Safety and efficacy of Avizyme 1505 (endo-1,4-beta-xylanase, alpha-amylase, subtilisin) as a feed additive for turkeys for fattening Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (Question No EFSA-Q-2007-112) Adopted on 17 June 2009

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to issue a scientific opinion on the safety and efficacy of Avizyme 1505 as a feed additive for turkeys for fattening. The additive Avizyme 1505 is a preparation of endo-1,4-beta- xylanase produced by the genetically modified micro-organism (GMM) Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by the GMM Bacillus amyloliquefaciens (ATCC 3978) and subtilisin (protease) produced by the GMM Bacillus subtilis (ATCC 2107). In a previous opinion, the safety of this product for the consumer, the user and the environment, as well as the safety aspects of the genetic modification were established. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the safety aspects, other than those related to the new target species, are covered in the previous opinion and would not be affected by this extension of use. Therefore, the present opinion focuses only on the safety and efficacy of this enzyme preparation for the target species turkeys for fattening. Avizyme 1505 is intended to be used in diets for turkeys for fattening at a dose of 200 mg kg(-1) complete feed (endo-1,4-beta-xylanase 300, subtilisin 4000, alpha-amylase 400 units of activity kg(-1) of complete feed). The tolerance trial provided showed that turkeys for fattening tolerated a 15-fold overdose of Avizyme 1505. Therefore, the FEEDAP Panel concludes that the use of the additive at the recommended conditions is safe for turkeys for fattening. A significant effect of Avizyme 1505 at a dose of 200 mg kg(-1) on the performance of turkeys for fattening was observed in three efficacy trials. Therefore, the FEEDAP Panel considers that there is evidence to support the efficacy of Avizyme 1505 at this dose in turkeys for fattening. The FEEDAP Panel notes that the method of analysis for the xylanase present in Avizyme 1505 is not considered by the CRL as fit for the purpose of official control methods.