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欧盟评估非转基因黑曲霉菌株PHY93-08生产的3-植酸酶的安全性

放大字体  缩小字体 发布日期:2024-07-02  来源:   作者:泽夕  浏览次数:66
核心提示:2024年7月1日,欧盟食品安全局就一种食品酶3-植酸酶(3-phytase)的安全性评价发布意见。
     2024年7月1日,欧盟食品安全局就一种食品酶3-植酸酶(3-phytase)的安全性评价发布意见。
 
  据了解,这种食品酶是由非转基因黑曲霉菌株PHY93-08生产的,旨在用于7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 3-phytase (myo-inositol-hexakisphosphate 3-phosphohydrolase EC 3.1.3.8) is produced with the non-genetically modified Aspergillus niger strain PHY93-08 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in nine food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in two of the food manufacturing processes, dietary exposure was calculated only for the remaining seven processes. It was estimated to be up to 0.763 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. 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 2560 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 3355. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches 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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