The importance of the Product Information File (PIF)

In the cosmetics industry, regulatory compliance is essential to ensure consumer safety and meet legal requirements. One document crucial for compliance with EU regulations is the Product Information File (PIF). Let’s dive into what a PIF entails and why it’s vital for cosmetic products sold in the European Union.

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:

• 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 ?

1. A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product
2. The CPSR part A and B
3. The annexes of the CPSR
4. Formula in raw materials
5. Specification sheet and/or certificate of analysis of the finished product
6. Documentation on each raw material (MSDS, CofA, IFRA and allergen report if applicable)
7. Stability study
8. Microbiological information (challenge tests – microbiological analysis)
9. Information about the packaging material (material description, impurities statement, food contact statement,)
10. Toxicological evaluation with the normal and reasonably foreseeable use, exposure data, MoS calculation, toxicological profile of each substance.
11. Undesirable effects statement
12. Other tests if any
13. The diploma of the safety assessor
14. A description of the method of manufacturing
15. A statement on compliance with good manufacturing practice
16. Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product
17. Data on any animal testing on the finished product and on each raw material
18. The labels
19. PIFs must be in English (in case Biorius takes the RP for the UK, french accepted if for EU)

Where Do I Find the Right Data?

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 is a vital component for any cosmetic product entering the EU market. It not only fulfills regulatory obligations but also helps safeguard consumer trust by demonstrating a commitment to product safety. For brands looking to streamline this process, working with professionals like Biorius can help ensure smooth compliance and allow the business to focus on growth. Biorius, Your Regulatory Expert can assist you in many ways concerning your Product Information File (PIF) :

• BIORIUS can make the PIF for you and become your Responsible Person
• BIORIUS can audit your current cosmetic PIF to see if they are aligned with the current legislation
• BIORIUS provides many advices or services that can help you to obtain mandatory information as toxicological test
• BIORIUS adapts its offer to your specific needs to assist you in this process

Need a piece of advice, a quotation or answers to your questions? Contact us…

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As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

• First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
• 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
• A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
• A best-in-class IT tool, free of charge, and saving a lot of your time.
• More than 1,500 international clients have already chosen Biorius!
• We evaluated more than 100,000 products and have always successfully managed compliance over 15 years of existence