Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Bonvital, a preparation of Enterococcus faecium, as a feed additive for sows in accordance with Regulation (EC) No 1831/2003

The microbial feed additive Bonvital is a preparation of Enterococcus faecium (DSM 7134). This product is authorised for use in piglets and pigs for fattening, and provisionally authorised for sows from 25 days before farrowing and during lactation and chickens for fattening. The applicant is now seeking a ten year authorisation for use of this product as a zootechnical additive (functional group: gut flora stabilisers) in sows during the full reproductive cycle at a dose range of 0.5 x 109 - 1 x 109 CFU kg-1 of complete feedingstuff. The safety of this product for the consumer, user and the environment has been previously assessed by SCAN with a favourable outcome. Therefore, the current assessment focuses only on the efficacy and safety of this product for the target species for which authorisation is sought. Evidence was provided that Bonvital when given at the minimum recommended dose (0.5 x 109 CFU kg-1 complete feed) to sows has a positive effect on the survival and growth of piglets. In three studies the weight gain of piglets was improved, and in two other studies a positive effect on the number of piglets born alive or weaned was observed. However, there is no evidence to suggest that these benefits require the use of the product for the full reproductive cycle of sows. In three of the studies, the positive effects observed were seen when Bonvital was introduced into the sow diet from day 90 of pregnancy to the end of lactation. Bonvital at ten times the maximum recommended dose was well tolerated by sows and their piglets. Consequently, the FEEDAP Panel considers that use of the product at the maximum recommended dose is safe for sows (and their piglets).