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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2013]
[CITE: 21CFR74.303]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 74 -- LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

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 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.

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