Extension of 26 phytosanitary substances in the EU: what changes for manufacturers and farmers in 2026

Key data

Manufacturers and distributors of phytosanitary products operating in the European market have the green light to continue marketing their products without immediate changes. Commission Implementing Regulation (EU) 2026/2348, published on 26 October 2026, extends the approval of 26 active substances listed in Regulation 540/2011, the reference regulatory framework for phytosanitary products in the EU.

The reason for the extension is not that these substances have passed a new safety evaluation, but that the re-evaluation processes have not been completed on time. This has a direct implication for companies: the authorization is temporary and conditional, and an unfavorable re-evaluation may force reformulation or withdrawal of products from the market.

What does this regulation establish?

Regulation 2026/2348 amends Commission Implementing Regulation (EU) No 540/2011, which is the official list of active substances authorized in the European Union for phytosanitary use. The amendment extends the approval period for the 26 substances detailed below, classified by type of action:

The extension is applied because the re-evaluation processes for these substances have not been completed within the planned timeframe. It does not imply a confirmation of definitive safety: the authorization remains provisional until the technical review is completed.

Economic and operational impact

For companies in the sector, the extension has an immediate positive effect: there is no interruption in marketing. Products formulated with these 26 substances can continue to be sold and used in the European market without the need for urgent withdrawals or reformulations.

However, the operational impact in the medium term can be significant. If the re-evaluation of any of these substances concludes unfavorably, companies will need to:

• Reformulate the affected products, replacing the active substance with an authorized alternative.
• Request new marketing authorizations for the reformulated products.
• Manage the depletion of stocks of products with the withdrawn substance, according to the timelines set by the Commission.

For farmers, the extension guarantees continued access to these products during the valid period, without risk of immediate supply shortages. The agri-food chain as a whole maintains operational stability in the short term.

Who does it affect?

• Manufacturers of phytosanitary products that formulate products with any of the 26 extended substances: can continue producing and marketing without immediate changes.
• Distributors and wholesalers of phytosanitary products in the European market: no sales restrictions during the extended period.
• Farmers and agricultural operations that use products with these substances: guaranteed access without interruptions.
• Regulatory and R&D departments of phytosanitary companies: must monitor the re-evaluation status of each substance to anticipate reformulation decisions.
• Agricultural advisors and field technicians: must inform their farmer clients about the provisional status of these authorizations.

Practical example

A biological fungicide manufacturer that markets in Spain and France a product formulated with Trichoderma harzianum strain T-22 had planned to review its product strategy in the face of possible expiration of European authorization.

With the entry into force of Regulation 2026/2348, the extension allows it to continue marketing that product without interruptions or additional procedures during the extended period. However, the regulatory department must now activate monitoring of the re-evaluation process for this specific strain: if the evaluation concludes unfavorably, the company will need sufficient time to identify an authorized alternative strain, reformulate the product and obtain new national marketing authorizations, a process that can take between 12 and 36 months.

The same scenario applies to any manufacturer working with the extended fumigants (aluminum, magnesium or zinc phosphide), whose technical replacement is especially complex due to the lack of direct alternatives on the market.

What should companies do now?

1. Identify which of the 26 extended substances are present in your product portfolio. Review technical sheets and authorization records for each marketed product.
2. Monitor the re-evaluation status of each substance. The European Commission and EFSA publish the progress of review processes. Assign an internal or external responsible party for this monitoring.
3. Plan reformulation scenarios in advance. For substances with higher risk of unfavorable re-evaluation, begin searching for technical alternatives and analyzing regulatory feasibility.
4. Communicate the situation to the sales network and farmer clients. Confirm that current products can continue to be used and sold without restrictions during the extended period.
5. Review long-term supply contracts that include regulatory compliance clauses, to ensure they contemplate scenarios of withdrawal or reformulation.

Official source

View 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_202602348