A CPSR example, section by section
A cosmetic product safety report (CPSR) has two parts, set out in Annex I to Regulation (EC) 1223/2009. Part A is the safety information: what is true about the product. Part B is the safety assessment: what a qualified person concludes from Part A. Below, each section in turn, with what a real report contains and what a weak one does instead.
We do not publish a client's report, and a sample document with the numbers blanked out teaches less than it seems to. What follows is the structure every report has to follow, annotated.
Part A — the safety information
Part A is data. Every line of it should be traceable to a document in the product information file: a supplier specification, a certificate of analysis, a stability study, a challenge test, a published toxicological endpoint. The main sections of Annex I, Part A (it has ten; two exposure sections are taken together here):
| Section | A real report | A weak report |
|---|---|---|
| Quantitative and qualitative composition | Every substance, with a concentration; trade names resolved to INCI | A range too wide to assess ("between 1 % and 20 %"); a trade name with the composition behind it unknown |
| Physical and chemical characteristics, and stability | Traceable to a stability study in the file | A statement with no study behind it |
| Microbiological quality | Traceable to a challenge test or a certificate | Asserted, not evidenced |
| Impurities, traces, packaging material | Taken from supplier specifications and certificates of analysis | Left out |
| Normal and reasonably foreseeable use | Stated for this product type | Generic |
| Exposure to the product, and to its substances | Calculated for this product | Copied from another product type |
| Toxicological profile of each substance | A sourced endpoint per substance, checked by a person | A placeholder no one has accepted |
| Undesirable effects | What is on record | Missing |
Part B — the safety assessment
Part B is what a qualified person concludes from Part A: the reasoning, the conclusion on the safety of the product, any warnings and instructions for use that the conclusion depends on, and the assessor's credentials and approval.
Part B cannot be assembled. It is professional judgement, and it is the thing you are actually buying. If Part B is three paragraphs of boilerplate that would read identically against a different formula, you have a template with your product's name typed into it.
Two checks you can run on any report
Does Part B refer to Part A in terms specific to your product? The reasoning should name your substances, your exposure and your figures.
Is the person who signed it named, with their qualification? The assessment has to be carried out by someone holding a university qualification in pharmacy, toxicology, medicine or a similar discipline (Art. 10(2), Reg. (EC) 1223/2009).
Where the official guidance is
The Commission's guidelines on Annex I are set out in Commission Implementing Decision 2013/674/EU of 25 November 2013. They are the reference for how each section of the report is expected to be filled in.
What each part means, who may sign and what stops a signature are in What is a CPSR?. The report is one item inside the product information file (Art. 11(2)) — the PIF checklist lists the rest. How we write and sign one: registration; what it costs is published.
Questions people ask
Can I use a CPSR example as my own report?
No. A report has to be the report for the product placed on the market (Art. 10(1)). An example describes someone else's formula.
How long is a typical CPSR?
There is no set length. What matters is that every figure in Part A has a document behind it, and that Part B reasons from those figures.
Who may sign Part B?
A person holding a university qualification in pharmacy, toxicology, medicine or a similar discipline (Art. 10(2), Reg. (EC) 1223/2009). Every report we issue is signed by David Vandevoort, pharmacist.
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