Project service

Product Information File (PIF) compilation.

The technical dossier every cosmetic on the EU, UK and Swiss markets must have, compiled and kept current.

Regulatory dossier open beside a cosmetic product

What the law requires

A complete technical dossier the Responsible Person holds.

Every cosmetic product placed on the EU, UK or Swiss market must have a Product Information File. The PIF is the complete technical dossier for the product. It must be held by the Responsible Person at the address printed on the label, kept up to date, and made available to a competent authority on request. In the EU the file is defined by Article 11 of Regulation (EC) No 1223/2009, and it must be kept for ten years after the last batch of the product was placed on the market. The UK Cosmetics Regulation carries the same ten-year rule, and Switzerland requires the file to be retained for ten years from the date the last batch was first placed on the market.

An incomplete or missing PIF is one of the most common reasons a first-time brand is asked to relabel or withdraw a product. When market surveillance contacts the Responsible Person, the file is what has to be produced, and it has to be produced quickly. A file that is complete, current and structured to the regulation removes that risk.

Article 11 requires a PIF to contain
A description of the cosmetic product.
The Cosmetic Product Safety Report (the CPSR).
The manufacturing method and a statement of compliance with good manufacturing practice (ISO 22716).
Proof of the claimed effect, where the nature of the claim justifies it.
Data on any animal testing carried out for the product or its ingredients.

How the pieces fit

PIF, CPSR and the safety assessment are not the same thing.

These three terms are often used as if they were interchangeable. They sit inside one another, and getting the relationship right is what keeps a dossier defensible. Our comparison guide puts all three side by side.

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

The Product Information File is the complete dossier Article 11 requires for every EU cosmetic: product description, the signed CPSR, GMP evidence, claims support and animal-testing data, kept ten years at the Responsible Person's address. CIG assembles it, keeps it current and produces it on inspection.

Legal basis: EUR-Lex: Regulation (EC) 1223/2009, ISO 22716.

1

The safety assessment

The technical judgement of whether the product is safe for human health under normal and reasonably foreseeable use. It weighs the toxicological profile of every ingredient, the exposure, and the Margin of Safety, and it is signed by a qualified assessor.

2

The CPSR

The written safety report that records that assessment. Its Part A gathers the safety information (composition, stability, microbiological quality, impurities, exposure, toxicological profile). Its Part B is the assessor's conclusion, warnings, reasoning and signature.

3

The PIF

The full file that holds the CPSR alongside the product description, the manufacturing method and GMP statement, proof of claims, and animal-testing data. The PIF is the container. The CPSR is one part of it.

A product needs all three, and the PIF is what the Responsible Person is asked to produce when an authority comes calling.

How CIG covers it

What is included.

A full file built to the structure each market requires, then kept complete as your formula, labelling or the regulations change.

We compile your full Product Information File to the Article 11 structure, in the format the EU, UK or Swiss market requires.

We include your signed safety report as Part A and Part B of the file, so the dossier is complete on the day it is handed over.

We assemble the supporting records around it: the product description, the manufacturing method with the GMP statement, proof for any claim that needs it, and the animal-testing data.

We hold it and keep it available so the Responsible Person can produce it for a competent authority on request, in the language the market accepts.

We update it when your formula, packaging, labelling or claims change, or when the regulation moves, so the file on record matches the product on the shelf.

What we need from you

The inputs that let us build the file.

A PIF is only as good as the source records behind it. Most of what we ask for is material you already hold or can get from your manufacturer. Where something is missing, we will tell you plainly what has to be produced before the file can be completed, so there are no surprises late in the process.

If you do not yet have a safety report, we can produce and sign the CPSR as part of the same piece of work, then build the file around it. If you already hold a valid, correctly signed report, we can compile the file around your existing document.

To compile your file we ask for
The full formulation with INCI names and exact percentages.
Raw-material specifications and safety data sheets from your suppliers.
The manufacturing method and the GMP or ISO 22716 statement for the site.
Stability, challenge (preservative) and microbiological test data.
Packaging details and compatibility information.
Artwork for the label and packaging, with the intended claims.
Evidence for any claim that needs substantiation.

Timeline

How long a file takes.

Compiling the file is fast once the inputs are in. The part that takes real time sits upstream, in laboratory testing, and it is worth planning for early.

When your records are complete, we compile the file promptly and hand it over ready for the Responsible Person to hold.

If the CPSR is part of the work, the safety assessment step runs first, then the file is assembled around the signed report.

Laboratory testing is the long pole. Stability testing alone commonly runs three to twelve months for a new formulation, and challenge testing and microbiological work take their own time. A brand that starts the file late because testing was booked late will miss its launch window, so we flag any gaps at the start.

For a new EU product, notification on CPNP can only follow once the PIF and CPSR are in place, so building the file early keeps the launch on schedule.

Edge cases

Products that need a wider scope.

Some products carry a heavier documentation and testing burden. If yours falls into one of these, the file and the safety report behind it need to reflect it.

Nanomaterials

An EU product that contains a nanomaterial requires a separate notification to the Commission under Article 16 of Reg. 1223/2009, six months before it is placed on the market, in addition to the standard CPNP notification. The file has to record the nanomaterial and its safety data.

Baby and child products

Products intended for children, and for the under-threes in particular, are assessed to a higher standard because exposure and skin sensitivity differ. The safety reasoning inside the file has to account for that, and the assessment is more involved.

Higher-scope categories

Sunscreens, hair dyes and permanent-wave products, and products making a stronger claim, tend to need more substantiation and more testing behind the file. The claim data has to be strong enough to hold under Article 19 labelling scrutiny.

Product variants

A shade, scent or size variant is a separate product for the file. Where variants share a base formula, much of the underlying work carries across, but each variant still needs its own complete dossier and its own notification.

How it fits the four markets

One file, held differently in each market.

The EU, UK and Switzerland each require a PIF, but they are separate regimes. A file compiled for one is not automatically the file another market accepts, and the notification portals do not talk to each other.

EU

The PIF sits under Article 11 of Reg. 1223/2009 and is held by your EU Responsible Person. The product cannot be notified on CPNP or placed on the market until the file and its CPSR are in place.

UK

Great Britain runs its own regime under the UK Cosmetics Regulation. The file is held by a UK Responsible Person with a genuine UK address, and the product is notified through SCPN via the OPSS, separately from the EU.

Switzerland

There is no notification portal. A file compiled abroad can satisfy Swiss requirements if it meets Swiss cosmetics and labelling rules, and it may be written in an official Swiss language or in English. It is held on Swiss territory and produced during cantonal inspections.

US (MoCRA)

MoCRA does not use a PIF. It requires facility registration and annual product listing with the FDA, plus a safety substantiation dossier kept on file. The safety work behind your PIF supports that substantiation, but the US filing is a different route.

Who it is for

Any product sold in the EU, UK or Switzerland.

Every cosmetic on these markets must have a Product Information File held by its Responsible Person. There is no small-business exemption and no turnover threshold. A hobbyist selling a few bars of soap carries the same PIF obligation as a large brand, which is why the fixed cost of getting the file right matters most to the smallest sellers.

This service suits brands that need a complete, audit-ready dossier for a product, either as a standalone deliverable or bundled with the safety report and notification in a launch pack. It also suits brands moving to CIG from another provider who want the file rebuilt or brought current before an inspection or a marketplace check.

Why brands choose CIG for this
A complete, audit-ready file the Responsible Person can produce on request.
Fixed pricing per product, so the cost is known before you start.
Fast turnaround once your records are in.
The safety report signed by a qualified assessor and built into the file.
Held and maintained alongside your Responsible Person mandate across markets.

Pricing

Fixed, transparent pricing.

A Product Information File per product, or bundled with the safety report and notification in the launch pack.

Product Information File, per product $400
EU and UK launch pack (CPSR, PIF and notification per product) $1,500

Prices in USD, per product.

See full pricing →

Where this service fits

The Product Information File in your compliance path.

FAQ

Common questions.

Cosmetic law does not require an SDS for a finished cosmetic; that document belongs to chemical regulation, and the safety case for a cosmetic lives in the CPSR and the PIF instead. Carriers and freight forwarders still ask for one regularly, especially for perfumes, aerosols and other flammable goods, because transport rules are separate from cosmetic rules. Raw material SDSs, which your suppliers must provide, are collected in the PIF as part of the file we assemble.

Every cosmetic product placed on the EU, UK or Swiss market must have a Product Information File held by its Responsible Person and made available to a competent authority on request. The United States does not use a PIF. Under MoCRA it requires facility registration, product listing and a safety substantiation dossier instead.

Under Article 11 of Reg. 1223/2009 the file contains the product description, the Cosmetic Product Safety Report (CPSR), the manufacturing method with a statement of good manufacturing practice (ISO 22716), proof of the claimed effect where the claim justifies it, and data on any animal testing. We compile all of it into one dossier structured to the regulation.

The safety assessment is the technical judgement of whether the product is safe. The CPSR is the written report that records that judgement, with a Part A of safety information and a Part B signed by the assessor. The PIF is the full file that holds the CPSR alongside the product description, manufacturing method, claims evidence and animal-testing data. A product needs all three.

Yes. The signed CPSR is a required part of the PIF. If you already hold a valid, correctly signed report, we build the file around it. If you do not, we can produce and sign the CPSR as part of the same work, then assemble the file around it.

Yes. Each product needs its own file, and a shade, scent or size variant is treated as a separate product. Where variants share a base formula much of the underlying work carries across, but each variant still needs its own complete dossier and its own notification.

The full formulation with INCI names and percentages, raw-material specifications and safety data sheets, the manufacturing method and GMP or ISO 22716 statement, stability, challenge and microbiological test data, packaging and compatibility details, and label artwork with your intended claims. If anything is missing we will tell you plainly what has to be produced before the file can be completed.

A file compiled in the EU can satisfy Swiss requirements if it complies with Swiss cosmetics and labelling rules. It may be written in an official Swiss language (German, French or Italian) or in English. Switzerland has no notification portal, so the file is held on Swiss territory and produced during cantonal inspections rather than filed in advance.

Yes. An EU product containing a nanomaterial needs a separate notification to the Commission under Article 16 of Reg. 1223/2009, six months before it is placed on the market, on top of the standard CPNP notification. The file has to record the nanomaterial and its safety data.

The PIF must be kept for ten years after the last batch of the product was placed on the market, and this applies in the EU, the UK and Switzerland. We keep your file complete and available for that period, and update it as your formula, labelling or the regulations change.

Related

Pairs well with.

Need a Product Information File?

Tell us your product and we will quote your PIF at a fixed price.

In practice

Compliance, in the real world.

Product Information File binder open on a deskINCI and formula documentationA PIF held ready for authorities