Classification of new mutagenesis techniques
Biotech industry association criticises European Court of Justice ruling
Press release of 25 July 2018
The sector association of the biotechnology industry BIO Deutschland has read with concern the ruling of the European Court of Justice (ECJ) published today on the classification of genetic modification techniques known as mutagenesis. The long-awaited decision expressly excludes new genome editing methods from the exemptions laid down in Article 3 paragraph 1 of the GMO Directive 2001/18/EC in conjunction with Annex I B (known as “the mutagenesis exemption”). Organisms obtained by genome editing are now to be treated as GMOs within the meaning of the European Directive on the deliberate release into the environment of genetically modified organisms (2001/18/EC). It is the association’s view that this ruling does not take into account current scientific findings, as these new techniques are able to modify organisms using processes that could occur naturally.
Peter Heinrich, chairman of the board of BIO Deutschland, says: “We are disappointed that today’s ruling does not correspond to the opinion of Advocate General Bobek on the classification of new molecular biological methods for the modification of genetic material. It would have been more appropriate to shift the focus from the process to the end product, i.e. the altered organism. What matters is whether the organism could have developed naturally and whether the precautionary principle is respected – not how the organism is created.”
BIO Deutschland’s Managing Director Viola Bronsema adds: “These new genome editing techniques are extremely precise and targeted compared to mutagenesis induced by chemicals or radiation, which are both long-standing techniques. It is therefore highly regrettable and incomprehensible that the ECJ has decided to remove these more precise methods from the mutagenesis exemption. The ruling prevents groundbreaking scientific findings from being used to develop important innovations in healthcare, climate protection and environmental protection.”