How to keep a cosmetic PIF.
The product information file (PIF) is the file the Responsible Person keeps for every cosmetic product: for ten years after the last batch is placed on the market, at the address on the label, in a language the authority can read. This guide covers what goes in it, where it is kept and how files get lost.
Reviewed by Oğuzhan Eker, M.Sc. Chemist · Last reviewed
01/Article 11
What does Article 11 ask for? Four conditions.
Article 11 sets four conditions for the product information file, and all four apply to every product at once.
A file for every product placed on the market.
Ten years from the last batch, not the first.
Readily accessible at the address on the label.
In a language the authority can easily understand.
Great Britain keeps all four, but sets the address and the language its own way: see below.
02/The clock
When can a file be closed?
The last batch starts the clock, not the launch. A product discontinued in 2026 whose final batch shipped in 2025 keeps its file until 2035.
Ten-year calculator
If a company does not record last-batch dates, it cannot know when a file may be closed: it either keeps every file forever or risks closing one too early.
03/Contents
What goes in the file?
Article 11(2) names five parts. Each one is kept up to date, not filed once and forgotten.
Product information file
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Product description
A description that lets the product be clearly attributed to the file: name, variants, pack sizes, the formula version the file covers.
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Cosmetic product safety report
The CPSR, Parts A and B, signed, with its updates. What a CPSR contains.
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Manufacturing method and GMP statement
A description of the method of manufacture and a statement of compliance with good manufacturing practice (Article 8), usually a GMP certificate or self-declaration from the manufacturing site.
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Proof of the effect claimed
Where the nature or effect of the product justifies it: test reports, literature or consumer studies behind each claim.
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Data on animal testing
Any animal testing performed by the manufacturer, its agents or suppliers in relation to development or safety assessment, including testing done to meet the requirements of third countries.
Around these five sit the documents that support them, and that an inspector is likely to ask for next: raw material safety data sheets, specifications and certificates of analysis, IFRA certificates for fragrances, stability and challenge test reports, packaging declarations, label artwork as placed on the market, and the notification receipt.
04/Where
Where is the file kept, and in which language?
At the Responsible Person’s address printed on the label. The file can be electronic, as long as it can be produced there when asked for.
Article 11(3)
The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.
A file held on a consultant’s laptop, in a laboratory’s archive or in a supplier’s portal meets the condition only if the Responsible Person can produce it at that address when asked.
The language rule is set by each country: many authorities accept English, some require their own language for all or part of the report. A company selling in several Member States checks the rule in each one where it keeps a file.
Great Britain is stricter on both points: the file must be in English, and it is kept at the address notified for it in SCPN.
05/Inspection
What does an inspector ask for?
In market surveillance under Article 22, the authority asks for the file, or parts of it, usually in writing and with a deadline set in the request. It typically asks in this order.
The product description, the CPSR and the notification.
The GMP statement and the evidence behind one or two claims.
Whatever the first answers raise: a supplier certificate, a stability report, the toxicological source behind a NOAEL.
“Readily accessible” is measured against that deadline. A file that exists but takes a week to find does not meet it.
06/How files get lost
How do files get lost?
Usually through one of these.
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The consultant who prepared the report leaves, and the only copy was theirs.
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The laboratory that ran the tests closes, and the reports were never collected.
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The file is a folder on one laptop, and the laptop is replaced.
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Supplier documents were gathered once and never refreshed; the specification on file is three versions old.
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The formula changed, the report did not; the file describes a product that is no longer sold.
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Nobody recorded the last-batch date, so nobody knows which files must still be kept.
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The Responsible Person changed, and the file did not travel with the product.
07/Checklist
The Article 11 checklist.
The five parts, the supporting documents, the four conditions and the last-batch date.
08/Line by line
The rule, line by line.
The conditions of Article 11, read as a checklist: what the law asks, what it means in practice, and where it is handled in Unique Alphabet®.
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One file per product, kept ten years from the last batch
- In practice
- Record the last-batch date; close no file early
- In Unique Alphabet®
- While your account is active, the archive keeps discontinued products readable and restorable; there is no last-batch date field yet
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The safety report, signed and kept up to date
- In practice
- Keep every version; don’t overwrite
- In Unique Alphabet®
- The current report has its own section in the PIF; a new upload replaces it, so keep earlier versions elsewhere for now
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Manufacturing method and GMP statement
- In practice
- A certificate or declaration from the site, renewed when it expires
- In Unique Alphabet®
- Separate sections for the GMP declaration and the flow chart
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Proof of the effect claimed
- In practice
- A test report or study behind each claim
- In Unique Alphabet®
- A section for claim tests; Label Check reads the claims against the formula
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Data on animal testing
- In practice
- A statement, usually that none was done
- In Unique Alphabet®
- A standard statement in the report text; no separate section yet
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Readily accessible at the address on the label
- In practice
- Produce it in days, not weeks
- In Unique Alphabet®
- ZIP export per product (on a paid plan); a read-only share link for the inspector
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A language the authority can read
- In practice
- Check the rule for each Member State
- In Unique Alphabet®
- The report language, set on a template you edit
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Who changed what, and when
- In practice
- A record an inspector can follow
- In Unique Alphabet®
- Changes to the file are recorded in the Audit Log; hosting and protection are covered on the Security and data page
Questions about the PIF.
Does the ten years start at launch or at the last batch?
At the last batch. Ten years from the date the last batch of the product was placed on the market, under Article 11(1).
Can the file be electronic?
Yes. Article 11(3) allows electronic or other format; the condition is that it is readily accessible at the Responsible Person’s address and readable by the authority.
Who may keep the file on the Responsible Person’s behalf?
Anyone, as long as the Responsible Person can produce it at the address on the label when asked. Handing over the storage does not hand over the duty.
What happens to the file when the Responsible Person changes?
The new Responsible Person needs the file from the day they take over, because the duty is theirs from that day. The handover is agreed between the two in a contract; the Regulation does not arrange it.
One file per product, for ten years.
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