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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 3]
[Revised as of April 1, 2018]
[CITE: 21CFR173.65]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 173 -- SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

Subpart A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.65 Divinylbenzene copolymer.

Divinylbenzene copolymer may be used for the removal of organic substances from aqueous foods under the following prescribed conditions:

(a) The copolymer is prepared in appropriate physical form and is derived by the polymerization of a grade of divinylbenzene which comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-percent ethylvinylbenzene, and no more than 4 weight-percent nonpolymerizable impurities.

(b) In accordance with the manufacturer's directions, the copolymer described in paragraph (a) of this section is subjected to pre-use extraction with a water soluble alcohol until the level of divinylbenzene in the extract is less than 50 parts per billion as determined by a method titled, "The Determination of Divinylbenzene in Alcohol Extracts of Amberlite XAD-4," which is incorporated by reference. Copies of this method are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The copolymer is then treated with water according to the manufacturer's recommendation to remove the extraction solvent to guarantee a food-grade purity of the resin at the time of use, in accordance with current good manufacturing practice.

(c) The temperature of the aqueous food stream contacting the polymer is maintained at 79.4 deg. C (175 deg. F) or less.

(d) The copolymer may be used in contact with food only of Types I, II, and VI-B (excluding carbonated beverages) described in table 1 of paragraph (c) of 176.170 of this chapter.

[50 FR 61, Jan. 2, 1985]

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