The PIF (Product Information File) for Cosmetics
- 5 days ago
- 3 min read
The role of the PIF in placing products on the market
In the European Union, a cosmetic product cannot be placed on the market without a complete file known as the Product Information File (PIF). This is a legal requirement defined by Regulation (EC) No 1223/2009.
The PIF serves as regulatory proof that your product is safe, compliant, and scientifically substantiated before commercialization. It must be kept up to date and made available to authorities in the event of an inspection.
At CEHTRA, we support brands at every stage of PIF preparation and compliance (toxicological assessment, safety report drafting, labeling, etc.) to ensure a smooth and compliant market entry.
What is the PIF?
The PIF is a comprehensive technical dossier containing all necessary information about a cosmetic product: product identity, formulation, safety data, scientific evidence, regulatory compliance, etc. It has been mandatory since the implementation of the EU Cosmetic Regulation.
It is the reference file demonstrating that all mandatory steps required by European regulation have been carried out before placing the product on the market.
Who is it mandatory for?
The PIF is mandatory for every cosmetic product placed on the European Union market. This means that each variant (size, fragrance, specific formulation) must have its own PIF.
Responsibility: The Responsible Person (RP) manufacturer, importer, or designated distributor,is legally required to compile and maintain the PIF.
When must it be created?
The PIF must be established before placing the cosmetic product on the market. It ensures product safety, supports product efficacy when specific claims are made, and accurately describes the product to link the dossier content with the product available on the market.
What does a PIF contain?
The PIF is a structured compilation of elements required by the EU Cosmetic Regulation:
a) Detailed product description
Trade name and product function
Cosmetic category
Intended use and target population
Product reference number (unique identity linking all dossier data to the product)
b) Cosmetic Product Safety Report (CPSR)
Part A: safety data (ingredients, toxicology, concentrations)
Part B: final safety assessment
This report must be prepared by a qualified safety assessor and constitutes the scientific core of the dossier.
c) Manufacturing information
Production method
Compliance with Good Manufacturing Practices (GMP)
d) Test data and evidence
Results supporting claims (e.g., “moisturizing”, “anti-aging”)
e) Animal testing information
List of animal tests conducted by the manufacturer or suppliers on the product or its ingredients, including those performed to meet third-country requirements
Additional CPSR content, the CPSR also includes:
Qualitative and quantitative composition of the formula (chemical names, INCI, CAS/EINECS/ELINCS identifiers)
Role and function of each substance
Stability data
Microbiological data
Shelf life and availability
European regulation requires that the PIF be kept for at least 10 years after the last batch has been placed on the market.
It must also be made available to competent authorities within 72 hours in case of inspection.
Relationship with CPNP notification
The PIF is linked to the product notification in the Cosmetic Product Notification Portal (CPNP), the European notification platform. Information from the PIF is used to complete this notification.
Why is a well-structured PIF essential?
An incomplete, insufficient, or outdated PIF can lead to:
Regulatory sanctions
Temporary or permanent product withdrawal
Loss of market trust
Customs or international market access issues
At CEHTRA, our expertise helps you anticipate these risks and build a robust, scientifically sound PIF.
Best practices for drafting a PIF
To ensure compliance:
Use a clear and updateable structure
Rely on recognized scientific sources for safety assessments
Monitor regulatory changes (e.g., new ingredient restrictions)
Update the PIF whenever there is a change in formulation, claims, or labeling
Get expert support in preparing your PIF and ensure full compliance of your products with European regulations.