Safety and efficacy of Avizyme 1505 (endo-1,4-β-xylanase, α-amylase, subtilisin) as a feed additive for chickens and ducks for fattening

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and the Panel on Genetically Modified Organisms (GMO) were asked to issue a scientific opinion on the safety and efficacy of Avizyme 1505 as a feed additive for chickens and ducks for fattening. Avizyme 1505 is an enzyme preparation with three declared activities, i.e. endo-1,4-beta-xylanase, alpha-amylase and alkaline protease (subtilisin). These three enzymes are produced by three genetically modified micro-organisms: endo-1,4-beta-xylanase by Trichoderma reesei, alpha-amylase by Bacillus amyloliquefaciens and alkaline protease by Bacillus subtilis. In the T. reesei strain, no DNA sequences causing concern have been introduced. In the B. amyloliquefaciens strain, resistance genes for neomycin and bleomycin are present in a plasmid which has been made non-mobile. In the B. subtilis strain, a chloramphenicol resistance gene has been inserted into the chromosome. The production micro-organisms are removed after fermentation and are not detected in the final enzyme preparations. The recombinant DNA is below the limit of detection in the final enzyme preparations. With respect to the genetic modification, there are no environmental safety concerns in relation to the final product. Avizyme 1505 is intended to be used in diets for chickens and ducks for fattening at a dose range of 50-200 mg kg-1 complete feed. Based on the tolerance study provided, it is concluded that Avizyme 1505 is safe for chickens and ducks for fattening at the recommended dose range. The studies conducted on the individual components of Avizyme 1505 are considered an adequate investigation of the safety of this product for the consumer. On the basis of the results of both genotoxicity tests and 90-day studies, it is not expected that there would be any risk to the consumer from the use of Avizyme 1505 in animal feed. There are no concerns for the safety of users provided that the MSDS recommendations are followed and appropriate measures are taken to avoid dermal and inhalation exposure. The active components of Avizyme 1505 are proteins 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 efficacy of Avizyme 1505 has been demonstrated in chickens for fattening at the dose of 125 mg kg-1 complete feed (equivalent to 187.5 U beta-xylanase kg-1, 250 U alpha-amylase kg-1 and 2500 U protease kg-1). The efficacy of Avizyme 1505 in ducks for fattening as minor species has been demonstrated at a dose of 50 mg kg-1. The FEEDAP Panel notes that the methods of analysis for the enzymes present in Avizyme 1505 are not considered by the CRL as fit for the purpose of official control methods.