[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: 21CFR74.101]
 
 [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. 74.101  FD&C Blue No. 1.
 
     (a) Identity. (1) The color additive FD&C Blue No. 1 is principally
 the disodium salt of ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]<greek-a>-
 (o-sulfophenyl) benzylidene] - 2,5 -cyclohexadien - 1 - ylidene] (m-
 sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the
 isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]-
 <greek-a>-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-
 sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o-
 sulfobenzyl) amino] - <greek-a>-(o -sulfophenyl) benzylidene]-2,5-
 cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt.
     (2) Color additive mixtures for food use (including dietary
 supplements) made with FD&C Blue No. 1 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.
     (b) Specifications. FD&C Blue No. 1 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 current good
 manufacturing practice:
 
 Sum of volatile matter (at 135 deg. C) and chlorides and sulfates
 (calculated as sodium salts), not more than 15.0 percent.
 Water-insoluble matter, not more than 0.2 percent.
 Leuco base, not more than 5 percent.
 Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.
 N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent.
 Subsidiary colors, not more than 6.0 percent.
 Chromium (as Cr), not more than 50 parts per million.
 Manganese (as Mn), not more than 100 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 Lead (as Pb), not more than 10 parts per million.
 Total color, not less than 85.0 percent.
 
     (c) Uses and restrictions. FD&C Blue No. 1 may be safely used for
 coloring foods (including dietary supplements) generally in amounts
 consistent with good manufacturing practice except
 
 [[Page 392]]
 
 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 Blue No. 1 shall be certified
 in accordance with regulations in part 80 of this chapter.
 
 [42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993]