Product information file

When a cosmetic product is placed on the European market, the Responsible Person (RP) must ensure that a dedicated Product Information File (PIF) will be accessible to Authorities in paper or electronic format upon request

A PIF is a comprehensive compilation of data from suppliers and documents relating to the safety, composition, and manufacturing of a product. It serves as a crucial element in ensuring products meet stringent regulatory standards before they can be marketed and sold. 

Following the European regulation No. 1223/2009, the PIF shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

Regulation 1223/2009 requires that the Product Information File consists of the five main following parts:

1. Description of the cosmetic product : A clear summary of the cosmetic product and its intended use.
2. Safety report of the cosmetic product: : A report that evaluates the safety of the product’s ingredients and formulation, known as the Cosmetic Product Safety Report (CPSR), including the Cosmetic Product Safety Assessment signed by an authorised safety assessor.
3. Manufacturing details: Information about the production process and adherence to good manufacturing practices (GMP).
4. Proof of claimed effect: Scientific backing for any product claims, such as “moisturizing” or “anti-aging.”
5. Data related to animal testing: Confirmation that the product complies with the EU ban on animal testing, where applicable.

PIFs reviewed by Authorities are frequent. According to Article 22 of the Regulation 1223/2009, Member States monitor the compliance through controls on products placed on the European market. If during an inspection the Authorities note that the product is non-compliant, sanctions may apply.

The PIF must be kept available for inspection by health Authorities at all times.

Maintaining state of the art Compliance:

Although there are no mandatory timelines for the revision, it is common sense to update your PIF with the latest product information and regulatory changes. This not only to ensure the compliance with EU regulation but also to protect consumer safety. Regular updates can help to avoid the risks associated with non-compliance matters, such as fines, product recalls, lowering the brand reputation.

Examples of non-compliant PIFs and the importance of updates:

• Missing or Incomplete Information: A PIF without a full ingredient list or safety assessment is considered non-compliant.
• Incorrect Information: Including misleading or incorrect details in the PIF can lead to compliance issues.
• Outdated Information: Data that no longer reflects the current product formulation can render a PIF invalid.