EU-approved pesticide found to have potential effects on brain development | Pesticides

Researchers re-running a key fungicide study on neurotoxicity have found significantly different findings, and campaigners are arguing the substance should now be withdrawn from the market.

A study conducted in 2005 by Huntingdon Life Sciences on behalf of fluazinam manufacturer ISK on the development of neurotoxicity of fluazinam in pregnant rats concluded that there was no statistically significant effect with respect to brain development in the offspring of the rats.

In 2008, the pesticide fluazinam was approved in the EU following a safety assessment. Fluazinam is a Pfas fungicide used to control various soil-borne fungal pathogens on potatoes and apples. In 2024, 340 tons of it were sold in Germany alone.

The 2005 study was not presented as part of the evidence for the consent judgment, as the Guardian previously revealed, but was used in subsequent discussions.

One new studyUsing the same statistical methods, Stockholm University researchers came to a different conclusion, finding six examples where exposure to pesticides that had not yet been peer-reviewed led to statistically significant effects on brain development.

Specifically, they found that exposure to pesticides led to reductions in brain weight and width in the rat offspring.

“In our view, the impact of a chemical on brain weight, width, and morphometric properties qualifies as serious, given the potentially lifelong consequences of deficits in brain development,” the authors write.

The researchers told the Guardian: “Based on the raw data from the 2005 report, it is impossible to accurately arrive at the conclusions in the 2005 report using the methods set out in the 2005 report. Drawing conclusions from the results is a more complex and less straightforward matter. We can say that the conclusions in the 2005 report (particularly those regarding the brain of adult offspring) are completely implausible and are not supported by the conclusions that should be reported.”

Antoine Bailleux, professor of EU law and legal theory at UCLouvain in Belgium, said failure to report statistical significance when it comes to developmental neurotoxicity would amount to a breach of EU pesticide regulations.

Dr. is head of science and policy at the Pesticide Action Network (Pan) European campaign group. Angeliki Lysimachou said that this study “was withheld from regulators and shielded from proper review. When it finally reached the authorities, warning signs were still missed. This is a breach of both legal obligations and scientific integrity that requires an urgent investigation, full accountability of those responsible, and the immediate withdrawal of fluazinam from the market.”

Given the effects of pesticides on brain development, the study’s authors say it is not possible to determine a safe level of exposure and therefore their use should not have been approved in 2008.

Hans Peter Arp, an environmental chemist at the Norwegian Geotechnical Institute who reviewed the study for the Guardian, agreed that the pesticide should not be approved based on these findings.

Fluazinam is being considered for reapproval in the EU. The fungicide was moved to the UK’s approved active substance register after Brexit, where it is approved for use until 2029.

Bailleux said fluazinam should not be renewed without further investigation.

Nick Mole, policy manager at Pan UK, said the UK Health and Safety Executive should “revoke his authority immediately”.

The study’s authors write that continued use of this pesticide since 2008 may have led to “unnecessary and potentially harmful human exposure.” Fluazinam was detected on: children’s playgrounds In Italy’s South Tyrol region, the pesticide is used to treat apple trees on nearby farms.

The lead author of the study, Dr. Axel Mie said animal studies cannot be directly extrapolated to humans. However, he said that if a substance harms brain development in mice, it should be assumed that the same situation may occur in humans.

Christina Rudén, professor of regulatory toxicology and ecotoxicology at Stockholm University and co-author of the study, said the current EU system for approving pesticides is “based on a conflict of interest” because the company that produces the pesticide is responsible for producing data on its safety.

EU is facing accusations Seeking to further weaken pesticide protections by introducing indefinite approvals.

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

The European Food Safety Authority (EFSA) said the Austrian Agency for Health and Food Safety (AGES) had been asked to review statistical analyzes and baseline data for approval of fluazinam.

A spokesman said: “This review is independent and follows established EU procedures. EFSA does not act alone: ​​conclusions are reached collectively with member states through the peer review process. Once AGES has completed its assessment, the findings will be reviewed in the context of the ongoing risk assessment of fluazinam. We expect to publish our conclusions on the safety of fluazinam, agreed and prepared with all EU member states, by the first quarter of 2027.”

A spokesman for Ages said the concerns raised in the study would be subject to “further assessment to provide a solid basis for a decision to renew approval for fluazinam”.

A spokesman for ISK said: “We are aware of the allegations relating to the 2005 study and are unable to comment further as we have not received the underlying analysis.

“The study on this active substance forms part of the regulatory assessment and has been reviewed by competent authorities in accordance with applicable procedures. We rely on established regulatory processes and emphasize that all relevant claims must be carefully examined and substantiated.”

Huntingdon Life Sciences did not respond to a request for comment.

This story was reported in cooperation with Bayerischer Rundfunk (BR/ARD) in Germany, FF Südtirol in Italy and Sveriges Television (SVT) in Sweden.