(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 FR. 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 As,O,), 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:

(i) Lead (as Pb), not more than 0.002 percent.

(ii) Arsenic (as As,O,), not more than 0.0002 percent.

(ii) 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.

§ 9.3 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.

A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of the regulations in this part, for use in food, drugs, and cosmetics, if such batch conforms to the requirements of § 9.2 and to the specifications in this subpart set forth for such color.

§ 9.21 FD&C Green No. 1.

Monosodium salt of 4-[4-(N-ethyl-psulfobenzylamino)-diphenylmethylene][1-(N-ethyl-N-p-sulfoniumbenzyl) -A3

cyclohexadieniminel.

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.

§ 9.22 FD&C Green No. 2.

Disodium salt of 4-{[4-(N-ethyl-psulfobenzylamino) - phenyl]- (4 - sulfonium-phenyl)-methylene} - [1-(N-ethylN-p-sulfobenzyl) - ▲ - cyclohexadieni

mine].

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 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Subsidiary dyes, not more than 5.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.40 FD&C Yellow No. 5.

Trisodium salt of 3-carboxy-5-hydroxy-1-p-sulfophenyl-4-p-sulfophenyl

azo-pyrazole.

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 0.3 percent.

Phenylhydrazine-p-sulfonic acid, not more than 0.1 percent.

Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

Subsidiary dyes, not more than 3.0 per

cent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.41 FD&C Yellow No. 6.

Disodium salt of 1-p-sulfophenylazo2-naphthol-6-sulfonic acid.

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 0.2 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Subsidiary dyes, not more than 5.0 per

cent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.61 FD&C Red No. 2.

Trisodium salt of 1-(4-sulfo-1-naphthylazo)-2-naphthol-3,6-disulfonic acid. Volatile matter (at 135° C.), not more than 10.0 percent.

Mixed oxides, not more than 1.0 percent.

Permitted range of organically combined iodine in pure dye, free from water of crystallization, 53.8 to 58.5 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent. § 9.63 FD&C Red No. 4.

Disodium salt of 2-(5-sulfo-2, 4xylylazo)-1-naphthol-4-sulfonic acid.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 0.3 percent.

Ether extracts, not more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Subsidiary dyes, not more than 5.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

[30 F.R. 10289, Aug. 19, 1965]

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 0.3 percent.

Ether extracts, not more than 0.4 percent.

Chlorides and sulfates of sodium, not more than 4.0 percent.

Sodium acetate, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Subsidiary dyes, not more than 5.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.81

FD&C Blue No. 2. Disodium salt of 5, 5'-indigotindisulfonic acid.

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 0.5 percent.

Chlorides and sulfates of sodium, not more than 7.0 percent.

Mixed oxides, not more than 1.0 percent.

Lower sulfonated dyes, not more than 5.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

89.90 FD&C Violet No. 1.

Monosodium salt of 4-{[4-(N-ethyl-psulfobenzylamino) -phenyl]-[4-(N-ethyl-p-sulfoniumbenzylamino) - phenyl]methylene} - (N,N-dimethyl - A2-cyclohexadienimine).

Volatile matter (at 135° C.), not more than 8.0 percent.

Water-insoluble matter, not more than 0.3 percent.

Ether extracts, not more than 0.4 percent. acid, not

p-Dimethylaminobenzoic

more than 0.2 percent.

Chlorides and sulfates of sodium, not more than 4.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

The sum of the volatile matter, chlorides and sulfates of sodium, pure dye, and leuco base of the dye, not less than 95.0 percent.

(2) Specifications. Prepared from

previously certified colors listed in this subpart.

Soluble chlorides and sulfates (as sodium salts), not more than 2.0 percent. Inorganic matter, insoluble in HCl, not more than 0.5 percent.

(b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows:

(1) The listed name of the color from which the lake is prepared;

(2) The name of the basic radical combined in such color; and

(3) The word "Lake".

(For example, the name of a lake prepared by extending the aluminum salt prepared from FD&C Blue No. 1 upon the substratum would be FD&C Blue No. 1-Aluminum Lake.)

Subpart C-Straight Colors and Specifications for Their Certification for Use in Drugs and Cosmetics

A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in drugs and cosmetics, if such batch conforms to the requirements of § 9.2 and to the specifications set forth in this subpart for such color.

§ 9.103 D&C Green No. 5.

Disodium salt of 1,4-bis(o-sulf-ptoluino) -anthraquinone.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

1,4-Dihydroxy- anthraquinone, more than 0.2 percent.

not

Chlorides and sulfates of sodium, not more than 15.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 75.0 percent.

§ 9.104 D&C Green No. 6.

1,4-bis-(p-Toluino) -anthraquinone. Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 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 per

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 8.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 80.0 percent.

§ 9.106 D&C Green No. 8.

Trisodium salt of 10-hydroxy-3,5,8pyrene-trisulfonic acid.

Volatile matter (at 135° C.), not more than 15.0 percent.

Water-insoluble matter, not more than 0.5 percent.

Chloroform extract, not more than 0.5 percent.

Pyrene, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 20.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as calculated from organically combined sulfur), not less than 65.0 percent.

Ether extracts, not more than 0.5 percent.

Chlorides and sulfates of sodium, not more than 8.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 82.0 percent.

§ 9.133 D&C Yellow No. 10.

Disodium salt of disulfonic acid of 2(2-quinolyl)-1,3-indandione.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Quinaldine, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 6.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as calculated from organically combined nitrogen), not less than 82.0 percent.

§ 9.134 D&C Yellow No. 11.

2-(2-Quinolyl)-1,3-indandione.

Volatile matter (at 135° C.), not more than 1.0 percent.

Sulfated ash, not more than 1.0 per

cent.

Matter insoluble in alcohol, not more than 0.5 percent.

Quinaldine, not more than 0.2 percent. Pure dye (as calculated from organically combined nitrogen), not less than 96.0 percent.

Melting point, not less than 235° C. § 9.150 D&C Red No. 5.

Disodium salt of 1-xylylazo-2-naphthol-3,6-disulfonic acid.

Volatile matter (at 135° C.), not more than 12.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Xylidine, not more than 0.2 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.

§ 9.151 D&C Red No. 6.

Monosodium salt of 4-(o-sulfo-p-tolylazo)-3-hydroxy-2-naphthoic acid.

Volatile matter (at 135° C.), not more than 10.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 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.

§ 9.152 D&C Red No. 7.

Calcium salt of 4-(0-sulfo-p-tolylazo)-3-hydroxy-2-naphthoic acid. Volatile matter (at 135° C.), not more than 8.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Chlorides and sulfates (as calcium salts), not more than 6.0 percent.

Oxides of iron and aluminum, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 85.0 percent.

§ 9.153 D&C Red No. 8.

Monosodium salt of 1-(4-chloro-osulfo-5-tolylazo)-2-naphthol.

Volatile matter (at 135° C.), not more than 10.0 percent.

Ether extracts (isopropyl ether), not more than 0.5 percent.

Lake Red C Amine, not more than 0.2 percent.

B-Naphthol, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 5.0 percent.

Mixed oxides, not more than 1.0 percent.