Efficacy of Bacillus subtilis DSM 28343 as a zootechnical additive (gut flora stabiliser) for calves for rearing

zootechnical additive, gutflora stabilisers,Bacillus subtilis DSM 28343, efficacy
First published in the EFSA Journal
23 juillet 2019
4 juillet 2019
Scientific Opinion


Bacillus subtilis DSM 28343 is a preparation of viable spores of a single strain of Bsubtilisintended to be used as a zootechnical additive (functional group: gut flora stabilizer) in feed for calves for rearing to increase growth. In 2018, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Bacillus subtilis DSM 28343 as a feed additive for calves for rearing. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. In that opinion, the FEEDAP Panel was unable to conclude on the efficacy of the additive, under the condition of use as proposed by the applicant, due to insufficient data provided. In the current opinion, additional data to demonstrate the efficacy of Bacillus subtilis DSM 28343 were assessed. Based on one study of this application and two studies submitted in the previous application, the Panel concluded that Bacillus subtilis DSM 28343 has the potential to be efficacious as gut flora stabiliser used in feed for calves for rearing at the proposed use level.

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 Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
feedap [at] efsa.europa.eu
EFSA Journal 2019;17(7):5793
Question Number
On request from
European Commission