Ensure full compliance with EU and UK cosmetic regulations with a professionally compiled Product Information File (PIF). Patient Guard supports manufacturers, brand owners, and importers by preparing, reviewing, and maintaining PIFs to meet regulatory requirements and facilitate smooth market access.
Cosmetic manufacturers must prepare and maintain a Product Information File (PIF) to demonstrate compliance with EU Cosmetic Regulation (EC) No 1223/2009 and UK cosmetic regulations.
A Product Information File is a mandatory requirement for placing cosmetic products on the market in the European Union and the United Kingdom. It must contain detailed information about the product, including safety data, formulation, manufacturing processes, and supporting documentation.
Patient Guard acts as your cosmetic regulatory consultancy, supporting manufacturers with PIF preparation, documentation review, and regulatory compliance.
Without a compliant PIF, cosmetic products cannot be legally placed on the market or registered on the Cosmetic Product Notification Portal (CPNP) or the Submit Cosmetic Product Notifications (SCPN) system.
We provide expert PIF services for cosmetic manufacturers worldwide, ensuring your documentation is complete, compliant, and audit-ready.
Speak to our regulatory experts today to ensure your cosmetic products meet EU and UK regulatory requirements.
Under EU and UK cosmetic regulations:
We assess your product formulation, ingredients, and documentation
We gather all required safety, manufacturing, and supporting data
We compile your Product Information File in line with regulatory requirements
We verify that your documentation meets EU and UK regulations
We deliver your PIF and provide ongoing support for updates and compliance
We support a wide range of cosmetic products, including:
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Support your market access with expertly prepared, fully compliant Cosmetic Product Information Files (PIFs). Pricing starts at £500 per PIF, with preferential rates for multiple products.
Provide formulation, ingredient data, packaging, and supporting documentation
Our experts compile and verify your Product Information File to ensure full compliance
Receive your completed PIF, with optional updates and support for future regulatory needs.
Efficient delivery: PIFs are typically completed within 5–10 working days, with timelines tailored to product complexity and data readiness.
A PIF is a regulatory document that contains all the information required to demonstrate that a cosmetic product is safe and compliant with EU and UK cosmetic regulations.
Yes, a PIF is a legal requirement for all cosmetic products placed on the EU or UK market.
A PIF includes the Cosmetic Product Safety Report (CPSR), product description, manufacturing information, labelling details, and supporting data.
A PIF must be retained for at least 10 years after the last batch of the product has been placed on the market.
Click on the links below to discover more:
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2026 represents a significant milestone for the amended IVDR transitional provisions framework.
If you sell cosmetics in the UK or EU, you are legally required to maintain a Cosmetics Product Information File – even if you’re a tiny indie brand mixing batches between client emails.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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