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Plants obtained by certain new genomic techniques and their food and feed

TA-9-2024-0067 · P9_TA(2024)0067 · PE754.658

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Parliament's amended version of the proposed regulation on plants obtained by certain new genomic techniques (NGTs) and their food and feed lays down rules for their release and marketing, ensuring a high level of protection for health and the environment. It establishes two categories of NGT plants: category 1, equivalent to conventional plants, and category 2, subject to authorization. It also excludes NGT plants from patentability and amends Directive 98/44/EC accordingly. The text sets criteria for equivalence, including limits on genetic modifications, and requires labelling and traceability for category 1 NGT plants. It prohibits the use of category 1 NGT plants in organic production until further consideration, and requires monitoring for category 2 NGT plants. It also calls for reports on patents' impact and on other sectors like microorganisms, and for a review of equivalence criteria every four years.

Key points

  1. The regulation applies the precautionary principle and aims to ensure a high level of protection of human and animal health and the environment.
  2. Category 1 NGT plants are those equivalent to conventional plants, meeting criteria in Annex I and at least one trait in Annex III Part 1, and not having exclusion traits.
  3. Category 1 NGT plants are excluded from patentability, as are plant material, genetic information, and process features.
  4. Directive 98/44/EC is amended to exclude NGT plants and plants from techniques listed in Annex I B of Directive 2001/18/EC from patentability.
  5. Category 1 NGT plants are prohibited in organic production, but adventitious presence is allowed; the Commission must report on consumer and producer perception after 7 years.
  6. Category 2 NGT plants require consent or authorization, and monitoring plans for environmental effects are always required initially, with possible waiver only upon renewal.
  7. Plant reproductive material of category 1 NGT plants must be labelled 'New Genomic Techniques' with the identification number.
  8. Traceability for NGT products must be ensured by transmitting and holding information at each stage of placing on the market.
  9. Competent authorities can withdraw decisions if monitoring shows risks to health or environment, with 15 days for observations and immediate marketing prohibition.
  10. Incentives for category 2 NGT plants apply only if they have traits listed in Article 51(1) of the proposed Plant Reproductive Material Regulation and no exclusion traits.
  11. The Commission must report by June 2025 on patents' impact on breeders' and farmers' access, and by 2024 on other sectors like microorganisms.
  12. The Commission must assess and update equivalence criteria every four years via delegated acts.

Who is affected

  • Breeders and farmers: they are protected from patents on NGT plants, ensuring access to genetic material.
  • Organic producers: category 1 NGT plants are prohibited in organic production, but adventitious presence is allowed.
  • Applicants for category 1 NGT status: they must provide information on techniques and traits, and face possible withdrawal of decisions.
  • Patent holders: their rights are limited for NGT plants and biological material.

Figures and deadlines

  • 30 working days for competent authority to prepare verification report.
  • 20 days for other Member States and Commission to make reasoned objections.
  • 10 working days for national authority to adopt decision after no objections.
  • 45 working days for Commission to prepare draft decision after objections.
  • 15 days for beneficiary to make observations on withdrawal decision.
  • 5 years for delegation of power, with report 9 months before end.
  • 24 months after entry into force for application, but Articles 4a and 33a apply from entry into force.
  • No more than 20 nucleotides for substitution or insertion, and no more than 3 per protein-coding sequence.