Safety and efficacy of RONOZYME® HiPhos (6-phytase) as a feed additive for sows and fish

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Article
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
FSA Journal 2016; 14(2):4393 [10 pp.].
doi
10.2903/j.efsa.2016.4393
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, J€urgen Gropp, Boris Kolar, Maryline Kouba, Secundino Lopez Puente, Marta Lopez-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-2014-00289
Adopted
26 January 2016
Approved
24 February 2016
Published in the EFSA Journal
16 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract
RONOZYME® HiPhos is a preparation of 6-phytase which is authorised in the EU for use in poultry and pigs. The applicant requested to lower the authorised dose in sows and for a new use of the product as a feed additive for fish. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the conclusions reached in previous opinions regarding the safety for the consumer, user and environment would not be affected by the current application. The Panel concluded 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. The Panel considered that the current request would not affect previous conclusions in this regard. Considering the tolerance for target species, the FEEDAP Panel also evaluated in a previous opinion the safety for the target species, including a tolerance trial carried out with sows and concluded that the additive is safe at the dose of 4,000 FYT (phytase units)/kg. The proposed reduction in the minimum recommended dose would not affect that conclusion. 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. In the case of sows and considering welfare aspects, study of the digestibility may suffice. Four short-term trials in sows showed that the supplementation of the diet with RONOZYME® HiPhos increases apparent faecal digestibility of phosphorus at 500 FYT/kg feed; the Panel concluded that the additive is efficacious at that dose. 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.
Keywords
zootechnical additive, 6-phytase, safety efficacy, sows, fish
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Number of Pages
10