The European Union is taking a significant step toward establishing a dedicated regulatory framework for New Genomic Techniques (NGTs), also referred to as Assisted Evolution Techniques (TEA). After months of negotiations and a prolonged institutional deadlock, the European Parliament and the EU Council have announced a political agreement that will allow these technologies to be applied across various agricultural sectors.

New Genomic Techniques are already being tested in several strategic agricultural fields, from viticulture and fruit growing to large-scale crops such as tomato, eggplant, wheat, barley, and rice. These projects aim to develop more resilient plant varieties capable of fully expressing their quality traits.

Although the legislative process still needs to be completed, with formal approval from both institutions (the European Parliament and the EU Council), the direction is clear: enabling the development and marketing of new plant varieties obtained through advanced genome editing techniques, while acknowledging their distinction from traditional GMOs (and therefore excluding them from mandatory GMO labeling).

Before examining the measures currently under review by the European Union, it is useful to clarify the key differences between GMOs and the two categories of New Genomic Techniques (NGT-1 and NGT-2).

The differences between GMOs and NGT

Genetically modified organisms (GMOs) are plants, animals, or microorganisms whose DNA is altered by inserting genetic material from another species. This process, known as transgenesis, belongs to traditional genetic engineering and is regulated in the European Union by a strict and detailed framework that includes comprehensive risk assessments, prior authorizations, traceability requirements, and mandatory labeling for products obtained through these methods.

New Genomic Techniques (NGT), also referred to as Assisted Evolution Techniques (TEA), work differently. They modify the plant genome with greater precision, without introducing foreign genes, and reproduce mutations that could naturally occur. This group includes approaches such as targeted mutagenesis, genome editing, and cisgenesis, which allow specific changes to the DNA while preserving the species' genetic identity.

NGT-1 and NGT-2: the classification outlined in the European agreement

The new European framework introduces a clear distinction between two categories of plants developed through NGT, based on the type and extent of the genetic modifications involved.

NGT category 1

NGT category 1 includes varieties in which genetic changes mirror those that could occur spontaneously in nature or be achieved through traditional breeding. No DNA from other species is inserted, and the modifications remain limited, controlled, and consistent with natural plant processes.

For this category, the European Union has established a simplified authorization process: the stringent procedures applied to GMOs will not be required, nor will specific labeling for the final product. The only obligation concerns seeds and reproductive material, which must indicate that NGT methods were used during production.

NGT-1 plants are intended to enhance resilience to climate change (such as drought tolerance or resistance to extreme rainfall) and to improve adaptation to emerging plant diseases, with the potential to reduce the use of pesticides and fertilizers. The European text also addresses intellectual property and patent management, aiming to encourage innovation without concentrating technological control in the hands of a few and ensuring fair access for researchers, producers, and farmers.

NGT category 2

NGT category 2 includes plants developed with genomic techniques that lead to broader modifications or changes that could not occur naturally (which cannot be achieved through natural evolution or conventional breeding). In these cases, the existing GMO legislation will continue to apply, including comprehensive risk assessments, prior authorization for market release, full traceability, and mandatory GMO labeling.

To make the differences between GMOs and the two NGT categories easier to understand, the table below summarizes the main distinctions.

The agreement reached by the European Union marks the beginning of a transitional phase. The final regulatory details will determine how NGTs will be integrated into European production systems.

Safety and traceability

For NGT-1 varieties, a preliminary technical assessment is required. Competent authorities must verify that the genetic modifications fall within the strict limits set for this category (for example, a maximum number of moderate insertions or deletions and the absence of foreign DNA) and that excluded traits have not been introduced (such as herbicide tolerance or insecticidal properties). Only after this verification can the plant be authorized for market release, ensuring a safety profile comparable to that of conventional varieties.

Today, the international scientific community generally considers NGTs - particularly targeted genome editing approaches such as CRISPR - as safe as traditional plant breeding techniques when the modifications fall within the NGT-1 criteria (that is, mutations that could occur naturally). Several European academic and scientific institutions have repeatedly emphasized that targeted edits performed without introducing foreign DNA do not increase risks for the environment or consumers compared to conventional varieties.

In addition, NGT-1 varieties must be listed in a public database and their reproductive material (seeds) labeled as generated using NGT, ensuring full transparency and traceability. This system will allow researchers, farmers, and supply chain operators to identify the origin of the varieties used and monitor their spread, providing greater oversight along the entire production chain.