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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2018]
[CITE: 21CFR74.340]



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. 74.340 FD&C Red No. 40.

(a) Identity. (1) The color additive FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid.

(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 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.

(3) The listing of this color additive includes lakes prepared as described in 82.51 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by 82.51 of this chapter.

(b) Specifications. FD&C Red No. 40 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.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent.

Water-insoluble matter, not more than 0.2 percent.

Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.

Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.

Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not more than 1.0 percent.

Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent.

4-Amino-5-methoxy-o- toluenesulfonic acid, not more than 0.2 percent.

Disodium salt of 6,6'-oxybis (2-naphthalene-sulfonic acid), not more than 1.0 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 85.0 percent.

(c) Uses and restrictions. FD&C Red No. 40 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 the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any lakes or 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. 40 and lakes thereof shall be certified in accordance with regulations in part 80 of this chapter.

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