ECHA Board of Appeal Overturns Agency's Decision in Chemical Mutagenicity Case

Parties Involved

• Appellant: Dragon Chemical Europe GmbH, Germany
• Representatives for the Appellant: Ruxandra Cana, Eléonore Mullier, and Hannah Widemann from Steptoe LLP, Belgium
• Interveners: The National Institute of Health, Italy; PETA Science Consortium International e.V., Germany

Decision Background

The European Chemicals Agency's contested decision required Dragon Chemical Europe to provide additional in vivo testing data to assess the mutagenicity potential of 5-amino-o-cresol. The decision was challenged on several legal grounds, including errors in assessment, proportionality, protection of legitimate expectations, and a failure to adequately state reasons.

Appeal Proceedings

The Board of Appeal, comprising Chairman Antoine Buchet, Technically Qualified Member Nikolaos Georgiadis, and Legally Qualified Member and Rapporteur Marijke Schurmans, thoroughly examined the case. After detailed consideration of all arguments and evidence, including those presented at an oral hearing on 3 October 2023, the Board reached its conclusions.

Detailed Findings and Conclusions

1. Error in Risk Assessment: The Board identified errors in the Agency's risk assessment regarding the substance's potential for mutagenicity.
2. Admissibility of Pleas: Some of the pleas by the PETA Science Consortium were deemed admissible as they were connected to the main subject matter of the dispute.
3. Principle of Proportionality: The Board found that the Agency had breached the principle of proportionality by not adequately demonstrating that the requested tests were necessary and the least onerous measure.
4. Legitimate Expectations and Duty to State Reasons: It was concluded that the Agency had not breached the appellant’s legitimate expectations or its duty to state reasons adequately.
5. Animal Welfare Considerations: The decision emphasized adherence to the principle of using animals for testing only as a last resort, aligning with European Union regulations on animal welfare.

Implications of the Decision

The annulment of the contested decision highlights the rigorous checks and balances in place within the European regulatory framework concerning chemical evaluations. This decision underscores the importance of adhering to scientific and legal standards in environmental and public health protection measures.