据了解，这种食品酶是由转基因地衣芽孢杆菌菌株CCTCC M 2023118生产的，旨在用于6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。基于所提供的有关该食品酶制剂中存在桔霉素的数据，专家小组无法排除该食品酶的遗传毒性和致癌性风险。部分原文报道如下：

 

　　The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain CCTCC M 2023118 by Sunson Industry Group Co., Ltd. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. Consequently, it does not fulfil the requirements for the qualified presumption of safety approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. No concerns were identified from the food enzyme manufacturing process. Citrinin was detected in all food enzyme preparation batches at a concentration exceeding 405 μg/kg. The food enzyme is intended to be used in six food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining four food manufacturing processes. It was estimated to be up to 5.166 mg TOS/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the α-amylase to known allergens was made and two matches with respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. based on the data provided on the presence of citrinin in the food enzyme preparation, the Panel could not exclude genotoxicity and carcinogenicity concerns for the food enzyme.

 

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