欧盟评估一种过氧化氢酶的安全性

 

　　据了解，这种食品酶是由非转基因黑曲霉（Aspergillus niger）菌株CTS 2093生产的，旨在用于八种食品生产过程：烘焙过程、谷物加工、咖啡加工、鸡蛋加工、果汁生产的蔬菜加工、茶叶加工、草药和水果浸剂加工、鲱鱼籽加工和奶酪生产的牛奶加工。

 

　　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，评估小组认为接触限度不足以排除预期使用条件下的安全问题。部分原文报道如下：

 

　　The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase; EC 1.11.1.6) is produced with the non-genetically modified Aspergillus niger strain CTS 2093 by Shin Nihon Chemical Co., Ltd. It is considered free from viable cells of the production organism. The food enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, coffee processing, egg processing, vegetable processing for juice production, processing of tea, herbal and fruit infusions, herring roe processing and milk processing for cheese production. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 3.61 mg TOS/kg body weight (bw) per day in European populations. In addition, it is used in the production of acacia gum with the highest dietary exposure at the 95th percentile of 0.018 mg TOS/kg bw per day in infants, when acacia gum is used as a food additive. 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 56 mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of 16. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. based on the data provided, the Panel considered the margin of exposure as insufficient to exclude safety concerns under the intended conditions of use.

 

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