The Product Information File — What It Contains, Who Holds It, and Why It Matters

The PIF is the complete technical dossier behind every cosmetic product on the UK and EU market. It must be held by the Responsible Person and made available to authorities on request. For ten years.

The PIF is a legal requirement for every cosmetic product and must be retained for ten years after the last batch of the product is placed on the market.

Authorities such as OPSS in the UK and competent authorities across the EU may request access to the PIF. A product without a complete and up-to-date PIF does not meet regulatory requirements.

What Goes in the PIF

The PIF includes, a description of the cosmetic product, the Cosmetic Product Safety Report (CPSR), a description of the method of manufacture and a statement of compliance with Good Manufacturing Practice (GMP), evidence supporting product claims, where applicable, data on animal testing in line with regulatory requirements and the name and address of the Responsible Person.

The PIF should also be kept up to date with relevant post-market information, including data on undesirable effects, as part of ongoing cosmetovigilance obligations.

What It Costs to Get This Wrong

An incomplete or out-of-date PIF is not just an administrative issue. It is the document authorities rely on to assess whether a product meets regulatory requirements. Where documentation is incomplete or inconsistent, this may lead to corrective actions or restrictions on the product.

Common issues include PIFs not updated after formulation changes, CPSRs that do not reflect the current formulation, and post-market surveillance records that are incomplete or not systematically maintained.

Common PIF Problems

Typical deficiencies include, PIFs that are incomplete at the point of market placement, PIFs not updated to reflect formulation or labelling changes, CPSRs that do not correspond to the current product formulation, PIFs not held or accessible at the Responsible Person’s address, Post-market surveillance or cosmetovigilance records that are absent or insufficient.

Arcus structures and maintains Product Information Files as part of the ongoing Responsible Person service, supporting completeness at product launch and ongoing maintenance throughout the product lifecycle.

Get Your PIF Structured Correctly