What is a cosmetic product information file, who keeps it, and what happens when a line is empty
The list is easy to find. We could not find a page that says what happens when a line on the list is empty — which is the situation almost every brand is actually in.
Looking for the item-by-item list, or a template to copy? That is the PIF checklist and template. This page covers what the file is, who keeps it, where, for how long, and what happens when a line is empty.
What the Regulation asks for
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. — Art. 11(1), Reg. (EC) 1223/2009
Art. 11(2), Reg. (EC) 1223/2009 lists five things the file has to contain: (a) a description of the cosmetic 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) where justified by the nature or the effect of the product, proof of the effect claimed; and (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.
Item (c), the manufacturing method and GMP statement: This is the item non-EU brands most often cannot produce, because the manufacturer treats it as confidential and the brand has never asked in writing. Item (d), proof of the effect claimed: If your pack says the product does something, the evidence that it does lives here. This is where the claims work lands.
The item-by-item version: what done looks like for each item, and a template to copy →
Three further operational requirements sit alongside the list. The file is kept at the responsible person's address as indicated on the label (Art. 11(3), first subparagraph, Reg. (EC) 1223/2009) — which is the same address Art. 19(1)(a) puts on the pack. It has to be readily accessible, in electronic or other format. And the information in it must be available in a language that can be easily understood by the competent authorities of the Member State (Art. 11(3), second subparagraph).
That is the point at which most makers working from a kitchen or a spare room ask whether their home address ends up on the pack. It has a real answer, and it is not "yes": the address required is the responsible person's, and who holds that role has not been decided at the point you are asking. Under Art. 4, the manufacturer established in the Union is the responsible person unless it designates someone else by written mandate; for an imported product the importer is, unless it designates otherwise; a distributor becomes the responsible person when it places the product under its own name or trademark; and any person established in the Union may be designated by written mandate and accept in writing (Art. 4(3)–(6), Reg. (EC) 1223/2009). We can be appointed as your EU Responsible Person, by written mandate. How that works → What a Responsible Person does, and whose address goes on the label →
Ten years after the last batch
Read the retention wording again, because it is longer than people think.
Ten years from the date the last batch was placed on the market. Not ten years from the notification. Not ten years from when you stopped making it. If you sell a product from 2026 to 2036 and the final batch goes out in 2036, the file is live until 2046. A discontinued line still has a live file for a decade after the last unit left.
Two practical consequences. First, batch records matter — you need to be able to say when the last batch was placed. Second, the file has to survive things: a change of shop system, a change of accountant, a change of responsible person. A folder on somebody's laptop does not satisfy "readily accessible" in year nine.
"Readily accessible" means promptly, not eventually
The Regulation asks for a file that is readily accessible at a stated address. An inspector arriving at that address expects to be given the file, not a promise to compile it.
That is the single difference between a file and a pile of documents. If your safety report is with an assessor, your certificates of analysis are in an inbox, your artwork is with a designer and your GMP statement has never been requested, you do not have a product information file. You have the raw material for one.
What a file looks like when it is real: an index, every document present and named, each item mapped to the article or annex that requires it, a hash or version marker so you can tell which revision of the report belongs to which revision of the formula, and a list of what is missing. Ours is built that way — an indexed folder with the gaps stated on the front, not hidden in the middle.
What happens when a line is empty
This is the part that decides whether the file is worth having.
We do not estimate. Where something cannot be established, it is recorded as missing — in the file, and again in the report — so a gap can never quietly turn into a figure. Nothing is signed over an unresolved substance, an unconfirmed toxicological endpoint, a placeholder value not accepted by a named person, or a registry that has not been reviewed by a human being. The signature follows once those are settled.
Concretely, the gaps we see most often:
No allergen statement for an aromatic raw material. The commonest gap in a botanical file by a wide margin. Without it, you cannot build the ingredient list correctly, so we ask the supplier for the lot rather than assume a level.
No GMP statement from the contract manufacturer. Art. 11(2)(c) asks for it. Many manufacturers will produce one immediately when asked in writing against the article. Many have never been asked.
A raw material with no INCI name. Traditional and botanical materials often arrive under a trade or vernacular name. That is a resolvable problem — we come back to you with the candidates we can see and ask which one you bought; we do not pick one for you — but it is not a problem that can be skipped.
Composition given as a range too wide to assess. A supplier who says "5–40 %" has not told you the composition.
Claim evidence that does not exist. Art. 11(2)(d) asks for proof of the effect claimed where justified. Where there is no evidence, the honest resolution is to change the claim, not to find a form of words. We read every claim on the pack and the page against the six common criteria for claims set out in Commission Regulation (EU) 655/2013, and any claim with no evidence behind it is raised with you by name before anything is delivered — it is never quietly dropped and never quietly passed.
Batch numbers. A maker preparing a file asked this on a forum:
I thought you had to note down all the batch numbers for your ingredients, but since they are not included what do you do then?
The answer is traceability rather than a rule about which numbers to copy. You need to be able to connect the finished batch you sold to the raw-material lots that went into it — because that is what an investigation of an undesirable effect will ask you for, and because a certificate of analysis is only evidence about the lot it was issued for. Where a supplier gives no lot identity, that is a gap in your traceability, and it is better recorded as one than papered over.
In every one of these cases the deliverable is the same shape: here is the missing item, here is the article that requires it, here is the request to send to the person who has it.
PIF and CPSR are not the same thing
The safety report is one item inside the file (Art. 11(2)(b)). The file is the folder and everything else in it: the description, the manufacturing method and GMP statement, the claim evidence, the animal-testing data, the labelling and the raw-material documentation the report was built from.
You can buy a safety report and still not have a product information file. That happens constantly, and it is why a retailer's document request lands badly on brands who believed they were finished.
Language
The information in the file has to be available in a language that can be easily understood by the competent authorities of the Member State (Art. 11(3), second subparagraph, Reg. (EC) 1223/2009). That is not the same as "translate everything into every EU language", and it is not "English is fine everywhere" either. It depends on the Member State where the file is kept — the one at the responsible person's address on the label. Tell us where that is and we will tell you what it implies for your file before you pay a translator.
FAQ
What is a PIF?
The product information file: the folder the responsible person keeps for each cosmetic product placed on the market, containing the description, the safety report, the manufacturing and GMP statement, the claim evidence where justified, and animal-testing data (Art. 11, Reg. (EC) 1223/2009).
What is the difference between a PIF and a CPSR?
The CPSR is the safety report. The PIF is the file that holds it, along with everything the report was built from. One is a document; the other is a folder with an obligation attached.
How long must you keep a PIF?
Ten years following the date on which the last batch was placed on the market (Art. 11(1)).
Who keeps the product information file?
The responsible person, at the address indicated on the label (Art. 11(3)) — which is the address Art. 19(1)(a) requires on the pack.
Does the PIF have to be in the local language?
It has to be available in a language easily understood by the competent authorities of the Member State (Art. 11(3), second subparagraph). Which language that is depends on the Member State where the file is kept.
Will my home address have to go on the label?
What Art. 19(1)(a) requires is the name and address of the responsible person. If you are your own responsible person and you work from home, that is your home address. If someone else holds the role, it is theirs — and Art. 4(3)–(6) sets out who that can be. The Regulation contains no mail-forwarding or PO-box provision, so the honest way to change the answer is to change who holds the role, not to find a different address for the same person.
For which ingredients do I need batch numbers?
Think traceability rather than a list. You need to be able to connect a finished batch to the raw-material lots in it, because that is what an investigation will ask for and because a certificate of analysis speaks only for its own lot.
Can I use supermarket ingredients since they are food safe?
Food-grade is a different specification from what a cosmetic assessment needs. What matters for the file is whether you have a specification and a certificate of analysis identifying what you actually used. Very often, for a supermarket pack, you do not.
My manufacturer will not send the documents. Can you still build the file?
We can build everything that does not depend on them, itemise exactly what is missing against the article requiring it, and write the request. We will not invent the missing content.
What do I get while documents are still outstanding?
An indexed file, a gap list naming each missing item and the article behind it, and a document request ready to send. That stands on its own while you wait.
The registry behind it
Every Annex II–VI entry as consolidated on 18 May 2026 — 2,385 entries, 36,023 substances — re-checked daily against EUR-Lex, CosIng, SCCS and IFRA. Every report is signed by David Vandevoort, pharmacist (Master, KU Leuven; PhD, KU Leuven 2010).
Start with the free check — see what your listing is missing, while you wait.