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REPORT (COM(2023)0779 – C90449/2023 – 2023/0453(COD))

On the proposal for a regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals

A-10-2025-0018

Committee on the Environment, Climate and Food Safety · Rapporteur: Dimitris Tsiodras

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Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's amended version of the proposed regulation establishes a common data platform on chemicals, managed by the European Chemicals Agency, to integrate chemicals data from Union agencies and the Commission, with dedicated services and rules on accessibility and usability. It lays down rules for data findability, accessibility, interoperability and reusability, including unique chemical identifiers, standard formats, and controlled vocabularies, and sets up a monitoring and outlook framework with indicators and an early warning system. It requires business operators and laboratories to notify studies on chemicals to a database of study notifications, with confidentiality protections, and allows the ECHA to commission studies, including Union-wide human biomonitoring, prioritizing non-animal methods. It grants authorities access to all data, including confidential, while the public gets access to non-confidential data free of charge, and requires authorities to respect the originator principle and confidentiality markings.

Committee position. The Committee on the Environment, Climate and Food Safety proposes to amend the Commission proposal to strengthen data accessibility, confidentiality protections, and the role of agencies, and to expand the platform's scope to include more data types and research data.

Key points

  1. The common data platform must be established within three years of entry into force and include datasets listed in Annex IIIa, with further datasets integrated within eight years.
  2. The Commission must adopt an implementation plan within six months of entry into force, and establish a governance scheme with a platform steering committee including representatives from all Union agencies.
  3. Agencies and the Commission must make chemicals data available to the ECHA in standard formats, indicating confidentiality, and the ECHA must make data available within 30 days of receipt.
  4. Researchers funded by Union or national framework programmes must make human biomonitoring data available to the EEA and environmental sustainability data to the ECHA.
  5. The EEA, ECHA, EFSA, EMA, EU-OSHA and the Commission may process human biomonitoring personal data for specified purposes, acting as data controllers, and must not share such data with third parties.
  6. The ECHA must establish a database on chemicals in articles and a database on safer alternatives to substances of concern, integrating existing information from waste and ecodesign legislation.
  7. The ECHA must establish a database on regulatory processes, including information on whether animal testing is involved, and make that information public without undue delay.
  8. The ECHA must establish a repository of reference values, including values from research programmes, and a database of study notifications that is kept confidential and not made public.
  9. The ECHA must establish an observatory for specific chemicals selected by the Commission, and may commission scientific studies, including Union-wide human biomonitoring surveys every five years, with samples from business operators if needed.
  10. The EEA must develop an early warning and action system, drawing up annual reports, and authorities must act on early warning signals or justify inaction within six months.
  11. The Commission must publish guidance for the uptake of research data, and the ECHA must establish an online platform for researchers to submit such data.
  12. The Commission must review the workload and resources of agencies, and assess extending the platform to additional medicinal active substances and data types.

Who is affected

  • Business operators and laboratories must notify commissioned studies on chemicals to the ECHA database, with exemptions for research-only studies.
  • Researchers and research consortia funded by Union or national programmes must provide human biomonitoring and environmental sustainability data.
  • The European Medicines Agency must include data on medicinal active substances, with older data included after eight years.
  • The general public gets free access to non-confidential data on the platform.
  • Authorities, including Member State competent authorities and Union agencies, have access to all data and must respect confidentiality.

Figures and deadlines

  • Three years after entry into force for establishment of the platform and its dedicated services.
  • Eight years from entry into force for integration of further datasets.
  • 30 days for the ECHA to make received data available through the platform.
  • 6 months after entry into force for the Commission to adopt the implementation plan.
  • 18 months after entry into force for the study notification obligations to apply.
  • Every five years for Union-wide human biomonitoring studies.
  • Eight years after entry into force for inclusion of EMA data from procedures concluded before entry into force.

Legal basis: Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union