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EC legislation proposal on certain NGTs: The Long Way to Get into an Agreement Before its Adoption

An article by Paulo Peralta, Technical Expert at CIOPORA

On July 5th the European Commission (EC) released the legislation proposal on plants obtained by certain new genomic techniques (NGTs) and their food and feed. This legislation draft is structured around two categories of plants aiming to distinguish varieties "considered equivalent to conventional plants" – 'Category 1 NGT plants' – from all other plants obtained through NGTs – 'Category 2 NGT plants'. Furthermore, it considers several aspects intending to facilitate the deregulation process of plants and products developed through NGTs, as explained in Figure 1.

The two categories defined by the EC for the proposal legislation proposal
Fig. 1. EC legislation proposal defined NGT plants produced by mutagenesis, cisgenesis and intragenesis in two categories, each of them with separate regulatory pathways

The proposal is currently before the European Parliament (EP) and the Council of the European Union (Council) for discussion. A long legislative procedure is expected around the text until the EP, the Council and the EC could reach an agreement.

European Parliament

In the EP, the responsible committee is Environment, Public Health and Food Safety (ENVI), and the associated body is the Committee on Agriculture and Rural Development (AGRI). AGRI published a Committee opinion on December 13th, 2023 with 75 amendments, which will be voted on January 24th, 2024 by ENVI. Then, a vote in plenary is expected in February 2024.

Some of the main changes to the document are summarized below.

  • NGT plants Cat 1 shall be allowed in organic farming.

  • Seven years after the entry into force of the Regulation, the EC shall present a report on the evolution of the consumers' and producers' perception, accompanied, if appropriate, by a legislative proposal to lift the ban on the use of NGTs in organic production.

  • Amendments in the definition of Cat 1 NGT plants (Annex 1) improving the coverage of polyploids and the number of genetic modifications.

  • A statement to clarify that NGT plants should not be subject to patent legislation and that they should only be subjected to PBRs. Before 2026, the EC shall present the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and particularly on the opportunities for SMEs.

  • Removal of the possibility for Member States (MS) to restrict the cultivation of NGT plants in their territory (so-called opt-out option).

  • Removal of the requirement of labeling of Cat 1 NGT plants and prohibition of labeling of NGT products

  • Inclusion of herbicide-tolerant plants as part of sustainable traits and, therefore, the benefits derived from it.

  • A declaration that MS should organize factual public information campaigns regarding the safety and benefits of plants obtained through NGTs.

  • An amendment to express that the application of this Regulation shall not prevent imports of NGT plants and products from third countries that meet the same standards as those laid down in the Regulation.

  • A clearer definition of the verification procedure regarding timelines, objections, and responsible authorities.

  • A periodic review of the approach to establish equivalence between conventional breeding methods and NTGs will be required.

  • The available knowledge will be reviewed for a future proposal of regulation on microorganisms developed by NTGs.

Both committees, ENVI and AGRI, are cooperating to find a strong position that would be publicly communicated among the state members, citizens, and stakeholders to promote consciousness on the importance of coming out with a new legislation on NGTs plants.

Council of the European Union

In the meantime, in the Council, the Spanish presidency has failed in the first attempt to adopt a political agreement pending the first reading position of the Parliament, also known as a 'general approach.' A general approach agreed on in the Council could help speed up the legislative procedure and even facilitate an agreement between the policymakers. However, a qualified majority (at least 55% of the MS, representing 65% of the population) accepting the compromise text presented by the Spanish presidency has not been achieved yet.

The compromise text prepared at the Council keeps the ban on NGT plants in organic farming and makes amendments to the definition of Cat 1 and Cat 2 NGT plants (annex 1). Furthermore, herbicide-tolerant traits would not be considered as Cat 1 NGT plants, and Cat 2 NGT plants would remain subject to existing opt-out provisions for GMOs. Whilst, a provision has been included, requiring analysis of the impact of patents by a report from the EC at the end of 2025.

Austria, Romania, Croatia, Poland, Hungary, Slovakia, Luxembourg, and Slovenia disagreed with the compromise text prepared at the Council due to agricultural political reasons. While Germany and Bulgaria have abstained from voting on the text. Several ministers stressed the need to prioritize the quality of the results of the negotiations, rather than the speed. The coexistence of organic agriculture with NGT plants is a common contentious issue among those MS opposing the current text, as well as the lack of traceability measures from seeds to food and feed products derived from all types of NTG plants. Furthermore, the absence of a provision allowing EU countries to ban the cultivation of NGT plants on their territory, and the treatment of patents have emerged as a limitation to obtaining an agreement.

Some of the extreme positions presented by MS include Romania, alleging that without proper traceability of seeds, food, and feed, export products from the Middle East, North Africa and Türkiye could represent a threat to their local agriculture. Also, Cyprus and Malta, are demanding the inclusion of an exception for small territories with fragmented agricultural spaces, which will not be able to implement coexistence of organic farming and NGT plants.

Moving forward: What to expect?

In the Council, the discussions will continue at a technical level with the aim of reaching a political agreement by the end of the year. In January 2024, the presidency will be taken by Belgium and the expectation is that this proposal will be part of its priorities. Acceptance by Poland would be enough to get a qualified majority, so, likely, the issues related to traceability from seed to consumers and the prohibition of patentability of plant materials and DNA sequences would need to be addressed.

In the EP, the situation seems to take a more progressive approach. The results from the prospective plenary in February would tell if the proposal would be ready to be adopted in a first reading, or if it should continue for a second or even a third one (refer to figure 2).

EU countries remain split on several controversial elements, namely the coexistence of organic agriculture with NGT plants, the absence of a provision allowing EU countries to ban the cultivation of NGT plants on their territory, the treatment of patents, or the provision of labeling for consumers. The EC has announced the receptivity to accelerate the study of patentability and subsequently the implementation of a separate legal proposal to cope with it.

Possible scenarios of the legislation proposal pathway
Fig. 2. Possible scenarios of the legislation proposal pathway

Although there is political willingness to advance this proposal, given the fact that the EU is lagging in competitiveness in the development of plant varieties by NGT, still there is a lot of opposition from very influential sectors that see this new technology as a threat more than an opportunity.


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