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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 Mar 22, 2024.

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]
[CITE: 21CFR172.870]



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 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I - Multipurpose Additives

Sec. 172.870 Hydroxypropyl cellulose.

The food additive hydroxypropyl cellulose may be safely used in food, except standardized foods that do not provide for such use, in accordance with the following prescribed conditions:

(a) The additive consists of one of the following:

(1) A cellulose ether containing propylene glycol groups attached by an ether linkage that contains, on an anhydrous basis, not more than 4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a minimum viscosity of 10 centipoises for a 10 percent by weight aqueous solution at 25 degrees C.

(2) A cellulose ether containing propylene glycol groups attached by an ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The common name for this form of the additive is low substituted hydroxypropyl cellulose.

(b) The additive is used or intended for use as follows:

(1) The additive identified in paragraph (a)(1) of this section is used or intended for use as an emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener in food, in accordance with good manufacturing practice. The additive also may be used as a binder in dietary supplements, in accordance with good manufacturing practice.

(2) The additive identified in paragraph (a)(2) of this section is used or intended for use as a binder and disintegrator in tablets or wafers containing dietary supplements of vitamins and/or minerals. The additive is used in accordance with good manufacturing practice.

[46 FR 50065, Oct. 9, 1981, as amended at 76 FR 41689, July 15, 2011]

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