欧盟评估一种转基因地衣芽孢杆菌生产的α-淀粉酶的安全性

 

　　据了解，这种食品酶是由转基因地衣芽孢杆菌（Bacillus licheniformis）菌株 DP‐Dzb45生产的，旨在用于酿造过程和蒸馏酒的生产中。

 

　　经过评估，专家小组认为，在预期的使用条件下，生产蒸馏酒可以排除过敏性致敏和诱发反应的风险，但在酿造中使用该酶时则不能排除。根据提供的数据，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 α‐amylase (1,4‐α‐D‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzb45 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of an antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this was not considered to be a risk. The α‐amylase is intended to be used in brewing processes and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation, no dietary exposure was calculated for this intended use. based on the maximum use levels recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.138 mg TOS/kg body weight per day in European populations. Toxicological tests with the food enzyme indicated that there was no concern with respect to genotoxicity or systemic toxicity. A no observed adverse effect level was identified in rats, which, compared with the dietary exposure, results in a margin of exposure of at least 484. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions can be excluded in distilled alcohol production but cannot be excluded when the enzyme is used in brewing. 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.