[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.203]
[Page 389-390]
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. 74.203 FD&C Green No. 3.
(a) Identity. (1) The color additive FD&C Green No. 3 is principally
the inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3-
sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-
cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide (CAS Reg.
No. 2353-45-9); with smaller amounts of the isomeric inner salt disodium
salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl] amino]phenyl](4-
hydroxy-2-sulfophenyl)methylene]-2,5-
[[Page 390]]
cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium hydroxide; of N-
ethyl-N-[4-[[4-[ethyl[(4-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-
sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-4-
sulfobenzenemethanaminium hydroxide and of N-ethyl-N-[4-[[4-[ethyl[(2-
sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-
cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide.
Additionally, FD&C Green No. 3 is manufactured by the acid catalyzed
condensation of one molecule of 2-formyl-5-hydroxybenzenesulfonic acid
with two molecules from a mixture consisting principally of 3-
[(ethylphenylamino)methyl]
benzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl]
benzenesulfonic acid and 2-[(ethylphenylamino)methyl]
benzenesulfonic acid to form the leuco base. The leuco base is then
oxidized with lead dioxide and acid or with dichromate and acid to form
the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acid is
prepared by the potassium permanganate oxidation of 2,2'-(1,2-
ethenediyl)-bis(5-aminobenzenesulfonic acid) to sodium 5-amino-2-
formylbenzenesulfonate. This amine is diazotized and the resulting
diazonium salt is hydrolyzed to the desired 2-formyl-5-
hydroxybenzenesulfonic acid.
(2) Color additive mixtures for food use (including dietary
supplements) made with FD&C Green No. 3 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 food.
(b) Specifications. The color additive FD&C Green No. 3 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 0.2 percent.
Leuco base, not more than 5 percent.
Sum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than
0.5 percent.
Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic
acid, disodium salts, not more than 0.3 percent.
2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5
percent.
Subsidiary colors, not more than 6 percent.
Chromium (as Cr), not more than 50 parts per million.
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 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 Green No. 3 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. 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 Green No. 3 shall be
certified in accordance with regulations in part 80 of this chapter.
[47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982]
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