Cosmetic Product Information File (PIF)

Each type of cosmetic product (and their variants) placed on the EU and UK market place are required to have a Product Information File (PIF). The PIF details all of the product and safety data required to demonstrate compliance with the cosmetics regulations EC No 1223/2009. The information required in a PIF is as follows:

• Product Description
• Cosmetic Product Safety Report (CPSR)
• Manufacturing information
• GMP compliance statement
• Product Claims 
• Animal Testing Statement

This template provides the wording of the regulation under each section along with the EU guidance wording (2013/674/EU), to help identify specifically what is required for each section of the PIF according to the regulations and the opinions of the EU experts. The CPSR should be completed by a qualified person such as a toxicologist.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.