Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on a request from the Commission on the safety of “Fecinor” for chickens for fattening, for use as feed additive in accordance with Council Directive 70/524/EEC

Fecinor® is a microbial feed additive based on a single strain of Enterococcus faecium CECT 4515. This product has provisionally been authorized at Community level for piglets and calves. The notifier is now seeking authorization for an extension of use for chickens for fattening when used as a feed additive in feedingstuff at the recommended dose (109 CFU kg-1). European Food Safety Authority has been requested by the European Commission to give an opinion on the safety of Fecinor® for the consumer, for chickens for fattening, the user of the product and the environment. A 30 day tolerance study including a Fecinor treated group given the product at ten-times the recommended dose (1010 CFU kg-1 feed) was reported. None of the tested parameters were affected by high inclusion level of E. faecium CECT 4515 in the feed. Microbiological analysis of the gut flora of birds given Fecinor at the recommended dose did not show any numerical differences which might indicate a source of concern. It is concluded that this microbial additive was well tolerated by chickens for fattening. In the course of the previous assessment the safety for users of the additive and for consumers of products derived from animals fed the additive was found not to be of concern. It was also concluded that no environmental risk assessment was necessary. While generally agreeing with the conclusions reached, FEEDAP Panel noted a need to revise three elements of the assessment taking account of more recent scientific developments. These were the molecular identification of the strain, data demonstrating the absence of genes encoding for virulence factors and more recent data on antibiotic resistance. A chromosomal DNA sequence has been defined and shown suitable for strain identification and detecting CECT 4515 in the presence of other E. faecium strains. MIC values (minimum inhibitory concentrations) for all antibiotics tested were below the SCAN breakpoints indicating the absence of resistance determinants against antibiotics of human and veterinary importance. No information was submitted on the resistance to streptogramins. The E. faecium strain CECT 4515 was shown free from known virulence determinants. Thus, FEEDAP Panel considers Fecinor® (Enterococcus faecium CECT 4515) to be safe for chickens for fattening, for users of the product and for the wider environment. Safety for consumers would otherwise be considered demonstrated but the lack of data on MICs for streptogramins did not allow to conclude on that aspect