• Open Access

Scientific Opinion on the safety and efficacy of Bacillus subtilis PB6 for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches

Authors

  • EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)


  • Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Reinhard Kroker, Lubomir Leng, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Derek Renshaw and Maria Saarela
  • Correspondence: feedap@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on Micro-organisms, including Guido Rychen and Atte von Wright, for the preparatory work on this scientific opinion.
  • Adoption date: 15 March 2011
  • Published date: 29 March 2011
  • Question number: EFSA-Q-2010-01150
  • On request from: European Commission

Abstract

Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. It is presently authorised for use with chickens for fattening at a minimum dose of 1 × 107 CFU/kg of complete feedingstuffs. The applicant is now seeking authorisation for use with chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches. B. subtilis is a species that is considered by EFSA to be suitable for Qualified Presumption of Safety (QPS) approach to safety assessment. The sensitivity to antibiotics and the absence of toxigenic potential qualified the strain for QPS status. On this basis the product can be presumed safe for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening, and ostriches, for consumers of products derived from these species, and for the environment. Safety for users was examined in the course of the assessment made for chickens for fattening. In the view of the FEEDAP Panel the use with the additional avian species will not introduce hazards not already considered. Evidence that Bacillus subtilis PB6 has the potential to be efficacious in chickens for fattening can be directly extended to include chickens reared for laying when used at the same dose. By extrapolation from results obtained with a physiologically-similar major species (chickens for fattening) the product is considered efficacious when used with ducks for fattening and quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches at a minimum dose of 1 × 107 CFU/kg complete feedingstuffs.

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