Safety and efficacy of RONOZYME® NP (6-phytase) as a feed additive for pigs for fattening

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Article
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2016;14(2):4392 [10 pp.].
doi
10.2903/j.efsa.2016.4392
Panel members at the time of adoption
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Enzymes including Paul Brantom and Noël Dierick for the preparatory work on this scientific output. 

Contact
feedap@efsa.europa.eu
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2014-00450
Adopted
26 January 2016
Published
10 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The additive RONOZYME® NP is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. This product 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. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded in previous assessments that the additive is safe for the target species, the consumers and the environment, and that 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 target animals, consumer, user and environment. Three trials carried out with growing pigs were submitted in order to support the efficacy at the new recommended dose. In all the trials faecal apparent digestibility of phosphorus was measured, 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; consequently the efficacy at the newly recommended dose was not demonstrated.

Summary

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.

Keywords
zootechnical additive, 6-phytase, efficacy, pigs for fattening
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Number of Pages
10