[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: 21CFR74.2705]
 
[Page 421-422]
 
                        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 C--Cosmetics
 
Sec. 74.2705  FD&C Yellow No. 5.
 
    (a) Identity. 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-aminobenzenesulfonic 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.
    (b) Specifications. (1) 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.
 
[[Page 422]]
 
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.
 
    (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance
with the requirements of Sec. 82.51 of this chapter.
    (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used
for coloring cosmetics generally, including cosmetics intended for use
in the area of the eye, in amounts consistent with current good
manufacturing practice.
    (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring
cosmetics intended for use in the area of the eye, subject to the
restrictions on use of color additives in Sec. 70.5(b) and (c) of this
chapter, in amounts consistent with current good manufacturing practice.
    (d) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
    (e) Certification. All batches of FD&C Yellow No. 5 shall be
certified in accordance with regulations in part 80 of this chapter.
 
[50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59
FR 60898, Nov. 29, 1994]