A Product Information File is created when a cosmetic product is placed on the market within the EU and must be made available to the competent authorities at the Responsible Person’s address.
Every cosmetic product must have a PIF
Pursuant to Articles 10 and 11 of the Cosmetics Regulation, creating a PIF is mandatory for all cosmetic products placed on the market in a European Union Member State.
What’s in the PIF?
Submitted in hard or electronic format, the PIF should contain the following product information:
- A description of the cosmetic product to establish a clear link between it and its PIF:
- The product name, reference, and brand
- A picture of the labelling and packaging
- The Responsible Person
- The manufacturing and packaging address
- The Cosmetic Product Safety Report written in accordance with Annex I to the Cosmetics Regulation (Its content is detailed in question 7)
- A description of the manufacturing and packaging methods
- Statement of GMP (Good Manufacturing Practices) compliance – To learn more about the Good Manufacturing Practices, please refer to question 6
- Proof of the product’s claimed effect
- Test results and active ingredients with proven properties
- Animal testing information
(Source: Institut du savon [Institute of Soap])
Who checks the PIF?
In France, the ANSM and DGCCRF departments responsible for inspecting cosmetic facilities, oversee PIF compliance with the European Cosmetics Regulation.
During any PIF control, the competent authority will draw up an inspection report setting out any compliance discrepancies and, where appropriate, order the facility to take the corrective measures necessary to become compliant with the Cosmetics Regulation.
For how long is the PIF valid?
The PIF must be retained for 10 years after the last batch of the product was placed on the market; it must be kept by the Responsible Person and made available at the address indicated on the product. It must also be written in the language of the country in which the product is being sold so that it can be understood by the local authorities. In France, the PIF must be written in French or contingently in English.
What are the Responsible Person’s obligations?
Before a cosmetic product is placed on the market, the responsible person must ensure that:
- The cosmetic product is safe for human health under its normal conditions of use.
- The product’s safety has been assessed based on appropriate information.
- A Cosmetic Product Safety Report has been drawn up pursuant to Annex I of the Cosmetics Regulation.
- A safety assessment has been carried out “by a person holding a degree or other qualification awarded on completion of a university course comprising theoretical and practical instruction in pharmacy, toxicology, medicine or a similar discipline, or training recognised as equivalent by a Member State.”
- The safety report must be regularly updated with additional relevant information generated throughout the product’s life cycle.