This electronic document was downloaded from the GPO web site, August 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

 [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: 21CFR74.303]
 
 [Page 394-395]
 
                         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 395]]
 
 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.


Color Additive Regulations
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