The genetic engineering ruling of the European Court of Justice in the summer of 2018 has political repercussions: the European Council, the EU's leading political body, has asked the EU Commission to clarify how "novel genomic techniques" are to be legally classified and regulated in the future. The results of this study are to be presented by April 2021 - including proposals and an impact assessment.

Surprising ruling of the ECJ

Last year, the ECJ came to a surprising decision: All organisms obtained by mutagenesis are considered genetically modified organisms (GMOs) and are subject to the strict regulation of the European Release Directive (2001/18/EC) for genetically modified organisms. This also applies to targeted mutagenesis using the genome scissors called CRISPR-Cas and other tools known as genome editing, with which the genetic material of organisms can be modified and processed much more specifically than before.

Practical questions raised

The EU Council's explanatory memorandum for the request for the investigation states: "The ruling brought legal clarity as to the status of new mutagenesis techniques, but also raised practical questions which have consequences for the national competent authorities, the Union’s industry, in particular in the plant breeding sector, research and beyond. Those questions concern, inter alia, 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, and how to ensure, in such a situation, the equal treatment between imported products and products produced within the Union."

The Council invites the Commission to submit by 30 April 2021 a study in light of the Court's judgment on the status of novel genomic techniques under Union law and, if necessary, to submit a proposal for new legislation and an impact assessment.

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