NGTs, The New European Framework Takes Shape: Rules, Procedures, and Intellectual Property

With the entry into force of the new European Regulation on NGTs, the decisive phase of implementation has now begun. Delegated and implementing acts will need to define in detail the procedures for Category 1 and Category 2 plants, while the role of Member States and the delicate balance between intellectual property protection and access to innovation remain central. We discussed this with Federico Caruso, an attorney and partner at SIB LEX, who specializes in intellectual property and the legal implications of innovation in the plant sector.

The Regulation has entered into force, but many of its provisions will require implementing acts and delegated acts. What is the scope of the Commission’s action at this stage, and which aspects of the new regulatory framework will be specifically defined through these acts?

There is work to be done, especially for the Commission, which must prepare these acts—necessary to establish and operate all the structures and mechanisms upon which the new system will be based.

For Category 1 NGT plants, a delegated act is planned, which—according to the Regulation’s implementation strategy published by the Commission—must be adopted in the first quarter of 2028. The delegated act will introduce provisions regarding the information that must be provided and the specific procedure for verifying the status of Category 1 NGT plants. A quick review of the feedback submitted by numerous stakeholders as part of the recently concluded call for evidence shows that everyone is calling for clear implementing rules that allow for a uniform and predictable application of the regulation.

For Category 2 NGT plants, however, an implementing act (a Commission implementing regulation) will be required, which will be adopted by July 17, 2028.

It is worth noting that the choice of two different types of acts (a delegated act for Category 1 plants and an implementing act for Category 2 plants) already reflects the different regimes provided for by the regulation. A delegated act, in fact, is a non-legislative act of general application that supplements or amends certain non-essential elements of the legislative act. The adoption procedure is relatively streamlined.

In contrast, implementing acts are legally binding acts that enable the Commission to lay down rules to ensure uniform conditions for the implementation of the regulation. For such acts, the adoption procedure is more complex, and the oversight exercised by the Council and the Parliament is more thorough.

The Regulation distinguishes between Category 1 and Category 2 NGTs plants, establishing a status verification procedure for the former and an evaluation and authorization process for the latter. What are the main differences between the two regimes, and what will be the most sensitive legal and procedural aspects to define for their implementation?

From a legal standpoint, the differences in treatment between the two categories of plants are significant. In fact, the new Regulation “exempts” only Category 1 NGT/TEA plants from the rules set forth in EC Directive 18/2001 on GMOs (and their related national implementations); these plants—as is well known —will no longer be subject to the authorization regime provided for by the GMO Directive, which is very restrictive and to which—in essence—Category 2 NGT will remain subject. For Category 1 NGT, a verification procedure will be used to examine the information and documents provided by the applicant, in accordance with the procedure to be outlined in the delegated act issued by the Commission. Barring complications, the verification procedure, in accordance with the provisions of the regulation, should be completed within 3 to 4 months.

Please note: however, this does not mean that Category 1 NGT will be completely deregulated; on the contrary, the European regulation specifically provides that it is primarily the Member States that are responsible for verifying any violations

One of the most complex issues in the negotiations was intellectual property. What questions remain unresolved regarding the relationship between patents on innovations derived from NGTs, access to genetic material, and the activities of breeders?

The regulation adopted a balanced, compromise solution. Having averted the danger of a patent ban—which had been included in the proposal approved by Parliament in 2024 and would have had very serious consequences for the entire European market—the regulation preserved patent protection while introducing measures designed to prevent and mitigate the risks of abuse.

First and foremost, it is worth noting the transparency rules—not only the (mandatory) patent declaration and the (optional) licensing declaration, which will form an integral part of the dossiers submitted for Category 1 NGT assessments, but also the Category 1 plant database, which must include patent information.

In addition, a code of conduct on intellectual property will be developed by stakeholders under the supervision of the Commission, which will publish guidelines that will give significant attention to the issue of IP.

Finally, let us not forget that the regulation has provided for monitoring mechanisms, including the establishment of a group of experts on intellectual property who will assist the Commission in the periodic monitoring of the sector and evaluate the practices of stakeholders (right holders, producers, research institutions). Consequently, should cases of abuse or difficulties in accessing genetic material be identified, or should there be an excessive increase in litigation, the regulation could be amended—even in a manner less favorable to patents and their holders.

The European Regulation will be directly applicable, but Member States will still be required to fulfill various obligations. Where, in practice, will the line be drawn between European regulations and the responsibilities of national authorities?

As mentioned, Member States will have the task—which is fundamental to the success of the reform and also to convincing the most skeptical—of monitoring compliance with the Regulation’s provisions and of imposing any penalties, which are the same as those currently applied to those who use a GMO in the field or place it on the market without the necessary authorizations.

The role of Member States and national authorities is not limited solely to that of “enforcers.” In fact, particularly for Category 1 NGT plants, if verification is required for purposes other than placing on the market (for example, for experimental purposes), the procedure will be initiated before the national authority responsible for GMO notifications under Directive 18/2001—and, therefore, in the case of Italy, the MASE.

National authorities must operate in accordance with the provisions of the regulation and its delegated and implementing acts. For this reason, there must be no discrepancies in interpretation or implementation in the practices that will be developed over time by the national authorities of individual Member States: industry operators need certainty, including the assurance that the process for verification is the same in all Member States.