Principal insights on the cosmetic Product Information File (PIF)
The Product Information File (PIF) is an important and mandatory document to be compiled before placing a cosmetic product into the European Union (EU) market, offering a comprehensive overview of all pertinent information about the product. This article explores the significance and structure of the PIF.
What is the PIF?
The PIF is a detailed technical dossier about the cosmetic product, gathering all the necessary and relevant information and documentation associated with the product. This data is sourced from several players within the cosmetic product life cycle, from the raw materials suppliers to the safety assessor, who signs the Cosmetic Product Safety Report (CPSR), the most important part of this dossier.
Key elements of the PIF
Although there is no standard structure for it, the PIF should contain all required information on the cosmetic product, including:
- Product description: providing a clear identification of the cosmetic product.
- Manufacturing method and GMP: describing the manufacturing process and stating compliance with GMP.
- Packaging and labelling information: detailing the packaging and labelling of the cosmetic product.
- CPSR: documenting the safety assessment of the cosmetic product.
- Animal testing data: covering all relevant information on any animal testing.
- Proof of claims: supporting any claims made about the product.
Legal requirements
The PIF is a legal obligation under Regulation (EC) No. 1223/2009. For each cosmetic product placed on the EU market, there must be a PIF.
As stated in the Regulation, the PIF should be readily accessible to and in a language easily understood by the competent authority and should be kept up-to-date in view of changes in the product information and/or additional relevant information generated after placing the product on the market.
The PIF shall be kept for a period of ten years after the last batch of the cosmetic product was placed on the market.
References:
Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products