PIF authoring is what you need when the regulation is not the problem. Most brands that stall on their Product Information File know perfectly well what Article 11 of Regulation (EC) No 1223/2009 requires. What they do not have is a factory that will send the raw material specifications, or that sends them in Mandarin, or that cannot understand why a European customer needs a certificate of analysis for an ingredient that has been in the formula for five years.
That is a supply chain problem wearing a compliance costume, and it is the single most common reason a launch slips. This guide covers what the PIF has to contain, why overseas and private-label manufacturing makes it hard, and how to get the documents out of a factory that has never been asked for them.
Key takeaways
- The PIF is required by Article 11 and must be kept for ten years after the last batch was placed on the market.
- It must be held at the Responsible Person‘s EU address and be accessible to a competent authority in an easily understandable language.
- The hard part is almost never the regulation. It is getting documents from the manufacturer.
- Brands manufacturing in China, South Korea, Türkiye or private label face the widest documentation gap.
- A request naming the exact document in the factory’s own vocabulary gets answered. “Send the safety documents” does not.
- PIF Review and PIF Authoring are different services. Review checks a dossier you hold; authoring builds one you do not.
- The CPSR is a separate signature and is not included in document collection work.
- An incomplete PIF is an enforcement finding in itself, separate from any product safety issue.
What Article 11 actually requires
The Product Information File is the dossier that proves your product is what you say it is. Article 11 sets out the contents:
- A description of the cosmetic product that allows the PIF to be clearly attributed to it.
- The Cosmetic Product Safety Report referred to in Article 10 and Annex I.
- A description of the method of manufacturing and a statement of compliance with good manufacturing practice, for which ISO 22716 is the harmonised standard.
- Proof of the effect claimed, where justified by the nature or effect of the product.
- Data on animal testing performed by the manufacturer, agents or suppliers in relation to development or safety assessment.
It must be kept for ten years from the date the last batch was placed on the market, held at the address of the Responsible Person stated on the label, and made available to the competent authority of that Member State in a language they can readily understand. Our guides to preparing a cosmetic PIF and the difference between a CPSR, a PIF and an SDS cover the document set itself.
Where it actually breaks down
The list above is short and the underlying documents are not. To produce a compliant PIF you need, from your manufacturer or their suppliers:
| Document | Who holds it | Why it stalls |
|---|---|---|
| Exact quantitative formula | Manufacturer | Treated as proprietary; ranges supplied instead of percentages |
| Raw material specifications | Ingredient supplier via manufacturer | Two steps removed from you; often only a trade name is known |
| Certificates of analysis | Ingredient supplier | Batch specific, so they have to be requested repeatedly |
| Safety data sheets | Ingredient supplier | Supplied to another market’s format, not EU CLP |
| Fragrance allergen declaration | Fragrance house | Generic certificate supplied rather than one at your dosage |
| Composition of compound raw materials | Supplier | Trade secret; needs a confidentiality route rather than refusal |
| Manufacturing method and GMP statement | Manufacturer | May exist only as an internal document in the local language |
| Stability and challenge test reports | Manufacturer or lab | Often never run, or run to a different market’s protocol |
| Animal testing declaration | Manufacturer and suppliers | Rarely understood as a required EU statement |
The Article 18 animal testing declaration is the one most often missing from imported files, and it is not a formality. The EU ban covers testing of finished products and ingredients for cosmetic purposes, and it applies regardless of where the testing took place. A supplier who tested an ingredient for cosmetic purposes outside the EU does not solve your problem by being outside the EU. You need the declaration, in writing, from the chain.
Why overseas and private-label manufacturing is harder
None of this is a criticism of the factories. The gap exists because of what they have historically been asked for.
A manufacturer in China or South Korea supplying a domestic or US market has been asked for a different document set entirely, formatted differently, in a different regulatory vocabulary. A Turkish manufacturer may hold much of what you need, but in Turkish and in a format built for the Turkish authority. A private-label facility anywhere sells a finished product from a catalogue and often treats the formula as the core of its commercial value, which makes an exact quantitative composition a negotiation rather than a request.
Three failure patterns follow:
- The vague request. “Please send the safety documents for our order” produces whatever the factory has to hand, which is usually a certificate of analysis for the finished product and nothing else.
- The language gap. Documents arrive in the local language, in a format that does not map onto Annex I, and the brand has no way to tell whether what arrived is what was needed.
- The trade secret standoff. The factory refuses to disclose the formula to the brand. This is usually solvable, because the formula can go directly to the safety assessor under confidentiality rather than through you, but nobody proposes that route.
The trade secret standoff is the most solvable of the three and the one that stalls launches longest. A manufacturer that will not send a formula to its customer will very often send it to a named assessor under a confidentiality agreement, because that is a normal arrangement in their own market too. What is required is someone who knows to ask for that specifically, in terms the factory recognises.
How to get the documents out
What works, in order of impact:
Name the exact document. Ask for the “raw material specification and certificate of analysis for each ingredient”, not “the ingredient information”. Technical staff answer technical requests; commercial staff forward vague ones and lose them.
Use their vocabulary. A factory that does not know what a PIF is will recognise a request for the composition table, the manufacturing process description and the finished product specification. Explaining the EU regulation first usually goes nowhere; asking for documents they already have usually works.
Offer the confidentiality route immediately. Put the option of sending the formula directly to the safety assessor on the table in the first message, not after two months of refusals.
Ask the fragrance house directly. Allergen declarations at your actual dosage come from the fragrance supplier, not from the factory that bought the accord. Going one step down the chain is usually faster than going through the middle.
Get it in writing, in English. A verbal assurance that “there is no animal testing” is not an Article 18 declaration. A translated document with no original attached is not much better.
Do it before the order, not after. Documentation requests carry weight while a purchase order is still open and very little once it has shipped.
PIF Review and PIF Authoring are not the same service
This distinction saves money in one direction and time in the other.
PIF Review takes a dossier you already hold, checks it against Article 11 and Annex I, and tells you what is missing, inadequate or out of date. If your manufacturer is responsive and you have most of the documents, this is the cheaper and correct choice.
PIF Authoring is for when the dossier does not exist and the information sits with a factory that will not respond to you. We correspond with the manufacturer directly, in a technical vocabulary they recognise, collect and review what arrives, follow up on what is missing, and assemble the complete file. You also get a written statement of anything still outstanding, so you know exactly where you stand rather than assuming the file is complete.
Neither includes the Cosmetic Product Safety Report, which is a separate service and a separate signature by a qualified assessor, and neither includes laboratory testing. Where tests are missing we identify them and can arrange them, quoted separately. Our guide to who can sign a CPSR explains why the assessment is a distinct piece of work.
Bringing it all together
An incomplete PIF is an enforcement finding in its own right. A market surveillance authority asking for the file does not need to find a safety problem to act; it only has to find that the file is not there, not complete, or not accessible at the stated address. Our article on what happens if you sell non-compliant cosmetics covers the consequences.
The practical lesson is that the PIF is a procurement task before it is a regulatory one. Ask for the right documents, by name, in the right language, at the point in the commercial relationship where you still have leverage. If that conversation is not going anywhere, it is usually because it is being had by the wrong person.
Lexora’s PIF Authoring service puts that conversation on us: we contact your manufacturer or private-label supplier directly and keep going until the dossier is complete. If you already hold the documents, PIF Review is cheaper and the right choice. And if you want the assessment, the file, the notification and the Responsible Person handled together, the Full Compliance Pack covers the route to market end to end.
Frequently asked questions
What is the difference between PIF Review and PIF Authoring?
PIF Review checks a dossier you already hold against Article 11 and Annex I and tells you what is missing or inadequate. PIF Authoring is for when you do not have a dossier and the information sits with a manufacturer who will not respond to you: we contact them directly, collect and review the documents, and assemble the file. If you already have the documents, Review is cheaper and correct.
My factory will not give me the formula. What now?
This is usually solvable rather than fatal. A manufacturer who will not disclose a formula to its customer will often send it directly to a named safety assessor under a confidentiality agreement, which is a normal arrangement in most manufacturing markets. What matters is proposing that route explicitly and early rather than after months of refusals.
Does the PIF include the CPSR?
Yes, the safety report is one of the required contents of the file under Article 11. But collecting documents and writing the safety report are two different pieces of work: the CPSR must be prepared and signed by a person meeting the qualification requirements in the regulation, and that signature is a separate service from assembling the dossier around it.
How long must I keep the PIF?
Ten years from the date the last batch of the product was placed on the EU market. It must be held at the address of the Responsible Person shown on the label, in electronic or other format, and be readily accessible to the competent authority of that Member State in a language they can easily understand.
Can the PIF be in English if I sell in Germany?
Article 11 requires the file to be available in a language readily understandable by the competent authorities of the Member State concerned. In practice most authorities accept English, but that is not guaranteed everywhere and some may request translation of specific parts. Build the file in English and expect to translate on request.
Do I need a PIF if my manufacturer already has one?
Yes. The obligation sits with the Responsible Person for the product placed on the EU market, not with the manufacturer. A factory file held in another country, in another language, to another market’s structure does not satisfy Article 11. You need the file accessible at your Responsible Person’s EU address.
What if some documents simply cannot be obtained?
Then you need to know that clearly rather than discover it during an inspection. Our authoring service ends with a written statement of anything still outstanding, so you can decide whether to press the supplier, commission the missing testing, or reconsider the product. An honest gap you know about is manageable; one you do not know about is not.
