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Scientific Opinion on the efficacy of Bentonite (dioctahedral montmorillonite) for all species

EFSA Journal 2011;9(6):2276 [9 pp.]. doi:10.2903/j.efsa.2011.2276
  EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel Members Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Reinhard Kroker, Lubomir Leng, Secundino López Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf Acknowledgment The Panel wishes to thank the members of the Working Group on Mycotoxin detoxifying agents, including Anna Maria Pérez Vendrell, for the preparatory on this scientific opinion Contact FEEDAP@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2011-00335 Adopted: 14 June 2011 Published: 23 June 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In a previous opinion on bentonite, the Panel concluded that it has the potential to be efficacious as aflatoxin binder in feed of dairy cows, and extended this conclusion to all ruminants. However, the Panel was not in a position to assess the efficacy of the bentonite under application as aflatoxin binder for any other animal species than ruminants due to the absence of data. The applicant has submitted a supplementary dossier to support the efficacy of the additive for all species. However, no new efficacy studies have been provided, only reference to published data. The FEEDAP Panel fully reviewed all data, considerations and statements provided by the applicant in the supplementary dossier. No convincing argument or experimental result could be found which would alter the former position of the Panel. The FEEDAP Panel reiterates therefore, its former conclusion that it can not assess the efficacy of the bentonite under application as aflatoxin binder for any other animal species than ruminants due to the absence of appropriate in vivo data.

© European Food Safety Authority, 2011

Summary

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of bentonite (dioctahedral montmorillonite) as feed additive for all animal species.

The FEEDAP Panel concluded in a previous opinion that the bentonite under application has the potential to be efficacious as aflatoxin binder in feed of dairy cows, and extended this conclusion to all ruminants. However, the Panel was not in a position to assess the efficacy of the bentonite under application as aflatoxin binder for any other animal species than ruminants due to the absence of data.

The applicant has submitted a supplementary dossier to support the efficacy of the additive for all species. However, no new efficacy studies have been provided, only reference to published data.

The FEEDAP Panel fully reviewed all data, considerations and statements provided by the applicant in the supplementary dossier. No convincing argument or experimental result could be found which would alter the former position of the Panel. The FEEDAP Panel reiterates therefore, its former conclusion that it can not assess the efficacy of the bentonite under application as aflatoxin binder for any other animal species than ruminants due to the absence of appropriate in vivo data.

Keywords

Technological additive, mycotoxin binder, bentonite, montmorillonite, aflatoxin, mycotoxins, efficacy