No. 4 (§ 9.63 of this chapter) and of all mixtures containing this color additive were canceled affective June 9, 1965, insofar as food (except maraschino cherries as provided in § 8.503 (c)), ingested drugs (except for limited use as provided in § 8.503(c)) and ingested cosmetics are concerned, and use of this color additive in the manufacture of food (except maraschino cherries as provided in § 8.503 (c)) and ingested drugs (except for limited use as provided in § 8.503 (c)) and ingested cosmetics after that date will result in adulteration. The certificates shall continue in effect for the use of this color additive in drugs and cosmetics which are not ingested. The Commissioner finds that no action needs to be taken to remove food and ingested drugs and cosmetics containing this color additive from the market on the basis of the scientific evidence before him, taking into account that the additive is not an acutely toxic substance and that it is used only in small amounts in food and ingested drugs and cosmetics. (d) Certificates issued for the following color additives and all mixtures containing these color additives are canceled and have no effect after October 4, 1966, and use of such color additives in the manufacture of foods, drugs, or cosmetics after that date will result in adulteration: FD&C Green No. 1 (§ 9.21 of this chapter). Ext. D&C Yellow No. 6 (§ 9.306 of this chapter). Ext. D&C Red No. 1 (§ 9.340 of this chapter). Ext. D&C Orange No. 1 (§ 9.420 of this chapter). Ext. D&C Orange No. 4 (§ 9.423 of this chapter). (e) Certificates issued for the following color additives and all mixtures containing these color additives are canceled and have no effect after July 1, 1968, and use of such color additives in the manufacture of drugs or cosmetics after that date will result in adulteration: D&C Brown No. 1 (§ 9.230 of this chapter). Ext. D&C Yellow No. 3 (§ 9.303 of this chapter). Ext. D&C Red No. 8 (§ 9.347 of this chapter). Ext. D&C Violet No. 2 (§ 9.411 of this chapter). Ext. D&C Orange No. 3 (§ 9.422 of this chapter). [25 F.R. 11214, Nov. 26, 1960, as amended at 29 F.R. 16983, Dec. 11, 1964, 30 F.R. 13057, Oct. 14, 1965; 31 F.R. 5490, 1966; 32 F.R. 10932, July 26, 1967] § 8.515 Limitation of certificates. Certificates issued heretofore for color additives being retained on the provisional list in § 8.503, but under tolerance and usage restrictions, are hereby limited to those uses and under those conditions imposed by that section. Use of such color additives in any other manner after December 1, 1960, in drugs or cosmetics will result in adulteration. Any color additive certified under such tolerance and usage restrictions after October 12, 1960, shall bear a label statement of the name of the color additive and of the tolerance and use limitations applicable to it. [25 F.R. 9761, Oct. 12, 1960] Subpart E-Listing of Color Additives for Drug Use Subject to Certification § 8.4070 D&C Green No. 6. (a) Identity. The color additive D&C Green No. 6 is 1-4-di-p-toluidino anthraquinone. It conforms to the general specifications of § 8.120 (Subpart B) and the following specific requirements: Volatile matter (at 135° C.), not more than 2.0 percent. Water-soluble matter, not more than 0.3 percent. Matter, insoluble in carbon tetrachloride, not more than 1.5 percent. Intermediates, not more than 0.5 percent. Pure dye (as determined by titration with titanium trichloride), not less than 96.0 percent. Melting point, not less than 210° C. (b) Uses and restrictions. The color additive may be safely used for coloring polyethylene terephthalate surgical sutures, including sutures for ophthalmic use, subject to the following restrictions: (1) The quantity of the color additives does not exceed 0.75 percent by weight of the suture material. (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) The listing of D&C Green No. 6 for the purposes described in paragraph (b) of this section is not to be construed as a listing for any other use. (c) Labeling. The color additive shall bear labeling complying with the regulations under Subpart A of this part. (d) Certification. All batches of D&C Green No. 6 shall be certified in accordance with regulations promulgated under Subpart A of this part. [27 F.R. 12829, Dec. 28, 1962; 28 F.R. 71 Jan. 3, 1963] § 8.4132 D&C Red No. 39. (a) Identity. (1) The color additive D&C Red No. 39 is o-[pß,ß'-dihydroxydiethylamino)-phenylazo]-benzoic acid. (2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR Part 212. (b) Specifications. D&C Red No. 39 shall conform to the following requirements: Volatile matter (at 100° C.), not more than 2.0 percent. Matter insoluble in acetone, not more than Anthranilic acid, not more than 0.2 percent. more than 0.2 percent. Subsidiary colors, not more than 3.0 percent. Lead, as Pb, not more than 20 parts per million. Arsenic, as As, not more than 3 parts per million. Pure dye, not less than 95.0 percent. (c) Uses and restrictions. The color additive D&C Red No. 39 may be safely used for the coloring of quaternary ammonium type germicidal solutions intended for external application only, and subject to the further restriction that the quantity of the color additive does not exceed 0.1 percent by weight of the finished drug product. (d) Labeling requirements. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32. (e) Certification. All batches of D&C Red No. 39 shall be certified in accordance with regulations promulgated under Subpart A of this part. [30 F.R. 15211, Dec. 9, 1965; 30 F.R. 15804, Dec. 22, 1965] § 8.4175 FD&C Yellow No. 5. (a) Identity. (1) The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of § 8.275(a) (1) and (b). (2) Color additive mixtures for ingested drug use made with FD&C Yellow No. 5 may contain only those diluents listed in Subpart F of this part as safe and suitable in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. FD&C Yellow No. 5 may be safely used for coloring ingested drugs generally, provided that not more than 30 milligrams of the color additive is consumed per day if the recommended drug dosage is followed. (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) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in Subpart A of this part. [31 F.R. 3008, Feb. 22, 1966] NOTE: 8.4175 was stayed in its entirety at 31 F.R. 8369, June 15, 1966. Subpart F-Listing of Color Additives for Drug Use Exempt From Certification § 8.6000 Diluents in color additive mixtures for drug use exempt from certification. The following diluents may be safely used in color additive mixtures that are exempt from certification and which are to be used for coloring drugs, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since § 8.6001 Synthetic iron oxide. (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. Restriction In color coatings for pharmaceutical forms; no residue. (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 § 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 certification requirements of section 706(c) of the act. [31 F.R. 2653, Feb. 11, 1966] § 8.6002 Caramel. (1) (a) Identity and specifications. The color additive caramel shall conform in identity and specifications to the requirements of § 8.303 (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 F 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. (a) Identity. (1) The color additive annatto extract shall conform in identity and specifications to the requirements of § 8.305(a) (1) and (b). (2) The diluents in color additive mixtures for drug use containing annatto extract shall be limited to those listed in subpart F of this Part as safe and suitable in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. Annatto extract may be used for coloring ingested drugs generally in amounts consistent with good manufacturing practice. (c) Labeling requirements. In addition to all other information required by the act, labels of annatto extract and mixtures prepared therefrom shall bear information showing the color is derived from annatto seed and shall declare all Ingredients by their specific names with the exception of residues of solvents listed in § 8.305 (a) (1) (ii). (a) Identity and specifications. (1) The color additive B-carotene shall conform in identity and specifications to the requirements of § 8.304 (a)(1) and (b). (2) The diluents in color additive mixtures for drug use containing ß-carotene are limited to those listed in Subpart F of this Part 8 as safe and suitable in color additive mixtures for coloring ingested drugs. (b) Uses and restrictions. B-Carotene may be used for coloring ingested drugs generally 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 § 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. [29 F.R. 3003, Mar. 5, 1964] § 8.6005 Titanium dioxide. (1) (a) Identity and specifications. The color additive titanium dioxide shall conform in identity and specifications to the requirements of § 8.316 (a)(1) and (b). (2) Color additive mixtures for drug use made with titanium dioxide may contain only those diluents listed in this Subpart F as safe and suitable in color additive mixtures for coloring drugs, and the following: Silicon dioxide, SiO2, and/or aluminum oxide Al,O,, as dispersing aids-not more than 2 percent total. (b) Uses and restrictions. 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 requirements. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions 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. [31 F.R. 1065, Jan. 27, 1966] § 8.6006 Pyrophyllite. (a) Identity. (1) The color additive pyrophyllite is a naturally occurring mineral substance consisting predominantly of a hydrous aluminum silicate, Al2O3 4SiO2 H2O, 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 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. (1) (a) Identity and specifications. 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. Alumina (b) Specifications. (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 (Al2O,), 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. |