轉(zhuǎn)基因生物在進(jìn)入歐洲市場(chǎng)之前要經(jīng)過風(fēng)險(xiǎn)評(píng)估和監(jiān)管批準(zhǔn)。根據(jù)立法（指令2001/18/EC、條例（ EC ）第1829/2003號(hào)和條例（ EU ）第503/2013號(hào)）以及EFSA關(guān)于轉(zhuǎn)基因植物食品和飼料風(fēng)險(xiǎn)評(píng)估和轉(zhuǎn)基因植物環(huán)境風(fēng)險(xiǎn)評(píng)估的指導(dǎo)文件，申請(qǐng)人需要對(duì)插入轉(zhuǎn)基因植物基因組中的任何DNA序列進(jìn)行分子鑒定。本解釋性說明提供了確定新表達(dá)蛋白質(zhì)水平的關(guān)鍵方法方面的細(xì)節(jié)，申請(qǐng)人應(yīng)該考慮和報(bào)告這些內(nèi)容，以便協(xié)調(diào)提交給EFSA的轉(zhuǎn)基因植物申請(qǐng)中的信息。

 

    部分原文報(bào)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.

 

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