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