Abstract
Provita LE is a preparation of Enterococcus faecium and Lactobacillus rhamnosus authorised for use in piglets and calves. EFSA was requested to re-evaluate Provita LE when used with calves for rearing up to four months in the range of 1 × 10(9) to 5 × 10(9) CFU/kg feedingstuffs. The identity of both strains has been established and no resistance to clinically relevant antibiotic detected. L. rhamnosus satisfies the requirements for the qualified presumption of safety approach to safety assessment, and is presumed safe for the target animals, consumers and the environment. Safety of the complete additive for the target species at the proposed dose range was demonstrated in a tolerance study in which no adverse effects were seen when a 100-fold overdose of the additive was administered to calves. The enterococcal strain was shown not to contain marker genes typical of hospital-associated isolates responsible for clinical infections and does not raise additional safety concerns. Since no other sources of concern were identified, Provita LE is considered safe for consumers. No data on skin/respiratory sensitisation were provided. In the absence of data, the potential of the additive to be a skin/respiratory sensitiser cannot be excluded. The dustiness of the additive tested indicated a potential for users to be exposed via inhalation. Given the proteinaceous nature of the active agents, the additive should be considered to have the potential to be a skin/respiratory sensitiser and treated accordingly. E. faecium is a natural component of the gut microbiota and its use as Provita LE in animal feeding is not expected to pose any risk to the environment. The data from three trials presented showed that Provita LE has the potential to improve the zootechnical performance of calves for rearing at 1 × 10(9) CFU/kg milk replacer or complementary feed.