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, Sicuri Maria Chiara, Cavanna Daniele, Liu Yi
EFSA J. 2025 Mar 28;23(3):e9328. doi: 10.2903/j.efsa.2025.9328. 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 XEA by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. The dietary exposure was calculated to be up to 0.316 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1852 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5861. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised 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通过转基因菌株XEA生产。此前已对该食品酶进行了安全性评估，欧洲食品安全局（EFSA）得出结论，该食品酶在两种食品制造工艺中使用时不会引发安全问题。随后，申请人请求将其使用范围扩大至另外四种工艺。在本次评估中，EFSA对该食品酶在总共六种食品制造工艺中的使用安全性评估进行了更新。经计算，欧洲人群的膳食暴露量高达每天0.316毫克总有机固体（TOS）/千克体重（bw）。当与先前报告的未观察到不良反应水平（每天1852毫克TOS/千克bw，测试的最高剂量）相结合时，专家小组得出的暴露边际至少为5861。基于新数据、修订后的暴露边际和先前的评估，专家小组得出结论，在修订后的预期使用条件下，该食品酶不会引发安全问题。
