The additive Natuphos is a preparation of 3-phytase produced by a genetically modified strain of Aspergillus niger. The product is currently authorised in the EU as a zootechnical feed additive for chickens and turkeys for fattening, laying hens, ducks, piglets, pigs for fattening and sows. The applicant is now asking for an extension of use to minor avian species and ornamental birds. The safety of phytase from Natuphos has been previously established in physiologically similar major poultry species with a margin of safety of more than ten times the respective maximum recommended doses. Therefore, considering the established mode of action of phytase and the wide margin of safety shown in the species evaluated, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that Natuphos is safe for minor avian species and ornamental birds at the maximum recommended dose (500 FTU/kg). Similarly, the efficacy of Natuphos in physiologically related major species has already been established. The mode of action of phytase can be reasonably assumed to produce the same effect in the major and minor avian species. Taking this into account and the experimental evidence provided in a balance study with geese, which showed an effect at 150 FTU/kg, the FEEDAP Panel concludes that the efficacy of Natuphos in minor avian species and ornamental birds can be assumed at the dose of 250 FTU/kg complete feed.

Scientific Opinion on the safety and efficacy of Natuphos® (3-phytase) for minor avian species (quails, pheasants, partridges, guinea fowl, geese, pigeons, ostriches, peacocks, flamingos) and ornamental birds / E. Panel on Additives, P. or Substances used in Animal Feed, G. Aquilina, G. Bories, P. Brantom, F. Caloni, A. Chesson, P.S. Cocconcelli, J. de Knecht, N.A. Dierick, M.A. Gralak, J. Gropp, I. Halle, N.G. Ilbäck, R. Kroker, L. Leng, S. Lindgren, A.K. Lundebye Haldorsen, A. Mantovani, M. Mézes, D. Renshaw, M. Saarela. - In: EFSA JOURNAL. - ISSN 1831-4732. - 8:1, art. 1427(2010), pp. 1-9. [10.2903/j.efsa.2010.1427]

Scientific Opinion on the safety and efficacy of Natuphos® (3-phytase) for minor avian species (quails, pheasants, partridges, guinea fowl, geese, pigeons, ostriches, peacocks, flamingos) and ornamental birds

F. Caloni;
2010

Abstract

The additive Natuphos is a preparation of 3-phytase produced by a genetically modified strain of Aspergillus niger. The product is currently authorised in the EU as a zootechnical feed additive for chickens and turkeys for fattening, laying hens, ducks, piglets, pigs for fattening and sows. The applicant is now asking for an extension of use to minor avian species and ornamental birds. The safety of phytase from Natuphos has been previously established in physiologically similar major poultry species with a margin of safety of more than ten times the respective maximum recommended doses. Therefore, considering the established mode of action of phytase and the wide margin of safety shown in the species evaluated, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that Natuphos is safe for minor avian species and ornamental birds at the maximum recommended dose (500 FTU/kg). Similarly, the efficacy of Natuphos in physiologically related major species has already been established. The mode of action of phytase can be reasonably assumed to produce the same effect in the major and minor avian species. Taking this into account and the experimental evidence provided in a balance study with geese, which showed an effect at 150 FTU/kg, the FEEDAP Panel concludes that the efficacy of Natuphos in minor avian species and ornamental birds can be assumed at the dose of 250 FTU/kg complete feed.
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
2010
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/149996
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