§ 73.1010 Alumina (dried aluminum hydroxide).
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(a) Identity. (1) The color additive alumina (dried aluminum hydroxide) is a white, odorless, tasteless, amorphous powder consisting essentially of aluminum hydroxide (Al2 O3· XH2 O).
(2) Color additive mixtures for drug use made with alumina (dried aluminum hydroxide) may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Alumina (dried aluminum hydroxide) shall conform to the following specifications:
Acidity or alkalinity: Agitate 1 gram of the color additive with 25 milliliters of water and filter. The filtrate shall be neutral to litmus paper.
Matter insoluble in dilute hydrochloric acid, not more than 0.5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.
Aluminum oxide (Al2 O3), not less than 50 percent.
(c) Uses and restrictions. Alumina (dried aluminum hydroxide) may be safely used in amounts consistent with good manufacturing practice to color drugs generally.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1015 Chromium-cobalt-aluminum oxide.
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(a) Identity. The color additive chromium-cobalt-aluminum oxide is a blue-green pigment obtained by calcining a mixture of chromium oxide, cobalt carbonate, and aluminum oxide. It may contain small amounts (less than 1 percent each) of oxides of barium, boron, silicon, and nickel.
(b) Specifications. Chromium-cobalt-aluminum oxide shall conform to the following specifications:
Chromium, calculated as Cr2 O3, 34–37 percent.
Cobalt, calculated as CoO, 29–34 percent.
Aluminum, calculated as AL2 O3, 29–35 percent.
Lead (as Pb), not more than 30 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total oxides of aluminum, chromium, and cobalt not less than 97 percent.
Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the chromium-cobalt-aluminum oxide for 15 minutes in 50 milliliters of 0.5 N hydrochloric acid.
(c) Uses and restrictions. The color additive chromium-cobalt-aluminum oxide may be safely used for coloring linear polyethylene surgical sutures, United States Pharmacopeia (U.S.P.), for use in general surgery, subject to the following restrictions:
(1) For coloring procedure, the color additive is blended with the polyethylene resin. The mixture is heated to a temperature of 500°–550 °F. and extruded through a fixed orifice. The filaments are cooled, oriented by drawing, and set by annealing.
(2) The quantity of the color additive does not exceed 2 percent by weight of the suture material.
(3) The dyed suture shall conform in all respects to the requirements of the U.S.P. XX (1980).
(4) When the sutures are used for the purpose specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(5) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act, is in effect for it.
(d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]
§ 73.1025 Ferric ammonium citrate.
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(a) Identity. The color additive ferric ammonium citrate consists of complex chelates prepared by the interaction of ferric hydroxide with citric acid in the presence of ammonia. The complex chelates occur in brown and green forms, are deliquescent in air, and are reducible by light.
(b) Specifications. Ferric ammonium citrate 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:
Iron (as Fe), not less than 14.5 percent and not more than 18.5 percent.
Lead (as Pb), not more than 20 p/m.
Arsenic (as As), not more than 3 p/m.
(c) Uses and restrictions. Ferric ammonium citrate may be safely used in combination with pyrogallol (as listed in §73.1375), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery subject to the following conditions:
(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).
(2) The level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.
(3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d) Labeling. The labeling of the color-additive shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]
§ 73.1030 Annatto extract.
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(a) Identity and specifications. (1) The color additive annatto extract shall conform in identity and specifications to the requirements of §73.30(a)(1) and (b).
(2) Color additive mixtures for drug use made with annatto extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.
(b) Uses and restrictions. Annatto extract may be safely used for coloring drugs generally, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter. Labels shall bear information showing that the color is derived from annatto seed. The requirements of §70.25(a) of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in §73.30(a)(1)(ii) of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are evempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 36994, July 19, 1977]
§ 73.1070 Calcium carbonate.
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(a) Identity. (1) The color additive calcium carbonate is a fine, white, synthetically prepared powder consisting essentially of precipitated calcium carbonate (CaCO3).
(2) Color additive mixtures for drug use made with calcium carbonate may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Calcium carbonate shall meet the specifications for precipitated calcium carbonate in the United States Pharmacopeia XX (1980).
(c) Uses and restrictions. Calcium carbonate may be safely used in amounts consistent with good manudacturing practice to color drugs generally.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]
§ 73.1075 Canthaxanthin.
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(a) Identity and specifications. (1) The color additive canthaxanthin shall conform in identity and specifications to the requirements of §73.75(a)(1) and (b).
(2) Color additive mixtures for ingested drug use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.
(b) Uses and restrictions. Canthaxanthin may be safely used for coloring ingested drugs generally in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1085 Caramel.
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(a) Identity and specifications. (1) The color additive caramel shall conform in identity and specifications to the requirements of §73.85(a) (1), (2), and (3) and (b).
(2) The diluents in color additive mixtures for drug use containing caramel shall be limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.
(b) Uses and restrictions. Caramel may be used for coloring ingested and topically applied drugs generally in amounts consistent with good manufacturing practice.
(c) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirement of section 721(c) of the act.
§ 73.1095 β-Carotene.
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(a) Identity and specifications. (1) The color additive β-carotene shall conform in identity and specifications to the requirements of §73.95(a)(1) and (b).
(2) The diluents in color additive mixtures for drug use containing β-carotene are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring ingested drugs.
(b) Uses and restrictions. The color additive β-carotene may be safely used in coloring drugs generally, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The labeling of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]
§ 73.1100 Cochineal extract; carmine.
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(a) Identity and specifications. (1) The color additives cochineal extract and carmine shall conform in identity and specifications to the requirements of §73.100(a) (1) and (2) and (b).
(2) Color additive mixtures for drug use made with carmine and cochineal extract may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs.
(b) Uses and restrictions. Cochineal extract and carmine may be safely used for coloring ingested and externally applied drugs in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).
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(a) Identity. (1) The color additive potassium sodium copper chlorophyllin is a green to black powder obtained from chlorophyll by replacing the methyl and phytyl ester groups with alkali and replacing the magnesium with copper. The source of the chlorophyll is dehydrated alfalfa.
(2) Color additive mixtures for drug use made with potassium sodium copper chlorophyllin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring drugs.
(b) Specifications. Potassium sodium copper chlorophyllin 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:
Moisture, not more than 5.0 percent.
Nitrogen, not more than 5.0 percent.
pH of 1 percent solution, 9 to 11.
Total copper, not less than 4 percent and not more than 6 percent.
Free copper, not more than 0.25 percent.
Iron, not more than 0.5 percent.
Lead (as Pb)), not more than 20 parts per million.
Arsenic (as As), not more than 5 parts per million.
Ratio, absorbance at 405 mμ to absorbance at 630 mμ, not less than 3.4 and not more than 3.9.
Total color, not less than 75 percent.
(c) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are drugs at a level not to exceed 0.1 percent. Authorization for this use shall not be construed as waiving any of the requirements of section 505 of the act with respect to the drug in which it is used.
(d) Labeling. The label of the color additive 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) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1128 Mica-based pearlescent pigments.
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(a) Identity. (1) The color additive is formed by depositing titanium and/or iron salts onto mica, followed by heating to produce one of the following combinations: Titanium dioxide on mica; iron oxide on mica; titanium dioxide and iron oxide on mica. Mica used to manufacture the color additive shall conform in identity to the requirements of §73.1496(a)(1).
(2) Color additive mixtures for drug use made with mica-based pearlescent pigments may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring ingested drugs.
(b) Specifications. Mica-based pearlescent pigments 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:
(1) Lead (as Pb), not more than 4 parts per million (ppm).
(2) Arsenic (as As), not more than 3 ppm.
(3) Mercury (as Hg), not more than 1 ppm.
(c) Uses and restrictions. Mica-based pearlescent pigments may be safely used to color ingested drugs in amounts up to 3 percent, by weight, of the final drug product. The maximum amount of iron oxide to be used in producing said pigments is not to exceed 55 percent, by weight, in the finished pigment.
(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.
[70 FR 42273, July 22, 2005]
§ 73.1150 Dihydroxyacetone.
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(a) Identity. (1) The color additive dihydroxyacetone is 1,3-dihydroxy-2-propanone.
(2) Color additive mixtures for drug use made with dihydroxyacetone may contain only those diluents that are listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b) Specifications. Dihydroxyacetone 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:
Volatile matter (at 34.6 °C. for 3 hours at a pressure of not more than 30 mm. mercury), not more than 0.5 percent.
Residue on ignition, not more than 0.4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Iron (as Fe), not more than 25 parts per million.
1,3-dihydroxy-2-propanone, not less than 98 percent.
(c) Uses and restrictions. Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied drugs intended solely or in part to impart a color to the human body. Authorization for this use shall not be construed as waiving any of the requirements of section 505 of the act with respect to the drug in which it is used.
(d) Labeling requirements. The label of the color additive 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) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1162 Bismuth oxychloride.
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(a) Identity. (1) The color additive bismuth oxychloride is a synthetically prepared white or nearly white amorphous or finely crystalline, odorless powder consisting principally of BiOCl.
(2) Color additive mixtures for drug use made with bismuth oxychloride may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring externally applied drugs.
(b) Specifications. The color additive bismuth oxychloride 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:
Volatile matter, not more than 0.5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Bismuth oxychloride, not less than 98 percent.
(c) Uses and restrictions. The color additive bismuth oxychloride may be safely used in coloring externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
[42 FR 52394, Sept. 30, 1977]
§ 73.1200 Synthetic iron oxide.
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(a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances.
(2) Color additive mixtures for drug use made with synthetic iron oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring drugs.
(b) Specifications. Synthetic iron oxide shall conform to the following specifications, all on an “as is” basis:
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg), not more than 3 parts per million.
(c) Uses and restrictions. The color additive synthetic iron oxide may be safely used to color ingested or topically applied drugs generally subject to the restriction that if the color additive is used in drugs ingested by man the amount consumed in accordance with labeled or prescribed dosages shall not exceed 5 milligrams, calculated as elemental iron, per day.
(d) Labeling requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification requirements of section 721(c) of the act.
§ 73.1298 Ferric ammonium ferrocyanide.
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(a) Identity. (1) The color additive ferric ammonium ferrocyanide is the blue pigment obtained by oxidizing under acidic conditions with sodium dichromate the acid digested precipitate resulting from mixing solutions of ferrous sulfate and sodium ferrocyanide in the presence of ammonium sulfate. The oxidized product is filtered, washed, and dried. The pigment consists principally of ferric ammonium ferrocyanide with smaller amounts of ferric ferrocyanide and ferric sodium ferrocyanide.
(2) Color additive mixtures for drug use made with ferric ammonium ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Ferric ammonium ferrocyanide shall conform to the following specifications and shall be free of impurities other than those named to the extent that the other impurities may be avoided by good manufacturing practice:
Oxalic acid or its salts, not more than 0.1 percent.
Water soluble matter, not more than 3 percent.
Water soluble cyanide, not more than 10 parts per million.
Volatile matter, not more than 4 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Nickel (as Ni), not more than 200 parts per million.
Cobalt (as Co), not more than 200 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total iron (as Fe corrected for volatile matter), not less than 33 percent and not more than 39 percent.
(c) Uses and restrictions. Ferric ammonium ferrocyanide may be safely used in amounts consistent with good manufacturing practice to color externally applied drugs, including those for use in the area of the eye.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therfore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979]
§ 73.1299 Ferric ferrocyanide.
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(a) Identity. (1) The color additive ferric ferrocyanide is a ferric hexacyanoferrate pigment characterized by the structual formula Fe4[Fe(CN)6]3·XH2O, which may contain small amounts of ferric sodium ferrocyanide and ferric potassium ferrocyanide.
(2) Color additive mixtures for drug use made with ferric ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Ferric ferrocyanide 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:
Water soluble cyanide, not more than 10 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Nickel (as Ni), not more than 200 parts per million.
Cobalt (as Co), not more than 200 parts per million.
Mercury (as Hg), not more than 1 part per million.
Oxalic acid, not more than 0.1 percent.
Water soluble matter, not more than 3 percent.
Volatile matter, not more than 10 percent.
Total iron (as Fe corrected for volatile matter), not less than 37 percent and not more than 45 percent.
(c) Uses and restrictions. Ferric ferrocyanide may be safely used in amounts consistent with good manufacturing practice to color externally applied drugs including those intended for use in the area of the eye.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification requirements of section 721(c) of the act.
[43 FR 54235, Nov. 21, 1978]
§ 73.1326 Chromium hydroxide green.
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(a) Identity. (1) The color additive chromium hydroxide green is principally hydrated chromic sesquioxide (Cr2O3·XH2O).
(2) Color additive mixtures for drug use made with chromium hydroxide green may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Chromium hydroxide green 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:
Water soluble matter, not more than 2.5%.
Chromium in 2% NaOH extract, not more than 0.1% as Cr2O3 (based on sample weight).
Boron (as B2O3), not more than 8 percent.
Total volatile matter at 1000 °C, not more than 20%.
Cr2O3 not less than 75%.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. Chromium hydroxide green may be safely used in amounts consistent with good manufacturing practice to color externally applied drugs, including those for use in the area of the eye.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom lintended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 36451, July 15, 1977, as amended at 42 FR 59852, Nov. 22, 1977]
§ 73.1327 Chromium oxide greens.
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(a) Identity. (1) The color additive chromium oxide greens is principally chromic sesquioxide (Cr2O3).
(2) Color additive mixtures for drug use made with chromium oxide greens may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. the color additive chormium oxide greens 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:
Chromium in 2% NaOH extract, not more than 0.075% as Cr2O3 (based on sample weight).
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 1 part per million.
Cr2O3, not less than 95%.
(c) Uses and restrictions. Chromium oxide greens is safe for use in coloring externally applied drugs, including those intended for use in the area of eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from certification pursuant to section 721(c) of the act.
[42 FR 36451, July 15, 1977]
§ 73.1329 Guanine.
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(a) Identity. (1) The color additive guanine is the crystalline material obtained from fish scales and consists principally of the two purines, guanine and hypoxanthine. The guanine content will vary from 75 to 97 percent, and the hypoxanthine will vary from 3 to 25 percent, depending on the particular fish and tissue from which the crystals are derived.
(2) Color additive mixtures for drug use made with guanine 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 guanine 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:
Guanine, not less than 75 percent.
Hypoxanthine, not more than 25 percent.
Ash (ignition at 800 °C), not more than 2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Assay, not less than 96 percent total purines.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. Guanine is safe for use in coloring externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from certification pursuant to section 721(c) of the act.
[42 FR 37537, July 22, 1977]
§ 73.1375 Pyrogallol.
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(a) Identity. The color additive pyrogallol is 1,2,3-trihydroxybenzene.
(b) Specifications. Pyrogallol 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:
Melting point, between 130° and 133 °C.
Residue on ignition, not more than 0.1 percent.
Lead (as Pb), not more than 20 p/m (parts per million).
Arsenic (as As), not more than 3 p/m.
(c) Uses and restrictions. Pyrogallol may be safely used in combination with ferric ammonium citrate (as listed in §73.1025), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery, 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 level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.
(3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissues.
(4) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]
§ 73.1400 Pyrophyllite.
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(a) Identity. (1) The color additive pyrophyllite is a naturally occurring mineral substance consisting predominantly of a hydrous aluminum silicate, Al2O3·4SiO2·H2 O, intimately mixed with lesser amounts of finely divided silica, SiO2. Small amounts, usually less than 3 percent, of other silicates, such as potassium aluminum silicate, may be present. Pyrophyllite may be identified and semiquantitatively determined by its characteristic X-ray powder diffraction pattern and by its optical properties.
(2) Color additive mixtures made with pyrophyllite are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b) Specifications. Pyrophyllite shall conform to the following specifications:
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the pyrophyllite for 15 minutes in 50 milliliters of 0.5N hydrochloric acid.
(c) Uses and restrictions. Pyrophyllite may be safely used in amounts consistent with good manufacturing practice to color drugs that are to be externally applied.
(d) Labeling requirements. The labeling of the color additive 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) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1410 Logwood extract.
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(a) Identity. The color additive logwood extract is a reddish brown-to-black solid material extracted from the heartwood of the leguminous tree Haematoxylon campechianum. The active colorant substance is principally hematein. The latent coloring material is the unoxidized or leuco form of hematein called hematoxylin. The leuco form is oxidized by air.
(b) Specifications. Logwood extract shall conform to the following specifications and shall be free from impurities other than those named to the extent that such imnurities may be avoided by good manufacturing practice:
Volatile matter (at 110 °C), not more than 15 percent.
Sulfated ash, not more than 20 percent.
Hematein, not less than 5 percent and not more than 20 percent.
Lead (as Pb), not more than 70 parts per million.
Arsenic (as As), not more than 4 parts per million.
Mercury (as Hg), not more than 3 parts per million.
(c) Use and restrictions. Logwood extract may be safely used to color nylon 66 (the copolymer of hexamethylenediamine and adipic acid), nylon 6 (the polymer of e-caprolactam), or silk non-absorable sutures for use in general and ophthalmic surgery subject to the following restrictions:
(1) The quantity of color additive does not exceed 1.0 percent by weight of the suture.
(2) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.
(3) If the suture is a new drug, an approved new drug application, pursuant to section 505 of the act, is in effect for it.
(d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. 10, 1978]
§ 73.1496 Mica.
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(a) Identity. (1) The color additive mica is a white powder obtained from the naturally occurring mineral, muscovite mica, consisting predominantly of a potassium aluminum silicate, K2Al4(Al2Si6O20)(OH)4 or, alternatively, H2KAl3(SiO4)3. Mica may be identified and semiquantitatively determined by its characteristic X-ray diffraction pattern and by its optical properties.
(2) Color additive mixtures for drug use made with mica may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Mica 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:
Fineness, 100 percent shall pass through a 100-mesh sieve.
Loss on ignition at 600–650 °C, not more than 2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. Mica may be safely used in amounts consistent with good manufacturing practice to color dentifrices and externally applied drugs, including those for use in the area of the eye.
(d) Labeling requirements. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 38561, July 29, 1977, as amended at 52 FR 29665, Aug. 11, 1987]
§ 73.1550 Talc.
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(a) Identity. (1) The color additive talc is a finely powdered, native, hydrous magnesium silicate sometimes containing a small proportion of aluminum silicate.
(2) Color additive mixtures for drug use made with talc may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.
(b) Specifications. Talc shall meet the specifications for talc in the United States Pharmacopeia XX (1980) and the following:
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the talc for 15 minutes in 50 milliliters of 0.5N hydrochloric acid.
(c) Uses and restrictions. Talc may be safely used in amounts consistent with good manufacturing practice to color drugs generally.
(d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984)
§ 73.1575 Titanium dioxide.
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(a) Identity and specifications. (1) The color additive titanium dioxide shall conform in identity and specifications to the requirements of §73.575(a)(1) and (b).
(2) Color additive mixtures for drug use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring drugs, and the following: Silicon dioxide, SiO2, and/or aluminum oxide, Al2O3, as dispersing aids—not more than 2 percent total.
(b) Uses and restrictions. The color additive titanium dioxide may be used for coloring ingested and externally applied drugs generally, in amounts consistent with good manufacturing practice. External application includes use in the area of the eye.
(c) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of the chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.1645 Aluminum powder.
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(a) Identity. (1) The color additive aluminum powder shall be composed of finely divided particles of aluminum prepared from virgin aluminum. It is free from admixture with other substances.
(2) Color additive mixtures for external drug use made with aluminum powder may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b) Specifications. Aluminum powder 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:
Fineness, 100 percent shall pass through a 200-mesh screen and 95 percent shall pass through a 325-mesh screen.
Mercury, not more than 1 part per million.
Arsenic, not more than 3 parts per million.
Lead, not more than 20 parts per million.
Aluminum, not less than 99 percent.
(c) Uses and restrictions. Aluminum powder is safe for use in externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from certification pursuant to section 721(c) of the act.
[42 FR 38563, July 29, 1977]
§ 73.1646 Bronze powder.
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(a) Identity. (1) The color additive bronze powder is a very fine metallic powder prepared from alloys consisting principally of virgin electrolytic copper and zinc with small amounts of the virgin metals aluminum and tin. It contains small amounts of stearic or oleic acid as lubricants.
(2) Color additive mixtures for drug use made with bronze powder 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. Bronze powder 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:
Stearic or oleic acid, not more than 5 percent.
Cadmium (as Cd), not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million
Aluminum (as Al), not more than 0.5 percent.
Tin (as Sn), not more than 0.5 percent.
Copper (as Cu), not more than 95 percent and not less than 70 percent.
Zinc (as Zn), not more than 30 percent.
Maximum particle size 45µ (95 percent minimum).
Aluminum, zinc, tin, and copper content shall be based on the weight of the dried powder after being thoroughly washed with ether.
(c) Uses and restrictions. Bronze powder may be safely used in color externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 33723, July 1, 1977]
§ 73.1647 Copper powder.
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(a) Identity. (1) The color additive copper powder is a very fine free-flowing metallic powder prepared from virgin electrolytic copper. It contains small amounts of stearic or oleic acid as lubricants.
(2) Color additive mixtures for drug use made with copper powder 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. Copper powder 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:
Stearic or oleic acid, not more than 5 percent.
Cadmium (as Cd), not more than 15 parts per million.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Copper (as Cu), not less than 95 percent.
Maximum particle size 45µ (95 percent minimum).
(c) Uses and restrictions. Copper powder may be safely used in coloring externally applied drugs, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 33723, July 1, 1977]
§ 73.1991 Zinc oxide.
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(a) Identity. (1) The color additive zinc oxide is a white or yellow-white amorphous powder manufactured by the French process (described as the indirect process whereby zinc metal isolated from the zinc-containing ore is vaporized and then oxidized). It is principally composed of Zn.
(2) Color additive mixtures for drug use made with zinc oxide may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
(b) Specifications. Zinc oxide 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:
Zinc oxide (as ZnO), not less than 99 percent.
Loss on ignition at 800 °C, not more than 1 percent.
Cadmium (as Cd), not more than 15 parts per million.
Mercury (as Hg), not more than 1 part per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
(c) Uses and restrictions. The color additive zinc oxide may be safely used for coloring externally applied drugs, including those used in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixtues prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certifiation pursuant to section 721(c) of the act.
[42 FR 37537, July 22, 1977]
Subpart C—Cosmetics
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§ 73.2030 Annatto.
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(a) Identity and specification. The color additive annatto shall conform in identify and specification to the requirements for annatto extract in §73.30(a) (1) and (b).
(b) Use and restriction. The color additive annatto may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 36994, July 19, 1977]
§ 73.2085 Caramel.
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(a) Identity and specifications. The color additive caramel shall conform in identity and specifications to the requirements of §73.85(a)(1), (2), and (3) and (b).
(b) Uses and restrictions. Caramel is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirement of section 721(c) of the act.
[46 FR 38501, July 28, 1981]
§ 73.2087 Carmine.
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(a) Identity and specifications. The color additive carmine shall conform in identity and specifications to the requirements of §73.100 (a)(2) and (b)(2).
(b) Use and restrictions. Carmine may be safely used in cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 32228, June 24, 1977]
§ 73.2095 β-Carotene.
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(a) Identity and specifications. The color additive β-carotene shall conform in identity and specifications to the requirements of §73.95(a)(1) and (b).
(b) Uses and restrictions. The color additive β-carotene may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 33722, July 1, 1977]
§ 73.2110 Bismuth citrate.
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(a) Identity. The color additive bismuth citrate is the synthetically prepared crystalline salt of bismuth and citric acid, consisting principally of BiC6H5O7.
(b) Specifications. The color additive bismuth citrate shall conform to the following specifications and shall be free from impurities other than those named to the extent that those impurities may be avoided by good manufacturing practice:
Bismuth citrate, not less than 97 percent.
Mercury (as Hg), not more than 1 part per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 20 parts per million.
Volatile matter, not more than 1 percent.
(c) Uses and restrictions. The color additive bismuth citrate may be safely used in cosmetics intended for coloring hair on the scalp, subject to the following restrictions:
(1) The amount of bismuth citrate in the cosmetic shall not be in excess of 0.5 percent (w/v).
(2) The cosmetic may not be used for coloring eyelashes, eyebrows, or hair on parts of the body other than the scalp.
(d) Labeling. (1) The label of the color additive bismuth citrate shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(2) The label of a cosmetic containing the color additive bismuth citrate shall bear, in addition to other information required by law, the following statement, conspicuously displayed thereon:
Keep this product out of children's reach. Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts of the body other than the scalp. Wash hands thoroughly after each use.
(e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health, and, therefore, batches thereof are exempt from certification requirements of section 721(c) of the act.
[43 FR 44831, Sept. 29, 1978]
§ 73.2120 Disodium EDTA-copper.
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(a) Identity. The color additive disodium EDTA-copper is disodium [[N,N′- 1,2- ethanediylbis[N - (carboxymethyl) glycinato]] (4-)-N,N′,O,O′,ON ,ON ′] cuprate (2-).
(b) Specifications. Disodium EDTA-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 good manufacturing practice:
Total copper, not less than 13.5 percent.
Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent.
Free copper, not more than 100 parts per million.
Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent.
Moisture, not more than 15 percent.
Water insoluble matter, not more than 0.2 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
(c) Uses and restrictions. Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics.
(d) Labeling requirements. The labeling of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.
§ 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).
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(a) Identity and specifications. The color additive potassium sodium copper chlorophyllin shall conform in identity and specifications to the requirements of §73.1125(a)(1) and (b).
(b) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are cosmetics subject to the following conditions:
(1) It shall not be used at a level in excess of 0.1 percent.
(2) It may be used only in combination with the following substances:
Water.
Glycerin.
Sodium carboxymethylcellulose.
Tetrasodium pyrophosphate.
Sorbitol.
Magnesium phosphate, tribasic.
Calcium carbonate.
Calcium phosphate, dibasic.
Sodium N-lauroyl sarcosinate.
Artificial sweeteners that are generally recognized as safe or that are authorized under subchapter B of this chapter.
Flavors that are generally recognized as safe or that are authorized under subchapter B of this chapter.
Preservatives that are generally recognized as safe or that are authorized under subchapter B of this chapter.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.2150 Dihydroxyacetone.
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(a) Identity and specifications. The color additive dihydroxyacetone shall conform in identity and specifications to the requirements of §73.1150 (a)(1) and (b).
(b) Uses and restrictions. Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied cosmetics intended solely or in part to impart a color to the human body.
(c) Labeling requirements. The labeling of the color additive 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) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.
§ 73.2162 Bismuth oxychloride.
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(a) Identity and specifications. (1) The color additive bismuth oxychloride shall conform in identity and specifications to the requirements of §73.1162(a)(1) and (b).
(2) Color additive mixtures of bismuth oxychloride may contain the following diluents:
(i) For coloring cosmetics generally, only those diluents listed under §73.1001(a)(1);
(ii) For coloring externally applied cosmetics, only those diluents listed in §73.1001(b) and, in addition, nitrocellulose.
(b) Uses and restrictions. The color additive bismuth oxychloride may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
[42 FR 52394, Sept. 30, 1977]
§ 73.2180 Guaiazulene.
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(a) Identity. (1) The color additive, guaiazulene, is principally 1,4-dimethyl-7-isopropyl-azulene.
(2) Color additive mixtures of guaiazulene for cosmetic use may contain the following diluent:
Polyethylene glycol-40 castor oil (PEG–40 castor oil).
Saponification No., 60 to 70.
Hydroxyl No., 63 to 78.
Acid No., 2.
Specific gravity, 1.05 to 1.07.
(b) Specifications. Guaiazulene 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.
Melting point, 30.5 °C to 31.5 °C.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 99 percent.
(c) Uses and restrictions. Guaiazulene may be safely used in externally applied cosmetics in amounts consistent with good manufacturing practice.
(d) Labeling. The label of the color additive 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) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.2190 Henna.
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(a) Identity. The color additive henna is the dried leaf and petiole of Lawsonia alba Lam. (Lawsonia inermis L.). It may be identified by its characteristic odor and by characteristic plant histology.
(b) Specifications. Henna shall conform to the following specifications:
It shall not contain more than 10 percent of plant material from Lawsonia alba Lam. (Lawsonia inermis L.) other than the leaf and petiole, and shall be free from admixture with material from any other species of plant.
Moisture, not more than 10 percent.
Total ash, not more than 15 percent.
Acid-insoluble ash, not more than 5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
(c) Uses and restrictions. The color additive henna may be safely used for coloring hair only. It may not be used for coloring the eyelashes or eyebrows, or generally in the area of the eye.
(d) Labeling. The label for henna shall bear the information required by §70.25 of this chapter and the following statements or their equivalent:
“Do not use in the area of the eye.”
“Do not use on cut or abraded scalp.”
(e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.2250 Iron oxides.
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(a) Identity. The color additives iron oxides consist of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances.
(b) Specifications. Iron oxides shall conform to the following specifications, all on an “as is” basis:
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg), not more than 3 parts per million.
(c) Uses and restrictions. Iron oxides are safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
§ 73.2298 Ferric ammonium ferrocyanide.
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(a) Identity and specifications.The color additive ferric ammonium ferrocyanide shall conform in identify and specifications to the requirements of §73.1298 (a)(1) and (b).
(b) Uses and restrictions. Ferric ammonium ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 38562, July 29, 1977, as amended at 43 FR 6939, Feb. 17, 1978]
§ 73.2299 Ferric ferrocyanide.
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(a) Identity and specifications. The color additive ferric ferrocyanide shall conform in identity and specifications to the requirements of §73.1299(a)(1) and (b).
(b) Uses and restrictions. Ferric ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification under section 721(c) of the act.
[43 FR 54236, Nov. 21, 1978]
§ 73.2326 Chromium hydroxide green.
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(a) Identity and specifications.The color additive chromium hydroxide green shall conform in identity and specifications to the requirements of §73.1326 (a)(1) and (b).
(b) Uses and restrictions. Chromium hydroxide green is safe for use in coloring externally applied cosmetics, including those intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
[42 FR 36452, July 15, 1977]
§ 73.2327 Chromium oxide greens.
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(a) Identity and specifications. The color additive chromium oxide greens shall conform in identify and specifications to the requirements of §73.1327 (a)(1) and (b).
(b) Uses and restrictions. The color additive chromium oxide greens may be safely used in externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 36452, July 15, 1977]
§ 73.2329 Guanine.
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(a) Identity and specifications. (1) The color additive guanine shall conform in identity and specifications to the requirements of §73.1329 (a)(1) and (b).
(2) Color additive mixtures of guanine may contain the following diluents:
(i) For coloring cosmetics generally, only those diluents listed under §73.1001(a)(1);
(ii) For coloring externally applied cosmetics, only those diluents listed in §73.1001(b) and, in addition, nitrocellulose.
(b) Use and restrictions. The color additive guanine may be safely used in cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 37537, July 22, 1977]
§ 73.2396 Lead acetate.
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(a) Identity. The color additive lead acetate is the trihydrate of lead (2+) salt of acetic acid. The color additive has the chemical formula Pb (OOCCH3)2·3H2O).
(b) Specifications. Lead acetate 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:
Water-insoluble matter, not more than 0.02 percent.
pH (30 percent solution weight to volume at 25 °C), not less than 4.7 and not more than 5.8.
Arsenic (as As), not more than 3 parts per million.
Lead acetate, not less than 99 percent.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. The color additive lead acetate may be safely used in cosmetics intended for coloring hair on the scalp only, subject to the following restrictions:
(1) The amount of the lead acetate in the cosmetic shall be such that the lead content, calculated as Pb, shall not be in excess of 0.6 percent (weight to volume).
(2) The cosmetic is not to be used for coloring mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp.
(d) Labeling requirements. (1) The label of the color additive lead acetate shall conform to the requirements of §170.25 of this chapter, and bear the following statement or equivalent:
Wash thoroughly if the product comes into contact with the skin.
(2) The label of the cosmetic containing the color additive lead acetate, in addition to other information required by the act, shall bear the following cautionary statement, conspicuously displayed thereon:
CAUTION: Contains lead acetate. For external use only. Keep this product out of children's reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.
(e) Exemption for certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[45 FR 72117, Oct. 31, 1980]
§ 73.2400 Pyrophyllite.
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(a) Identity and specifications. The color additive pyrophyllite shall conform in identity and specifications to the requirements of §73.1400 (a)(1) and (b).
(b) Uses and restrictions. Pyrophyllite may be safely used for coloring externally applied cosmetics, in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to all applicable requirements of law, including the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
§ 73.2496 Mica.
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(a) Identity and specifications. The color additive mica shall conform in identity and specifications to the requirements of §73.1496(a)(1) and (b).
(b) Uses and restrictions. Mica is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 38561, July 29, 1977]
§ 73.2500 Silver.
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(a) Identity. (1) The color additive, silver, is a crystalline powder of high purity silver prepared by the reaction of silver nitrate with ferrous sulfate in the presence of nitric, phosphoric and sulfuric acids. Polyvinyl alcohol is used to prevent the agglomeration of crystals and the formation of amorphous silver.
(2) Color additive mixtures of silver may contain only those diluents listed in §73.1001(b) and, in addition, nitrocellulose.
(b) Specifications. Silver 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:
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 5 parts per million.
Mercury (as Hg), not more than 1 part per million.
Silver (as Ag), not less than 99.9 percent.
(c) Uses and restrictions. The color additive silver may be safely used for coloring fingernail polish at a level not to exceed 1 percent of the final product.
(d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[44 FR 65974, Nov. 16, 1979]
§ 73.2575 Titanium dioxide.
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(a) Identity and specifications. The color additive titanium dioxide shall conform in identity and specifications to the requirements on §73.575 (a)(1) and (b).
(b) Uses and restrictions. The color additive titanium dioxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
§ 73.2645 Aluminum powder.
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(a) Identity and specifications. The color additive aluminum powder shall conform in identity and specifications to the requirements of §73.1645 (a)(1) and (b).
(b) Uses and restrictions. Aluminum powder may be safely used in coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 38563, July 29, 1977]
§ 73.2646 Bronze powder.
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(a) Identity and specifications. The color additive bronze powder shall conform in identity and specifications to the requirements of §73.1646 (a)(1) and (b).
(b) Uses and restrictions. Bronze powder may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 33724, July 1, 1977]
§ 73.2647 Copper powder.
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(a) Identity and specifications. The color additive copper powder shall conform in identity and specifications to the requirements of §73.1647 (a)(1) and (b).
(b) Uses and restrictions. Copper powder may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of the color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[42 FR 33724, July 1, 1977]
§ 73.2725 Ultramarines.
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(a) Identity. The color additives, ultramarines (blue, green, pink, red, and violet) are pigments obtained by calcining at temperatures above 700 °C. a mixture of kaolin, sulfur, sodium carbonate, silicious matter, sodium sulfate, and carbonaceous matter, but not necessarily all these substances, to produce a single color. The ultramarines are complex sodium aluminum sulfosilicates having a typical formula Na(AlSiO)S with proportions of each element varying with each color.
(b) Specifications. The ultramarines 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.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. The ultramarine pigments may be safely used for coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling requirements. The color additives and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
§ 73.2775 Manganese violet.
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(a) Identity. The color additive manganese violet is a violet pigment obtained by reacting phosphoric acid, ammonium dihydrogen orthophosphate, and manganese dioxide at temperatures above 450 °F. The pigment is a manganese ammonium pyrophosphate complex having the approximate formula: Mn(III)NH4P2O7.
(b) Specifications. Manganese violet 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:
Ash (at 600 °C), not less than 81 percent.
Volatile matter at 135 °C for 3 hours, not more than 1 percent.
Water soluble substances, not more than 6 percent.
pH of filtrate of 10 grams color additive (shaken occasionally for 2 hours with 100 milliliters of freshly boiled distilled water), not more than 4.7 and not less than 2.5.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, based on Mn content in “as is” sample, not less than 93 percent.
(c) Uses and restrictions. Manganese violet is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.
(d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.
§ 73.2991 Zinc oxide.
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(a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of §73.1991 (a)(1) and (b).
(b) Uses and restrictions. Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice.
(c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act.
[42 FR 37538, July 22, 1977]
§ 73.2995 Luminescent zinc sulfide.
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(a) Identity. The color additive luminescent zinc sulfide is zinc sulfide containing a copper activator. Following excitation by daylight or a suitable artificial light, luminescent zinc sulfide produces a yellow-green phosphorescence with a maximum at 530 nanometers.
(b) Specifications. Luminescent zinc sulfide 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:
Zinc sulfide, not less than 99.8 percent.
Copper, 100±5 parts per million.
Lead, not more than 20 parts per million.
Arsenic, not more than 3 parts per million.
Mercury, not more than 1 part per million.
Cadmium, not more than 15 parts per million.
(c) Uses and restrictions. The color additive luminescent zinc sulfide may be safely used for coloring externally applied facial makeup preparations and nail polish included under §720.4(c)(7)(ix) and (c)(8)(v) of this chapter, respectively, to the following restrictions:
(1) The amount of luminescent zinc sulfide in facial makeup preparations shall not exceed 10 percent by weight of the final product.
(2) Facial makeup preparations containing luminescent zinc sulfide are intended for use only on limited, infrequent occasions, e.g., Halloween, and not for regular or daily use.
(d) Labeling requirements. (1) The label of the color additive and any mixtures prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by §70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.
(2) The label of a facial makeup preparation containing the color additive shall bear, in addition to other information required by the law, the following statement conspicuously displayed:
Do not use in the area of the eye.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000]
Subpart D—Medical Devices
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§ 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers.
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(a) Identity. The color additives are 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester (CAS Reg. No. 109561–07–1) copolymerized either with glyceryl methacrylate, methyl methacrylate, and ethylene glycol dimethacrylate monomers, or with N,N-dimethyl acrylamide, methyl methacrylate, and ethylene glycol dimethacrylate monomers to form the contact lens material.
(b) Uses and restrictions. (1) The substances listed in paragraph (a) of this section may be used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) 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 (the act) with respect to the contact lens made from the color additives.
(c) Labeling. The label of the color additives shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health and therefore the color additives are exempt from the certification requirements of section 721(c) of the act.
[61 FR 51586, Oct. 3, 1996]
§ 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
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(a) Identity. The color additive is 1,4-bis[(2-methylphenyl)amino]-9,10-anthracenedione (CAS Reg. No. 6737–68–4).
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with 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 (the act). A person intending to introduce a device containing 1,4-bis[(2-methylphenyl)amino]-9,10-anthracenedione listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[49 FR 30066, July 26, 1984]
§ 73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.
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(a) Identity. The color additive is 1,4-bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone (CAS Reg. No. 121888–69–5), copolymerized with hydroxyethyl methacrylate monomer, or a blend of hydroxyethyl methacrylate and N-vinyl pyrrolidone monomers, or a blend of 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate (CAS Reg. No. 134072–99–4) and N-vinyl pyrrolidone monomers to form the contact lens material.
(b) Uses and restrictions. (1) The substances listed in paragraph (a) of this section may be used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) 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 (the act) with respect to contact lenses made from the color additives.
(c) Labeling. The label of the color additives shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health and, therefore, the color additives are exempt from the certification requirements of section 721(c) of the act.
[58 FR 17507, Apr. 5, 1993, as amended at 60 FR 10497, Feb. 27, 1995]
§ 73.3107 Carbazole violet.
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(a) Identity. The color additive is carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358–30–1, Colour Index No. 51319).
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 (the act) with respect to the contact lens in which the color additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[53 FR 41324, Oct. 21, 1988]
§ 73.3110 Chlorophyllin-copper complex, oil soluble.
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(a) Identity. The color additve is chlorophyllin-copper complex, oil soluble. The chlorophyllin is obtained by extraction from a mixture of fescue and rye grasses. The chlorophyll is acid-treated to remove chelated magnesium which is replaced with hydrogen, which is turn is replaced with copper. This mixture is diluted to a 5 percent concentration with a mixture of palm oil, peanut oil, and hydrogenated peanut oil.
(b) Specifications. The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), 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:
Moisture, not more than 0.5 percent.
Nitrogen, not less than 0.2 percent and not more than 0.3 percent.
Total copper, not less than 0.2 percent and not more than 0.4 percent.
Free copper, not more than 200 parts per million.
Lead, not more than 20 parts per million.
Arsenic, not more than 5 parts per million.
Sulfated ash, not more than 2.5 percent.
Total color, not less than 4.5 percent and not more than 5.5 percent.
(c) Uses and restrictions. (1) The color additive chlorophyllin-copper complex, oil soluble (5 percent in palm oil, peanut oil, and hydrogenated peanut oil), may be safely used to color polymethylmethacrylate bone cement. Chlorophyllin-copper complex may be used at levels that do not exceed 0.003 percent by weight of the bone cement.
(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 polymethylmethacrylate bone cement in which chlorophyllin-copper complex, oil soluble, is used.
(d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[48 FR 56370, Dec. 21, 1983]
§ 73.3110a Chromium-cobalt-aluminum oxide.
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(a) Identity. The color additive chromium-cobalt-aluminum oxide (Pigment Blue 36) (CAS Reg. No. 68187–11–1, Colour Index No. 77343) shall conform in identity and specifications to the requirements of §73.1015 (a) and (b).
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 (the act) with respect to the contact lens in which the color additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[53 FR 41325, Oct. 21, 1988]
§ 73.3111 Chromium oxide greens.
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(a) Identity and specifications. The color additive chromium oxide greens (chromic oxide) (CAS Reg. No. 1308–38–9), Color Index No. 77288, shall conform in identity and specifications to the requirements of §73.1327 (a)(1) and (b).
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with 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 lenses in which the additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[51 FR 24816, July 9, 1986]
§ 73.3112 C.I. Vat Orange 1.
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(a) Identity. The color additive is C.I. Vat Orange 1, Colour Index No. 59105.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 (the act) with respect to the contact lens in which the color additive is used. A person intending to introduce a device containing C.I. Vat Orange 1 into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[50 FR 20407, May 16, 1985]
§ 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.
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(a) Identity. The color additive2-[[2,5-diethoxy-4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol is formed in situ in soft (hydrophilic) contact lenses.
(b) Uses and restrictions. The color additive 2-[[2,5-diethoxy-4-[(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol may be safely used to mark soft (hydrophilic) contact lenses with the letter R or the letter L for identification purposes subject to the following restrictions:
(1) The quantity of the color additive does not exceed 1.1×10−7 grams in a soft (hydrophilic) contact lens.
(2) When used as specified in the labeling, there is no measurable migration of the color additive from the contact lens to the surrounding ocular tissue.
(3) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k) and 515 of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[48 FR 22706, May 20, 1983]
§ 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.
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(a) Identity. The color additive is 16,23-dihydrodinaphtho [2,3- a:2′,3′-i] napth [2′,3′:6,7] indolo [2, 3-c] carbazole-5,10, 15,17,22,24-hexone (CAS Reg. No. 2475–33–4), Colour Index No. 70800.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[48 FR 31375, July 8, 1983]
§ 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
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(a) Identity. The color additive is N,N′-(9,10-dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide (CAS Reg. No. 82–18–8), Colour Index No. 61725.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[48 FR 31375, July 8, 1983]
§ 73.3119 7,16-Dichloro–6,15-dihydro-5,9,14,18-anthrazinetetrone.
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(a) Identity. The color additive is 7,16-dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone (CAS Reg. No. 130–20–1), Colour Index No. 69825.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[48 FR 31376, July 8, 1983]
§ 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.
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(a) Identity. The color additive is 16,17-dimethoydinaphtho[1,2,3,-cd:3′,2′,1′-lm]perylene-5,10-dione (CAS Reg. No. 128–58–5), Colour Index No. 59825.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[48 FR 31376, July 8, 1983]
§ 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.
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(a) Identity. The color additives are formed by reacting one or more of the reactive dyes listed in this paragraph with poly(hydroxyethyl methacrylate), so that the sulfate group (or groups) or chlorine substituent of the dye is replaced by an ether linkage to poly(hydroxyethyl methacrylate). The dyes that may be used alone or in combination are
(1) Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-tetrasodium salt] (CAS Reg. No. 17095–24–8);
(2) Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-N29 ,N30 ,N31 ,N32 )-, sulfo((4-((2-sulfooxy)ethyl)sulfonyl)phenyl)amino) sulfonyl derivs] (CAS Reg. No. 73049–92–0);
(3) Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-] CAS Reg. No. 68189–39–9);
(4) Reactive Yellow 15 [benzensulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl) sulfonyl)phenyl)azo)-3-methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS Reg. No. 60958–41–0);
(5) Reactive Blue No. 19 [2-anthracene-sulfonic acid, 1-amino-9,10-dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580–78–1);
(6) Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS Reg. No. 4499–01–8);
(7) C.I. Reactive Red 11 [5-((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-((1-sulfo-2-naphthalenyl)azo)-2, 7-naphthalenedisulfonic acid, trisodium salt] (CAS Reg. No. 12226–08–3);
(8) C.I. Reactive Yellow 86 [1,3-benzenedisulfonic acid, 4-((5-aminocarbonyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl)azo)-6-(4,6-dichloro-1,3,5-triazin-2-yl)amino)-, disodium salt] (CAS Reg. No. 61951–86–8);
(9) C.I. Reactive Blue 163 [triphenodioxazinedisulfonic acid, 6,13-dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5-triazin-2-yl)amino) sulfophenyl)amino)-, tetrasodium salt] (CAS Reg. No. 72847–56–4); and
(10) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7- naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114–32–0).
(b) Uses and restrictions. (1) The substances listed in paragraph (a) of this section may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dyes.
(3) Authorization and compliance with 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 (the act). A person intending to introduce a device containing a poly(hydroxyethyl methacrylate)-dye copolymer listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c) Labeling. The label of the color additives shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore these color additives are exempt from the certification requirements of section 721(c) of the act.
[49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, 1984, as amended at 50 FR 9425, Mar. 8, 1985; 50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. 18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, Feb. 22, 1993]
§ 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.
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(a) Identity. The color additive is 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H- pyrazol-3-one (CAS Reg. No. 6407–78–9).
(b) Uses and restrictions. (1) The substances listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[51 FR 11432, Apr. 3, 1986]
§ 73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.
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(a) Identity. The color additive is 6-ethoxy-2-(6-ethoxy-3-oxobenzo [b]thien-2(3H)-ylidene)benzo[b]thiophen-3(2H)-one (CAS Reg. No. 3263–31–8), Colour Index No. 73335.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[51 FR 11436, Apr. 3, 1986]
§ 73.3124 Phthalocyanine green.
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(a) Identity. The color additive is phthalocyanine green (CAS Reg. No. 1328–53–6), Colour Index No. 74260.
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[51 FR 11433, Apr. 3, 1986]
§ 73.3125 Iron oxides.
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(a) Identity and specifications. The color additive iron oxides (CAS Reg. No. 1332–37–2), Color Index No. 77491, shall conform in identity and specifications to the requirements of §73.2250 (a) and (b).
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with 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 additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[51 FR 24816, July 9, 1986, as amended at 69 FR 24511, May 4, 2004]
§ 73.3126 Titanium dioxide.
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(a) Identity and specifications. The color additive titanium dioxide (CAS Reg. No. 13463–67–7), Color Index No. 77891, shall conform in identity and specifications to the requirements of §73.575(a)(1) and (b).
(b) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with 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 lenses in which the additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore the color additive is exempt from the certification requirements of section 721(c) of the act.
[51 FR 24816, July 9, 1986]
§ 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.
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(a) Identity. The color additives are formed by reacting the dyes, either alone or in combination, with a vinyl alcohol/methyl methacrylate copolymer, so that the sulfate groups of the dyes are replaced by ether linkages to the vinyl alcohol/methyl methacrylate copolymer. The dyes are:
(1) C.I. Reactive Red 180 [5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphthalenyl)azo)-2,7-naphthalenedisulfonic acid, tetrasodium salt] (CAS Reg. No. 98114–32–0).
(2) C.I. Reactive Black 5 [2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-3,6-bis((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-, tetrasodium salt] (CAS Reg. No. 17095–24–8).
(3) C.I. Reactive Orange 78 [2-naphthalenesulfonic acid, 7-(acetylamino)-4-hydroxy-3-((4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-] (CAS Reg. No. 68189–39–9).
(4) C.I. Reactive Yellow 15 [benzenesulfonic acid, 4-(4,5-dihydro-4-((2-methoxy-5-methyl-4-((2-(sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS Reg. No. 60958–41–0).
(5) C.I. Reactive Blue No. 19 [2-anthracenesulfonic acid, 1-amino-9,10-dihydro-9,10-dioxo-4-((3-((2-(sulfooxy)ethyl)sulfonyl)phenyl)amino)-, disodium salt] (CAS Reg. No. 2580–78–1).
(6) C.I. Reactive Blue 21 [copper, (29H,31H-phthalocyaninato(2-)-N29 , N30 , N31 , N32 )-, sulfo((4-((2-(sulfooxy) ethyl)sulfonyl)phenyl)amino)sulfonyl derivatives] (CAS Reg. No. 73049–92–0).
(b) Uses and restrictions. (1) The substances listed in paragraph (a) of this section may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive dye.
(3) Authorization and compliance with 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 (the act). A person intending to introduce a device containing a vinyl alcohol/methyl methacrylate-dye reaction product listed under this section into commerce shall submit to the Food and Drug Administration either a premarket notification in accordance with subpart E of part 807 of this chapter, if the device is not subject to premarket approval, or submit and receive approval of an original or supplemental premarket approval application if the device is subject to premarket approval.
(c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore, this color additive is exempt from the certification requirements of section 721(c) of the act.
[58 FR 3227, Jan. 8, 1993, as amended at 58 FR 17510, Apr. 5, 1993]
§ 73.3128 Mica-based pearlescent pigments.
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(a) Identity and specifications. The color additive is formed by depositing titanium or iron salts from a basic solution onto mica, followed by calcination to produce titanium dioxide or iron oxides on mica. Mica used to manufacture the color additive shall conform in identity and specifications to the requirements of §73.1496(a)(1) and (b).
(b) Uses and restrictions. (1) Mica-based pearlescent pigments listed in paragraph (a) of this section may be used as a color additive in contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization and compliance with 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 (the act) with respect to the contact lenses in which the additive is used.
(c) Labeling. The label of the color additive shall conform to the requirements in §70.25 of this chapter.
(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.
[67 FR 65312, Oct. 24, 2002]
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