On 3 April 2025, the European Commission presented its final REACH reform proposal at the CARACAL-54 meeting, marking the most significant overhaul of EU chemical regulation in nearly two decades.
The comprehensive revision introduces 10-year registration validity limits, mandatory Digital Product Passports (DPP), enhanced ECHA enforcement powers, and new assessment methodologies. Industry stakeholders, led by Cefic, warn of 40% cost increases for SMEs and significant administrative burden increases, particularly affecting cosmetics supply chains where each ingredient >1 tonne annually requires REACH registration.
Registration System Changes
- 10-year validity: All REACH registrations limited to 10-year validity periods
- Mandatory updates: Dossiers must be updated when substances become SVHC or receive harmonized classifications
- ECHA revocation authority: Enhanced powers to revoke non-compliant registration numbers
- Simplified registrations abolished: 1-10 tonne registrations must now include full data requirements
Digital Product Passport Implementation
- Mandatory DPP: Digital Product Passports required for supply chain communication
- Digital SDS: Safety Data Sheets must align with DPP requirements
- Substance of concern tracking: Enhanced communication for hazardous substances
- Raw materials coverage: Cosmetic ingredients exported to EU require SDS and DPP establishment
Enhanced Risk Assessment
- New assessment metrics: PMT (Persistent, Mobile, Toxic) and vPvM (very Persistent, very Mobile) substances
- Mixture Assessment Factor (MAF): New methodology for substances >1000 tonnes annually
- Enhanced testing requirements: All in vivo tests require testing proposals regardless of tonnage
Enforcement Strengthening
- Systematic audits: Both systematic and ad-hoc audits across Member States
- Enhanced penalties: Strengthened enforcement mechanisms
- Q4 2025: Final legislative package adoption expected
- 2026-2027: Implementation phase begins with registration system changes
European Commission CARACAL-54 Meeting: REACH Revision Proposal, 3 April 2025