Silano Vittorio, Bolognesi Claudia, Castle Laurence, Chipman Kevin, Cravedi Jean-Pierre, Fowler Paul, Franz Roland, Grob Konrad, Gürtler Rainer, Husøy Trine, Kärenlampi Sirpa, Mennes Wim, Milana Maria Rosaria, Pfaff Karla, Riviere Gilles, Srinivasan Jannavi, Tavares Poças Maria de Fátima, Tlustos Christina, Wölfle Detlef, Zorn Holger, Chesson Andrew, Glandorf Boet, Herman Lieve, Jany Klaus-Dieter, Marcon Francesca, Penninks André, Smith Andrew, van Loveren Henk, Želježić Davor, Aguilera-Gómez Margarita, Arcella Davide, Kovalkovičová Natália, Maia Joaquim, Liu Yi, Engel Karl-Heinz
EFSA J. 2018 Apr 27;16(4):e05228. doi: 10.2903/j.efsa.2018.5228. eCollection 2018 Apr.
The food enzyme is an endo-1,4-β-xylanase (EC 3.2.1.8) produced with a genetically modified strain of (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption 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 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-β-xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-β-xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to 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），由帝斯曼食品特种产品有限公司使用转基因菌株（菌株XEA）生产。该食品酶旨在用于烘焙和酿造过程。根据食品加工推荐的最大使用水平以及欧洲食品安全局综合欧洲食品消费数据库中的个体消费数据，估计欧洲人群通过膳食接触该食品酶的总有机固体（TOS）最高可达每天0.310毫克TOS/千克体重。对该食品酶进行的遗传毒性测试未显示出遗传毒性问题。用这种内切-1,4-β-木聚糖酶对啮齿动物进行的重复剂量90天口服毒性研究表明，在全身毒性方面没有问题。通过搜索氨基酸序列与已知过敏原的相似性来评估致敏性；未发现匹配情况。专家小组认为，通过膳食接触食品酶内切-1,4-β-木聚糖酶不会引起过敏致敏和激发反应。基于微生物来源、所进行的基因改造、制造工艺、提供的成分和生化数据、膳食暴露评估、毒理学研究结果以及致敏性评估，专家小组得出结论，在预期使用条件下，这种食品酶不会引发安全问题。
