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, Herman Lieve, Jany Klaus-Dieter, Kärenlampi Sirpa, Penninks André, Želježić Davor, Aguileria-Gómez Margarita, Arcella Davide, Horn Christine, Kovalkovičová Natália, Liu Yi, Maia Joaquim Manuel, Chesson Andrew
EFSA J. 2019 Mar 12;17(3):e05629. doi: 10.2903/j.efsa.2019.5629. eCollection 2019 Mar.
The food enzyme glucose oxidase (β-d-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with a genetically modified strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.004 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an asparaginase from (strain ASP). The Panel considered this enzyme as a suitable substitute to be used in the toxicological studies, because they derive from the same recipient strain, the location of the inserts are comparable, no partial inserts were present and the production methods are essentially the same. Genotoxicity tests did not raise 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 (NOAEL) at the highest dose of 1,038 and 1,194 mg TOS/kg bw per day (for males and females, respectively) that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) (of at least 260,000). Similarity of the amino acid sequence 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 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.
食品酶葡萄糖氧化酶（β-D-葡萄糖：氧1-氧化还原酶；EC 1.1.3.4）由帝斯曼食品特种产品有限公司使用转基因菌株ZGL生产。这些基因改造不会引发安全问题。该食品酶不含生产生物体的活细胞和重组DNA。葡萄糖氧化酶拟用于烘焙过程。根据最大使用量，估计膳食中该食品酶总有机固体（TOS）的暴露量最高可达每天0.004毫克TOS/千克体重（bw）。毒性研究使用了来自（菌株ASP）的天冬酰胺酶进行。专家小组认为该酶是毒理学研究中合适的替代品，因为它们源自同一受体菌株，插入片段的位置具有可比性，不存在部分插入，且生产方法基本相同。遗传毒性试验未引发安全问题。通过对大鼠进行为期90天的重复剂量口服毒性研究评估了全身毒性。专家小组确定，在最高剂量分别为每天1038和1194毫克TOS/千克bw（雄性和雌性）时未观察到不良影响水平（NOAEL），与估计的膳食暴露量相比，这导致了足够高的暴露边际（MoE）（至少为260,000）。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，在预期的使用条件下，不能排除膳食暴露引起过敏致敏和激发反应的风险，但认为发生的可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不会引发安全问题。
