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The cosmetic product information file, explained

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 is a cosmetic product information file?

A cosmetic product information file is the technical dossier that proves a cosmetic product is safe and compliant. It is required by Regulation (EC) No 1223/2009, and the Responsible Person must hold one for every product placed on the EU market. The file is not a form. It is the evidence base behind the safety claim.

Article 11 sets out exactly what the file must contain, and it must be available to a competent authority on request. The same dossier is then held differently in the UK, Switzerland and the US. CIGREG assembles and maintains the file as the Responsible Person, so one dossier serves every market you sell into.

What a cosmetic product information file must contain

Article 11 of Regulation (EC) No 1223/2009 defines the contents. Annex I of the Regulation lists the parts, and a file missing any one of them is incomplete — not merely thin.

Required part What it is
Description of the product A clear identification of the cosmetic and its intended function, so the file can be matched to the product on the shelf.
Cosmetic Product Safety Report (CPSR) The safety assessment itself, in two parts: Part A (safety information) and Part B (the assessor's conclusion and labelling warnings).
Manufacturing method and GMP statement How the product is made and confirmation that production follows ISO 22716 Good Manufacturing Practice.
Proof of claimed effect Substantiation for any claim made on the label or in advertising — the data behind the promise.
Animal testing data Any data relating to animal testing carried out by the manufacturer, its agents or suppliers in developing the product.
Labelling and packaging The artwork, the outer packaging and the product itself, including the ingredient list and any warnings.
Nanomaterial notification data Where a nanomaterial is present, the Article 16 notification and the supporting safety data.

Stability testing usually sits behind the CPSR rather than beside it. For a new formulation it commonly runs three to twelve months, and the file cannot be signed off before the data exists. Build the dossier around the test schedule, not after it.

PIF vs CPSR vs safety assessment: three different things

The three terms get used interchangeably. They are not interchangeable, and conflating them is how files end up incomplete.

The safety assessment

The work itself. A qualified safety assessor reviews the formulation, the raw material data, the stability results and the exposure profile, then reaches a conclusion on whether the product is safe for its intended use.

The CPSR

The written record of that work — Part A and Part B, signed and dated by the assessor. It is a document, and it is the single most substantial component of the file.

The PIF

The container. The PIF holds the CPSR plus the product description, the GMP statement, the claim substantiation, the labelling and the animal testing data. The CPSR is inside the PIF; the PIF is not inside the CPSR.

Practical consequence: you can hold a valid CPSR and still have an incomplete PIF. The safety report answers one question. The file answers all of them.

Who must hold the cosmetic product information file, and for how long

The Responsible Person holds the file. Not the manufacturer, not the distributor, not the brand owner by default — the Responsible Person, which is the entity named on the label and established in the relevant market.

Retention is ten years after the last batch of the product is placed on the market. That clock starts on the final batch, not the first, and it applies in the EU, the UK and Switzerland. A discontinued product still has a live file obligation for a decade.

The file must be kept in a language easily understood by the competent authority of the member state where it is held, and it must be made available to that authority on request — electronically is acceptable. There is no small-business exemption and no turnover threshold. A single-unit brand carries the same obligation as a multinational.

Practical consequence: appoint the Responsible Person before you place the product, because the file obligation attaches to that role from day one.

When a cosmetic product information file must be updated

A file is a living document. It reflects the product as it is sold today, and it must be revised whenever the product or its evidence base changes.

  • Reformulation. Any change to the ingredient list, including a change of supplier for a raw material, invalidates the existing safety conclusion.
  • New or changed claims. A new efficacy claim needs substantiation added to the file before the claim goes live.
  • New stability or challenge test data. Fresh results replace assumptions and can alter the assessor's conclusion.
  • Labelling or packaging changes. Updated artwork, warnings or ingredient declarations must be reflected.
  • Regulatory change. Annex amendments, restrictions or new entry requirements can force a reassessment of an unchanged formula.
  • New market entry. Selling into the UK, Switzerland or the US adds market-specific requirements to the same dossier.
  • Adverse event or complaint signal. New safety information must be assessed and recorded.

Practical consequence: treat the file as version-controlled. An outdated file is treated as a missing file when an authority asks for it.

Cosmetic product information file requirements by market

The dossier content is broadly consistent. What changes is who holds it, where it lives and what else must be filed alongside it.

Market Legal basis Who holds the file Retention Market-specific requirement
EU Regulation (EC) No 1223/2009, Article 11 Responsible Person established in the EU 10 years after last batch placed on market Product notification via CPNP before placing on the market
UK Retained EU law as amended by the UK Cosmetics Regulation UK Responsible Person 10 years after last batch placed on market Notification via SCPN; a separate UK Responsible Person is required
Switzerland Swiss Cosmetics Ordinance, aligned with EU rules Responsible Person established in Switzerland 10 years after last batch placed on market Swiss notification; the EU file can be reused with Swiss-specific additions
US (MoCRA) MoCRA (FD&C Act, as amended) Responsible Person named on the label Records retained as required under MoCRA Facility registration and product listing; safety substantiation records

Practical consequence: build one dossier and hold it per market. Rebuilding from scratch in each jurisdiction duplicates cost and creates version drift.

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. CIGREG 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 CIGREG 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 CIGREG from another provider who want the file rebuilt or brought current before an inspection or a marketplace check.

Why brands choose CIGREG 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.

Finished cosmetics are generally not classified as dangerous goods, so a Safety Data Sheet is usually not required for shipping. The document that governs market access is the cosmetic product information file, not the MSDS. CIGREG builds the file that authorities actually ask for.

The EU, the UK and Switzerland all require a product information file, and each requires a Responsible Person established in that market. The US takes a different route under MoCRA, which requires safety substantiation records rather than a PIF in the EU format. CIGREG holds the file across all four markets from one dossier.

Article 11 of Regulation (EC) No 1223/2009 sets the contents: a product description, the Cosmetic Product Safety Report, the manufacturing method and GMP statement, proof of claimed effect, animal testing data, labelling and packaging, and nanomaterial notification data where relevant. Every part is mandatory. CIGREG assembles all of them into one indexed file.

The safety assessment is the work; the CPSR is the signed written record of that work; the PIF is the file that contains the CPSR plus the product description, GMP statement, claim substantiation, labelling and animal testing data. A valid CPSR does not by itself make a complete PIF. CIGREG produces both, so the file is complete on delivery.

Yes. The Cosmetic Product Safety Report is a mandatory component of the file, not a separate document held elsewhere. It sits alongside the product description, the GMP statement and the claim substantiation. CIGREG holds the CPSR inside the file so a single request satisfies an authority.

Each cosmetic product needs its own file. Variants that differ in formulation, colour, fragrance or claims need their own assessment, because the safety conclusion is product-specific. Variants that share a base formula can often be grouped, but the grouping has to be justified in the file. CIGREG scopes this at the start so you are not paying for files you do not need.

You need the full formulation with percentages, the raw material safety data sheets and specifications, the manufacturing and GMP information, the label artwork, and any existing test data such as stability or challenge testing. Missing inputs are the main cause of delay. CIGREG tells you what is outstanding before the file is opened.

Yes, largely. Switzerland aligns with EU cosmetic rules, so the EU file can be reused with Swiss-specific additions and a Responsible Person established in Switzerland. The file still has to be held and available in the market. CIGREG adapts the existing dossier rather than rebuilding it.

Yes. A nanomaterial triggers a notification under Article 16 of Regulation (EC) No 1223/2009, which must be filed six months before the product is placed on the market. The notification data then forms part of the file. CIGREG handles the notification and the file together, because the six-month lead time drives the whole timeline.

Ten years after the last batch of the product is placed on the market. The clock starts on the final batch, not the first, and the same period applies in the EU, the UK and Switzerland. A discontinued product still carries a live file obligation for a decade. CIGREG maintains the file for the full retention period.

Related

Pairs well with.

Need a Product Information File?

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In practice

Compliance, in the real world.

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