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. [28 F.R. 3693, Apr. 16, 1963]

NOTE: 8.6001 was stayed in its entirety at 28 F.R. 5719, June 12, 1963. § 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.

(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 706(c) of the act. [28 F.R. 8309, Aug. 14, 1963]

(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).

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof

(1)

(a) Identity and specifications. 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. 8-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]

Subpart G-Listing of Color Additives for Cosmetic Use Subject to Certification [Reserved]

Subpart H-Listing of Color Additives for Cosmetic Use Exempt From Certification

§ 8.8002 Henna.

(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.

1 See 30 F.R. 5797, Apr. 24, 1965.

Sec.

9.873 Ext D&C Blue No. 4. 9.400 Ext D&C Green No. 1. 9.411 Ext D&C Violet No. 2. 9.420 Ext D&C Orange No. 1. 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 9 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 F.R. 9761, Oct. 12, 1960.

For the purposes of this part: (a)-(f) [Reserved]

(g) The term “alumina” means a suspension in water of precipitated aluminum hydroxide.

(h) The term "blanc fixe" means a suspension in water of precipitated barium sulfate.

(1) The term "gloss white" means a suspension in water of co-precipitated aluminum hydroxide and barium sulfate.

(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 As2O1), 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.

(1) 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.

§ 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.

Subpart B-Straight Colors and Speci

fications for Their Certification for Use in Food, Drugs, and Cosmetics § 9.20

General.

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) -▲3⁄4_

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.

§ 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 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) - A3-cyclohexa

dienimine].

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.

§ 9.62 FD&C Red No. 3.

Disodium salt of 9-o-carboxyphenyl-6hydroxy-2,4,5,7-tetraiodo-3-isoxanthone. Volatile matter (at 135° C.), not more than 12.0 percent.

Water-insoluble matter, not more than 0.2 percent.

Ether extracts, not more than 0.1 percent.

Chlorides and sulfates of sodium, not more than 2.0 percent.

Sodium carbonate, not more than 0.5 percent.

Sodium iodide, not more than 0.4 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]

§ 9.80 FD&C Blue No. 1.

Disodium salt of 4-{[4-(N-ethyl-psulfobenzylamino) - phenyl]- (2-sulfoniumphenyl)-methylene)-[1-(N-ethylN-p-sulfobenzyl)-A, - cyclohexadieni

mine].

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.