PDF(Pubmed)
Abstract：
As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. This Technical Note to the applicants puts together requirements and recommendations for the quality assessment of the methodology, analysis and reporting when DNA sequencing is used for the molecular characterisation of GM plants. In particular, it applies to the use of Sanger sequencing and next-generation sequencing for the characterisation of the inserted genetic material and its flanking regions at each insertion site, the determination of the copy number of all detectable inserts and the analysis of the genetic stability of the inserts. This updated document replaces the EFSA 2018 Technical Note and reflects the current knowledge in scientific-technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. It does not take into consideration the verification and validation of the detection method which remains under the remit of the Joint Research Centre (JRC).
摘要：
作为转基因(GM)植物风险评估(RA)要求的一部分，根据法规（EU）No503/2013和EFSA关于转基因植物食品和饲料的RA的指南（EFSAGMO小组2011），申请人需要对插入到转基因植物基因组中的DNA序列进行分子表征。给申请人的本技术说明将方法质量评估的要求和建议放在一起，当DNA测序用于转基因植物的分子表征时，分析和报告。特别是,它适用于使用Sanger测序和下一代测序来表征插入的遗传物质及其在每个插入位点的侧翼区，测定所有可检测的插入物的拷贝数和分析插入物的遗传稳定性。此更新文件取代了EFSA2018技术说明，并反映了用于生成和验证的科学技术方法的当前知识，以标准化的方式，转基因植物RA背景下的DNA测序数据。它没有考虑到检测方法的验证和验证，这仍然在联合研究中心（JRC）的职权范围内。
