Product Information File for Cosmetics
Ensuring compliance for Cosmetics Product Information Files (PIFs) and Streamlining Documentation for Cosmetic Product Safety in the European Union
The Cosmetics Product Information File (PIF) serves as a comprehensive documentation containing essential information about a cosmetic product. It is a vital requirement established by Regulation (EC) No. 1223/2009 on cosmetic products, which replaced the Cosmetic Directive 76/768/EC. This regulation has been fully implemented since July 2013.
To comply with Regulation (EC) No. 1223/2009, it is necessary to prepare a Product Information File (PIF) before introducing a cosmetic product into the European Union market. The PIF is composed of several sections, each containing specific information.
The PIF includes:
Detailed Description of the Cosmetic Product: This section provides necessary information for connecting the cosmetic product with its corresponding documentation.
Cosmetic Product Safety Report:
Part A: Cosmetic Product Safety Information: It comprises various aspects such as the qualitative and quantitative composition of the cosmetic product, physical/chemical characteristics and stability, microbiological quality, information about impurities and traces, as well as details regarding the packaging materials. It also covers the normal and reasonably foreseeable use of the product, data on exposure to the cosmetic product and its substances, toxicological profiles of the substances, and information on any undesirable effects and serious undesirable effects.
Part B: Cosmetic Product Safety Assessment: This section includes the assessment conclusion, instructions for use and labelled warnings, reasoning behind the safety assessment, and the credentials and approval of the Safety Assessor.
Detailed Description of the Production Process: This section provides a comprehensive account of the production process involved in manufacturing the cosmetic product.
Evidence of Compliance with Good Manufacturing Practices (GMP): This section includes a signed statement serving as proof of adherence to good manufacturing practices.
Proof of Claimed Effects: Here, evidence is presented to support the effects claimed for the cosmetic product.
Statement on Animal Testing: This section includes a statement on whether cosmetic products have been tested on animals or, if such testing has been conducted, it provides data related to animal testing for the purpose of placing the product on the market outside the European Union.
Product Labelling: This section encompasses the primary and secondary packaging of the cosmetic product, including all necessary labeling information.
Additionally, if you require assistance in generating your PIF, AF Pharma can provide valuable support. AF Pharma specializes in PIF generation and can help ensure that your documentation is complete and compliant with the relevant regulations.
Please note that it is essential to stay updated with the latest regulations and guidelines regarding cosmetic product documentation to maintain compliance with applicable laws.