Overview
This newsletter is a regular source for the latest updates and insights on regulatory developments in the chemicals and sustainability sector. It provides comprehensive coverage of new regulations, guidelines and compliance requirements from EU regulatory bodies and other key agencies.
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European Parliament Vote on the One Substance One Assessment (OSOA) Package
On April 1, 2025, the European Parliament adopted a series of amendments concerning the three legislative proposals forming part of the OSOA package. The package had been put forward as a part of the chemicals strategy for sustainability announced by the Commission in 2020. The three aforementioned legislative proposals were adopted by the European Commission in December 2023, with the purpose of streamlining the assessment of chemicals via EU legislation, enhancing the knowledge on said chemicals and improving both early detection and action regarding chemical risks.
The OSOA package comprises the following proposals:
- a regulation establishing a common data platform on chemicals,
- a directive concerning s regards the re-attribution of scientific and technical tasks to the European Chemicals Agency (ECHA), and
- a regulation aimed at the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals.
As proposed by the European Commission in 2023, the common data platform on chemicals (item 1 above) intends to gather an unprecedented amount of information compiled under EU legislation regarding hazards, physico-chemical properties, presence in the environment, emissions, uses, environmental sustainability as well as levels of chemicals found in human monitoring data. The data would be made accessible and available to authorities to use in any regulatory context.
The Members of the European Parliament (MEPs) have voted for in favor of the common data platform on chemicals and sought via amendments to further extend the scope of information that the platform would include. Notably, the amendments would require ECHA, as platform manager, to include a database on chemicals in articles and a database on safer alternatives to substances of concern.
MEPs also expressed their position via the vote on the two other files of the package (items 2 and 3 above) seeking to improve cooperation among EU agencies competent in the area of chemicals. They proposed amendments to the texts and a longer period for the new rules on tasks attributed to ECHA to enter into force.
As the Council agreed on its position on the files taken in June 2024, both the Parliament and the Council are now ready to enter inter-institutional negotiations with the objective of the final adoption of the texts.
Omnibus Package: « Stop-the-Clock » Proposal Passes in Parliament
On February 26, 2025, the Commission published its first set of omnibus proposals intended to simplify EU sustainability legislation, enhance competitiveness of EU industries and bring additional investment capacity. In essence, the Omnibus Package includes:
- A proposal postponing the application of the CSRD for certain companies by two years and postponing the transposition deadline and the first wave of application of the CSDDD by one year – the so-called "stop-the-clock" proposal;
- A proposal for a Directive amending the requirements of the Corporate Sustainability Reporting Directive (CSRD) and the Corporate Sustainability Due Diligence Directive (CSDDD);
- A draft Delegated act amending the Taxonomy Disclosures and the Taxonomy Climate and Environmental Delegated Acts;
- A proposal for a Regulation amending the Carbon Border Adjustment Mechanism Regulation (CBAM).
For more details about the package, please refer to our Client Alert on this topic describing the EU regulatory changes the Omnibus package would bring forth if adopted1.
On April 1, 2025, the European Parliament voted in favor - with a total of 427 votes for, 221 against and 14 abstentions - of applying the urgency procedure in order to fast-track the decision regarding the stop-the-clock proposal.
Two days later, on April 3, 2025, the European Parliament voted in favor of the stop-the-clock proposal. With 531 votes for, 69 against and 17 abstentions, MEPs supported the Commission proposal.
The proposal now only requires formal approval by the Council, which had already endorsed the stop-the-clock proposal on March 26, 2025.
If adopted, the stop-the-clock proposal will:
- postpone by two years the application of the CSRD reporting requirements for companies that are due to report in 2026 and 2027 (so-called wave 2 and 3 companies);
- postpone the CSDDD transposition deadline for the Member States by one year (to July 26, 2027); and
- postpone the first phase of the CSDDD’s implementation by one year (to July 26, 2028), giving the initial group of companies (more than 5,000 employees and generating a net worldwide turnover of more than EUR 1.5 billion) more time to prepare for their obligations under the amended Directive.
These extended deadlines would enter into force while the co-legislators debate the Commission's proposed substantive changes to the CSRD and the CSDDD.
First Details on the Scope of the EU REACH Revision
Please join Steptoe and Acumen for a complimentary webinar on Friday, April 11 to discuss the details of the Commission's presentation of directions for the REACH revision, presented at CARACAL. We will go through the details as made available, and the next steps in the process.
Date: Friday, April 11, 2025
Time: 3:00 p.m. - 3:45 p.m. CET | 9:00 a.m. - 9:45 a.m. EDT
New Oxidative Substances Coalition – Join Us on May 15
We are collecting interest from companies to form an industry coalition on genotoxicity testing issues for oxidative substances.
The purpose of the coalition will be to share experiences with testing of oxidative substances for genotoxic endpoints (in particular on inconclusive results and false positives) and to identify actions to address this issue. Companies owning, relying or expecting to rely on such tests for their substances, regardless of the regulatory context (REACH, CLP, BPR, cosmetics), and organizations involved in oxidative substances or non-animal testing methods are welcome.
If this is relevant and you would like to hear more, please use the link below link to register for our introductory session on Thursday, May 15. The purpose of this session will be to explain in more details the scientific concern, as well as the intended purpose and functioning of the coalition. No confidential information, including details about specific testing results or regulatory strategies for individual substances, may or will be exchanged.
Participants wishing to join the coalition will be invited to confirm their interest in a second stage.
Date: Thursday, May 15, 2025
Time: 3:00 p.m. - 4:00 p.m. CET | 9:00 a.m. - 10:00 a.m. EDT
For any questions, please contact Steptoe partner Eléonore Mullier at emullier@steptoe.com
[1] https://www.steptoe.com/en/news-publications/eu-commission-publishes-omnibus-directive-what-you-need-to-know-about-the-latest-eu-regulatory-changes.html
