Safety and efficacy of EB15 10 (Bacillus subtilis DSM 25841) as a feed additive for piglets (suckling and weaned), pigs for fattening, sows in order to have benefits in piglets, sows for reproduction and minor porcine species

• Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Jaume Galobart, Orsolya Holczknecht, Paola Manini, Fabiola Pizzo, Jordi Tarrés‐Call, Montserrat Anguita
• Format: Article
• Language: English
• Published: Wiley 2019-11-01
• Series: EFSA Journal
• Subjects: Example: zootechnical additive; gut flora stabilisers; Bacillus subtilis; safety; efficacy; pigs
• Online Access: https://doi.org/10.2903/j.efsa.2019.5884

Abstract 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 all pigs. 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, and has been previously characterised by the FEEDAP Panel. 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, and consequently, the additive was 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. The data made available by the applicant allowed the Panel to conclude that the additive in either form has a potential to be efficacious as a zootechnical additive when added to feed for piglets (suckling and weaned), pigs for fattening and sows (excluding a benefit from sows to suckling piglets) at 5 × 108 CFU/kg (corresponding to 1.7 × 108 CFU/L water) The conclusions on the efficacy were extrapolated to all Suidae species.