[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.870]
[Page 99-100]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION--Table of Contents
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 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 deg.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.
[[Page 100]]
(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]