Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain DP-Dzb105

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase, EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP-Dzb105 by Genencor International B.V. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism, but not from its DNA. It is intended to be used in two food manufacturing processes. Since residual amounts of food enzyme-total organic solids are removed in these two processes, dietary exposure was not calculated. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, the Panel considered toxicity tests unnecessary. A search for the homology of the amino acid sequence of the α-amylase to known allergens was made and matches with one respiratory allergen and one contact allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.