Stat. 1049, as amended, 1052, as amended, 55, as amended, 1056, as amended, 1058; 21 3.C. 346, 354, 364, 372, 376.

SOURCE: §§ 9.1 to 9.440 appear at 24 F.R. 51, May 14, 1959, except as otherwise noted. Subpart A-General

NOTE: §§ 9.1 to 9.3 of Part 9 shall continue effect, insofar as they are not inconsistent th the provisional regulations of Part 8, til new regulations for the enforcement of tion 706 of the Federal Food, Drug, and smetics Act basic color additives amendents of 1960 can be proposed and made ective, 25 F.R. 9761, Oct. 12, 1960.

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

(g) The term "alumina” means a susnsion in water of precipitated alumiim hydroxide.

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

(i) The term "gloss white" means a spension in water of co-precipitated iminum hydroxide and barium sulfate. (j) The term "mixed oxides" means e sum of the quantities of aluminum, ›n, calcium, and magnesium (in whater combination they may exist in a al-tar color) calculated as aluminum oxide, ferric oxide, calcium oxide, and agnesium oxide.

(k)-(m) [Reserved]

(n) The term "externally applied ugs and cosmetics" means drugs and smetics which are applied only to exmal parts of the body and not to the s or any body surface covered by icous membrane.

(0) and (p) [Reserved]

(q) The definitions and interpretans of terms contained in section 201 the Federal Food, Drug, and Cosmetic t shall be applicable also to such terms en used in this part.

F.R. 3851, May 14, 1959, as amended at F.R. 6739, June 29, 1963]

(b) It conforms to the following specifications:

(1) In the case of a straight color listed in Subpart B:

(i) 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:

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

(ii) Arsenic (as As2O.), 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 BaCl2), 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)-42,5

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 mor than 10.0 percent.

Water-insoluble matter, not more tha 0.5 percent.

Ether extracts, not more than 0.4 per cent.

Chlorides and sulfates of sodium, n more than 5.0 percent.

Mixed oxides, not more than 1.0 per cent.

Subsidiary dyes, not more than 5 percent.

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

§ 9.40 FD&C Yellow No. 5.

Trisodium salt of 3-carboxy-5-hy droxy-1-p-sulfophenyl-4-p-sulfopheny

azo-pyrazole.

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

Water-insoluble matter, not more tha 0.5 percent.

Ether extracts, not more than 0.3 per cent.

Phenylhydrazine-p-sulfonic acid, no more than 0.1 percent.

Chlorides and sulfates of sodium, D more than 6.0 percent.

Mixed oxides, not more than 1.0 pe

cent.

Subsidiary dyes, not more than 3.0 pet

cent.

Pure dye (as determined by titration ith titanium trichloride), not less than 5.0 percent.

9.41 FD&C Yellow No. 6.

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

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

Water-insoluble matter, not more than 5 percent.

Ether extracts, not more than 0.2 pernt.

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

Mixed oxides, not more than 1.0 per

nt.

Subsidiary dyes, not more than 5.0 per

nt.

Pure dye (as determined by titration th titanium trichloride), not less than .0 percent.

9.61 FD&C Red No. 2.

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

Ether extracts, not more than 0.2 per..nt.

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

Mixed oxides, not more than 1.0 pernt.

Subsidiary dyes, not more than 4.0 rcent.

Pure dye (as determined by titration th titanium trichloride), not less than 0 percent.

9.62 FD&C Red No. 3.

Disodium salt of 9-o-carboxyphenyl-6droxy-2,4,5,7-tetraiodo-3-isoxanthone.

5. Volatile matter (at 135° C.), not more an 12.0 percent. Water-insoluble matter, not more than percent.

Ether extracts, not more than 0.1 perat.

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

Sodium carbonate, not more than 0.5 rcent.

Sodium iodide, not more than 0.4 perat.

Mixed oxides, not more than 1.0 perat.

Permitted range of organically comled iodine in pure dye, free from water he crystallization, 53.8 to

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-2,4-xylylazo)-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 per

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.)

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 § 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-sulfo-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, no more than 0.2 percent.

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 mor than 2.0 percent.

Sulfated ash, not more than 1.0 per