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 the product Lactiferm for chickens for fattening for use as a feed additive

The active ingredient of the microbial feed additive Lactiferm are viable cells of Enterococcus faecium NCIMB 11181 (M74). This product has been provisionally authorised as a feed additive for use in calves and piglets. The European Food Safety Authority has been requested by European Commission to assess the safety of micro-organism product "Lactiferm", for the chickens for fattening, the human consumer, the user of the product and the environment, when this product is used as feed additive at the dose 2.5 x 108 – 15 x 109 cfu kg-1 of complete feedingstuff. The five-weeks tolerance study was performed with 253 broiler chickens fed with ten-times the maximum recommended dose of the additive (150 x 109 cfu kg-1 feed). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concludes from the data provided that the product is well tolerated by chickens for fattening. In one experiment the effect of the product on gut microbiota was analysed, enumerating enterococci and E. coli of birds fed with E. faecium NCIMB 11181 at levels lower than the maximum recommended dose. The inadequate design and the low number of bacterial species investigated did not allow conclusions to be drawn. However, the FEEDAP Panel recognises that that E. faecium is a normal constituent of the gut microbiota of the production species. The MIC (Minimum Inhibitory Concentration) values of Enterococcus faecium NCIMB 11181 for clinically relevant antibiotics were below or at the same level as the SCAN breakpoints indicating the absence of resistance determinants against antibiotics of human and veterinary importance. The E. faecium strain NCIMB 11181 was shown to be free from known virulence determinants. The FEEDAP Panel concludes that the product is well-tolerated by the target species, and is safe for consumers and users. The FEEDAP Panel also agrees with the previous SCAN opinion that the environmental risk assessment is not necessary in this case.