Safety evaluation of the food enzyme glucan 1,4-α-maltohydrolase from the genetically modified Bacillus subtilis strain MAMDSM

The food enzyme glucan 1,4-alpha-maltohydrolase (4-alpha-d-glucan alpha-maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain MAMDSM by DSM Food Specialties. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for the production of baked and brewed products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.204 mg TOS/kg body weight (bw) per day in European populations. The production strain meets the requirements for the QPS approach. As no concerns arising from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that the risk of allergic reactions by dietary exposure 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.