EU NGT Regulation 2024/903: What Biotech Companies and Plant Breeders Need to Know
The EU's groundbreaking Regulation 2024/903 on New Genomic Techniques (NGTs) fundamentally changes how gene-edited crops are regulated. This guide explains what NGTs are, how they differ from traditional GMOs, and what compliance requirements apply to your products and operations.
What Are New Genomic Techniques?
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Key takeaway: NGTs can achieve genetic modifications that are indistinguishable from what could occur through conventional breeding, which is the foundation of the new regulatory framework.
Why a New Regulation Was Needed
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NGT 1 vs NGT 2: The Key Distinction
NGT 1 Plants
Definition & Criteria: NGT 1 plants contain genetic modifications that could theoretically have been produced through conventional breeding, crossing with compatible species, or natural processes. They must be equivalent to what already exists in nature or in cultivated varieties.
Regulatory Treatment: NGT 1 plants are exempt from GMO authorisation requirements under Regulation 2024/903. They do not need the lengthy risk assessment and approval process required for traditional GMOs.
Labelling & Traceability: No mandatory labelling or traceability requirements apply to NGT 1 plants, though voluntary labelling is allowed.
NGT 2 Plants
Definition & Criteria: NGT 2 plants are those that cannot be produced through conventional breeding but do not fall into the NGT 1 category. They contain genetic modifications that could not occur naturally or through conventional techniques, or they exceed a certain number of stacked modifications.
Authorisation Procedure: NGT 2 plants follow a streamlined but distinct regulatory pathway. They still require authorisation, but with shorter timelines and simplified data requirements compared to traditional GMOs. The procedure typically takes 3-4 years rather than 10+.
Labelling & Traceability: Mandatory labelling for NGT 2 products (if detected above thresholds) and traceability requirements apply, though these are less stringent than for conventional GMOs.
The Authorisation Procedure for NGT 2 Plants
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Intellectual Property and Patent Considerations
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Impact on ABS and Nagoya Protocol Obligations
If your NGT crops use genetic resources from third countries (e.g., traditional crop varieties, wild relatives collected after October 2014), you must also comply with the Nagoya Protocol and EU Regulation 511/2014. Key considerations include:
- Prior Informed Consent (PIC): Secure PIC from the source country for use of their genetic resources
- Mutually Agreed Terms (MAT): Document benefit-sharing arrangements with source countries
- Due Diligence: Exercise due diligence to ensure genetic resources were accessed legally
- Disclosure: Comply with EU member state disclosure requirements (e.g., Belgium's requirements) when seeking patents or market authorisation
For more information on Nagoya Protocol obligations, see our Nagoya Protocol Compliance Guide.
How 3BIO Can Help
3BIO specialises in helping biotech companies and plant breeders navigate the new NGT regulatory landscape. Our services include:
- NGT Classification Assessment: Determine whether your modified plants qualify as NGT 1, NGT 2, or traditional GMOs
- Regulatory Strategy Development: Plan your optimal regulatory pathway, including timelines and data requirements
- Technical Dossier Support: Prepare comprehensive technical and risk assessment documentation for NGT 2 authorisations
- Cultivation Trial Support: Assist with regulatory approvals for NGT development and field trials in Belgium and the EU
- ABS Compliance: Ensure your NGT development complies with Nagoya Protocol and biodiversity legislation
- Post-Market Compliance: Support for labelling, traceability, and ongoing regulatory compliance once products are authorised
Visit our Biotech Regulatory services page to learn more, or contact us to discuss your NGT regulatory strategy.
Frequently Asked Questions
Q: What are New Genomic Techniques (NGTs)?
A: New Genomic Techniques (NGTs) are biotechnological methods developed after 2001 that can modify an organism's genetic material in ways that do not necessarily involve introducing foreign DNA. The most well-known NGT is CRISPR-Cas9 gene editing. Other techniques include TALENs, meganucleases, and cisgenesis. Under EU Regulation 2024/903, NGTs are distinguished from traditional GMOs by their potential to produce changes that could also occur through conventional breeding or natural processes.
Q: What is the difference between NGT 1 and NGT 2 plants?
A: EU Regulation 2024/903 establishes two categories. NGT 1 plants are those that could have been produced by conventional breeding — they contain modifications equivalent to what could occur naturally or through traditional techniques. They are exempt from GMO authorisation requirements. NGT 2 plants contain more complex genetic modifications and follow a streamlined but distinct authorisation procedure compared to traditional GMOs, with new labelling requirements.
Q: Does the NGT Regulation apply to animals and microorganisms?
A: EU Regulation 2024/903 currently applies only to plants intended for food, feed, or cultivation in the EU. Animals and microorganisms modified by NGTs remain subject to existing GMO legislation (Directive 2001/18/EC and Regulation 1829/2003). The European Commission has indicated that guidance for other organisms may follow.
Q: How does the NGT Regulation affect my existing GMO authorisations?
A: Existing GMO authorisations are not affected by the NGT Regulation. However, companies with products in development should assess whether their modified plants could now qualify as NGT 1 or NGT 2, which could simplify or change their regulatory pathway. 3BIO can help you conduct this assessment and develop your regulatory strategy.
Talk to Our Biotech Regulatory Experts
Need guidance on NGT classification, authorisation strategy, or regulatory compliance? Our biotech specialists are here to help.
Schedule a ConsultationOr email us at info@3bio.eu