April 19, 2021. The Product Information File (PIF) is the technical documentation that every cosmetic product intended for 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 qualified Safety Assessor issues a Product Safety Assessment Report (SAR). 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 EU Responsible Person (RP) must keep the PIF at the address specified on the label for 10 years after the last batch was placed on the market.
The EU RP should hold the PIF in a safe storage location, easily accessible to the EU Competent Authorities.
It is vital for the beauty brand to maintain updated the PIF in light of regulatory news and changes to the product. The PIF has to record every single change. If a change occurred, it is necessary to verify with the Responsible Person what are the implications and whether documentation needs any modifications.