Silano Vittorio, Barat Baviera José Manuel, Bolognesi Claudia, Brüschweiler Beat Johannes, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Glandorf Boet, Marcon Francesca, Penninks André, Aguilera Jaime, Andryszkiewicz Magdalena, Arcella Davide, Maia Joaquim, Liu Yi, Chesson Andrew
EFSA J. 2019 Mar 8;17(3):e05631. doi: 10.2903/j.efsa.2019.5631. eCollection 2019 Mar.
The food enzyme has three declared activities (endo-1,3(4)-β-glucanase EC 3.2.1.6, endo-1,4-β-xylanase EC 3.2.1.8 and cellulase (endo-1,4-β-d-glucanase EC 3.2.1.4)) and is produced with a non-genetically modified strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.411 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 620 mg TOS/kg bw per day, the highest dose tested. When the NOAEL is compared to the estimated dietary exposure, this results in a margin of exposure of at least 1,500. A search was made for similarity of the amino acid sequence of the declared activities with those of known allergens. Four matches were found with endo-1,3(4)-β-glucanase to known respiratory allergens, two from dust mites and two allergens. The Panel considered that an allergic reaction upon oral ingestion of enzymes produced by strain NZYM-ST in individuals respiratory sensitised to these allergens cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.
这种食品酶具有三种宣称的活性（内切-1,3(4)-β-葡聚糖酶，酶委员会编号3.2.1.6；内切-1,4-β-木聚糖酶，酶委员会编号3.2.1.8；纤维素酶（内切-1,4-β-D-葡聚糖酶，酶委员会编号3.2.1.4）），由诺维信公司（Novozymes A/S）使用非转基因菌株生产。它拟用于烘焙和酿造工艺。对于这两种预期用途，根据推荐的最大使用量以及欧洲食品安全局（EFSA）综合欧洲食品数据库中的个体数据，估计通过饮食接触该食品酶的总有机固体（TOS）量最高可达每天0.411毫克TOS/千克体重（bw）。遗传毒性试验未引发安全担忧。通过对大鼠进行的90天重复剂量经口毒性研究评估了全身毒性。在该研究中，专家小组确定未观察到有害作用水平（NOAEL）至少为每天620毫克TOS/千克bw，这是所测试的最高剂量。将NOAEL与估计的饮食接触量进行比较时，得出的接触边际至少为1500。对宣称活性的氨基酸序列与已知过敏原的氨基酸序列进行了相似性搜索。发现内切-1,3(4)-β-葡聚糖酶与已知呼吸道过敏原存在四处匹配，其中两处来自尘螨，两处为其他过敏原。专家小组认为，对于对这些过敏原产生呼吸道致敏的个体，口服NZYM-ST菌株产生的酶后发生过敏反应不能排除，但认为可能性较低。总体而言，专家小组得出结论，在预期使用条件下并根据所提供的数据，这种食品酶不会引发安全担忧。
