in this Subpart F 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 § 8.32. (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 706(c) of the act. [31 F.R. 5070, Mar. 29, 1966] § 8.6009 Carmine. (a) Identity and specifications. (1) The color additive carmine shall conform in identity and specifications to the requirements of § 8.317 (a) (1) and (b). (2) Color additive mixtures for drug use made with carmine may contain only those diluents listed in Subpart F as safe and suitable in color additive mixtures for coloring drugs. (b) Uses and restrictions. 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 additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 8.32. (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 706(c) of the act. [32 F.R. 6132, Apr. 19, 1967] (a) Identity. (1) The color additive alumina (dried aluminum hydroxide) is a white, odorless, tasteless, amorphous powder consisting essentially of aluminum hydroxide (Al2O, X H2O). (2) Color additive mixtures for drug use made with alumina (dried aluminum hydroxide) may contain only those diluents listed in this Subpart F 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 hydrocholric 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 (Al,O), 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 § 8.32. (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 706 (c) of the act. [32 F.R. 6686, May 2, 1967] § 8.6012 Calcium carbonate. (a) Identity. (1) The color additive calcium carbonate is a fine, white, synthetically prepared powder consisting essentially of precipitated calicum carbonate (CaCO3). (2) Color additive mixtures for drug use made with calcium carbonate may contain only those diluents listed in this Subpart F 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 U.S.P. (c) Uses and restrictions. Calcium carbonate 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 § 8.32. (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 706(c) of the act. [32 F.R. 6686, May 2, 1967] (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 F as safe and suitable for use in color additive mixtures for coloring drugs. (b) Specifications. Talc shall meet the specifications for talc in the U.S.P. 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 § 8.32. (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 706 (c) of the act. [32 F.R. 6686, May 2, 1967] (a) Identity. (1) 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 general specifications set forth in § 8.110 (c)1 for color additives to be used in cosmetics and the following specific requirements: (1) It shall contain not more than 10 percent of plant material from Lawsonia alba Lam. (Lawsonia inermis L.) other than the leaf and petiole, and is free from admixture with material from any other species of plant. (2) Moisture, not more than 10 percent. (3) Total ash, not more than 15 percent. (4) Acid-insoluble ash, not more than 5 percent. (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, in addition to the other information required by the act and § 8.30, the following statements or their equivalent: "Do not use in the area of the eye." (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 706(c) of the act. [30 F.R. 7705, June 15, 1965] Ext D&C Orange No. 1. 9.151 D&C Red No. 6. 9.422 Ext D&C Orange No. 3. 9.423 Ext D&C Orange No. 4. 9.440 Lakes (Ext D&C). AUTHORITY: The provisions of this Part issued under secs. 406, 504, 604, 701, 702, 706, 52 Stat. 1049, as amended, 1052, as amended, 1055, as amended, 1056, as amended, 1058, as amended; 21 U.S.C. 346, 354, 364, 371, 372, 376. SOURCE: The provisions of this Part 9 appear at 24 F.R. 3851, May 14, 1959, unless otherwise noted. Subpart A-General NOTE: 9.1 to 9.3 of Part 9 shall continue In effect, insofar as they are not inconsistent with the provisional regulations of Part 8, until new regulations for the enforcement of section 706 of the Federal Food, Drug, and Cosmetics Act basic color additives amendments of 1960 can be proposed and made effective, 25 FR. 9761, Oct. 12, 1960. (j) The term "mixed oxides" means the sum of the quantities of aluminum, iron, calcium, and magnesium (in whatever combination they may exist in a coal-tar color) calculated as aluminum trioxide, ferric oxide, calcium oxide, and magnesium oxide. (k)-(m) [Reserved] (n) The term "externally applied drugs and cosmetics" means drugs and cosmetics which are applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane. (0) and (p) [Reserved] (q) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also to such terms when used in this part. [24 F.R. 3851, May 14, 1959, as amended at 28 F.R. 6739, June 29, 1963] § 9.2 General specifications for straight colors. No batch of a straight color listed in Subpart B, C, or D shall be certified under this part unless: (a) It is free from all impurities (other than those named in paragraph (b) of this section or in the specifications set forth in such paragraph for such color) to the extent that such impurities can be avoided by good manufacturing practice. (b) It conforms to the following specifications: (1) In the case of a straight color listed in Subpart B: (1) Lead (as Pb), not more than 0.001 percent. (ii) Arsenic (as As2O.), not more than 0.00014 percent. (iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than trace. (2) In the case of a straight color listed in Subpart C or D: (1) Lead (as Pb), not more than 0.002 percent. (ii) Arsenic (as As,O,), not more than 0.0002 percent. (iii) Heavy metals (except Pb and As) (by precipitation as sulfides), not more than 0.003 percent. (3) In the case of a straight color which contains a barium salt listed in Subpart C or D-soluble barium (in dilute HCl) (as BaCl,), not more than 0.05 percent. 89.3 Mixtures that may be certified. (a) A batch of a mixture which contains no straight color listed in Subpart C or D may be certified for use in food, drugs, and cosmetics, if: (1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture; (2) Each diluent in such batch of mixture is harmless and suitable for use therein; and (3) No diluent (except resins, natural gum, pectin and, in the case of mixtures which are aqueous solutions or aqueous pastes, sodium benzoate in a quantity of not more than 10 of 1 percent) in such mixture is a nonnutritive substance, unless such mixture is for external application to shell eggs, or for use in coloring a food specified in the requests for certification of such batch submitted in accordance with 9.5(c), and such diluent, in the usual process of manufacturing such food, is removed and does not become a component of such food. (b) A batch of a mixture which contains no straight color listed in Subpart D, or which contains a diluent not permitted by paragraph (a) (3) of this section, may be certified in accordance with the provisions of this part, for use only in drugs and cosmetics, if: (1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture. (2) Each diluent in such batch of mixture is harmless and suitable for use therein. (c) A batch of a mixture which contains a straight color listed in Subpart D may be certified in accordance with the provisions of this part, for use only in externally applied drugs and cosmetics, if: (1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture; and (2) Each diluent in such batch of mixture is harmless and suitable for use therein. Monosodium salt of 4-[4-(N-ethyl-psulfobenzylamino) -diphenylmethylene) [1-(N-ethyl-N-p-sulfoniumbenzyl) -▲2 cyclohexadienimine]. Volatile matter (at 135° C.), not more than 10.0 percent. Water-insoluble matter, not more than 0.5 percent. Ether extracts, not more than 0.4 percent. Chlorides and sulfates of sodium, not more than 6.0 percent. Mixed oxides, not more than 1.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent. Volatile matter (at 135° C.), not more than 10.0 percent. Water-insoluble matter, not more than 0.5 percent. Ether extracts, not more than 0.4 percent. Chlorides and sulfates of sodium, not more than 6.0 percent. Mixed oxides, not more than 1.0 percent. Subsidiary dyes (as FD&C Green No. 1), not more than 5.0 percent. Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent. § 9.23 FD&C Green No. 3. Disodium salt of 4-{[4-(N-ethyl-psulfobenzylamino) -phenyl]-(4-hydroxy2-sulfoniumphenyl) - methylene}-[1-(Nethyl-N-p-sulfobenzyl) - A”-cyclohexa dienimine]. |