EU NGT Regulation: Final Steps Toward a Differentiated Framework

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), zinc finger nucleases, meganucleases, and oligonucleotide-directed mutagenesis (ODM). NGTs also include techniques introducing genetic modifications without inserting genetic material from non-crossable species, such as cisgenesis and intragenesis, 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. 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 Deliberate Release 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 2018 Court of Justice ruling referred to above confirmed that such organisms nonetheless fall within the existing GMO regime, highlighting 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 authorisation processes were criticised as overly burdensome and lengthy, potentially stifling agricultural innovation. The proposed Regulation aims to create a more proportionate approach, with a specific framework for 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 or level of uncertainty, 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. Limits apply, in particular as regards the number and type of targeted genetic modifications permitted. NGT plants that include tolerance to herbicides or produce a known insecticidal substance among the traits intended to be conveyed by the genetic modifications are excluded from category 1 status and therefore by default subject to the provisions on category 2 NGT plants.

Regulatory Treatment: A category 1 NGT plant declaration shall be obtained, on the basis of the scientific equivalence criteria and the exclusion of certain traits, prior to any deliberate release in the Union (first field trial or placing on the market). Once obtained, the declaration exempts category 1 NGT plants from the GMO authorisation requirements and the associated risk assessment and approval procedure.

Labelling & Traceability: The general GMO labelling and traceability obligations do not apply; however, plant reproductive material containing or consisting of category 1 NGT plants is subject to specific labelling indications.

NGT 2 Plants

Definition & Criteria: NGT 2 plants are genetically modified plants obtained by targeted mutagenesis or cisgenesis, or a combination thereof, which do not contain any genetic material originating from outside the breeders' gene pool but which do not fulfil the criteria for category 1 NGT plants. This category includes, in particular, plants exceeding the permitted number or type of targeted modifications, as well as plants conferring tolerance to herbicides or producing a known insecticidal substance.

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.

Labelling & Traceability: Mandatory labelling for NGT 2 products and traceability requirements apply, equivalent to conventional GMOs.

Obtaining a Declaration for NGT 1 Plants

To obtain a category 1 NGT (NGT 1) declaration, an operator must submit a verification request demonstrating that the plant's genetic modifications meet the equivalence criteria of Annex I to the proposed Regulation — meaning they are of a type and extent achievable through conventional breeding — and that none of the excluded traits are present. The request must include the plant's specification, relevant DNA sequence data and studies, a declaration on excluded traits supported by scientific evidence, and patent information.

If the declaration is sought prior to a field trial, the request is submitted to the relevant national competent authority, which prepares a verification report within 30 working days. In the absence of reasoned objections from other Member States or the Commission within 20 days, the authority adopts the decision; otherwise the Commission decides after consulting the European Food Safety Authority (EFSA).

If the declaration is sought prior to placing a product on the market, the request goes directly to EFSA, which delivers a statement within 30 working days. The Commission then bases an implementing decision on that statement within a further 30 working days.

In both cases, the resulting decision is published in the Official Journal and entered in a publicly accessible Commission database, and all plant reproductive material made available to third parties must subsequently be labelled ‘NGT-1’.

The Authorisation Procedure for NGT 2 Plants

Under the proposed Regulation, NGT 2 plants would follow a streamlined authorisation procedure designed to be faster and less burdensome than traditional GMO approvals. The process is expected to begin with submitting a technical dossier to EFSA, including detailed information about the genetic modifications, risk assessment data, and intended uses. The application would include molecular characterisation, toxicological and allergenicity studies, and environmental risk assessment, but with reduced data requirements compared to conventional GMOs. EFSA would evaluate the dossier and provide a scientific opinion, which Member States would consider in their decision-making. Cultivation trials may be required to generate additional safety data before full authorisation. Key differences from traditional GMO procedures are expected to include simplified data requirements, faster timelines, and a focus on comparative assessments rather than absolute safety proofs. Once authorised, NGT 2 plants would be able to be cultivated, processed for food/feed, or placed on the market across the EU, subject to traceability and labelling requirements.

Intellectual Property and Patent Considerations

Intellectual property protection for NGT plants will continue to follow standard patent eligibility criteria, but the eventual regulatory classification is likely to influence patent strategies. NGT 1 plants, being treated as equivalent to conventionally bred varieties, may face challenges in obtaining patents where the modifications could theoretically occur through traditional breeding. The specific NGT methods used (such as CRISPR) can in many cases be patented separately. NGT 2 plants are generally expected to 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 maximise 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 prepare for the emerging 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

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