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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

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 x 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 physiologicallysimilar 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 x 107 CFU/kg complete feedingstuffs.

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