The Cosmetic Product Information File is the most important regulatory document for cosmetic products sold in regulated markets, especially in the European Union (EU). The PIF is a technical dossier that contains all essential product information. This includes formulation details, manufacturing data, safety assessments, and labeling compliance. The Responsible Person must keep the PIF accessible for regulatory authorities at all times.

The PIF is not an administrative formality. It is the primary legal proof that a cosmetic product complies with Regulation (EC) No 1223/2009. It also confirms that the product is safe for human use under normal conditions.

Core Components of the Product Information File (PIF)

A compliant Product Information File contains several structured sections. Each section demonstrates product safety, quality control, and legal compliance.

Product Description and Formulation Information

This section describes the cosmetic product and its intended use. It includes the full qualitative and quantitative composition of the formula. Each ingredient and its concentration must be clearly identified.

The PIF must also describe the manufacturing method. This description must demonstrate compliance with Good Manufacturing Practices (GMP). The file must include evidence supporting any product claims, such as moisturizing or protective effects.

Product Safety and Cosmetic Product Safety Report (CPSR)

Product safety documentation is the core of the PIF. The Cosmetic Product Safety Report (CPSR) represents this requirement. A qualified safety assessor must prepare and sign the CPSR.

CPSR Part A contains all safety-related data. This includes raw material information, toxicological profiles, and microbiological quality results. It also covers stability data and packaging material safety.

CPSR Part B presents the safety assessment. The assessor evaluates the finished product and ingredient exposure levels. The assessor then confirms whether the product is safe for human use under normal and foreseeable conditions.

Manufacturing and Regulatory Compliance Documentation

The PIF must include a statement confirming GMP compliance. Manufacturers usually demonstrate this through ISO 22716 certification.

This section must also address potential contaminants. Heavy metal test results and raw material purity data must be included. Where applicable, the PIF may confirm that no animal testing was conducted.

Proof of Efficacy, Stability, and Label Compliance

The PIF must include physical and chemical stability test results. These results support the product’s shelf life and Period After Opening (PAO).

Preservative Efficacy Testing (PET) results must also be included. If the product qualifies for an exemption, the file must provide a scientific justification. The PIF must also confirm label compliance with Article 19 of Regulation (EC) No 1223/2009. This includes ingredients, warnings, usage instructions, and PAO or expiry information.

The Importance of PIF Maintenance and Ongoing Compliance

The Responsible Person must maintain the Product Information File continuously. The file must remain accessible for ten years after the last batch enters the market.

The PIF serves as a single auditable compliance record. It proves that the product was formulated, manufactured, tested, and labeled correctly. Without a complete PIF, authorities may classify the product as non-compliant and remove it from the market.

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