EU’s Proposal on NGTs: Updates and Recent Developments
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The European Commission recognizes the potential of new genomic techniques (NGTs) in contributing to a more sustainable and resilient agricultural sector. In July 2023, the Commission released the Proposal on New Genomic Techniques (NGTs) and Plant Reproductive Material (PRM). The proposal, suggested by the Council of the European Union in 2019, will significantly impact Europe's seed companies, farmers, and vegetable growers. The Proposal suggests that plants derived from targeted mutagenesis and cisgenesis be categorized separately from genetically modified organisms (GMOs) and also introduces a notification process for “conventional-like” category 1 plants to confirm their status.
By adapting the regulatory framework, the EU aims to foster innovation while ensuring the safety of humans, animals, and the environment. Since its launch in 2023, the Proposal has been open for feedback from interested parties while the European Council works to reach a common position on the proposal. This has been challenging due to disagreements among member states on issues such as coexistence with organic farming and patenting.
Support for the Proposal on NGTs
On February 7, 2024, Members of the European Parliament (MEPs) adopted a positive position for negotiations with member states on the Commission proposal on New Genomic Techniques (NGTs), with 307 votes in favor, 263 against, and 41 abstentions. The positive vote aims for a more sustainable and resilient food system by developing improved plant varieties that are climate resilient, pest resistant, and give higher yields or that require fewer fertilizers and pesticides.
After the vote, rapporteur Jessica Polfjärd (EPP, Sweden) said, “NGTs are crucial to strengthen Europe's food security and to green our agricultural production. The new rules will allow the development of improved plant varieties that can ensure higher yields, be climate resistant, or require fewer fertilizers and pesticides. I hope member states will soon adopt their position so we can adopt the new rules before the European elections and give the farmers the tools they need for the green transition."
Before the MEPs' positive vote, the European Parliament's Environment Committee (ENVI) approved the Proposal on NGTs on January 24, 2024, with 47 votes in favor to 31 against, and 4 abstentions, marking a significant advancement in fostering plant breeding innovations in the region.
The positive vote of the MEPs was supported by agri-food associations, research and public institutions, NGOs, and farmers’ organizations. Over thirty Nobel prize winners, including CRISPR pioneers Emanuelle Charpentier and Jennifer Doudna, and thousands of scientists signed an open letter urging the Environment Committee to endorse NGTs.
In a video released in October 2024, the American Seed Trade Association featured experts from across the agricultural supply chain on the transformative potential of NGTs. The experts said that MEPs need to act and embrace NGTs for the good of European farmers, global food systems, and the planet.
Challenges of the Proposal
In late 2023, the French Agency for Food, Environmental, and Occupational Health and Safety (ANSES), and the European national agencies raised their concerns about the potential risks that NGTs could pose. The French Agency for Food, Environmental and Occupational Health & Safety openly challenged the main elements of the Commission's 2023 draft legislation on plants edited with NGTs in two opinions. The opinions criticized the Commission's criteria for categorizing NGTs and argued that the risks associated with products from NGTs are comparable to those created by transgenesis, the process used in developing genetically modified organisms.
The European Commission countered the critical remarks of the French food agency and defended the scientific robustness of the new legislation on new genetic techniques for plants during a hearing before the European Parliament's Environment Committee on April 9, 2024. Klaus Berend from the Commission's general directorate for health emphasized that the draft law is based on scientific research provided by the European Food Safety Authority (EFSA) since 2012, as well as on impact analyses on human and animal health, the environment, and economic and social risks. Berend also cited the letter signed by Nobel Prize winners defending the safety of NGTs.
In a report presented to the European Union's Parliament's Committee on the Environment, Public Health, and Food Safety, EFSA confirmed that Category 1 NGT plants present no additional hazards compared to those produced through conventional breeding. EFSA concluded that genetic modifications in NGT plants align with those found in conventionally bred plants, justifying their equivalence.
In May 2024, the Belgian presidency presented a new compromise text to break the stalemate on the regulation for plants created with NGTs. Despite the new compromise text, national experts of the European Union could not find an agreement. The attempt was not successful, and a minority of member states, including Poland, Austria, Croatia, and Slovakia were still reluctant to endorse the legislation.
Poland took over the chair of intergovernmental policy talks on January 25 as holder of the rotating EU Council presidency. According to reports, Poland sought to move forward from the stringent EU licensing and traceability requirements and wants to discard Hungary's call to reopen the entire policy discussion – reverting instead to an earlier outline of the definition and focusing on the patent issue.
Uncertainty about the EU Proposal
The EU proposal on NGTs represents a significant step towards adapting regulations to the rapid advancements in biotechnology. By differentiating between NGT1 and NGT2 plants, the proposal aims to streamline the approval process for those deemed to be as safe as conventionally bred crops while maintaining scrutiny for more complex modifications.
The EU proposal on NGTs has the potential to reshape the future of plant breeding in Europe, offering opportunities for innovation while prioritizing safety and sustainability. It could benefit farmers and consumers. Farmers could have access to more crops that meet their needs. Consumers could have more food options with improved taste, nutrition, and fewer allergens. However, with various stakeholders holding different views and arguments, it became a more complex issue. While it aims to create a more suitable regulatory framework for NGTs, the Proposal needs to address some of the concerns brought by the other European governments such as categorization, risk assessment, coexistence with organic agriculture, patents, and public perception.
For Further Reading:
- European Parliament Votes to Support Proposal on NGTs
- EU Proposal for Gene-Edited Plants Gets First Green Light from Parliament
- EU Researchers and Farmers Call on Members of Parliament to Embrace NGTs
- EU Commission Defends Proposal on NGTs Against French Food Safety Agency
- EFSA: Category 1 NGT Plants Equivalent to Conventional Breeding
- EU Fail to Find Agreement on NGT Proposal
- Poland Seeks to Break EU Deadlock on NGT Proposal
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