(b) Specifications. Citrus Red No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 100° C.), not more than 0.5 percent.

Water-soluble matter, not more than 0.3 percent.

Matter insoluble in carbon tetrachloride, not more than 0.5 percent.

Uncombined intermediates, not more than 0.05 percent.

Subsidiary dyes, not more than 2.0 percent. Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than part per million.

Pure color, not less than 98 percent.

(e) Uses and restrictions. (1) Citrus Red No. 2 shall be used only for coloring the skins of oranges that are not intended or used for processing (or if so used are designated in the trade as "Packinghouse elimination") and that meet minimum maturity standards established by or under the laws of the States in which the oranges are grown.

(2) Oranges colored with Citrus Red No. 2 shall bear not more than 2.0 parts per million of such color additive, calculated on the basis of the weight of the whole fruit.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 8.32. To meet the requirements of § 8.32 (b) and (c) the label shall bear:

(1) The statement (or its equivalent) "To be used only for coloring skins of oranges."

(2) Directions for use to limit the amount of the color additive to not more than 2.0 parts per million, calculated on the basis of the weight of the whole fruit. (e) Certification. All batches of Citrus Red No. 2 shall be certified in accordance with regulations in Subpart A of this Part 8.

[33 F.R. 8813, June 18, 1968]

§ 8.202 Orange B.

(a) Identity. (1) The color additive Orange B is principally the disodium salt of 1-4-sulfophenyl)-3-ethylcarboxy-4(4-sulfonaphthylazo) - 5-hydroxypyr

azole.

(2) The diluents in color additive mixtures for food use containing Orange B are limited to those listed in Subpart D of this part as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Orange B shall conform to the following specifications: Volatile matter (at 135° C.), not more than 6.0 percent.

Chlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent. Water insoluble matter, not more than 0.2 percent. 1-(4-Sulfophenyl)

3 ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3carboxy-5-hydroxypyrazolone, not more than 0.7 percent.

Naphthionic acid, not more than 0.2 percent. Phenylhydrazine-p-sulfonic acid, not more than 0.2 percent.

The trisodium salt of 1-(4-sulfophenyl)-3carboxy-4-(4- sulfonaphthylazo)-5-bydroxypyrazole, not more than 6.0 percent. Other subsidiary dyes, not more than 1.0 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Pure color, not less than 87.0 percent.

(c) Uses and restrictions. Orange B may be safely used for coloring the casings or surfaces of frankfurters and sausages subject to the restriction that the quantity of the color additive does not exceed 150 parts per million by weight of the finished food.

(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) Certification. All batches of Orange B shall be certified in accordance with regulations promulgated urder Subpart A of this part.

[31 F.R. 8, Jan. 4, 1966]

§ 8.206 FD&C Blue No. 1.

(a) Identity. (1) The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl[4-[p[ethyl (m-sulfobenzyl) amino]-α-(0-sulfophenyl) benzylidene J-2,5-cyclohexadien-1-ylidene ] (m-sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl[4-[p[ethyl (o-sulfobenzyl) amino]-a-(0-sul

fophenyl)

benzylidene]-2,5-cyclohexa

dien 1-ylidene] (p-sulfobenzyl) ammonium hydroxide inner salt and ethyl[4[p-lethyl (o-sulfobenzyl)amino] - α - (o sulfophenyl) benzylidenel-2,5-cyclohexadien 1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt.

(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in Subpart D of this part as safe for use in color additive mixtures for coloring foods.

(b) Specifications. FD&C Blue No. 1 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter (at 135° C.) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent. Water-insoluble matter, not more than 0.2 percent.

Leuco base, not more than 5 percent. Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.

N-ethyl, N-(m-sulfobenzyl) sulfanilic acid, not more than 0.3 percent.

Subsidiary colors, not more than 6.0 percent. Chromium (as Cr), not more than 50 parts per million.

Arsenic (as As), not more than 3 parts per million.

Lead (as Pb), not more than 10 parts per million.

Total color, not less than 85.0 percent.

(c) Uses and restrictions. FD&C Blue No. 1 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label 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) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in Subpart A of this part.

[34 F.R. 7445, May 8, 1969]

one, disodium salt, with smaller amounts of lower iodinated fluoresceins.

(2) Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in Subpart D of this part as safe for use in color additive mixtures for coloring foods.

(b) Specifications. FD&C Red No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 135° C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent. Water-insoluble matter, not more than 0.2 percent.

Unhalogenated intermediates, total not more than 0.1 percent.

Sodium iodide, not more than 0.4 percent. Triiodoresorcinol, not more than 0.2 percent. 2(2',4'-Dihydroxy-3',5'-diiodobenzoyl) benzoic acid, not more than 0.2 percent. Monoiodofluoresceins not more than 1.0

percent.

Other lower iodinated fluoresceins, not more than 9.0 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Total color, not less than 87.0 percent.

(c) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring foods generally (including dietary supplements) in amounts consistent with good manufacturing practices except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label 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) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in Subpart A of this part.

[34 F.R. 7446, May 8, 1969] § 8.244

FD&C Red No. 40.

(a) Identity. (1) The color additive FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy5-methyl-4- sulfophenyl) azo]- 2- naphthalenesulfonic acid.

(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may contain

only those diluents that are suitable and that are listed in Subpart D of this part as safe for use in color additive mixtures for coloring foods.

(3) The listing of this color additive includes lakes prepared as described in § 9.100 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 9.100.

(b) Specifications. FD&C Red No. 40 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice; Sum of volatile matter (at 135° C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent. Water-insoluble matter, not more than 0.2 percent.

Higher sulfonated subsidiary colors

(as

sodium salts), not more than 1.0 percent. Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent. Disodium salt of 6-hydroxy-5-[(2-methoxy5-methyl-4-sulfophenyl) azo]-8-(2-meth

oxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not more than 1.0 per

cent.

Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent. 4-Amino-5-methoxy-o-toluenesulfonic acid, not more than 0.2 percent.

Disodium salt of 6,6'-oxybis (2-naphthalenesulfonic acid), not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Total color, not less than 85.0 percent.

(c) Uses and restrictions. FD&C Red No. 40 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations in Subpart A of this part.

[36 F.R. 6892, Apr. 10, 1971, as amended at 36 F.R. 23553, Dec. 10, 1971]

EFFECTIVE DATE: At 36 F.R. 23553, Dec. 10, 1971, effective 40 days after publication, § 8.244 was amended as follows: (a) (3) was added, in (b) "Arsenic" was revised, and (d) and (e) were revised. For the convenience of the user the superseded text is set forth below:

(b)

Arsenic (as As), not more than 1 part per million.

(d) Labeling. The label 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) Certification. All batches of FD&C Red No. 40 shall be certified in accordance with regulations in Subpart A of this part.

§ 8.275 FD&C Yellow No. 5.

(a) Identity. (1) The color additive FD&C Yellow No. 5 is 5-oxo-1-(psulfophenyl)-4-[(p-sulfophenyl) azo]-2pyrazoline-3-carboxylic acid, trisodium

salt.

(2) Color additive mixtures for food use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and that are listed in Subpart D of this part as safe for use in color additive mixtures for coloring foods.

(b) Specifications. FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Volatile matter (at 135° C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13.0 percent. Water insoluble matter, not more than 0.2 percent.

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

Other uncombined intermediates, not more than 0.2 percent each.

Subsidiary dyes, not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Total color, not less than 87.0 percent.

(c) Uses and restrictions. FD&C Yellow No. 5 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(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) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in Subpart A of this part.

[34 F.R. 7447, May 8, 1969]

Subpart D-Listing of Color Additives for Food Use Exempt From Certification

§ 8.300 Diluents in color additive mixtures for food use exempt from certification.

The following substances may be safely used as diluents in color additive mix

As set forth in U.S.P. XVI.

Castor oil.

Dioctyl sodium sulfosuccinate.

As set forth in $121.1137 of this chapter.

tures for food use exempt from certification, 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 certification. If a specification for a particular diluent is not set forth in this Subpart D, the material shall be of a purity consistent with its intended use.

(a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201 (s) of the act.

(2) Substances meeting the definitions and specifications set forth under Part 121 of this chapter, and which are used only as prescribed by such regulations. (3) The following:

Restrictions

(a) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, separated from its culture broth), molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. The algae cells are produced by suitable fermentation, under controlled conditions, from a pure culture of the genus Spongiococcum.

(b) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in accordance with the following prescribed conditions:

(1) The color additive is used to enhance the yellow color of chicken skin and eggs.

(2) The quantity of the color additive incorporated in the feed is such that the finished feed:

(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in subparagraph (1) of this paragraph; and

(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 121.202 of this chapter.

(c) Labeling. The label of the color additives and any premixes prepared therefrom shall bear in addition to the information required by § 8.32:

(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.

(2) Adequate directions to provide a final product complying with the limita

Physical state, solid.

1 percent solution in chloroform, clear. Melting point (decomposition), 136° C.-140° C. (corrected).

Loss of weight on drying, not more than 0.2 percent.

Residue on ignition, not more than 0.2 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Assay (spectrophotometric), 96-101 percent. (c) Uses and restrictions. The color

additive B-apo-8'-carotenal may be