欧盟评估非转基因黑曲霉菌株294生产的纤维素酶的安全性

 　　  2023年7月12日，欧盟食品安全局就一种食品酶纤维素酶（cellulase）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294生产的，旨在用于八种食品制造过程：烘焙工艺、谷物加工、酿造工艺、生产淀粉和谷蛋白的谷物处理、果汁生产中的水果和蔬菜加工、果汁以外产品的水果和蔬菜加工、蒸馏酒精生产和葡萄酒及葡萄酒醋的生产。
 
　　经过评估，专家小组认为，在预期的使用条件下（蒸馏酒精生产除外），不能排除饮食暴露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隐患。部分原文报道如下：
 
　　The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan-4-glucanohydrolase; EC 3.1.2.4) is produced with the non-genetically modified Aspergillus niger strain 294 by Kerry Ingredients & Flavours Ltd. The food enzyme is considered free from viable cells of the production organism. The enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, brewing processes, grain treatment for the production of starch and gluten fractions, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and grain treatment for the production of starch and gluten fractions, dietary exposure was only calculated for the remaining six food manufacturing processes. It was estimated to be up to 5.706 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 794 mg TOS/kg bw per day, the highest dose tested. The calculated margin of exposure for each age group was 184 (infants), 146 (toddlers), 139 (children), 219 (adolescents), 305 (adults) and 441 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by 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 for adolescents, adults and the elderly.