PMC Vlissingen Netherlands BV filed a lawsuit against the European Commission at the General Court of the European Union (Case T-169/24). The case disputes the new regulation classifying dibutyltin oxide (DBTO) as a Category 1B reproductive toxicant, which means it is considered highly toxic to reproduction. PMC, represented by lawyers J.-P. Montfort, P. Chopova-Leprêtre, and N. Kyriazopoulou, aims to have this regulation annulled and seeks to have the Commission pay for the legal costs.
Key Points of the Legal Challenge
PMC Vlissingen’s lawsuit is based on four main arguments, each pointing out issues with how the European Commission handled the regulation process:
- Incomplete Consideration of Evidence: PMC argues that the Commission didn't take into account all the available scientific data when assessing the risk of DBTO. They claim that a crucial study, which became available before the final regulation was adopted, was ignored. This, according to PMC, violates the principle of sound administration and the specific requirements under the relevant EU regulations.
- Unjustified Use of Read-Across Approach: The second argument is that the Commission wrongly used a "read-across" approach. This method involves inferring data from similar substances when direct data is not available. PMC claims that this approach was not necessary or justified by the available evidence. They argue that the Commission failed to follow the proper guidelines and frameworks set by the European Chemicals Agency (ECHA).
- Lack of Clear Evidence for High-Risk Classification: PMC’s third argument is that the Commission did not provide clear and sufficient evidence to classify DBTO as a Category 1B reproductive toxicant. They contend that the studies used by the Commission did not clearly demonstrate that DBTO has the specific property to harm reproduction. PMC also points out that severe maternal toxicity in the studies might have influenced the results, making the classification unjustified.
- Procedural Breach in Consultation: Finally, PMC claims that the Commission did not follow the correct procedure before adopting the regulation. They argue that the Commission failed to properly consult with the Committee for Risk Assessment, which is a required step in the process. This procedural oversight, according to PMC, invalidates the regulation.
Why This Matters
This case highlights the ongoing debates and disagreements between chemical companies and regulatory authorities over the safety classifications of substances. PMC’s challenge brings attention to the importance of how scientific evidence is assessed and the procedures followed in regulatory decisions. The outcome of this case could have significant implications for how substances are regulated in the future.
If PMC wins, it could lead to stricter requirements for evaluating scientific data and more rigorous procedural compliance for regulatory bodies. This would potentially make it more difficult for the European Commission to classify substances without comprehensive and clear evidence, ensuring a more transparent and scientifically sound regulatory process.
