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Guide: How to create a cosmetic product information file (PIF)
Compliant with EC Regulation 1223/2009?

Introduction

The Product Information File (PIF) is the cornerstone of cosmetic compliance in Europe. It guarantees consumer safety, transparency of information and regulatory compliance of the product before it is placed on the market .

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Regulation (EC) 1223/2009 requires every brand, regardless of size , to create a comprehensive Product Information File (PIF) that is readily available to the authorities. DGCCRF (French Directorate General for Competition Policy, Consumer Affairs and Fraud Control) inspections also target very small businesses, craftspeople, self-employed individuals, and emerging brands , as demonstrated by the official Cosmetics survey. New micro-enterprises in the sector too often lack knowledge of the regulations .

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A well-constructed DIP protects the brand, secures launches and strengthens credibility with distributors and partners.

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What is a PIF?

The DIP is a mandatory regulatory file containing all the information needed to demonstrate that a cosmetic product is safe , compliant and manufactured according to best practices .

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It must be:

  • available before being placed on the market;

  • kept at the address of the Responsible Person ;

  • updated with each change (formula, packaging, tests, claims).

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The official DGCCRF guide " I'm launching my cosmetics business" reminds us that this obligation applies to all businesses, even the smallest ones.

Official content of the PIF in accordance with EC Regulation 1223/2009

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

DIP Cosmétique

This section specifically identifies the product:

  • Product reference and trade name.

  • Formula reference / version number.

  • EAN code.

  • Product category and application area.

  • Product description and its use.

  • Photo of the product and packaging.

  • Variants (fragrance, shade, format).

  • Packaging information (material, distribution system)

Evaluation de la sécurité cosmétique

2. Evaluation of the safety of the cosmetic product

The security assessment is the core of the PIF. It comprises two inseparable parts.

 

Part A: Product Safety Information

  • Qualitative and quantitative composition.

  • Physico-chemical characteristics and stability.

  • Microbiological quality.

  • Impurities, traces, packaging materials.

  • Normal and reasonably foreseeable conditions of use.

  • Consumer exposure.

  • Toxicological profile of the substances.

  • Side effects and serious adverse effects.

  • Relevant information about the finished product.

 

Part B: Security Assessment

  • Conclusion on security.

  • Scientific justification.

  • Warnings and instructions for use.

  • Qualifications of the toxicologist.

GMP

3. Good Manufacturing Practices (GMP: ISO 22716)

  • Declaration of conformity to GMP: certification or self-declaration are possible.
  • Make sure to keep your GMP procedure up to date.
Claim

4. Evidence of the claimed effect

  • Efficacy studies.
  • Consumer tests.
  • Scientific bibliography.
  • Consistency between claims, wording, and results.
CPNP Notification

5. Additional mandatory information

  • Manufacturing method.

  • Packaging procedure.

  • Metrology certificate / net weight.

  • Certificate of no animal testing.

  • Establishment declaration (DGCCRF or ANSM).

  • Proof of CPNP notification.

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What documents must be included in a PIF?

Data collection and verification:

  • Gather raw material documents (SDS, certificates, allergens, purity).

  • Check the conformity of the ingredients (annexes II to VI of regulation 1223/2209).

  • Obtain the specifications and packaging documentation.

  • Compile the laboratory tests performed.

 

Why entrust Part A and Part B to the toxicologist?

Although regulations do not require Part A to be written by a toxicologist, it is the only truly safe approach .

 

A qualified toxicologist:

  • re-decompose the formula to check the consistency between the declared formula and the supplier documents;

  • analyzes each raw material in depth;

  • identifies undeclared substances present in raw materials: antioxidants, residual preservatives, solvents, technical additives, impurities;

  • ensures that all substances present in the finished product are evaluated in Part B;

  • avoids oversights that could render the PIF non-compliant during a DGCCRF inspection .

 

Product information file (PIF) whose Part A sections are written without a toxicologist frequently contain 5 to 15% missing substances, a major risk for the brand.

 

 

Finalization of the PIF:

  • Drafting of Part A (ideally by the toxicologist).

  • Drafting of Part B (mandatory by the toxicologist).

  • Internal verification of the PIF.

  • Digital archiving and continuous updating.

 

Complete checklist of necessary items

Cosmetics dossier

Here is the list of elements that need to be gathered and provided to your toxicologist so that they can write the safety assessment of the cosmetic product:

-> checklist of items .

 

In addition to this , you will need to gather the elements listed below to complete your PIF:

  • GMP Certificate

  • Evidence of the claimed effects

  • Manufacturing method.

  • Packaging procedure.

  • Metrology certificate / net weight.

  • Certificate of no animal testing.

  • Establishment declaration (DGCCRF or ANSM).

  • Proof of CPNP notification.

 

Common mistakes to avoid

Certain recurring errors can compromise the compliance of the PIF, or even lead to its rejection by the competent authorities during an audit. 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 safety 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.

  • Labelling non-compliance : missing mandatory information, translation errors, incorrect pictograms, etc.

  • Unjustified or misleading claims : any allegation must be supported by solid scientific evidence.

  • Part B written by an unqualified person: only a qualified toxicologist can sign this part of the PIF.

 

Failure to comply with the regulations may result in: product withdrawal from the market, administrative and criminal fines, damage to brand reputation, legal liability in the event of serious adverse effects.

 

The French authorities (DGCCRF) are empowered to conduct inspections and can request access to the Product Information File (PIF) at any time . It is therefore crucial to create a compliant and complete PIF from the product development phase onwards.

PIF cosmetic

Useful resources

  • Regulation (EC) 1223/2009 .

  • GMP - ISO 22716.

  • European Commission guides.

  • DGCCRF investigation: Cosmetics: new micro-enterprises in the sector that too often lack knowledge of the regulations .

  • DGCCRF Guide I am launching my cosmetics company (reference document).

  • Safety assessment frameworks: SCCS Guideline 12th revision .

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