Product information file for cosmetics

Whenever a company plans to launch a cosmetic product, the responsible person is obliged under article 11 of the EU Cosmetics Regulation to compile a product information file (PIF). This requirement is in place for all cosmetic products without exception, including samples or similar articles.

Formal PIF requirements

The competent authority must be able to easily access PIFs at the address indicated on the product label. It must be possible to present the PIFs within a period of 72 hours. PIFs have to be retained for ten years as of the point in time when the last batch of a specific cosmetic product was launched on the market.

The content of a product information file features several items such as:

  • Description of the cosmetic product (formulation, product specifications, manufacturing specifications, print templates, etc.)
  • Safety report
  • Description of manufacturing methods; GMP certificate
  • Proof of the claimed effect for the product (dermatological tests, if necessary)
  • Information about animal testing

Safety report

The cosmetic product safety report (Article 10 of the EU Cosmetics Regulation) represents the core of the product information file. Its precise contents are described in detail in Annex I.

The safety report consists of Part A, which includes safety-related information on the cosmetic product, and Part B, which includes the actual safety assessment itself. The assessment summarises and evaluates the information provided in Part A.

The content of the safety report includes information about issues such as impurities in the raw materials used and the relevant characteristics of packaging materials. Part B defines and requires proof of the assessor’s credentials (degree in pharmacy, toxicology, medicine or similar); the assessor’s signature serves as confirmation of the safety report.