Risk assessment considerations for RNAi-based genetically modified plants

被引:0
作者
Barro, Francisco
European Food Safety Author EFSA, Albert
Braeuning, Albert
Goumperis, Tilemachos
Lewandowska, Aleksandra
Moxon, Simon
Papadopoulou, Nikoletta
Sanchez-Brunete, Elena
机构
关键词
genetically modified organisms; molecular characterisation; non-coding RNA; off-target; risk assessment; RNA interference; MICRORNA; PREDICTION;
D O I
10.2903/j.efsa.2025.9321
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
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.
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页数:8
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