Open AccessSafety and efficacy of EB15 10 ( Bacillus subtilis DSM 25841) as a feed additive for weaned piglets and minor porcine species
Author(s) -
Rychen Guido,
Aquilina Gabriele,
Azimonti Giovanna,
Bampidis Vasileios,
Bastos Maria de Lourdes,
Bories Georges,
Chesson Andrew,
Cocconcelli Pier Sandro,
Flachowsky Gerhard,
Gropp Jürgen,
Kolar Boris,
Kouba Maryline,
LópezAlonso Marta,
López Puente Secundino,
Mantovani Alberto,
Mayo Baltasar,
Ramos Fernando,
Villa Roberto Edoardo,
Wallace Robert John,
Wester Pieter,
Brozzi Rosella,
Saarela Maria
Publication year - 2018
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2018.5199
Subject(s) - feed additive , bacillus subtilis , european commission , food science , biology , animal feed , microbiology and biotechnology , toxicology , zoology , bacteria , european union , genetics , broiler , business , economic policy
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 EB 15 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 × 10 8 CFU /kg complete feedingstuffs and in water for drinking at 1.7 × 10 8 CFU /L. The additive exists in two forms, EB 15 and EB 15 10, which contain the bacterium in concentrations of 1.25 × 10 9 CFU /g additive and 1.25 × 10 10 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.