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 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 x 108 and a maximum content of 1 x 109 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 1 109 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.
The additive is not irritant to skin or eyes and is not a skin sensitiser. Biomin C3 should be treated as a potential respiratory sensitiser as a result of its proteinaceous nature. The three species are natural components of gut microbiota and their use as Biomin C3 in animal feeding would not be expected to pose any additional risk to the environment.
In four of the five studies carried out in chickens for fattening, Biomin C3 showed the potential to improve the performance of birds at the minimum dose of 1 x 108 CFU/kg of complete feedingstuffs. This was supported by a meta-analysis which showed significant improvements in final weight across the five trials. The three strains are compatible with robenidine hydrochloride, maduramycin ammonium and diclazuril but not with monensin sodium and lasalocid A sodium.
