[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of
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-
(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
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
Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0
Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -
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
(e) Certification. All batches of FD&C Red No. 40 and lakes thereof
shall be certified in accordance with regulations in part 80 of this
Additives that reference this regulation: