The EU’s long‑awaited regulation on New Genomic Techniques (NGTs) has now cleared its final legislative hurdle, with the European Parliament voting to approve the agreed framework, rejecting last‑minute attempts to reopen key aspects of the political compromise.
As we discussed in our earlier blog on the provisional agreement, the regulation introduces a significant and carefully negotiated shift in the EU’s approach to gene‑edited crops. In particular, it allows certain plants to benefit from lighter regulation and, for those plants, moves the EU closer to a more product‑focused assessment such as that adopted in the UK under the Precision Breeding Act.
The final text confirms the two‑tier system of “conventional‑like” NGT‑1 plants and more complex gene-edited NGT-2 plants.
NGT-1 plants will benefit from a simplified pathway to market and will not require product-level labelling. It is hoped that the clearer and more proportionate regulatory pathway for NGT-1 plants will lead to more competitive positioning of Europe relative to global markets, in turn leading to greater innovation and shorter time-to-market. At the same time, the greater disclosure and transparency requirements for patents covering these plants are likely to present a significant additional burden for applicants, and will merit careful consideration in portfolio strategy.
NGT‑2 plants will remain subject to existing GMO authorisation, traceability, and labelling requirements.
Overall, this two‑tier system represents a meaningful step towards a more workable and innovation‑enabling framework, reflecting the considerable effort from policymakers, industry stakeholders and the scientific community to find common ground. It is expected to ease regulatory burdens in key areas and accelerate the development of crops with improved resilience to abiotic and biotic stresses, helping to reduce the food security impacts of climate change.
While the new framework provides a more innovation‑friendly pathway for certain genome‑edited crops, the framework retains elements of the EU’s traditionally process‑focussed approach – regulating crops primarily based on the process used to introduce a trait, rather than the characteristics of the trait itself. As a result, Europe will continue, at least for now, to lag behind the most progressive jurisdictions around the world, including the US and parts of South America. The broader debate around patents, licensing and access to breeding material is likely to continue as the regime is implemented in practice in 2028.
For those developing or investing in NGT‑based products, today marks a really positive step in ensuring that Europe remains at the forefront of agricultural innovation. The focus is now on making this framework work in practice – in particular, by reviewing how candidate products are likely to be classified and ensuring that IP and regulatory strategies are aligned to take advantage of the opportunities that the new framework presents.
