Today, the Court of Justice of the European Union (“CJEU”) has issued its much awaited decision on the classification of genome-editing tools such as CRISPR/Cas9, Talen or zinc finger within the framework of the EU’s Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment (“GMO Directive”).
In essence, the court held that:
- Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.
- Only organisms obtained by mutagenesis techniques that have conventionally been used in a number of applications and have a long safety record are exempt from those obligations (“Exempted Technologies”). Such exemptions would not apply for new technologies like CRISPR/Cas9.
- Genetically modified varieties of beet, fodder plant, cereal, potato and oil and fibre plant obtained by mutagenesis techniques, except for Exempted Technologies, can only be listed in the ‘common catalogue of varieties of agricultural plant species the seed of which may be marketed’ if appropriate measures to avoid risks to human health and the environment have been taken.
- The EU Member States are free to adopt stricter regulations regarding Exempted Technologies in compliance with general EU law principles (in particular, the principle of free movement of goods).