Safety and efficacy of the product Sorbiflore, a preparation of Lactobacillus rhamnosus and Lactobacillus farciminis, as feed additive for piglets

Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the safety and efficacy of the product Sorbiflore, a preparation of Lactobacillus rhamnosus and Lactobacillus farciminis, intented for use as a feed additive for weaned piglets of up to two months of age. The Panel on Additives and Products or substances used in Animal Feed (FEEDAP) notes that the bacterial counts are expressed as VFU, a measure based on the use of epifluorescent microscopy for the determination of the viable cells. Non-cultivable cells apparently contribute to the beneficial effects of the additive as indicated by the lack of cultivable lactobacilli in the feed used in the efficacy trials, while the VFU counts remained at the declared level. Since cultivable cells do not appear to be essential for the effectiveness of the product, the colony forming unit, the measure normally applied to microbial products, is inappropriate. The FEEDAP Panel considers that the additive should be treated as a product of a fermentation and the dose measured in g per kg of feedingstuffs. Three trials showing a statistically significant improvement in animal production parameters have been provided by the applicant at a dose of 5 g kg-1, demonstrating the potential efficacy of Sorbiflore in piglets at this dose level. No data supporting efficacy at a lower dose was provided. The molecular method used establishes the identity of the production organisms as strains of Lactobacillus rhamnosus and Lactobacillus farciminis, and consequently the QPS approach can be taken to establish safety. Both strains were sensitive to antibiotics of human clinical and veterinary importance (other than vancomycin for which there is intrinsic resistance). Consequently, the strains meet the qualifications required by the QPS approach and can be considered as safe for the target species, consumers and the wider environment. The additional experimental data provided in support of safety to target species, do not conflict in any way with the conclusion reached on safety using the QPS approach. No data on safety for the user was provided. However, as both strains have QPS status, the absence of systemic toxicity can be presumed. Sorbiflore, as an additive containing proteinacious material, is considered by the FEEDAP Panel as a potential respiratory sensitiser. The FEEDAP Panel recommends a number of major changes to the Register entry.