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: 21CFR74.340]
 
 [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
 
 [[Page 396]]
 
 certified in accordance with regulations in part 80 of this chapter.


Color Additive Regulations
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