Case A-002-2024 concerns a compliance check. ECHA rejected read-across adaptations in a registration dossier and required the appellant to fill a number of data gaps. The appellant argued that ECHA’s decision was incorrect and submitted additional information to the Board of Appeal to support its read-across adaptations.
The Board of Appeal held that ECHA did not commit an error in considering that the information contained in the dossier at the time of the decision was insufficient. It also held that the additional information submitted in the appeal proceedings cannot alter that conclusion, as it was not contained in the dossier at the relevant time. However, that information may be assessed in a follow-up procedure.
The appeal was therefore mainly rejected, but the Board of Appeal corrected a mistake in the decision concerning the route of administration for certain required studies.
