Cosmetics guide · Sources checked October 2026
Cosmetic PIF requirements: a checklist for the UK and EU
Cosmetic PIF requirements are set by Article 11 of Regulation (EC) No 1223/2009: the Responsible Person must keep a product information file for each cosmetic product placed on the market, containing five things: a product description, the cosmetic product safety report, the manufacturing method with a good manufacturing practice statement, proof of any claimed effect where justified, and data on animal testing. The same five items apply in Great Britain, under the retained version of the regulation, and in the EU and Northern Ireland.
Last updated .
What must be in a cosmetic PIF
The five Article 11 contents
Article 11(2) lists what the product information file must contain, and says the information “shall be updated as necessary”. The wording is the same in the GB and EU texts.
On smaller screens, scroll the table sideways to see every column.
| PIF item | What the regulation says | Source |
|---|---|---|
| (a) Product description | A description of the cosmetic product that lets the file be clearly attributed to that product | Article 11(2)(a), GB text; EU text, checked October 2026 |
| (b) Cosmetic product safety report | The safety report referred to in Article 10(1), set up in line with Annex I (Part A safety information, Part B safety assessment) | Article 11(2)(b), GB text; EU text, checked October 2026 |
| (c) Manufacturing method and GMP | A description of the method of manufacturing and a statement on compliance with good manufacturing practice under Article 8 | Article 11(2)(c), GB text; EU text, checked October 2026 |
| (d) Proof of claimed effect | Where justified by the nature or the effect of the product, proof of the effect claimed for it. The regulation does not list which claims need proof; that depends on the product and the claim | Article 11(2)(d), GB text; EU text, checked October 2026 |
| (e) Animal testing data | Data on any animal testing by the manufacturer, its agents or suppliers relating to the development or safety assessment of the product or its ingredients, including testing to meet other countries’ requirements | Article 11(2)(e), GB text; EU text, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; take advice from a qualified safety assessor or regulatory adviser for your products.
UK cosmetics PIF requirements vs EU cosmetics PIF requirements
Where GB and EU rules differ
The contents list is the same. Where the file is kept, its language, the Responsible Person’s location and where products are notified differ.
On smaller screens, scroll the table sideways to see every column.
| Point | Great Britain | EU and Northern Ireland | Source |
|---|---|---|---|
| Responsible Person | Must have a UK address to make products available in GB | Must be established in the EU; for Northern Ireland, in Northern Ireland or the EU | GOV.UK: cosmetic products in GB; Article 4, EU text; GOV.UK: Northern Ireland guidance, checked October 2026 |
| Language of the PIF | Must be in English (Article 11(4), GB text) | A language easily understood by the competent authority of the Member State where the file is kept (Article 11(3), EU text) | Article 11, GB text; EU text, checked October 2026 |
| Where the PIF is kept | Readily accessible to a competent authority, electronically or otherwise, at the address notified under Article 13 as the place the PIF is kept | Readily accessible, electronically or otherwise, at the Responsible Person’s address on the label, to the competent authority of the Member State where the file is kept | Article 11(3), GB text; EU text, checked October 2026 |
| Product notification | Before the product is placed on the GB market, through the Submit cosmetic product notifications (SCPN) service | Through the EU Cosmetic Products Notification Portal (CPNP), including for Northern Ireland | GOV.UK: submit a cosmetic product notification; Article 13, EU text; GOV.UK: Northern Ireland guidance, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; take advice from a qualified safety assessor or regulatory adviser for your products.
Responsible person PIF requirements
What a Responsible Person should check
A cosmetic PIF audit checklist, built from what the regulation asks for. The regulation does not set a format or a template for the file; these checks are a practical reading of it, not a legal test.
Sources: Annex I in the GB text and the EU text; Article 11 in the GB text, checked October 2026. For who prepares each part of the safety report, read the difference between a CPSR and a PIF.
- The product description identifies this exact product, so nobody can confuse the file with another shade, size or version.
- The safety report has both parts: Part A (the ten sections of safety information in Annex I) and Part B (the assessment conclusion, label warnings, reasoning, and the assessor’s name, proof of qualification, date and signature).
- The formula in Part A matches the formula you actually make and sell today.
- There is a description of the manufacturing method and a good manufacturing practice statement.
- Every claim on the label and in your marketing that needs proof has its evidence in the file.
- Animal testing data, or a record of what you know about it, is in the file.
- In GB, the file is in English and kept at the address you gave in your SCPN notification.
- Undesirable effects you know about are reflected in Part A, section 9, and serious ones have been reported.
How to create a cosmetic PIF: worked example (fictional)
Putting together a PIF for one product
A fictional business and product, for illustration only. It shows the order in which the parts usually come together; it is not advice on what your product needs.
1
Describe the product
Example Botanicals Ltd, a fictional UK company, plans to sell “Sample Oat Hand Cream, 50 ml” in Great Britain. The file opens with the product name, size, product code and the formula reference, so it can only belong to this cream.
2
Collect the safety information (Part A)
The team gathers the full formula with INCI names, stability and microbiological test results, packaging details and the exposure information. Example Botanicals provides this as the Responsible Person.
3
Get the safety assessment (Part B)
A qualified safety assessor reviews Part A, concludes the cream is safe for its intended use, states the label warnings needed, explains the reasoning, and signs and dates Part B.
4
Add manufacturing, GMP, claims and animal testing
The contract manufacturer supplies a description of the manufacturing method and a good manufacturing practice statement. The claim “for dry hands” is supported by the evidence the company holds, which goes in the file. Animal testing data from suppliers is recorded.
5
Notify and keep the file ready
Example Botanicals notifies the cream through SCPN, giving the address where the PIF is kept, and keeps the English-language file there ready for a competent authority.
Cosmetic compliance checklist: next steps
Keeping the PIF current
A PIF is not finished when the product launches.
The regulation says the file must be updated as necessary and kept for ten years after the last batch is placed on the market. Read how long to keep a cosmetic PIF and when to update it. If you are choosing a tool to hold your files, see cosmetic PIF software compared.
PIF tracking is not available yet
Soteriaa is building PIF tracking; join the waitlist. It is not available yet, and it will not prepare or sign a safety report. Join the cosmetics PIF waitlist to hear when it opens.
FAQ
Common questions
What must be in a cosmetic PIF?
Article 11(2) of Regulation (EC) No 1223/2009 lists five items: a product description, the cosmetic product safety report, the manufacturing method with a good manufacturing practice statement, proof of any claimed effect where justified, and data on animal testing. The list is the same in the GB and EU texts.
Who is responsible for the PIF?
The Responsible Person. In Great Britain they must have a UK address; for the EU they must be established in the EU, and for Northern Ireland in Northern Ireland or the EU.
Is there an official PIF template?
No. The regulation sets what the file must contain, not its format. It can be kept electronically or in another format, as long as it is readily accessible to the competent authority.
Join the cosmetics PIF waitlist
Leave your email and we will tell you when cosmetics PIF tracking opens. Nothing is on sale yet.