Based on the trials provided, it was concluded by FEEDAP 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.
Following a request from the European Commission, the 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 HiPhos M/L (6-phytase) as a feed additive for poultry and pigs.
The additive is an enzyme preparation containing 6-phytase produced by a genetically modified strain of Aspergillus oryzae.
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 1,000 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.
It is intended to be used as a zootechnical feed additive for poultry, weaned piglets and pigs for fattening in a dose range of 500 to 4,000 FYT/kg feed; and in sows in a dose range of 1,000 to 4,000 FYT/kg feed.
Since both the production organism and the level of recombinant DNA are below the limit of detection, the final product does not trigger any safety concern with regard to its genetic modification. Solid and liquid forms of the additive are considered equivalent in terms of safety and efficacy.
The fermentation product is non-genotoxic and there are no concerns for consumer safety. The fermentation product is not an irritant to skin or eye but in the absence of data should be treated as a skin sensitizer. 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 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.