Safety and efficacy of Bacillus subtilis DSM 28343 for pigs for fattening

Zootechnical additive, gutflora stabiliser,Bacillus subtilis, safety, efficacy, QPS, pigs forfattening
First published in the EFSA Journal
6. Juni 2019
15. Mai 2019
Scientific Opinion


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 Bacillus subtilis DSM 28343 when used in feed for pigs for fattening. The additive is a preparation containing viable spores of a strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In a previous opinion, the FEEDAP Panel concluded that Bacillus subtilis DSM 28343 is not an eye/skin irritant but should be considered as a potential respiratory sensitizer and that no conclusion could be drawn on its skin sensitisation potential. These conclusions apply also to the current application. Bacillus subtilis DSM 28343 at 2 × 108 CFU/kg complete feed has the potential to be efficacious in pigs for fattening.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, 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 Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
feedap [at]
EFSA Journal 2019;17(6):5725
Question Number
On request from
European Commission