欧盟评估非转基因曲霉属菌株GD-FAL生产的β-半乳糖苷酶的安全性

 

　　据了解，这种食品酶是由非转基因曲霉属菌株GD-FAL生产的，旨在用于牛奶加工中的乳糖水解。

 

　　经过评估，专家小组认为，在预期的使用条件下，不能排除饮食暴露引起过敏反应的风险，但这种可能性被认为很低。基于对遗传毒性的其余关注、对大鼠进行的90天重复剂量口服毒性研究的不足以及关于食品酶中缺乏生产菌株的活细胞的缺失数据，评估小组无法就该食品酶的安全性得出结论。部分原文报道如下：

 

　　The food enzyme β-galactosidase (EC 3.2.1.23) is produced with the non-genetically modified Aspergillus sp. strain GD-FAL by Godo Shusei Co., Ltd. The food enzyme is intended to be used in milk processing for the hydrolysis of lactose. The absence of viable cells of the production organism in the food enzyme was not demonstrated. based on the assumption that all milk/dairy products are enzymatically treated, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.301 mg TOS/kg body weight per day in European populations. The data provided did not allow concerns of genotoxicity of the food enzyme to be excluded. The systemic toxicity could not be assessed in the absence of an appropriate repeated dose 90-day oral toxicity study. Consequently, a margin of exposure was not calculated. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match 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 remaining concerns on genotoxicity, the inadequacies of the 90-day repeated dose oral toxicity study in rats and the missing data regarding the absence of viable cells of the production strain in the food enzyme, the Panel could not conclude on the safety of this food enzyme.

 

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