Safety evaluation of an extension of use of the food enzyme endo-1,4-β-xylanase from the genetically modified Aspergillus oryzae strain NZYM-FA.

The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus oryzae strain NZYM-FA by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four food manufacturing processes. The dietary exposure to the food enzyme-Total Organic Solids (TOS) was calculated to be up to 0.031 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1101.3 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 35,526. Based on the revised exposure estimation, the newly derived margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.