New study finds fluazinam exposure linked to brain development changes in rats

A new analysis of a 2005 study on the fungicide fluazinam found six instances of statistically significant effects on brain development in the offspring of exposed rats, according to researchers who re-ran the study using the same methods. The original study, conducted by Huntingdon Life Sciences for manufacturer ISK, concluded there were no statistically significant effects.

The new analysis reported decreases in brain weight and width among the offspring.

Regulatory background Fluazinam was approved for use in the EU in 2008 after a safety evaluation. The 2005 study was not submitted for the initial approval but was referenced in later discussions. The substance is used on potatoes and apples to control soil-borne fungal pathogens. In 2024, 340 tonnes were sold in Germany.

Current review and responses Fluazinam is being evaluated for re-approval in the EU. The UK carried the substance into its approved register after Brexit, where authorization runs until 2029. The European Food Safety Authority said the Austrian Agency for Health and Food Safety has been asked to review the statistical analysis and underlying data.

The authority expects to publish conclusions agreed with member states by the first quarter of 2027. A spokesperson for ISK said the company is aware of the claims but has not received the underlying analysis and cannot comment further. The company stated that the study formed part of the regulatory assessment reviewed by competent authorities.

Huntingdon Life Sciences has not responded to a request for comment.