EU regulatory guide

The Product Information File, explained.

The PIF is the complete technical dossier behind every cosmetic product on the EU market: defined by Article 11, held by your Responsible Person, and kept for ten years after the last batch. This guide covers what goes in it, where it lives, and how long it must survive.

A Product Information File dossier open beside a cosmetic product

Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026

What is the Product Information File?

The PIF is the mandatory technical dossier for each cosmetic product on the EU market, required by Article 11 of Regulation (EC) No 1223/2009. Your Responsible Person holds it, keeps it current, and produces it when a competent authority asks.

The PIF is not filed anywhere: unlike the CPNP notification, nobody receives a copy. It sits at your Responsible Person's address, ready for inspection, for the entire life of the product and a decade beyond.

What must the PIF contain?

Article 11 lists five things: a description of the product; the signed Cosmetic Product Safety Report; a description of the manufacturing method with a statement of GMP compliance; proof of claimed effects where the claim's nature justifies it; and data on any animal testing.

The heart of the file is the CPSR (its inputs are covered in our CPSR inputs guide), the safety assessment signed by a qualified assessor. The GMP statement is normally evidenced against ISO 22716, the international GMP standard for cosmetics. Claim evidence is the piece brands most often underestimate: a "clinically proven" on the label needs its proof in the file.

Where must the PIF be kept?

At the Responsible Person's address stated on the label, in electronic or other format, accessible to the competent authority of the member state where it is kept. When an authority asks, the Responsible Person must make it available promptly.

That address requirement is why the PIF and the Responsible Person appointment are inseparable: whoever holds the role physically anchors the file. The full picture of the role is in our EU Responsible Person requirements guide.

How long must the PIF be kept?

Ten years after the last batch of the product was placed on the market, not ten years from launch. A product sold for five years carries a fifteen-year documentation obligation, and the file must stay accurate and producible for all of it.

This is the timescale that makes dossier quality a governance question rather than a paperwork one: the person who assembled the file may be long gone when an authority asks for it. How CIG keeps files defensible over that span is described on our governance page.

Article 11 of Regulation 1223/2009 on EUR-Lex with the ten-year retention rule highlighted
Article 11(1) of Regulation (EC) No 1223/2009, the ten-year retention rule, as published on EUR-Lex, consolidation of 1 May 2026 (02009R1223, EN, 040.001). Captured 26 July 2026. View the official text.

What is the difference between the PIF and the CPSR?

The CPSR is one document inside the PIF: the safety assessment, in two parts, signed by a qualified assessor. The PIF is the whole dossier around it: product description, manufacturing and GMP, claim evidence and animal-testing data. You cannot have a compliant PIF without a signed CPSR.

Brands often use the terms interchangeably and order the wrong deliverable. The sequence runs: CPSR first, then the PIF assembled around it, then the notification filed once the file is complete. The full side-by-side (who produces each document, who sees it, and what each costs) is in our CPSR vs PIF vs notification comparison.

Do the UK and Switzerland need a PIF too?

Yes, in parallel forms. Great Britain requires a PIF under the UK Cosmetics Regulation, held by the UK Responsible Person. Switzerland requires a self-monitoring file held at a Swiss address for ten years. Both usually adapt the EU file rather than rebuild it.

One well-built dossier travels: the same core documents, adapted per market, satisfy all three regimes. That reuse is the practical reason to build the EU file properly first. See the UK guide and the Swiss guide for the market-specific holders.

When does the PIF need updating?

Whenever the product changes: reformulation, a new supplier or raw-material specification, new stability or safety data, label or claim changes, adverse-event learnings. The file must reflect the product as sold, throughout its time on the market.

An out-of-date PIF is one of the most common findings in market-surveillance checks: the product evolved and the file did not. Keeping dossiers current across markets is the recurring work of Compliance Care.

What does a PIF cost to build?

CIG assembles and maintains the PIF at a fixed published price as part of its Product Information File service, with the CPSR priced separately and the two typically bundled in the launch pack.

Full prices and worked examples are on the pricing page.

Put this into practice

From reading to a market-ready file.

FAQ

PIF questions brands ask.

Yes: one file per product. Shades and close variants can share underlying data where the assessment covers them, but each marketed product needs its own complete, retrievable file.

Yes. Article 11 allows electronic or other formats, as long as the file is kept at the Responsible Person's address and can be made accessible to the authority there. What matters is retrievability and completeness, not paper.

Market-surveillance authorities, during checks or after an incident, sometimes years after launch. The file is your product's defence on the day someone asks; an incomplete one converts a routine check into an enforcement problem.

Not as-is. The EU file has a defined structure with an EU-format CPSR signed by an EU-recognised assessor at its core. Your existing data feeds the work, but the assessment and file are built to the EU's requirements.

Need your PIF built properly?

Tell us your products and we will assemble the file around a signed CPSR, keep it current, and hold it with your Responsible Person, at a fixed price per product.