Product Information Files - EU 1223/2009
The requirements for the Product Information File (PIF) are listed in Article 11 of Regulation 1223/2009.
The PIF is to be held by the Responsible Person (RP) and shall be kept for a period of 10 years after the last batch has been placed on the market. Whilst on the market, the file shall be updated accordingly as and when necessary, particularly if changes to the approved formulation or packaging has been made.
In particular, the PIF shall contain the following information and data:
- Description of the cosmetic product.
- Cosmetic Product Safety Report.
- Description of the manufacturing method used and a statement on GMP compliance.
- Proof of the effect claimed for the cosmetic product.
- Data on any animal testing conducted.
The RP will make the PIF readily available to the competent authority of the Member State in which the file shall be kept.
Advena has the experience in preparing and compiling Product Information Files in accordance with Article 11 of the Cosmetic Regulation EU 1223/2009. This includes regulatory assistance with labelling requirements, restricted substances and claims.