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A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of manufacture etc. and is open for inspection by the Regulatory authority. According to the Cosmetic Regulation (EC) No 1223/2009, when a cosmetic product is placed in the European market, the Responsible person for the product is required to maintain a Product Information File (PIF). The PIF must be maintained by the Responsible person for at least 10 years post the date, on which the last batch of the product was distributed in the market. In case any changes are made to the product, the PIF must be updated immediately.

A PIF should entail:

  1. Description of the cosmetic product – The description part establishes a clear relation between the cosmetic product and its PIF. It includes the name of the product, product's formula, identification and code, all the names in the national language of European Union (EU), if the product must be commercialized in the EU member countries etc.
  2. Product Safety Report – The aim of the product safety report is to evaluate the safety of the cosmetic product. It consists of two parts:
  • Part A – It contains all the necessary data required to conduct the safety assessment. For example, microbiological quality of the product, toxicological profile, exposure to the substance and cosmetic products, physical/chemical properties etc.
  • Part B – Contains the conclusion of the product safety report based on the safety assessments. It includes references of the person in charge, scientific reasoning, conclusion of the safety assessment, instructions displayed on the label.
  1. Manufacturing Method – This part contains manufacturing methods of the cosmetic product and a declaration to the Good Manufacturing Practices (GMP) of the product’s compliance.
  2. Proof of the claimed effect – This part contains information which can support the claims of the product.
  3. Data related to animal testing – If no animal testing has been performed, it should be clearly mentioned in the PIF. Else, the following data should be declared in the PIF:
  4. Place of the test
  5. Date of animal testing
  6. Identification of animal testing
  7. Ingredients used
  8. Legal objective and justification related to animal testing

Products for which PIF is required

Every product that falls under the definition of a cosmetic product and is placed in the European market, requires a PIF.

Format and Language of PIF

  • It should be kept in electronic or any other (example: paper) format as long as it is maintained
  • The information included should be easily understood by the verifier of the PIF
  • It should be in the national language of the country it is kept in
  • Any supporting documents such as laboratory reports, letters or publications should be retained in the original language they are written in

PIF is a crucial part of placing a cosmetic product in the EU market. Consult our experts regarding authoring, compiling and submitting PIFs. Reach out to us at sales@freyrsolutions.com.