Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%–65% at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, no acquired antimicrobial resistance genes of concern were detected in any of the two active agents and no evidence of toxigenic potential was found in B. subtilis DSM 33862. Therefore, the FEEDAP Panel concluded that the use of the strains as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive contains microorganisms and therefore should be considered as a potential skin and respiratory sensitiser. The additive is not irritant to skin or eyes. Inhalation and dermal exposure is considered a risk. These conclusions would apply, in principle, to any preparations containing the active agents. The FEEDAP Panel concluded that the additive containing B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1 × 108 CFU/kg fresh material has the potential to extend the aerobic stability of silage prepared from fresh plant materials with a DM range of 32%–65%.