European Court of Justice decision on ‘in vitro’ mutagenesis strengthens 2018 ruling subjecting gene editing to EU GMO Directive

The recent ruling by the European Court of Justice, published on 7 February, closes a 2015 case brought forward by the French small farmers’ association Confédération Paysanne, together with eight other environmental organizations. It clarifies the legal status of old GMO methods of mutagenesis under the EU Regulation and confirms that gene editing techniques should fall under the EU GMO Directive 2001/18/EC.  

2018: European Court of Justice says new genomic techniques are GMOs

The July 2018 ruling of the European Court of Justice provided clarity on new mutagenesis techniques, stating that the latter should be considered genetically modified organisms as laid out by the EU Directive, and in turn, new Genetically Modified Organisms (GMOs) must be regulated in the same way as old GMOs. However, the status of ‘random mutagenesis’ techniques, creating old GMOs, was still uncertain.  

Random mutagenesis, both in vivo and in vitro exempted from GMO legislation

Random mutagenesis induces spontaneous mutations on the gene level in living organisms, by using certain mutagenic agents, such as chemicals or physical agents (e.g., radiation) that can alter the genetic composition of plant cells. Random mutagenesis can be applied ‘in vitro’ and ‘in vivo’. ‘In vitro’ means that mutagenic agents are applied to plant cells and the whole plant is then reconstituted, whereas ‘in vivo’ processes refer to processes where mutagenic agents are applied to the whole plant or plant parts.  

The Directive 2001/18/EC provides for an exemption whereby certain genetic modification techniques fall outside its very strict scope. In vivo random mutagenesis was declared exempt from the 2018 ruling, whereas In vitro mutagenesis was still contested. The ruling this February states that both random mutagenesis techniques qualify for an exemption from the EU’s GMO directive. So, now, mutagenic agents applied not only to whole plants or seeds, but also to cells (in vitro) are exempted. The Court put emphasized that this judgement is supported by the dual criterion: 
(i) conventional use in a number of [breeding] applications and 
(ii) with a long history of safe use.  

A precedent to upcoming Commission proposal on new genomic techniques?

The ruling comes at a critical point in time with the upcoming legislative proposal on New Genomic Techniques (NGTs) announced for publication in June 2023. While the agrochemical and big seed industry actors like Bayer and Euroseeds reacted positively to this judgement, green groups and small farming associations warned the ruling risks opening the door to a deregulation of new GMOs. Notably, the farmer’s union European Coordination Via Campesina stated in their press release that “These techniques [in vitro mutagenesis] are all patentable and are therefore neither natural nor traditional. They were developed shortly before 2001 at the same time as transgenesis (even though most products arrived on the market well after 2001) and generate the same health and environmental risks that justify the current regulatory obligations of risk assessment, labelling and traceability.” 

However, importantly, the Court’s ruling does not strip gene editing or NGTs, such as that performed using the CRISPR/Cas method, from any regulatory safeguards for gene-edited plants, such as risk assessment, traceability, and labelling. These plants continue to fall under the GMO regulation, as ruled by the Court of Justice in 2018. So, the outcome of the judgement confirms that there is a difference between random mutagenesis, which uses mutagenic agents (chemicals and physical agents like radiation) and directed or targeted mutagenesis, also called gene editing. According to the Court, the dual criterion mentioned above is in fact “closely linked to the very objective of that legislation, namely, in accordance with the precautionary principle laid down by EU law, to protect human health and the environment”.  

So, overall, the ruling strengthens the Court’s decision of 2018 to subject NGTs or gene editing to the current EU GMO Directive, sending a strong light towards the Commission. 

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