Court of Justice of the EU rules that gene-editing technologies are subject to EU GMO Directive requirements

Contrary to Advocate-General's opinion of 18 January 2018, the Court of Justice ruled last Wednesday in case C-528/16 that the GMO Directive also applies to organisms obtained by mutagenesis techniques that have emerged since its adoption. This ruling of the Court of Justice was long awaited – the case was pending since two years. It has a significant impact on certain innovative mutagenesis techniques, such as the CRISPR-Cas9 technology, in respect of which it was unclear whether the GMO Directive obligations would apply given that this technique does not involve foreign genes.

The Advocate General was of the opinion that mutagenesis techniques are exempt from the obligations of the GMO Directive provided that they do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by one or more of the methods listed in Annex I B of the GMO Directive (Directive 2001/18/EC). The AG acknowledged that the legislator is obliged to keep its regulation reasonably up to date, a duty he deemed crucial in respect of those areas and issues covered by the precautionary principle so that the validity of an EU law measure like the GMO Directive is not only to be assessed with regard to the facts and knowledge as they stood at the time of the adoption of that measure, but also with regard to the duty to keep legislation reasonably up to date. However, the AG did not see any grounds deriving from the general duty to update legislation (in this case enhanced by the precautionary principle) which could affect the validity of the mutagenesis exemption.

The Court of Justice also considered that no such update was necessary but did rule that new mutagenesis techniques were to be subject to the requirements under the GMO Directive, notably in light of Recital 17 of the directive that excludes organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record from the scope of the GMO Directive. The Court considered that it could not follow an interpretation of the exemption in Article 3(1) of the GMO Directive, read in conjunction with point 1 of Annex I B to the directive, that would amount to excluding organisms obtained by means of techniques/methods of mutagenesis from the scope of that directive, without any distinctions. Such interpretation would, in the words of the Court, "compromise the objective of protection pursued by the directive and would fail to respect the precautionary principle which it seeks to implement".

While voices rise to challenge certain findings of the Court, such as the fact that the risks linked to the use of those new techniques/methods of mutagenesis might prove to be similar to those which result from the production and release of a GMO through transgenesis, the ruling of the Court constitutes an illustration of the weight of the precautionary principle in the EU law. This decision is not only likely to have an impact on the R&D activities in the field of gene editing in the EU, but also on the marketability of food products containing ingredients with edited genes, given the obligation to label GMO-containing food products on the one hand, and the perception and attitude of EU consumers towards GMO products on the other. The reaffirmation of the prohibition of GMOs in organic production will also lead to the exclusion of the use of gene-editing technologies such as CRISPR-Cas9 in organic production.

The full text of the judgment of the Court of Justice can be read here.

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