of each request for certification submitted in accordance with § 8.22(j) (1) and (2), shall be 15 cents per pound of the batch covered by such requests, but no such fee shall be less than $100.00.

(b) Fees for repacks of certified color additives and color additive mixtures. The fees for the services provided under the regulations in this part in the case of each request for certification submitted in accordance with § 8.22(j) (3) and (4) shall be:

Weight of batch 100 pounds or less. Over 100 pounds

but not over 1,000 pounds. Over 1,000 pounds.

$6.00

Fees

$6.00 plus 4 cents for
each pound over 100
pounds.
$42.00 plus 1 cent per
pound for each pound
in excess of 1,000
pounds.

(c) Advance deposits. Any person regularly requesting certification services may deposit funds in advance of requests as prepayment of fees required by this section.

(d) Method of payment. All deposits and fees required by this section shall be paid by money order, bank draft, or certified check, drawn to the order of the Food and Drug Administration, collectable at par at Washington, D.C. All such deposits and fees shall be forwarded to the Food and Drug Administration, Department of Health, Education, and Welfare, Washington 25, D.C., whereupon after making appropriate records thereof, they will be transmitted to the Treasurer of the United States for deposit to the special account "Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration."

(e) Refunds from advance deposits. Whenever in the judgment of the Commissioner the ratio between fees collected (which are based upon experience and the best estimate of costs and the best estimate of earnings) and the costs of providing the service during an elapsed period of time, in the light of all circumstances and contingencies, warrants a refund from the fund collected during such period, he shall make ratable refunds to those persons to whom the services were rendered and charged, except that no refund shall be made where the com

puted ratable amount for the elapsed period is less than $5.00.

§§ 8.52-8.100 [Reserved]

Subpart B-General Specifications and General Restrictions for Color Additives for Use in Foods, Drugs, and Cosmetics

§ 8.101 General restrictions on use of color additives.

(a) Color additives for use in the area of the eye. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use in the area of the eye unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use in the area of the eye, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under Subparts E, F, G, and H of this part, even though such color additive is certified and/or listed for other uses.

(b) Color additives for use in injections. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use in injections unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use in injections, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under Subparts E and F of this part, even though such color additive is certified and/or listed for other uses.

(c) Color additives for use in surgical sutures. No listing or certification of a color additive shall be considered to authorize the use of ary such color additive in any article intended for use as a surgical suture unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use as a surgical suture, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive

(a) Identity. (1) The color additive Citrus Red No. 2 is principally 1-(2,5dimethoxyphenylazo) -2-naphthol.

(2) The following diluents may be used in aqueous suspension, in the percentages specified, to facilitate application to oranges in accordance with paragraph (c) (1) of this section:

(i) Suitable diluents used in accordance with § 8.300(a).

(ii) Volatile solvents that leave no residue after application to the orange. (iii) Salts of fatty acids meeting the requirements of § 121.1071 of this chapter.

more thar 0.05 percent.

not

(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 1 part per million.

Pure color, not less than 98 percent.

(c) 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, calcu

lated 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.

(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-hydroxypyrazole, 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

(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-(o-sulfophenyl)benzylidene 1-2,5-cyclohexadien-1-ylidene ] (m-sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl[4-[p[ethyl (p-sulfobenzyl) amino]-α-(o-sulfophenyl)

benzylidenel-2,5-cyclohexadien-1-ylidene] (p-sulfobenzyl) ammonium hydroxide inner salt and ethyl[4[p-lethyl (o-sulfobenzyl)amino] - α- ·(osulfophenyl)benzylidene]-2,5-cyclohexa

dien 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]

(a) Identity. (1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 (o-carboxyphenyl)-6-hy

droxy-2,4,5,7-tetraiodo-3H-xanthen-3one, 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

plements) 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]

§ 8.275 FD&C Yellow No. 5.

(a) Identity. (1) The color additive FD&C Yellow No. 5 is 5-oxo-1-(psulfophenyl)-4-[(p-sulfophenyl) azol-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 mixtures 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: