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Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178).

EFSA Panel on Genetically Modified Organisms (GMO), Ewen Mullins, Jean-Louis Bresson,Tamas Dalmay,Ian Crawford Dewhurst, Michelle M Epstein,Leslie George Firbank,Philippe Guerche,Jan Hejatko,Francisco Javier Moreno, Hanspeter Naegeli, Fabien Nogué,Nils Rostoks,Jose Juan Sanchez Serrano, Giovanni Savoini,Eve Veromann, Fabio Veronesi,Josep Casacuberta, Ana Afonso,Paolo Lenzi, Nikoletta Papadopoulou,Tommaso Raffaello

EFSA journal. European Food Safety Authority(2024)

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摘要
EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions.
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关键词
genetically modified plants,genome editing,new genomic techniques,risk assessment
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