The Product Information File (PIF) is a compilation of technical documentation that every cosmetic product that is to be placed on the EU market must have.
According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to:
- Product Description
- Safety Report
For each cosmetic product, a Product Safety Assessment Report is issued and it includes the following information as per Article 11 of the EU Cosmetics Regulation:
- Method of Manufacturing
- Evidence of compliance with Good Manufacturing Practices (GMP)
- Proof of the effect claimed (where justified)
- Data on Animal Testing
- Labelling (taking into account the primary packaging and outer/ secondary packaging)
- Data on Serious Undesirable Effects
On behalf of non-EU manufacturers, the PIF must be kept by the EU Responsible Person (RP) at the address specified on the label for 10 years after the last batch was placed on the market.
The PIF should be held in a safe storage location, easily accessible to the EU Competent Authorities.
It is vital for the PIF to be kept updated and every single change should be recorded. If a change occurred, it is necessary to verify with the Responsible Person what are the implications and whether documentation needs to be updated.