COSMETICS PRODUCT INFORMATION FILE (PIF)

The cosmetic Product Information File (PIF) is a compiled document containing all relevant information about a cosmetic product. Cosmetic products in the European Union (EU) are regulated under Regulation (EC) No. 1223/2009, which replaced the previous Cosmetic Directive 76/768/EEC and has been fully implemented since July 2013. This regulation strengthens and modernizes the regulatory framework by introducing stricter safety requirements, mandatory Product Information Files (PIF), centralized product notification (CPNP), enhanced market surveillance, and clearer responsibilities for the Responsible Person. As part of these requirements, every cosmetic product must have a PIF before being placed on the EU market. The PIF is made up of several sections, which provide detailed information about the product:

• 1. A detailed description of the cosmetic product (the necessary information for connecting cosmetic products with documentation)
• 2. Cosmetic Product Safety Report (CPSR)

Part A: Cosmetic Product Safety Information:

• Qualitative and quantitative composition of cosmetic product
• Physical/chemical characteristics and stability of the cosmetic product
• Microbiological quality
• Impurities, traces, information about the packaging material
• Normal and reasonably foreseeable use
• Data on exposure to the cosmetic product
• Data on exposure to the substances
• Toxicological profile of the substances
• Undesirable effects and serious undesirable effects

Part B: Cosmetic Product Safety Assessment:

• Assessment conclusion
• Instructions for use and labelled warnings
• Reasoning
• Safety Assessor's credentials and approval

• 3. A detailed description of the production process
• 4. Evidence (a signed statement) on compliance with good manufacturing practices - GMP
• 5. A proof of the effects claimed for the cosmetic product
• 6. A statement on testing cosmetic products on animals (or data on animal testing, if conducted, for the purpose of placing on the market outside the European Union)
• 7. Product labelling, which includes primary and secondary packaging

The completed PIF documentation is essential for notifying a cosmetic product through the European central electronic system for cosmetic products, known as the EU CPNP portal. Once the notification process is finalized, the product is ready to be placed on the EU market. The EU market includes the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and EFTA countries: Norway, Switzerland, Iceland, Lichtenstein.

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