Annulment of ECHA Decision on DPHP Substance Evaluation Due to Testing Feasibility Issues

DECISION OF THE BOARD OF APPEAL OF THE EUROPEAN CHEMICALS AGENCY 23 April 2024 (Substance evaluation – DPHP – Amphibian metamorphosis assay with non-standard specifications – Proportionality – Necessity – Appropriateness to achieve the objective pursued – Burden of proof)

The document outlines the proceedings of the Board of Appeal of the European Chemicals Agency regarding the appeal by BASF SE against a decision made on the substance evaluation of bis(2-propylheptyl) phthalate (DPHP). This chemical, used extensively in producing various materials, had been flagged for a detailed assessment due to concerns about its potential endocrine disrupting properties in the environment. The contested decision demanded a complex amphibian metamorphosis assay (AMA) to investigate these properties further, specifying intricate testing conditions due to DPHP's low solubility and potential environmental impact.

BASF SE contested the decision, arguing that the required study was unnecessary, inappropriate, and disproportionately burdensome. They also raised concerns about the feasibility of the testing method involving the substance's solubility and the effects of using acetone in test feeds. The Board of Appeal concluded that the AMA, as prescribed, was not feasible and could not yield meaningful results, thus annulling the original decision and remitting the case for further review by the Agency. The appeal was decided in favor of BASF SE, leading to the refund of the appeal fee.