The emergence of new genomic techniques (NGTs) has enabled the development of plant varieties with enhanced traits, including improved tolerance to diseases and pests, higher resilience to climate change, and better efficiency for nutrient uptake and water-use efficiency.
On July 5th, the European Commission (EC) published a regulatory proposal on plants obtained through certain NGTs. The objective of the proposal is to maintain the level of protection for human, animal, and environmental health while promoting innovation and sustainability in the EU agri-food sector, boosting competitiveness. The proposal aligns with other Union policies and strategies such as the European Green Deal, Farm to Fork, and Biodiversity strategies, as well as the Union's Strategy on Adaptation to Climate Change. Additionally, the legislation seeks to align with the policy, currently under review, on the marketing of seeds and Plant and Forest Reproductive Material (‘PRM’, ‘FRM’).
1. A long way to come out for a change
The proposal is the outcome of a thorough analysis of the Union's legal framework (Directive 2001/18/EC) on genetically modified plants (GMOs). The analysis revealed that the current policy was no longer suitable for the rapidly evolving global biotech innovation landscape. External studies conducted between 2010 and 2011 highlighted this challenge. Subsequent stakeholder consultations held between 2021 and 2022 showcased a divided stance among different sectors. Academia, research, breeders, farmers (excluding those in organic and GM-free production), agri-food chain operators, and public authorities favored adapting the legislation to a more enabling framework. On the other hand, environmental organizations, NGOs, and consumer groups supported maintaining the status quo.
To devise the new legislation, an impact assessment study was conducted, exploring various approaches. The preferred option emerged as a verification procedure instead of authorization for NGT plants and products that could also occur naturally or be produced by conventional breeding. While for all other NGT plants and products, would need authorization, an adapted risk assessment, and the traceability would be maintained as the baseline for GMOs, with differentiated labeling to promote sustainability.
2. The proposal…
The regulation proposal focuses on plants and plant products obtained by targeted mutagenesis and cisgenesis (including intragenesis), excluding those developed by other NGTs. Plants carrying genetic material from non-crossable species would be treated as GMOs.
The text establishes two categories of NGT plants. Category 1 NGT plants would be those with genomic modifications that closely resemble or cannot be easily distinguished from those of conventionally bred or naturally occurring plant varieties. The criteria of equivalence of NGT plants to conventional plants will rely on the fact that the genetic modification does not exceed 20 nucleotides (either inserted, deleted, or to interrupt an endogenous gene), target an inversion of any number of nucleotides, or any other targeted modification of any size that is also found in a species from the breeders’ gene pool. Then, Category 2 would include all NGT plants that do not fit in Category 1.
In terms of regulation, category 1 NGT plants would require a verification procedure but not authorization, risk assessment, traceability, or labeling. While category 2, would need authorization and an adapted risk assessment to address diverse risk profiles and detection challenges. Traceability would be maintained as the baseline for GMOs, with differentiated labeling to promote sustainability for this latter category.
According to the legal proposal, the use of NGTs is currently incompatible with the current EU regulation on organic production and labeling, as reflected by most of the organic sector. This implies that NGT plants will remain prohibited in organic production and may involve indicating NGTs' use in seed labeling and providing information in public registries.
Verification of the notification criteria and the risk assessment would be carried out, in certain cases, by a EU regulatory body (in other cases, the procedures would be handled by the Member States). The European Food Safety Authority (EFSA) tasks would include the notification and authorization of NGT plants from 2025 onwards.
3. Structure of the proposal
The regulation is divided into 34 articles grouped by 4 chapters. The chapters explain from the general provisions to the treatment of category 1 and 2 NGT plants and products.
Chapter I:
General Provisions (Arts. 1-4)
This chapter establishes the subject, scope, and definitions of the regulation. It specifies that the regulation applies to the intentional release of NGT plants for any other purpose than placing on the market and placing on the market of NGT products.
Chapter II:
Category 1 NGT plants and Category 1 NGT products (Arts. 5-11)
It explains that category 1 NGT plants are exempted from the requirements of GMO legislation and are subject to the provisions applicable to conventional plants. However, they are prohibited in organic production.
The chapter also mentions the verification procedure to establish equivalence with conventional plants and products. The verification procedure will be done by Member States, when field trials have been carried out in the Union, or submitted to EFSA in no field trials is needed. Verification of the plant status before intentional release for any purpose other than the placing on the market (Art. 6), and before the placing on the market of NGT products (Art. 7).
A database of decisions declaring the category 1 NGT plant status (Art. 9) would be publicly available.
Labeling of category 1 NGT plant reproductive material, including breeding material, and for scientific purposes should be labeled (Art. 10).
Confidentiality (Art. 11) - Certain parts of applications should be considered confidential, such as DNA sequence information, breeding patterns and strategies, and manufacturing process for food and feed, and commercial information revealing sourcing and market shares.
Chapter III:
Category 2 NGT plants and Category 2 NGT products (Arts. 12-25)
The GMO legislation procedures are adapted for these plants, considering risk assessments, detection methods, monitoring requirements, and renewal procedures. Regulatory incentives apply to category 2 NGT plants with certain desirable traits.
Category 2 NGT plants and products are still subject to traceability and labeling requirements in the Union's GMO legislation, with the possibility to include a factual statement about the genetic modification's intended purpose. Member States cannot restrict or prohibit the cultivation of category 2 NGT plants, but they must adopt coexistence measures to prevent their unintended presence in organic and conventional crops.
Chapter IV:
Final provisions (Arts. 26-34)
This chapter contains the provisions on delegating and implementing acts (Arts. 16-28), guidance (Art. 29), monitoring, reporting and evaluation (Art. 30), references to other Union legislation (Art. 31), administrative review (32) and amendments of other legislation (Art. 33).
4. Expected results from the legislation plan
Diverse authorization procedures: The authorization and risk assessment requirements would be tailored to the specific characteristics of different products, reducing cost and administrative procedures.
Support for Breeders: It is expected that the proposal would simplify and future-proof the regulatory framework, supporting breeders' global competitiveness and innovative power.
Increased Varieties for Farmers: Farmers would have access to more varieties of crops that are adapted to current needs, including plant traits contributing to a sustainable agri-food system.
Consumer Benefits: Consumers would benefit from products designed to meet their expectations and needs, such as improved taste, enhanced nutrient profiles, or reduced allergen content.
Opportunities for Academic/Research Institutions: Academic and research institutions would have more funding opportunities within the EU for their research in NGTs.
Conclusions
The European Commission's proposal on plants obtained by certain is a result of a comprehensive analysis of the Union's current legal framework on genetically modified plants. The proposal distinguishes between two categories of NGT plants: Category 1, which is treated similarly to conventional plants and exempted from GMO legislation requirements by a verification procedure, and Category 2, which requires authorization, but is still a simpler procedure compared to the current legislation on GMOs. The expected results from the legislation plan include diverse authorization procedures, which would reduce costs and administrative burdens for breeders.
The new policy acknowledges that the use of NGTs is currently incompatible with the EU regulation on organic production and labeling, as reflected by most of the organic sector. This means that NGT plants will remain prohibited in organic farming, and there may be indications of NGTs' use in seed labeling and public registries.
Even though the legislative proposal is just the first step, before being discussed and approved by the European Parliament and the Council of Ministers from individual EU member states, it also represents an act of action to the emerging technologies in plant breeding. According to EC, the proposal aims to strike a balance between fostering innovation and sustainability in the EU agri-food sector while safeguarding human, animal, and environmental health with the release of this text.
In response to this proposal, CIOPORA is currently implementing a strategy to engage the international community of breeders, other breeders' associations, and other stakeholders to gather valuable feedback and to produce a document to be sent to EC to improve the policy.
Additional information: Current EU legal framework on GMOs
Cartagena Protocol on Biosafety to the UN Convention on Biological Diversity.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms.
(1) Disclaimer
This article has been prepared based on the following documents prepared by European Commission:
The provision of this document (and the information contained therein) do not represent the position of CIOPORA, it is solely intended to inform the members about the legislation proposal presented by the European Commission and does not constitute legal or technical advice.