Safety and efficacy of the product Ronozyme® NP (6-phytase) for use as feed additive for poultry, weaned piglets and pigs for fattening

Following a request from European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of the product Ronozyme® NP when used as a feed additive for poultry, weaned piglets and pigs for fattening. The additive Ronozyme® NP is a preparation of 6-phytase produced by the genetically modified micro-organism Aspergillus oryzae. Ronozyme® NP is intended to be used in feed for laying hens at a dose range of 600–1500 FYT kg-1, and for the other poultry species/categories, weaned piglets and pigs for fattening at a dose range of 1500–3000 FYT kg-1. In a previous opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the safety and efficacy of this product when used as a feed additive for chickens for fattening, and the safety for the consumer, user and the environment, as well as the safety aspects of the genetic modification, were established. The FEEDAP Panel considers that the safety aspects other than those related to the new target species are covered in the previous opinion and would not be affected by this extension of use. Therefore, the present opinion focuses on the efficacy in chickens for fattening and the safety for the user of the new formulation (Ronozyme® NP (M)), and on the safety and efficacy of the product for the new target species. The FEEDAP Panel concludes that Ronozyme® NP improves the utilisation of phytate-bound P in chickens and turkeys for fattening, piglets and pigs for fattening at 1500 FYT kg-1 feed, and in laying hens at 600 FYT kg-1 feed. The efficacy can be extrapolated to all poultry species. The minimum recommended dose for all poultry should be 1500 FYT kg-1 feed and 600 FYT kg-1 feed for fattening and laying poultry, respectively. The use of Ronozyme® NP allows the use of diets with a lower level of inorganic P, which may in turn reduce the excretion of P. Based on the tolerance studies performed and considering the well stablished mode of action of phytases, it is concluded that Ronozyme® NP is safe at the maximum recommended dose for chickens and turkeys for fattening, laying hens, piglets and pigs for fattening. The FEEDAP Panel considers that these results can be extrapolated to all poultry, considering that the maximum dose does not exceed 3000 FYT kg-1 feed for growing birds and 1500 FYT kg-1 feed for laying birds. All solid and liquid forms of the product are considered to be essentially equivalent in terms of safety for the target species and efficacy when used at the same dose. Ronozyme® NP (M) is assumed to be a dermal and eye irritant as well as a respiratory sensitiser, thus appropriate user safety precautions are required. No risk for the environment is expected from the use of this product as a feed additive under the conditions specified.