Safety evaluation of the food enzyme α-amylase from Bacillus amyloliquefaciens strain BANSC.

Abstract

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified B. amyloliquefaciens strain BANSC by Advanced Enzyme Technologies Ltd. The α‐amylase is intended to be used in brewing and baking processes and in starch processing for glucose syrups production and other starch hydrolysates. Since residual amounts of the food enzyme are removed during the starch processing for glucose syrups production, it is excluded from the dietary exposure estimation. Based on the maximum recommended use levels for brewing and 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 0.468 mg TOS/kg body weight (bw) per day. The parental strain meets the required qualifications to be considered as a Qualified Presumption of Safety (QPS) organism and is therefore presumed to be safe. The conclusions on safety of the food enzyme are made following the QPS approach in relation to the production strain, with additional consideration of the conditions of manufacture. Consequently, the Panel considers no toxicological studies other than assessment of allergenicity necessary. Similarity of the amino acid sequence to those of known allergens was searched and one match was 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 is considered low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.