1. By 2 January 2027, the EEA shall establish a Union early warning system for emerging chemical risks, which it shall manage.
2. For the purpose of paragraph 1, the EEA shall compile data on early warning signals, which shall include at least signals from:
(a) the EFSA’s emerging risks exchange network;
(b) national early warning systems;
(c) data that the EEA holds, including human biomonitoring data, and data from the framework of indicators as referred to in Article 21;
(d) targeted literature searches performed by the EEA;
(e) data made available by the ECHA, the EFSA, EU-OSHA and the EMA in accordance with paragraph 3;
(f) relevant datasets from the EU dataset catalogue established pursuant to Article 79 of Regulation (EU) 2025/327;
(g) relevant information resulting from the implementation of Union law.
The early warning signals compiled by the EEA pursuant to the first subparagraph may be based on a positive identification of an emerging risk or on an uncertainty in the data leading to a potential positive identification of an emerging risk.
3. The ECHA, the EFSA, EU-OSHA and the EMA shall identify and gather relevant available data on early warning signals from the fields falling within their respective mandates and provide those data to the EEA, including data obtained pursuant to this Regulation.
4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. The first report shall be prepared by 2 July 2027. The EEA shall present that report to the Authorities. Within nine months of the presentation of each annual report, the Authorities shall consider undertaking regulatory, policy or enforcement actions accordingly, and provide a justification if they decide not to proceed with any action.
5. The EEA shall make all data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for incorporation in the common data platform.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.