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74.2101 FD&C Blue No. 1.

Home > Regulations > Listing of color additives subject to certification > 74.2101 FD&C Blue No. 1.






[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR74.2101]



[Page 411]

 

                        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-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]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 2101


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