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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR74.101]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 74 -- LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

Subpart A - Foods

Sec. 74.101 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]-[alpha]-(o -sulfophenyl) benzylidene] - 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]-[alpha]-(o -sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p -sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p -[ethyl (o -sulfobenzyl) amino] - [alpha] - (o -sulfophenyl) benzylidene]-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 part 73 of this chapter 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 current good manufacturing practice:

Sum of volatile matter (at 135 deg.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.

Manganese (as Mn), not more than 100 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 § 70.25 of this chapter.

(e) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993]

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