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

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Article
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
Acknowledgement

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

Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2011-00335
Adopted
14 Giugno 2011
Published
23 Giugno 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (118.18 KB)118.18 KB
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.

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
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Number of Pages
9