EU NGT Regulation 2024/903: What Biotech Companies and Plant Breeders Need to Know

What Are New Genomic Techniques?

New Genomic Techniques (NGTs) are advanced biotechnological methods developed after 2001 that enable precise modifications to an organism's genetic material. Unlike traditional genetic engineering, which often involves introducing foreign DNA, NGTs can achieve targeted changes that may not require external genetic material. The most prominent example is CRISPR-Cas9 gene editing, which acts like molecular scissors to cut and modify DNA at specific locations. Other NGTs include TALENs (Transcription Activator-Like Effector Nucleases), meganucleases, and cisgenesis, where genes are transferred between sexually compatible organisms. These techniques differ from earlier genetic engineering by their precision and ability to produce modifications that could theoretically occur through conventional breeding or natural processes. The EU needed new regulations because the 2001 GMO Directive was designed for older technologies and didn't adequately address these sophisticated methods. NGTs can create plants with improved traits like disease resistance or enhanced nutrition, but their novelty challenged existing regulatory frameworks that focused on the process rather than the product.

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

The 2001 GMO Directive was inadequate for regulating NGTs because it focused on the genetic engineering process rather than the final product. This created uncertainty when NGT-modified organisms were indistinguishable from conventionally bred varieties. The European Court of Justice's 2018 ruling that gene-edited organisms are GMOs under existing law highlighted the need for reform. The European Commission's regulatory review process involved extensive stakeholder consultation, including scientists, farmers, environmental groups, and industry representatives. The goal was to balance innovation in plant breeding with the EU's precautionary principle for environmental and health protection. Traditional GMO authorization processes were criticized as overly burdensome and lengthy, potentially stifling agricultural innovation. The new regulation aims to create a more proportionate approach, exempting NGT plants that could occur through conventional breeding while maintaining oversight for more complex modifications. This reflects scientific consensus that not all genetic modifications pose the same risks, allowing for differentiated regulatory treatment based on the nature and complexity of the changes.

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

NGT 2 plants follow a streamlined authorization procedure designed to be faster and less burdensome than traditional GMO approvals. The process begins with submitting a technical dossier to the European Food Safety Authority (EFSA), including detailed information about the genetic modifications, risk assessment data, and intended uses. Unlike traditional GMOs, the timeline is compressed to approximately 3-4 years total. The application includes molecular characterization, toxicological and allergenicity studies, and environmental risk assessment, but with reduced data requirements compared to conventional GMOs. EFSA evaluates the dossier and provides a scientific opinion, which member states consider in their decision-making. Cultivation trials may be required to generate additional safety data before full authorization. Key differences from traditional GMO procedures include simplified data requirements, faster timelines, and a focus on comparative assessments rather than absolute safety proofs. Once authorized, NGT 2 plants can be cultivated, processed for food/feed, or placed on the market across the EU, subject to traceability and labeling requirements.

Intellectual Property and Patent Considerations

Intellectual property protection for NGT plants follows standard patent eligibility criteria, but regulatory classification affects patent strategies. NGT 1 plants, being equivalent to conventionally bred varieties, may face challenges in obtaining patents if the modifications could theoretically occur through traditional breeding. However, the specific NGT methods used (like CRISPR) can often be patented separately. NGT 2 plants generally qualify for standard patent protection under the European Patent Convention, as they involve more complex modifications. International IP considerations are crucial, as patent protection varies globally—NGT plants may be patentable in the US and other jurisdictions even if exempt from EU GMO regulations. Companies should consider patenting the NGT methods, specific genetic constructs, and resulting traits. Strategies for protecting NGT innovations include securing broad patent claims on gene editing tools, maintaining trade secrets for proprietary sequences, and using plant variety rights for new varieties. Regulatory data protection periods may also apply, providing market exclusivity. Consulting IP specialists early in development is essential to maximize protection and avoid conflicts with existing patents.

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

Talk to Our Biotech Regulatory Experts

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