Zakonodaja  s področja kozmetike v EU

What is PIF? 

The Product Information File (PIF) is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the EU market. It includes cosmetic product safety assesment of product, signed by relevant safety assesor.

Why is PIF needed?

According to EU legislation (Directive 1223/2009) each cosmetic product placed on the EU market must have  PIF . Under Directive 76/768 PIF contains information about the product (composition, purity criteria statement) and assessment of product safety.

Under the new Regulation 1223/2009 PIF contains product information files (description, production methods, rationale arguments and assessments cosmetic product safety report), Cosmetic Product Safety Report:

Part A: Information on the cosmetic product safety (composition, purity, exposure calculation,etc).

Part B: Cosmetic product safety assessment (conclusion, warnings, resoning)

With the introduction of the Directive 1223/2009 PIF gets more precisely defined structure, arguments and manufacturer’s declarations on scientific calculations based foundation. PIF particularly stresses

• Stability and compatibility

• Calculation of the margin of safety (MOS)

• Evaluation and calculations based on exposure to product

• Stress testing

• Assess the effectiveness of tests and scientific methods used

• Analysisof possible side effects.

How can we help?

We can help you establish and maintain a PIF, including the drafting of reports on the safety of cosmetic products and the safety assessment of cosmetic products

MORE: What is PIF?

PIF- Product Information File

The responsible person shall keep a product information file for cosmetic product. The documentation on the product information is kept for 10 years after the date on which the last batch of the cosmetic product placed on the market. The Responsible Person must provide PIF in language that is easily understood by the Competent Authorities.Product Information File includes the following information and data which is updated as appropriate:

  • Product Description
  • Safety Report:
    • Part A: Cosmetic Product Safety Information
    • Part B: Cosmetic Product Safety Assessment Report
  • Method of Manufacturing
  • Evidence of compliance with Good Manufacturing Practices (GMP)
  • Proof of the effect claimed (where justified)
  • Data on Animal Testing
  • Labeling (taking into account the container and outer packaging)
  • Data on Serious Undesirable Effects