Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on a request from the Commission on the safety of the enzyme preparation Natugrain Wheat + for chickens for fattening

Natugrain® Wheat+ is an enzyme preparation containing endo-xylanase (E.C. 3.2.1.8) produced from a recombinant strain of Aspergillus niger available in liquid and powder forms, both containing 5600 xylanase units (TXU) g-1 of final product. The European Food Safety Authority (EFSA) received a request to assess the safety of the product Natugrain Wheat + for the consumer, the user, the environment and for the target animal category chickens for fattening. The production strain of Aspergillus niger is based on an industrial strain with an established safety record with additional recombinant and conventional engineering used to introduce multiple copies of a cDNA gene expressing endo-xylanase. The genetic strategy employed has inherent safety advantages that restrict DNA introduction to the necessary enzyme expression trait and minimise disruption of the production host genome. The endo-xylanase production strain is expected to be as safe as the established industrial strain on which it is based. A tolerance study was conducted on a total of 540 male chickens (six replicates of 15 broilers per treatment) for 35 days. The highest dose used was over 10 times the maximum recommended dose (800 TXU kg-1). From the experimental data provided by the petitioner, it can be concluded that chickens tolerate the consumption of ten times the maximum recommended dose of Natugrain Wheat + in feed. The safety for the consumers was studied in GLP compliant studies. Genotoxicity was assessed in two studies, and the oral toxicity in a 90 day oral toxicity study in rats. All the studies required have been conducted and showed no evidence of any effects that would be of concern regarding consumer safety. In the absence of data provided by the applicant, sensitisation due to this product, as with any other proteinacious substance, would be expected to occur via respiratory and possibly by dermal route. On the basis of potential inhalation of dusts and aerosols suitable protective measures are recommended which should ensure safety for those handling these products. The active ingredient is a natural substance and has been considered of no environmental concern. Thus, no further environmental assessment is required. The FEEDAP Panel has reviewed the data provided by the petitioner on the enzyme preparations and has no concerns about the safety of Natugrain Wheat + for chickens for fattening, for the consumer and for the environment. Provided appropriate protective measures are employed to avoid dermal and inhalation exposure there is also no concern for the safety of users.