PIF, or Product Information File, is established as soon as a cosmetic product is placed on the market. This must be kept at the disposal of the competent authorities at the address of the responsible person.
PIF, imposed by the regulation, plays an essential role in the synthesis of the toxicological risks of ingredients (part A) and the assessment of the safety for human health (part B) of cosmetic products.
What does the PIF (Product Information File) contain?
PIF information – part A :
- Quantitative and qualitative formula.
- Physical/chemical characteristics and stability.
- Microbiological quality.
- Impurities, traces, packaging information.
- Normal and reasonably foreseeable use.
- Exposure to cosmetic product.
- Exposure to substances.
- Toxicological profile of substances.
- Undesirable effects and serious undesirable effects.
- Information on the cosmetic product.
PIF safety assessment – part B :
- Conclusion of assessment.
- Warnings and instructions for use on the label.
- References of the person in charge of the assessment.
What is the validity of the PIF ?
The Product Information File (PIF) is valid for 10 years from the date of marketing of the last batch of the cosmetic product concerned. During this period, the DIP must be kept by the person responsible, who is required to make it available to the competent authorities at the address indicated on the product. It is also important to note that the DIP must be written in the language of the country where the product is marketed, to facilitate its understanding by local authorities. In France, for example, the PIF must be written in French, or possibly in English.
What are the obligations of the person responsible?
The person responsible for a cosmetic product has several obligations to fulfill before placing it on the market.
Here are the main ones:
- ensure that the cosmetic product is safe for human health when used under normal conditions.
- Carry out a thorough safety assessment of the product, based on appropriate information.
- Draw up a detailed report on the safety of the cosmetic product in accordance with the guidelines of the cosmetics regulation.
- The product safety assessment must be carried out by a qualified person, holding a diploma or recognized title attesting to university training in fields such as pharmacy, toxicology, medicine or an equivalent discipline, and recognized by a Member State.
- It is essential to keep the product safety report up to date on a regular basis, taking into account relevant information collected throughout the product’s marketing period.
Who is responsible for checking PIF files?
In the cosmetics sector, PIF files are controlled by various bodies in France. The ANSM (National Agency for the Safety of Medicines and Health Products) and the DGCCRF (General Directorate for Competition, Consumer Affairs and Fraud Control) are responsible for inspecting cosmetics establishments and checking that the PIF complies with European cosmetics regulations.
During a PIF inspection, the competent authority draws up an inspection report outlining any deviations from the rules. Where necessary, the establishment is then required to implement the corrective measures necessary to comply with the requirements of the cosmetics regulation. These measures are designed to ensure the regulatory compliance of cosmetic products and guarantee their safety for consumers. As experts in Quality & Regulatory Services in the cosmetics field, our role is to support establishments in the preparation and management of DIP dossiers, and to advise them on the corrective measures to be implemented in the event of non-compliance.
Drafting the PIF (product information file) :
The regulatory compliance of your cosmetic products is essential to their success on the market, and we understand the importance of complying with the specific regulations of each country.
The experts in our Quality & International Regulations department are at your disposal to guide you through this complex process, whatever the country in which you operate. Our aim is to advise you, share our expertise and provide you with the tools you need to ensure the compliance and safety of your cosmetics.
We carry out scrupulous, methodical monitoring to guarantee the compliance of all your cosmetics projects.
Because your success is our success, we scrupulously and methodically monitor the regulatory compliance of all your cosmetics projects.