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Product Information File and Safety Report in compliance with 1233/2009 Cosmetic Regulation. The Product Information File (PIF) is a major requirement of the Cosmetic Regulation (EU) 1223/2009. PIF is a summary of information that all cosmetic products are required to include in order to comply with regulatory requirements.The Cosmetic Product Safety Report (CPSR), edited in accordance with Annex I of Regulation 1223/2009, is the most important section of a PIF.
Product Information File (PIF)
A Product Information File must be developed in order to place cosmetic items on the market in countries that are members of the European Union, as described in the Cosmetic Regulation 1223/2009. The Product Information File is required and must be completed for each cosmetic product separately.
The responsible person must keep the product information file (PIF) with the relevant safety report at the address stated on the label easily accessible to the competent authorities of the Member State concerned.
The following information is required in the product information file (PIF):
- A cosmetic product description that allows the PIF to be explicitly attributed to the cosmetic product.
- The report on cosmetic product safety
- A statement on compliance with good manufacturing practice and a description of the manufacturing method
- Proof of the stated impact for the cosmetic product, where justified by the type or effect of the cosmetic product
- Information about animal testing conducted by the company, his representatives, or his suppliers.
Cosmetic Safety Report:
Each cosmetic product that is put on the market must be safe to use and pass an expert safety evaluation. There are two sections to the cosmetic product safety report: safety information and safety assessment. The first section comprises the following:
- The cosmetic product’s quantitative and qualitative components
- Physical and chemical properties of the cosmetic product, as well as stability evaluations for storage under reasonably foreseeable conditions
- The product’s microbiological parameters and the results of the preservation challenge test
- The purity of the ingredients and mixtures utilized in the product, as well as the packaging material’s purity and stability.
- Information on the cosmetic product’s exposure as well as the toxicological profile of the chemicals
- Data on the cosmetic product’s unfavorable effects is currently available.
