[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1155]
[Page 501-502]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
Subpart B Listing of Specific Substances Affirmed as GRAS
Sec. 184.1155 Bentonite.
(a) Bentonite
(Al2O34SiO2nH2O, CAS Reg.
No. 1302-0978-099) is principally a colloidal hydrated aluminum
silicate. Bentonite contains varying quantities of iron, alkalies, and
alkaline earths in the commercial products. Depending on the cations
present, natural deposits of bentonite range in color from white to
gray, yellow, green, or blue. Bentonite's fine particles provide large
total surface area and, hence, pronounced adsorptive capability.
(b) FDA is developing food-grade specifications for bentonite in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a suitable purity for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food with no limitation other than current good manufacturing practice.
The affirmation of this ingredient as generally recognized as safe
(GRAS) as a direct human food ingredient is based upon the following
current good manufacturing practice conditions of use:
[[Page 502]]
(1) The ingredient is used as a processing aid as defined in Sec.
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice results
in no significant residue in foods.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 43367, Oct. 1, 1982]
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