Safety evaluation of the food enzyme glucan 1,4-alpha-maltohydrolase from the genetically modified Bacillus licheniformis strain NZYM-SD

Abstract

[EN] The food enzyme glucan 1,4-alpha-maltohydrolase (4-alpha-d-glucan alpha-maltohydrolase; 3.2.1.133) is produced with the genetically modified Bacillus licheniformis strain NZYM-SD by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes, namely baking processes and brewing processes and starch processing for glucose syrup production and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for baking and brewing processes. Dietary exposure was estimated to be up to 0.57 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues arising from the production process, the Panel concluded that the food enzyme glucan 1,4-alpha-maltohydrolase produced with the genetically modified B. licheniformis strain NZYM-SD does not give rise to safety concerns under the intended conditions of use.