Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B-50508, B.amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510) as a feed additive for pigs for fattening and minor porcine species.

Abstract

The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be established and evidence that they lack toxigenic potential and acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. The identity of the three active agents is established and the lack of toxigenic potential confirmed. The two B. amyloliquefaciens strains do not show resistance to relevant antibiotics, and are presumed safe for the target species, consumers and the environment. The B. subtilis strain showed a low level of resistance to streptomycin, for which acquired resistance genes were not identified. Therefore, it also complies with the QPS qualifications and is presumed safe for the target species, consumer and the environment. Since no other component give rise to concerns, Cinergy® Life B3 HiCon is also considered safe for the target species, consumers and the environment. In the absence of data, no conclusions can be made on the skin or eye irritancy or the potential for dermal sensitisation of the additive. Owing to the proteinaceous nature of the active agents, the additive is considered a potential respiratory sensitiser. However, the low dusting potential makes it unlikely that additive poses a risk for the respiratory system. Cinergy® Life B3 HiCon showed a potential to improve the feed to gain ratio in pigs for fattening given the additive at a minimum inclusion level of 1.5 × 108 CFU/kg complete feed. This conclusion is extrapolated to minor porcine species at the same application rate and for an equivalent growth phase.