Safety evaluation of the food enzyme ß-amylase from Bacillus flexus strain AE-BAF.

The food enzyme ß-amylase (4-α-d-glucan maltohydrolase, EC 3.2.1.2) is produced with the non-genetically modified Bacillus flexus strain AE-BAF by Amano Enzyme Inc. The production strain has been shown to qualify for Qualified Presumption of Safety (QPS) status. The food enzyme is intended to be used in baking and brewing processes, and in starch processing for the production of glucose syrups 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 not calculated for this food process. Based on the maximum use levels recommended by the applicant for the baking and brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure was estimated to be up to 2 mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary given the QPS status of the production strain and the nature of the manufacturing process. Similarity of the amino acid sequence to those of known allergens was searched and no match was 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, in particular, the QPS status of the production strain and that no issues of concern arose from the production process, the Panel concluded that the food enzyme ß-amylase produced with B. flexus strain AE-BAF does not give rise to safety concerns under the intended conditions of use.