欧盟评估转基因大肠杆菌菌株EBASSC生产的交替糖蔗糖酶的安全性

 

　　据了解，这种食品酶是由转基因大肠杆菌菌株EBASSC生产的，旨在用于糖的加工，以生产麦芽糖交替糖寡糖。

 

　　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。根据所提供的数据，评估小组得出结论，这种食品酶在预期使用条件下不会引起安全问题。部分原文报道如下：

 

　　The food enzyme alternansucrase (sucrose:1,6(1,3)-α-d-glucan 6(3)-α-d-glucosyltransferase; EC 2.4.1.140) is produced with the genetically modified Escherichia coli strain EBASSC by Advanced Enzyme Technologies Ltd. The production strain of the food enzyme contains a known antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in the processing of sugars for the production of maltose alternan gluco-oligosaccharides. Two sets of dietary exposure estimates were made, using the default or more specific input factors. The refined dietary exposure was estimated to be up to 0.586 mg total organic solids (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 500 mg TOS/kg bw per day, the mid-dose tested, which when compared with the refined exposure estimate, results in a margin of exposure of at least 853. A search for the homology of the amino acid sequence of the alternansucrase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme 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.

 

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