[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: 21CFR74.705]
 
 [Page 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. 74.705  FD&C Yellow No. 5.
 
     (a) Identity. (1) The color additive FD&C Yellow No. 5 is
 principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-
 [4-sulfophenyl-azo]-1H-pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-
 0). To manufacture the additive, 4-amino-benzenesulfonic acid is
 diazotized using hydrochloric acid and sodium nitrite. The diazo
 compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-
 pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or
 a salt of this carboxylic acid. The resulting dye is purified and
 isolated as the sodium salt.
     (2) Color additive mixtures for food use made with FD&C Yellow No. 5
 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 Yellow No. 5 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 (275 deg. F) and chlorides and
 sulfates (calculated as sodium salts), not more than 13 percent.
 Water-insoluble matter, not more than 0.2 percent.
 4,4'-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-
 diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.
 4-[(4',5-Disulfo[1,1'-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-
 sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more
 than 1 percent.
 Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-
 sulfophenyl)hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not
 more than 1 percent.
 Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-
 carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-
 (4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more
 than 0.5 percent.
 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.
 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid,
 disodium salt, not more than 0.2 percent.
 Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-
 carboxylate, sodium salt, not more than 0.1 percent.
 4,4'-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not
 more than 0.05 percent.
 4-Aminoazobenzene, not more than 75 parts per billion.
 4-Aminobiphenyl, not more than 5 parts per billion.
 Aniline, not more than 100 parts per billion.
 Azobenzene, not more than 40 parts per billion.
 Benzidine, not more than 1 part per billion.
 1,3-Diphenyltriazene, not more than 40 parts per billion.
 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 87 percent.
 
     (c) Uses and restrictions. FD&C Yellow No. 5 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 requirements. (1) The label of the color additive and
 any mixtures intended solely or in part for coloring purposes prepared
 therefrom shall conform to the requirements of Sec. 70.25 of this
 chapter.
     (2) Foods for human use that contain FD&C Yellow No. 5, including
 butter, cheese, and ice cream, shall specifically declare the presence
 of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5
 among the list of ingredients.
     (e) Certification. All batches of FD&C Yellow No. 5 shall be
 certified in accordance with regulations in part 80 of this chapter.
 
 [42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at
 44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986]