Cosmetics product information file (PIF)


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This presentation explains what is a product information file (PIF) and which information it consists of.

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Cosmetics product information file (PIF)

  1. 1. EU REGULATION 1223/2009© CE.way Regulatory Consultants Ltd
  2. 2. LEGISLATION• EU cosmetic regulation 1223/2009 (replacing directive 76/768/EC)• Applicable: July 2013 onwards© CE.way Regulatory Consultants Ltd
  3. 3. PRODUCT INFORMATION FILE• “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.” (Regulation 1223/2009, Article 11.1)• PIF has to be kept by the responsible person© CE.way Regulatory Consultants Ltd
  4. 4. PRODUCT INFORMATION FILE• Responsible person has to make PIF:  Readily accessible in electronic or other format to the competent authorities of the Member State in which PIF is kept  At his address indicated on the product label*  Available in a language which can be easily understood by the competent authorities of the Member State where the responsible person is established• *PIF should be made readily accessible at one single address within the EU  one responsible person per product© CE.way Regulatory Consultants Ltd
  5. 5. PRODUCT INFORMATION FILE• PIF has to be fully compliant with the provisions set out in the regulation before the notification can be performed• Find out more on our website (• PIF must always be kept updated and compliant with the regulation!© CE.way Regulatory Consultants Ltd
  6. 6. PRODUCT INFORMATION FILE CONTENT• PIF has to contain the following information and data  A description of the cosmetic product  Cosmetic product safety report  A description of the method of manufacturing and a statement on GMP compliance  Proof of the effect claimed for the product  Any data on animal testing© CE.way Regulatory Consultants Ltd
  7. 7. PRODUCT INFORMATION FILE CONTENT• Cosmetic product safety report:  Part A: Safety information  Part B: Safety assessment• Safety assessor performing the safety assessment has to be qualified  University degree in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State• Also cosmetic products notified under the directive 76/768/EEC have to undergo a safety assessment according to 1223/2009© CE.way Regulatory Consultants Ltd
  8. 8.© CE.way Regulatory Consultants Ltd