The regulatory framework for cosmetic products is provided by the European Cosmetics Regulation 1223/2009.

This regulation replaces the Cosmetics Directive 76/768/EEC as amended.

The new Regulation reinforces the link between the product information file, the product safety report and the cosmetic safety assessment and places greater responsibilities on the Responsible Person and the safety assessor.

Pharmafile can act on behalf our clients for:

  • Notification to the competent Authorities
  • Declarations to Poison Centres
  • Compiling the Labelling requirements
  • Writing the safety assessment of finished products based on the toxicological profile of the ingredients
  • Preparing and auditing Product Information Files (PIF)
  • Safety assessments and preparing Cosmetic Product Safety Reports (CPSR)
  • Substantiating claims
  • REACH registration process
  • Ensuring compliance with ISO22716 Cosmetics-Good Manufacturing Practices

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