Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of RONOZYME® NP (6-phytase) as a feed additive for pigs for fattening. The opinion should consider the modification of the terms of the authorisation proposed by the applicant.
RONOZYME® NP is authorised in the European Union as a feed additive for poultry, weaned piglets, pigs for fattening and sows. The authorisation of RONOZYME® NP for use in pigs for fattening is at a minimum dose of 1,500 FYT/kg feed (recommended range 1,500–3,000 FYT/kg feed). The applicant requested to modify the terms of the authorisation for this species/category of animals, by lowering the minimum recommended dose from 1,500 to 1,000 FYT/kg feed.
Safety aspects regarding the use of this additive in feed including the safety of the genetic modification of the production strain, the safety for the consumers, for the users and for the environment have been previously established. The Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected. Considering the safety for the user, the solid forms of the additive are regarded as dermal and eye irritants and all forms are assumed to be respiratory sensitisers. The reduction in the dose proposed would not change the previous conclusions regarding the safety for the consumer, user and environment.
In a previous opinion, the FEEDAP Panel evaluated also a tolerance trial carried out with weaned piglets. Considering the results of that trial and the well-established mode of action of phytases, the FEEDAP Panel concluded that RONOZYME® NP is safe for pigs for fattening at the dose of 3,000 FYT/kg feed. The proposed reduction in the minimum recommended dose would not affect that conclusion.
Three trials carried out with growing pigs were submitted in order to support the efficacy at the dose of 1,000 FYT/kg. In all the trials, faecal apparent digestibility of phosphorus was measured and retention was measured only in one trial. The demonstration of efficacy for a phytase requires three studies showing positive and significant effects on the retention of phosphorus. In the trials submitted, the phosphorus retention was studied only in one trial. The FEEDAP Panel considers that phosphorus retention is the key end-point for the efficacy assessment of phytases. In the absence of this parameter in two of the three efficacy studies assessed, the FEEDAP Panel cannot conclude on the efficacy of the product at the newly proposed minimum recommended dose.