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74.303 FD&C Red No. 3.

Home > Regulations > Listing of color additives subject to certification > 74.303 FD&C Red 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: 21CFR74.303]



[Page 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.  74.303  FD&C Red No. 3.



    (a) Identity. (1) The color additive FD&C Red No. 3 is principally 

the monohydrate of 9 (o- carboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo-

3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated 

fluoresceins.

    (2) Color additive mixtures for food use made with FD&C Red 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 foods.

    (b) Specifications. FD&C Red 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 good 

manufacturing practice:



Volatile matter (at 135 [deg]C.) and chlorides and sulfates (calculated 

as the sodium salts), total not more than 13 percent.

Water-insoluble matter, not more than 0.2 percent.

Unhalogenated intermediates, total not more than 0.1 percent.

Sodium iodide, not more than 0.4 percent.

Triiodoresorcinol, not more than 0.2 percent.

2(2',4'-Dihydroxy-3', 5'-diiodobenzoyl) benzoic acid, not more than 0.2 

percent.

Monoiodofluoresceins not more than 1.0 percent.

Other lower iodinated fluoresceins, not more than 9.0 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 3 parts per million.

Total color, not less than 87.0 percent.



    (c) Uses and restrictions. FD&C Red No. 3 may be safely used for 

coloring foods generally (including dietary supplements) 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 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 Red No. 3 shall be certified 

in accordance with regulations in part 80 of this chapter.










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 74, Section 303


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