Bentonite Clay

Bentonite is a colloidal clay permitted for unrestricted use in EU cosmetics under Regulation (EC) No. 1223/2009 and listed as colorant CI 77004. The CIR Expert Panel concluded it is safe in cosmetics at present practices of use, except available data are insufficient for products that may be incidentally inhaled due to potential respirable crystalline silica impurities. SCCS confirmed low bioavailability with dermal absorption of 0.00192% and safety in non-sprayable products, with sprayable products safe when ≤20% of particles are <10 μm. GRAS under 21 CFR §184.1155 in the US.

GRAS affirmed under 21 CFR §184.1155 as a direct food substance (processing aid, cGMP limitation, no significant residue in food). Also listed under 21 CFR §582.1155 (GRAS for animal feed) and as an indirect food additive in 21 CFR §175.105, 175.300, 176.170, and 178.3297. Not approved as a color additive in the US. Permitted for non-colorant cosmetic functions under FDA's general cosmetic ingredient safety framework. Not specifically listed in FDA OTC monographs; related clay Kaolin is approved as a skin protectant at 4-20% under 21 CFR §347.10.