Scientific Opinion on the safety and efficacy of Axtra (R) PHY 15 000 L (6-phytase) as a feed additive for poultry and porcine species

The additive Axtra (R) PHY 15 000 L is a liquid preparation of 6-phytase produced by a genetically modified strain of Trichoderma reesei. This product is intended for use as a zootechnical additive, functional group of digestibility enhancers, in feed for poultry and porcine species. The Panel on Additives and Products or Substances used in Animal Feed concluded that Axtra (R) PHY 15 000 L does not give rise to safety concerns with regard to the genetic modification of the production strain. Neither the production strain nor its recombinant DNA was detected in the additive. The Panel concluded that the additive is safe for chickens and turkeys for fattening, laying hens, weaned piglets and sows at the maximum recommended dose (2 000 phytase units (FTU)/kg feed) and considered that this conclusion can be extended to other poultry categories/species and porcine categories/species at the same maximum dose. The Panel concluded that the use of Axtra (R) PHY 15 000 L as a feed additive gives rise to no concerns for consumers. This additive is not considered a dermal sensitiser but should be considered an irritant. Owing to the proteinaceous nature of its active substance, the additive is considered a potential respiratory sensitiser. The Panel concluded that the use of Axtra (R) PHY 15 000 L as a feed additive poses no risks to the environment. The efficacy studies submitted showed that the phytase present in Axtra (R) PHY 15 000 L is efficacious in chickens and turkeys for fattening, laying hens, piglets, pigs for fattening and sows at the dose of 250 FTU/kg feed. This conclusion can be extended to chickens reared for laying, turkeys reared for breeding, and to turkeys for breeding purposes, and extrapolated to minor poultry species for fattening and minor porcine species, at the same dose.