According to the European cosmetic Regulation (CE) n°1223/2009, every cosmetic product must have its own Product Information File, known as a PIF. Organized around the safety assessment, it must be finalized before the product is launched on the market. As it requires a lot of work and documentation, it's not a last-minute work.

The conception of the PIF

Every cosmetic product must have its own product information file, including samples or products with only one ingredient. The PIF is a real ID document for cosmetics: it contains all the information about the product and follows it its entire lifespan, even afterward. Indeed, the Responsible Person must keep the PIF for 10 years after the last batch of the product has been placed on the market.

The Responsible Person must assure that the PIF can be accessible to the competent authorities who request to view it. That's why the address where the PIF is accessible must be clearly specified on the packaging (as required by the cosmetic packaging regulations) (lien article etiquetage): if there are several addresses on the packaging, the one where the PIF is located must be highlighted/underlined. The language of the PIF must be easily understandable by the enforcement authorities of the country where it is located. Many member states accept English written PIF, in France the required language is French.

The design of the PIF is not specified by the Cosmetic Regulation, so each Responsible Person can build it like they want, digital or print. Since it can be viewed at any time by the competent authorities, it's better to have a well-structured and easy to read PIF.  

The cosmetic Regulation requires minimal information on the PIF (info box). In actuality, the PIF contains much more data, actually all the data that is necessary for the Responsible Person to ensure the safety and control the life cycle of the cosmetic product. The PIF essentially provides all the relevant information necessary for the cosmetic safety assessment.
 

What's in the PIF (according to the Cosmetic Regulation (CE) n°1223/2009)?

  • The description of the product: it aims to link the cosmetic product and its PIF;
  • The Cosmetic Product Safety Report (CPSR, also called safety assessment) (see below);
  • A description of the manufacturing method and a statement of compliance with the Good Manufacturing Practices (GMP, for example by complying with the ISO 22716 norm);
  • Proof of the claimed effect if justified.
  • Data relating to animal testing (for example if required by a third-party country).

The cosmetic product safety assessment

The Cosmetic Product Safety Report (CPSR) is the key element of the PIF. This report ensures that the cosmetic product complies with the primary obligation of the Responsible Person: to put a safe product on the market under reasonably foreseeable conditions of use. It follows the requirements of annex I of the Cosmetic Regulation 1223/2009, and includes two parts, A and B. The first one gathers all the data needed by the safety assessor to ensure the safety of the product:
  • Quantitative and qualitative composition of the product: each substance is specified, including its identification, its concentration, its function. Raw materials are detailed if needed. Allergens are notified if present.
  • Physical and chemical characteristics of the raw materials and the finished product. They allow, amongst other things, the control of the product once on the market.
  • Stability data: test results and methods are provided. If the product has a PAO, data allowing its justification are provided too.
  • Microbiological quality: microbiological characteristics of the raw materials and the finished product are provided, so as the result of the challenge test if applicable.
  • Impurities and traces from the raw materials.
  • Information about the packaging material: they must allow the safety assessor to assess the safety of the packaging and the possible interactions between the packaging and the content.
  • Normal and reasonably foreseeable use of the product.
  • Exposure to the cosmetic product: for example, product category, quantity per application, application areas, the target population, etc. The possibility of secondary exposure should also be considered.
  • Exposure to the substances contained in the product (including traces/impurities if necessary).
  • Toxicological profile of the substances.
  • Adverse effects, especially when the formula is already on the market (for example, in the case of a white label cosmetic product).
  • Results of tolerance testing and all other useful tests.
  • Any other useful information.
Part B of the CPSR is the field of expertise of the safety assessor (part A can be compiled by the Responsible Person, an employee, or a service provider), who explains the scientific reasoning that leads to the final assessment. The safety assessor also gives the assessment conclusion and the eventual caveats. This may lead to additional warnings or specific instructions of use to be added to the labeling. Part B also specifies the credentials of the safety assessor. Because analyzing cosmetics formulations, especially in the case of a safety assessment, cannot be improvised. The Cosmetic Regulation specifies the required diplomas (pharmacy, toxicology, medicine, or similar field), but it can vary depending on the member state.

The European Commission has published guidelines on the management of the CPSR.

The PIF, a dynamic document

Once the cosmetic product on the market, it's not the end of the story for the PIF, far from it. As a major resource for the Responsible Person, the PIF needs regular updates to match exactly to the product on the market at any given moment. These updates can follow a switch of raw material, a modification of the contact information of the Responsible Person, the manufacturing process, or the packaging, etc.  

Formula management may also lead to an update of the CPSR, as packaging, raw materials, or other information is modified. If too many modifications are made, it may impact the safety of the product. It may be necessary to ask for a new CPSR from the safety assessor. The decision of an update should be discussed with the safety assessor.

The PIF is also the place where cosmetovigilance data should be collected, ideally each year. The ratio between adverse effects and the number of sales each year should be specified.

Conclusion

The PIF is the identity document of a cosmetic product, a pass for a smooth launch on the market. Built around the Cosmetic Product Safety Report, it should contain all the data necessary about the product. It should evolve to reflect the product on the market at any given moment, its entire lifespan, even afterward. Requiring a lot of exchanges with various contacts, it can be complex to complete. Specific software can help facilitate its management, as much as a robust formulation software.