Safety and efficacy of EB15 10 (Bacillus subtilis DSM 25841) as a feed additive for weaned piglets and minor porcine species

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Published on: Fri, 20 Apr 2018 00:00:00 +0200

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of EB15 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus subtilis intended for use in feed at the proposed dose of 5 × 10⁸ CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 10⁸ CFU/L. The additive exists in two forms, EB15 and EB15 10, which contain the bacterium in concentrations of 1.25 × 10⁹ CFU/g additive and 1.25 × 10¹⁰ CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.