At the CARACAL-54 meeting on 3 April 2025, the European Commission outlined its latest proposals to revise the REACH Regulation. These updates, forming part of the broader Chemicals Industry Package, are now open for public consultation until 25 April 2025. Adoption of the final legislative package is targeted for the fourth quarter of 2025.
The revision aims to simplify registration requirements, improve enforcement through new auditing tools, accelerate digitalisation of supply chain communication and modernise risk management procedures. Together, the proposals represent the most significant update to REACH since its inception
Key changes under the REACH revision package include:
1. Overhaul of the Registration System
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Registration validity will be limited to 10 years. ECHA may revoke registration numbers in several cases, including expiry of the validity period, failure to submit a required update after an evaluation decision, lack of a complete dataset for previously notified substances (NONS), or incompleteness identified during an ad-hoc completeness check.
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New dossier update requirements if a substance is identified as substance of very high concern (SVHCs).
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Removal of reduced requirements for substances notified under previous legislation (NONS).
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New obligations for polymers, including:
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Notification for all polymers above 1 tonne per year.
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Registration for polymers requiring registration (PRRs), based on hazard-related criteria.
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Stronger provisions to encourage data sharing between registrants and reduce duplication of studies. Data access mechanisms will apply to studies on structurally similar substances, especially after the expiry of data protection periods.
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Reinforced commitment to reduce animal testing, in line with Directive 2010/63/EU. Testing on vertebrate animals must be avoided whenever possible, and testing proposals will be required even for some lower-tier endpoints (Annex VII and VIII).
2. Reinforced Evaluation and Compliance Checks
The REACH revision introduces several changes aimed at improving the effectiveness, transparency, and impact of both dossier and substance evaluation.
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ECHA will be empowered to revoke registration numbers following persistent non-compliance with evaluation decisions. This applies to both dossier and substance evaluations when registrants fail to act on required updates or decisions issued by ECHA.
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The compliance check process will be clarified, particularly regarding the use of available information that is not currently part of the dossier. This aims to make ECHA’s decisions more predictable and legally sound.
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ECHA will gain stronger powers to require specific adaptations, such as read-across or derivation of Derived No-Effect Levels (DNELs) or Predicted No-Effect Concentrations (PNECs), rather than defaulting to animal testing.
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The substance evaluation procedure will explicitly allow selection based on hazard concerns, in addition to potential risks. Substances may also be selected based on similarity to other chemicals, including degradation products or constituents.
3. Streamlined Authorisation Process
The REACH revision introduces greater flexibility and clearer prioritisation in the authorisation system.
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The Candidate List will become a general tool for risk management prioritisation, not just a step toward authorisation.
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New substance prioritisation criteria will focus on high-volume chemicals, those with limited uses, or potential substitutes for existing Annex XIV substances.
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The revised approach allows uses to be included or excluded from Annex XIV, enabling tailored combinations of authorisation and restriction where appropriate.
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Greater use of Regulatory Management Option Analyses (RMOAs) will help identify the best regulatory path earlier in the process.
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The essential use concept and Derived Minimal Effect Levels (DMELs) are being considered to simplify decision-making.
4. More Targeted and Efficient Restriction Procedure
Changes to the restriction process aim to reduce delays and improve enforceability.
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Restriction proposals will be better prioritised and scoped upfront, avoiding overload and unnecessary complexity.
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The generic risk management approach will be expanded to more hazard classes, particularly for consumer uses.
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Early information on use, exposure, and alternatives will support more targeted proposals.
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Forum advice will be integrated directly into the restriction process to improve enforceability.
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The essential use concept will also play a role in simplifying restriction decisions.
5. Enhanced Enforcement and Market Surveillance
To level the playing field across the EU, the Commission proposes stronger enforcement mechanisms:
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A new European Audit Capacity will allow the Commission to assess Member States' enforcement systems.
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Customs controls will be improved via:
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Mandatory provision of safety data sheets (SDS) at import.
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Automated verification of registration and authorisation numbers.
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Potential integration with the EU Single Window Environment for Customs.
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The European Anti-Fraud Office (OLAF) will be empowered to investigate serious cross-border REACH violations.
5. Tackling Distance Sales and Enabling Public Participation
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Distance sales into the EU will require a designated EU-based economic operator to ensure REACH compliance.
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Individuals and organisations will be allowed to submit substantiated concerns about non-compliance.
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Member States will be required to implement whistle-blower protections and follow Aarhus Convention principles on access to justice.
6. Digitalisation of Supply Chain Communication
Digital transformation is central to the proposals, especially for Safety Data Sheets and product traceability:
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Introduction of harmonised electronic formats for SDS to support digital exchange across the supply chain.
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Gradual integration of Digital Product Passports (DPPs) for articles, initially covering batteries and later expanding to toys, detergents, textiles, and furniture.
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The aim is to reduce the administrative burden while increasing transparency on the presence of substances of concern.
7. Clarification of Nanomaterials Requirements
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The REACH revision will align with the EU’s 2022 definition of nanomaterials.
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Clarified registration and reporting rules will improve predictability and transparency, particularly for downstream users and nanoform characterisation.
REACH Revision Set to Modernise EU Chemicals Law by End of 2025
These proposed updates represent the most comprehensive revision of REACH in nearly two decades. They respond to long-standing challenges related to complexity, inefficiency, and uneven enforcement while also positioning the EU chemicals legislation to support the goals of the Green Deal and the circular economy.
The Commission is expected to finalise the legislative proposal following public feedback, CARACAL consultation, and internal legal drafting. Adoption is targeted for late 2025.
Stakeholders are encouraged to engage with the Commission’s consultation process, which remains open until 25 April 2025. Feedback will help shape the final legislative proposal, expected for adoption by the end of the year as part of the EU Chemicals Industry Package.
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