Product Information File: What Does It Include And How Long Is It Retained?

The safe marketing of cosmetic products depends not only on the effectiveness of formulations but also on the complete preparation of the necessary documentation in terms of legal compliance and product safety. Among these documents, the most fundamental and mandatory is the Product Information File (PIF).

This article details what the PIF is, what information it covers, and how long it must be legally retained.

What is the Product Information File (PIF)?
The Product Information File is a technical document that certifies that a cosmetic product is:

Safe (does not pose a risk to human health),
Effective (delivers the promised function),
Legally compliant (in accordance with regulatory requirements).

Manufacturers or responsible persons placing cosmetic products on the market are obligated to prepare this file and present it to competent authorities upon request. The PIF facilitates scientifically based decision-making during product development and ensures transparency during inspection processes.

Mandatory Information to be Included in the PIF

Product Description
- Product name and brand
- Cosmetic category (e.g., hand cream, shampoo)
- Packaging type and target user group
Qualitative and Quantitative Composition
- INCI names of all ingredients in the formulation
- Intended functions and percentage of each ingredient
- MSDS (Material Safety Data Sheet) for each ingredient
IFRA Certificate and Allergen Declaration for Products Containing Fragrance
- IFRA compliance certificates
- Declaration of allergens required by regulation
Physico-Chemical, Stability, and Microbiological Properties
- Physico-chemical data such as pH, viscosity, density
- Stability test reports
- Microbiological analysis results (including Challenge Test)
Manufacturing Process and GMP Practices
- Process descriptions under Good Manufacturing Practices (GMP - ISO 22716)
- Quality control and hygiene protocols
Cosmetic Product Safety Assessment Report (CPSR)
- Toxicological assessment
- Exposure scenarios
- Potential effects on human health
Undesirable Effects and Feedback Mechanism
- List of possible adverse effects resulting from product use
- Monitoring and reporting methods
Scientific Evidence of Claims
- Clinical, in vitro, or user tests supporting claims such as “hypoallergenic” or “dermatologically tested”
Label and Packaging Information
- All information to appear on the product packaging: ingredient list, usage instructions, warnings, PAO period, manufacturer details, etc.
- Packaging material and design

How Long Must the Product Information File Be Retained?
The PIF must be kept by the manufacturer or importer for a minimum of 10 years from the date the last batch of the product was placed on the market. During this period, the file must:

Be kept up to date
Be revised as needed with formulation changes or new analyses
Be ready to be presented in full and complete form when requested by the Turkish Medicines and Medical Devices Agency (TMMDA) or the competent authorities in the European Union

Cosming’s PIF Preparation and Compliance Consulting
At Cosming Laboratory, we support manufacturers and brands in documenting cosmetic products in compliance with regulations, providing services including:

Formulation review and INCI verification
Safety assessment and CPSR preparation
Conducting stability and microbiological tests
Label compliance checks
Full assembly and revision of the PIF with complete components

Cosming'de arayın.

Product Information File: What Does It Include And How Long Is It Retained?

Be among the first to hear about industry updates.