Safety evaluation of the food enzyme glucan 1,4‐α‐maltotetraohydrolase from the genetically modified Bacillus licheniformis strain DP‐Dzf95

Abstract The food enzyme glucan 1,4‐α‐maltotetraohydrolase (4‐α‐D‐glucan maltotetraohydrolase; EC 3.2.1.60) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzf95 by Genencor international B.V. The genetic modifications do not give rise to safety concerns. 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 (TOS) are removed in one process, dietary exposure was calculated for the remaining food manufacturing process. It was estimated to be up to 0.253 mg TOS/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 glucan 1,4‐α‐maltotetraohydrolase 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 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.