Safety evaluation of the food enzyme maltogenic α-amylase from the genetically modified Bacillus subtilis strain ROM

The food enzyme maltogenic α-amylase (glucan 1,4-α-maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain ROM by DSM Food Specialities B.V. The genetic modifications do not give rise to safety concerns. The maltogenic α-amylase is considered free from viable cells of the production organism and its recombinant DNA. The food enzyme is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.065 mg TOS/kg body weight (bw) per day. As the production strain of B. subtilis ROM qualifies for the Qualified Presumption of Safety approach to safety assessment and no issue of concern arose from the production process, no toxicological data are required. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and six matches were found. The Panel considered that under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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.