Options for regulating new genomic techniques for plants in the European Union.

Which option for regulating plants derived from new genomic techniques in European Union law is feasible and justifiable scientifically? The European Commission has proposed a new regulation on plants obtained by specific new genomic techniques, which is now subject to discussion in the legislative process. From the perspective of the European Commission's envisaged legal reforms of European Union law towards the integration of greater sustainability, we conclude that the option focusing on plant traits delivering sustainability benefits should be chosen, which is most fitting to facilitate a contribution to climate action, the transition towards climate neutrality, and promptly integrate sustainability into all food-related policies. To assist the decision-making in the legislative process, we outline six regulatory options resulting from regulatory research involving interdisciplinary teams.

Potential, Challenges, and Threats for the Application of New Breeding Techniques by the Private Plant Breeding Sector in the EU.

Reconciling sustainability with agricultural productivity in the face of climate change relies strongly on the development of resilient, high-yielding crops of superior nutritional value that can be grown more resource efficiently. Therefore, innovation in plant breeding has gained unprecedented importance. Plant breeding depends upon genetic variability within crops and their relatives as a basis for developing new plant varieties with improved characteristics. Plant breeders are continuously integrating the latest methods in plant biology and genetics into their breeding toolbox to more efficiently use existing diversity but also to induce new genetic variation. Over the past years, ever more precise and efficient plant breeding methods have been developed. This plant breeding innovation leap is based on an in-depth understanding of plant genomes and refinement of breeding methods, enabling more efficient, more precise and faster progress in achieving the desired breeding goals. Consequently, these plant breeding innovations are rapidly being developed and utilized internationally and across the seed sector, public and private research, plant species and markets. The results of a survey among 62 private plant breeding companies conducted by Euroseeds and presented in this publication confirm the enormous interest of companies in using new breeding techniques (NBTs) for a wide range of crop species and traits and the negative impact of the current regulatory situation in the EU on companies' decisions for investments in NBT-related R&D activities for the EU market and beyond.

Will the EU stay out of step with science and the rest of the world on plant breeding innovation?

Innovations in plant breeding like genome editing methods raised questions about the adequacy of established regulatory policies for plant breeding and biotechnology in view of these new breeding methods and the resulting products. Most countries follow the principle approach that only those plants will be regulated under biotech regulations that include a novel combination of genetic material following the Cartagena protocol. In contrast to this, the European Court of Justice interpreted the current EU biotech regulations in a way that these also apply to plants resulting from new mutagenesis breeding, even if these plants are indistinguishable from conventionally bred plants. This ruling created strong reactions and concerns stating that recent technical developments have made the EU GMO Directive no longer fit for purpose. The article describes ongoing policy developments on EU level that might result in an update of current regulations.