Proposed changes to REACH chemical regulation

The European Commission’s proposal to overhaul the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation marks a turning point in chemicals regulation. The changes aim to make EU chemical regulation more streamlined, transparent, and future-ready, with a strong focus on digitalisation, ethical practices and public safety.

The revised proposals form part of the broader Chemicals Industry Package. The final package – expected to be adopted by the end of 2025 – will simplify registration, enhance enforcement, drive digitalisation and modernise risk management. This will be the most significant update to REACH since its creation, shaping the future of chemicals regulation in Europe.

Stakeholders react: applause, apprehension and appeals for clarity

The European Commission’s proposed REACH revision has sparked mixed reactions from stakeholders, drawing early attention to the high stakes and far-reaching implications of the changes.

SMEs and chemical manufacturers have voiced concerns about specific elements of the proposal, such as the 10-year registration validity and European Chemicals Agency's (ECHA) extended powers to revoke registration numbers, warning these could strain resources and disproportionately impact smaller players. New requirements for polymers and Digital Product Passports (DPPs), along with harmonised Safety Data Sheets (SDS), have also raised concerns about cost and accessibility.

On the other hand, regulatory authorities and public interest bodies have largely welcomed the proposals. They have praised the efforts to reinforce non-animal testing alternatives, enhance clarity around nanomaterials, and introduce more transparent risk prioritisation. Still, they call for proportional enforcement systems and clearer guidelines to prevent overburdening businesses with administrative requirements.

Despite differing perspectives, there is broad alignment on the importance of modernising REACH to support both safety and innovation.

Timeline of the REACH Revision
A new era: streamlined, flexible and digital registrations

One of the most significant changes in the revised REACH Regulation is the overhaul of the registration system. Registration validity will now be limited to 10 years, and ECHA will be able to revoke registration numbers for failure to submit updates or incomplete data.

Polymers, previously exempt, will now be subject to registration requirements if produced in quantities above 1 tonne per year, with those meeting specific hazard criteria will require full registration. This ensures better data quality and regulatory clarity for previously excluded substances.

Digitalisation will play a key role in these updates, with harmonised electronic formats for Safety Data Sheets (SDS) and the gradual introduction of Digital Product Passports (DPPs) for products such as batteries, textiles, and furniture. These tools will improve traceability, reduce administrative burdens and provide greater transparency on substances of concern.

Enhanced enforcement: a level playing field for all

To strengthen compliance, the Commission proposes the creation of a European Audit Capacity to assess how effectively Member States enforce REACH, ensuring uniformity across the EU. This initiative will promote fair competition and increase trust in the enforcement process.

Customs controls will also be enhanced with mandatory SDS provisions at import and automated verification of registration and authorisation numbers. The European Anti-Fraud Office (OLAF) will be empowered to investigate cross-border REACH violations ensuring all market players comply with the law.

Targeted and efficient restrictions: a focus on public safety

The revised REACH Regulation will streamline the restriction process, reducing delays and improving enforcement. By prioritising and scoping proposals upfront, decision-making will be quicker and more effective, especially for consumer products.

A key addition is the "essential use" concept, which identifies substances critical to society yet pose a significant risk. This ensures that safety measures focus on the most important substances.

Incorporating early information on exposure, use and alternatives will ensure that restriction proposals are more targeted and effective. These changes aim to make the process quicker and more transparent while ensuring the safety of both consumers and the environment.

Reinforcing compliance: stronger evaluation and dossier checks

Once revised, REACH will introduce more stringent evaluation and compliance checks. ECHA will be empowered to revoke registrations for persistent non-compliance with evaluation decisions, providing clearer procedural guarantees. The new system will also clarify how additional information not currently in dossiers can be used, making evaluations more predictable.

Companies will be encouraged to prioritize alternatives to animal testing, such as read-across methods or methods for deriving no-effect levels (DNELs), aligning with the EU's commitment to ethical scientific practices. In cases where testing proposals are necessary, companies may suggest specific adaptations instead of defaulting to animal testing. These changes aim to increase efficiency, improve compliance, and enhance the predictability of the evaluation process.

Navigating emerging concerns: nanomaterials and cross-border sales

As scientific advancements progress, the EU is also looking to address emerging issues. For instance, the revised REACH Regulation will clarify provisions around nanomaterials. It will introduce the 2022 Commission Recommendation definition of nanomaterials and update descriptions of nanoforms accordingly. This includes clarifying the reporting requirements for downstream users, particularly regarding characterisation and chemical safety assessments of nanoforms.

The regulation will also provide better guidance on the compliance checks for nanoforms, ensuring that they meet specific information requirements. Registrants will be required to follow new guidelines that facilitate the implementation of concepts around nanoforms and similar nanoforms.

To address the issues raised by distance selling, the revised framework will require a designated EU-based operator for businesses outside the EU selling products into the European market, ensuring that all sales comply with REACH standards.

Public participation and feedback: a call for stakeholder engagement

These revisions represent the most comprehensive overhaul of REACH in nearly 20 years. 
Set for adoption in late 2025, the final updates will modernise chemicals legislation, balancing safety, scientific progress, and market innovation. The changes will also support the EU's Green Deal and circular economy goals, building a safer, more sustainable chemicals sector across Europe.

How can Ricardo help?

As the REACH Regulation undergoes its most significant transformation in nearly two decades, staying ahead of the changes is essential. Our expert REACH team is here to help you navigate the evolving regulatory landscape. Whether you need strategic advice, hands-on dossier support, or help implementing digital compliance tools like Safety Data Sheets and Digital Product Passports, we provide tailored guidance to ensure your business remains compliant and competitive.

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