Product Information File (PIF)
Obligations, Content and Best Practices

Why is DIP mandatory in cosmetics?

The Product Information File (PIF) is a key document in the European cosmetics industry. It constitutes the cornerstone of regulatory compliance for a cosmetic product placed on the market in the European Union. Established by Regulation (EC) No. 1223/2009 , the PIF allows authorities to verify the safety of the product for human health at any time. Its creation is a legal obligation and a guarantee for consumers.

For brands, a well-structured DIP is also a strategic tool: it promotes traceability , strengthens credibility , facilitates distribution and anticipates compliance issues . It also helps protect the brand in the event of an audit or dispute.

What does European regulation (EC 1223/2009) say?

Regulation (EC) No. 1223/2009 on cosmetic products is the reference text governing the marketing of cosmetic products in Europe. It replaces Directive 76/768/EEC and harmonizes requirements across all EU member states.

According to Article 11 of this Regulation, each cosmetic product placed on the market must have a DIP, kept at the address of the responsible person (RP). The DIP must be easily accessible to the competent authorities, in a language easily understood by the authorities of the country where the product is marketed.

The regulation specifies that the DIP must contain all data relating to the product: formulation, tests carried out, evidence of the effectiveness of the claims, safety assessment, toxicological data, etc.

Legal obligations for brands

For each cosmetic product, the brand (or its representative) must:

Responsible Person

PIF

CPNP

Conformity

Security

What documents must be included in a DIP?

The DIP includes the following items:

Description of the cosmetic product
Cosmetic product safety report (Part A and Part B)
Manufacturing methods and compliance with GMP (Good Manufacturing Practices)
Declaration of establishment
Proof of claimed effect (claim justification)
Animal testing data
Proof of certification (labels)

Let's take a closer look at the two essential parts of the safety report:

Part A: Product safety information

Part A contains all the data required for a safety assessment:

Qualitative and quantitative product composition
Data and documents on raw materials
Physico-chemical characteristics and formula stability
Impurities present in raw materials
Intended use and exposure
Toxicological data on ingredients
Stability and compatibility tests
Safety tests
Data on reported adverse reactions (post-market safety)

This section brings together the information and scientific bases that will then be analyzed in Part B by the toxicologist.

For the initiated, this part can be written in-house (by the brand). However, if you are a project leader, we strongly advise you to entrust this task to your toxicologist or regulatory expert.

Part B: Safety assessment

This section is written by a qualified toxicologist. It includes :

Interpretation of data provided in Part A
Justification of the product's safety under normal conditions of use
Conclusion on overall product safety
The identity, qualifications and signature of the toxicologist

The toxicologist assumes professional responsibility for this assessment. It is therefore a crucial step.

The DIP, an essential regulatory requirement

The preparation of a Product Information File (PIF) should ideally begin during the product design phase . It is crucial to collect all necessary data upfront to avoid any delays or oversights at the time of product launch.

The quality of raw materials must be rigorously verified: this involves collecting technical data sheets, safety data sheets (SDS), and supplier certificates. In addition, all required tests must be anticipated and carried out to ensure the product's safety and stability, such as stability, compatibility, conservation (challenge) tests, and patch tests.

Collaboration with a qualified toxicologist is essential, particularly for the preparation of Part B of the safety report. It is also essential to use an accurate INCI nomenclature to describe ingredients and to ensure that labeling strictly complies with the requirements of the European regulation.

Finally, all data must be centralized in an organized and secure storage system , ensuring its accessibility and traceability in the event of an audit. By following these best practices, brands ensure they create a compliant, complete, and robust DIP.

Common mistakes to avoid

Certain recurring errors can compromise the compliance of the DIP, or even lead to its rejection by the competent authorities during an inspection. It is therefore essential to identify them in order to better anticipate them:

Incomplete or inconsistent formula : An error in the formulation can call into question the entire security assessment.
Missing or outdated documents : Raw material data must be up-to-date and complete.
Lack of testing or insufficient data: particularly on stability, compatibility or skin tolerance.
Non-compliance of labeling : missing mandatory information, translation errors, incorrect pictograms, etc.
Unsubstantiated or misleading claims : Any claim must be supported by solid scientific evidence.
Part B written by an unqualified person: only a qualified toxicologist can sign this part of the DIP.

Non-compliance with the regulation may result in: withdrawal of the product from the market, administrative and criminal fines, damage to the brand's reputation, legal liability in the event of serious adverse effects.

The French authorities (DGCCRF) are authorized to carry out inspections and can request access to the DIP at any time. It is therefore crucial to create a compliant and complete DIP, starting from the product development phase.

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Product Information File (PIF) Obligations, Content and Best Practices