[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: 21CFR74.102]
 
 [Page 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. 74.102  FD&C Blue No. 2.
 
     (a) Identity. (1) The color additive FD&C Blue No. 2 is principally
 the disodium salt of 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-
 2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 860-22-0) with
 smaller amounts of the disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-
 indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg.
 No. 54947-75-0) and the sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-
 ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 605-
 18-5). Additionally, FD&C Blue No. 2 is obtained by heating indigo (or
 indigo paste) in the presence of sulfuric acid. The color additive is
 isolated and subjected to purification procedures. The indigo (or indigo
 paste) used above is manufactured by the fusion of N-phenylglycine
 (prepared from aniline and formaldehyde) in a molten mixture of sodamide
 and sodium and potassium hydroxides under ammonia pressure. The indigo
 is isolated and subjected to purification procedures prior to
 sulfonation.
     (2) Color additive mixtures for food use (including dietary
 supplements) made with FD&C Blue No. 2 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. The color additive FD&C Blue No. 2 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 (275 deg.F) and chlorides and
 sulfates (calculated as sodium salts), not more than 15 percent.
 Water insoluble matter, not more than 0.4 percent.
 Isatin-5-sulfonic acid, not more than 0.4 percent.
 5-Sulfoanthranilic acid, not more than 0.2 percent.
 Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-
 dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than 18 percent.
 Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-dihydro-3-
 oxo-1H-indole-5-sulfonic acid, not more than 2 percent.
 Lead (as Pb), not more than 10 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 Mercury (as Hg), not more than 1 part per million.
 Total color, not less than 85 percent.
 
     (c) Uses and restrictions. The color additive FD&C Blue No. 2 may be
 safely used for coloring foods (including dietary supplements) generally
 in amounts consistent with current 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 Federal Food, Drug, and
 Cosmetic 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. 2 shall be certified
 in accordance with regulations in part 80 of this chapter.
 
 [48 FR 5260, Feb. 4, 1983]