Safety and efficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I-3698 and Companilactobacillus sp. CNCM I-3699 for all animal species (STI Biotechnologie).

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 and efficacy of a feed additive consisting of CNCM I-3698 and sp. CNCM I-3699 intended to be used as a technological additive (functional group: silage additives) in forage for all species. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 10 Viable Forming Units (VFU)/g additive. However, in that opinion the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address these gaps. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I-3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. The additive is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive. The Panel reiterated its previous conclusions that no conclusions can be drawn on the efficacy of the additive to improve the ensiling process of forage.