AseBio calls for a science-based, proportionate European regulatory framework for new genomic techniques that fosters innovation

On 31 August, the European Commission launched a Call for Evidence to prepare the delegated and implementing acts that will further develop the new Regulation on plants obtained through new genomic techniques (NGTs). This process is key to defining the requirements and procedures that will determine how the Regulation is implemented across the European Union.

The Spanish Bioindustry Association (AseBio) has participated in this consultation by submitting two contributions focusing on the verification of Category 1 NGT plants (NGT1) and the risk assessment and authorisation procedures for Category 2 NGT plants and products (NGT2).

Through these proposals, we advocate a regulatory framework based on scientific evidence, with streamlined, proportionate and harmonised procedures across the European Union. This approach should maintain high safety standards while avoiding unnecessary administrative burdens and unjustified delays that could hinder biotechnological innovation and its access to the market.

Streamlined, science-based verification for NGT1 plants

Regarding the delegated acts, we consider it essential that the requirements for verifying the classification of NGT1 plants reflect the biological complexity of plant species and the practical realities of plant breeding programmes.

In this regard, the application of the limits on genetic modifications established in the Regulation should take into account the characteristics of different genomes, particularly in polyploid species, and focus on changes attributable to interventions using new genomic techniques.

We also maintain that genetic variations arising spontaneously or during conventional breeding processes should not be counted when determining a plant's category.

Furthermore, we advocate allowing previously verified NGT1 plants to be used as starting material in subsequent plant breeding programmes, without adding previously verified modifications to those introduced at a later stage. Under this approach, the limit of 20 modifications established in the Regulation would apply only to new modifications introduced through NGTs, enabling the successive development of new plant varieties without imposing cumulative restrictions that could hinder innovation.

Another key priority is the need to establish fast, predictable verification procedures tailored to plant breeding practices. To this end, we propose introducing mechanisms for grouped verification of plants or lines that share relevant modifications and a common evidence base, avoiding the repeated submission of equivalent information.

Against this background, and given that verified NGT1 plants will be treated in a manner comparable to plants obtained through conventional breeding, their verification should not become a de facto authorisation procedure.

Finally, we consider it essential to ensure that a classification recognised in one Member State has clear legal effects throughout the European Union. Any objections raised by other Member States should be scientifically substantiated, based on transparent criteria and should not lead to unjustified delays or new barriers within the internal market.

Proportionate, product-specific risk assessment for NGT2 plants

Regarding the implementing acts, which address applications concerning NGT2 plants and products, we advocate a risk assessment tailored to the specific characteristics of each plant and the traits introduced.

We believe that information requirements and the studies considered necessary should be based on scientifically substantiated risk hypotheses, avoiding the automatic application of requirements developed for other types of genetically modified organisms when they are not relevant.

This approach would make it possible to draw on existing scientific evidence and limit additional studies to cases where there is a specific justification. Similarly, AseBio proposes facilitating exemptions from post-market environmental monitoring when no risks or uncertainties are identified that would justify the need for such monitoring, in accordance with the provisions for exemptions set out in the Regulation.

In addition, we call for clear requirements, predictable timelines and technically feasible analytical solutions for authorisation procedures. In particular, we believe that technical difficulties in identifying or unequivocally attributing certain genetic modifications to a specific product should not prevent its authorisation. To address this, we propose accepting adapted analytical methods and complementary measures that ensure effective official controls, as well as providing for exemptions where even these alternatives cannot meet the required validation criteria.

We also emphasise the importance of preserving the simplifications provided for in the Regulation, such as the unlimited validity of authorisations following their first renewal, while avoiding the introduction of new obligations that would recreate unnecessary administrative burdens.

Finally, AseBio considers it essential to provide clear, harmonised and regularly updated technical guidance to facilitate the implementation of the requirements and procedures applicable to both NGT1 and NGT2 plants. This guidance should be adaptable to scientific and technological advances in new genomic techniques, preventing technological developments from creating regulatory uncertainty or unnecessary difficulties in implementing the Regulation.

AseBio will continue working to contribute to the development of a European regulatory framework for new genomic techniques that is based on scientific evidence, ensures legal certainty, fosters innovation and enables the full potential of plant biotechnology to be harnessed in advancing towards more sustainable and competitive agriculture.