Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

zootechnical additive, gutflora stabiliser, Probion Forte®,Bacillus subtilis,Bacilluscoagulans, safety, efficacy
First published in the EFSA Journal
12 marzo 2019
Adopted
26 febbraio 2019
Type
Scientific Opinion

Abstract

In 2017, the EFSA Panel on Additive and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Probion Forte®(Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) as a feed additive for chickens for fattening. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment provided that the identity of the strains is established and the lack of toxigenic potential and acquired antimicrobial resistance for antibiotics of human and veterinary importance are demonstrated. In that opinion, the FEEDAP Panel was unable to conclude on the safety and efficacy of the additive due to inadequacy of the data available. In the current dossier, the applicant submitted a new cytotoxicity study in support to the safety of the active agents, a new skin sensitisation study and three new efficacy trials performed with chickens for fattening. The FEEDAP Panel identified a limitation in the experimental design of the cytotoxicity study which did not allow excluding the possible toxigenic potential of the strains. One of the three efficacy trials was not considered due to the high mortality (including culling) reported in the control group. On the basis of the data available, the FEEDAP Panel could not conclude on the safety of Probion Forte® for the target species and for the consumer. Probion Forte® was not considered a skin sensitiser. The FEEDAP Panel could not conclude on the efficacy of Probion Forte® for chickens 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 Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5644
EFSA Journal 2019;17(3):5644
Question Number
On request from
European Commission