My bookmarksSign up free

Regulation (EU) 2025/2455 CHAPTER X — REVIEW AND ENTRY INTO FORCE

Article 32–Article 33 · 2 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Reports and review

Article 32

1.   No later than 2 January 2032, the Commission shall assess and adopt a report on the appropriateness and cost-benefit ratio of including in the common data platform the following chemicals data relating to medicinal products pursuant to Article 3(3): (a) new categories of data types; (b) chemicals data on substances other than active substances; (c) chemicals data on active substances that do not meet the criteria referred to in Article 3(3), point (b); (d) chemicals data collected and submitted under Union legal acts listed in Annex I, Part 2, and held by competent authorities of the Member States and not by the Agencies. 2.   No later than 2 January 2030, and taking into account the work done by the OECD on the generation, reporting and use of peer-reviewed published research data for regulatory assessments, the Commission shall assess whether to collaborate with scientific and academic publishers and operators of databases containing contents of peer-reviewed journals on: (a) harmonised reporting of peer-reviewed published research data to scientific peer-reviewed journals; and (b) the use of tools to search, screen and extract peer-reviewed published research data relevant for chemicals assessments from databases containing content from peer-reviewed journals. 3.   Within two years of completing the human biomonitoring study referred to in Article 25, the Commission shall assess the appropriateness of requiring the ECHA and the EFSA, in cooperation with the EEA, to commission regular human biomonitoring studies, as well as the resources necessary for such studies and the practical arrangements for involving Member States in such studies. On the basis of that assessment the Commission may present a legislative proposal. 4.   By 2 January 2032, the Commission shall carry out a general review of this Regulation and present a report to the European Parliament and to the Council, accompanied, if appropriate, by a legislative proposal. The report shall assess the progress made on the implementation and functioning of the common data platform, whether this Regulation has achieved its objectives, in particular to make it easier to reuse data across the Union legal acts listed in Annex I, and the appropriateness of resource allocation to the Agencies and the Commission.

Entry into force

Article 33

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Back to Regulation (EU) 2025/2455 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next