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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: 21CFR74.250]



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. 74.250 Orange B.

(a)Identity. (1) The color additive Orange B is principally the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-sulfonaphthylazo)-5-hydro-xypyrazole.

(2) The diluents in color additive mixtures for food use containing Orange B are limited to those listed in part 73 of this chapter as safe and suitable in color additive mixtures for coloring foods.

(b)Specifications. Orange B shall conform to the following specifications:

Volatile matter (at 135 deg. C.), not more than 6.0 percent.

Chlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent.

Water insoluble matter, not more than 0.2 percent.

1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent.

Naphthionic acid, not more than 0.2 percent.

Phenylhydrazine-p -sulfonic acid, not more than 0.2 percent.

The trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent.

Other subsidiary dyes, not more than 1.0 percent.

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

Arsenic (as As), not more than 1 part per million.

Total color, not less than 87.0 percent.

(c)Uses and restrictions. Orange B may be safely used for coloring the casings or surfaces of frankfurters and sausages subject to the restriction that the quantity of the color additive does not exceed 150 parts per million by weight of the finished food.

(d)Labeling requirements. 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 70.25 of this chapter.

(e)Certification. All batches of Orange B shall be certified in accordance with regulations promulgated under part 80 of this chapter.

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