In November 2024, the European Food Safety Authority (EFSA) identified fludioxonil, a widely used fungicide, as an endocrine disruptor affecting estrogen, androgen, and steroidogenesis (EAS) pathways. This classification has significant implications for regulatory compliance, consumer safety, and environmental health.

Key Insights from EFSA’s Peer Review

Human Health Concerns

Fludioxonil meets the criteria for endocrine disruption (ED) under EU Regulation (EC) No 1107/2009. It affects EAS modalities in humans and non-target organisms, raising concerns about its safety.

• Metabolite CGA227731: Identified as genotoxic in vitro and in vivo.
• Consumer Dietary Risks: Unresolved data gaps related to residue definitions for primary and rotational crops, and insufficient information on the effects of water treatment processes on residues.

Environmental Concerns

• Groundwater Contamination: Data gaps in the identification of certain soil metabolites prevent a conclusive groundwater exposure assessment.
• Exceeding Parametric Limits: For certain uses, predicted groundwater metabolite levels exceed the parametric limit of 0.1 μg/L.

Ecotoxicology and Non-Target Organisms

Fludioxonil demonstrates endocrine-disrupting properties for non-target organisms, posing risks to the ecosystem.

Source: EFSA

Regulatory and Industry Impact

This peer review is part of the renewal process under Commission Implementing Regulation (EU) No 844/2012, amended by Regulation (EU) No 2018/1659. Fludioxonil’s representative uses include applications on wheat, oats, grapes, pome fruit, and strawberries for fungicidal efficacy.

While the evaluation highlights no critical issues in physical, chemical, and technical properties, gaps in toxicological and environmental data remain significant barriers to final approval.

What This Means for Stakeholders

Manufacturers, agricultural producers, and regulatory bodies must address data deficiencies to align with EU standards. These findings emphasize the need for rigorous safety evaluations in pesticide applications.

About Fludioxonil

Fludioxonil is a broad-spectrum fungicide known for its efficacy in controlling fungal diseases in crops like wheat, grapes, and strawberries. However, the EFSA’s latest evaluation highlights concerns over its endocrine-disrupting properties and potential impacts on human and environmental safety.

For further information on regulatory compliance and market access for pesticides, reach out to our experts at REACH24H.