Safety and efficacy of Danisco Xylanase G/L (endo-1,4-beta-xylanase) as a feed additive for chickens for fattening, laying hens and ducks for fattening

The European Food Safety Authority (EFSA) has been requested to deliver an opinion on the efficacy and safety of the product Danisco Xylanase for the target animal categories chickens for fattening, laying hens and ducks for fattening, and for the consumers, users and the environment. Danisco Xylanase is an enzyme feed additive with endo 1,4 beta-xylanase as its main activity produced by a genetically modified strain of Trichoderma reesei. The additive is marketed in two forms: Danisco Xylanase G (powder form) containing 40000 U g-1 and Danisco Xylanase L (liquid form) containing 40000 U g-1. The T. reesei sequence that encodes xylanase was modified to render the enzyme thermotolerant. The final enzyme preparation contains no cultivable producer organism. Fragments of recombinant DNA are present in the final concentrate in trace amounts. Since no sequences which cause concern are introduced, the genetic modification and the presence of the low concentration of recombinant DNA in the final product do not raise any particular safety concern. The efficacy of Danisco Xylanase G/L has been demonstrated in chickens for fattening at 625 U kg-1 and extrapolated to ducks for fattening at the same dose, and in laying hens at 2500 U kg-1. However, the data provided does not support the minimum recommended dose proposed by the applicant for chickens for fattening (250 U kg-1) and for laying hens (625 U kg-1). The tolerance tests provided have shown that Danisco Xylanase G/L is well tolerated at at least a ten-fold overdose in all the target species studied. It can therefore be concluded that the use of Danisco Xylanase at the maximum recommended dose (2500 U kg-1) is safe for chickens for fattening, laying hens and ducks for fattening. Danisco Xylanase G/L does not represent a genotoxic hazard and did not show a toxic response of consumer relevance in a sub-chronic toxicity study. It is concluded that there is no evidence for concern regarding consumer safety. The concerns for the safety of the users are limited to possible eye irritation and, in common with other proteinaceous substances, respiratory sensitisation. The use of Danisco Xylanase G/L is considered of no environmental concern.