In this article
The short answer
A cosmetic Product Information File (PIF) must contain five things: a description of the product, the Cosmetic Product Safety Report, a description of the manufacturing method with a GMP statement, proof of any claimed effect, and data on animal testing. The Responsible Person keeps it, at the address on the label, for ten years after the last batch is placed on the market. The template below organises all of it.
Key takeaways
- The five sections of a PIF are set by Article 11 of the Cosmetics Regulation; the template below follows them exactly.
- The CPSR is the largest single component, but a PIF without the other four sections is incomplete and does not meet the regulatory requirement.
- A PIF is a living file: every formula change, supplier change, new claim or label revision needs to be reflected and dated.
- Keep it for ten years after the last batch, readily accessible at the Responsible Person's address, in a language the authority can read.
- One PIF per product; variants such as shades or scents can share a file only where the safety assessment covers them together.
Every cosmetic sold in the UK or European Union must have a Product Information File, and yet the PIF is the document makers most often assemble badly, usually because they think of it as a folder to put the CPSR in and stop there. The law is more specific. Article 11 of Regulation (EC) No 1223/2009, carried into Great Britain by the Cosmetic Products Enforcement Regulations 2013, names five categories of information that must be in the file, requires the Responsible Person to keep it for ten years after the last batch, and gives the Office for Product Safety and Standards and its EU counterparts the right to see it on request.
This article gives you a free, practical PIF template you can copy into your own folder structure, a checklist for each of the five sections, guidance on organising variants and updates, and the mistakes that leave a file incomplete. It complements our Product Information File service for makers who would rather have it built for them.
The five legal sections of a PIF
Article 11 requires the PIF to contain, and keep updated, the following: a description of the cosmetic product enabling the file to be clearly linked to it; the Cosmetic Product Safety Report; a description of the method of manufacture and a statement that it complies with good manufacturing practice; where justified by the nature or effect of the product, proof of the effect claimed; and data on any animal testing performed by the manufacturer, its agents or suppliers in relation to the development or safety evaluation of the product or its ingredients. Everything in the template below hangs off those five headings.
The template
Set up one folder or binder per product with the following sections and documents. Number them exactly like this so an inspector, or a future you, can find anything in seconds.
| Section | What it contains | Documents to include |
|---|---|---|
| 0. Cover and control | Identifies the file and tracks changes | Product name, Responsible Person name and address, file version, date created, change log with dates and reasons |
| 1. Product description | Links the file unambiguously to the product | Product name and variants, function, pack sizes, photos of product and packaging, notification reference numbers (SCPN and CPNP), label artwork for every pack size |
| 2. Cosmetic Product Safety Report | The signed safety assessment | Part A safety information, Part B safety assessment with assessor's qualification and signature, all supporting raw material documents referenced in Part A |
| 3. Manufacturing and GMP | How it is made and a statement of compliance | Batch manufacturing method or process description, GMP statement or ISO 22716 declaration, batch record template, hygiene and cleaning procedures, batch coding scheme, quality control checks such as pH and appearance |
| 4. Proof of claimed effect | Evidence for claims that need it | List of all claims on label, website and marketing, with the evidence for each: published literature, supplier substantiation, in house or third party testing, or a note that the claim is descriptive and needs no proof |
| 5. Animal testing data | Required statement even if the answer is none | Declaration of any animal testing by you, your agents or suppliers on the product or ingredients, or a signed statement that none was performed, plus supplier statements where available |
Section by section checklist
Section 1: product description
- Product name exactly as it appears on the label
- Every variant covered by this file, with what distinguishes each
- Function statement, such as body lotion or shampoo bar
- All pack sizes and container types
- Final label artwork for each pack size, dated
- SCPN and CPNP notification references and dates
- Photographs of the finished product
Section 2: the CPSR
- Part A complete with all eleven information headings
- Part B signed, with the assessor's name, address, qualifications and date
- Supplier documents for every raw material: SDS, specifications, certificates of analysis, IFRA certificates and allergen statements
- Stability and, where relevant, challenge test data referenced in Part A
- Packaging specifications and compatibility information
- A note of the date the CPSR should next be reviewed
Section 3: manufacturing and GMP
- Step by step manufacturing method
- GMP statement referencing the harmonised standard, ISO 22716, or an equivalent
- Blank batch record template and completed records for batches placed on the market
- Equipment cleaning and sanitisation procedures
- Raw material receipt and storage procedure
- Batch coding explanation so any batch can be traced
- Release checks performed before sale
Section 4: proof of claimed effect
- A complete list of claims from label, website, social media and packaging
- For each claim: evidence, or a note that it is a descriptive claim needing none
- Supplier substantiation for ingredient related claims such as moisturising or antioxidant
- Any consumer or instrumental test reports
- Confirmation that no medicinal claims are made anywhere
Section 5: animal testing
- Your own signed declaration of no animal testing on the finished product
- Supplier statements on ingredient testing where available
- Where any testing was performed to meet non cosmetic legislation, the details required by the regulation
The safety report at the heart of the file is the single variant or multiple variant CPSR; the all in one compliance pack delivers the CPSR, PIF and notification together.
Variants: one file or several?
A PIF is kept per product, but a product can have variants. Where a safety assessor has assessed a range of shades, scents or sizes together in a multiple variant CPSR, those variants can sit in one PIF, with the description section listing each variant and the label artwork for each. Where products differ in formula beyond what the assessment covers, they are different products and need separate files. If in doubt, ask your assessor which variants their report covers; that answer defines the boundary of the PIF.
Keeping the PIF alive
The regulation requires the PIF to be kept updated, not merely kept. Every change to the formula, a raw material supplier, the packaging, the label or the claims must be reflected, and significant changes require the safety assessment to be reviewed. Use the change log in section zero to record what changed, when, why and what was updated as a result. New regulatory restrictions on an ingredient you use are also a trigger to revisit the file. A PIF that was perfect at launch and untouched for three years is very likely non compliant today.
Retention, location and language
- How long. Ten years from the date the last batch of the product was placed on the market.
- Where. Readily accessible in electronic or other format at the address of the Responsible Person given on the label.
- Language. One easily understood by the competent authority of the country where the file is kept; English for Great Britain, and for EU market files the authority's language or one it accepts.
- Who holds it. The Responsible Person, which may be you, your company, or a service provider you appoint for the UK or EU.
If you sell into both markets, you need a Responsible Person established in each, and each must hold the file. Our UK and EU Responsible Person services include holding and maintaining the PIF.
How much detail is enough?
Makers swing between two errors: a file so thin it is little more than the CPSR in a folder, and a file so padded that the essentials are buried. The test for each section is whether a competent stranger could, from the documents alone, identify the product, confirm it was assessed as sold, understand how a batch was made and traced, verify each claim and confirm the animal testing position. If a document does not help answer one of those questions it probably does not belong in the file. Conversely, if any of those questions cannot be answered from what is filed, the section is incomplete. A manufacturing method should be detailed enough that another trained person could follow it, not a marketing description of your process. A claims table should cite specific evidence, not say supplier information. Proportionate detail, consistently dated, is the standard.
Paper, digital or both?
The regulation allows the PIF to be kept in electronic or other format, and most makers now keep a digital master with a printed copy for inspection. A well organised cloud folder mirroring the five sections, with a version controlled cover sheet, works well, provided it is backed up and can be produced at the Responsible Person's address without delay. Name files consistently, date every document, and keep superseded versions in a clearly marked archive subfolder rather than deleting them. If you use a compliance platform or a Responsible Person service that hosts files, make sure you retain your own copy; the legal duty to hold the file is yours or your Responsible Person's, not the software vendor's.
How a PIF is actually inspected
Inspections are rarer than makers fear and more specific than they imagine. A Trading Standards or OPSS officer, or a marketplace compliance team, typically asks for the PIF for a named product, expects it within a reasonable period, and reads it in a predictable order: the cover and change log to see whether the file is maintained; the label artwork against the product in front of them; the CPSR to confirm it is signed by a qualified assessor and covers the product as sold; the claims table against the label and website; and batch records for traceability. A file that follows the five section structure, is dated throughout, and matches the product on the shelf usually ends the conversation quickly. A file that is missing sections, undated or out of step with the label prolongs it.
PIFs for private label and imported products
If you sell a product made by a contract manufacturer under your brand, you are the Responsible Person and the PIF is your obligation, not the manufacturer's. You will need the manufacturer to supply the manufacturing method, GMP statement and batch records for section three, and the raw material documents for section two, and you should agree at the outset who commissions and holds the CPSR. If you import a finished cosmetic from outside the UK or European Union, you are the importer and Responsible Person, the overseas manufacturer's documents must be obtained and, where necessary, translated, and a CPSR meeting UK or EU market requirements must exist even if the product was assessed elsewhere. Building the PIF early in these arrangements avoids discovering at launch that a supplier will not share the information you are legally required to hold.
Building the PIF alongside the CPSR: a timeline
- While formulating. Start section two: collect SDS, specifications, IFRA certificates and allergen statements as you choose ingredients.
- Before ordering packaging. Draft the label and claims list so the assessor can check them and section four can be planned.
- During assessment. Write up the manufacturing method and GMP statement for section three; the assessor may ask about hygiene and stability.
- On receipt of the CPSR. File it in section two, finalise the label with the assessor's required warnings, and complete section one with artwork and photos.
- Before first sale. Notify through SCPN or CPNP, record the references in section one, sign the animal testing statement in section five, and open the change log.
- Ongoing. File every batch record, and log every change.
Common PIF mistakes
- Treating the CPSR as the PIF. The CPSR is one of five sections.
- No claims evidence. Makers list moisturising, soothing and brightening on the label and have nothing in section four.
- No batch records. A manufacturing method with no records of actual batches cannot demonstrate traceability.
- Stale supplier documents. Expired IFRA certificates and superseded SDS in section two.
- No change log. Updates made but not recorded, so the file's history cannot be shown.
- Wrong location. A PIF on a laptop in a different country from the Responsible Person's address.
A label and packaging review is a fast way to make sure the label artwork and claims in sections one and four agree with each other and with the CPSR.
Myths we hear
- The PIF is the same thing as the CPSR. The CPSR is only one part of the Product Information File, which also holds the product description, manufacturing method and GMP statement, claims evidence and animal-testing data.
- The PIF can be kept anywhere. It must be readily accessible at the Responsible Person's address shown on the label.
- Once the product launches, the PIF can be archived and forgotten. It must be kept up to date and retained for 10 years after the last batch is placed on the market.
- A CPSR is a lab test. A CPSR is a written safety assessment by a qualified assessor; testing provides supporting data.
- You only need a CPSR in the EU. Great Britain also requires a CPSR under its own Cosmetics Regulation.
What to do this week
- Create the file structure and cover control section: Set up one folder or binder per product and start with Section 0, Cover and control. Include the product name, Responsible Person name and address, file version, date created, and a change log with dates and reasons.
- Add the product description section: Add Section 1, Product description, to link the file unambiguously to the product. Include the product name exactly as on the label, all covered variants and what distinguishes them, the function statement, all pack sizes and container types, final label artwork for each pack size, SCPN and CPNP references and dates, and photos of the finished product.
- Compile the Cosmetic Product Safety Report: Add Section 2, the CPSR. Include Part A with all eleven information headings, Part B signed with the assessor's name, address, qualifications and date, supplier documents for each raw material, stability and relevant challenge test data, packaging specifications and compatibility information, and the date the CPSR should next be reviewed.
- Document manufacturing and GMP: Add Section 3, Manufacturing and GMP. Include the step-by-step manufacturing method, a GMP statement referencing ISO 22716 or an equivalent, blank batch record template and completed records for batches on the market, equipment cleaning and sanitisation procedures, raw material receipt and storage procedure, the batch coding explanation, and release checks performed before sale.
- Assemble claims evidence: Add Section 4, Proof of claimed effect. List all claims from label, website, social media and packaging, and for each claim include evidence or a note that it is descriptive and needs none. Include supplier substantiation, consumer or instrumental test reports where used, and confirmation that no medicinal claims are made anywhere.
- Record animal testing position: Add Section 5, Animal testing data. Include a signed declaration of no animal testing on the finished product, supplier statements on ingredient testing where available, and any details required where testing was performed to meet non-cosmetic legislation.
- Keep variants within the file boundary defined by the assessor: Keep one PIF per product, but include multiple variants in one file only when the safety assessor has covered the range of shades, scents or sizes together in a multiple variant CPSR. Put each variant in the description section with its label artwork; if products differ beyond what the assessment covers, treat them as separate products and make separate files.
- Keep the file updated and accessible: Keep the PIF updated for changes to the formula, raw material supplier, packaging, label, claims, or relevant regulations, and review the safety assessment when changes are significant. Retain it for ten years from the last batch placed on the market, keep it readily accessible at the Responsible Person's address, use a language accepted by the competent authority, and maintain a backed-up digital or other copy with dated documents and archived superseded versions.
Frequently asked questions
What must a cosmetic PIF contain?
Five things under Article 11: a product description, the Cosmetic Product Safety Report, the manufacturing method with a GMP statement, proof of any claimed effect where justified, and data on animal testing. The template in this article organises all five.
Is the CPSR the same as the PIF?
No. The CPSR is the safety assessment and is one section of the PIF. The PIF also holds the product description, manufacturing and GMP information, claims evidence and animal testing data.
How long must a PIF be kept?
Ten years from the date the last batch of the product was placed on the market, readily accessible at the Responsible Person's address given on the label.
Can several products share one PIF?
Only variants covered together by the same safety assessment, such as shades or scents in a multiple variant CPSR. Products with different formulas beyond that need their own files.
Do I need a PIF if I only sell online?
Yes. The PIF is required for every cosmetic placed on the market, whether sold online, at markets or in shops, and marketplaces increasingly ask to see evidence of it.
What counts as proof of claimed effect?
Evidence proportionate to the claim: supplier substantiation, published literature or test data for functional claims such as moisturising, and a note that no proof is needed for purely descriptive claims. Medicinal claims are never permitted.
Who is allowed to hold the PIF?
The Responsible Person named on the label, which can be you or your company if established in the market, or an appointed Responsible Person service in the UK or EU.
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