[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1155]

[Page 500]
 
                        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 
SAFE--Table of Contents
 
        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:
    (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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