Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for minor poultry species for fattening and reared for laying
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) | Guido Rychen | 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 | Marta López‐Alonso | Secundino López Puente | Alberto Mantovani | Baltasar Mayo | Fernando Ramos | Roberto Edoardo Villa | Robert John Wallace | Pieter Wester | Rosella Brozzi | Maria Saarela
Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Alterion NE® when used in feed for chickens for fattening and chickens reared for laying. Alterion NE® is a preparation containing viable spores of Bacillus subtilis DSM 29784 intended for use in feed for the target species at the recommended dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis is a species considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the same opinion, the FEEDAP Panel concluded that 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 could be drawn on the dermal sensitisation of the additive. Alterion NE® at the recommended dose 1 × 108 CFU/kg feed has the potential to be efficacious in minor poultry species for fattening and reared for laying. B. subtilis DSM 29784 is compatible with the coccidiostats monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride and decoquinate at the respective authorised levels.
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