Regulation of GMO field trials in the EU and new genomic techniques: will the planned reform facilitate experimenting with gene-edited plants?

This work was prepared in the course of a research project No. UMO-2020/39/D/HS5/03144, Transformation of biosafety legislation in agriculture in the EU law and the laws of its selected trade partners, with respect to the scientific development financed by the funds of the National Science Centre.

This study presents the possible consequences of maintaining the current regulatory regime of the experimental release of genetically modified higher plants in the EU for the products of new genomic techniques (NGTs). Currently, the experimental release is a crucial stage before the authorization of a product for the market. By analyzing the data on the performance of field trials in the EU (numbers, sizes, dominating countries) and comparing the present regulatory provisions with those of selected third countries (including new provisions adopted in the UK), this study shows that the current framework of GMO (genetically modified organisms) field trials is ill-fitted for breeding activities. Due to strict limitations placed on the operator of a field trial in the EU, easing the regulatory burdens on the authorization of certain NGT products for the market may not provide researchers (especially, plant breeders) the competitive position they need if the present legal conditions for carrying out GMO field trials with certain NGT products (especially, those that are considered GMOs covered by the EU GMO legislation) are not going to change as well.