Open AccessSafety and efficacy of Alterion NE ® ( Bacillus subtilis DSM 29784) as a feed additive for minor poultry species for fattening and reared for laying
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,
López Puente Secundino,
Mantovani Alberto,
Mayo Baltasar,
Ramos Fernando,
Villa Roberto Edoardo,
Wallace Robert John,
Wester Pieter,
Brozzi Rosella,
Saarela Maria
Publication year - 2018
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.2018.5204
Subject(s) - context (archaeology) , feed additive , european commission , bacillus subtilis , animal feed , biology , food science , coccidiostats , microbiology and biotechnology , toxicology , veterinary medicine , european union , medicine , business , bacteria , paleontology , genetics , broiler , economic policy , coccidiosis
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 × 10 8 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 × 10 8 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.