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, Glandorf Boet, Herman Lieve, Aguilera Jaime, Andryszkiewicz Magdalena, Liu Yi, Ferreira de Sousa Rita, Rainieri Sandra, Chesson Andrew
EFSA J. 2022 Jul 1;20(7):e07370. doi: 10.2903/j.efsa.2022.7370. eCollection 2022 Jul.
The food enzyme α-amylase (4-α-d-glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified strain NZYM-BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, cereal-based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme-TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme 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 by dietary exposure cannot be excluded, but the likelihood was considered to be 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（Novozymes A/S）使用转基因菌株NZYM-BC生产。基因改造不会引发安全问题。生产菌株被证明符合安全合格推定（QPS）状态。该食品酶不含生产生物体的活细胞及其DNA。它拟用于六种食品制造工艺，即用于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、酿造工艺、谷物加工工艺、精制和非精制糖生产以及用于果汁生产的水果和蔬菜加工。由于总有机固体（TOS）的残留量在葡萄糖浆生产过程中通过蒸馏和纯化步骤被去除，因此未对这两种食品制造工艺计算膳食暴露量。对于其余四种工艺，估计欧洲人群膳食中食品酶-TOS的暴露量高达每天0.05毫克TOS/千克体重。遗传毒性试验未引发安全问题。对该食品酶的氨基酸序列与已知过敏原的氨基酸序列进行了比对，发现有一个匹配。专家小组认为，在预期的使用条件下，不能排除因膳食暴露引起过敏致敏和激发反应的风险，但认为可能性较低。根据提供的数据，专家小组得出结论，该食品酶在预期的使用条件下不会引发安全问题。
