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, Riviere Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Glandorf Boet, Herman Lieve, Kärenlampi Sirpa, Penninks André, Željeżić Davor, Aguilera-Gómez Margarita, Andryszkiewicz Magdalena, Arcella Davide, Kovalkovičová Natália, Liu Yi, Roncancio Peña Claudia, Horn Christine, Chesson Andrew
EFSA J. 2018 Nov 16;16(11):e05480. doi: 10.2903/j.efsa.2018.5480. eCollection 2018 Nov.
The food enzyme is an endo-1,4-β-xylanase (EC 3.2.1.8) produced with a genetically modified strain of 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 proposed maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.027 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. Subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. In this study, effects were seen in the control group on reproductive parameters (particularly the seminiferous epithelium atrophy in the testes) at incidences that far exceeded the background range. Consequently, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, including haematological parameters and the immunology cohort, was conducted. The Panel identified a no observed adverse effect level at the highest dose tested of 1,101.3 mg TOS/kg bw per day. When compared with the dietary exposure, resulted in a sufficiently high margin of exposure (at least 40,000). 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 for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.
这种食品酶是一种内切-1,4-β-木聚糖酶（EC 3.2.1.8），由诺维信公司（Novozymes A/S）的转基因菌株生产。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。这种木聚糖酶旨在用于烘焙和谷物加工过程。根据提议的最大使用量，估计欧洲人群通过饮食接触该食品酶的总有机固体（TOS）最高可达每天0.027毫克TOS/千克体重（bw）。遗传毒性试验未引发安全问题。通过在大鼠中进行的重复剂量90天口服毒性研究评估了亚慢性毒性。在这项研究中，对照组在生殖参数（特别是睾丸生精上皮萎缩）方面出现的影响发生率远远超过背景范围。因此，进行了一项结合重复剂量毒性研究与生殖/发育毒性筛选试验，包括血液学参数和免疫学队列研究。专家小组确定在最高测试剂量1101.3毫克TOS/千克bw/天时未观察到不良影响水平。与饮食接触量相比，产生了足够高的暴露边际（至少40,000）。搜索了该氨基酸序列与已知过敏原的相似性，未发现匹配。专家小组认为，在预期使用条件下，不能排除通过饮食接触引起过敏致敏和激发反应的风险，但可能性较低。根据所提供的数据，专家小组得出结论，这种食品酶在预期使用条件下不会引发安全问题。
