Scientific Opinion on the safety and efficacy of micro-organism DSM 11798 when used as a technological feed additive for pigs

Bacterial transformation, trichothecene mycotoxins, deoxynivalenol, safety, efficacy, piglets, pigs for fattening
First published in the EFSA Journal
6 May 2013
16 April 2013
Scientific Opinion

The additive, based on a single bacterial strain (DSM 11798), is intended for use in feeds for pig to reduce the epoxide group of contaminating trichothecene mycotoxins to a less toxic metabolite. To establish an identity for the strain a phylogenetic analysis was made based on the genomic sequence of the strain and 24 genome sequences available for the family Coriobacteriaceae. The three approaches used consistently suggested an assignment to a new taxonomic unit within the family Coriobacteriaceae. The Panel accepts that a new species and/or genus may have to be established. In the interim the deposition of the bacterium in a European culture collection is sufficient to ensure that any authorisation would apply only to the additive under application. Based on the results of a tolerance study the additive is considered safe for piglets and pigs for fattening at the maximum dose proposed. The live organism is not expected to present a hazard for consumers and the negative findings in a series of genotoxicity and oral toxicity tests indicates that toxic metabolites are not produced. Since the additive is expected to act only by the biotransformation of trichothecene mycotoxins to less toxic forms, no hazards for consumers would arise from the use of the additive in animal production. The additive was non-irritant to eyes and skin and was not a skin sensitiser, but the potential for respiratory sensitization cannot be excluded. As the strain has a very limited capability to survive in aerobic conditions, its use in animal production is unlikely to introduce an environmental concern. The evidence presented in ex vivo and in vivo studies with deoxynivalenol confirms that the capacity to transform trichothecenes can be realised in pigs when the additive is incorporated into diets at a minimum dose of 1.7 x 108 CFU/kg complete feed.

Panel members at the time of adoption
Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, 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(5):3203
Question Number
On request from
European Commission