Permitted range of organically combined bromine in pure dye, 47.5-51.5 percent.

Pure dye (as determined gravimetrically), not less than 93.0 percent.

§ 9.167 D&C Red No. 22.

Disodium salt of 2,4,5,7-tetrabromo-9o-carboxyphenyl-6-hydroxy-3-isoxan

thone.

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 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Free bromine, not more than 0.02 percent.

Permitted range of crganically combined bromine in pure dye, 44.5-48.5 percent.

Pure dye (as determined gravimetricaily), not less than 85.0 percent.

§ 9.172

D&C Red No. 27. 2,4,5,7-Tetrabromo-12,13,14,15-tetra

chloro-3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 5.0 percent.

Insoluble matter (alkaline solution), not more than 1.0 percent.

Ether extracts (from alkaline solution), not more than 0.5 percent.

Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Free halogens, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 38.5-42.5 percent.

Permitted range of organically combined chlorine in pure dye, 16.0-19.0 percent.

Pure dye (as determined gravimetrically), not less than 90.0 percent. § 9.173 D&C Red No. 28.

Disodium salt of 2,4,5,7-tetrabromo-9(3,4,5,6-tetrachloro-o-carboxyphenyl)

6-hydroxy-3-isoxanthone.

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 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Free halogens, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye 36.5-40.5 percent.

Permitted range of organically combined chlorine in pure dye, 16.0-18.0 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent. § 9.174 D&C Red No. 29.

1,4,5,8,15 - Pentabromo-2,7-dicarboxy3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 per

cent.

Insoluble matter (alkaline solution), not more than 0.3 percent.

Soluble matter (in 1 percent aqueous hydrochloric acid), not more than 2.0 percent.

Free bromine, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 47.0-51.0 percent.

Pure dye (as determined gravimetrically), not less than 95.0 percent.

§ 9.175 D&C Red No. 30.

5,5'-Dichloro-3,3′ - dimethyl - thioin

digo.

Volatile matter (at 135° C.), not more than 5.0 percent.

Matter insoluble in xylene, not more than 1.0 percent.

Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.176 D&C Red No. 31.

Calcium salt of 3-hydroxy-4-phenylazo-2-naphthoic acid.

Volatile matter (at 135° C.), not more than 5.0 percent.

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

Aniline, not more than 0.2 percent. Chlorides and sulfates (as calcium salts), not more than 5.0 percent.

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

Disodium salt of 8-amino-2-phenylazo-1-naphthol-3,6-disulfonic acid. Volatile matter (at 135° C.), not more than 6.0 percent.

Water-insoluble matter, not more than 1.0 percent.

Ether extracts, not more than 0.5 percent.

Aniline, not more than 0.2 percent. Chlorides and sulfates of sodium, not more than 10.0 percent.

Mixed oxides, not more than 1.0 percent.

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

§ 9.179 D&C Red No. 34.

Calcium salt of 4-(1-sulfo-2-naphthylazo)-3-hydroxy-2-naphthoic acid. Volatile matter (at 135° C.), not more than 5.0 percent.

Ether extracts, not more than 0.5 percent.

Tobias acid, not more than 0.2 percent. Chlorides and sulfates (as calcium salts), not more than 10.0 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.

Matter insoluble in benzene, not more than 0.5 percent.

Diethyl-m-aminophenol,

than 0.2 percent.

not more

Stearic acid (not part of the dye), not more than 50.0 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 50.0 percent.

§ 9.184 D&C Red No. 39.

o-[p-(8,8'-Dihydroxy-diethylamino) phenylazo)-benzoic acid.

Volatile matter (at 100° C.), not more than 2.0 percent.

Matter insoluble in acetone, not more than 1.5 percent.

Ether extract (petroleum ether), not more than 0.5 percent. N,N(8,8'-Dihydroxy-diethyl) not more than 0.2 percent.

aniline,

Sulfated ash, not more than 1.5 percent.

Pure dye (as determined by titration with titanium trichloride), not less than 95.0 percent.

§ 9.201 D&C Orange No. 4.

Monosodium salt of 1-p-sulfophenylazo-2-naphthol.

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.

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.

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

§ 9.202 D&C Orange No. 5.

4,5-Dibromo-3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 5.0 percent.

Insoluble matter (alkaline solution), not more than 1.0 percent.

Ether extracts (from alkaline solution), not more than 0.5 percent.

Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Free bromine, not more than 0.02 percent.

Permitted range of organically combined bromine in pure dye, 31.0-35.0 percent.

Pure dye (as determined gravimetrically), not less than 90.0 percent. § 9.207 D&C Orange No. 10.

4,5-Diiodo-3,6-fluorandiol.

Volatile matter (at 135° C.), not more than 5.0 percent.

Insoluble matter (alkaline solution), not more than 1.0 percent.

Ether extracts (from alkaline solution), not more than 0.5 percent.

Sodium chloride, not more than 3.0 percent.

Mixed oxides, not more than 1.0 percent.

Free iodine, not more than 0.05 percent.

Permitted range of organically combined iodine in pure dye, 41.5-45.5 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent.

§ 9.208 D&C Orange No. 11.

Disodium salt of 9-0-carboxyphenyl-6hydroxy-4,5-diiodo-3-isoxanthone. 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 3.0 percent.

Mixed oxides, not more than 1.0 percent

Free iodine, not more than 0.05 percent.

Permitted range of organically combined iodine in pure dye, 38.5-42.5 percent.

Pure dye (as determined gravimetrically), not less than 85.0 percent.

§ 9.214 D&C Orange No. 17.

1-(2.4-Dinitrophenylazo) -2-naphthol. Volatile matter (at 135° C.), not more than 5.0 percent.

Sulfated ash, not more than 1.0 per

cent.

Matter insoluble in toluene, not more than 1.5 percent.

2,4-Dinitroaniline, not more than 0.2

percent.

B-Naphthol, not more than 0.2 percent. Pure dye (as determined by titration with titanium trichloride), not less than 90.0 percent.

§ 9.240 D&C Blue No. 4.

Diammonium salt of 4-{[-(N-ethylp-sulfobenzylamino) -phenyl]-(2 - sulfo

2-Amino anthraquinone, not more than 0.2 percent.

Matter extractable by alcoholic HCI, not more than 1.0 percent.

Permitted range of organically combined chlorine in pure dye, 13.0-14.8 percent.

Pure dye (as calculated from organically combined nitrogen), not less than 97.0 percent.

§ 9.270 D&C Violet No. 2.

1 - Hydroxy-4-p - toluino - anthraquinone.

Volatile matter (at 135° C.), not more than 2.0 percent.

Sulfated ash, not more than 1.0 percent.

Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p-Toluidine, 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 185° C.

§ 9.280 Lakes (D&C).

(a) (1) General. Any lake, other than those listed in Subpart B, made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or any combination of two or more of these, (i) one of the straight colors (except lakes) listed in Subpart B or hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium; or (ii) a salt prepared from one of the straight colors (except lakes) listed in Subpart B, or hereinbefore listed in this subpart, by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium.

(2) Specifications.

Ether extracts, not more than 0.5 percent.

Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2

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, except that if such name contains the symbol "FD&C" such symbol shall be changed to "D&C";

(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 color D&C Red No. 9 upon a substratum is "D&C Red No. 9-Barium Lake", and a lake prepared by extending the aluminum salt prepared from FD&C Green No. 1 upon a substratum other than alumina is "D&C Green No. 1-Aluminum Lake".) Subpart D-Straight Colors and Specifications for Their Certification for Use in Externally Applied Drugs and Cosmetics

ance with the provisions of this part, for use in externally applied 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.

§ 9.301 Ext D&C Yellow No. 1. Monosodium salt of 4-m-sulfophenylazo-diphenylamine.

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

Water-insoluble matter, not more than 1.0 percent.

Chloroform-soluble matter, not more than 0.5 percent.

Diphenylamine, not more than 0.2

percent.

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

Mixed oxides, not more than 1.0 percent.

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

§ 9.307 Ext D&C Yellow No. 7.

Disodium salt of 2,4-dinitro-1-naphthol-7-sulfonic acid.

Volatile matter (at 135° C.), not more than 10.0 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 5.0 percent.

Mixed oxides, not more than 1.0 percent.

Martius yellow, not more than 0.03 percent.

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

§ 9.400 Ext D&C Green No. 1.

Ferric salt of 6-sodiumsulfo-1-isonitroso-1,2-naphthoquinone.

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

Ether extracts, not more than 0.5 percent.

Water-insoluble matter, not more than 1.0 percent.

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

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

(a) (1) General. Any lake made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or on any combination of two or more of these (1) one of the straight colors hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, barium, or calcium; or (ii) a salt prepared from one of the straight colors hereinbefore listed in this subpart by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium.

(2) Specifications.

Ether extracts, not more than 0.5 percent.

Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent.

Sec.

10.1 10.2

Intermediates, not more than 0.2

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 radica} combined in such color; and

(3) The word "Lake."

(For example, the name of a lake prepared by extending the color Ext D&C Yellow No. 2 upon a substratum is “Ext D&C Yellow No. 2-Calcium Lake," and a lake prepared by extending the barium salt prepared from Ext D&C Red No. 2 upon the substratum is "Ext D&C Red No. 2-Barium Lake.")

PART 10-DEFINITIONS AND STANDARDS FOR FOOD

Definitions and interpretations. Procedure for establishing food standards under the Federal Food, Drug, and Cosmetic Act.

10.3 Conformity to definitions and standards of identity.

10.4 Food additives proposed for use in foods for which definitions and standards of identity are established. 10.5 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity. 10.6 General methods for water capacity and fill of containers.

10.7 General statements of substandard quality and substandard fill of container.

AUTHORITY: The provisions of this Part 10 issued under secs. 401, 701, 52 Stat. 1046, 1055 as amended; 21 U.S.C. 341, 371.

SOURCE: The provisions of this Part 10 appear at 27 F.R. 11255, Nov. 15, 1962, unless otherwise noted.

CROSS-REFERENCE: For other regulations in this chapter concerning definitions and standards for foods, see also §§ 3.1, 3.17, 3.38, 5.2, 5.3, 5.4, 121.8 and Parts 14 through 53, inclusive. For other regulations in this chapter concerning procedure for establishing regulations, see also Subpart F of Part 2.

$ 10.1

Definitions and interpretations.

(a) The definitions and interpretations of terms contained in section 201 of the act shall be applicable also to such terms when used in regulations promulgated under the act.

(b) If a regulation prescribing a definition and standard of identity for a food has been promulgated under section 401 of the act and the name therein specified for the food is used in any other regulation under section 401 or any other provision of the act, such name means the food which conforms to such definition and standard, except as otherwise specifically provided in such other regulation.

(c) No provision of any regulation prescribing a definition and standard of identity or standard of quality or fill of container under section 401 of the act shall be construed as in any way affecting the concurrent applicability of the general provisions of the act and the regulations thereunder relating to adulteration and misbranding. For example, all regulations under section 401 contemplate that the food and all articles used as components or ingredients thereof shall not be poisonous or deleterious and shall be clean, sound, and fit for food. A provision in such regula