Scientific Opinion on the safety and efficacy of a preparation of bentonite-and sepiolite (Toxfin® Dry) as feed additive for all species


Technological additive, substances for reduction of the contamination of feed with mycotoxins, bentonite, safety, efficacy
First published in the EFSA Journal
9 aprile 2013
14 marzo 2013
Opinion of the Scientific Committee/Scientific Panel

The safety assessment of the additive is based on the separate consideration of its two constituents, bentonite and sepiolite. The currently authorised maximum contents for bentonite and sepiolite when used individually (20 000 mg/kg complete feed) are considered safe for all animal species. In consequence, Toxfin® Dry would be safe for all animals species and categories up to a maximum concentration of 20 000 mg/kg complete feed. Bentonite and sepiolite, in common with other clays, are not absorbed to any measurable extent. Consequently, it is unlikely that the consumption of edible tissues/products of treated animals would expose the consumer to harmful amounts of residues of any chemical component derived from Toxfin® Dry. The FEEDAP Panel considers that there is no concern for the safety of consumers of food products derived from animals fed diets containing the additive. Dust generated from Toxfin® Dry during normal handling has the potential to expose the whole of the respiratory tract of users to potentially harmful substances (bentonite, sepiolite and crystalline silica) for which no safe levels of exposure have been identified. Measures must be taken to limit exposure of users to dust. In the absence of data for sepiolite, it would be prudent to treat ToxFin® Dry as a skin and eye irritant and a skin sensitiser. Bentonite and sepiolite are naturally occurring clays widely distributed in the environment. Therefore, it is not expected that the use of the additive in animal nutrition would adversely affect the environment. Since only one in vivo study in chickens has been provided, the FEEDAP Panel considers that there is insufficient evidence to conclude on the efficacy of the additive as a substance for reduction of contamination of feed with mycotoxins.

Panel members at the time of adoption
Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal 2013;11(4):3179 [21 pp.].
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European Commission
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