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. (13th November 2019)

• Record Type: Journal Article
• Authors: Bampidis, Vasileios; Azimonti, Giovanna; Bastos, Maria de Lourdes; Christensen, Henrik; Dusemund, Birgit; Kouba, Maryline; Kos Durjava, Mojca; López‐Alonso, Marta; López Puente, Secundino; Marcon, Francesca; Mayo, Baltasar; Pechová, Alena; Petkova, Mariana; Ramos, Fernando; Sanz, Yolanda; Villa, Roberto Edoardo; Woutersen, Ruud; Galobart, Jaume; Holczknecht, Orsolya; Manini, Paola; Pizzo, Fabiola; Tarrés‐Call, Jordi; Anguita, Montserrat
• Is Part Of: EFSA journal. Volume 17:Number 11(2019)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-11-13
• Subjects: Example: zootechnical additive -- gut flora stabilisers -- Bacillus subtilis -- safety -- efficacy -- pigs; Food -- Europe -- Safety measures -- Periodicals; Food Safety; Food -- Safety measures; Europe; Periodicals; Periodicals; Fulltext; Government Publications, International; Internet Resources; Periodicals; Periodicals; 363.19209405
• DOI: 10.2903/j.efsa.2019.5884
• Languages: English
• ISSNs: 1831-4732

Abstract

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 × 10 8 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 10 8 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 × 10 8 CFU/kg (corresponding to 1.7 × 10 8 CFU/L water) The conclusions on the efficacy were extrapolated to all Suidae species.