[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: 21CFR74.340]

[Page 395-396]
 
                        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. 74.340  FD&C Red No. 40.

    (a) Identity. (1) The color additive FD&C Red No. 40 is principally 
the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-
sulfophenyl)azo]-2-naphthalenesulfonic acid.
    (2) Color additive mixtures for food use (including dietary 
supplements) made with FD&C Red No. 40 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.
    (3) The listing of this color additive includes lakes prepared as 
described in Sec. 82.51 of this chapter, except that the color additive 
used is FD&C Red No. 40 and the resultant lakes meet the specification 
and labeling requirements prescribed by Sec. 82.51 of this chapter.
    (b) Specifications. FD&C Red No. 40 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 good 
manufacturing practice:

Sum of volatile matter (at 135 [deg]C.) and chlorides and sulfates 
(calculated as sodium salts), not more than 14.0 percent.
Water-insoluble matter, not more than 0.2 percent.
Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 
percent.
Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 
percent.
Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -
8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not 
more than 1.0 percent.
Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), 
not more than 0.3 percent.
4-Amino-5-methoxy-o- toluenesulfonic acid, not more than 0.2 percent.
Disodium salt of 6,6'-oxybis (2-naphthalene-sulfonic acid), not more 
than 1.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Total color, not less than 85.0 percent.

    (c) Uses and restrictions. FD&C Red No. 40 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 lakes or 
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 Red No. 40 and lakes thereof 
shall be

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certified in accordance with regulations in part 80 of this chapter.