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欧盟评估非转基因Talaromyces versatilis菌株PF8生产的内切-1,3(4)-β-葡聚糖酶的安全性

放大字体  缩小字体 发布日期:2024-10-10  来源:   作者:泽夕  浏览次数:53
核心提示:2024年10月9日,欧盟食品安全局就一种食品酶内切-1,3(4)-β-葡聚糖酶(endo-1,3(4)-β-glucanase)的安全性评价发布意见。
     2024年10月9日,欧盟食品安全局就一种食品酶内切-1,3(4)-β-葡聚糖酶(endo-1,3(4)-β-glucanase)的安全性评价发布意见。
  
  据了解,这种食品酶是由非转基因Talaromyces versatilis菌株PF8生产的,旨在用于4种食品生产过程。
  
  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。根据所提供的数据,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-1,3(4)-β-glucanase (3-(1–3;1–4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Talaromyces versatilis strain PF8 by Erbslöh Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.110 mg 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 2229 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure resulted in a margin of exposure of at least 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.
  
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