Fecinor® is a feed additive based on lyophilised cells of a single strain of Enterococcus faecium. The applicant is seeking re-authorisation of Fecinor® as a zootechnical additive in feeds for weaned piglets. The additive is produced in two formulations, Fecinor®, containing 1 x 109 colony-forming units (CFU/)g additive, and a more concentrated form, Fecinor® plus, containing 1 x 1010 CFU/g additive. The E. faecium strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and does not harbour acquired genes coding for antibiotic resistance. On the basis of the known characteristics of the organism and formulation of the product, Fecinor® is considered safe for weaned piglets at the recommended dose. Since neither the active agent nor the other components of the additive give rise to concerns, the FEEDAP Panel considers the use of the additive Fecinor® safe for consumers. Fecinor® has not been tested for user safety. Its active agent is not irritant to skin or eyes and is not a skin sensitiser. However, given the proteinaceous nature of the active agent, both forms of the additive should be considered to have the potential to be respiratory sensitisers. The physical characteristics of the two forms of the additive are such that users could be exposed to a respirable dust. E. faecium is a natural component of gut microbiota and its use as Fecinor® in animal feeding would not be expected to pose any additional risk to the environment. Insufficient evidence of an effect of Fecinor® on the performance of weaned piglets has been provided to allow the Panel to reach conclusions on the efficacy of the additive. The Panel considers that these conclusions apply to both formulations when used to deliver the same dose of the active agent.
