What is a CPSR, and how is it prepared?
A cosmetic product safety report (CPSR) is the document every cosmetic product needs before it is placed on the EU or GB market. Part A gathers the safety information; Part B is a qualified assessor’s reasoned conclusion and signature.
Reviewed by Oğuzhan Eker, M.Sc. Chemist · Last reviewed
01/Who needs one
Who needs a CPSR, and when?
Every cosmetic product placed on the market in the EU needs a CPSR before the first unit is sold. Great Britain has the same rule, under the GB Cosmetics Regulation.
Before the first unit is sold, and kept up to date after that.
The Responsible Person: manufacturer or importer.
Kept in the product information file and shown on request.
The report is not written once and filed away. Article 10 asks the Responsible Person to keep it up to date as new information comes in after the product is on sale: a new supplier, a new impurity profile, an undesirable effect, a changed annex limit.
02/Part A
Part A: ten sections.
Part A is the information the assessment is based on. Annex I lists ten sections; if any of them is missing or unexplained, the report is incomplete.
Cosmetic product safety information
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Quantitative and qualitative composition
Every ingredient by INCI name, CAS or EC number, function and percentage, down to the components of fragrance and flavour compositions.
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Physical and chemical characteristics and stability
Of the raw materials and of the finished product, with the stability data under reasonably foreseeable storage.
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Microbiological quality
Specifications and the preservation challenge test, or the reason none is needed.
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Impurities, traces and information about the packaging material
Purity of substances, traces of prohibited substances with evidence they are technically unavoidable, and the characteristics of the packaging that matter for the product.
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Normal and reasonably foreseeable use
How the product is used, where on the body, how often and by whom; the exposure sections that follow are worked out from this.
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Exposure to the cosmetic product
Site of application, surface area, amount per application, frequency, population, including children where relevant.
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Exposure to the substances
The exposure to each ingredient, derived from the exposure to the product and the concentration.
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Toxicological profile of the substances
For each ingredient, the relevant toxicological endpoints, with sources, and the NOAEL used for the margin of safety.
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Undesirable effects and serious undesirable effects
Data available on the product and, where relevant, on similar products.
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Information on the cosmetic product
Other relevant data, such as studies on human volunteers or confirmed risk assessments from other fields.
03/Part B
Part B: four sections.
Part B is the assessment itself. It is written and signed by the assessor.
Cosmetic product safety assessment
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Assessment conclusion
Whether the product is compliant under Article 3 when used as described.
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Labelled warnings and instructions of use
The warnings and instructions of use that must appear on the label.
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Reasoning
How the conclusion follows from Part A, including the margin of safety for each substance where that applies.
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Assessor’s credentials and approval of Part B
Name, qualification and signature of the assessor.
04/Margin of safety
How is the margin of safety calculated?
For each ingredient, the assessor compares two doses: the dose at which studies saw no adverse effect, and the dose a consumer actually absorbs from the product. The margin of safety is the first divided by the second.
The systemic exposure dosage is worked out from the amount applied each day, the ingredient’s concentration, its dermal absorption and a default body weight of 60 kg.
The SCCS Notes of Guidance treat a margin of at least 100 as the usual threshold. A lower value is not forbidden, but the assessor has to justify it in the reasoning. For ingredients listed in Annexes III to VI with a maximum concentration, the assessor can often rely on the SCCS opinion behind the limit instead of a new calculation.
A worked example with the SCCS defaults: a face cream containing 0.5% of an ingredient whose NOAEL, from a 90-day oral study, is 100 mg/kg body weight per day. There are no dermal absorption data for it.
| Step | Value |
|---|---|
| Daily exposure to a face cream, per kg of body weight | 24.14 mg/kg/day |
| Concentration of the ingredient | 0.5% |
| Dermal absorption, no data: SCCS default | 50% |
| SED = 24.14 × 0.5% × 50% | 0.0604 mg/kg/day |
| NOAEL from the oral study | 100 mg/kg/day |
| Systemic NOAEL, oral absorption not known: SCCS default 50% | 50 mg/kg/day |
| MoS = 50 ÷ 0.0604 | 828, above 100 |
The ingredient and its NOAEL are illustrative; in a real report every value comes from that ingredient’s own data. The exposure figure, the two 50% defaults and the threshold of 100 are from the SCCS Notes of Guidance, 12th revision ↗ (SCCS/1647/22).
05/Who may sign
Who can sign a CPSR?
The assessor can be an employee of the Responsible Person, an independent professional or a service provider. What counts is the qualification, and the personal signature under Part B.
Article 10(2)
The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
There is no register of assessors; the authority that reads the report checks the qualification. Great Britain uses the same wording, and there the Secretary of State recognises equivalent courses.
06/Software
What can software do, and what can it not?
Software can do everything that can be derived or calculated. It cannot make the assessment.
Calculation
- Each ingredient’s INCI name, CAS and EC number and annex status
- The NOAEL and its source, from a library
- Exposure, SED and the margin of safety, line by line
- The label, checked against the formula
- Part A, laid out in the order Annex I requires
Judgement and signature
- Weighing the evidence and reaching a judgement
- Deciding what to do with a margin under 100
- The decision that a trace is technically unavoidable
- The signature under Part B
What software produces is a CPSR draft. A report that presents a calculation as its conclusion is missing Part B.
In Unique Alphabet®, the CPSR draft comes from the product record, with Parts A and B laid out on a template you can edit. Record your assessor once in Company Profile; they review the draft and their signature prints in Part B. Without one, the signature is a service in Türkiye, quoted per file.
The Compare page puts CPSR tools side by side, using what each says on its own public pages.
07/Second market
What the file needs before you sell in the EU.
A file prepared for a market whose rules mirror the EU’s is mostly ready for the EU: the ten sections of Part A and the five parts of the PIF are the same. Four things are missing, and none of them changes the formula.
A report in a language the authority reads
The file must be in a language the Member State’s authority can easily understand; most accept English, some ask for their own. The platform prints the same report in each language it offers.
A signature from an assessor qualified in the EU
Part B is signed by an assessor who meets Article 10(2). A qualification recognised only in another market is not enough on its own.
A Responsible Person established in the EU
A natural or legal person inside the EU who keeps the PIF, notifies the product and answers to the authority. A Responsible Person in another market cannot take this role in the EU.
The CPNP notification
Made before the product goes on sale, in the Responsible Person’s name; one notification covers the whole EU. Great Britain needs a separate SCPN notification and a Responsible Person established in the UK.
Then there are the EU annexes themselves. Where a market’s annexes follow the EU’s with a delay, a formula can still look compliant there after an EU limit has changed. Regulatory Watch reports the EU change by product name, with the date.
08/Line by line
Where each line of the report comes from.
What Annex I asks for on each line, where that information comes from, and where it sits in Unique Alphabet®.
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Composition
- Where it comes from
- Your formula and your suppliers’ specifications
- In Unique Alphabet®
- The formula matched to CosIng, line by line
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Physical and chemical characteristics, stability
- Where it comes from
- Laboratory tests on the finished product
- In Unique Alphabet®
- The stability report is uploaded to its own section of the PIF. The testing is laboratory work, not software
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Microbiological quality, challenge test
- Where it comes from
- Laboratory
- In Unique Alphabet®
- Separate sections for the microbiology and challenge-test reports
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Impurities, traces, packaging material
- Where it comes from
- Supplier specifications and declarations
- In Unique Alphabet®
- Supplier documents (SDS, CoA, IFRA), filed under each ingredient
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Use and exposure
- Where it comes from
- The product’s use and the SCCS default values
- In Unique Alphabet®
- Exposure and SED per ingredient
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Toxicological profile and NOAEL
- Where it comes from
- Toxicological literature and SCCS opinions
- In Unique Alphabet®
- Your library, with a source for each ingredient
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Undesirable effects
- Where it comes from
- Your own records
- In Unique Alphabet®
- Written into the report text; it has no separate section yet
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Part B: conclusion, warnings, reasoning, signature
- Where it comes from
- The qualified assessor
- In Unique Alphabet®
- Your assessor’s signature, printed in Part B, or the signature service in Türkiye
09/Sample
Download a sample CPSR.
A complete draft for a fictional leave-on product: Parts A and B, exactly as the platform prints them.
Questions about the CPSR.
Is a CPSR the same as a safety assessment?
The assessment is the assessor’s work in Part B. The CPSR is the full report: Part A’s information and Part B’s assessment together. In conversation the words are used for each other; in the Regulation they are not.
Does the CPSR go to the authority?
No. It stays in the product information file at the Responsible Person’s address and is shown to the competent authority on request. Notification in CPNP or SCPN is a separate step and does not include the report.
When does a CPSR have to be updated?
Whenever relevant information changes: the formula, a supplier’s specification, an impurity profile, a reported undesirable effect, or an annex limit that affects an ingredient. Article 10 asks for the report to be kept up to date, and a changed formula in practice means a new assessment.
How long does it take to prepare one?
Part A takes as long as gathering the data takes: supplier documents, stability and challenge tests, toxicological sources. Once the data is in, software produces the draft in minutes; the assessment is the assessor’s time, and that is not measured in minutes.
Create your first CPSR draft.
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