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

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.