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15 May 2025
Detailed Explanation of the EU REACH 2.0 Revision
At the recent CARACAL-54 meeting, the European Commission presented its latest REACH Regulation revision proposals. These updates form part of a broader chemical industry package open for public consultation, with the final legislation expected in Q4 2025.
The revision aims to simplify registration, strengthen enforcement, accelerate digital supply chain communication, and modernize risk management — the most significant update since REACH's inception.
Key Changes in the REACH Revision Proposal
1. Registration System Reform
1.1. Registration validity limited to 10 years; ECHA may revoke registrations due to expiration, failure to update, incomplete data, or integrity issues.
1.2. New dossiers required for substances identified as SVHC (Substances of Very High Concern).
1.3. Removal of previous reduction requirements for notified substances (NONS).
1.4. New obligations for polymers:
- Notification for polymers produced over 1 tonne/year.
- Registration for polymers requiring registration (PRR) based on hazard criteria.
1.5. Stronger data-sharing rules to reduce duplicate testing and support data access post-protection period.
1.6. Enhanced commitment to reduce animal testing per Directive 2010/63/EU, including submission of test plans.
2. Enhanced Evaluation and Compliance Checks
2.1. ECHA can revoke registration numbers for persistent non-compliance after evaluation decisions.
2.2. Clarified compliance check procedures using available information outside dossiers to improve decision predictability.
2.3. ECHA empowered to request specific adjustments (e.g., read-across, DNEL, PNEC) instead of default animal testing.
2.4. Substance evaluation allows hazard- and risk-based selection, considering similarity to other chemicals.
3. Simplified Authorization Process
3.1. Candidate List becomes a universal risk prioritization tool, not just an authorization step.
3.2. New prioritization focuses on high-volume, limited-use chemicals, or substitutes for Annex XIV substances.
3.3. Revised approach permits inclusion/exclusion of uses in Annex XIV for tailored authorizations and restrictions.
3.4. Greater use of Regulatory Management Option Analysis (RMOA) to identify optimal regulatory paths early.
3.5. Consideration of "essential uses" and Derived Minimal Effect Levels (DMEL) to streamline decisions.
4. More Precise and Efficient Restriction Procedures
4.1. Improved prioritization and early scoping reduce delays and complexity.
4.2. Expanded generic risk management to more hazard classes, especially consumer uses.
4.3. Early data on use, exposure, and alternatives supports targeted restriction proposals.
4.4. Forum recommendations integrated into restriction process to enhance enforceability.
4.5. "Essential use" concept aids restriction decision simplification.
5. Strengthened Enforcement and Market Surveillance
5.1. New EU audit capacity to assess member states' enforcement systems.
5.2. Enhanced customs controls requiring:
- Mandatory Safety Data Sheets (SDS) at import.
- Automatic verification of registration and authorization numbers.
- Possible integration with EU Customs Single Window.
5.3. European Anti-Fraud Office (OLAF) empowered to investigate serious cross-border REACH violations.
6. Addressing Remote Sales and Promoting Public Participation
6.1. Remote sales entering the EU must appoint designated EU economic operators to ensure REACH compliance.
6.2. Individuals and organizations may submit substantiated non-compliance concerns.
6.3. Member states must implement whistleblower protections and comply with Aarhus Convention access to justice principles.
7. Digitalization of Supply Chain Communication
7.1. Introduction of coordinated electronic format for SDS to support digital supply chain exchange.
7.2. Gradual adoption of digital product passports (DPP), starting with batteries, then toys, detergents, textiles, furniture.
7.3. Aim to reduce administrative burden and increase SVHC transparency.
8. Clarification of Nanomaterial Requirements
8.1. Alignment with the 2022 EU nanomaterial definition.
8.2. Clear registration and reporting rules improve predictability, especially for downstream users and nanoform characterization.
Modernizing EU Chemicals Law by End of 2025
These revisions are the most comprehensive update to REACH in nearly 20 years. They address complexity, inefficiency, and uneven enforcement, supporting the EU Green Deal and circular economy goals.
After consultation and drafting, the final proposal is expected by the end of 2025. Stakeholders are encouraged to provide feedback by April 25, 2025.
Industry Reactions
9. Cefic (European Chemical Industry Council)
9.1. Criticized the proposal as increasing administrative burden, especially on SMEs, calling it misleading to label it "simplification."
9.2. Highlighted disconnect between Commission services and EU political leadership.
10. Other Views
10.1. EEB Chemicals Policy Manager called the proposal weak and misguided, prioritizing industry convenience over public safety.
10.2. ClientEarth legal expert warned the new "pre-assessment" will further slow decision-making.
10.3. The Commission appears to be retreating from Green Deal commitments, weakening key REACH restrictions and fast-track procedures under Article 68(2).
Disclaimer: Blooming reserves the right of final explanation and
revision for all the information.