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

Abstract

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety andefficacy of a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I-3698 and Companilactobacillus 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× 108 Viable Forming Units (VFU)/g additive. However, in that opinion the Panelcould 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 Panelconcluded that the data available do not allow to fully characterise the additive. The Panelwas 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 Panelwas 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 Panelcould not conclude on the eye irritancy or skin sensitisation potential of the additive. The Panelreiterated its previous conclusions that no conclusions can be drawn on the efficacy of the additive to improve the ensiling process of forage.