Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified Bacillus subtilis strain DP-Ezd119

Abstract

The food enzyme endo-1,4-β-xylanase (4-β-D-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain DP-Ezd119 by Genencor International B.V. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.085 mg total organic solids/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the endo-1,4-β-xylanase to known allergens was made, and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.