21 C.F.R. § 172.870   Hydroxypropyl cellulose.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart I—Multipurpose Additives

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§ 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 which contains, on an anhydrous basis, not more than 4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a minimum viscosity of 145 centipoises for 10 percent by weight aqueous solution at 25 °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 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]

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