4 March 2025
The importance of the Product Information File (PIF)
In the cosmetics industry, regulatory compliance is not just a legal obligation but also a fundamental aspect of ensuring consumer safety, product efficacy, and brand credibility. Companies must adhere to strict guidelines to bring their products to market while maintaining transparency and accountability.
One of the most critical documents required for compliance with European Union regulations is the Product Information File (PIF). This comprehensive dossier serves as a repository of essential data related to a cosmetic product, including its formulation, manufacturing process, safety assessment, and supporting documentation.
Regulatory authorities rely on the PIF to verify that a product meets all safety and legal requirements before it is placed on the market. Without a properly compiled PIF, a cosmetic product cannot be legally sold within the EU.
Table of Content
What does a Product Information File include?
A Product Information File is a comprehensive record that contains all necessary details about a cosmetic product. It’s required by Regulation (EC) No 1223/2009 to demonstrate that the product is safe before being sold in the EU. This document must be made available to authorities for review when requested.
Some key elements of the PIF are:
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Product description: A clear summary of the cosmetic product and its intended use. -
Safety Report: A report that evaluates the safety of the product’s ingredients and formulation, known as the Cosmetic Product Safety Report (CPSR). -
Manufacturing details: Information about the production process and adherence to good manufacturing practices (GMP). -
Evidence of claims: Scientific backing for any product claims, such as “moisturizing” or “anti-aging.” -
Animal testing compliance: Confirmation that the product complies with the EU ban on animal testing, where applicable.
Which documents and information must be part of the cosmetic PIF?
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A detailed description of the cosmetic product, ensuring clear identification within the Product Information File (PIF). -
The Cosmetic Product Safety Report (CPSR) – including both Part A (data on the product) and Part B (safety assessment). -
Annexes related to the CPSR. -
Formula composition with raw materials breakdown. -
The Specification Sheet and/or Certificate of Analysis (CoA) for the finished product. -
Documentation for each raw material, including Material Safety Data Sheets (MSDS), Certificates of Analysis (CoA), IFRA compliance reports, and allergen reports, where applicable. -
Stability testing results. -
Microbiological data, such as challenge test results and microbiological analysis. -
Information on packaging materials, including material descriptions, impurity statements, and food contact compliance statements. -
Toxicological evaluation, covering normal and foreseeable product use, exposure data, Margin of Safety (MoS) calculations, and toxicological profiles of all substances. -
A statement on undesirable effects, if any. -
Additional test results, if available. -
The diploma or certification of the responsible safety assessor. -
A detailed description of the manufacturing process. -
A declaration of compliance with Good Manufacturing Practices (GMP). -
If applicable, scientific proof or studies supporting product claims based on its nature or intended effects. -
Data on animal testing, if any, conducted on the finished product or its raw materials. -
Copies of the product labels, ensuring compliance with EU regulations.
Where Do I Find the Right Data?
Some of the data comes from:
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Product manufacturers
Other data comes from:
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Independent laboratories -
A duly qualified safety assessor with degrees recognized by Article §2
Why Is the PIF So Important?
The Product Information File plays a key role in ensuring that a cosmetic product meets all safety standards and is compliant with EU regulations. Without a valid PIF, a product cannot be legally sold in the EU, and failure to maintain an up-to-date file can result in fines, product recalls, or market bans.
The Responsible Person (RP) designated for the product is tasked with maintaining the PIF and ensuring it complies with the law. This ensures that if a regulatory authority requests the file, the brand can provide it without delay.
Staying Compliant
Keeping a PIF compliant requires ongoing attention, especially when product formulations or regulations change. Companies often seek help from regulatory experts like Biorius to maintain up-to-date files for all their cosmetic products, ensuring continued compliance without disruptions.
Conclusion
The Product Information File (PIF) is an essential requirement for any cosmetic product entering the EU market. More than just a regulatory obligation, it plays a crucial role in protecting consumer health and reinforcing trust by showcasing a brand’s dedication to product safety and compliance.
For companies looking to navigate this process efficiently, partnering with regulatory experts like Biorius can simplify compliance, reduce risks, and allow businesses to focus on growth. As your trusted regulatory partner, Biorius offers comprehensive support in managing your Product Information File (PIF), ensuring that your products meet all necessary EU standards.
Author
Biorius
First Class specialists in cosmetic regulations in Europe, United Kingdom, United States, Canada and in more than 60 countries
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