Scientific Opinion on the safety and efficacy of Oralin? (Enterococcus faecium) as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening and dogs

摘要

Oralin? is a preparation containing viable cells of Enterococcus faecium. It is currently authorised for use in calves, piglets, chickens and turkeys for fattening and dogs. The applicant is now requesting the re‐evaluation of the additive when used in feeds for calves for rearing, piglets, chickens and turkeys for fattening, and dogs at different doses. Oralin? is safe for calves, piglets, cats, and chickens and turkeys for fattening. Since the additive has shown a wide and comparable margin of safety in three major species, it is considered safe for dogs. The Oralin? strain does not contain marker genes typical of hospital‐associated isolates responsible for clinical infections and is not resistant to clinically relevant antibiotics. Since no other sources of concern have been identified in the additive, the use of the Oralin? is considered safe for consumers. Oralin? is not irritant to skin or eyes or a skin sensitiser, but in its solid forms should be considered to have the potential to be a respiratory sensitiser. E. faecium is a natural component of gut microbiota and its use as Oralin? in animal feeding would not be expected to pose any risk to the environment. The addition of Oralin? to feed has the potential to improve the performance of calves for rearing, chickens for fattening, turkeys for fattening, suckling and weaned piglets. However, the minimum dose found efficacious was higher than that proposed by the applicant for turkeys for fattening, and that for suckling piglets should be expressed in CFU/piglet/day. Three studies showed a limited but significant improvement of faecal scores in dogs treated with Oralin?. However, such limited improvement in faecal scores is questionable in terms of biological relevance. The active agent of Oralin? is compatible with lasalocid sodium, semduramicin sodium, diclazuril, robenidine hydrochloride, maduramicin ammonium, decoquinate and halofuginone.