RONOZYME® HiPhos (DSM) is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae which is authorized in the EU for use in poultry and pigs. The applicant requested a new use of the product as a feed additive for fish. The European Food Safety Authority Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered 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. 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. 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.
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