Metalaxyl-M 2026: what changes for manufacturers, distributors and farmers

Key data

If your company manufactures, distributes or uses plant protection products containing metalaxyl-M, this regulation affects you directly and requires immediate action. The Implementing Regulation (EU) 2026/1353, published on 16 June 2026, modifies the approval conditions for this active substance, altering the legal framework under which all products containing it operate.

Metalaxyl-M is a systemic fungicide widely used in agricultural crops to combat fungal diseases. Its presence in the European market has been regulated for years, and this new regulation updates the requirements that products incorporating it as an active substance must meet.

What does this regulation establish?

Regulation (EU) 2026/1353 introduces amendments to two previous regulations governing metalaxyl-M:

In practical terms, the regulation requires that all registered plant protection products containing metalaxyl-M be reviewed in accordance with the new approval conditions. Member States have the responsibility to execute that review: they can update existing authorizations by adapting them to the new requirements, or revoke them if the products do not comply.

Economic and operational impact

The impact of this regulation translates into three specific areas for companies in the sector:

• Cost of adapting registrations: Authorization holders will have to review the technical documentation of their products and, if necessary, submit new files to the competent authorities of each Member State. This process may involve regulatory consulting costs, additional tests and administrative fees.
• Risk of loss of authorization: If a product does not pass the review in accordance with the new conditions, the Member State may revoke its authorization. This implies the withdrawal of the affected product from the market, with the consequent impact on sales and agricultural campaign planning.
• Uncertainty in the supply chain: Distributors and farmers who depend on products containing metalaxyl-M must anticipate possible changes in the availability of these fungicides while authorization review processes are resolved in each country.

The regulation does not establish specific economic figures for penalties or fees, but the operational risk of not acting is significant: the marketing or use of a product whose authorization has been revoked may result in serious administrative violations under the national legislation of each Member State.

Who does it affect?

• Plant protection product manufacturers: Companies that produce and market products containing metalaxyl-M as an active substance. They must review all their product authorizations and adapt them to the new conditions.
• Plant protection product distributors: Companies that distribute these products in the market. They must verify that the products in their catalog maintain valid authorizations after the review.
• Farmers and agricultural operations: End users of products containing metalaxyl-M. They must ensure that the products they use remain authorized and that the conditions of use have not changed.
• Technical advisors and agricultural consultants: Professionals who recommend the use of plant protection products and who must update their recommendations in accordance with the new approved conditions.
• Competent authorities of the Member States: National bodies responsible for executing the review and updating or revocation of existing authorizations.

Practical example

A Spanish fungicide manufacturing company has three registered plant protection products in its portfolio that contain metalaxyl-M as an active substance. Following the publication of Regulation (EU) 2026/1353, the Spanish Ministry of Agriculture—as the competent authority—must review the authorizations of those three products in accordance with the new approval conditions.

If one of those products does not meet the new requirements established in the regulation, the authority may revoke its authorization. The company would lose the right to market that product in Spain, would have to withdraw existing stock from the distribution channel and communicate the change to its agricultural customers who used it in their treatment campaigns. For the other two products that do adapt to the new conditions, the company will have to update the technical documentation and obtain the revised authorization before it can continue to market them with full legal guarantees.

What should companies do now?

1. Identify all affected products: Review the complete catalog of own or distributed plant protection products that contain metalaxyl-M as an active substance or co-formulant.
2. Consult the new approval conditions: Read the full text of Regulation (EU) 2026/1353 and compare the new requirements with the conditions under which current authorizations were obtained.
3. Contact the national competent authority: In Spain, the Ministry of Agriculture, Fisheries and Food manages the authorizations of plant protection products. Consult the specific deadlines established for the review of authorizations.
4. Prepare or update technical documentation: If products require adaptation, start the authorization file update process as soon as possible to avoid marketing gaps.
5. Inform the distribution chain and agricultural customers: Proactively communicate to distributors and farmers the status of authorizations for affected products so they can plan their treatment campaigns without interruptions.
6. Evaluate alternatives if any product loses authorization: Identify alternative fungicides with approved active substances that can replace products that do not pass the review.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601353