[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.706]
[Page 392-393]
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. 74.706 FD&C Yellow No. 6.
(a) Identity. (1) The color additive FD&C Yellow No. 6 is
principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-
naphthalenesulfonic acid (CAS Reg. No. 2783-94-0). The trisodium salt of
3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid (CAS
Reg. No. 50880-65-4) may be added in small amounts. The color additive
is manufactured by diazotizing 4-aminobenzenesulfonic acid using
hydrochloric acid and sodium nitrite or sulfuric acid and sodium
nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-
sulfonic acid. The dye is isolated as the sodium salt and dried. The
trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-
naphthalenedisulfonic acid which may be blended with the principal color
is prepared in the same manner except the diazo benzenesulfonic acid is
coupled with 3-hydroxy-2,7-naphthalenedisulfonic acid.
(2) Color additive mixtures for food use made with FD&C Yellow No. 6
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 Yellow No. 6 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 13 percent.
Water insoluble matter, not more than 0.2 percent.
Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent.
Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3
percent.
Disodium salt of 6,6'-oxybis[2-naphthalenesulfonic acid], not more than
1 percent.
Disodium salt of 4,4'-(1-triazene-1,3-diyl)bis[benzenesulfonic acid],
not more than 0.1 percent.
Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic
acid and the sodium salt of 4-[(2-hydroxy-1-
naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent.
Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-
naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not
more than 5 percent.
4-Aminoazobenzene, not more than 50 parts per billion.
4-Aminobiphenyl, not more than 15 parts per billion.
Aniline, not more than 250 parts per billion.
Azobenzene, not more than 200 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million.
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. The color additive FD&C Yellow No. 6 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 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
[[Page 393]]
purposes prepared therefrom shall conform to the requirements of Sec.
70.25 of this chapter.
(2) [Reserved]
(e) Certification. All batches of FD&C Yellow No. 6 shall be
certified in accordance with regulations in part 80 of this chapter.
[51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53
FR 49138, Dec. 6, 1988]
Additives that reference this regulation: |
