
Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.


the European Commission has renewed the approval of the active substance metrafenone, an essential fungicide used in the agricultural sector. The decision, formalised through Commission Implementing Regulation (EU) 2024/2390, extends the use of metrafenone until 31 October 2039, with the new approval set to take effect from 1 November 2024.
Metrafenone, primarily used for controlling powdery mildew in crops such as cereals, fruits, and vegetables, was first approved under Commission Directive 2007/6/EC. The recent renewal follows an extensive review process led by Latvia and Slovakia as rapporteur and co-rapporteur Member States, respectively.
The renewal comes with additional provisions to ensure continued safety and environmental protection. Member States are tasked with paying special attention to operator and worker protection and ensuring that consumer exposure to residues remains within safe limits. These risk mitigation measures are necessary to uphold the high safety standards of the European Union.
Furthermore, additional assessments have been requested to confirm that metrafenone does not possess endocrine-disrupting properties. The applicant must provide updated information on this by March 2026. Additionally, by December 2024, updated assessments regarding the genotoxicity of certain metabolites must be submitted.
The European Food Safety Authority (EFSA) played a pivotal role in assessing metrafenone's safety, ensuring that the substance meets the approval criteria laid out under Regulation (EC) No 1107/2009. Despite some concerns raised during public consultations, EFSA's conclusion confirmed that metrafenone is expected to meet the safety standards required for its continued use in plant protection products.
This decision underscores the EU’s commitment to promoting safe and sustainable agricultural practices while balancing the need for effective crop protection solutions. The renewal of metrafenone’s approval represents a critical step in safeguarding crop yields from harmful diseases, contributing to the stability and resilience of European agriculture over the next 15 years.
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