- p- p- o- p- p- o- o- o- (2) Color additive mixtures for use in externally applied drugs made with D&C Blue No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o-, m p- N-ethyl, N-( m- Subsidiary colors, not more than 6 percent. Chromium (as Cr), not more than 50 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1109 D&C Blue No. 9. (a) Identity. (b) Specifications. Volatile matter (at 135 °C.), not more than 3 percent. Matter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent. 2-Amino anthraquinone, not more than 0.2 percent. Organically combined chlorine in pure dye, 13.0-14.8 percent. Lead (as Pb), not more than 20 p/m. Arsenic (as As), not more than 3 p/m. Total color, not less than 97 percent. (c) Uses and restrictions. (1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980). (2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture. (3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue. (4) If the suture is a new drug, a new-drug application approved pursuant to section 505 of the act is in effect for it. (d) Labeling. (e) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993] § 74.1203 FD&C Green No. 3. (a) Identity and specifications. (2) Color additive mixtures for drug use made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Uses and restrictions. (c) Labeling. (d) Certification. [47 FR 52144, Nov. 19, 1982] § 74.1205 D&C Green No. 5. (a) Identity. (2) Color additive mixtures for use in drugs made with D&C Green No. 5 may contain only those diluents that are suitable and those that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. Water insoluble matter, not more than 0.2 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 2-Amino- m Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 80 percent. (2) D&C Green No. 5 for use in coloring drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. Water-insoluble matter, not more than 0.2 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. Sulfonated toluidines, total not more than 0.2 percent. p Sum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not more than 3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 80 percent. (c) Use and restrictions. e (i) The quantity of color additive does not exceed 0.6 percent by weight of the suture. (ii) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue. (iii) If the suture is a new drug, an approved new drug application, under section 505 of the act, is in effect for it. (2) D&C Green No. 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (d) Labeling. (e) Certification. [47 FR 24284, June 4, 1982; 47 FR 27551, June 25, 1982, as amended at 59 FR 40805, Aug. 10, 1994] § 74.1206 D&C Green No. 6. (a) Identity. (b) Specifications. Volatile matter (at 135 °C), not more than 2.0 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96.0 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr. 2, 1982; 47 FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986] § 74.1208 D&C Green No. 8. (a) Identity. (2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Volatile matter (at 135 °C), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Chlorides and sulfates (calculated as sodium salt), not more than 20 percent. The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent. The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent. Pyrene, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 65 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1254 D&C Orange No. 4. (a) Identity. (2) Color additive mixtures for use in externally applied drugs made with D&C Orange No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 2-Naphthol, not more than 0.4 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 3 percent. 4,4′-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981] § 74.1255 D&C Orange No. 5. (a) Identity. (2) Color additive mixtures for drug use made with D&C Orange No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs. (b) Specifications. 4′,5′-dibromofluorescein, not less than 50 percent and not more than 65 percent. 2′,4′,5′-tribromofluorescein, not less than 30 percent and not more than 40 percent. 2′,4′,5′,7′-tetrabromofluorescein, not more than 10 percent. Sum of 2′,4′-dibromofluorescein and 2′,5′-dibromofluorescein, not more than 2 percent. 4′-Bromofluorescein, not more than 2 percent. Fluorescein, not more than 1 percent. Phthalic acid, not more than 1 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Brominated resorcinol, not more than 0.4 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984] § 74.1260 D&C Orange No. 10. (a) Identity. (2) Color additive mixtures for drug use made with D&C Orange No. 10 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent. Fluorescein, not more than 1 percent. 4′-Iodofluorescein, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 percent. 2′,4′,5′,7′-Tetraiodofluorescein, not more than 10 percent. 4′,5′-Diiodofluorescein, not less than 60 percent and not more than 95 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 92 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Certification. [46 FR 18953, Mar. 27, 1981] § 74.1261 D&C Orange No. 11. (a) Identity. (2) Color additive mixtures for drug use made with D&C Orange No. 11 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Water-insoluble matter, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, sodium salt, not more than 0.5 percent. Fluorescein, disodium salt, not more than 1 percent. 4′-Iodofluorescein, disodium salt, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 percent. 2′,4′,5′,7′-Tetraiodofluorescein, disodium salt, not more than 10 percent. 4′,5′-Diiodofluorescein, disodium salt, not less than 60 percent and not more than 95 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 92 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Certification. [46 FR 18953, Mar. 27, 1981] § 74.1303 FD&C Red No. 3. Link to an amendment published at 90 FR 4634, Jan. 16, 2025. (a) Identity and specifications. (2) Color additive mixtures for ingested drug used made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.1304 FD&C Red No. 4. (a) Identity. (2) Color additive mixtures for use in externally applied drugs made with FD&C Red No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 0.2 percent. 4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1306 D&C Red No. 6. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium salt, not more than 0.5 percent. p- Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012] § 74.1307 D&C Red No. 7. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium salt, not more than 0.5 percent. p Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012] § 74.1317 D&C Red No. 17. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 17 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Volatile matter (at 135 °C), not more than 5 percent. Matter insoluble in both toluene and water (color additive mixed in toluene and the resultant residue isolated and mixed with water to obtain the matter insoluble in both toluene and water), not more than 0.5 percent. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Aniline, not more than 0.2 percent. 4-Aminoazobenzene, not more than 0.1 percent. 2-Naphthol, not more than 0.2 percent. 1-(Phenylazo)-2-naphthol, not more than 3 percent. 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977] § 74.1321 D&C Red No. 21. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 21 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. Brominated resorcinol, not more than 0.4 percent. Fluorescein, not more than 0.2 percent. Sum of mono- and dibromofluoresceins, not more than 2 percent. Tribromofluoresceins, not more than 11 percent. 2′,4′,5′,7′-Tetrabromofluorescein, not less than 87 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 53846, Nov. 30, 1982] § 74.1322 D&C Red No. 22. (a) Identity. (2) Color additive mixtures for drug use made with Red No. 22 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as soduim salts), not more than 10 percent. Water-insoluble matter not more than 0.5 percent. Disodium salt of phthalic acid, not more than 1 percent. Sodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.5 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. Brominated resorcinol, not more than 0.4 percent. Sum of disodium salts of mono- and dibromofluoresceins, not more than 2 percent. Sum of disodium salts of tribromofluoresceins, not more than 25 percent. Disodium salt of 2′,4′,5′,7′-Tetrabromofluorescein, not less than 72 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 53846, Nov. 30, 1982] § 74.1327 D&C Red No. 27. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 27 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982] § 74.1328 D&C Red No. 28. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 28 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 15 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 42568, Sept. 28, 1982] § 74.1330 D&C Red No. 30. (a) Identity. b H b H (2) Color additive mixtures for drug use made with D&C Red No. 30 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Volatile matter (at 135 °C), not more than 5 percent. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Matter soluble in acetone, not more than 5 percent. Total color, not less than 90 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. (d) Labeling. (e) Certification. [47 FR 22510, May 25, 1982] § 74.1331 D&C Red No. 31. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 31 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. Aniline, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1333 D&C Red No. 33. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 33 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.3 percent. 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not more than 0.3 percent. 4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt, not more than 3.0 percent. Aniline, not more than 25 parts per million. 4-Aminoazobenzene, not more than 100 parts per billion. 1,3-Diphenyltriazene, not more than 125 parts per billion. 4-Aminobiphenyl, not more than 275 parts per billion. Azobenzene, not more than 1 part per million. Benzidine, not more than 20 parts per billion. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 82 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Certification. [53 FR 33120, Aug. 30, 1988] § 74.1334 D&C Red No. 34. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 34 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated at 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. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1336 D&C Red No. 36. (a) Identity. (2) Color additive mixtures for drug use made with D&C Red No. 36 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Volatile matter at 135 °C (275 °F), not more than 1.5 percent. Matter insoluble in toluene, not more than 1.5 percent. 2-Chloro-4-nitrobenzenamine, not more than 0.3 percent. 2-Naphthalenol, not more than 1 percent. 2,4-Dinitrobenzenamine, not more than 0.02 percent. 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent. 4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 percent. 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. 1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 95 percent. (c) Uses and restrictions. (d) Labeling requirements. (e) Certification. [53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at 53 FR 52130, Dec. 27, 1988] § 74.1339 D&C Red No. 39. (a) Identity. o- p (2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212. (b) Specifications. Volatile matter (at 100 °C.), not more than 2.0 percent. Matter insoluble in acetone, not more than 1.0 percent. Anthranilic acid, not more than 0.2 percent. N,N- Subsidiary colors, not more than 3.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 95.0 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1340 FD&C Red No. 40. (a) Identity and specifications. (2) Color additive mixtures for drug use made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (3) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by §§ 82.51 or 82.1051 of this chapter.) (b) Uses and restrictions. (2) Other lakes of FD&C Red No. 40 may be safely used in coloring drugs, subject to the restrictions on the use of color additives in § 70.5 of this chapter, in amounts consistent with current good manufacturing practice. (c) Labeling. (d) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994] § 74.1602 D&C Violet No. 2. (a) Identity. (2) Color additive mixtures for use in externally applied drugs made with D&C Violet No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Volatile matter (at 135 °C.), not more than 2.0 percent. Matter insoluble in both carbon tetrachloride and water, not more than 0.5 percent. p- 1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent. Subsidiary colors, not more than 1.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 96.0 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, 1990] § 74.1705 FD&C Yellow No. 5. (a) Identity and specifications. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (3) Color additive mixtures for drug use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Uses and restrictions. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, when prepared in accordance with § 82.51 of this chapter. (c) Labeling requirements. (2) The label of OTC and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive using the names FD&C Yellow No. 5 and tartrazine. The label shall bear a statement such as “Contains FD&C Yellow No. 5 (tartrazine) as a color additive” or “Contains color additives including FD&C Yellow No. 5 (tartrazine).” The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as: antibacterial mouthwashes and fluoride toothpastes, need not comply with this requirement provided they comply with the requirements of § 701.3 of this chapter. (3) For prescription drugs for human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) of this chapter shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement “This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions” section of the labeling. (d) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 29, 1994] § 74.1706 FD&C Yellow No. 6. (a) Identity and specifications. (2) Color additive mixtures for drug use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Uses and restrictions. (c) Labeling requirements. (2) [Reserved] (d) Certification. [51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988] § 74.1707 D&C Yellow No. 7. (a) Identity. (2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 6 percent. Matter insoluble in alkaline water, not more than 0.5 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 94 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1707a Ext. D&C Yellow No. 7. (a) Identity. (2) Color additive mixtures for drug use made with Ext. D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. 1-Naphthol, not more than 0.2 percent. 2,4-Dinitro-1-naphthol, not more than 0.03 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1708 D&C Yellow No. 8. (a) Identity. (2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in alkaline water, not more than 0.3 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.1710 D&C Yellow No. 10. (a) Identity. H H H H H H (2) Color additive mixtures made with D&C Yellow No. 10 for drug use may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs. (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in both water and chloroform, not more than 0.2 percent. Total sulfonated quinaldines, sodium salts, not more than 0.2 percent. Total sulfonated phthalic acids, sodium salts, not more than 0.2 percent. 2-(2-Quinolinyl)-1 H H Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1 H H Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1 H H 2-(2,3-Dihydro-1,3-dioxo-1 H Diethyl ether soluble matter other than that specified, not more than 2 parts per million, using added 2-(2-quinolinyl)-1 H H Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984] § 74.1711 D&C Yellow No. 11. (a) Identity. (2) Color additive mixtures, for drug use made with D&C Yellow No. 11 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. Volatile matter (at 135 °C), not more than 1 percent. Ethyl alcohol-insoluble matter, not more than 0.4 percent. Phthalic acid, not more than 0.3 percent. Quinaldine, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. Subpart C—Cosmetics § 74.2052 D&C Black No. 2. (a) Identity. 2 (b) Specifications. (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m 2 (2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent. (3) Ash content, not more than 0.15 percent. (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million). (5) Lead (total), not more than 10 mg/kg (10 parts per million). (6) Mercury (total), not more than 1 mg/kg (1 part per million). (7) Total sulfur, not more than 0.65 percent. (8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion). (9) Benzo[ a (10) Dibenz[ a,h (11) Total color (as carbon), not less than 95 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. [69 FR 44930, July 28, 2004, as amended at 72 FR 10357] § 74.2053 D&C Black No. 3. (a) Identity. (b) Specifications. (1) Calcium hydroxyapatite (CaO and P 2 5 (2) Elemental carbon, not less than 7 percent; (3) Moisture, not more than 7 percent; (4) Silica (SiO 2 (5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts per million (ppm)); (6) Lead, not more than 10 mg/kg (10 ppm); and (7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm). (c) Uses and restrictions. (d) Labeling. (e) Certification. [72 FR 33666, June 19, 2007] § 74.2101 FD&C Blue No. 1. (a) Identity. p m o m p p o p p o o o (b) Specifications. (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (d) Labeling. (e) Certification. [47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, 1994] § 74.2104 D&C Blue No. 4. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2151 D&C Brown No. 1. (a) Identity. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 16 percent. Water-insoluble matter, not more than 0.2 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Resorcinol, not more than 0.2 percent. Xylidines, not more than 0.2 percent. Disodium salt of 4[[5-[(4-sulfophenyl)-azo]-2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not more than 3 percent. Monosodium salt of 4[[5-[(2,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 29 percent and not more than 39 percent. Monosodium salt of 4[[5-[(2,5-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 12 percent and not more than 17 percent. Monosodium salt of 4[[5-[(2,3-dimethyl-phenyl)azo] - 2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 6 percent and not more than 13 percent. Monosodium salt of 4[[5-[(2-ethylphenyl)-azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 5 percent and not more than 12 percent. Monosodium salt of 4[[5-[(3,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 9 percent. Monosodium salt of 4[[5-[(2,6-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 8 percent. Monosodium salt of 4[[5-[(4-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 2 percent and not more than 8 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 84 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.2203 FD&C Green No. 3. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. [47 FR 52144, Nov. 19, 1982] § 74.2205 D&C Green No. 5. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 24285, June 4, 1982, as amended at 59 FR 40805, Aug. 10, 1994] § 74.2206 D&C Green No. 6. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 14146, Apr. 4, 1982, as amended at 51 FR 9784, Mar. 21, 1986] § 74.2208 D&C Green No. 8. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2254 D&C Orange No. 4. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. [42 FR 52396, Sept. 30, 1977] § 74.2255 D&C Orange No. 5. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. [47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984] § 74.2260 D&C Orange No. 10. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [46 FR 18954, Mar. 27, 1981] § 74.2261 D&C Orange No. 11. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [46 FR 18954, Mar. 27, 1981] § 74.2304 FD&C Red No. 4. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2306 D&C Red No. 6. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 57688, Dec. 28, 1982] § 74.2307 D&C Red No. 7 (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 57688, Dec. 28, 1982] § 74.2317 D&C Red No. 17. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2321 D&C Red No. 21. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 53846, Nov. 30, 1982] § 74.2322 D&C Red No. 22. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 53846, Nov. 30, 1982] § 74.2327 D&C Red No. 27. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 42568, Sept. 28, 1982] § 74.2328 D&C Red No. 28. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 42568, Sept. 28, 1982] § 74.2330 D&C Red No. 30. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [47 FR 22511, May 25, 1982] § 74.2331 D&C Red No. 31. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2333 D&C Red No. 33. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [53 FR 33120, Aug. 30, 1988] § 74.2334 D&C Red No. 34. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2336 D&C Red No. 36. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling requirements. (d) Certification. [53 FR 29031, Aug. 2, 1988] § 74.2340 FD&C Red No. 40. (a) Identity and specifications. (2) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 or § 82.1051 of this chapter. (b) Uses and restrictions. (1) The color additive may be used in amounts consistent with current good manufacturing practice. (2) The color additive shall not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives or any other condition that may affect their integrity. (c) Labeling. (d) Certification. [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994] § 74.2602 D&C Violet No. 2. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2602a Ext. D&C Violet No. 2. (a) Identity. (b) Specifications. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.4 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent. p- p- Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 80 percent. (c) Uses and restrictions. (d) Labeling. (e) Certification. § 74.2705 FD&C Yellow No. 5. (a) Identity. H H (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H H 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (d) Labeling. (e) Certification. [50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994] § 74.2706 FD&C Yellow No. 6. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. [51 FR 41782, Nov. 19, 1986] § 74.2707 D&C Yellow No. 7. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2707a Ext. D&C Yellow No. 7. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2708 D&C Yellow No. 8. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. § 74.2710 D&C Yellow No. 10. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. [48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984] § 74.2711 D&C Yellow No. 11. (a) Identity and specifications. (b) Uses and restrictions. (c) Labeling. (d) Certification. Subpart D—Medical Devices § 74.3045 [Phthalocyaninato(2-)] copper. (a) Identity. (b) Specifications. Volatile matter 135 °C (275 °F), not more than 0.3 percent. Salt content (as NaC1), not more than 0.3 percent. Alcohol soluble matter, not more than 0.5 percent. Organic chlorine, not more than 0.5 percent. Aromatic amines, not more than 0.05 percent. Lead (as Pb), not more than 40 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 98.5 percent. (c) Uses and restrictions. alpha omega (i) The quantity of the color additive does not exceed 0.5 percent by weight of the suture, haptic material, or orientation mark. (ii) The dyed suture shall conform in all respects to the requirements of the U.S. Pharmacopeia. (2) The color additive [phthalocyaninato(2-)] copper may be safely used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. (3) Authorization for these uses shall not be construed as waiving any of the requirements of section 510(k), 515, or 520(g) the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which [phthalocyaninato(2-)] copper is used. (d) Labeling. (e) Certification. [48 FR 34947, Aug. 2, 1983, as amended at 50 FR 16228, Apr. 25, 1985; 51 FR 22929, June 24, 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371, Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR 19620, May 10, 1990; 64 FR 23186, Apr. 30, 1999; 81 FR 75692, Nov. 1, 2016] § 74.3054 D&C Black No. 4. (a) Identity. 2 (b) Specifications. (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 50 to 260 m 2 (2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent. (3) Ash content, not more than 0.15 percent. (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million). (5) Lead (total), not more than 10 mg/kg (10 parts per million). (6) Mercury (total), not more than 1 mg/kg (1 part per million). (7) Total sulfur, not more than 0.65 percent. (8) Total polycyclic aromatic hydrocarbons (PAHs), not more than 0.5 mg/kg (500 parts per billion). (9) Benzo[ a (10) Dibenz[ a,h (11) Total color (as carbon), not less than 95 percent. (c) Uses and restrictions. (2) Authorization and compliance with this use must not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the ultra-high molecular weight polyethylene surgical sutures in which D&C Black No. 4 is used. (d) Labeling. (e) Certification. [83 FR 26359, June 7, 2018] § 74.3102 FD&C Blue No. 2. (a) Identity. (b) Specifications. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water insoluble matter, not more than 0.4 percent. Isatin-5-sulfonic acid, not more than 0.4 percent. Isomeric colors, not more than 18 percent. Lower sulfonated subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 85 percent. (2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina for use in bone cement shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (i) The quantity of color additive does not exceed 1 percent by weight of the suture; (ii) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980); and (iii) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissues. (2) The color additive FD&C Blue No. 2-Aluminum Lake on alumina may be safely used for coloring bone cement at a level not to exceed 0.1 percent by weight of the bone cement. (3) Authorization and compliance with these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which the color additive FD&C Blue No. 2 and the color additive FD&C Blue No. 2-Aluminum Lake on alumina are used. (d) Labeling. (e) Certification. [64 FR 48290, Sept. 3, 1999] § 74.3106 D&C Blue No. 6. (a) Identity. (b) Specifications. Volatile matter at 135 °C (275 °F), not more than 3 percent. Matter insoluble in N,N- Isatin, not more than 0.3 percent. Anthranilic acid, not more than 0.3 percent. Indirubin, not more than 1 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 95 percent. (c) Uses and restrictions. (i) Not to exceed 0.2 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures for general surgical use; (ii) Not to exceed 0.25 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for general surgical use; (iii) Not to exceed 0.5 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for ophthalmic surgical use; (iv) Not to exceed 0.5 percent by weight of the suture material for coloring polypropylene surgical sutures for general surgical use; and (v) Not to exceed 0.5 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for ophthalmic and general surgical use. (2) Authorization for these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which the color additive is used. (d) Labeling. (e) Certification. [49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 50 FR 30698, July 29, 1985] § 74.3206 D&C Green No. 6. (a) Identity. (b) Specifications. (c) Uses and restrictions. (i) Not to exceed 0.03 percent by weight of the lens material for coloring contact lenses; (ii) Not to exceed 0.75 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures, including sutures for ophthalmic use; (iii) Not to exceed 0.1 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter greater than U.S.P. size 8-0, including sutures for ophthalmic use; (iv) Not to exceed 0.5 percent by weight of the suture material for coloring polyglycolic acid surgical sutures with diameter not greater than U.S.P. size 8-0, including sutures for ophthalmic use; (v) Not to exceed 0.21 percent by weight of the suture material for coloring poly(glycolic acid- co (vi) Not to exceed 0.10 percent by weight of the haptic material for coloring polymethylmethacrylate support haptics of intraocular lenses. (2) Authorization for these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which D&C Green No. 6 is used. (d) Labeling. (e) Certification. [48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27, 1986; 58 FR 21542, Apr. 22, 1993] § 74.3230 D&C Red No. 17. (a) Identity and specifications. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (c) Labeling. (d) Certification. [55 FR 22898, June 5, 1990] § 74.3602 D&C Violet No. 2. (a) Identity and specifications. (b) Uses and restrictions. (2) D&C Violet No. 2 may be safely used for coloring sutures for use in surgery subject to the following conditions: (i) At a level not to exceed 0.2 percent by weight of the suture material for coloring copolymers of 90 percent glycolide and 10 percent L-lactide synthetic absorbable sutures for use in general and ophthalmic surgery; and (ii) At a level not to exceed 0.3 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for use in general and ophthalmic surgery. (iii) At a level not to exceed 0.25 percent by weight of the suture material for coloring poliglecaprone 25 (ε-caprolactone/glycolide copolymer) synthetic absorbable sutures for use in general surgery. (iv) At a level not to exceed 0.1 percent by weight of the suture material for coloring poly(ε-caprolactone) absorbable sutures for use in general surgery. (v) At a level not to exceed 0.2 percent by weight of the suture material for coloring glycolide/dioxanone/trimethylene carbonate tripolymer absorbable sutures for use in general surgery. (vi) At a level not to exceed 0.2 percent by weight of the suture material for coloring absorbable sutures prepared from homopolymers of glycolide for use in general surgery. (3) The color additive, D&C Violet No. 2, may be safely used for coloring polymethylmethacrylate intraocular lens haptics at a level not to exceed 0.2 percent by weight of the haptic material. (4) The color additive, D&C Violet No. 2, may be safely used for coloring absorbable meniscal tacks made from poly (L-lactic acid) at a level not to exceed 0.15 percent by weight of the tack material. (5) Authorization for these uses shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical devices in which the color additive is used. (c) Labeling. (d) Certification. [52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000] § 74.3708 D&C Yellow No. 8. (a) Identity and specifications. (b) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens solution in which the color additive is used. (c) Labeling. (d) Certification. [83 FR 48375, Sept. 25, 2018] § 74.3710 D&C Yellow No. 10. (a) Identity. (b) Specifications. (c) Uses and restrictions. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used. (d) Labeling. (e) Certification. [52 FR 28690, Aug. 3, 1987]