[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.2101]
[Page 412-413]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 74 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
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-
[[Page 413]]
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 Sec. 74.101(b).
(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance
with the requirements of Sec. 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 Sec. 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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