Product Information File (PIF)

When a cosmetic product is placed on the market, the responsible person must keep a Product Information File (PIF) for the product for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

The product information file must contain the following information and data which must be kept updated:

  1. a specific description of the cosmetic product which enables the PIF to be clearly attributed to the cosmetic product;
  2. the Cosmetic Product Safety Report (CPSR);
  3. a description of the method of manufacturing and a state­ment on compliance with Good Manufacturing Practice (GMP);
  4. proof of any effect claimed for the cosmetic product;*
  5. data on any animal testing performed by the manufacturer, agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, includ­ing any animal testing performed to meet the legislative or regulatory requirements of third countries outside the EEA.

The PIF must also include the “Physical and chemical characteristics of the substances or mixtures, as well as of the cosmetic product.” which is covered in the raw materials’ MSDS sheets.  Further guidance from Cosmetics Europe – Guidelines on Product Information File (PIF) Requirement.

The responsible person must make the PIF readily accessible in electronic or other format at the physical address indicated on the product label to the competent authority of the Member State in which the file is kept.

The information contained in the PIF must be available in a language which can be easily understood by the competent authorities of the Member State.

* Adequate and appropriate evidence to support any cosmetic products’ claims by following the six criteria below:

  1. Legal compliance
  2. Truthfulness
  3. Evidential support
  4. Honesty
  5. Fairness
  6. Informed decision-making

Further guidance from Cosmetics Europe – Guiding Principles on Responsible Advertising and Marketing Communication.