欧盟评估一种来自转基因荧光假单胞菌的α-淀粉酶的安全性

　　食品伙伴网讯  2020年3月5日，欧盟食品安全局发布关于来自一种转基因荧光假单胞菌（Pseudomonas fluorescens）的α-淀粉酶（alpha‐amylase）安全性的评估结果。

 

　　据了解，这种食品酶是由BASF Enzymes LLC1公司用转基因枯草芽孢杆菌菌株BD15754生产的。这种食品酶旨在用于蒸馏酒精生产和用于生产葡萄糖浆的淀粉加工，不含生产生物体的活细胞和重组DNA。经过评估，专家小组得出结论，由于这种食品酶存在促进耐药性发展的风险，被认为是不安全的。

 

　　部分原文报道如下：

 

　　The food enzyme α‐amylase （4‐a‐d‐glucan glucanohydrolase; EC 3.2.1.1） is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The α‐amylase is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids （TOS） are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated. Genotoxicity tests did not raise 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 （NOAEL） at the highest dose of 887 mg TOS/kg body weight （bw） per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is considered to be low. However, the food enzyme contains residual amounts of a highly important antimicrobial for human medicine, with the consequent risk of promoting the development of resistance. Therefore, the Panel concludes that the food enzyme α‐amylase, produced with the genetically modified P. fluorescens strain BD15754 cannot be considered safe.

 

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