Europe approves gene editing for crop improvement, reaching a historic milestone

Current situation and next steps of the European legislation on New Genomic Techniques

As of June 17, 2026, the EU legislation on plants obtained through New Genomic Techniques (NGT/NTG) and the derived food and feed is in the final phase of the ordinary legislative procedure, with the political content already agreed but some formal steps pending completion. According to El Demócrata, the European Parliament approved the Regulation itself on June 17, 2026, while other technical sources still indicated that formal approval in Plenary was pending. In any case, the Council already adopted the text on April 21, 2026, and the framework is practically closed. The next key milestones are publication in the Official Journal of the EU, its entry into force, and, after a transitional period of 24 months, its full effective application, likely around 2028.

1. Exact stage of the procedure

The proposed Regulation on plants obtained through certain NGTs and the derived food and feed was presented by the Commission on July 5, 2023, establishing a two-category system (NGT1 and NGT2) and also amending Regulation (EU) 2017/625 on official controls. This general framework is collected and explained, among others, in the Spanish Ministry of Agriculture's FAQ document (MAPA – FAQ NGT).

The Council of the EU reached a political agreement and finally formally adopted the Regulation on April 21, 2026, as sectoral analyses such as Revista Mercados and Phytoma report. From the Parliament side, the substantive position was already closed since its first reading, and the interinstitutional agreement was consolidated at the end of 2025.

The relevant novelty is that, according to El Demócrata, the Plenary of the European Parliament gave the green light to the Regulation on June 17, 2026, thus culminating the political approval of the text. Other more technical sources available until recently indicated that "formal approval by the European Parliament was missing," but this is consistent with the final vote being scheduled precisely for mid-June. From this moment, the Regulation is considered adopted by the co-legislators and enters the purely formal phase (signature and publication).

2. Essential content of the new NGT framework

All sources agree that the Regulation introduces a key differentiation between two categories of NGT plants. On one hand, NGT1, which include limited genetic modifications comparable to those achievable through conventional breeding; these will be subject to simpler requirements (notification, registration, certain conditions) and will no longer bear the full regulatory burden of traditional GMOs. On the other hand, NGT2, with more complex modifications, will remain under a regime close to that of classic genetically modified organisms, with risk assessment and comprehensive authorizations, as described by Revista Mercados and Revista Agricultura.

Additionally, the Parliament promoted a very restrictive approach regarding patents on NGT plants and NGT plant reproductive material, aiming to avoid seed market concentration and excessive litigation; this approach has been maintained, with adjustments, in the final compromise text. The Regulation also foresees public registers of NGT varieties, transparency and labeling obligations in certain cases, and coexistence measures to protect organic farming, aspects highlighted by MAPA itself in its technical analysis (FAQ NGT).

3. Formal next steps in the EU

After approval in the Parliament Plenary and adoption in the Council, the remaining procedure is fundamentally formal but legally decisive. First, the Regulation must be signed by the Presidents of the European Parliament and the Council. Then, it will be published in the Official Journal of the European Union (OJEU), from which point the timeline for entry into force and application will begin.

According to Revista Mercados, the agreed text foresees that the Regulation enters into force 20 days after its publication in the OJEU. However, its material application will be deferred by a 24-month transitional period, so the new framework would start to be fully applied around mid-2028. During this interval, the Commission must adopt implementing acts (technical classification criteria, notification formats, etc.) and issue guidance for authorities and operators.

4. Implementation and effects in Member States, focusing on Spain

As it is a Regulation, there will be no classic transposition into national law: the rule will be directly applicable in all Member States, including Spain, from the date of application set. However, States must adapt their administrative organization, control systems, and related regulations (for example, regarding seeds, variety registers, or distribution of competences among authorities). MAPA has already explained, in documents such as its 2023 FAQ, that the reform implies clearly separating the regulatory treatment of NGT from conventional GMOs.

Spain played an active role promoting this file during its Presidency of the Council in the second half of 2023, as national analyses recall (MAPA – FAQ NGT, UPA – Anuario 2024). In practice, the Spanish administration will have to: designate or adjust competent authorities for NGT, organize official controls, coordinate with autonomous communities, and provide guidance to the agricultural sector and food industry. Until the Regulation effectively begins to apply, the current GMO regime (Directive 2001/18/EC and Regulation 1829/2003, among others) will remain in force, with NGT largely treated as GMOs, according to the 2018 CJEU doctrine.

In summary, the European procedure is practically completed and the focus now shifts to the implementation phase: publication in the OJEU, preparation of implementing acts, and internal administrative and regulatory adjustments, especially relevant for an agricultural country like Spain.

Summary answer

The powers and functions of the Minister of Agriculture, Fisheries and Food, a position held by Luis Planas Puchades in the Government of Spain, are defined by combining the general regulations on Government members and the specific regulation of the Ministry of Agriculture, Fisheries and Food (MAPA). The Law 50/1997, of November 27, on the Government, establishes his status as minister and head of department, responsible for politically directing the agricultural, fishing, and food area and promoting the corresponding legislation. The Royal Decree 717/2024, of July 23, on the basic organizational structure of MAPA, specifies that the Ministry is competent in proposing and executing the Government's policy on agricultural, livestock, and fishing resources, food, agri-food industry, and rural development, and distributes functions among its bodies. Additionally, various sectoral laws (animal and plant health, food chain, rural development, maritime fishing, etc.) assign concrete material functions to MAPA and, by extension, to its head.

General framework of the ministerial position: Law 50/1997 on the Government

The Law 50/1997, of November 27, on the Government, establishes the general statute of ministers, applicable to Luis Planas as a Government member and head of MAPA. According to the provisions cited in the consulted information, the key points are:

First, ministers are members of the Government and heads of a ministerial Department, responsible for a specific sector of governmental action (articles 4, 8 and related). Second, within the framework of article 5, they participate in the direction of internal and external policy, civil and military administration, and State defense, in the part corresponding to their material scope. More specifically, article 10 assigns ministers the direction of the administrative activity sectors integrated into their department, the promotion and drafting of legislative projects within their scope, the exercise of regulatory power as provided by law, and the submission to the Council of Ministers of proposals and matters of their department. Article 12 regulates the possibility of delegating and decentralizing competences within the ministry.

Consequently, based on Law 50/1997, Luis Planas politically directs MAPA, is politically responsible for its management, promotes agricultural, fishing, and food legislation, and adopts or proposes governmental decisions in that field.

Material competences of MAPA: Royal Decree 717/2024

According to official information on MAPA's functions and structure available in transparency (link) and Ministry notes (link), the Royal Decree 717/2024, of July 23, sets the basic organizational structure of MAPA and specifies its major competence blocks. This royal decree establishes that the Ministry is the body of the General State Administration responsible for the proposal and execution of the Government's policy in:

agricultural, livestock, and fishing resources; food; agri-food industry and safety; and rural development. It also assigns the drafting of state legislation in agricultural, fishing, food, and rural development matters, as well as the proposal and execution of the general guidelines of agricultural, fishing, and food policy. Furthermore, it contemplates the definition and execution of policies on food industries and markets, animal and plant health, sanitary and phytosanitary agreements with third countries, and bilateral and multilateral agri-food relations.

The Royal Decree distributes these competences among the Department's senior and management bodies. For example, Government information highlights that the General Secretariat of Agriculture and Food, dependent on the minister, assumes the management of the Common Agricultural Policy (CAP), rural development policy, irrigation, and coordination of policies on food industries and markets, agricultural and livestock resources, and animal and plant health (general regulatory link). The minister, as head of the Department, exercises direction and coordination over all these bodies.

Sectoral laws specifying MAPA's functions

Beyond the Government Law and the structural royal decree, several sectoral laws assign material competences to the State and MAPA, which the minister heads:

The Law 8/2003, on animal health, and the Law 43/2002, on plant health, regulate livestock and phytosanitary health defense; MAPA's structure integrates these matters as part of its functions in animal and plant health. The Law 12/2013, on measures to improve the functioning of the food chain, grants the Ministry a key role in supervising the functioning of the chain, food markets, and agri-food industries, as reflected in the available sectoral analysis (link).

The Law 45/2007, for the sustainable development of rural areas, assigns the General State Administration competences in rural development planning and coordination, assumed by MAPA according to its organic law. The Law 3/2001, on State Maritime Fishing, sets state competences in maritime fishing, within which MAPA proposes and executes fishing policy. Finally, the Law 20/2013, on guaranteeing market unity, although general, conditions the Ministry's regulatory action in food markets and product circulation.

Specific functions of the Minister of Agriculture, Fisheries and Food

Integrating these norms, Luis Planas's functions as minister can be summarized in the following blocks:

First, the political and administrative direction of the Department: coordinating senior bodies (state or general secretariats, undersecretariat, general directorates), setting strategic priorities, and ensuring the execution of government policy in agriculture, fishing, food, and rural development, under the terms of Law 50/1997 and Royal Decree 717/2024. Second, the normative function: promoting before the Government draft laws and royal decrees, and exercising regulatory power within its scope to develop sectoral laws (animal and plant health, food chain, fishing, rural development, etc.).

Third, the management and coordination of sectoral public policies, including the CAP and agricultural aid, irrigation policy, animal and plant health, agri-food safety and quality, and fishing policy; this also involves coordination with autonomous communities and other public administrations. Fourth, the institutional representation of the State in forums and international bodies in the agricultural, fishing, and food fields, in coordination with the Ministry of Foreign Affairs, as reflected in official Government profiles (biography and functions; profile at La Moncloa).

These functions are complemented by political responsibility before the General Courts for the Department's actions, in line with Law 50/1997, and the obligation to coordinate with other ministries on all cross-cutting aspects of agri-food, environmental, economic, and territorial policy.

Summary answer

Under the new European Union regulatory framework on "new genomic techniques" (NGT), a crop is classified as NGT‑1 if the modifications introduced in its genome are equivalent to those that could be obtained through conventional breeding or natural or classical mutagenesis, and also meet strict limits on the number and type of changes. When the modification exceeds those limits (for example, introducing genes from another species or complex combinations difficult to achieve by conventional breeding), the crop is classified as NGT‑2. NGT‑1 is subject to a regulatory regime very similar to conventional crops, while NGT‑2 is essentially treated as a classic genetically modified organism (GMO), with full requirements for risk assessment, authorization, and labeling. Below are the key technical and legal criteria that determine each category.

General concept of NGT and classification logic

European regulation on NGT starts from a distinction between:

a) Modifications "similar to nature" or achievable by conventional breeding, considered not to increase risks beyond traditional crops.
b) Modifications that introduce new, more complex genetic combinations or from other species, potentially with different risk profiles.

Based on this, two groups are created: NGT‑1 (low risk, akin to conventional) and NGT‑2 (other NGTs, treated as GMOs). Classification depends not only on the technique used (e.g., CRISPR) but on the specific genetic outcome.

Legal requirements to be classified as NGT‑1

A crop produced by NGT (gene editing or other targeted techniques) can only be considered NGT‑1 if it simultaneously meets several substantive criteria, articulated in the regulatory proposal as a "box of equivalence" with conventional breeding:

1. Equivalence with conventional breeding
Genome modifications must be possible through traditional crosses or mutagenesis (chemical or radiation), albeit with less precision or more time. That is, it cannot obtain a genetic combination that, in practice, is not achievable by reasonable classical breeding programs.

2. Allowed types of changes
Broadly admitted are:

– Point mutations (substitutions, short insertions or deletions) in one or several loci.
– Loss of function of one or several genes (knock-out) when equivalent to natural or induced mutation.
– Small genome rearrangements (e.g., limited inversions or duplications) provided they do not introduce sequences from other species or large new DNA blocks.

3. Quantitative and structural limits
The rule establishes a maximum number of modifications and restrictions on their length and location, precisely to ensure equivalence with conventional mutagenesis. Although final details may be adjusted in implementing acts, the logic is:

– Limit the number of edited loci in the genome (e.g., several tens at most).
– Avoid large insertions or rearrangements not plausible in a traditional breeding program.
– Do not allow constructs that simultaneously integrate multiple complex traits obtained in a single editing event if this exceeds what is expected by cumulative conventional breeding.

4. Absence of stable functional exogenous DNA
A central requirement for NGT‑1 is that the final product does not contain stably integrated functional exogenous DNA, especially from species not sexually crossable with the crop. Vectors or auxiliary sequences may have been used during the process but must have been removed from the genome in the commercial line.

5. Verification and notification procedure
To be recognized as NGT‑1, the developer must:

– Submit to the competent authority a technical dossier describing the genetic modification, the technique used, and evidence that it meets equivalence criteria.
– Provide molecular characterization data (sequencing, analysis of affected loci) showing no undesired exogenous insertions and that changes comply with defined limits.

– Await official classification; if the authority confirms it is NGT‑1, the crop is subject to a regime close to conventional varieties (without full environmental risk assessment as GMO, no specific mandatory labeling, though with basic registration and traceability).

Requirements and consequences of classification as NGT‑2

Any crop obtained by new genomic techniques that does not meet any of the above requirements automatically falls into the NGT‑2 category. This occurs, in particular, when:

– Stable exogenous DNA from non-crossable species is introduced (e.g., genes from bacteria or another plant family).
– Extensive rearrangements or combinations of multiple complex traits not reasonably achievable by conventional breeding are generated.
– The number or magnitude of genetic modifications exceeds the thresholds set for NGT‑1.

From a legal perspective, an NGT‑2 is subject to a regime very similar to GMOs already regulated by the EU:

– Full risk assessment for human, animal, and environmental health, including toxicological, allergenicity, insertion stability, effects on non-target organisms, etc.
– Authorization procedure at EU level, with scientific opinion from the food safety authority and voting by Member States.
– Mandatory labeling as derived from NGT‑2 / GMO, and reinforced traceability requirements in the food chain.
– Possibility for Member States to adopt certain territorial or cultivation restrictions, depending on how coexistence rules are finally defined.

Practical implications and relation to Spanish policy

From the Spanish political and regulatory perspective, this NGT‑1 / NGT‑2 classification will condition:

– The work of the Ministry of Agriculture, Fisheries and Food and the Ministry for the Ecological Transition in adapting internal regulations and defining control protocols.
– Spain's position in Council and European Parliament debates, where more open approaches (aimed at facilitating NGT‑1 for climate resilience and input reduction) have confronted more cautious stances focused on precaution and consumer transparency.
– Autonomous decisions on agricultural strategies, since the spread of NGT‑1 crops could influence competitiveness, sustainability, and risk management in different territories.

In any case, the key line of the EU framework is that NGT‑1 are legally conceived as an extension of conventional breeding, while NGT‑2 follow the robust treatment of classic GMOs, with much more demanding requirements for safety demonstration and regulatory control.