Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying

Alterion NE®, Bacillus subtilis DSM 29784, zootechnical additive, chickens, safety, QPS, efficacy
First published in the EFSA Journal
18 July 2017
4 July 2017
Scientific Opinion

The additive Alterion NE® is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE® is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE® at the recommended dose 1 × 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride and decoquinate at the highest authorised levels.

Panel members at the time of adoption
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Panel on Additives and Products or Substances used in Animal Feed
feedap [at]
EFSA Journal 2017;15(7):4933
Question Number
On request from
European Commission