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Book chapter2024Peer reviewed

Regulatory aspects of plants resulting from new genomic techniques in the European Union

Molitorisová, A.; Purnhagen, K.P.; Rostoks, N.; Eriksson, D.; Wasmer, M.


Nobel Prize-winning CRISPR/Cas gene-editing technology will strengthen plant breeding in terms of efficiency and precision. The technology is based on precise site-directed alterations in plant genomes, with the possibility of off-target changes greatly reduced compared to conventionally used randomly induced mutagenesis. In the European Union (EU), the Court of Justice of the European Union adopted the reasoning that organisms obtained by novel mutagenesis techniques share a comparable risk profile as those obtained by transgenesis. Hence, EU genetically modified organism (GMO) law applies to the same extent. However, it has not yet been clarified by a binding legal interpretation if the EU GMO law applies to all products of new genomic techniques (NGTs), such as gene editing. Here we describe in detail the GMO regulatory system in the EU as well as the recent developments regarding different NGTs. Finally, we examine the potential solutions for the regulatory conundrum and the potential impact of EU regulation on the commercial development of gene-edited organisms in the EU.


biosafety regulation; CRISPR/Cas9; gene-edited organisms; Genetically modified organisms; SDN; site-directed nucleases

Published in

Title: Global Regulatory Outlook for CRISPRized Plants : Genome Modified Plants and Microbes in Food and Agriculture
ISBN: 978-0-443-18444-4
Publisher: Elsevier

    UKÄ Subject classification

    Genetics and Breeding

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