Every cosmetic product placed on the EU market must be supported by a complete and up-to-date Product Information File (PIF). This documentation obligation lies with the Responsible Person, who bears full accountability for the product’s safety and regulatory compliance.

Table of contents

  1. Obligation to Retain Product Documentation
  2. Scope of the PIF Documentation
  3. Importance of Product Documentation for Compliance and Audits
  4. Common Documentation Errors
  5. GCB Services in Product Documentation Verification

Obligation to Retain Product Documentation

According to Article 11 of Regulation (EC) No 1223/2009, product documentation must be retained for 10 years from the date of placing the last batch on the market. It must remain readily available to competent authorities in electronic or physical form within the EU, enabling prompt verification in case of inspections or market incidents.

Scope of the PIF Documentation

A complete Product Information File must include at minimum:

  • Product description – clear identification of the cosmetic and its intended use,
  • Safety Report (CPSR) – risk assessment and confirmation of safe use,
  • Production method and GMP compliance statement – reference to ISO 22716,
  • Evidence of claimed functional effects – where relevant (e.g. anti‑aging claims),
  • Animal testing information – details on any animal testing conducted, if applicable, especially for export markets,
  • Complaint handling and corrective action records – documentation of post‑market actions taken.

Importance of Product Documentation for Compliance and Audits

The PIF serves as a primary means of demonstrating legal compliance and audit readiness. It allows for quick responses to consumer complaints, post‑market investigations, and the need to establish conformity in export markets. Properly maintained PIFs enhance brand credibility and support consumer safety.

Common Documentation Errors

  • Failure to update documentation after formulation or supplier changes,
  • Insufficient evidence for claimed effects,
  • Incomplete description of manufacturing methods or lack of GMP reference,
  • No documentation supporting label compliance or ingredient declarations.

GCB Services in Product Documentation Verification

GCB offers independent verification services for cosmetic product documentation against the requirements of Regulation 1223/2009. Our review includes the safety report, ingredient data, functional evidence, and label compliance. The service delivers a summary report that highlights conformity status and identifies any documentation gaps, which may be used in preparation for audits or regulatory inspections.