Framework of indicators
1. The EEA and the ECHA shall, in collaboration with the EFSA, the EMA, EU-OSHA and the Commission, and in consultation with the Member States, establish, manage and update as appropriate a framework of indicators to:
(a)
monitor chemical pollution throughout a chemical’s lifecycle, including emissions, occurrence and fate;
(b)
monitor the drivers and impacts of exposure to chemicals; and
(c)
measure the effectiveness of Union law on chemicals and the transition towards the production of safe and sustainable chemicals.
2. The framework of indicators shall, where meaningful and to the extent possible, include an aggregated territory-based risk indicator to monitor, as regards the exposure of populations to individual and multiple chemicals:
(a)
time and spatial trends in such exposure;
(b)
health risks associated with such exposure.
3. The framework of indicators shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available to the public through the common data platform.
Early warning and action system for emerging chemical risks
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.
Observatory for specific chemicals with the potential to contribute to emerging chemical risks
1. The ECHA shall establish and manage an observatory for specific chemicals or groups of chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on properties, safety aspects, uses and market presence of those chemicals.
2. The Commission shall select the chemicals for the purposes of the observatory referred to in paragraph 1on the basis of scientific and technical progress and using the signals of the early warning system referred to in Article 22. The selection shall include potential contributors to new and emerging chemical risks among innovative rationally designed materials with new or enhanced properties or targeted or enhanced structural features at nanoscale.
3. By 2 July 2026 the Commission shall adopt and publish a list of the chemicals selected pursuant to paragraph 2 by means of an implementing act. The Commission shall review the list regularly and adopt any revision thereof by the same means. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29.
4. For the purpose of operating the observatory referred to in paragraph 1, the ECHA shall:
(a)
make use of relevant chemicals data incorporated in the common data platform and compile, analyse and curate further available data on selected chemicals or classes of chemicals;
(b)
commission studies and, where relevant, use the data generation mechanism established under Article 24 to address knowledge gaps or significant uncertainties;
(c)
make compiled data available to the public through the common data platform or other communication and outreach tools, as appropriate, to facilitate the identification of potential further research needs or risk management measures, and to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update those data.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
