PIF template and checklist: the cosmetic product information file, item by item
A product information file (PIF) is the folder the responsible person keeps for each cosmetic product placed on the EU market (Art. 11(1), Reg. (EC) 1223/2009). Art. 11(2) lists five items. It is kept at the responsible person's address on the label, for ten years after the last batch. Below: each item, what done looks like, and the gaps we see most.
What a PIF is, who keeps it and what happens when a line is empty: our guide to the product information file.
The checklist
The five items, in the Regulation's own order (Art. 11(2), Reg. (EC) 1223/2009):
- (a) A description of the cosmetic product, enough that the file can be clearly attributed to the product.
- (b) The cosmetic product safety report referred to in Art. 10(1), Part A and Part B, set out in accordance with Annex I.
- (c) A description of the method of manufacturing and a statement on compliance with good manufacturing practice.
- (d) Proof of the effect claimed, where justified by the nature or the effect of the product.
- (e) Data on any animal testing performed by the manufacturer, its agents or suppliers, relating to the development or safety assessment of the product or its ingredients.
What "done" looks like for each item
(a) Description. Name, variant and pack, with no doubt about which product the folder belongs to. The gap we see: variants and pack sizes that are not told apart.
(b) Safety report. A signed Part B that refers to Part A in terms specific to this formula. The gaps we see: no allergen statement for an aromatic raw material; composition given as a range too wide to assess ("5–40 %"); a raw material with no INCI name.
(c) Manufacturing method and GMP statement. A written statement from the manufacturer that actually makes the product. The gap we see: the contract manufacturer has never been asked in writing, so no statement exists. Many produce one straight away when asked against the article.
(d) Proof of the effect claimed. Evidence for each effect the pack or the product page claims. The gap we see: a claim with nothing behind it. The honest fix is to change the claim, not to find a form of words.
(e) Animal testing data. Whatever the manufacturer, its agents and its suppliers have done, relating to the product or its ingredients.
One more line belongs in every file even though Art. 11(2) does not list it by name: traceability. You need to be able to connect the finished batch you sold to the raw-material lots that went into it, because a certificate of analysis is only evidence about the lot it was issued for.
Where the file is kept, for how long, and in which language
Where. At the responsible person's address indicated on the label (Art. 11(3), first subparagraph) — the same address Art. 19(1)(a) puts on the pack.
In what form. Readily accessible, in electronic or other format. That means handed over promptly when an authority asks, not compiled after it arrives.
How long. Ten years from the date on which the last batch of the product was placed on the market (Art. 11(1)). A discontinued line still has a live file for a decade after the last unit left.
Which language. A language that can be easily understood by the competent authorities of the Member State (Art. 11(3), second subparagraph). That is neither "every EU language" nor "English everywhere"; it depends on the Member State where the file is kept.
A template is not a file
A template is a list of headings. A product information file is the documents themselves: the signed safety report for this formula, the manufacturer's GMP statement, the evidence behind each claim, indexed and kept at the responsible person's address, ready to hand over.
If your safety report is with an assessor, your certificates of analysis are in an inbox and your GMP statement has never been requested, a template does not change that. You have the raw material for a file, not a file.
What happens when a line on this list is empty is in our guide to what goes in a PIF. Assembling and keeping the file is part of registration; what it costs is published.
A PIF template you can copy
This is a skeleton, not a file: the headings from Art. 11(2), in the Regulation's own order, each with a one-line placeholder for what has to sit under it. Copy the structure. The documents behind each heading are still the work.
PRODUCT INFORMATION FILE — [product name, variant, pack size]
Responsible person: [name and address, as it appears on the label]
Kept at: [address] · Language: [language easily understood by the competent authority]
(a) DESCRIPTION OF THE COSMETIC PRODUCT
[name, variant, pack — enough to attribute this file to this product without doubt]
(b) COSMETIC PRODUCT SAFETY REPORT (Art. 10(1), Annex I)
Part A — safety information: [composition, physical/chemical data, exposure, toxicological profile]
Part B — safety assessment: [qualified assessor's reasoning, conclusion, assessor's name and qualification]
(c) METHOD OF MANUFACTURING AND GMP STATEMENT
[manufacturer's written statement that GMP was followed]
(d) PROOF OF EFFECT CLAIMED (where justified)
[evidence for each claim made on the pack or product page]
(e) DATA ON ANIMAL TESTING
[testing done by the manufacturer, its agents or its suppliers, on the product or its ingredients]
TRACEABILITY (not listed by name in Art. 11(2), but needed throughout)
[batch numbers connecting the finished batch sold to the raw-material lots used in it]
Fill a heading and it stops being a placeholder. Leave one empty and it is a gap — what happens next is in our PIF guide.
Questions people ask
Is there an official PIF template?
The Regulation lists what the file must contain (Art. 11(2)) and says it may be kept in electronic or other format (Art. 11(3)). It does not prescribe a form to fill in.
Can I keep the PIF myself if I am outside the EU?
The file is kept at the responsible person's address on the label (Art. 11(3)), and the responsible person must be designated within the Union (Art. 4(1)). A brand outside the EU keeps copies; the file the Regulation requires sits with its EU Responsible Person.
How long do I keep the file after I stop selling a product?
Ten years from the date the last batch was placed on the market (Art. 11(1)).
Start with the free check — see what your listing is missing, while you wait.