Applicability of the EFSA Opinion on site‐directed nucleases type 3 for the safety assessment of plants developed using site‐directed nucleases type 1 and 2 and oligonucleotide‐directed mutagenesis

SCIENTIFIC OPINIONADOPTED: 14 October 2020doi: 10.2903/j.efsa.2020.6299Applicability of the EFSA Opinion on site-directed nucleasestype 3 for the safety assessment of plants developed usingsite-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesisEFSA Panel on Genetically Modified Organisms (EFSA GMO Panel),Hanspeter Naegeli, Jean-Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst,Michelle M Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko,Francisco Javier Moreno, Ewen Mullins, Fabien Nogue, Jose Juan Sanchez Serrano,Giovanni Savoini, Eve Veromann, Fabio Veronesi, Josep Casacuberta, Andrea Gennaro,Konstantinos Paraskevopoulos, Tommaso Raffaello and Nils RostoksAbstractThe European Commission requested the EFSA Panel on Genetically Modified Organisms (GMO) toassess whether section 4 (hazard identification) and the conclusions of EFSA’sScientific opinion on therisk assessment of plants developed using zincfinger nuclease type 3 technique (ZFN-3) and othersite-directed nucleases (SDN) with similar functionare valid for plants developed via SDN-1, SDN-2and oligonucleotide-directed mutagenesis (ODM). In delivering this Opinion, the GMO Panel comparedthe hazards associated with plants produced via SDN-1, SDN-2 and ODM with those associated withplants obtained via both SDN-3 and conventional breeding. Unlike for SDN-3 methods, the applicationof SDN-1, SDN-2 and ODM approaches aims to modify genomic sequences in a way which can resultin plants not containing any transgene, intragene or cisgene. Consequently, the GMO Panel concludesthat those considerations which are specifically related to the presence of a transgene, intragene orcisgene included in section 4 and the conclusions of the Opinion on SDN-3 are not relevant to plantsobtained via SDN-1, SDN-2 or ODM as defined in this Opinion. Overall, the GMO Panel did not identifynew hazards specifically linked to the genomic modification produced via SDN-1, SDN-2 or ODM ascompared with both SDN-3 and conventional breeding. Furthermore, the GMO Panel considers that theexistingGuidance for risk assessment of food and feed from genetically modified plantsand theGuidance on the environmental risk assessment of genetically modified plantsare sufficient but areonly partially applicable to plants generated via SDN-1, SDN-2 or ODM. Indeed, those guidancedocuments’requirements that are linked to the presence of exogenous DNA are not relevant for therisk assessment of plants developed via SDN-1, SDN-2 or ODM approaches if the genome of thefinalproduct does not contain exogenous DNA.