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EU-approved pesticide fluazinam linked to potential brain development effects

Created at 2 Jul · 5:06 AM1 source↑ Market-relevant
IN SHORT

A new study suggests fluazinam, an EU-approved fungicide, may negatively impact brain development in rat offspring, raising concerns about its market approval and continued use. Regulators are reviewing the findings.

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Key Numbers

2005year of original neurotoxicity study
2008year fluazinam was approved in EU
340 tonnesfluazinam sold in Germany in 2024
sixinstances of statistically significant impacts found in new study
2029fluazinam approval expiry in UK
Q1 2027expected publication of EU safety conclusions

Who's Involved

Stockholm University researchers
conducted new study on fluazinam's neurotoxicity
Huntingdon Life Sciences
conducted original 2005 study on fluazinam
ISK
manufacturer of fluazinam fungicide
Antoine Bailleux
professor of EU law and legal theory
Dr Angeliki Lysimachou
head of science and policy at Pesticide Action Network (Pan) Europe
Hans Peter Arp
environmental chemist at Norwegian Geotechnical Institute
Nick Mole
policy manager at Pan UK
Dr Axel Mie
lead author of the new study
Christina Rudén
professor at Stockholm University and co-author of the study
European Food Safety Authority (EFSA)
EU agency reviewing fluazinam safety
Austrian Agency for Health and Food Safety (AGES)
asked to review fluazinam data by EFSA

↳ Why This Matters

The findings raise serious questions about the safety of a widely used pesticide and the integrity of the EU's pesticide approval process, potentially impacting public health, particularly children's neurological development, and necessitating a review of regulatory oversight.

Key facts

  • A new study suggests the EU-approved fungicide fluazinam may negatively impact brain development in rat offspring.
  • The study found statistically significant impacts on brain development, including decreases in brain weight and width.
  • Researchers claim the original 2005 study, used in the EU's 2008 approval, had flawed conclusions and methodology.
  • Campaigners and experts are calling for fluazinam's withdrawal from the market and an investigation into its approval process.
  • EU regulators are reviewing the new findings, with conclusions expected by the first quarter of 2027.

A new study by Stockholm University researchers has raised significant concerns about the safety of fluazinam, a fungicide approved for use in the European Union since 2008. The study, which re-analyzed data from a 2005 study conducted by Huntingdon Life Sciences on behalf of manufacturer ISK, found statistically significant negative impacts on the brain development of rat offspring, including decreases in brain weight and width.

Campaigners and some experts argue that the original 2005 study's conclusions were flawed and that fluazinam should not have been approved. They contend that failing to report such findings constitutes a breach of EU pesticide regulations and scientific integrity, demanding an urgent investigation and the immediate withdrawal of the fungicide from the market. Fluazinam is used to control fungal pathogens in potatoes and apples, with 340 tonnes sold in Germany alone in 2024.

The authors of the new study state that it is impossible to establish a safe level of exposure for fluazinam given its potential effects on brain development. They also noted that the original 2005 study's conclusions were unreasonable and not supported by the raw data when using the specified methods. The fungicide is currently undergoing re-approval in the EU and remains approved in the UK until 2029.

In response, the European Food Safety Authority (EFSA) has requested the Austrian Agency for Health and Food Safety (AGES) to review the statistical analysis and underlying data for fluazinam's approval. AGES will conduct further assessments, with conclusions on the safety of fluazinam expected by the first quarter of 2027. ISK, the manufacturer, stated they are aware of the claims but cannot comment further without receiving the underlying analysis.

Frequently asked questions

Fluazinam is a fungicide approved for use in the EU since 2008, used to control fungal pathogens in crops like potatoes and apples.

A new study suggests fluazinam exposure may negatively impact brain development in rat offspring, causing decreases in brain weight and width.

A 2005 study on behalf of the manufacturer concluded there were no statistically significant effects on brain development in rat offspring.

EFSA has asked AGES to review the statistical analysis and data, with conclusions on fluazinam's safety expected by the first quarter of 2027.

What Happens Next

01AGES will complete its assessment of fluazinam's statistical analysis and data.
02EFSA and EU member states will scrutinize the findings in the context of fluazinam's ongoing risk assessment.
03Conclusions on the safety of fluazinam are expected to be published by the first quarter of 2027.

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Cadence

How It Developed

A 2005 study by Huntingdon Life Sciences on behalf of ISK found no significant effects of fluazinam on rat brain development.
The EU approved the fungicide fluazinam in 2008 for use on potatoes and apples.
A new, un-peer-reviewed study by Stockholm University researchers using the same statistical methods found six instances of statistically significant impacts on brain development.
The new study noted decreases in brain weight and width in rat offspring exposed to fluazinam.
Authors of the new study stated that the conclusions of the 2005 report were unreasonable and unsupported by the data.
Legal experts suggest that failing to report statistical significance in developmental neurotoxicity could breach EU pesticide regulations.
Campaign groups called for an investigation, accountability, and the immediate withdrawal of fluazinam from the market.
The study authors argue that a safe exposure level cannot be established, and fluazinam should not have been approved.

Sources

T1
EU-approved pesticide found to have potential effects on brain developmentThe Guardian

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