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, Andryszkiewicz Magdalena, Apergi Kyriaki, Fernàndez-Fraguas Cristina, Liu Yi, Peluso Silvia, di Piazza Giulio, Chesson Andrew
EFSA J. 2023 Jul 31;21(7):e08157. doi: 10.2903/j.efsa.2023.8157. eCollection 2023 Jul.
The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice-based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel could not conclude on the safety of this food enzyme, 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HBI酶公司使用非转基因微生物菌株BA生产。所评估的这种酶拟用于六个食品加工过程：烘焙过程、酿造过程、蒸馏酒精生产、用于生产葡萄糖浆和其他淀粉水解产物的淀粉加工、乳类代用品生产以及米制食品生产。由于在蒸馏过程以及葡萄糖浆和其他淀粉水解产物的生产过程中总有机固体（TOS）的残留量会被去除，因此仅针对其余四个食品制造过程计算膳食暴露量。据估计，欧洲人群每天的膳食暴露量高达4.805毫克TOS/千克体重（bw）。申请人未提供充分数据来证明生产菌株符合安全合格假定（QPS）标准，也未提供食品酶中不存在生产生物体的活细胞和DNA的证据。因此，专家小组无法就微生物来源的安全性得出结论。由于缺乏毒理学研究，无法计算暴露边际。对该食品酶的氨基酸序列与已知过敏原的相似性进行了搜索，发现与呼吸道过敏原存在两个匹配项。专家小组认为，在预期使用条件下（蒸馏酒精生产除外），不能排除因膳食暴露引发过敏反应的风险，但可能性较低。根据所提供的数据，专家小组无法就该食品酶在预期使用条件下的安全性得出结论。
