基于RNA干扰的转基因植物的风险评估考量
Risk assessment considerations for RNAi-based genetically modified plants.
作者信息
Barro Francisco, Braeuning Albert, Goumperis Tilemachos, Lewandowska Aleksandra, Moxon Simon, Papadopoulou Nikoletta, Sánchez-Brunete Elena
出版信息
EFSA J. 2025 Mar 21;23(3):e9321. doi: 10.2903/j.efsa.2025.9321. eCollection 2025 Mar.
The risk assessment (RA) requirements for genetically modified plants (GMPs) are defined in Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011). When a GMP is developed to silence transcripts by RNA interference (RNAi), some specific additional analysis needs to be provided by the applicant. This guidance describes the requirements and recommendations for the GMP applications submitted to EFSA. It covers the molecular characterisation, focusing on bioinformatic analysis and confirmation of the trait, as well as the food and feed safety and dietary exposure assessment of RNAi-based GMPs. This document replaces the GMO panel strategy for the risk assessment of RNAi off targets in plants, described in Annex II to the minutes of the 118th Plenary meeting of the Scientific Panel on GMO and takes into account the current knowledge on the mechanisms of RNAi in plants.
转基因植物（GMPs）的风险评估（RA）要求在欧盟法规（EU）No 503/2013以及欧洲食品安全局（EFSA）关于转基因植物食品和饲料风险评估的指南（EFSA转基因生物小组，2011年）中有所规定。当开发一种通过RNA干扰（RNAi）使转录本沉默的转基因植物时，申请人需要提供一些特定的额外分析。本指南描述了提交给EFSA的转基因植物申请的要求和建议。它涵盖了分子特征分析，重点是生物信息学分析和性状确认，以及基于RNAi的转基因植物的食品和饲料安全性及膳食暴露评估。本文件取代了转基因生物科学小组第118次全会会议记录附件二中所述的转基因植物中RNAi脱靶风险评估的转基因生物小组策略，并考虑了目前关于植物中RNAi机制的知识。
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