The creation of a Product Information File (PIF) is the mandatory process for compiling all technical and scientific Documentation needed to demonstrate that a cosmetic product is safe and legally compliant, primarily under the EU Cosmetics Regulation. This process, known as PIF Creation, systematically gathers data across four main areas.
Phase 1: Gathering Raw Material and Formulation Data
The first and most complex step is securing complete information on the product’s composition.
- Raw Material Documentation: You must obtain comprehensive files from all suppliers for every substance used in the formula. This includes:
- Safety Data Sheets (SDS): Toxicological and physical data.
- Certificates of Analysis (CoA): Batch-specific purity confirmations.
- Technical Data Sheets (TDS): INCI names, CAS numbers, and percentage use.
- Allergen and IFRA Certificates (for fragrances/perfumes).
- Formula Details: You must define the precise qualitative and quantitative composition of the finished product. This detailed formula is the core data used for the safety assessment.
Phase 2: Product Testing and Manufacturing Proof
Before a product can be assessed for safety, its stability and quality must be proven through Testing.
- Stability Testing: Necessary to determine the shelf life and the Period After Opening (PAO). This also checks compatibility between the formula and the packaging material.
- Microbiological Quality: Must include a Preservative Efficacy Test (PET/Challenge Test) to confirm the preservative system is effective throughout the product’s lifespan.
- Manufacturing Documentation: The PIF must contain a detailed description of the manufacturing method and a statement of compliance with Good Manufacturing Practices (GMP), often demonstrated via ISO 22716 certification.
Phase 3: The Cosmetic Product Safety Report (CPSR)
The CPSR is the most critical component of the PIF Documentation and must be performed by a qualified safety assessor.
- CPSR Part A (Safety Information): The assessor compiles all the data from the Raw Material documentation and Testing (stability, microbiology, packaging safety). This part details the toxicological profile of all substances in the finished product.
- CPSR Part B (Safety Assessment): The assessor formally evaluates the risk associated with all ingredients at their concentration in the final product. This results in the final safety declaration and outlines all required warnings and instructions for use.
Phase 4: Final Documentation and Labelling Compliance
The final steps ensure the product’s consumer interface and claims are legally sound.
- Cosmetic Labelling: The PIF must include a copy of all final primary and secondary label artwork. This artwork must demonstrate compliance with all labeling rules, including the INCI list, warnings, the PAO symbol, and any specific national symbols (like the Triman in France).
- Claims Substantiation: All marketing claims made on the label must be supported by evidence (clinical trials, consumer data, etc.), which is included in the PIF.
The resulting comprehensive file must be kept accessible by the Responsible Person for ten years after the last batch of the product is placed on the market.
