Scientific Opinion on the safety and efficacy of Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as silage additives for all animal species

The two strains of Lactobacillus plantarum are each intended for use as technological additives to improve the ensiling process at a proposed dose of 1 x 10⁹ CFU/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the QPS approach to safety assessment. As the identity of the strains have been established and no antibiotic resistance detected, 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. Given the proteinaceous nature of the active agents and its high dusting potential, the additives should be considered to have the potential to be skin and respiratory sensitisers. Three studies with laboratory-scale silos are described, each lasting 90 days, involving both strains of L. plantarum used individually and made with tall fescue, red clover and lucerne with different water-soluble carbohydrate content, representing material easy to ensile, moderately difficult to ensile and difficult to ensile. In each case, replicate silos containing treated forage were compared to identical silos containing the same untreated forage. Both additives consistently showed the potential to improve the production of silage by increasing the preservation of dry matter and reducing the loss of protein.

© European Food Safety Authority, 2012

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety for the target animals, consumer, user and for the environment and on the efficacy of two additives based on different strains of Lactobacillus plantarum when used as technological additives intended to improve the ensiling process. The proposed dose for each strain is 1 x 10⁹ CFU/kg fresh material.

The bacterial species Lactobacillus plantarum is considered by EFSA to be suitable for the QPS approach to safety assessment. 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 both strains as Lactobacillus plantarum 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 agents are 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.

Both additives, each consisting of a single strain of L. plantarum, have the potential to improve the production of silage by increasing the preservation of dry matter and reducing the loss of protein. This was demonstrated in a range of easy, moderately difficult and difficult to ensile forage species.

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