Lambré Claude, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Roos Yrjö, Aguilera Jaime, Andryszkiewicz Magdalena, Apergi Kyriaki, Cavanna Daniele, Peluso Silvia, de Sousa Rita Ferreira, Liu Yi, Chesson Andrew
EFSA J. 2023 Aug 2;21(8):e08160. doi: 10.2903/j.efsa.2023.8160. eCollection 2023 Aug.
The food enzyme α-amylase (4-α-D-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism strain T74 by Novozymes A/S. The production strain met the qualifications of the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in eight food manufacturing processes: starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, refined and unrefined sugar production, brewing processes, cereal-based processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and the production of dairy analogues. Since residual amounts of total organic solids (TOS) are removed during two food processes (starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production), dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 0.291 mg TOS/kg body weight per day in European populations. Since the production strain meets the requirements for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), 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.
食品酶α-淀粉酶（4-α-D-葡聚糖葡聚糖水解酶；EC 3.2.1.1）由诺维信公司使用非转基因微生物菌株T74生产。生产菌株符合安全合格假定（QPS）方法的要求。该食品酶拟用于八种食品制造工艺：生产葡萄糖浆和其他淀粉水解产物的淀粉加工、蒸馏酒精生产、精制和非精制糖生产、酿造工艺、谷物加工工艺、用于果汁生产的果蔬加工、用于非果汁产品的果蔬加工以及乳制品类似物的生产。由于在两种食品工艺（生产葡萄糖浆和其他淀粉水解产物的淀粉加工、蒸馏酒精生产）中会去除总有机固体（TOS）的残留量，因此仅针对其余六种食品制造工艺计算膳食暴露量。据估计，欧洲人群的膳食暴露量最高可达每天0.291毫克TOS/千克体重。由于生产菌株符合QPS方法的要求，且该食品酶的生产过程未出现任何令人担忧的问题，因此专家小组认为无需进行毒理学研究。对该食品酶的氨基酸序列与已知过敏原进行了相似性搜索，未发现匹配情况。专家小组认为，在预期使用条件下，不能排除膳食接触该食品酶后发生过敏反应的风险（蒸馏酒精生产除外），但可能性较低。根据所提供的数据，专家小组得出结论，该食品酶在预期使用条件下不会引起安全问题。
