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Recent legal developments on GEd crops in the EU

New Genomic Technics carries the promise to accelerate plant breeding contributions in the coming years, in a way it has never seen before. Regulatory policies cannot keep pace with the fast-moving scientific advances and the European Union is facing an interesting discussion that our members should follow closely.


By Paulo Peralta.-


In 2018 the European Court of Justice (ECJ) decided that organisms obtained by mutagenesis should be subjected to the same obligations laid down by the GMO Directive, as a resolution to a case presented by a group of French agricultural associations and unions.


The interpretation given by the ECJ extended to all GEd crops and therefore imposed a relevant restriction to the development of NGTs within EU. Right after the turning point established by the ECJ, the European Commission (EC) conducted a study on the status of NGTs, publishing the results in Abril 2021.


The main conclusion of the study was the need of a new policy for GEd crops. During 2022, an impact assessment on the prospective new legislation for plants produced by certain NGTs is being conducted with targeted stakeholder groups and public authorities. The aim of the EC is to gather all relevant data and views to start building the new policy by the second quarter of 2023.


What to expect from the new law?

Based on the consultations taking place at this moment, the European Commission (EC) is proposing different scenarios based on the basic elements presented to the stakeholders. The most unlikely alternative would be no changes to the current policy and regulations. This scenario will keep propitiating the current drawbacks of the legal policy, such as future menaces for trade disputes, preventing innovation and holding up uncertainty.



The EC is proposing a second scenario, where sustainability benefits derived from GEd will be promoted. Three alternatives are being considered: i) unchanged policy and regulation, ii) sustainability incentives for authorization or iii) no authorization if detrimental to sustainability. For instance, this calls for the use of labeling to differentiate GEd crops resistant to pests and diseases or with improved nutritional profiles. The label will allow to accomplish the traceability requirements. However, there is a high opposition from certain stakeholders that might be affected by the emergence of a new product taking part of their market share, particularly organic farmers.


Another scenario is linked to the risk assessment, proposing the three alternatives: i) the legal framework unchanged in 2030-2035, ii) authorization with proportionate risk assessment and adapted detection method requirements or iii) pre-notification of products that are also obtainable naturally or by conventional breeding. Part of the considerations of these plans includes strategic impacts on the SME market share in the breeding/seed industry, research in NGTs, food security in EU, market concentration, IP rights and EU trade.


Perspectives

NGTs carry the promise to accelerate plant breeding contributions in the coming years, in a way it has never seen before. Regulatory policies cannot keep pace with the fast-moving scientific advances. Some of the challenges to face are the speed at which new technologies are being developed, regulations not fitting the NGTs, difficulties with international coordination, lack of public understanding and trust, and lack of political will. Many countries are still in the process of developing regulatory approaches for products of GEd plants, so the opportunity remains for enhancing global regulatory coordination. Among many countries that have already built a GEd regulatory approach, some positive alignment is emerging in terms of using a “case-by-case” method, offering the ability to distinguish between GMOs and non-GMOs.