New genetic engineering: The EU plays for time

In July 2018, the European Court of Justice (ECJ) clarified that new genetic engineering processes such as CRISPR/Cas and the organisms produced with them are subject to genetic engineering law. Since then, EU member states have been discussing how to deal with this ruling. As there is no consensus, they first tasked the European Commission with conducting a study – and thus postponed the issue.

According to a decision of the European Council of November 8^th 2021, the Commission is supposed to “submit a study in light of the Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law” by April 30^th 2021. At the same time, it is requested to submit “a proposal, if appropriate in view of the outcomes of the study”, or otherwise inform the Council of necessary action required following the study.

While the ECJ decision clarified the legal status of new mutagenesis procedures, it also raised some practical questions for national authorities, industry and research, the Council of the European Union justified its decision. Among these is the question, “how to ensure compliance with Directive 2001/18/EC when products obtained by means of new mutagenesis techniques cannot be distinguished, using current methods, from products resulting from natural mutation”.

Netherlands and Spain call for a review

Several members states commented on this decision, showing their disunity in their statements. For example, Hungary, Poland and three other countries declare: “The protection of human health and the environment requires that due attention be given to controlling the risks from any technique that alters the genetic material, and the current level of protection should be maintained.” They justify this with the objective of “protecting the environment and human health, respecting the precautionary principle”. The Netherlands and Spain, on the other hand, explicitly calling for “a review of the current GMO legislation”. Therefore, they expect the study by the Council “to address the adequacy, efficiency and consistency of the currently existing legal framework”. The two states urge that particularly “in view of the broad extent of implications of the current situation”, there is an urgent need for action. They stress that next to the precautionary principle, the Commission should also take into account the principle of proportionality.

The German Federal Ministry of Agriculture informed the Informationsdienst Gentechnik (Genetic Engineering news portal) that Germany had abstained from the preparatory vote on this decision. The reasons is that the parties to the grand coalition were divided on the question of how new genetic engineering processes should be treated legally. According to the Informationsdienst Gentechnik, Mute Schimpf of Friends of the Earth Europe also assessed the decision “as a first step to remove the new genetic engineering processes from genetic engineering law”.

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