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Scientific Opinion on the safety and efficacy of Cylactin® ( Enterococcus faecium NCIMB 10415) as a feed additive for pigs for fattening, piglets and sows

Cylactin® is the trade name for a preparation of Enterococcus faecium. It is currently authorised for use several animal species. The product is intended for use with sows at a minimum dose of 7 × 108 and a maximum dose of 1.25 × 109 colony-forming unit (CFU)/kg feed and with weaned and suckling piglets and pigs for fattening at a minimum dose of 3.5 × 108 and a maximum dose of 1.0 × 109 CFU/kg feed. The characterisation of the additive was fully described and its safety for consumers, users and the environment was assessed in previous opinions and it was found not to give rise to any concerns. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is unaware of any new data which would lead it to revise its conclusions. Therefore, the focus of the present opinion is on the safety and efficacy of Cylactin® when used with the target animals. Results on the safety and efficacy apply to all forms of the additive when delivering the same dose. When used at 100 times the maximum recommended dose, Cylactin® did not show any adverse effect on the performance or mortality of piglets and sows. Therefore, the additive is considered safe for suckling and weaned piglets, pigs for fattening and sows at the maximum proposed dose. Cylactin® has the potential to be efficacious in sows and suckling piglets when supplemented to both sows and suckling piglets at 7.0 × 108 and 1 × 109 CFU/kg feed, respectively. Cylactin® also has the potential to be efficacious in weaned piglets when supplemented at the minimum recommended dose of 3.5 × 108 CFU/kg feed. Insufficient data were provided to support the efficacy of Cylactin® when used in pigs for fattening.

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