欧盟发布关于授权转基因植物申请背景下新表达蛋白水平测定的解释性说明

 

    转基因生物在进入欧洲市场之前要经过风险评估和监管批准。根据立法（指令2001/18/EC、条例（ EC ）第1829/2003号和条例（ EU ）第503/2013号）以及EFSA关于转基因植物食品和饲料风险评估和转基因植物环境风险评估的指导文件，申请人需要对插入转基因植物基因组中的任何DNA序列进行分子鉴定。本解释性说明提供了确定新表达蛋白质水平的关键方法方面的细节，申请人应该考虑和报告这些内容，以便协调提交给EFSA的转基因植物申请中的信息。

 

    部分原文报道如下：

 

    Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation （Directive 2001/18/EC, Regulation （EC） No 1829/2003 and Regulation （EU） No 503/2013） and the EFSA guidance documents on the risk assessment of food and feed from genetically modified （GM） plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any DNA sequence inserted in the GM plant genome. When a GM plant is designed to produce one or more newly expressed proteins, an aspect of the risk assessment process is to characterise these proteins and to reliably determine their levels in the GM plant tissues. A number of methods to measure protein expression levels are used and several experimental factors within these methods are of critical importance in order to obtain reliable results. This explanatory note provides details on key methodological aspects for the determination of newly expressed protein levels that should be considered and reported by applicants in order to harmonise the information in GM plant applications submitted to EFSA.