What is a PIF?
A Product Information File (PIF) is a regulatory document containing all information related to a cosmetic product, which must be available before the product is placed on the market in the European Union (EU). This file ensures transparency and product safety for consumers and regulatory authorities.
The PIF must be drawn up and maintained by the person responsible for placing the product on the market (often the manufacturer or importer) and must be accessible to national authorities for 10 years after the last production of the batch.
A Product Information File (PIF) for cosmetic products in Europe , as established by Regulation (EC) No 1223/2009 , must comply with several key characteristics to ensure that the product is safe and complies with current regulations in the European Union.
Main features of the PIF in the European Union
Exhaustiveness
Contains all relevant information on the safety, efficacy and manufacturing of the product.
Accessibility
It must be available to national authorities for a period of 10 years.
Continuous update
The PIF must be updated if there are changes to the product or regulations.
Regulatory compliance
Ensures that the product complies with Good Manufacturing Practices and other EU regulations.
Main characteristics of a PIF
Person Responsible for the PIF
The PIF must be in the custody of a responsible person in the EU, who may be the manufacturer, the importer or a designated representative.
This person is responsible for ensuring that the product complies with all applicable EU rules and regulations and, consequently, for keeping the PIF up to date.
Availability
The PIF must be available in electronic or physical format and be accessible to national control authorities for a minimum of 10 years after the last production of the product batch.
It must be in a language that the competent authorities can easily understand.
PIF Contents
The PIF must contain several essential elements. These are:
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Product Description
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CPSR Cosmetic Product Safety Report
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Description of the manufacturing method and compliance with Good Manufacturing Practices (GMP)
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Tests and studies on the effects attributed to the product
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Stability testing
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Microbiological tests
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Data on animal testing (if applicable)
Marketing records
The PIF must include information on the date of placing the product on the market in the EU.
Continuous review
The PIF is not a static document. It must be continually updated if there are changes in the product formulation, manufacturing process, regulations, or any other factor that may affect the safety or regulatory compliance of the product.
Confidentiality
Although the PIF contains sensitive information, such as product formulations, only the competent EU authorities have access to it, ensuring the confidentiality of the information.
Notification in the CPNP (Cosmetic Products Notification Portal)
Although the PIF is not the same as registration with the CPNP, it is necessary for all cosmetic products in the EU to be notified on this portal before they are placed on the market. The information contained in the PIF may be required during this notification process.
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