Safety and efficacy of a feed additive consisting of 3-phytase produced by (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 3-phytase produced by (CECT 13171) (FSF10000/FLF1000) as a zootechnical additive for poultry species, pigs for fattening and minor porcine species. The production strain (CECT 13171) is genetically modified and was developed from a strain that had been previously assessed by the FEEDAP Panel. The genetic modifications present in CECT 13171 do not raise safety concerns and no recombinant DNA was detected in the final formulations of the additive (FSF10000/FLF1000). However, the Panel could not conclude on the identity of the production strain and uncertainty remained on the possible presence of viable cells of the production strain in the final formulations. Owing to these uncertainties, the FEEDAP Panel could not conclude on the safety of the additive regarding the production strain. The additive in either form is not irritant to eyes and skin, the liquid formulation is not a dermal sensitiser but the solid formulation is, and the two formulations should be considered potential respiratory sensitisers. The FEEDAP Panel concluded that the 3-phytase present in the additive is safe for the target species at a level of 1,000 FTU/kg feed and that would not raise safety concerns for the environment. However, considering the uncertainties on the identification of the production strain and the possible presence of viable cells in the final formulations, the Panel could not conclude on the safety of the additive for the target species, consumer, users, and the environment. The FEEDAP Panel concluded that the additive is efficacious at 500 FTU/kg feed in poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species and at 1,000 FTU/kg feed in laying hens.