EU Council Endorses Negotiating Mandate for New Genomic Techniques Regulation

Key Takeaways

• EU Council representatives (Coreper) approved the negotiating mandate on the regulation of plants obtained by new genomic techniques (NGTs).
• The proposal aims to foster innovation and sustainability in the agrifood sector while ensuring food security and health protections.
• Two categories of NGT plants are defined:
  • Category 1: Plants that could occur naturally or through conventional breeding; exempt from GMO rules but subject to seed labelling.
  • Category 2: Other NGT plants, regulated under existing GMO laws with risk assessment, authorization, and labelling requirements.
• Patenting regulations will require transparency through a public database and an expert group to assess industry impacts.
• The mandate allows Member States to opt out of cultivating Category 2 NGT plants and implement measures to prevent cross-border contamination.
• The Council and European Parliament will negotiate the final text before the regulation is formally adopted.

EU Council Advances Regulation on New Genomic Techniques

The Council of the European Union has endorsed a negotiating mandate for the regulation of plants obtained by new genomic techniques (NGTs). The proposal, aimed at modernizing EU regulations, distinguishes between two categories of NGT plants and outlines safety, labelling, and patenting requirements.

The regulation seeks to support innovation in plant breeding while ensuring human, animal, and environmental health protections. It also aims to reduce EU dependencies on external food sources by encouraging precision breeding technologies that improve crop resilience and reduce the need for fertilizers and pesticides.

Key Provisions in the Regulation

Defining Two Categories of NGT Plants

The proposal creates a two-tier system for NGT plants:

• Category 1 NGT Plants:

  • Could occur naturally or through conventional breeding methods.
  • Exempt from GMO legislation but require seed labelling.
  • Cannot include herbicide tolerance traits to maintain traceability.

• Category 2 NGT Plants:

  • Subject to EU GMO regulations, including risk assessment, authorization, and mandatory labelling.
  • Member states can opt out of cultivation within their territories.
  • Measures can be taken to prevent cross-border contamination.

Patenting and Transparency Measures

The regulation introduces patent disclosure requirements for Category 1 NGT plants:

• Companies must provide information on existing or pending patents when registering a Category 1 NGT plant.
• The European Commission will maintain a public database listing patented NGT plants for transparency.
• A patenting expert group will assess the impact of patents on:
  • Innovation in plant breeding.
  • Seed availability for farmers.
  • Competitiveness of the EU plant breeding sector.

Additionally, the Commission will conduct a study on patenting effects one year after the regulation takes effect, with a potential follow-up study within four to six years.

Labelling and Consumer Information

• Category 2 NGT plants must include mandatory labelling.
• If product labels highlight genetic modifications, all modified traits must be listed to ensure comprehensive consumer information (e.g., if a plant is both drought-tolerant and gluten-free, both traits must be disclosed).

Next Steps in the Legislative Process

With the EU Council’s negotiating mandate approved, discussions with the European Parliament will now begin to finalize the regulation. The legislation must be formally adopted by both institutions before it enters into force.

The regulation represents a significant shift in EU agricultural policy, adapting to technological advancements in plant breeding while ensuring safety, transparency, and competitiveness in the sector.

Read more here.