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74.705 FD&C Yellow No. 5.

Home > Regulations > Listing of color additives subject to certification > 74.705 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: 21CFR74.705]



[Page 391-392]

 

                        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.  74.705  FD&C Yellow No. 5.



    (a) Identity. (1) 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-amino-benzenesulfonic 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.

    (2) Color additive mixtures for food use made with FD&C Yellow No. 5 

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. 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.



    (c) Uses and restrictions. FD&C Yellow No. 5 may be safely used for 

coloring foods (including dietary supplements) generally in amounts 

consistent with 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



[[Page 392]]



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 purposes prepared 

therefrom shall conform to the requirements of Sec.  70.25 of this 

chapter.

    (2) Foods for human use that contain FD&C Yellow No. 5, including 

butter, cheese, and ice cream, shall specifically declare the presence 

of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5 

among the list of ingredients.

    (e) Certification. All batches of FD&C Yellow No. 5 shall be 

certified in accordance with regulations in part 80 of this chapter.



[42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at 

44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 705


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