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Specialist Wet Wipe & Sachet Manufacturer

Safety Assessments and Product Information Files (PIF)

Every cosmetic product placed on the market requires a safety assessment carried out by a suitably qualified European professional. The new Regulation imposes new requirements for the documents that need to be included in the Product Information File (PIF) a summary of the requirements are below:

The assessment will form part of the product information file (PIF)

  • A description of the cosmetic product
  • Product labelling
  • The Cosmetic Product Safety Report (described in Annex I of the Regulation, including the Safety Assessment)
  • Description of the method of manufacturing and a statement of compliance with the Good Manufacturing Practice (GMP)
  • Where justified, proof of the effect claimed for the cosmetic product
  • Any data on animal testing

The Responsible Person (RP) shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept, within a reasonable time period (i.e. 72 hours).

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