May 23, 2025 by Sylwia Kosmala-Grzechnik
The EU is preparing for a significant revision of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), its chemicals legislation. The European Commission published its final proposal of the ‘new’ REACH Regulation for consultation in April, and the final version of the legislation is expected in Q4 of 2025. The update to the legislation is part of the Commission’s priority “new plan for Europe’s sustainable prosperity and competitiveness”, and aims to modernize the regulation, streamline compliance, and strengthen protections for human health and the environment.
Why Is REACH Being Revised?
REACH has been an operating regulation for chemicals within the EU since it entered into force in 2007. However, an evaluation conducted in 2018 highlighted opportunities for improvement, including simplification and burden reduction. The upcoming revision aligns with the European Commission’s 2025 work programme, focusing on “simplification” as part of the broader strategy for “sustainable prosperity and competitiveness”.
Key Changes related to the REACH Registrations
- A 10-year validity for registrations, with ad-hoc completeness checks by ECHA and option for ECHA to revoke registration numbers following expiry of the validity period, after an ad-hoc completeness check, after the deadline to update NONS registrations with full data-sets, or if a registrant fails to update the dossier following an Evaluation decision;
- Obligation to update the dossier if a substance is identified as a Substance of Very High Concern (SVHC);
- Introduction of Testing Proposals for all in vivo tests and complex endpoints (which would also apply for substances registered in 1 – 10 tonnes per year (t/y) and 10 – 100 t/y);
- Changes in the REACH Annexes, including proposed deletion of REACH Annexes III (reduced information requirements) and XIII (PBT/vPvB), and modifications of information requirements in Annexes I, VI–X, and XI (with details still to be discussed by CARACAL);
- Updated Chemical Safety Assessment to include persistent, mobile, and toxic (PMT) and very persistent, very mobile (vPvM) and Endocrine Disruptors (EDs) assessment;
- Introduction of a Mixture Assessment Factor (MAF) to account for combined chemical exposure for substances registered at >1000 t/y.
Other Changes
- Introduction of digital supply chain communication, including the digital safety data sheets and alignment with the Digital Product Passport (DPP) for products;
- Introduction of the nanomaterial definition as agreed in the 2022 Commission recommendation, and adding the definition for the nanoform of a substance;
- Introduction of obligatory notifications of all polymers manufactured or imported at ≥ 1 t/y and obligatory registration requirement for polymers identified as ‘Polymers requiring registration’ (PRR).
Summary
As the European Commission indicated in its work programme for 2023, the aim of the REACH revision is to simplify the regulatory framework, making it more accessible for businesses by streamlining procedures and reducing administrative burdens. However, it introduces significant changes that will increase compliance demands for chemical companies, especially for small and medium-sized enterprises (SMEs). These changes also put additional responsibilities on regulatory authorities and the European Chemicals Agency (ECHA), especially concerning the administration of new updates.
While these changes aim to enhance the protection of human health and the environment, it’s essential to assess whether they effectively balance the original objectives of REACH. These objectives include maintaining market access for companies introducing chemicals to the EU market and ensuring the safe use of those chemicals. The success of the revision will depend on its ability to streamline regulatory processes while upholding high safety standards.
In light of the proposed changes to REACH, companies should review what impact these would have on their obligations, especially those companies who have substances registered under Annex III reduced information requirements or substances notified under the Notification of New Substances (NONS) which have not been upgraded to full REACH registrations, who may wish to consider what changes would be required to their registrations and start planning how to address these.
At wca, we have extensive experience with REACH and CLP, and we have assisted many companies with their obligations under EU or UK REACH. Therefore, if you have any questions or would like assistance with any aspects of EU or UK REACH, including understanding how these changes could impact you, please contact us so we can discuss further how we can help.