GrokFood Home
Loading

74.2705 FD&C Yellow No. 5.

Home > Regulations > Listing of color additives subject to certification > 74.2705 FD&C Yellow No. 5.






[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: 21CFR74.2705]



[Page 417-418]

 

                        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.

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.



[[Page 418]]



    (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]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 2705


Home | About | Search