Scientific Opinion on the safety and efficacy of Lactobacillus plantarum (DSM 8862 and DSM 8866) (BIO‐SIL®) as a silage additive for pigs, bovines, sheep, goats and horses

Abstract

Abstract Lactobacillus plantarum is a technological additive intended to improve the ensiling process at a proposed dose of 3 × 108 CFU/Kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the Qualified Presumption of Safety approach. Therefore, the strains do not require any specific demonstration of safety other than confirming the absence of any determinants of resistance to antibiotics of human and veterinary clinical significance. As the identity of the strains has been clearly established and as no antibiotic resistance was detected in either of them, the use of the strains in the production of silage is considered safe for livestock species, consumers of products from animals fed the treated silage and for the environment. Once an active agent has been authorised as a silage additive, different formulations can be placed on the market with reference to that authorisation. However, for assessing the safety for the user of the additive, the active agent is the principal concern provided that other components do not introduce concerns. For this specific product, all excipients used are food grade, and their use in the additive would not introduce an additional risk to their conventional use. Given the lack of information, its proteinaceous nature and the high dusting potential, the active agents have the potential to be skin and respiratory sensitisers. The additive containing equal amounts of the two strains of Lactobacillus plantarum has the potential to improve the production of silage from all forages by reducing the pH and increasing the preservation of dry matter.

Keywords

• Technological additive
• silage additive
• Lactobacillus plantarum
• QPS
• safety
• efficacy