Common data platform on chemicals, establishing a monitoring and outlook framework for chemicals
TA-10-2025-0045 · P10_TA(2025)0045 · PE763.255
- Adopted in plenary on · Adopted 481–170–22 · See the decision →
- Full procedure 2023/0453
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Parliament's amended version of the proposed regulation establishes a common data platform on chemicals managed by the European Chemicals Agency (ECHA), bringing together chemicals data from Union agencies and the Commission to improve assessments and transparency.¶¶¶ It sets rules on data access, confidentiality, and interoperability, and creates dedicated services including databases on study notifications, regulatory processes, chemicals in articles, safer alternatives, and environmental sustainability, plus an early warning system and indicators.¶¶¶ It requires business operators and laboratories to notify studies on chemicals, allows ECHA to commission studies, and mandates human biomonitoring studies, with provisions for personal data processing and confidentiality.¶¶
Key points
- The common data platform must be established within three years of entry into force, with datasets listed in Annex IIIa, and further datasets integrated within eight years.¶
- ECHA must make data available through the platform within 30 days of receiving it, and the platform must provide easy, free access to authorities and the public, except for confidential data.¶¶
- Each chemical or material on the platform must have a unique identifier and chemical notation, and data must be stored in interoperable formats with controlled vocabularies.¶¶
- ECHA must establish a database of study notifications, keeping notifications confidential, and only making them public when corresponding regulatory dossiers are submitted, respecting confidentiality.¶¶¶
- ECHA must create databases on chemicals in articles and on safer alternatives to substances of concern, integrating information from existing Union acts.¶¶¶
- The EEA, with other agencies, must develop and update every two years a dashboard of indicators, including an aggregated territory-based risk indicator, to monitor chemical pollution and impacts.¶¶¶
- An early warning and action system is established: the EEA must compile annual reports on emerging chemical risks, and authorities must act on them or justify inaction within six months.¶¶
- ECHA may commission scientific studies, including on emerging risks and Union-wide human biomonitoring, and may request samples from business operators; animal testing only as last resort.¶¶¶
- Business operators and laboratories must notify studies on chemicals to the database, with exceptions for research-only studies and those under other regulations; obligations start 18 months after entry into force.¶¶¶
- The Commission must adopt implementing acts for the implementation plan, governance scheme, and other measures, and is assisted by a committee.¶¶¶
- The Commission must review the workload of agencies and the extension of the platform to additional medicinal substances and data types within specified timelines.¶
Who is affected
- European Chemicals Agency (ECHA): manages the platform and several databases, commissions studies, and receives data.¶¶¶
- European Environment Agency (EEA): collects and hosts human biomonitoring data, develops indicators, and runs early warning system.¶¶¶
- Business operators and laboratories: must notify studies on chemicals to the database.¶¶
- Researchers and research consortia funded by Union or national programmes: must make human biomonitoring and environmental sustainability data available.¶¶
- European Medicines Agency (EMA): provides data on medicinal products, with inclusion of older data after eight years.¶¶¶
Figures and deadlines
- three years after entry into force: platform establishment¶
- eight years from entry into force: integration of further datasets
- 30 days: period for making data available
- six months after entry into force: Commission adopts implementation plan¶
- 18 months after entry into force: study notification obligations apply¶
- eight years after entry into force: EMA data from concluded procedures included¶
- every two years: update indicators¶
- six months after end of first calendar year: first early warning report¶