32025R2455#rec_37Regulation (EU) 2025/2455 of the European Parliament and of the Council

Recital (37)

To ensure consistency between those two study notification mechanisms, as well as to ensure certainty for business operators that are required to notify studies, the rules on the public dissemination of study notifications should, where relevant, correspond in that the notifications should only be made available through the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution. In order to respect the confidentiality of relevant elements of study notifications when they are incorporated in the common data platform, where the Commission or one of the Agencies makes the corresponding registration, application, notification or other relevant regulatory dossier available to the ECHA, it should also indicate which elements of the study notification are to be confidential when it is included in the common data platform. Only those elements should be indicated as confidential where the same element is indicated as confidential in the corresponding application, notification or other relevant regulatory dossier in accordance with the provisions on confidentiality under the originating Union act. In order to facilitate compliance with the requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a common approach for the identification of notified information in order to facilitate the traceability of studies notified to their respective databases. To avoid uncertainty for business operators resulting from the existence of two databases of study notifications, one managed by the ECHA and one by the EFSA, the ECHA should lay down, in close cooperation with the EFSA and in consultation with stakeholders, practical arrangements to facilitate the implementation of the notification obligation, including details as regards the type of studies requiring notification.

Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.