2025年3月19日,欧盟食品安全局就一种食品酶内切-1,4-β-木聚糖酶(endo-1,4-β-xylanase)的安全性评价发布意见。
据了解,这种食品酶是由转基因黑曲霉菌株XYL生产的,旨在用于4种食品制造过程。
经过评估,专家小组认为,在预期的使用条件下,不能排除通过饮食接触引起过敏反应的风险,但这种情况发生的可能性很低。根据新的数据和以前提供的数据,小组得出结论,该食品酶在预期的使用条件下不会引起安全问题。部分原文报道如下:
The food enzyme endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger 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.