EU-Approved Fungicide Fluazinam Under Scrutiny After New Neurotoxicity Findings

Fluazinam, a per- and polyfluoroalkyl substance (PFAS) fungicide used on potatoes and apples, received EU approval in 2008 following a safety evaluation that relied on a 2005 developmental neurotoxicity (DNT) study conducted by Huntingdon Life Sciences for the manufacturer ISK. By 2024, German sales reached 340 tonnes, and the compound was retained on the United Kingdom’s active-substance register for use until 2029. Detection of fluazinam residues has also been reported at children’s playgrounds in South Tirol, Italy.

The Guardian

Researchers at Stockholm University re-examined the raw data from the 2005 report using the same statistical methods. Their analysis identified six statistically significant adverse outcomes, including reductions in brain weight and brain width of rat offspring exposed prenatally. The authors argue that such morphometric changes constitute severe effects with potential lifelong consequences, and they contend that a safe exposure level cannot be established.

Suppressed Neurotoxicity Data Exposes EU Pesticide Approval Flaws

The European Food Safety Authority (EFSA) has asked the Austrian Agency for Health and Food Safety (AGES) to reassess the statistical analysis and underlying data. EFSA’s spokesperson emphasized that the review follows established EU procedures and that conclusions will be reached collectively with member states. AGES indicated that the concerns will be examined further to inform the pending renewal decision. ISK, the pesticide’s manufacturer, stated it has not received the underlying analysis and therefore cannot comment beyond affirming that the study was part of the regulatory assessment and reviewed by competent authorities.

The Guardian

Legal scholars argue that omitting statistically significant neurotoxicity findings breaches EU pesticide regulations. Campaign groups, including Pesticide Action Network (PAN) Europe, call for immediate market withdrawal, citing risks to children’s neurological development. In the United Kingdom, PAN policy manager Nick Mole urged the Health and Safety Executive to revoke fluazinam’s authorisation. Environmental chemist Hans Peter Arp affirmed that the new findings undermine the scientific basis for the original approval.

The Guardian

• 2005 DNT study originally reported no significant brain effects.

Suppressed Neurotoxicity Data Exposes EU Pesticide Approval Flaws

• Reanalysis found six significant adverse endpoints, notably decreased brain weight and width.

Suppressed Neurotoxicity Data Exposes EU Pesticide Approval Flaws

• 340 tonnes of fluazinam sold in Germany in 2024.

The Guardian

• Fluazinam is a PFAS fungicide applied to potatoes and apples across the EU.

The Guardian

• The pesticide is slated for re-approval evaluation in the EU and remains authorised in the UK until 2029.

The Guardian

The 2005 report concluded that fluazinam posed no neurodevelopmental risk, whereas the 2026 Stockholm University reanalysis reports significant effects. The original raw data were not submitted to regulators during the 2008 approval process, limiting independent verification. The new study has not yet undergone peer review, and EFSA’s final safety assessment is pending.

The Guardian

• “The researchers told the Guardian: “It is impossible to correctly reach the results in the 2005 report based on the raw data in the 2005 report using the methods specified in the 2005 report.” — Researchers, Stockholm University

The Guardian

• “These findings send exactly the opposite message: Europe needs stronger enforcement, greater transparency, and more independent scrutiny of industry science. When credible evidence points to risks for children’s neurological development, public health must come before commercial interests.” — Dr Angeliki Lysimachou, PAN Europe

The Guardian

• “immediately revoke its authorisation” — Nick Mole, Policy Manager, PAN UK

The Guardian

• “A spokesperson said: “This review is independent and follows established EU procedures.” — EFSA spokesperson

The Guardian

• “further assessments in order to provide a sound basis for the decision about the renewal of the approval of fluazinam.” — AGES spokesperson

The Guardian

AGES will complete its statistical reassessment in the coming months, after which EFSA and EU member states will finalize a risk assessment. The agency has indicated that its conclusions will be published by early 2027. Depending on the outcome, the EU may decide to maintain, amend, or withdraw fluazinam’s approval, while the United Kingdom’s regulator faces parallel pressure to reconsider its authorisation.

The Guardian