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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 Dec 22, 2023.

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

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[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR74.2101]



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 C - Cosmetics

Sec. 74.2101 FD&C Blue No. 1.

(a) Identity. 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. Additionally, FD&C Blue No. 1 is manufactured by the acid catalyzed condensation of one mole of sodium 2-formylbenzenesulfonate with two moles from a mixture consisting principally of 3-[(ethylphenylamino)methyl] benzenesulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid, or with dichromate and acid, or with manganese dioxide and acid to form the dye. The intermediate sodium 2-formylbenzenesulfonate is prepared from 2-chlorobenzaldehyde and sodium sulfite.

(b) Specifications. (1) The color additive FD&C Blue No. 1 shall conform in specifications to the requirements of § 74.101(b).

(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.

(c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.

(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.

(d) Labeling. The label of the color additive 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.

[47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, 1994]

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