Scientific Opinion on the safety and efficacy of Ronozyme® HiPhos M/L (6-phytase) as a feed additive for poultry and pigs

Ronozyme® HiPhos, phytase, safety, efficacy, genetically modified microorganisms, poultry, pigs
First published in the EFSA Journal
17 January 2012
Adopted
14 December 2011
Last Updated
4 June 2012. This version replaces the previous one/s.
Type
Scientific Opinion

Abstract

The additive Ronozyme® HiPhos M/L is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. It is intended to be used as a zootechnical feed additive for poultry and pigs. The final enzyme preparation contains no cultivable production organisms or recombinant DNA, given the limits of detection. Based on the trials provided, it was concluded that Ronozyme® HiPhos is safe for chickens for fattening, turkeys for fattening, laying hens, weaned piglets and sows when used at the maximum recommended dose. This conclusion can be extended to all poultry species and pigs for fattening. The fermentation product is non-genotoxic and there are no concerns for consumer safety. It is not an irritant to skin or eye but in the absence of data should be treated as a skin sensitiser. Since the additive is practically dust free, respiratory exposure from the solid preparation is unlikely. The liquid formulation is only used in contained environments. The active substance of Ronozyme® HiPhos M/L is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risks for the environment are expected and no further environmental risk assessment is required. The additive has the potential to improve phosphorus utilization in all poultry at the minimum dose of 500 FYT/kg complete feed, as demonstrated in short-term trials with chickens and turkeys for fattening, and laying hens. Improved phosphorus utilization was also seen in weaned piglets and pigs for fattening at the minimum dose of 500 FYT/kg complete feed, and at the minimum dose of 1000 FYT/kg complete feed for sows. The use of the additive allows the use of diets with a lower level of inorganic phosphorus, which may in turn reduce the excretion of phosphorus.

Panel members at the time of adoption

Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Reinhard Kroker, Lubomir Leng, Secundino López Puente, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf.
Panel on Additives and Products or Substances used in Animal Feed
Panel on Genetically Modified Organisms
Contact
FEEDAP [at] efsa.europa.eu
GMO [at] efsa.europa.eu
doi
10.2903/j.efsa.2012.2527
EFSA Journal 2012;10(1):2527
On request from
European Commission