How to Prepare a Fully Compliant Product Information File (PIF) for the EU and UK Market

Preparing a fully compliant Product Information File (PIF) is a legal requirement for every cosmetic product placed on the European Union market under Regulation (EC) No 1223/2009, as well as for products placed on the UK market under the UK Cosmetics Regulation.

For US cosmetic manufacturers, the PIF is often misunderstood as a formal or administrative requirement. In practice, it is the primary document reviewed during EU and UK market inspections and one of the most common bases for enforcement action, sales suspension, or product withdrawal.

This article explains the legal structure, regulatory role, and compliance implications of the Product Information File for US brands entering the EU and UK markets. It is intended for informational purposes only and does not replace a regulatory assessment, safety evaluation, or the role of the Responsible Person (RP).

During market controls, authorities typically focus first on the validity of the Cosmetic Product Safety Report (CPSR) and the substantiation of marketing claims documented in the PIF.

1. Responsible Person (RP): legal accountability in the EU and UK

Every cosmetic product placed on the EU market must have a designated Responsible Person (RP) established within the European Union. Likewise, products placed on the UK market must have a UK Responsible Person established in the United Kingdom.

The Responsible Person carries direct legal responsibility for product compliance under EU and UK cosmetics legislation.

maintaining the Product Information File at the EU or UK address stated on the product label,
providing the PIF to competent authorities within 72 hours upon request,
retaining the documentation for 10 years after the last batch of the product has been placed on the market.

Compliance implication for US brands:
If non-compliance is identified, enforcement measures are addressed to the Responsible Person, not to the non-EU manufacturer. Without a valid Responsible Person established in the EU and, where applicable, in the UK, a cosmetic product cannot be legally placed on either market.

2. Mandatory structure of the Product Information File

Article 11 of Regulation (EC) No 1223/2009 defines five mandatory components of the Product Information File. These elements must collectively demonstrate product safety and regulatory compliance.

2.1 Product description

The PIF must clearly identify the cosmetic product and allow it to be unambiguously linked to the documentation.

the product name and variants,
internal or external reference codes,
market-specific names where the product is sold under different designations.

2.2 Cosmetic Product Safety Report (CPSR)

The Cosmetic Product Safety Report (CPSR) is the scientific backbone of the Product Information File.

It consists of safety data (Part A) and a formal safety assessment (Part B) signed by a qualified assessor with appropriate scientific education and up-to-date knowledge of EU and UK cosmetic regulations.

An invalid CPSR undermines the validity of the entire Product Information File.

Download the EU & UK Cosmetic Compliance Checklist for US Exporters

2.3 Manufacturing method and GMP compliance

Cosmetic products must be manufactured in accordance with Good Manufacturing Practice (GMP), typically demonstrated through compliance with ISO 22716.

2.4 Claims substantiation

All marketing claims must be truthful, evidence-based, and verifiable in line with Regulation (EU) No 655/2013.

2.5 Animal testing statement

The Product Information File must contain information on any animal testing performed by the manufacturer or suppliers, including tests conducted to meet regulatory requirements in non-EU countries.

3. The Product Information File as a living compliance document

The Product Information File must be maintained and updated throughout the entire lifecycle of the product.

Failure to maintain an up-to-date PIF may result in the product being considered non-compliant during EU or UK market inspections.

Conclusion

For US cosmetic manufacturers, entering the EU and UK markets requires more than adapting labels or completing product notification. The Product Information File is a legal document evaluated during enforcement activities, not a procedural formality.

At Annel, we support US cosmetic brands across the full EU and UK regulatory lifecycle, from Responsible Person services and CPSR coordination to Product Information File maintenance and post-market compliance oversight.

Planning to launch cosmetics in the EU or UK?
Speak with our regulatory experts about your Product Information File, CPSR, and Responsible Person requirements.