Open AccessSafety and efficacy of bentonite as a feed additive for all animal species
Author(s) -
Rychen Guido,
Aquilina Gabriele,
Azimonti Giovanna,
Bampidis Vasileios,
Bastos Maria de Lourdes,
Bories Georges,
Chesson Andrew,
Cocconcelli Pier Sandro,
Flachowsky Gerhard,
Gropp Jürgen,
Kolar Boris,
Kouba Maryline,
LópezAlonso Marta,
Mantovani Alberto,
Mayo Baltasar,
Ramos Fernando,
Saarela Maria,
Villa Roberto Edoardo,
Wallace Robert John,
Wester Pieter,
Martelli Giovanna,
Renshaw Derek,
LópezGálvez Gloria,
López Puente Secundino
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.5096
Subject(s) - bentonite , mycotoxin , genotoxicity , aflatoxin , european commission , animal feed , feed additive , toxicology , food science , animal species , animal study , chemistry , toxicity , microbiology and biotechnology , biology , european union , medicine , business , surgery , paleontology , zoology , organic chemistry , broiler , economic policy
The EFSA Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP ) received a request from the European Commission to assess the safety and efficacy of bentonite when used as a technological feed additive (substances for reduction of the contamination of feed by mycotoxins) for all animal species. The applicant, EUBA aisbl (European Bentonite Association) representing six companies, submitted to EFSA a technical dossier to support the application. The applicant proposes to use bentonite at the maximum level of 20,000 mg/kg complete feed. The additive apparently interferes with the analysis of aflatoxin B1 in feed. The safety of the additive was already evaluated by the Panel in an opinion delivered in 2012. Bentonites are safe for all animal species, the consumers and the environment when used at a maximum level of 20,000 mg/kg complete feed. The results of a new genotoxicity study reinforced the previous conclusion that smectites are non‐genotoxic. Bentonites are not skin irritants but might be mildly irritant to the eye; based on a new study submitted, the additive is not a skin sensitiser. Owing to its silica content, the additive is a hazard by inhalation for the users. The in vitro study showed that the di‐ and tri‐octahedral smectites tested can adsorb aflatoxin B1 at different concentrations and at pH 5; however, no adequate in vivo studies were available. Therefore, the Panel cannot draw conclusions on the additive's efficacy. The Panel further considers the safety and efficacy conclusions to apply equally to the di‐ and tri‐octahedral smectites under assessment. The FEEDAP Panel posted some recommendations regarding the maximum content of other minerals in the additive and the incompatibilities of the additive with other medicinal substances. The Panel also drew a remark concerning the denomination of the additive and the current regulatory definition of Bentonite .