We have urged the European Commission to fully incorporate the rulings from three recent EU Court cases led by PAN Europe. These judgments - on cypermethrin, dimoxystrobin, and co-formulants - reveal a troubling pattern: the Commission and Member States' tendency to allow toxic pesticides or extend approvals without sufficient information or long-term safety data. Complying with the law is not an option, in a democratic space: protecting public health, water quality and the environment must take precedence over profit.
Last year, the EU Court of Justice ruled that the European Commission acted unlawfully in reapproving cypermethrin, due to reliance on unscientific risk mitigation measures and inadequate assessment of long-term toxicity. In another case, the EU Court found that the Commission’s practice of granting repeated and lengthy extensions to pesticide approvals is illegal. Lastly, the General Court of the EU clarified that Member States are required to demand toxicity data for co-formulants (hidden ingredients) used in pesticides. None of these legal decisions have, to date, led to changes in the regulatory practice.
The Cypermethrin case
The EU Court of Justice ruled that the Commission acted unlawfully when it reapproved cypermethrin, highly toxic to bees and suspected to disrupt the human endocrine system. They found the decision was not based on a solid and complete risk assessment and relied on unrealistic risk mitigation measures that had never been validated by EFSA.
The Court emphasised that when EFSA identifies critical areas of concern, the Commission may only depart from those conclusions with well-reasoned arguments. This case also highlights a recurring issue: the Commission’s reliance on unvalidated risk mitigation measures, which have also been used in the reapproval of other substances such as abamectin, captan, and quinoline-8-ol. This practice continues: the current proposal to renew mecoprop-P, for example, is based on measures that do not adequately address risks identified for children.
Furthermore, the Court clarified that it must be demonstrated that a long-term toxicity assessment of the pesticide was actually carried out. Currently, the European Commission never carries out such a long-term toxicity assessment.
Extension of approvals, Dimoxystrobin case
PAN Europe challenged the European Commission’s six-year extension of approval of the fungicide Dimoxystrobin. While EU law requires pesticides' safety to be reviewed every 10 to 15 years in the EU, the reality is that many substances like this one undergo an up to 10-year delay in the revision process after the initial approval period ends.
The EU Court of Justice ruled the Commission cannot systematically and automatically grant extensions of pesticide approvals in case of delays in the re-assessment process. Although dimoxystrobin was ultimately not renewed (10 years too late), the General Court ruled on the legality of the extension to prevent similar unlawful actions in the future.
Despite this ruling, the Commission has continued to propose draft regulations extending the approval periods of numerous active substances, including candidates for substitution, PFAS, and substances identified by EFSA as endocrine disruptors, such as cyprodinil, fludioxonil, and phenmedipham. While the Commission justifies these extensions on a case-by-case basis, its approach reflects a pattern of systematic prolongation, which contradicts the Court’s emphasis on the temporary and exceptional nature of such measures.
Systematic delays come from the fact that industry dossiers are of insufficient quality, leading to clarification requests from regulatory authorities. Another reason is the lack of resources provided to national administrations, who carry out a preliminary risk assessment of the application before sending them to the EU. Member States nevertheless have the legal possibility to raise fees for each pesticide application, and have the legal obligation to hire sufficient staff. It is thus a political decision from Member States to not provide the needed resources to allow for a timely and qualitative risk assessment.
Toxicity data of Co-formulants must be assessed
In a judgment, the General Court of the EU also clarified that EU Member States are required to demand toxicity data for co-formulants (hidden additional ingredients) used in pesticides. The absence of such data in pesticide industry applications must inevitably lead to the rejection of the request and suspension of national authorisation of pesticide formulations.
PAN Europe has long argued that a major legislative gap prevents the proper implementation of pesticide laws. To conduct a proper risk assessment of co-formulants, the European Commission should establish data requirements similar to those for active substances.
The Court’s ruling confirms the obligation of Member States to conduct thorough risk assessments of co-formulants and to request the necessary data from industry.
Conclusion: pesticide regulation practice must comply with EU legislation
These rulings in cases started by PAN Europe represent a significant step forward in ensuring that pesticide regulation practice in the EU is based on law, solid scientific evidence and the precautionary principle.
Based on these judgments, PAN Europe called on the Commission to reject incomplete dossiers without long-term toxicity data. We demand mandatory toxicity assessments for all pesticides and co-formulants, as well as strict enforcement of deadlines to prevent delays.
Additionally, EU Member States cannot provide a (re-)authorisation of a plant protection product without a proper risk assessment of all co-formulants. These measures aim to ensure science-based decisions and uphold public health and environmental safety.