EUROPEAN UNION — The European Food Safety Authority (EFSA) initiated a formal review of the fungicide fluazinam after a new study from Stockholm University challenged the scientific basis of its 2005 approval. The review addresses an earlier study that found no effects on brain development in rats, which was used for fluazinam's EU approval in 2008. Fluazinam is a PFAS fungicide used to control soil-borne fungal pathogens in potatoes and apples.

Researchers from Stockholm University conducted a new study on fluazinam using the same statistical methods as the 2005 report. This new study identified six instances where exposure to fluazinam led to impacts on brain development in rats. Specifically, the study found decreases in brain weight and width in the offspring of exposed rats. The new study has not yet undergone peer review.

Stockholm University researchers stated, "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." They further noted, "We would say that the conclusions in the 2005 report (specifically those relating to the brains in adult offspring) are entirely unreasonable and not supported by the results that should have been reported." The study authors wrote, "In our opinion, considering the potentially lifelong consequences of brain development deficits, an effect of a chemical on brain weight, width and morphometrics qualifies as severe."

Dr. Axel Mie, lead author of the Stockholm University study, stated that "Animal studies could not be directly extrapolated to humans." However, he added, "If a substance harmed brain development in rats, it must be assumed that the same could occur in humans." Fluazinam is currently being evaluated for re-approval in the EU. In 2024, 340 tonnes of fluazinam were sold in Germany. Fluazinam has also been detected at children's playgrounds in Italy's South Tirol region.

Dr. Angeliki Lysimachou, head of science and policy at Pesticide Action Network (Pan) Europe, stated, "This is a breach of both legal obligations and scientific integrity that demands an urgent investigation, full accountability for those responsible, and the immediate withdrawal of fluazinam from the market." Nick Mole, a policy manager at Pan UK, said the UK's Health and Safety Executive should "immediately revoke its authorisation." Fluazinam was carried into the UK's approved active substance register after Brexit and is approved for use in the UK until 2029.

EFSA stated that the Austrian Agency for Health and Food Safety (AGES) has been tasked with reviewing the statistical analysis and underlying data for fluazinam's approval. An EFSA spokesperson noted, "EFSA does not act alone: conclusions are reached collectively with member states through the peer review process." The spokesperson also indicated, "We expect to publish our conclusions on the safety of fluazinam, agreed and drawn up together with all EU member states, by the first quarter of 2027."

A spokesperson for ISK stated that the company has not received the underlying analysis of the new study. This spokesperson also said, "The study of this active substance forms part of the regulatory assessment and has been reviewed by competent authorities in accordance with applicable procedures."