Scientific Opinion on the safety and efficacy of Ronozyme® NP (6-phytase) as a feed additive for sows

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of the additive Ronozyme® NP for sows. Ronozyme® NP is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. It is intended to be used in feed for sows at a dose range of 1500–3000 FYT/kg. The safety for the consumer, user and the environment, including the safety aspects of the genetic modification, were established in previous opinions. Therefore, the present opinion considers only the safety and efficacy of the product for sows. The solid and liquid forms of the product are considered to be essentially equivalent in terms of efficacy and safety at the same dose. From the results obtained in the tolerance trial, in which no adverse effects were found when sows were fed at ten times the maximum recommended dose of the additive, the FEEDAP Panel concludes that Ronozyme® NP is safe for sows at the recommended dose levels. The applicant provided three digestibility trials which showed that Ronozyme® NP improves P digestibility in sows when supplemented at the minimum recommended dose of 1500 FYT/kg feed. The use of Ronozyme® NP allows the use of diets with a lower level of inorganic P, which may in turn reduce the release of P into the environment.