Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzyme preparation Ronozyme P5000 (CT) and Ronozyme P20000 (L) (6-phytase) as feed additive for ducks according to Regulation (EC) No 1831/2003

The additive Ronozyme P5000 (CT) and Ronozyme P20000 (L) (also traded as (Bio-Feed Phytase CT 2X and Bio-Feed Phytase L 4X) is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. This product in both solid and liquid forms is permanently authorised for use in chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening and sows (E 1614 (i)) and the liquid form only is provisionally authorised for salmonids (EC 50(i)). The applicant is now seeking extension for use of this product for ducks. In the three studies provided, efficacy (improvement in P retention) has been demonstrated at the minimum recommended dose (250 FYT kg-1) in one trial, and in all three studies at 500 FYT kg-1. The FEEDAP Panel concludes that, given that ducks are considered minor species, and that the product is authorised for both chickens and turkeys for fattening at 250 FYT kg-1, sufficient evidence has been provided to support efficacy at the lowest recommended dose (250 FYT kg-1). No adverse effects were observed after the supplementation of the diets with ten times the maximum recommended dose of Ronozyme P. Therefore, the FEEDAP Panel considers the use of 1000 FYT kg-1 to be safe for ducks for fattening. The safety for consumer, user and environment has been previously assessed by SCAN and the FEEDAP Panel. The FEEDAP Panel is not aware of any new information that might raise any safety concerns.