Article 3 — Common data platform on chemicals

1. The ECHA shall establish and manage a common data platform on chemicals (the common data platform). 2. The common data platform shall provide access to all chemicals data: (a) generated or submitted as part of the implementation of the Union legal acts listed in Annex I and held by the Agencies or the Commission; (b) generated as part of Union, national or international programmes or from research activities in the field of chemicals and held by the ECHA, the EEA, the EFSA, EU-OSHA or the Commission; (c) provided on a voluntary basis by Member States or other parties, including national agencies, research institutes and third-country organisations, and held or accepted by the ECHA, the EEA, the EFSA, EU-OSHA or the Commission. 3. By way of derogation from paragraph 2, the common data platform shall provide access to chemicals data related to human and veterinary medicinal products as part of the implementation of the Union legal acts listed in Annex I, Part 2, only if such data: (a) are held by the EMA; and (b) relate to active substances: (i) that are subject to regulatory processes under other Union legal acts listed in Annex I, Part 1; or (ii) that have particular persistent, bio-accumulative and toxic properties; or (iii) for which a high level of residues has been identified in the environment; and (c) fall into at least one of the following categories: (i) non-clinical safety data, including data related to environmental risk assessments, compiled pursuant to Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council; or (ii) data related to environmental risk assessments, compiled pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council; or (iii) maximum residue levels and the data from which they were derived, compiled pursuant to Regulation (EC) No 470/2009 of the European Parliament and of the Council. 4. The Commission is empowered to adopt delegated acts in accordance with Article 28 to amend: (a) paragraph 3, point (b), of this Article, by adding chemicals data relating to substances contained in medicinal products other than active substances or relating to active substances contained in medicinal products with properties other than those referred to in paragraph 3, point (b) (i) and (ii), of this Article, where relevant to the objectives of this Regulation or if, in view of scientific progress, there is new knowledge about the hazards or risks to the environment or human health; (b) paragraph 3, point (c), of this Article, by adding new categories of data types relevant to the objectives of this Regulation or, if, in view of scientific progress, there are new data on the hazard or risk to the environment or human health. 5. The following information shall not be included in the common data platform: (a) the information referred to in Article 45 of Regulation (EC) No 1272/2008; (b) the information related to cosmetic products and notified to the Cosmetic Product Notification Portal under Article 13 of Regulation (EC) No 1223/2009. 6. Documents relating to Authorities’ internal work or decision-making processes need not be included in the common data platform, unless required to be included pursuant to Article 10. 7. The ECHA shall ensure that each chemical or material for which chemicals data are hosted on the common data platform is identified by a unique technical identifier that links all chemicals data on that chemical or material, and, where possible and available, by specifying its molecular structure by means of a chemical notation, without prejudice to any confidentiality requirements in the originating Union act. 8. The common data platform shall provide the dedicated services identified in the governance scheme referred to in Article 4(3) including: (a) the Information Platform for Chemical Monitoring (IPCHEM), referred to in Article 7; (b) the repository of reference values, referred to in Article 8; (c) the Database of Study Notifications, referred to in Article 9; (d) the database containing information on regulatory processes, referred to in Article 10; (e) the database containing data on chemicals in articles or products, referred to in Article 11; (f) the database containing data on alternatives to substances of concern, referred to in Article 12; (g) the database containing information on obligations under Union law on chemicals, referred to in Article 13; (h) the repository of standard formats and controlled vocabularies, referred to in Article 14; (i) the database of environmental sustainability-related data, referred to in Article 15. The common data platform shall contain appropriate background and explanatory information in order to make it easier for the Authorities and the public to use those data in an informed manner. 9. The Authorities and the public shall, in accordance with Article 19, have easy access, free of charge, to the data contained in the common data platform, as well as to any related context data as referred to in Article 4(5), point (c). Where the data were generated by the Authorities, the context data shall include an indication to that effect. 10. Article 20 shall apply to the use of the data contained in the common data platform by the Authorities. 11. The data contained in the common data platform shall be made available in standard format, and through controlled vocabularies, where available. 12. The data contained in the common data platform shall be electronically accessible and searchable. The ECHA shall take measures to ensure a high standard of security appropriate to the security risks arising from the storage of chemicals data in the common data platform. The relevant Agencies shall take measures in cooperation with the ECHA to ensure that chemicals data are transmitted securely to the common data platform. The ECHA shall design the common data platform in a way that guarantees that any access to confidential data is auditable. 13. The Commission or Agencies under whose authority chemicals data are included in the common data platform shall remain responsible for handling any requests for access to documents made under Regulation (EC) No 1049/2001. 14. The common data platform and its dedicated services shall be established by 2 January 2029, unless specified otherwise. By 2 January 2029 the common data platform shall contain at least the datasets as set out in Annex IV. Other relevant datasets, including chemicals data generated or submitted before 1 January 2026, shall be incorporated progressively into the common data platform by 2 January 2036 in accordance with the implementation plan referred to in Article 4(1). Chemicals data related to human and veterinary medicinal products, as specified in paragraph 3, points (a), (b) and (c), of this Article, resulting from procedures that were concluded before 1 January 2026, shall be incorporated progressively into the common data platform from 2 January 2032. When the ECHA receives chemicals data in accordance with Article 5 belonging to a dataset which has already been incorporated, it shall make those data available through the common data platform within 90 days of receipt.