What is a PIF? The cosmetic product information file.
A PIF is the file the Responsible Person keeps for every cosmetic product on the market: the safety report, the manufacturing and GMP statement, the proof of claims and the animal-testing data, kept for ten years after the last batch. This guide says what it is, what is in it, who keeps it, and how it differs from the CPSR.
01/Definition
What is a PIF? One file per product, kept by law.
PIF stands for product information file. It is the dossier that shows a cosmetic product complies, and the one an authority asks for first. The law names it in Article 11 of Regulation (EC) No 1223/2009.
Article 11(1)
When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
“PIF” is the trade’s short form; the Regulation writes “product information file”. The same Article applies in Great Britain with its own wording on address and language. In Türkiye the Kozmetik Ürünler Yönetmeliği sets the same duty in its Article 14: the file is called ürün bilgi dosyası, and the abbreviation ÜBD is used in the market too.
02/Contents
What is in a PIF? Five parts, kept up to date.
Article 11(2) names five parts, in letters (a) to (e). The law adds that each is updated as necessary, so the file is never finished.
Product information file
Product description
A description that lets the file be clearly attributed to the product.
Cosmetic product safety report
The CPSR, which is the safety assessment in writing.
Manufacturing method and GMP statement
How the product is made, and a statement that it follows good manufacturing practice.
Proof of the effect claimed
Where the nature or the effect of the product justifies it.
Animal-testing data
Any animal testing by the manufacturer, its agents or suppliers, including testing for third countries.
The Turkish regulation lists the same five parts in Article 14(2), lettered a, b, c, ç and d. Around them sit the documents that support them: raw material safety data sheets, specifications, certificates of analysis and test reports.
03/Who, where, how long
Who keeps the PIF, and where? The Responsible Person, at the label address.
One person is accountable for the file: the Responsible Person named on the label. Where it is kept and in which language depends on the market.
European Union
- Kept by the Responsible Person.
- Ten years from the last batch placed on the market.
- At the address on the label, readily accessible to the competent authority.
- In a language the authorities of that Member State can easily understand.
Great Britain
- Kept by the Responsible Person.
- Ten years from the last batch placed on the market.
- At the address notified for it under Article 13.
- In English.
Türkiye
- Kept by the Sorumlu Kişi (Responsible Person).
- Ten years from the last batch placed on the market.
- At the address on the label, ready to be given to the Authority on request.
- In Turkish or English.
Anyone may store the files on the Responsible Person’s behalf, as long as it can be produced at that address when asked. Storage, ten-year clock and the common ways files get lost are in the guide on keeping a PIF.
04/PIF and CPSR
Is a PIF the same as a CPSR? No. The CPSR is one part of it.
The CPSR is item (b) in the list: the safety report. A PIF with only a CPSR is incomplete.
| Question | PIF |
|---|---|
| What it is | The whole file for one product: five parts, with the documents behind them. |
| Who is accountable | The Responsible Person, who keeps it. |
| Who writes it | Assembled by the Responsible Person from many sources. |
| When it is kept | Ten years from the last batch placed on the market. |
| Question | CPSR |
|---|---|
| What it is | One of the five parts: the written safety assessment. |
| Who is accountable | The Responsible Person keeps it in the PIF; the assessment itself is carried out by a qualified person. |
| Who writes it | Part B is carried out by a person with a pharmacy, toxicology, medicine or similar degree. See Article 10(2). |
| When it is kept | As part of the PIF, so for the same ten years. |
In practice the two are prepared together: the report first, then the other parts around it.
05/In Unique Alphabet®
How does Unique Alphabet® build a PIF? One file per product, with the gaps shown.
The PIF Files module holds the parts in one place for each product. A product that leaves the market goes to the archive, where it stays readable within your plan’s storage while your account is active.
Every part of the file, from the formula and MoS to the test reports. The safety report section takes either a draft made here or a CPSR you upload.
Upload SDS, TDS, CoA and IFRA certificates to the ingredient, and GMP certificates, flow charts and test reports to the PIF. The platform shows what is missing.
The file is stored in the cloud, kept separate per company. On a paid plan you can download the whole file as a ZIP at any time.
Restoring an archived product makes it active again: it needs a free active place and uses one new file.
Questions about the PIF.
What does PIF stand for?
Product information file. The Regulation writes the full term; PIF is the trade’s short form. In Türkiye the file is the ürün bilgi dosyası, also written ÜBD.
Is a PIF the same as a CPSR?
No. The cosmetic product safety report (CPSR) is one of the five parts of the PIF, listed as item (b) in Article 11(2). The PIF also holds the product description, the manufacturing method and GMP statement, proof of the effect claimed and animal-testing data.
Who must keep a PIF?
The Responsible Person, for every cosmetic product placed on the market. Article 11(1) of Regulation (EC) No 1223/2009 says so, and Article 14 of the Kozmetik Ürünler Yönetmeliği does the same in Türkiye.
How long must the PIF be kept?
For ten years following the date on which the last batch of the product was placed on the market. The clock starts at the last batch, not at the launch.
Is a PIF required in Türkiye?
Yes. Article 14 of the Kozmetik Ürünler Yönetmeliği requires the Sorumlu Kişi to keep it, available to the Authority on request, in Turkish or English.
One file per product, ten years.
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