[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: 21CFR74.303]
[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. 74.303 FD&C Red No. 3.
(a) Identity. (1) The color additive FD&C Red No. 3 is principally
the monohydrate of 9 (o- carboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo-
3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated
fluoresceins.
(2) Color additive mixtures for food use made with FD&C Red No. 3
may contain only those diluents that are
[[Page 392]]
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 Red No. 3 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:
Volatile matter (at 135 [deg]C.) and chlorides and sulfates (calculated
as the sodium salts), total not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
Unhalogenated intermediates, total not more than 0.1 percent.
Sodium iodide, not more than 0.4 percent.
Triiodoresorcinol, not more than 0.2 percent.
2(2',4'-Dihydroxy-3', 5'-diiodobenzoyl) benzoic acid, not more than 0.2
percent.
Monoiodofluoresceins not more than 1.0 percent.
Other lower iodinated fluoresceins, not more than 9.0 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 87.0 percent.
(c) Uses and restrictions. FD&C Red No. 3 may be safely used for
coloring foods generally (including dietary supplements) 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 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. 3 shall be certified
in accordance with regulations in part 80 of this chapter.
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