Listing of color additives subject to certification (21 CFR 74.101-74.3710)

454 21 CFR Ch. I (4–1–16 Edition) Pt. 74 PART 74—LISTING OF COLOR AD DITIVES SUBJECT TO CERTIFI CATION Subpart A—Foods Sec. 74.101 FD&C Blue No. 1. 74.102 FD&C Blue No. 2. 74.203 FD&C Green No. 3. 74.250 Orange B. 74.302 Citrus Red No. 2. 74.303 FD&C Red No. 3. 74.340 FD&C Red No. 40. 74.705 FD&C Yellow No. 5. 74.706 FD&C Yellow No. 6. Subpart B—Drugs 74.1101 FD&C Blue No. 1. 74.1102 FD&C Blue No. 2. 74.1104 D&C Blue No. 4. 74.1109 D&C Blue No. 9. 74.1203 FD&C Green No. 3. 74.1205 D&C Green No. 5. 74.1206 D&C Green No. 6. 74.1208 D&C Green No. 8. 74.1254 D&C Orange No. 4. 74.1255 D&C Orange No. 5. 74.1260 D&C Orange No. 10. 74.1261 D&C Orange No. 11. 74.1303 FD&C Red No. 3. 74.1304 FD&C Red No. 4. 74.1306 D&C Red No. 6. 74.1307 D&C Red No. 7. 74.1317 D&C Red No. 17. 74.1321 D&C Red No. 21. 74.1322 D&C Red No. 22. 74.1327 D&C Red No. 27. 74.1328 D&C Red No. 28. 74.1330 D&C Red No. 30. 74.1331 D&C Red No. 31. 74.1333 D&C Red No. 33. 74.1334 D&C Red No. 34. 74.1336 D&C Red No. 36. 74.1339 D&C Red No. 39. 74.1340 FD&C Red No. 40. 74.1602 D&C Violet No. 2. 74.1705 FD&C Yellow No. 5. 74.1706 FD&C Yellow No. 6. 74.1707 D&C Yellow No. 7. 74.1707a Ext. D&C Yellow No. 7. 74.1708 D&C Yellow No. 8. 74.1710 D&C Yellow No. 10. 74.1711 D&C Yellow No. 11. Subpart C—Cosmetics 74.2052 D&C Black No. 2. 74.2053 D&C Black No. 3. 74.2101 FD&C Blue No. 1. 74.2104 D&C Blue No. 4. 74.2151 D&C Brown No. 1. 74.2203 FD&C Green No. 3. 74.2205 D&C Green No. 5. 74.2206 D&C Green No. 6. 74.2208 D&C Green No. 8. 74.2254 D&C Orange No. 4. 74.2255 D&C Orange No. 5. 74.2260 D&C Orange No. 10. 74.2261 D&C Orange No. 11. 74.2304 FD&C Red No. 4. 74.2306 D&C Red No. 6. 74.2307 D&C Red No. 7. 74.2317 D&C Red No. 17. 74.2321 D&C Red No. 21. 74.2322 D&C Red No. 22. 74.2327 D&C Red No. 27. 74.2328 D&C Red No. 28. 74.2330 D&C Red No. 30. 74.2331 D&C Red No. 31. 74.2333 D&C Red No. 33. 74.2334 D&C Red No. 34. 74.2336 D&C Red No. 36. 74.2340 FD&C Red No. 40. 74.2602 D&C Violet No. 2. 74.2602a Ext. D&C Violet No. 2. 74.2705 FD&C Yellow No. 5. 74.2706 FD&C Yellow No. 6. 74.2707 D&C Yellow No. 7. 74.2707a Ext. D&C Yellow No. 7. 74.2708 D&C Yellow No. 8. 74.2710 D&C Yellow No. 10. 74.2711 D&C Yellow No. 11. Subpart D—Medical Devices 74.3045 [Phthalocyaninato(2-)] copper. 74.3102 FD&C Blue No. 2. 74.3106 D&C Blue No. 6. 74.3206 D&C Green No. 6. 74.3230 D&C Red No. 17. 74.3602 D&C Violet No. 2. 74.3710 D&C Yellow No. 10. 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. (1) The color additive FD&C Blue No. 1 is principally the di sodium salt of ethyl [4-[p-[ethyl (m sulfobenzyl) amino]-a-(o-sulfophenyl) benzylidene] - 2,5 -cyclohexadien - 1 ylidene] (m-sulfobenzyl) ammonium hy droxide inner salt with smaller amounts of the isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]-a-(o-sulfophenyl) benzylidene] 2,5-cyclohexadien-1-ylidene] (p sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o sulfobenzyl) amino] - a - (o sulfophenyl) benzylidene]-2,5 cyclohexadien-1-ylidene] (o VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00464 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 455 Food and Drug Administration, HHS § 74.102 sulfobenzyl) ammonium hydroxide inner salt. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 1 may con tain only those diluents that are suit able and that are listed in part 73 of this chapter as safe for use in color ad ditive mixtures for coloring foods. (b) Specifications. FD&C Blue No. 1 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent 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 so dium 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-, and p-sulfobenzaldehydes, not more than 1.5 percent. N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent. 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 mil lion. Total color, not less than 85.0 percent. (c) Uses and restrictions. FD&C Blue No. 1 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accord ance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993] § 74.102 FD&C Blue No. 2. (a) Identity. (1) The color additive FD&C Blue No. 2 is principally the di sodium salt of 2-(1,3-dihydro-3-oxo-5 sulfo-2H-indol-2-ylidene)-2,3-dihydro-3 oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 860–22–0) with smaller amounts of the disodium salt of 2-(1,3-dihydro-3 oxo-7-sulfo-2H-indol-2-ylidene)-2,3 dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 54947–75–0) and the so dium salt of 2-(1,3-dihydro-3-oxo-2H indol-2-ylidene)-2,3-dihydro-3-oxo-1H indole-5-sulfonic acid (CAS Reg. No. 605–18–5). Additionally, FD&C Blue No. 2 is obtained by heating indigo (or in digo paste) in the presence of sulfuric acid. The color additive is isolated and subjected to purification procedures. The indigo (or indigo paste) used above is manufactured by the fusion of N phenylglycine (prepared from aniline and formaldehyde) in a molten mixture of sodamide and sodium and potassium hydroxides under ammonia pressure. The indigo is isolated and subjected to purification procedures prior to sulfonation. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 2 may con tain only those diluents that are suit able and that are listed in part 73 of this chapter as safe for use in color ad ditive mixtures for coloring foods. (b) Specifications. The color additive FD&C Blue No. 2 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 (275 °F) and chlorides and sulfates (calculated as so dium salts), not more than 15 percent. Water insoluble matter, not more than 0.4 percent. Isatin-5-sulfonic acid, not more than 0.4 per cent. 5-Sulfoanthranilic acid, not more than 0.2 percent. Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo 2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H indole-5-sulfonic acid, not more than 18 percent. Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol 2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5 sulfonic acid, not more than 2 percent. Lead (as Pb), not more than 10 parts per mil lion. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00465 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 456 21 CFR Ch. I (4–1–16 Edition) § 74.203 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. The color ad ditive FD&C Blue No. 2 may be safely used for coloring foods (including die tary supplements) generally in amounts consistent with current good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 2 shall be certified in accord ance with regulations in part 80 of this chapter. [48 FR 5260, Feb. 4, 1983] § 74.203 FD&C Green No. 3. (a) Identity. (1) The color additive FD&C Green No. 3 is principally the inner salt disodium salt of N-ethyl-N [4-[[4-[ethyl[(3 sulfophenyl)methyl]amino]phenyl](4 hydroxy-2-sulfophenyl)methylene]-2,5 cyclohexadien-1-ylidene]-3 sulfobenzenemethanaminium hydrox ide (CAS Reg. No. 2353–45–9); with smaller amounts of the isomeric inner salt disodium salt of N-ethyl-N-[4-[[4 [ethyl[(3-sulfophenyl)methyl] amino]phenyl](4-hydroxy-2 sulfophenyl)methylene]-2,5 cyclohexadien-1-ylidene]-4 sulfobenzenemethanaminium hydrox ide; of N-ethyl-N-[4-[[4-[ethyl[(4 sulfophenyl)methyl]amino]phenyl](4 hydroxy-2-sulfophenyl)methylene]-2,5 cyclohexadien-1-ylidene]-4 sulfobenzenemethanaminium hydrox ide and of N-ethyl-N-[4-[[4-[ethyl[(2 sulfophenyl)methyl]amino]phenyl](4 hydroxy-2-sulfophenyl)methylene]-2,5 cyclohexadien-1-ylidene]-3 sulfobenzenemethanaminium hydrox ide. Additionally, FD&C Green No. 3 is manufactured by the acid catalyzed condensation of one molecule of 2 formyl-5-hydroxybenzenesulfonic acid with two molecules from a mixture consisting principally of 3 [(ethylphenylamino)methyl] 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 di chromate and acid to form the dye. The intermediate 2-formyl-5 hydroxybenzenesulfonic acid is pre pared 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 result ing 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 con tain only those diluents that are suit able and that are listed in part 73 of this chapter as safe for use in color ad ditive mixtures for coloring food. (b) Specifications. The color additive FD&C Green No. 3 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 (275 °F) and chlorides and sulfates (calculated as so dium 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, so dium 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 mil lion. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00466 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 457 Food and Drug Administration, HHS § 74.302 (c) Uses and restrictions. The color ad ditive FD&C Green No. 3 may be safely used for coloring foods (including die tary supplements) generally in amounts consistent with current good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Green No. 3 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982] § 74.250 Orange B. (a) Identity. (1) The color additive Or ange B is principally the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4 sulfonaphthylazo)-5-hydro-xypyrazole. (2) The diluents in color additive mixtures for food use containing Or ange B are limited to those listed in part 73 of this chapter as safe and suit able in color additive mixtures for coloring foods. (b) Specifications. Orange B shall con form to the following specifications: Volatile matter (at 135 °C.), not more than 6.0 percent. Chlorides and sulfates (calculated as the so dium salts), not more than 7.0 percent. Water insoluble matter, not more than 0.2 percent. 1-(4-Sulfophenyl)-3-ethylcarboxy-5 hydroxypyrazolone and 1-(4-sulfophenyl)-3 carboxy-5-hydroxypyrazolone, not more than 0.7 percent. Naphthionic acid, not more than 0.2 percent. Phenylhydrazine-p-sulfonic acid, not more than 0.2 percent. The trisodium salt of 1-(4-sulfophenyl)-3 carboxy-4-(4-sulfonaphthylazo)-5 hydroxypyrazole, not more than 6.0 per cent. Other subsidiary dyes, not more than 1.0 per cent. Lead (as Pb), not more than 10 parts per mil lion. Arsenic (as As), not more than 1 part per million. Total color, not less than 87.0 percent. (c) Uses and restrictions. Orange B may be safely used for coloring the cas ings or surfaces of frankfurters and sausages subject to the restriction that the quantity of the color additive does not exceed 150 parts per million by weight of the finished food. (d) Labeling requirements. The label of the color additive and any mixtures in tended solely or in part for coloring purposes prepared therefrom shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of Orange B shall be certified in accordance with regulations promulgated under part 80 of this chapter. § 74.302 Citrus Red No. 2. (a) Identity. (1) The color additive Citrus Red No. 2 is principally 1–(2,5– dimethoxyphenylazo)-2-naphthol. (2) The following diluents may be used in aqueous suspension, in the per centages specified, to facilitate appli cation to oranges in accordance with paragraph (c)(1) of this section: (i) Suitable diluents used in accord ance 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 chap ter. (iv) Sodium tripolyphosphate, not more than 0.05 percent. (b) Specifications. Citrus Red No. 2 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities may be avoided by good manufacturing prac tice: Volatile matter (at 100 °C.), not more than 0.5 percent. Water-soluble matter, not more than 0.3 per cent. 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 mil lion. Arsenic (as As), not more than 1 part per million. Total color, not less than 98 percent. (c) Uses and restrictions. (1) Citrus Red No. 2 shall be used only for coloring the skins of oranges that are not intended VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00467 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 458 21 CFR Ch. I (4–1–16 Edition) § 74.303 or used for processing (or if so used are designated in the trade as Packinghouse elimination) and that meet minimum maturity standards established by or under the laws of the States in which the oranges are grown. (2) Oranges colored with Citrus Red No. 2 shall bear not more than 2.0 parts per million of such color additive, cal culated on the basis of the weight of the whole fruit. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. To meet the requirements of § 70.25 (b) and (c) of this chapter the label shall bear: (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, cal culated on the basis of the weight of the whole fruit. (e) Certification. All batches of Citrus Red No. 2 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.303 FD&C Red No. 3. (a) Identity. (1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 (o- carboxyphenyl)-6 hydroxy - 2,4,5,7-tetraiodo-3H-xanthen 3-one, disodium salt, with smaller amounts of lower imdinated fluoresceins. (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. FD&C Red No. 3 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be avoided by good manufacturing prac tice: 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 per cent. Other lower iodinated fluoresceins, not more than 9.0 percent. Lead (as Pb), not more than 10 parts per mil lion. Arsenic (as As), not more than 3 parts per million. Total color, not less than 87.0 percent. (c) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring foods generally (including dietary sup plements) in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Red No. 3 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.340 FD&C Red No. 40. (a) Identity. (1) The color additive FD&C Red No. 40 is principally the di sodium salt of 6-hydroxy-5-[(2 methoxy-5-methyl-4-sulfophenyl)azo]-2 naphthalenesulfonic acid. (2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may con tain only those diluents that are suit able and that are listed in part 73 of this chapter as safe for use in color ad ditive 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 speci fication and labeling requirements pre scribed by § 82.51 of this chapter. (b) Specifications. FD&C Red No. 40 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00468 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 459 Food and Drug Administration, HHS § 74.705 avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as so dium salts), not more than 14.0 percent. Water-insoluble matter, not more than 0.2 percent. Higher sulfonated subsidiary colors (as so dium salts), not more than 1.0 percent. Lower sulfonated subsidiary colors (as so dium 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- toluenesulfonic acid, not more than 0.2 percent. 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 mil lion. Arsenic (as As), not more than 3 parts per million. Total color, not less than 85.0 percent. (c) Uses and restrictions. FD&C Red No. 40 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color ad ditive and any lakes or mixtures pre pared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regula tions in part 80 of this chapter. § 74.705 FD&C Yellow No. 5. (a) Identity. (1) The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-4-[4-sulfophenyl-azo]-1H pyrazole-3-carboxylic acid (CAS Reg. No. 1934–21–0). To manufacture the ad ditive, 4-amino-benzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (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. FD&C Yellow No. 5 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be avoided by good manufacturing prac tice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as so dium 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]-1H-pyrazol-1,3 diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono] 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr azole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-4-[(4-sulfophenyl)hydrazono] 1H-pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4 sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo 4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr azole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr azole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-1H-pyrazole-3-carboxylate, so dium salt, not more than 0.1 percent. 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 bil lion. 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 mil lion. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00469 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 460 21 CFR Ch. I (4–1–16 Edition) § 74.706 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. FD&C Yellow No. 5 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall con form to the requirements of § 70.25 of this chapter. (2) Foods for human use that contain FD&C Yellow No. 5, including butter, cheese, and ice cream, shall specifi cally declare the presence of FD&C Yellow No. 5 by listing the color addi tive as FD&C Yellow No. 5 among the list of ingredients. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. (1) The color additive FD&C Yellow No. 6 is principally the disodium salt of 6-hydroxy-5-[(4 sulfophenyl)azo]-2-naphthalenesulfonic acid (CAS Reg. No. 2783–94–0). The tri sodium salt of 3-hydroxy-4-[(4 sulfophenyl)azo]-2,7 naphthalenedisulfonic acid (CAS Reg. No. 50880–65–4) may be added in small amounts. The color additive is manu factured by diazotizing 4 aminobenzenesulfonic acid using hy drochloric acid and sodium nitrite or sulfuric acid and sodium nitrite. The diazo compound is coupled with 6-hy droxy-2-naphthalene-sulfonic acid. The dye is isolated as the sodium salt and dried. The trisodium salt of 3-hydroxy 4-[(4-sulfophenyl)azo]-2,7 naphthalenedisulfonic acid which may be blended with the principal color is prepared in the same manner except the diazo benzenesulfonic acid is cou pled with 3-hydroxy-2,7 naphthalenedisulfonic acid. (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. The color additive FD&C Yellow No. 6 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 so dium 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 subsidi aries, 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 bil lion. 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 mil lion. 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. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00470 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 461 Food and Drug Administration, HHS § 74.1104 (c) Uses and restrictions. The color ad ditive FD&C Yellow No. 6 may be safe ly used for coloring foods (including di etary supplements) generally in amounts consistent with current good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall con form to the requirements of § 70.25 of this chapter. (2) [Reserved] (e) Certification. All batches of FD&C Yellow No. 6 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. (1) For ingested drugs, the color additive FD&C Blue No. 1 shall conform in identity to the re quirements of § 74.101(a)(1). (2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the require ments 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. (1) The color addi tive FD&C Blue No. 1 for use in color ing drugs generally shall conform in specifications to the requirements of § 74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chap ter. (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for color ing drugs, including drugs intended for use in the area of the eye, in amounts consistent with current good manufac turing practice. (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. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994] § 74.1102 FD&C Blue No. 2. (a) Identity. (1) The color additive FD&C Blue No. 2 shall conform in iden tity to the requirements of § 74.102(a)(1). (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 in gested drugs in amounts consistent with current good manufacturing prac tice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 2 shall be certified in accord ance with regulations in part 80 of this chapter. [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. (1) The color additive D&C Blue No. 4 is principally the diammonium salt of ethyl[4-[p[ethyl(m sulfobenzyl)ami-no]-a-(o VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00471 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 462 21 CFR Ch. I (4–1–16 Edition) § 74.1109 sulfophenyl)benzylidene]-2,5-cyclo hexadien-1-ylidene] (m- sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric diammonium salts of ethyl [4-[p [ethyl(p- sulfobenzyl) amino]-a-(o sulfophenyl) benzylidene]-2,5 cyclohexadien - 1-ylidene](p sulfobenzyl) ammonium hydroxide inner salt and ethyl[4-[p-[ethyl (o sulfobenzyl)amino]-a-(o- sulfophenyl) benzylidene]-2,5-cyclohexadien-1 ylidene] (o- sulfobenzyl) ammonium hydroxide inner salt. (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. D&C Blue No. 4 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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, and p- sulfobenzaldehydes, am monium salt, not more than 1.5 percent. N-ethyl, N-(m- sulfobenzyl) sulfanilic acid ammonium salt, not more than 0.3 percent. 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 mil lion. 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&C Blue No. 4 may be safely used in externally ap plied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 4 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.1109 D&C Blue No. 9. (a) Identity. The color additive D&C Blue No. 9 is principally 7,16-dichloro 6,15 - dihydro - 5,9,14,18 - anthrazine tetrone. (b) Specifications. D&C Blue No. 9 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice: 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. D&C Blue No. 9 may be safely used for coloring cot ton and silk surgical sutures, including sutures for ophthalmic use, subject to the following 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. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 9 shall be certified in accord ance with regulations in part 80 of this chapter. [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. (1) The color additive FD&C Green No. 3 shall conform in identity and specifications VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00472 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 463 Food and Drug Administration, HHS § 74.1205 to the requirements of § 74.203(a)(1) and (b). (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. The color ad ditive FD&C Green No. 3 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Green No. 3 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 52144, Nov. 19, 1982] § 74.1205 D&C Green No. 5. (a) Identity. (1) The color additive D&C Green No. 5 is principally the di sodium salt of 2,2′-[(9,10-dihydro-9,10 dioxo-1,4-anthracenediyl)diimino]bis [5-methylbenzenesulfonic acid] (CAS Reg. No. 4403–90–1). (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. (1) D&C Green No. 5 for use in coloring surgical sutures shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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-toluenesulfonic acid, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 10 parts per mil lion. 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 color ing drugs shall conform to the fol lowing 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 so dium 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-Toluidine, not more than 0.0015 percent. Sum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not more than 3 per cent. Lead (as Pb), not more than 20 parts per mil lion. 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. (1) D&C Green No. 5 may be safely used to color nylon 66 (the copolymer of adipic acid and hexamethylenediamine) and/or nylon 6[poly-(e-caprolactam)]nonabsorbable surgical sutures for use in general sur gery, subject to the following restric tions: (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 addi tive 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, in cluding drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing prac tice. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00473 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 464 21 CFR Ch. I (4–1–16 Edition) § 74.1206 (e) Certification. All batches of D&C Green No. 5 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Green No. 6 is 1,4-bis[(4 methylphenyl)amino]-9,10 anthracenedione (CAS. Reg. No. 128–80– 3). (b) Specifications. The color additive D&C Green No. 6 for use in coloring ex ternally applied 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: Volatile matter (at 135 °C), not more than 2.0 percent. Water-soluble matter, not more than 0.3 per cent. Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p-Toluidine, not more than 0.1 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10 anthracenedione, not more than 5.0 per cent. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive D&C Green No. 6 may be safely used for coloring externally applied drugs in amounts consistent with cur rent good manufacturing practice. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Green No. 6 shall be certified in accord ance with regulations promulgated under part 80 of this chapter. [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. (1) The color additive D&C Green No. 8 is principally the tri sodium salt of 8-hydroxy-1,3,6-pyrene trisulfonic acid. (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. D&C Green No. 8 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tices: 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 mil lion. 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&C Green No. 8 may be safely used in externally applied drugs in amounts not exceeding 0.01 percent by weight of the finished product. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Green No. 8 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.1254 D&C Orange No. 4. (a) Identity. (1) the color additive D&C Orange No. 4 is principally the so dium salt of 4-[(2-hydroxy-1 naphthalenyl)azo]benzenesulfonic acid. (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 VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00474 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 465 Food and Drug Administration, HHS § 74.1255 for use in color additive mixtures for coloring externally applied drugs. (b) Specifications. D&C Orange No. 4 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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 mil lion. 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&C Orange No. 4 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 4 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. (1) the color additive D&C Orange No. 5 is a mixture con sisting principally the sodium salt of 4′,5′-dibromofluorescein (CAS Reg. No. 596–03–2) and 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709–83–5) and 2′,4′,5′,7′ tetrabromofluorescein (CAS Reg. No. 15086–94–9). D&C Orange No. 5 is manu factured by brominating fluorescein with elemental bromine. The fluores cein is manufactured by the acid con densation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination. (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. D&C Orange No. 5 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice. 4′,5′-dibromofluorescein, not less than 50 per cent 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 per cent. 4′–Bromofluorescein, not more than 2 per cent. 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 mil lion. 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&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested drugs in amounts consistent with current good manufacturing prac tice. D&C Orange No. 5 may be safely used in externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00475 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 466 21 CFR Ch. I (4–1–16 Edition) § 74.1260 (e) Certification. All batches of D&C Orange No. 5 shall be certified in ac cordance with regulations in part 80 of this chapter. [47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984] § 74.1260 D&C Orange No. 10. (a) Identity. (1) The color additive D&C Orange No. 10 is a mixture con sisting principally of 4′,5′ diiodofluorescein, 2′,4′,5′ triiodofluorescein, and 2′,4′,5′,7′ tetraiodofluorescein. (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. D&C Orange No. 10 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be avoided by good manufacturing prac tice: 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 per cent and not more than 95 percent. Lead (as Pb), not more than 20 parts per mil lion. 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&C Orange No. 10 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 10 shall be certified in ac cordance with regulations in part 80 of this chapter. [46 FR 18953, Mar. 27, 1981] § 74.1261 D&C Orange No. 11. (a) Identity. (1) The color additive D&C Orange No. 11 is a mixture con sisting principally of the disodium salts of 4′,5′-diiodofluorescein, 2′,4′,5′ triiodofluorescein and 2′,4′,5′,7′ tetraiodofluorescein. (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. The color additive D&C Orange No. 11 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: 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 per cent. 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 mil lion. 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&C Orange No. 11 may be safely used for coloring externally applied drugs in amounts VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00476 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 467 Food and Drug Administration, HHS § 74.1306 consistent with good manufacturing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Orange No. 11 shall be certified in ac cordance with regulations in part 80 of this chapter. [46 FR 18953, Mar. 27, 1981] § 74.1303 FD&C Red No. 3. (a) Identity and specifications. (1) The color additive FD&C Red No. 3 shall conform in identity and specifications to the requirements of § 74.303(a)(1) and (b). (2) Color additive mixtures for in gested 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 in gested drugs. (b) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 3 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.1304 FD&C Red No. 4. (a) Identity. (1) The color additive FD&C Red No. 4 is principally the diso dium salt of 3-[(2,4-dimethyl-5 sulfophenyl)azo] -4-hydroxy-1 naphthalenesulfonic acid. (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. FD&C Red No. 4 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as so dium 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, so dium salt, not more than 0.2 percent. Subsidiary colors, not more than 2 percent. Lead (as Pb), not more than 10 parts per mil lion. 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. FD&C Red No. 4 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Red No. 4 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.1306 D&C Red No. 6. (a) Identity. (1) The color additive D&C Red No. 6 is principally the diso dium salt of 3-hydroxy-4-[(4-methyl-2 sulfophenyl)azo]-2 naphthalenecarboxylic acid (CAS Reg. No. 5858–81–1). To manufacture the ad ditive, 2-amino-5 methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hy droxy-2-naphthalenecarboxylic acid. The resulting dye precipitates as the disodium salt. (2) Color additive mixtures for drug use made with D&C Red No. 6 may con tain only those diluents that are suit able and that are listed in part 73 of this chapter as safe for use in color ad ditive mixtures for coloring drugs. (b) Specifications. The color additive D&C Red No. 6 shall conform to the fol lowing specifications and shall be free from impurities other than those VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00477 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 468 21 CFR Ch. I (4–1–16 Edition) § 74.1307 named to the extent that such impuri ties may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, so dium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, so dium 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- Toluidine, not more than 15 parts per mil lion. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive 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 milli grams per daily dose of the drug. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 6 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012] § 74.1307 D&C Red No. 7. (a) Identity. (1) The color additive D&C Red No. 7 is principally the cal cium salt of 3-hydroxy-4-[(4-methyl-2 sulfophenyl)azo]-2 naphthalenecarboxylic acid (CAS Reg. No. 5281–04–9). To manufacture the ad ditive, 2-amino-5 methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hy droxy-2-naphthalenecarboxylic acid and the resulting dye converted to the calcium salt with calcium chloride. (2) Color additive mixtures for drug use made with D&C Red No. 7 may con tain only those diluents that are suit able and that are listed in part 73 of this chapter as safe for use in color ad ditive mixtures for coloring drugs. (b) Specifications. The color additive D&C Red No. 7 shall conform to the fol lowing specifications and shall be free from impurities other than those named to the extent that such impuri ties may be avoided by current good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, cal cium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, cal cium 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-Toluidine, not more than 15 parts per mil lion. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive 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 milli grams per daily dose of the drug. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 7 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012] § 74.1317 D&C Red No. 17. (a) Identity. (1) The color additive D&C Red No. 17 is principally 1-[[4 (phenylazo)phenyl]azo]-2-naphthalenol. (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 exter nally applied drugs. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00478 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 469 Food and Drug Administration, HHS § 74.1321 (b) Specifications. D&C Red No. 17 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities may be avoided by good manufacturing prac tice: 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 per cent. 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 mil lion. 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&C Red No. 17 may be safely used in externally ap plied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 17 shall be certified in accord ance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977] § 74.1321 D&C Red No. 21. (a) Identity. (1) The color additive D&C Red No. 21 is principally 2′,4′,5′,7′ tetrabromofluorescein (CAS Reg. No. 15086–94–9), and may contain smaller amounts of 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709–83–5) and 2′,4′,7′ tribromofluorescein (CAS Reg. No. 25709–84–6). The color additive is manu factured by brominating fluorescein with elemental bromine. The fluores cein is manufactured by the acid con densation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination. (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. The color additive D&C Red No. 21 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impuri ties may be avoided by current good manufacturing practice: 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 per cent. 2′,4′,5′,7′-Tetrabromofluorescein, not less than 87 percent. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive D&C Red No. 21 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 21 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00479 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 470 21 CFR Ch. I (4–1–16 Edition) § 74.1322 § 74.1322 D&C Red No. 22. (a) Identity. (1) The color additive D&C Red No. 22 is principally the diso dium salt of 2′,4′,5′7′ tetrabromofluorescein (CAS Reg. No. 17372–87–1) and may contain smaller amounts of the disodium salts of 2′,4′,5′ tribromofluorescein and 2′,4′,7′ tribromofluorescein. The color additive is manufactured by alkaline hydrolysis of 2′,4′,5′,7′-tetrabromofluorescein. 2′,4′,5′,7′-Tetrabromofluorescein is man ufactured by brominating fluorescein with elemental bromine. The fluores cein is manufactured by the acid con densation of resorcinol and phthalic acid or its anhydride. Fluorescein is isolated and partially purified prior to bromination. (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. The color additive D&C Red No. 22 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impuri ties may be avoided by current good manufacturing practice: 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 per cent. 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 mil lion. 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. The color ad ditive D&C Red No. 22 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 22 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982] § 74.1327 D&C Red No. 27. (a) Identity. (1) The color additive D&C Red No. 27 is principally 2′,4′,5′,7′ tetrabromo-4,5,6,7 tetrachlorofluorescein (CAS Reg. No. 13473-26-2). The color additive is manu factured by brominating 4,5,6,7 tetrachlorofluorescein with elemental bromine. The 4,5,6,7 tetrachlorofluorescein is manufactured by the acid condensation of resorcinol and tetrachlorophthalic acid or its an hydride. The 4,5,6,7 tetrachlorofluorescein is isolated and partially purified prior to bromination. (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. D&C Red No. 27 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by current good manufacturing practice: 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. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00480 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 471 Food and Drug Administration, HHS § 74.1330 Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per mil lion. 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&C Red No. 27 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing prac tice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 27 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982] § 74.1328 D&C Red No. 28. (a) Identity. (1) The color additive D&C Red No. 28 is principally the diso dium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7 tetrachlorofluorescein (CAS Reg. No. 18472–87–2) formed by alkaline hydrol ysis of the parent tetrabromotetrachlorofluorescein. (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. D&C Red No. 28 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by current good manufacturing practice: 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 mil lion. 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&C Red No. 28 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing prac tice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 28 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982] § 74.1330 D&C Red No. 30. (a) Identity. (1) The color additive D&C Red No. 30 is principally 6-chloro 2-(6-chloro-4-methyl-3 oxobenzo[b]thien-2(3H)-ylidene)-4 methyl-benzo[b]thiophen-3(2H)-one (CAS Reg. No. 2379–74–0). (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. D&C Red No. 30 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by current good manufacturing practice: 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 mil lion. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00481 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 472 21 CFR Ch. I (4–1–16 Edition) § 74.1331 (c) Uses and restrictions. D&C Red No. 30 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing prac tice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 30 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 22510, May 25, 1982] § 74.1331 D&C Red No. 31. (a) Identity. (1) The color additive D&C Red No. 31 is principally the cal cium salt of 3-hydroxy-4-(phenylazo)-2 naphthalenecarboxylic acid. (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 exter nally applied drugs. (b) Specifications. D&C Red No. 31 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities may be avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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 mil lion. 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&C Red No. 31 may be safely used in externally ap plied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 31 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.1333 D&C Red No. 33. (a) Identity. (1) The color additive D&C Red No. 33 is principally the diso dium salt of 5-amino-4-hydroxy-3 (phenylazo)-2,7-naphthalenedisulfonic acid (CAS Reg. No. 3567–66–6). To manu facture the additive, the product ob tained from the nitrous acid diazotization of aniline is coupled with 4-hydroxy-5-amino-2,7 naphthalenedisulfonic acid in an alka line aqueous medium. The color addi tive is isolated as the sodium salt. (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. D&C Red No. 33 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by current good manufacturing practices: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as so dium 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 per cent. 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 mil lion. Benzidine, not more than 20 parts per billion. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive D&C Red. No 33 may be safely VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00482 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 473 Food and Drug Administration, HHS § 74.1336 used for coloring ingested drugs, other than mouthwashes and dentifrices, in amounts not to exceed 0.75 milligram per daily dose of the drug. D&C Red No. 33 may be safely used for coloring ex ternally applied drugs, mouthwashes, and dentifrices in amounts consistent with current good manufacturing prac tice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 33 shall be certified in accord ance with regulations in part 80 of this chapter. [53 FR 33120, Aug. 30, 1988] § 74.1334 D&C Red No. 34. (a) Identity. (1) The color additive D&C Red No. 34 is principally the cal cium salt of 3-hydroxy-4-[(1-sulfo-2 naphthalenyl)azo]-2-naphthalene-car boxylic acid. (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 exter nally applied drugs. (b) Specifications. D&C Red No. 34 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities may be avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated at so dium 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 mil lion. 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. The color ad ditive D&C Red No. 34 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 34 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.1336 D&C Red No. 36. (a) Identity. (1) The color additive D&C Red No. 36 is 1-[(2-chloro-4 nitrophenyl)azo]-2-naphthalenol (CAS Reg. No. 2814–77–9). The color additive is manufactured by diazotization of 2 chloro-4-nitrobenzenamine in acid me dium and coupling with 2-naphthalenol in acid medium. (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. D&C Red No. 36 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by current good manufacturing practice: 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 mil lion. 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. The color ad ditive D&C Red No. 36 may be safely used for coloring ingested drugs, other VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00483 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 474 21 CFR Ch. I (4–1–16 Edition) § 74.1339 than mouthwashes and dentifrices, in amounts not to exceed 1.7 milligrams per daily dose of the drug for drugs that are taken continuously only for less than 1 year. For drugs taken con tinuously for longer than 1 year, the color additive shall not be used in amounts to exceed 1.0 milligram per daily dose of the drug. D&C Red No. 36 may be safely used for coloring exter nally applied drugs in amounts con sistent with current good manufac turing practice. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 36 shall be certified in accord ance with regulations in part 80 of this chapter. [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. (1) The color additive D&C Red No. 39 is o-[p(b,b′-dihydroxy diethylamino)-phenylazo]-benzoic acid. (2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, iso propyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212. (b) Specifications. D&C Red No. 39 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be avoided by good manufacturing prac tice: 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-(b,b′-Dihydroxy-diethyl) aniline, not more than 0.2 percent. Subsidiary colors, not more than 3.0 percent. Lead (as Pb), not more than 20 parts per mil lion. Arsenic (as As), not more than 3 parts per million. Total color, not less than 95.0 percent. (c) Uses and restrictions. The color ad ditive D&C Red No. 39 may be safely used for the coloring of quaternary am monium type germicidal solutions in tended for external application only, and subject to the further restriction that the quantity of the color additive does not exceed 0.1 percent by weight of the finished drug product. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 39 shall be certified in accord ance with regulations promulgated under part 80 of this chapter. § 74.1340 FD&C Red No. 40. (a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b). (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, ex cept that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and label ing requirements prescribed by §§ 82.51 or 82.1051 of this chapter.) (b) Uses and restrictions. (1) FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring drugs, including those intended for use in the area of the eye, subject to the restrictions on the use of color addi tives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (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. The label of the color ad ditive and any lakes or mixtures pre pared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00484 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 475 Food and Drug Administration, HHS § 74.1705 (d) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regula tions, in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994] § 74.1602 D&C Violet No. 2. (a) Identity. (1) The color additive D&C Violet No. 2 is principally 1-hy droxy -4-[(4-methylphenyl)amino]-9,10 anthracenedione. (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 mix tures for coloring externally applied drugs. (b) Specifications. D&C Violet No. 2 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities can be avoided by good manufacturing prac tice: Volatile matter (at 135 °C.), not more than 2.0 percent. Matter insoluble in both carbon tetra chloride and water, not more than 0.5 per cent. p- Toluidine, not more than 0.2 percent. 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 mil lion. Arsenic (as As), not more than 3 parts per million. Total color, not less than 96.0 percent. (c) Uses and restrictions. The color ad ditive D&C Violet No. 2 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Violet No. 2 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. (1) The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of § 74.705 (a)(1) and (b). (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. (1) FD&C Yel low No. 5 may be safely used for color ing drugs generally, including drugs in tended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (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. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall con form to the requirements of § 70.25 of this chapter. (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 ‘‘Con tains 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 com ply with this requirement provided VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00485 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 476 21 CFR Ch. I (4–1–16 Edition) § 74.1706 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 re quired under paragraph (c)(2) of this section, bear the warning statement ‘‘This product contains FD&C Yellow No. 5 (tartrazine) which may cause al lergic-type reactions (including bron chial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sen sitivity in the general population is low, it is frequently seen in patients who also have aspirin hyper sensitivity.’’ This warning statement shall appear in the ‘‘Precautions’’ sec tion of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. (1) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706(a)(1) and (b). (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. FD&C Yellow No. 6 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing prac tice. (c) Labeling requirements. (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall con form to the requirements of § 70.25 of this chapter. (2) [Reserved] (d) Certification. All batches of FD&C Yellow No. 6 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. (1) The color additive D&C Yellow No. 7 is principally fluo rescein. (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. D&C Yellow No. 7 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice: Sum of water and chlorides and sulfates (cal culated 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 mil lion. 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&C Yellow No. 7 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 7 shall be certified in ac cordance with regulations in part 80 of this chapter. § 74.1707a Ext. D&C Yellow No. 7. (a) Identity. (1) The color additive Ext. D&C Yellow No. 7 is principally the disodium salt of 8-hydroxy-5,7-di nitro-2-naphthalenesulfonic acid. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00486 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 477 Food and Drug Administration, HHS § 74.1710 (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 ex ternally applied drugs. (b) Specifications. Ext. D&C Yellow No. 7 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 good manufacturing practice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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 mil lion. 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. Ext. D&C Yellow No. 7 may be safely used in ex ternally applied drugs in amounts con sistent with good manufacturing prac tice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of Ext. D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter. § 74.1708 D&C Yellow No. 8. (a) Identity. (1) The color additive D&C Yellow No. 8 is principally the di sodium salt of fluorescein. (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. D&C Yellow No. 8 shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Sum of water and chlorides and sulfates (cal culated 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 mil lion. 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&C Yellow No. 8 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 8 shall be certified in ac cordance with regulations in part 80 of this chapter. § 74.1710 D&C Yellow No. 10. (a) Identity. (1) The color additive D&C Yellow No. 10 is a mixture of the sodium salts of the mono- and disulfonic acids of 2-(2-quinolinyl)-1H indene-1,3 (2H)-dione consisting prin cipally of the sodium salts of 2-(2,3 dihydro-1,3-dioxo-1H-indene-2-yl)-6 quinolinesulfonic acid and 2-(2,3 dihydro-1,3-dioxo-1H-indene-2-yl)-8 quinolinesulfonic acid with lesser amounts of the disodium salts of the disulfonic acids of 2-(2-quinolinyl)-1H indene-1,3(2H)-dione (CAS Reg. No. 8004–92–0). D&C Yellow No. 10 is manu factured by condensing quinaldine with phthalic anhydride to give the unsulfonated dye, which is then sulfo nated with oleum. (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. The color additive D&C Yellow No. 10 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00487 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 478 21 CFR Ch. I (4–1–16 Edition) § 74.1711 impurities may be avoided by current good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as so dium salts), not more than 15 percent. Matter insoluble in both water and chloro form, 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)-1H-indene-1,3 (2H)-dione, not more than 4 parts per million. Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not less than 75 percent. Sum of sodium salts of the disulfonates of 2 (2-quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 15 percent. 2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8 quinolinedisulfonic acid, disodium salt, not more than 3 percent. Diethyl ether soluble matter other than that specified, not more than 2 parts per mil lion, using added 2-(2-quinolinyl)-1H-in dene-1,3 (2H)-dione for calibration. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive D&C Yellow No. 10 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 10 shall be certified in ac cordance with regulations in part 80 of this chapter. [48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984] § 74.1711 D&C Yellow No. 11. (a) Identity. (1) The color additive D&C Yellow No. 11 is principally 2-(2 quinolyl)-1,3-indandione. (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 exter nally applied drugs. (b) Specifications. D&C Yellow No. 11 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities may be avoided by good manufacturing prac tice: 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 mil lion. 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&C Yellow No. 11 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 11 shall be certified in ac cordance with regulations in part 80 of this chapter. Subpart C—Cosmetics § 74.2052 D&C Black No. 2. (a) Identity. The color additive D&C Black No. 2 is a high-purity carbon black prepared by the oil furnace proc ess. It is manufactured by the combus tion of aromatic petroleum oil feed stock and consists essentially of pure carbon, formed as aggregated fine par ticles with a surface area range of 200 to 260 meters (m)2/gram. (b) Specifications. D&C Black No. 2 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be avoided by good manufacturing prac tice: (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m2/gram. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00488 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 479 Food and Drug Administration, HHS § 74.2101 (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]pyrene, not more than 0.005 mg/kg (5 parts per billion). (10) Dibenz[a,h]anthracene, not more than 0.005 mg/kg (5 parts per billion). (11) Total color (as carbon), not less than 95 percent. (c) Uses and restrictions. D&C Black No. 2 may be safely used for coloring the following cosmetics in amounts consistent with current good manufac turing practice: Eyeliner, brush-on brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foun dation, and nail enamel. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Black No. 2 shall be certified in accord ance with regulations in part 80 of this chapter. [69 FR 44930, July 28, 2004, as amended at 72 FR 10357] § 74.2053 D&C Black No. 3. (a) Identity. The color additive D&C Black No. 3 is a washed bone char pre pared from calcined cattle bones. The bones are twice heated in excess of 700 °C for at least 6 hours. (b) Specifications. D&C Black No. 3 shall conform to the following speci fications and shall be free from impuri ties other than those named, to the ex tent that such other impurities may be avoided by current good manufacturing practices: (1) Calcium hydroxyapatite (CaO and P2O5), not less than 75 percent and not more than 84 percent; (2) Elemental carbon, not less than 7 percent; (3) Moisture, not more than 7 per cent; (4) Silica (SiO2), not more than 5 per cent; (5) Arsenic, not more than 3 milli grams (mg)/kilogram (kg) (3 parts per million (ppm)); (6) Lead, not more than 10 mg/kg (10 ppm); and (7) Total polycyclic aromatic hydro carbons (PAHs), not more than 5 mg/kg (5 ppm). (c) Uses and restrictions. Cosmetics containing D&C Black No. 3 must com ply with § 700.27 of this chapter with re spect to prohibited cattle materials in cosmetic products. D&C Black No. 3 may be safely used for coloring the fol lowing cosmetics in amounts con sistent with current good manufac turing practice: Eyeliner, eye shadow, mascara, and face powder. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Black No. 3 shall be certified in accord ance with regulations in part 80 of this chapter. [72 FR 33666, June 19, 2007] § 74.2101 FD&C Blue No. 1. (a) Identity. The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl[4-[p-[ethyl(m sulfobenzyl)amino]-a-(o sulfophenyl)benzylidene]-2,5 cyclohexadien-1-ylidene](m sulfobenzyl)ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl[4-[p [ethyl(p-sulfobenzyl)amino]-a-(o sulfophenyl)benzylidene]-2,5 cyclohexadien-1-ylidene](p sulfobenzyl)ammonium hydroxide inner salt and ethyl[4-[p-[ethyl(o sulfobenzyl)amino]-a-(o sulfophenyl)benzylidene]-2,5 cyclohexadien-1-ylidene](o sulfobenzyl)ammonium hydroxide inner salt. Additionally, FD&C Blue No. 1 is manufactured by the acid cata lyzed condensation of one mole of so dium 2-formylbenzenesulfonate with two moles from a mixture consisting principally of 3 [(ethylphenylamino)methyl] benzenesulfonic acid, and smaller amounts of 4 VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00489 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 480 21 CFR Ch. I (4–1–16 Edition) § 74.2104 [(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 di chromate and acid, or with manganese dioxide and acid to form the dye. The intermediate sodium 2 formylbenzenesulfonate is prepared from 2-chlorobenzaldehyde and sodium sulfite. (b) Specifications. (1) The color addi tive FD&C Blue No. 1 shall conform in specifications to the requirements of § 74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chap ter. (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for color ing cosmetics generally, including cos metics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cos metics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of § 74.1104(a)(1) and (b). (b) Uses and restrictions. D&C Blue No. 4 may be safely used for coloring exter nally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Blue No. 4 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.2151 D&C Brown No. 1. (a) Identity. The color additive D&C Brown No. 1 is a mixture of the sodium salts of 4[[5-[(dialkylphenyl)- azo]-2,4 dihydroxyphenyl]azo]-benzene sulfonic acid. The alkyl group is principally the methyl group. (b) Specifications. D&C Brown No. 1 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such other impurities may be avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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 per cent 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 per cent 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 per cent and not more than 13 percent. Monosodium salt of 4[[5-[(2-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 5 per cent 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 per cent 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 per cent and not more than 8 percent. Monosodium salt of 4[[5-[(4-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 2 per cent and not more than 8 percent. Lead (as Pb), not more than 20 parts per mil lion. 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. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00490 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 481 Food and Drug Administration, HHS § 74.2254 (c) Uses and restrictions. D&C Brown No. 1 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Brown No. 1 shall be certified in ac cordance with regulations in part 80 of this chapter. § 74.2203 FD&C Green No. 3. (a) Identity and specifications. The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of § 74.203(a)(1) and (b). (b) Uses and restrictions. The color ad ditive FD&C Green No. 3 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of FD&C Green No. 3 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 52144, Nov. 19, 1982] § 74.2205 D&C Green No. 5. (a) Identity and specifications. 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). (b) Uses and restrictions. D&C Green No. 5 may be safely used for coloring cosmetics generally, including cos metics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Green No. 5 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b). (b) Uses and restrictions. D&C Green No. 6 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Green No. 6 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Green No. 8 shall conform in identity and specifications to the requirements of § 74.1208(a)(1) and (b). (b) Uses and restrictions. D&C Green No. 8 may be safely used for coloring externally applied cosmetics in amounts not exceeding 0.01 percent by weight of the finished cosmetic prod uct. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Green No. 8 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.2254 D&C Orange No. 4. (a) Identity and specifications. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of § 74.1254 (a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Orange No. 4 shall be certified in ac cordance with regulations in part 80 of this chapter. [42 FR 52396, Sept. 30, 1977] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00491 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 482 21 CFR Ch. I (4–1–16 Edition) § 74.2255 § 74.2255 D&C Orange No. 5. (a) Identity and specifications. The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255 (a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested cosmetics in amounts con sistent with current good manufac turing practice. D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be ap plied to the lips in amounts not exceed ing 5.0 percent by weight of the fin ished cosmetic products. D&C Orange No. 5 may be safely used for coloring externally applied cosmetics in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Orange No. 5 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements of § 74.1260(a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 10 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Orange No. 11 shall be certified in ac cordance with regulations in part 80 of this chapter. [46 FR 18954, Mar. 27, 1981] § 74.2261 D&C Orange No. 11. (a) Identity and specifications. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of § 74.1261(a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Orange No. 11 shall be certified in ac cordance with regulations in part 80 of this chapter. [46 FR 18954, Mar. 27, 1981] § 74.2304 FD&C Red No. 4. (a) Identity and specifications. The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of § 74.1304(a)(1) and (b). (b) Uses and restrictions. FD&C Red No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 4 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.2306 D&C Red No. 6. (a) Identity and specifications. The color additive D&C Red No. 6 shall con form in identity and specifications to the requirements of § 74.1306 (a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Red No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 6 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 57688, Dec. 28, 1982] § 74.2307 D&C Red No. 7 (a) Identity and specifications. The color additive D&C Red No. 7 shall con form in identity and specifications to VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00492 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 483 Food and Drug Administration, HHS § 74.2328 the requirements of § 74.1307 (a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Red No. 7 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 7 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 57688, Dec. 28, 1982] § 74.2317 D&C Red No. 17. (a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 17 may be safely used for coloring ex ternally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 17 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.2321 D&C Red No. 21. (a) Identity and specifications. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of § 74.1321(a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Red No. 21 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 21 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982] § 74.2322 D&C Red No. 22. (a) Identity and specifications. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of § 74.1322(a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Red No. 22 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 22 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982] § 74.2327 D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74.1327 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 27 may be safely used for coloring cos metics generally in amounts consistent with current good manufacturing prac tice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 27 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982] § 74.2328 D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74.1328 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 28 may be safely used for coloring cos metics generally in amounts consistent with current good manufacturing prac tice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 28 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00493 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 484 21 CFR Ch. I (4–1–16 Edition) § 74.2330 § 74.2330 D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74.1330 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 30 may be safely used for coloring cos metics generally in amounts consistent with current good manufacturing prac tice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 30 shall be certified in accord ance with regulations in part 80 of this chapter. [47 FR 22511, May 25, 1982] § 74.2331 D&C Red No. 31. (a) Identity and specifications. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of § 74.1331(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 31 may be safely used for coloring ex ternally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 31 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.2333 D&C Red No. 33. (a) Identity and specifications. The color additive D&C Red No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b). (b) Uses and restrictions. The color ad ditive D&C Red No. 33 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 33 may be safely used for coloring mouthwashes (including breath fresh eners), dentifrices, and externally ap plied cosmetics in amounts consistent with current good manufacturing prac tice. (c) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall con form to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 33 shall be certified in accord ance with regulations in part 80 of this chapter. [53 FR 33120, Aug. 30, 1988] § 74.2334 D&C Red No. 34. (a) Identity and specifications. The color additive D&C Red No. 34 shall conform in identity and specifications to the requirements of § 74.1334(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 34 may be safely used for coloring ex ternally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 34 shall be certified in accord ance with regulations in part 80 of this chapter. § 74.2336 D&C Red No. 36. (a) Identity and specifications. The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of § 74.1336 (a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Red No. 36 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 36 may be safely used for coloring exter nally applied cosmetics in amounts consistent with current good manufac turing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 36 shall be certified in accord ance with regulations in part 80 of this chapter. [53 FR 29031, Aug. 2, 1988] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00494 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 485 Food and Drug Administration, HHS § 74.2705 § 74.2340 FD&C Red No. 40. (a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b) of this chapter. (2) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, ex cept that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and label ing requirements prescribed by § 82.51 or § 82.1051 of this chapter. (b) Uses and restrictions. FD&C Red No. 40 may be safely used in coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring cosmetics intended for use in the area of the eye. These uses are sub ject to the following restrictions: (1) The color additive may be used in amounts consistent with current good manufacturing practice. (2) The color additive shall not be ex posed 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. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 40 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Violet No. 2 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Violet No. 2 shall be certified in ac cordance with regulations in part 80 of this chapter. § 74.2602a Ext. D&C Violet No. 2. (a) Identity. The color additive Ext. D&C Violet No. 2 is principally the monosodium salt of 2-[(9,10-dihydro-4 hydroxy -9,10-dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid. (b) Specifications. Ext. D&C Violet No. 2 shall conform to the following speci fications and shall be free from impuri ties, other than those named, to the ex tent that such other impurities may be avoided by good manufacturing prac tice: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as so dium 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- Toluidine, not more than 0.1 percent. p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per mil lion. 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. The color ad ditive Ext. D&C Violet No. 2 may be safely used for coloring externally ap plied cosmetics in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of Ext. D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter. § 74.2705 FD&C Yellow No. 5. (a) Identity. The color additive FD&C Yellow No. 5 is principally the tri sodium salt of 4,5-dihydro-5-oxo-(1-4 sulfophenyl)-4-[(4-sulfophenyl)azo]-1H pyrazole-3-carboxylic acid (CAS Reg. No. 1934–21–0). To manufacture the ad ditive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00495 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 486 21 CFR Ch. I (4–1–16 Edition) § 74.2706 acid. The resulting dye is purified and isolated as the sodium salt. (b) Specifications. (1) FD&C Yellow No. 5 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 good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as so dium 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]-1H-pyrazol-1,3 diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono] 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr azole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-4-[(4-sulfophenyl)hydrazono] 1H-pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4 sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo 4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr azole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr azole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4 sulfophenyl)-1H-pyrazole-3-carboxylate, so dium salt, not more than 0.1 percent. 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 bil lion. 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 mil lion. 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. (1) FD&C Yel low No. 5 may be safely used for color ing cosmetics generally, including cos metics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (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 con sistent with current good manufac turing practice. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706 (a)(1) and (b). (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for coloring cosmetics generally in amounts con sistent with current good manufac turing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of FD&C Yellow No. 6 shall be certified in ac cordance with regulations in part 80 of this chapter. [51 FR 41782, Nov. 19, 1986] § 74.2707 D&C Yellow No. 7. (a) Identity and specifications. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 7 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00496 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 487 Food and Drug Administration, HHS § 74.3045 (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 7 shall be certified in ac cordance with regulations in part 80 of this chapter. § 74.2707a Ext. D&C Yellow No. 7. (a) Identity and specifications. The color additive Ext. D&C Yellow No. 7 shall conform in identity and specifica tions to the requirements of § 74.1707a (a)(1) and (b). (b) Uses and restrictions. Ext. D&C Yellow No. 7 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of Ext. D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter. § 74.2708 D&C Yellow No. 8. (a) Identity and specifications. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1708(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 8 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 8 shall be certified in ac cordance with regulations in part 80 of this chapter. § 74.2710 D&C Yellow No. 10. (a) Identity and specifications. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b). (b) Uses and restrictions. The color ad ditive D&C Yellow No. 10 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 10 shall be certified in ac cordance with regulations in part 80 of this chapter. [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. The color additive D&C Yellow No. 11 shall conform in identity and specifications to the requirements of § 74.1711(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with good manu facturing practice. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 11 shall be certified in ac cordance with regulations in part 80 of this chapter. Subpart D—Medical Devices § 74.3045 [Phthalocyaninato(2-)] cop per. (a) Identity. The color additive is [phthalocyaninato(2-)] copper (CAS Reg. No. 147–14–8) having the structure shown in Colour Index No. 74160. (b) Specifications. The color additive [phthalocyaninato(2-)] copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by cur rent good manufacturing practice: 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 per cent. Lead (as Pb), not more than 40 parts per mil lion. 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. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00497 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 488 21 CFR Ch. I (4–1–16 Edition) § 74.3102 (c) Uses and restrictions. (1) The color additive [phthalocyaninato(2-)] copper may be safely used to color poly propylene sutures, polybutester (the generic designation for the suture fab ricated from 1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol and alpha-hydro-omega- hydroxypoly(oxy 1,4-butanediyl), CAS Reg. No. 37282–12– 5) nonabsorbable sutures for use in gen eral and ophthalmic surgery, polybutylene terephthalate nonabsorb able monofilament sutures for general and ophthalmic surgery, nonabsorbable sutures made from poly(vinylidene flu oride) and poly(vinylidene fluoride-co hexafluoropropylene) for general and ophthalmic surgery, and polymethylmethacrylate monofilament used as supporting haptics for intraocular lenses, subject to the following restrictions: (i) The quantity of the color additive does not exceed 0.5 percent by weight of the suture or haptic material. (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 Cos metic Act with respect to the medical device in which [phthalocyaninato(2-)] copper is used. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of [phthalocyaninato (2-)] copper shall be certified in accordance with regula tions in part 80 of this chapter. [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] § 74.3102 FD&C Blue No. 2. (a) Identity. The color additive FD&C Blue No. 2 shall conform in identity to the requirements of § 74.102(a)(1). (b) Specifications. (1) The color addi tive FD&C Blue No. 2 for use in color ing surgical sutures shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as so dium salts), not more than 15 percent. Water insoluble matter, not more than 0.4 percent. Isatin-5-sulfonic acid, not more than 0.4 per cent. 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 mil lion. 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 ac cordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) The color additive FD&C Blue No. 2 may be safe ly used for coloring nylon (the copoly mer of adipic acid and hexamethylene diamine) surgical sutures for use in general surgery subject to the fol lowing 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 VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00498 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 489 Food and Drug Administration, HHS § 74.3206 No. 2–Aluminum Lake on alumina are used. (d) Labeling. The labels of the color additive FD&C Blue No. 2 and the color additive FD&C Blue No. 2–Aluminum Lake on alumina shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 2 and its lake shall be cer tified in accordance with regulations in part 80 of this chapter. [64 FR 48290, Sept. 3, 1999] § 74.3106 D&C Blue No. 6. (a) Identity. The color additive D&C Blue No. 6 is principally [D2,2′ biindoline]-3,3′ dione (CAS Reg. No. 482–89–3). (b) Specifications. D&C Blue No. 6 shall conform to the following speci fications and shall be free from impuri ties other than those named to the ex tent that such impurities may be avoided by good manufacturing prac tice: Volatile matter at 135 °C (275 °F), not more than 3 percent. Matter insoluble in N,N dimethylformamide, not more than 1 per cent. 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 mil lion. 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. (1) D&C Blue No. 6 may be safely used at a level— (i) Not to exceed 0.2 percent by weight of the suture material for color ing polyethylene terephthalate sur gical sutures for general surgical use; (ii) Not to exceed 0.25 percent by weight of the suture material for color ing plain or chromic collagen absorb able sutures for general surgical use; (iii) Not to exceed 0.5 percent by weight of the suture material for color ing plain or chromic collagen absorb able sutures for ophthalmic surgical use; (iv) Not to exceed 0.5 percent by weight of the suture material for color ing polypropylene surgical sutures for general surgical use; and (v) Not to exceed 0.5 percent by weight of the suture material for color ing polydioxanone synthetic absorbable sutures for ophthalmic and general sur gical 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 addi tive is used. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 6 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Green No. 6 shall conform in identity to the requirements of § 74.1206(a). (b) Specifications. The color additive D&C Green No. 6 for use in medical de vices shall conform to the specifica tions of § 74.1206(b). (c) Uses and restrictions. (1) The color additive D&C Green No. 6 may be safe ly used at a level (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 color ing polyethylene terephthalate sur gical sutures, including sutures for ophthalmic use; (iii) Not to exceed 0.1 percent by weight of the suture material for color ing 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 color ing polyglycolic acid surgical sutures with diameter not greater than U.S.P. size 8–0, including sutures for oph thalmic use; (v) Not to exceed 0.21 percent by weight of the suture material for color ing poly(glycolic acid-co-trimethylene carbonate) sutures (also referred to as 1,4-dioxan-2,5-dione polymer with 1,3 VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00499 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 490 21 CFR Ch. I (4–1–16 Edition) § 74.3230 dioxan-2-one) for general surgical use; and (vi) Not to exceed 0.10 percent by weight of the haptic material for color ing 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. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Green No. 6 shall be certified in accord ance with regulations in part 80 of this chapter. [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. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317(a)(1) and (b). (b) Uses and restrictions. (1) The sub stance listed in paragraph (a) of this section may be used as a color additive in contact lens in amounts not to ex ceed the minimum reasonably required to accomplish the intended coloring ef fect. (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 con tact lens in which the color additive is used. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 17 shall be certified in accord ance with regulations in part 80 of this chapter. [55 FR 22898, June 5, 1990] § 74.3602 D&C Violet No. 2. (a) Identity and specifications. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b). (b) Uses and restrictions. (1) The color additive, D&C Violet No. 2, may be safely used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. (2) D&C Violet No. 2 may be safely used for coloring sutures for use in sur gery subject to the following condi tions: (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 syn thetic absorbable sutures for use in general and ophthalmic surgery; and (ii) At a level not to exceed 0.3 per cent 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 per cent by weight of the suture material for coloring poliglecaprone 25 (e caprolactone/glycolide copolymer) syn thetic absorbable sutures for use in general surgery. (iv) At a level not to exceed 0.1 per cent by weight of the suture material for coloring poly(e-caprolactone) ab sorbable sutures for use in general sur gery. (v) At a level not to exceed 0.2 per cent by weight of the suture material for coloring glycolide/dioxanone/ trimethylene carbonate tripolymer ab sorbable sutures for use in general sur gery. (vi) At a level not to exceed 0.2 per cent by weight of the suture material for coloring absorbable sutures pre pared 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 mate rial. (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 ex ceed 0.15 percent by weight of the tack material. (5) Authorization for these uses shall not be construed as waiving any of the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00500 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 491 Food and Drug Administration, HHS § 80.10 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 ad ditive is used. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Violet No. 2 shall be certified in ac cordance with regulations in part 80 of this chapter. [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] § 74.3710 D&C Yellow No. 10. (a) Identity. The color additive D&C Yellow No. 10 shall conform to the identity requirements of § 74.1710(a). (b) Specifications. The color additive D&C Yellow No. 10 for use in contact lenses shall conform to the specifica tions of § 74.1710(b). (c) Uses and restrictions. (1) The color additive D&C Yellow No. 10 may be used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. (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 addi tive is used. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 10 shall be certified in ac cordance with regulations in part 80 of this chapter. [52 FR 28690, Aug. 3, 1987] PART 80—COLOR ADDITIVE CERTIFICATION Subpart A—General Provisions Sec. 80.10 Fees for certification services. Subpart B—Certification Procedures 80.21 Request for certification. 80.22 Samples to accompany requests for certification. 80.31 Certification. 80.32 Limitations of certificates. 80.34 Authority to refuse certification serv ice. 80.35 Color additive mixtures; certification and exemption from certification. 80.37 Treatment of batch pending certifi cation. 80.38 Treatment of batch after certification. 80.39 Records of distribution. AUTHORITY: 21 U.S.C. 371, 379e. SOURCE: 42 FR 15662, Mar. 22, 1977, unless otherwise noted. Subpart A—General Provisions § 80.10 Fees for certification services. (a) Fees for straight colors including lakes. The fee for the services provided by the regulations in this part in the case of each request for certification submitted in accordance with § 80.21(j)(1) and (j)(2) shall be $0.35 per pound of the batch covered by such re quests, but no such fee shall be less than $224. (b) Fees for repacks of certified color additives and color additive mixtures. The fees for the services provided under the regulations in this part in the case of each request for certification sub mitted in accordance with § 80.21(j)(3) and (j)(4) shall be: (1) 100 pounds or less—$35. (2) Over 100 pounds but not over 1,000 pounds—$35 plus $0.06 for each pound over 100 pounds. (3) Over 1,000 pounds—$89 plus $0.02 for each pound over 1,000 pounds. (c) Advance deposits. Any person regu larly requesting certification services may deposit funds in advance of re quests as prepayment of fees required by this section. (d) Method of payment. All deposits and fees required by this section shall be paid by money order, bank draft, or certified check, drawn to the order of the Food and Drug Administration, collectible at par at Washington, DC. All such deposits and fees shall be for warded to the Center for Food Safety and Applied Nutrition (HFS–100), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, whereupon after making appropriate records thereof, they will be trans mitted to the Treasurer of the United VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00501 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B