32025R2455#art_9Regulation (EU) 2025/2455 of the European Parliament and of the Council

Article 9 — Database of Study Notifications

1. By 2 November 2027, the ECHA shall establish a Database of Study Notifications, which it shall manage. 2. The ECHA shall store the chemicals data notified to it in accordance with Article 26 in the Database of Study Notifications. 3. Data contained in the Database of Study Notifications shall be considered confidential and shall not be made public. 4. Without prejudice to paragraph 7 of this Article, where the Commission or any of the Agencies makes available to the ECHA, in accordance with Article 5(2), a registration, application, notification or other relevant regulatory dossier in the context of which a notification was submitted under Article 26, they shall indicate which elements of the study notifications are confidential when incorporated into the common data platform. Only the elements 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, shall be indicated as confidential in the study notification when incorporated into the common data platform. 5. Upon receipt by the ECHA, in accordance with Article 5(2), of a registration, application, notification or other relevant regulatory dossier in the context of which a notification was submitted under Article 26, the ECHA shall make the related notification information available to the public through the common data platform, and shall respect the confidentiality of the elements indicated confidential in accordance with paragraph 4 of this Article. 6. Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before those data are incorporated into the common data platform. 7. When the EFSA receives an application under Regulation (EC) No 178/2002 and has decided on the disclosure of the studies accompanying that application in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002, it shall make the data that are contained in the database referred to in Article 32b of Regulation (EC) No 178/2002 and that correspond to that application available to the ECHA for incorporation in the common data platform. 8. The ECHA and the EFSA shall cooperate to ensure a common approach for the identification of information notified to them in accordance with Article 26 of this Regulation and Article 32b of Regulation (EC) No 178/2002, respectively, and shall facilitate the traceability of the studies notified to their respective databases.

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