Major Revision to EU REACH Regulation Impacts the Cosmetics Industry

Date of publication: 03 April 2025
The European Commission presented its final REACH reform proposal at CARACAL-54, introducing 10-year registration validity, Digital Product Passports, and enhanced enforcement measures that will significantly increase compliance requirements and administrative burden for cosmetics companies operating in the EU market.

What’s new?

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.

Key provisions

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

What now?

  • Q4 2025: Final legislative package adoption expected
  • 2026-2027: Implementation phase begins with registration system changes

References

European Commission CARACAL-54 Meeting: REACH Revision Proposal, 3 April 2025

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Any REGULATORY QUESTION?

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Date of application:01/01/2023

Although the European Cosmetics Regulation is applicable to every cosmetic product made available in the European Union market, some national legislations may also apply. Environmental regulations in Italy and France specify mandatory labelling requirements applicable to packaged products marketed in these countries.

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Date of publication: 03/05/2022

Date of application: 01/12/2023

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