Fecinor (R) is a preparation of a strain of Enterococcus faecium currently authorised for use in feeds for weaned piglets and chickens for fattening at the level of 1 x 10(9) colony-forming units (CFU)/kg. Application has now been made for Fecinor (R) soluble and Fecinor (R) soluble plus, two new formulations which differ by the replacement of one excipient. Fecinor (R) soluble and Fecinor (R) soluble plus are intended for use in water for drinking for weaned piglets and chickens for fattening at 5 x 10(8) CFU/L. The safety of Fecinor (R) for consumers, users and the environment has been assessed in previous opinions. The safety for chickens for fattening and weaned piglets and the efficacy of the product when used in feeds for these target species have also been established at that time. The data provided on the physical properties of the two new formulations do not introduce concerns for the user not already considered. The Panel on Additives and Products or Substances used in Animal Feed is unaware of any new data that would lead it to revise its conclusions. Therefore, the focus of the present opinion is on the consequences of the new use in water for drinking. The dose proposed for use in water for drinking would provide essentially the same exposure as the dose currently authorised for use in feedingstuffs. Consequently, the conclusions on the safety and efficacy of the additive when used in feedingstuffs also apply to use in water for drinking for weaned piglets and chickens for fattening.

Scientific Opinion on the safety and efficacy of Fecinor® soluble and Fecinor® soluble plus (Enterococcus faecium CECT 4515) as a feed additive for piglets and chickens for fattening / G. Aquilina, V. Bampidis, M. de Lourdes Bastos, G. Bories, A. Chesson, P.S. Cocconcelli, M.L. Fernández-Cruz, G. Flachowsky, J. Gropp, B. Kolar, M. Kouba, S. López Puente, M. López-Alonso, A. Mantovani, B. Mayo, F. Ramos, G. Rychen, M. Saarela, R.E. Villa, R.J. Wallace, P. Wester. - In: EFSA JOURNAL. - ISSN 1831-4732. - 13:9(2015), pp. 4232.1-4232.2. [10.2903/j.efsa.2015.4232]

Scientific Opinion on the safety and efficacy of Fecinor® soluble and Fecinor® soluble plus (Enterococcus faecium CECT 4515) as a feed additive for piglets and chickens for fattening

R.E. Villa;
2015

Abstract

Fecinor (R) is a preparation of a strain of Enterococcus faecium currently authorised for use in feeds for weaned piglets and chickens for fattening at the level of 1 x 10(9) colony-forming units (CFU)/kg. Application has now been made for Fecinor (R) soluble and Fecinor (R) soluble plus, two new formulations which differ by the replacement of one excipient. Fecinor (R) soluble and Fecinor (R) soluble plus are intended for use in water for drinking for weaned piglets and chickens for fattening at 5 x 10(8) CFU/L. The safety of Fecinor (R) for consumers, users and the environment has been assessed in previous opinions. The safety for chickens for fattening and weaned piglets and the efficacy of the product when used in feeds for these target species have also been established at that time. The data provided on the physical properties of the two new formulations do not introduce concerns for the user not already considered. The Panel on Additives and Products or Substances used in Animal Feed is unaware of any new data that would lead it to revise its conclusions. Therefore, the focus of the present opinion is on the consequences of the new use in water for drinking. The dose proposed for use in water for drinking would provide essentially the same exposure as the dose currently authorised for use in feedingstuffs. Consequently, the conclusions on the safety and efficacy of the additive when used in feedingstuffs also apply to use in water for drinking for weaned piglets and chickens for fattening.
zootechnical additive; Fecinor((R)) soluble; Enterococcus faecium; piglets; chickens for fattening; efficacy; safety
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
2015
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/559027
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