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

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.