PIF Collation and Maintenance
When a Cosmetic Product is placed on the market, the Responsible Person shall keep a Product Information File (PIF). This is a legal requirement and the files are open to inspection by the Competent Authorities. Parts of the PIF can also be accessed by members of the general public upon request. The PIF has to be available to view by a Competent Authority within 72 hours of any request being made. Because of this requirement the PIF must be collated and maintained accurately as there may not be time to do so in an emergency.
The PIF must be updated anytime there is a change to the product, examples of changes which would trigger a PIF amendment are:
- Update to existing or generation of new product packaging artwork
- Change to product formulation
- Any serious undesirable effects
- A change to the manufacturing process
The finished PIF contains all of the documentation related to a product:
- A description of the cosmetic product
- The Cosmetic Product Safety Report
- The method of manufacturing
- A statement on compliance with good manufacturing practice
- Any substantiation for product claims
- Data on any animal testing that has been carried out or a statement to the effect that no animal testing has been completed
The PIF must be stored in the language of the member state of the Responsible Person and if the product ceases to be placed on the European market then the PIF shall be kept for a period of ten years following the date when the last batch of the cosmetic product was placed on the market.