A fungicide still widely used in European fields – including Italy – has returned to the center of scientific and regulatory debate. A new study indeed challenges the conclusions that contributed to its authorization in the European Union, indicating possible effects on brain development.
The case emerges while Brussels is accused of wanting to further relax the guarantees provided for pesticide approval, introducing authorizations without time limits.
THE STUDY THAT QUESTIONS THE AUTHORIZATION
The fungicide under investigation is fluazinam, a substance belonging to the PFAS family and used against various fungi that mainly affect potatoes and apple orchards. Approved in the European Union in 2008 after a safety assessment, it is now under review for the renewal of its authorization.
The case was reopened by a research, not yet peer-reviewed, which reevaluated a 2005 toxicological study conducted by Huntingdon Life Sciences on behalf of ISK, the producer of fluazinam. At the time, the study concluded that exposure of pregnant rats to the fungicide did not produce statistically significant effects on the brain development of the offspring.
Applying the same statistical methods declared in the original report, researchers from Stockholm University, however, reached different conclusions, identifying six statistically significant effects on brain development, including a reduction in the weight and width of the organ in rat pups.
“In our opinion, considering the potential permanent consequences of deficits in brain development, an effect of a chemical on brain weight, width, and morphometry must be considered serious,” the authors write.
According to the researchers, moreover, “it is impossible to correctly obtain the results reported in the 2005 study starting from the raw data” and the conclusions of the report, particularly those relating to the adult offspring’s brain, would be “completely unreasonable and unsupported by the results.”
THE PRESENCE OF FLUAZINAM IN ITALY
As previously revealed by the Guardian, the 2005 study was not included among the evidence used for the 2008 European approval, although it was referenced in subsequent assessments.
The fungicide, meanwhile, continues to be used in several European countries. Only in Germany, writes today the Guardian, 340 tons were sold in 2024.
Fluazinam is also used in Italy, particularly in the apple orchards of South Tyrol, states the British newspaper. And precisely in this region the substance has been detected in playgrounds near treated orchards. According to the study’s authors, the continued use of the pesticide since 2008 may have caused “unnecessary and potentially harmful human exposure.”
The lead author of the research, Axel Mie, also clarifies that animal studies cannot be automatically transferred to humans but emphasizes that a substance capable of altering brain development in rats must be considered potentially able to produce similar effects in humans.
CALLS FOR WITHDRAWAL
In light of the results obtained, the authors believe it is not possible to define a safe exposure level and argue that fluazinam should not have been authorized in 2008.
Hans Peter Arp, an environmental chemist at the Norwegian Geotechnical Institute, shared this assessment after reviewing the study for the Guardian.
For Antoine Bailleux, professor of European Union law at UCLouvain, the failure to report statistically significant results on developmental neurotoxicity would constitute a violation of European pesticide regulations and the renewal of the authorization should not proceed without further checks.
Angeliki Lysimachou, scientific officer at Pesticide Action Network (PAN) Europe, argues that the study was “kept hidden from regulators and withheld from proper scrutiny.” In her view, “this is a violation of both legal obligations and scientific integrity” that requires “the immediate withdrawal of fluazinam from the market.”
Nick Mole, head of policy at PAN UK, has also called for the UK Health and Safety Executive to revoke the product’s authorization.
EFSA REASSESSES THE DOSSIER WHILE THE EU CHANGES THE RULES
The European Food Safety Authority (EFSA) has announced that it has commissioned the Austrian Agency for Health and Food Safety (AGES) to reassess the statistical analysis and data used for the approval of fluazinam.
“This review is independent and follows the European Union’s established procedures,” explained an EFSA spokesperson, specifying that conclusions shared with Member States are expected by the first quarter of 2027. AGES also confirmed that the issues raised will be subject to further evaluation.
The debate on fluazinam comes as the European Union is accused of wanting to further weaken the pesticide protection system by introducing authorizations without an expiration date.
According to Lysimachou, the new findings point in the opposite direction: “Europe needs stricter controls, greater transparency, and independent verification of industry-funded research. When credible evidence exists of risks to children’s neurological development, public health must take priority over commercial interests.”
For its part, ISK stated it cannot comment on the new analyses as it has not received the data underlying the study, reaffirming confidence “in established regulatory processes” and the assessments of competent authorities.
