Product information file (PIF)

The Responsible person has to keep a Product Information File (PIF) – cosmetic product dossier, for each cosmetic product placed on the market, at the address specified on the product labelreadily accessible for the competent authority of the member state where the Responsible person is established. The Product Information File has to be available in the language easily understood by the local competent authority.

When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. (EU Regulation 1223/2009, Article 11.1)
The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State. (EU Regulation 1223/2009, Article 11.3)

The Product Information File has to be kept at one single address within the EU.

PRODUCT INFORMATION FILE (PIF) CONTENT

Product Information File content is described in Article 11 of the EU cosmetics regulation 1223/2009. According to article 11, the Product Information File has to contain the following information and data:

  • A description of the cosmetic product
  • Cosmetic product safety report (CPSR), the contents of which are described in annex I, and it consist of:
    • Part A: Cosmetic product safety information
      • Quantitative and qualitative composition of the cosmetic product
      • Physical/chemical characteristics and stability of the cosmetic product
      • Microbiological quality
      • Impurities, traces, information about the packaging material
      • Normal and reasonably foreseeable use
      • Exposure to the cosmetic product
      • Exposure to the substances
      • Toxicological profile of the substances
      • Undesirable effects and serious undesirable effects
      • Information on the cosmetic product
    • Part B: Cosmetic product safety assessment
      • Assessment conclusion
      • Labelled warnings and instructions for use
      • Reasoning
      • Assessor’s credentials and approval
  • A description of the method of manufacturing and a statement on compliance with good manufacturing practice (good manufacturing practice standard which has to be followed in the EU is standard ISO 22716)
  • Where justified a proof of the effect claimed for the cosmetic product
  • Any data on animal testing
  • The product information file should also contain product labelling

The most important and the most extensive part of the Product Information File is the Cosmetic product safety report (CPSR), which contains all of the different information, specifications and tests related to the raw materials, finished product, packaging etc. Based on these compliance and safety of the cosmetic product can be proven.

A complete Product Information File (cosmetic dossier) is the basis for the notification to the EU CPNP portal, which has to be performed before the cosmetic products can be placed on the market.