For almost twenty years it was considered safe by European authorities. Today, however, a new study could change the history of fluazinam, a fungicide used in agriculture to protect various crops from soil fungi, in particular potatoes and apples. A problem that concerns us closely since it is also used on Italian apple orchards.
A research carried out byStockholm University and published on July 1st as a preprint (therefore not yet subjected to peer review) claims that a reanalysis of the data used for the European approval of the pesticide highlights possible effects on brain development. If confirmed, these conclusions could have important consequences on the European authorization renewal process, currently underway.
What is fluazinam and where is it used
Fluazinam is a contact fungicide used to prevent and control numerous fungal diseases of agricultural crops. It belongs to the category of PFAS, fluorinated chemicals known for their high persistence in the environment.
It is used mainly in potato cultivation, but also in apple orchards, as well as on other horticultural and fruit crops. In Italy it is authorized in various plant protection products and is also used in areas with a strong apple-growing vocation, such as Alto Adige, where in the past it has also been detected in samples collected near playgrounds located near orchards. And experts have repeatedly raised the alarm about its potential danger.
Read also: In the playgrounds of South Tyrol there is a pesticide that worries experts
What the study found
The new work, signed by researchers Axel Mie and Christina Rudén, does not present new experiments but re-evaluates a 2005 toxicological study, commissioned at the time by the Japanese manufacturer ISK.
That study, conducted on pregnant rats, concluded that fluazinam did not cause statistically significant effects on the brain development of the offspring. Based on available knowledge, the fungicide then obtained approval in the European Union in 2008.
According to the Swedish researchers, however, applying the same statistical methods described in the original report reveals a very different picture. The reanalysis identified six statistically significant effects, including a reduction in weight and brain width in small rats exposed to the pesticide during development.
The authors write that alterations of this type represent a serious sign of possible developmental neurotoxicity and believe that, in light of these results, fluazinam should not have obtained European authorization.
What does this mean for human health? The researchers themselves urge caution. Results obtained in animals cannot be automatically transferred to humans. However, Axel Mie underlines that, in regulatory toxicology, when a substance shows effects on brain development in laboratory animals, the precautionary principle requires considering the possibility that it may also represent a risk for humans until proven otherwise.
For this reason, the authors believe that it is not possible to define with certainty a level of exposure considered safe on the basis of the available data.
How pesticides are authorized in Europe
The debate is not just about fluazinam, but also about how pesticides are authorized in Europe.
According to European legislation, in fact, it is the manufacturing company that finances and presents the studies necessary to demonstrate the safety of the active substance. A Member State carries out an initial scientific evaluation, which is subsequently reviewed by the European Food Safety Authority (EFSA) together with the other countries of the Union. Ultimately it is up to the European Commission and the Member States to decide whether or not to authorize the substance.
Researchers at Stockholm University and several environmental organizations argue that this system presents a potential conflict of interest, as the scientific data used in the initial assessments are produced or commissioned by the same companies seeking permission.
European law professor Antoine Bailleux told the Guardian that if it were confirmed that statistically significant findings on neurotoxicity were not adequately reported or considered, this could represent a breach of European pesticide regulations.
Europe is re-evaluating fluazinam
The new study comes at a particularly delicate moment. The approval of fluazinam is in fact being renewed. The European authorization should have expired already in 2018, but, as is the case with many active substances, the re-evaluation process is still ongoing and the authorization has been temporarily extended until the conclusion of the review.
After the publication of the new analysis, EFSA commissioned the Austrian Agency for Health and Food Safety (AGES) to verify the new statistical analysis and the original data.
The European Authority specified that the review will be independent and that the definitive conclusions on the safety of fluazinam should be published in the first quarter of 2027.
For its part, ISK, the Japanese multinational that developed the active ingredient fluazinam, declared that it was aware of the new accusations but could not comment on the merits without having examined the complete analysis, reiterating its trust in European regulatory procedures.
Beyond the outcome of the European evaluation, the matter brings to the center a broader question: how effective and transparent the control systems for chemical substances used in agriculture are.
If the new study were to be confirmed by scientific review and checks by the authorities, it could represent one of the most significant cases in recent years in the re-evaluation of an already authorized pesticide, with possible consequences not only for fluazinam but also for the way in which the toxicological data underlying European authorizations are analyzed and interpreted.
Sources: Stockholm University preprint / The Guardian
