Italy
The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT by Amano Enzyme Inc. In a previous opinion, a safety evaluation of this food enzyme was completed, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in starch processing for maltodextrin production. The applicant has now provided new data to extend the use of this food enzyme to six additional food manufacturing processes: baking processes, cereal‐based processes, plant processing for the production of dairy analogues, processing of tea, herbal and fruit infusions, brewing processes and the production of non‐wine vinegar. For its use in a total of seven food manufacturing processes, the dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Using the toxicological data provided in the previous opinion, with a NOAEL of 230 mg TOS/kg bw per day (the highest dose tested), the Panel derived a margin of exposure of at least 19,167. Based on the revised exposure calculation and the outcome of the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
