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, Herman Lieve, Roos Yrjö, Aguilera Jaime, Andryszkiewicz Magdalena, Cavanna Daniele, Criado Ana, Nielsen Elsa, Nørby Karin, di Piazza Giulio, Peluso Silvia, Liu Yi, Chesson Andrew
EFSA J. 2023 Mar 30;21(3):e07911. doi: 10.2903/j.efsa.2023.7911. eCollection 2023 Mar.
The food enzyme glucan 1,4--glucosidase (4--d-glucan -glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified strain NZYM-BO by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, brewing processes, cereal-based processes, distilled alcohol production, fruit and vegetable processing for juice production, production of dairy analogues and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by distillation and during starch processing, dietary exposure was not calculated for these two food manufacturing processes. For the remaining five food manufacturing processes, dietary exposure to the food enzyme-TOS was estimated to be up to 2.97 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,920 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 646. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by 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β-1,4-葡聚糖酶（4-α-D-葡聚糖葡糖水解酶；EC 3.2.1.3）由诺维信公司使用非转基因菌株NZYM-BO生产。它被认为不含有生产微生物的活细胞。它拟用于七种食品制造工艺：烘焙工艺、酿造工艺、谷物加工工艺、蒸馏酒精生产、水果和蔬菜制汁加工、乳类代用品生产以及淀粉加工以生产葡萄糖浆和其他淀粉水解产物。由于总有机固体（TOS）的残留量通过蒸馏和淀粉加工过程被去除，因此未对这两种食品制造工艺计算膳食暴露量。对于其余五种食品制造工艺，估计欧洲人群通过膳食接触该食品酶-TOS的量高达每天2.97毫克TOS/千克体重（bw）。遗传毒性试验未表明存在安全问题。通过对大鼠进行为期90天的重复剂量经口毒性研究评估了全身毒性。专家小组确定未观察到有害作用水平为每天1920毫克TOS/千克bw，这是测试的最高剂量，与估计的膳食暴露量相比，得出的暴露界限至少为646。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，发现与一种呼吸道过敏原存在一个匹配。专家小组认为，在预期的使用条件下，不能排除通过膳食接触该食品酶引发过敏反应的风险（蒸馏酒精生产除外），但可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不会引起安全问题。
