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, Engel Karl-Heinz, Kärenlampi Sirpa, Aguilera Jaime, Arcella Davide, Kovalkovicova Natalia, Liu Yi, Maia Joaquim, Chesson Andrew
EFSA J. 2019 Apr 30;17(4):e05685. doi: 10.2903/j.efsa.2019.5685. eCollection 2019 Apr.
The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified (strain NZYM-CE) by Novozymes A/S. 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. This xylanase is intended to be used in baking and cereal-based processes. Based on the maximum use levels recommended for the respective food processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a genotoxic concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of at least 1,020 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure, this results in a margin of exposure (MoE) of at least 85,000. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that based on the data provided and the derived MoE, this food enzyme does not give rise to safety concerns under the intended conditions of use.
食品酶内切-1,4-β-木聚糖酶（4-β-D-木聚糖木聚糖水解酶；EC 3.2.1.8）由诺维信公司（Novozymes A/S）使用转基因菌株NZYM-CE生产。这些基因改造不存在安全问题。该食品酶不含生产菌株的活细胞和重组DNA。这种木聚糖酶旨在用于烘焙和谷物加工过程。根据各自食品加工推荐的最大使用量以及欧洲食品安全局（EFSA）综合欧洲食品消费数据库的个体数据，估计欧洲人群通过饮食接触该食品酶——总有机固体（TOS）的量高达每天0.012毫克TOS/千克体重（bw）。遗传毒性试验未表明存在遗传毒性问题。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。专家小组确定未观察到有害作用水平（NOAEL）至少为每天1020毫克TOS/千克bw，这是所测试的最高剂量。将NOAEL值与估计的饮食接触量进行比较，得出的暴露边际（MoE）至少为85000。搜索了该氨基酸序列与已知过敏原的相似性，未发现匹配情况。专家小组认为，在预期的使用条件下，不能排除饮食接触该食品酶后发生过敏致敏和激发反应的风险，但认为可能性较低。总体而言，专家小组得出结论，根据所提供的数据和得出的MoE，该食品酶在预期的使用条件下不存在安全问题。
