Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Herman Lieve, Aguilera Jaime, Cavanna Dainele, Fraguas Cristina Fernandez, Kovalkovicova Natalia, Liu Yi
EFSA J. 2025 Mar 19;23(3):e9292. doi: 10.2903/j.efsa.2025.9292. eCollection 2025 Mar.
The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified strain XYL by DSM Food specialties. An evaluation of this food enzyme was made previously, in which EFSA could not conclude on its safety due to data gaps in a genotoxicity test. Subsequently, the applicant provided new data. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure was estimated to be up to 0.281 mg (total organic solids) TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 of 4095 mg TOS/kg bw per day for males and of 4457 mg TOS/kg bw per day for females, respectively, the highest doses tested. When compared with the estimated dietary exposure, it results in a margin of exposure of at least 14,573. A search for the homology of the amino acid sequence of the endo-1,4-β-xylanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the new data and the data provided previously, the Panel concluded that 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）由帝斯曼食品特种产品公司使用转基因菌株XYL生产。此前已对这种食品酶进行了评估，由于遗传毒性试验存在数据缺口，欧洲食品安全局无法对其安全性得出结论。随后，申请人提供了新的数据。基因改造不存在安全问题。该食品酶不含生产生物体的活细胞及其DNA。该食品酶拟用于四种食品制造工艺。据估计，欧洲人群的膳食暴露量高达每天0.281毫克（总有机固体）TOS/千克体重。遗传毒性试验未表明存在安全问题。通过对大鼠进行为期90天的重复剂量口服毒性研究来评估全身毒性。专家小组确定，雄性大鼠的无观察到有害作用水平分别为每天4095毫克TOS/千克体重，雌性大鼠为每天4457毫克TOS/千克体重，这是测试的最高剂量。与估计的膳食暴露量相比，得出的暴露边际至少为14573。对内切-1,4-β-木聚糖酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配项。专家小组认为，不能排除膳食接触该食品酶后发生过敏反应的风险，但可能性较低。根据新数据和先前提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不存在安全问题。
