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21 U.S.C. 321, 342, 348, 371.
42 FR 14653, Mar 15, 1977, unless otherwise noted.
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Subscribe to: 21 CFR 184.1155
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Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 69 FR 13717, Mar. 24, 2004; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; and 81 FR 49897, July 29, 2016.
(a) Bentonite (Al2O34SiO2nH2O, CAS Reg. No. 1302-78-9) 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) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 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 § 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, as amended at 73 FR 8606, Feb. 14, 2008; 76 FR 59249, Sept. 26, 2011]