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DRAFT 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

ENVI-PR-763255

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

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The draft report proposes amendments to the regulation establishing a common data platform on chemicals, focusing on data scope, confidentiality, and study notifications. It clarifies that only data submitted to EU agencies or the Commission is included, and strengthens confidentiality protections, with sector-specific laws prevailing. It adds a database on substances in articles and alternatives, and extends data-sharing obligations to nationally funded researchers. It limits study notifications to information supporting applications, with a three-month deadline, and excludes certain legislation from scope.

Committee position. The rapporteur proposes amendments to clarify data scope, strengthen confidentiality, add a database on substances in articles, and adjust study notification requirements.

Key points

  1. The scope is limited to data and information submitted to Union Agencies or the Commission under Union acts listed in Annex I.
  2. Confidentiality provisions are strengthened; sector-specific legislation prevails in case of conflict, and authorities must protect confidential data.
  3. The common data platform should include a database on substances in articles and their alternatives, integrating data from the ESPR web portal.
  4. Researchers funded by national programmes must make human biomonitoring and other chemical data available to the EEA or ECHA.
  5. Study notifications are required within three months of commissioning, limited to information like title and scope, with confidentiality claims allowed.
  6. The ECHA acts as data processor for personal data, and authorities remain data controllers for data they provide.
  7. The general public has access only to data considered public under the originating Union act, and the platform must note third-party ownership.
  8. Directive 2001/18/EC on GMOs and Regulation (EU) 2019/4 on medicated feed are removed from Annex I and III.
  9. For medicinal products, only data related to chemicals used in pharmaceuticals is included, and notification is required only after market authorisation application.

Who is affected

  • Business operators and laboratories must notify study information within three months, with confidentiality protections.
  • Researchers funded by national programmes must share chemical data with EU agencies.
  • EU agencies and the Commission must provide data to the ECHA and respect confidentiality rules.
  • The general public gets access only to non-confidential data, with clear terms on intellectual property.

Figures and deadlines

  • Three months from the date of commissioning for study notifications.
  • Six months after entry into force for national researchers to make data available.

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