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74.203 FD&C Green No. 3.

Home > Regulations > Listing of color additives subject to certification > 74.203 FD&C Green No. 3.






[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: 21CFR74.203]



[Page 388-389]

 

                        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-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.



[[Page 389]]



    (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]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 203


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