Cosmetics product information file (PIF)

ABOUT THE COSMETICS PRODUCT INFORMATION FILE (PIF)

The product information file is a cosmetic product dossier containing all the most important information about the product, ingredients, packaging, manufacturing process and labelling, which shows the product characteristics and its safety and efficacy. Each product sold in the EU needs to have a product information file prepared.

According to the EU Cosmetics Regulation 1223/2009, the responsible person must keep a product information file for each cosmetic product placed on the EU market, at the address specified on the product labelreadily accessible for the competent authority of the EU member state where the responsible person is established. The product information file has to be available in a language easily understood by the local competent authority of the country where the responsible person is keeping the cosmetics product information file.

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 must be kept at one single address within the EU, even if the cosmetic product is sold in various EU countries. This also means that there can only be one responsible person per product for the whole of the EU – there cannot, for example, be one responsible person in Germany and one in France for the same product.

PRODUCT INFORMATION FILE (PIF) CONTENT

The product information file content is described in article 11 of EU Cosmetics Regulation 1223/2009. The content of the cosmetics product information file is standardized and does not change, irrespective of the type of cosmetic product in question.

According to article 11, the product information file must 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, consisting of the following.
    • 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 manufacturingand either a good manufacturing practice certificate or a statement on compliance with good manufacturing practice (the GMP standard which must be followed in the EU is standard ISO 22716)
    • Where justified, a proof of the effect claimedfor the cosmetic product
    • Any data on animal testing
    • The product information file should also contain product labelling

The most important and most extensive part of the cosmetics product information file is the cosmetic product safety report (CPSR), which contains all the information, specifications and tests relating to the raw materials, finished product, packaging, etc. Based on these, the safety and the compliance of the cosmetic product with the EU cosmetics regulation can be proven.

A complete cosmetics product information file (PIF) is the basis for the notification to the EU CPNP portal, which must be performed before the cosmetic products can be placed on the EU market.

CE.WAY SERVICES RELATED TO THE PRODUCT INFORMATION FILE

CE.way can offer various services related to the preparation of the product information file. We can offer consultancy on: the product information file content, reviewing or compiling the cosmetics product information file, preparing the cosmetic product safety assessment, checking the product labelling, performing stability and compatibility tests, challenge testing and helping you prove the effects claimed for your cosmetic products.