Creating a Product Information File (PIF) is a mandatory regulatory requirement for cosmetic products placed on the EU market. The PIF functions as the central technical dossier that demonstrates compliance with Regulation (EC) No 1223/2009 and confirms that the cosmetic product is safe for human health. A well-prepared PIF also supports regulatory inspections and ensures long-term compliance with EU cosmetic legislation.

Companies typically structure the PIF creation process into four key phases, each addressing a specific legal and technical requirement.

Phase 1: Gathering Raw Material and Formulation Data

The first phase focuses on collecting complete and accurate information about the product’s composition. This information forms the scientific foundation of the safety assessment.

Manufacturers must obtain raw material documentation from every ingredient supplier. For each substance used in the formulation, suppliers must provide the following documents:

  • Safety Data Sheets (SDS) containing toxicological, physical, and chemical information
  • Certificates of Analysis (CoA) confirming batch-specific purity and quality
  • Technical Data Sheets (TDS) listing INCI names, CAS numbers, and recommended use levels
  • Allergen declarations and IFRA Certificates for fragrance materials

At the same time, the manufacturer must define the exact qualitative and quantitative composition of the finished product. This includes specifying the percentage of each ingredient in the formula. The finalized formulation serves as a core input for the Cosmetic Product Safety Report and must remain consistent across all regulatory documentation.

Phase 2: Product Testing and Manufacturing Proof

Before completing the safety assessment, manufacturers must confirm product stability, microbiological quality, and controlled manufacturing conditions.

Stability testing establishes the product’s shelf life, determines the Period After Opening (PAO), and verifies compatibility between the formulation and its packaging. These tests confirm that the product maintains its quality and safety throughout its intended lifespan.

Manufacturers must also perform microbiological quality testing. This includes conducting a Preservative Efficacy Test (PET), commonly known as a challenge test, to demonstrate that the preservative system effectively controls microbial growth during normal and foreseeable use.

The PIF must also include manufacturing documentation. This section describes the manufacturing process and confirms compliance with Good Manufacturing Practices (GMP). Companies often demonstrate GMP compliance through ISO 22716 certification or equivalent documentation.

Phase 3: Cosmetic Product Safety Report (CPSR)

The Cosmetic Product Safety Report represents the most critical component of the PIF and requires preparation by a qualified safety assessor, as defined under EU cosmetic legislation.

In CPSR Part A, the assessor compiles all relevant safety information. This section includes the full product formulation, toxicological profiles of raw materials, stability data, microbiological test results, packaging information, and foreseeable exposure conditions.

In CPSR Part B, the assessor evaluates the safety of each ingredient at its final concentration in the finished product. The assessment considers exposure levels, toxicological thresholds, and regulatory restrictions. The assessor then issues a formal safety conclusion and defines any mandatory warnings, instructions for use, or restrictions that must appear on the product label.

Phase 4: Final Documentation and Labelling Compliance

The final phase focuses on ensuring that all consumer-facing materials comply with EU cosmetic regulations and that marketing practices remain legally substantiated.

The PIF must include copies of all final cosmetic label artwork. Labels must meet EU requirements by displaying the correct INCI ingredient list, nominal content, PAO or expiry date, warnings, instructions for use, and the name and address of the Responsible Person. Where applicable, labels must also display country-specific symbols such as the Triman logo for France.

Manufacturers must also substantiate all cosmetic claims. Claims such as “dermatologically tested,” “moisturizing,” or “anti-aging” require adequate and verifiable evidence. Acceptable evidence includes clinical studies, instrumental measurements, consumer perception tests, or relevant scientific literature. The company must retain all supporting documentation within the PIF.

Once finalized, the Responsible Person must keep the Product Information File readily accessible for at least ten years after placing the last batch of the product on the EU market. This requirement supports post-market surveillance activities and enables authorities to conduct regulatory inspections when necessary.

From raw materials to CPSR and labeling compliance, we support your cosmetic PIF preparation at every step. Get in touch today!