Cosmetics
Cosmetic PIF and CPSR: What Each Document Actually Contains
The Product Information File and the Cosmetic Product Safety Report get treated as one thing constantly, and the confusion causes real problems — the CPSR is one component inside the much larger PIF, written by a different party, under a different standard of scrutiny.
PIF vs CPSR, in One Line Each
- PIF: the complete file — formulation, manufacturing, labelling, claims, and the CPSR
- CPSR: the safety assessment specifically, one component of the PIF
- Held by: the Responsible Person
- Retained: 10 years past the last batch placed on the market
Quick answer: A cosmetic PIF EU regulators can request contains the complete documentation package for a product — formulation, manufacturing and GMP evidence, labelling, claims substantiation — with the Cosmetic Product Safety Report (CPSR) as one component inside it, not a separate document you hold alongside the PIF. Product information file cosmetics EU rules, under Article 11 of Regulation (EC) No 1223/2009, require the whole package to be held by the Responsible Person and retained for 10 years past the last batch placed on the market, producible to authorities on request. A CPSR EU cosmetics authorities will accept has to come from a qualified safety assessor specifically — see the Part A/Part B breakdown below.
Inside the PIF
What the Full File Actually Contains
Product description
A clear description sufficient to link the file unambiguously to the specific product, including its name and code.
The full formulation
A qualitative and quantitative breakdown of the product's composition — the real ingredient list and concentrations, not a simplified label version.
Manufacturing method and GMP statement
A description of the manufacturing method, and a statement confirming it complies with Good Manufacturing Practice.
The CPSR
The Cosmetic Product Safety Report itself — Part A (the safety information) and Part B (the assessor's conclusion) — the scientific core the rest of the file supports.
Data on undesirable effects
Existing data on any undesirable or serious undesirable effects the product has caused, kept current as new information comes in.
Proof of claimed effects
Evidence substantiating any effect claimed for the product — a real evidentiary standard, not just marketing language repeated as fact.
Inside the CPSR Specifically
Part A and Part B
| Part A: Safety Information | Part B: Safety Assessment | |
|---|---|---|
| What it contains | Toxicological profile, exposure scenario, stability data, microbiological quality | The assessor's actual conclusion and reasoning based on Part A |
| Who produces it | Compiled from formulation, ingredient and testing data | Written by a qualified safety assessor specifically |
| Function | The evidence base | The professional judgment applied to that evidence |
Access & Retention
Who Can See It, and for How Long
Access on request
National competent authorities can request the PIF at any time — the Responsible Person has to be able to produce it, in an accessible format, without a long lead time to assemble it after the fact.
10-year retention
The full file, CPSR included, is retained for 10 years from the date the last batch of that product was placed on the market — not 10 years from launch, but from the final batch.
Real Scenario
A Pattern Worth Checking Your Own File Against
The PIF that exists but is not actually assembled
A common pattern: a brand has every individual piece of the PIF somewhere — formulation records with the manufacturer, the CPSR from the safety assessor, labelling files with the design team — but nothing consolidated into one accessible file the Responsible Person can actually hand over on request. When an authority asks, "producible in an accessible format" is the real test, and scattered documents across three parties do not satisfy it quickly enough. Consolidating the PIF into one held file, not just confirming every piece technically exists somewhere, is the difference that matters during an actual request.
FAQ
Common Questions About the PIF and CPSR
Is the CPSR the same document as the PIF?
No — the CPSR (Cosmetic Product Safety Report) is one component inside the larger PIF (Product Information File), which also includes the formulation, manufacturing evidence, labelling and claims substantiation. Confusing the two is common, but they are not interchangeable terms.
Who is allowed to write the CPSR for a cosmetic product?
A suitably qualified safety assessor specifically, not the brand itself and not a general testing lab — Part B of the CPSR requires professional judgment that only a qualified assessor is legally positioned to provide.
How long do I need to keep a product information file cosmetics regulators can request?
Ten years, counted from when the last batch of that specific product is placed on the EU market — not from the original launch date, and not a fixed calendar period independent of sales activity.
What happens if an authority requests my PIF and it is not ready?
This is treated as a real compliance failure, not an administrative delay — the Responsible Person is expected to produce the PIF promptly in an accessible format, and scrambling to assemble scattered documents after a request arrives is exactly the situation the retention requirement exists to prevent.
Does every cosmetic product need its own separate CPSR?
Yes, tied to the specific formulation — a genuinely different formulation needs its own CPSR, while minor packaging-only variations of an identical formulation typically do not. Confirm the boundary with your safety assessor for any specific product line.
Where the Facts Come From
Sources for This Page
Regulation (EC) No 1223/2009, Article 11 (Tier 1, EUR-Lex) is the sole legal basis for the PIF and CPSR content described on this page.
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