AseBio welcomes progress toward a specific framework for NGTs and calls for technical rigor and legal certainty in the implementation phase

The European Parliament and the Council of the European Union have reached a provisional political agreement that, for the first time, establishes a specific legal framework for New Genomic Techniques (NGTs), with the aim of strengthening the competitiveness of the agri-food sector, improving sustainability, and reducing external dependencies. This agreement paves the way for final negotiations and for the drafting of delegated and implementing acts that will define assessment and marketing procedures.

At AseBio, we view this progress positively, as the result of years of work and dialogue with European institutions, since it represents a decisive step toward modernising the European regulatory framework for plant biotechnology. However, we stress that the implementation phase will be key to ensuring that the regulation is proportionate, predictable, and based on scientific evidence, avoiding divergent interpretations among Member States.

NGT Category 1: avoiding arbitrary exclusions

The agreement introduces differentiated pathways for plants obtained through Category 1 NGTs versus Category 2 NGTs, seeking a risk-based regulation that allows for more streamlined authorisation of certain products.

The agreement establishes that NGT1 plants will not be labelled as NGTs, except for seeds, which must be labelled to allow operators to maintain “NGT-free” supply chains if they so wish. This represents an approach of equivalence with traditional plants, but with practical exceptions: the Council and the Parliament will draw up a list defining what falls under Category 1, and this list includes specific exclusions that would be classified as NGT2 to ensure authorisation and traceability, differing from the Commission’s initial proposal.

Nevertheless, we warn that the exclusions included in the NGT1 list (such as herbicide tolerance or the production of insecticidal proteins) should be reviewed on the basis of clear technical criteria, so as not to undermine the principle of proportionality or generate legal uncertainty. Likewise, we stress that this defining list must be technical, predictable, and not disproportionate.

NGT Category 2: a regime equivalent to GMOs

NGT2 will follow a regime similar to that of Genetically Modified Organisms (GMOs), with stricter authorisation, traceability, and labelling requirements, and with the possibility for Member States to opt out of cultivating NGT2 on their territory. We warn that these measures may lead to regulatory fragmentation and affect competitiveness and the agricultural single market.

Patents and protection of innovation

The Regulation incorporates transparency obligations, the possibility of voluntary information on licensing, the creation of an expert group, and a Commission study on the impact of patents one year after entry into force.

We value these elements positively, as they make it possible to assess the real impact of patents based on data and to design proportionate responses. However, any future intervention must preserve incentives for innovation, especially for SMEs and public breeders, avoiding measures that discourage R&D.

Call to institutions

During the regulatory development phase, AseBio calls for:

• Clear and stable rules that avoid regulatory fragmentation.
• Financial and technical support mechanisms for SMEs and industrial scale-up.
• Continuous dialogue with society, explaining benefits, risks, and health and environmental safeguards.

We reiterate our commitment to working with European institutions, national authorities, the agricultural sector, and the scientific community to ensure that the final regulation combines safety, sustainability, and incentives for innovation.