CPSR Part A vs Part B: What Each Section Covers
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Quick Answer
A cosmetic product safety report (CPSR) has two halves. Part A is the safety information: the facts about the formula, ingredients, stability, microbiology, exposure and toxicology. Part B is the safety assessment: the qualified assessor's conclusion on whether the product is safe, the warnings it needs, the reasoning behind that conclusion, and the assessor's credentials and signature. In short, Part A collects the evidence and Part B makes the judgement. The structure is set by Annex I of the Cosmetics Regulation.
Why the Split Exists
Many brand owners hear "CPSR" and picture one document written by one person. The Regulation sees two different jobs. Annex I separates the information that must be gathered from the assessment that must be made about it. That separation matters in practice, because the people who supply the first part (you, your formulator, your manufacturer, your suppliers) are usually not the person who signs the second. The European Commission's guidelines on Annex I say the responsible person and the safety assessor should work together to gather the information required by Part A, and that the Part B assessment is to be carried out by a qualified safety assessor.
Side by Side
| Part A: Safety information | Part B: Safety assessment | |
|---|---|---|
| Purpose | Gather the facts | Judge what the facts mean |
| Who supplies it | Responsible Person with the safety assessor, using data from formulator, manufacturer and suppliers | The qualified safety assessor |
| Number of headings | Ten | Four |
| Key output | Composition, stability, exposure and toxicology data | Conclusion on safety, warnings, reasoning, signature |
| Typical weak point | Missing or outdated supplier data | Conclusion not matched to the final formula and pack |
Part A: The Ten Headings
Annex I introduces Part A by saying the report must, as a minimum, contain the following ten items:
- Quantitative and qualitative composition of the product.
- Physical and chemical characteristics and stability.
- Microbiological quality, including challenge test results.
- Impurities, traces and information about the packaging material.
- Normal and reasonably foreseeable use.
- Exposure to the cosmetic product.
- Exposure to the substances.
- Toxicological profile of the substances.
- Undesirable effects and serious undesirable effects.
- Information on the cosmetic product.
Two of these are common stumbling blocks. Items 2 and 3 depend on test data, which we cover in our guide to stability and preservative challenge testing. Items 1, 4 and 8 depend on raw-material paperwork, which is why our guide to the 16 sections of a Safety Data Sheet is useful reading before the assessment starts. The Commission guidelines add that Part A information may be stored in different places and that the report can point to documents rather than reproduce them, so a well-organised file matters.
Part B: The Four Headings
This is where the assessor puts their name to a judgement.
The credentials matter legally. Article 10 requires the safety assessment to be carried out by a person holding formal qualifications in pharmacy, toxicology, medicine or a similar discipline, and the report must be kept up to date as new information arises after launch. The Commission guidelines describe the assessment as a weight-of-evidence approach that reviews data from all available sources and considers intended use and expected exposure to each ingredient in the final formulation.
What You Do, and What the Assessor Does
Your job is mostly Part A: give the assessor the final formula, specifications and SDSs, manufacturing and packaging details, stability and microbiology results, intended use and any complaint history. The assessor's job is Part B, and part of that is deciding whether Part A is good enough to rely on. If the data is incomplete, a responsible assessor will ask for more rather than sign. That is why gathering documents before the assessment begins shortens the process so much. For a broader comparison of the safety report with the Safety Data Sheet, see our article on SDS vs CPSR.
Where the CPSR Sits in the PIF
The safety report is the second of the five content areas that Article 11 requires in the Product Information File. It is the largest and most technical one, and its formula and pack must always match the product on sale. See our guide to the Product Information File for the other four.
Common Mistakes
Mistake #1 — Treating Part A as the whole report. A pile of data with no signed assessment is not a complete CPSR.
Mistake #2 — Commissioning Part B before Part A is ready. An assessment built on draft data may need to be redone.
Mistake #3 — Ignoring the warnings section. The label must reflect Part B's statement on warnings and instructions of use.
Mistake #4 — Never updating the report. New information after launch, such as complaints or a formula change, must feed back into the CPSR.
Practical Checklist
- Finalise the formula, pack and intended use before starting the assessment.
- Gather SDSs, specifications, stability and microbiology data for Part A.
- Confirm all ten Part A headings are covered or cross-referenced.
- Check Part B has a conclusion, warnings statement, reasoning and signed credentials.
- Confirm the assessor's qualifications meet Article 10.
- Transfer the Part B warnings and instructions onto the label.
- Set a trigger to review the CPSR when anything changes.
Frequently Asked Questions
Can I write Part A myself?
You can and usually will supply much of the information, but the Commission guidelines say the responsible person and the safety assessor should work together on Part A. The assessor should confirm the data is adequate before relying on it.
Who is allowed to sign Part B?
A person with formal qualifications in pharmacy, toxicology, medicine or a similar discipline, as set out in Article 10. The report must include the assessor's name, address, proof of qualification, date and signature.
Is a CPSR the same as a Safety Data Sheet?
No. An SDS describes a chemical substance or mixture for workplace and transport safety, while a CPSR assesses the safety of the finished cosmetic product for consumers. SDSs from suppliers are inputs to Part A.
Does a CPSR need updating after launch?
Yes. Article 10 requires the report to be kept up to date in view of additional relevant information generated after the product is placed on the market, such as complaints, reformulations or new scientific data.
Final Word
Understanding the two halves changes how you work with an assessor. Instead of handing over a formula and waiting, you can prepare Part A properly, ask sharper questions about Part B, and arrive at a signed report that matches the product you actually sell.
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Sources
- Regulation (EC) No 1223/2009, Annex I — Cosmetic product safety report (as it applies in the UK) — legislation.gov.uk
- Commission Implementing Decision 2013/674/EU on Guidelines on Annex I — legislation.gov.uk
- Regulation (EC) No 1223/2009, Article 10 — Safety assessment — legislation.gov.uk
- Regulation (EC) No 1223/2009, Article 11 — Product information file — legislation.gov.uk
- Related guides on this site: SDS vs CPSR, PIF explained, Stability and challenge testing
This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.