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PIF & Safety Report

The responsible person must keep the product information file (PIF) with the relevant safety report readily accessible to the competent authorities of the Member State concerned at the address specified on the label.

Data required in the product information file (PIF) include:

  • A description of the cosmetic product which enables the PIF to be clearly attributed to the cosmetic product
  • The cosmetic product safety report
  • A description of the method of manufacturing and a statement on compliance with good manufacturing practice
  • Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product
  • Data on animal testing performed by the manufacturer, his agents or suppliers.

Cosmetic Safety Report:

Each cosmetic product placed on the market should be safe to use and undergo an expert safety assessment. The cosmetic product safety report consists of two parts: safety information and safety assessment. The first part includes:

 

  • Quantitative and qualitative composition of the cosmetic product
  • Physical/chemical characteristics of the cosmetic product with the stability reports under reasonably foreseeable storage conditions
  • Microbiological specifications of the product and results of the preservation challenge test
  • The purity of the substances and mixtures used in the product and the purity and stability characteristics of the packaging material
  • Information on the exposure of the cosmetic product with the toxicological profile of the substances
  • Available data on the undesirable effects to the cosmetic product
The cosmetic product safety assessment can be carried out only by a person possessing formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline. The assessment shall contain a conclusion and an explanation of the scientific reasoning leading to this conclusion. For further details, please refer to Annex I of the Regulation (EC) No 1223/2009 on cosmetic products.

 

 

 

 

Tags:
cosmetics product information file
cosmetic product labelling
cosmetic product safety report
cosmetic product safety assessment
cosmetic product ingredient list
cosmetics formulation

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