Product Information File

What is a PIF?

A Product Information File – or PIF for short – is a mandatory document required by the EU cosmetics regulation for all cosmetic products placed on the EU market. The purpose of the PIF is to capture key safety information about the cosmetic.

Contents of a PIF

The PIF must contain specific information, including the product’s ingredients and quantities, lab test certificates, and safety data sheets. It must also include packaging mock-ups, as well as any post-marketing adverse reactions.

Responsible Person & PIF

The PIF should be held on file by the Responsible Person and be available to the authorities should they request it. The PIF should be updated with any changes to the product characteristics and safety information, among other things.

List of requirements

• Description of the product
• CPSR (signed by the cosmetic assessor)
• Any declarations including GMP statement & no animal testing
• Manufacturing Process Flow chart
• MSDS, CoAs & IFRA statements
• Product Specification
• Stability & compatibility test report
• Micro test report
• Challenge test report (if required)
• Evidence to support marketing claims
• Packaging material specification
• Label mock up
• Photos of the product
• Complaints & adverse reaction log

On file for 10 years

The Responsible person must keep the PIF for a period of 10 years following the date of the last
batch released on to the market. The PIF must be readily accessible in electronic in a language easily understood by competent authorities. This can be either the language native to the authority making the request or English.

FAQ

What should be in a Product Information File?

Ensure your Product Information File (PIF) includes essential data: product description, safety assessment, ingredient list, manufacturing process details, and labelling information.

What is the best format for creating a Product Information File?

Go for a user-friendly digital format such as PDF. This ensures easy access, sharing, and updating of your Product Information File. Maintain consistency and clarity in your documentation to help the authorities should they request to review your PIF.

How do you create a Product Information File?

Build a Product Information File by collating required documents: safety data, formulation details, manufacturing processes, and testing results. Organise these components systematically, following EU and UK cosmetic regulations, for the benefit of yourself and the authorities.

How long does it take to make a Product Information File?

Building a Product Information File duration varies based on product complexity including number of ingredients. Typically, allow several weeks for research, documentation compilation, and regulatory compliance checks (e.g CPSR authoring).

Why do you need a Product Information File?

A Product Information File (PIF) is a legal requirement for marketing cosmetics in the EU and UK. It serves as a comprehensive dossier, providing evidence of product safety, regulatory compliance, and facilitating market access. Be sure to keep your PIF updated and in-line with the changing regulations.