Adopted text
Plants obtained by certain new genomic techniques and their food and feed
TA-9-2024-0325 · P9_TA(2024)0325 · PE754.658
✦ In short · AI summary of this text, generated 4 Sept 2026
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Parliament's amended version of the proposed regulation on plants from new genomic techniques (NGTs) sets rules for their release and marketing, distinguishing category 1 (equivalent to conventional) and category 2 (subject to GMO rules).¶¶¶ It excludes NGT plants from patentability, requires labelling and traceability, and provides incentives for sustainable traits.¶¶¶
Key points
- Category 1 NGT plants are exempt from GMO rules if they meet equivalence criteria in Annex I, with a verification procedure before release or marketing.¶¶¶
- Category 2 NGT plants remain under GMO legislation but with adapted risk assessment and monitoring requirements.¶¶¶
- NGT plants, plant material, genetic information, and process features are excluded from patentability, and Directive 98/44/EC is amended accordingly.¶¶
- Category 1 NGT plant reproductive material must be labelled 'cat 1 NGT' and traceability information held at each market stage.¶¶
- Category 2 NGT products may be labelled with the trait conferred, and incentives apply for traits like yield, stress tolerance, and resource efficiency, but not herbicide tolerance.¶¶¶
- Member States must take measures to avoid unintended presence of category 2 NGT plants in non-GMO products, and Article 26b of Directive 2001/18/EC does not apply.¶¶
- The Commission must report on implementation, monitor impacts, and evaluate the regulation, including a report on patents by June 2025.¶¶¶
- The regulation applies from 24 months after entry into force, but patent exclusions apply from entry into force.¶¶
Who is affected
- Breeders and farmers: NGT plants are not patentable, ensuring access to genetic material, but must comply with labelling and traceability.¶¶
- Organic producers: Category 1 NGT plants are prohibited in organic production, with a review after 7 years.¶
- Small and medium-sized enterprises: Eligible for fee waivers and enhanced pre-submission advice.¶¶
- Importers: Imports from third countries meeting the same standards are not impeded.¶
Figures and deadlines
- 20 genetic modifications maximum for equivalence to conventional plants.¶
- 3 modifications per protein-coding sequence.¶
- 20 nucleotides for substitution or insertion.¶
- 30 working days for verification report and inadmissibility decisions.¶¶
- 20 days for comments on verification report.¶
- 6 months for EFSA opinion on category 2 applications.¶
- 5 years for delegated acts period.¶
- 24 months after entry into force for application.¶
Legal basis: Articles 43, 114 and 168(4)(b) of the Treaty on the Functioning of the European Union¶