Safety and efficacy of RONOZYME® HiPhos (6-phytase) as a feed additive for sows and fish

RONOZYME® HiPhos is a preparation of 6-phytase which is authorised in the EU for use in poultry and pigs. The applicant requested to lower the authorised dose in sows and for a new use of the product as a feed additive for fish. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the conclusions reached in previous opinions regarding the safety for the consumer, user and environment would not be affected by the current application. The Panel concluded that the additive is safe for the consumer and the environment; it is not an irritant to skin or eye but it should be treated as a skin sensitiser. The Panel considered that the current request would not affect previous conclusions in this regard. Considering the tolerance for target species, the FEEDAP Panel also evaluated in a previous opinion the safety for the target species, including a tolerance trial carried out with sows and concluded that the additive is safe at the dose of 4,000 FYT (phytase units)/kg. The proposed reduction in the minimum recommended dose would not affect that conclusion. On the basis of results obtained in a tolerance trial carried out with rainbow trout, the Panel concluded that the additive is safe for fish at the dose of 2,000 FYT/kg feed. The demonstration of the efficacy of phytases can be supported by three short-term studies provided that digestibility of phytate/total P and partial or total P retention is measured. In the case of sows and considering welfare aspects, study of the digestibility may suffice. Four short-term trials in sows showed that the supplementation of the diet with RONOZYME® HiPhos increases apparent faecal digestibility of phosphorus at 500 FYT/kg feed; the Panel concluded that the additive is efficacious at that dose. Five short-term trials were submitted to support the efficacy in fish; however, none of the studies provided evidence on the partial or total retention of phosphorus and consequently the Panel could not conclude on the efficacy of RONOZYME® HiPhos as a feed additive for fish.