Scientific Opinion on the safety and efficacy of Biomin C3 (Enterococcus faecium, Bifidobacterium animalis and Lactobacillus salivarius) for chickens for fattening

2012 EFSA Journal  
The full opinion will be published in accordance with Article 8(6) of Regulation (EC) No 1831/2003 once the decision on confidentiality, in line with Article 18(2) of the Regulation, will be received from the European Commission. SUMMARY Following a request from European Commission, the Panel on Additives and Product or Substances used in Animal Feed (FEEDAP) was asked to deliver an opinion on the safety and efficacy of Biomin C3 when used in diets for chickens for fattening. The additive
more » ... The additive Biomin C3 is a preparation of strains of Enterococcus faecium, Bifidobacterium animalis subsp. animalis and Lactobacillus salivarius subsp. salivarius. The product is intended to improve the performance of chickens for fattening when added in their diets at a minimum content of 1 10 8 and a maximum content of 1 x 10 9 CFU/kg of complete feedingstuffs. It has not been previously authorised in the European Union. The identity of the strains B. animalis subsp. animalis, L. salivarius subsp. salivarius and E. faecium has been established and no antibiotic resistance detected. On the basis of a tolerance study in which chickens for fattening showed no effects in the presence of 100 times the maximum recommended dose, the additive is considered safe for the target species at doses up to 1 10 9 CFU/kg of complete feedingstuffs Two of the three strains, B. animalis subsp. animalis and L. salivarius subsp. salivarius, satisfy the requirements for the qualified presumption of safety approach to safety assessment, and thus are presumed safe for consumers. The third strain, E. faecium, was shown not to contain marker genes typical of hospital-associated isolates responsible for clinical infections and does not raise additional safety concerns. Consequently, the FEEDAP Panel considers the use of the Biomin C3 safe for consumers.
doi:10.2903/j.efsa.2012.2965 fatcat:67g6yz52cvhuteamo7tfrjaszu