Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lambré Claude, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Herman Lieve, Aguilera Jaime, Andryszkiewicz Magdalena, Arcella Davide, Kovalkovicova Natalia, Liu Yi, Chesson Andrew
EFSA J. 2020 May 18;18(5):e06126. doi: 10.2903/j.efsa.2020.6126. eCollection 2020 May.
The food enzyme glucoamylase (4-α-D-glucan glucohydrolase; EC 3.2.1.3) is produced with the genetically modified strain DP-Nzh38 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in distilled alcohol production, starch processing for glucose syrup production, baking and brewing processes. Since residual amounts of total organic solids (TOS) are removed by distillation and by purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated for these uses. Based on the maximum use levels recommended for baking and brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-TOS was estimated to be up to 5.8749 mg TOS/kg body weight per day. The toxicity studies were carried out with another glucoamylase from (strain DP-Nzh49) considered by the Panel as a suitable substitute. Genotoxicity tests did not raise safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified no observed adverse effect level (NOAEL) at the highest dose tested of 1,149 mg TOS/kg body weight (bw) per day resulting in a margin of exposure of at least 195. Similarity of the amino acid sequence to those of known allergens was searched for 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 for this to occur is 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.
食品酶糖化酶（4-α-D-葡聚糖葡糖水解酶；EC 3.2.1.3）由丹尼斯克美国公司使用转基因菌株DP-Nzh38生产。基因改造不存在安全问题。该食品酶不含生产生物体的活细胞及其DNA。该食品酶拟用于蒸馏酒精生产、葡萄糖浆生产的淀粉加工、烘焙和酿造工艺。由于总有机固体（TOS）的残留量通过蒸馏和葡萄糖浆生产过程中应用的纯化步骤去除，因此，未针对这些用途计算膳食暴露量。根据烘焙和酿造工艺推荐的最大使用量以及欧洲食品安全局综合欧洲食品消费数据库的个体数据，估计膳食中该食品酶-TOS的暴露量高达每天5.8749毫克TOS/千克体重。毒性研究使用了另一种糖化酶（菌株DP-Nzh49）进行，专家小组认为该酶是合适的替代品。遗传毒性试验未引发安全问题。通过对大鼠进行的为期90天的重复剂量口服毒性研究评估了全身毒性。专家小组在测试的最高剂量1149毫克TOS/千克体重（bw）/天未发现观察到的不良反应水平（NOAEL），暴露边际至少为195。搜索了与已知过敏原氨基酸序列的相似性，发现了一个匹配项。专家小组认为，在预期使用条件下，不能排除膳食暴露引起过敏致敏和激发反应的风险，但认为发生这种情况的可能性较低。根据提供的数据，专家小组得出结论，该食品酶在预期使用条件下不存在安全问题。
