[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.101]

[Page 391-392]
 
                        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 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

[[Page 392]]

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 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.

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