If you are preparing a cosmetic product for the EU market, one question decides whether your paperwork stands or falls: who can write a CPSR? The honest answer is split in two: anyone competent can help gather the safety data, but the safety assessment itself — Part B of the report — may only be carried out and signed by a person holding specific university qualifications laid down in EU law. Regulation (EC) No 1223/2009 leaves no room for improvisation, and market surveillance authorities check assessors’ credentials during inspections.
This article explains what Article 10(2) requires, who may compile Part A versus sign Part B, what “a similar discipline” means in practice, what a real safety assessor does beyond signing, and the red flags of a worthless cheap report. New to the document itself? Start with our guide to the Cosmetic Product Safety Report.
Key takeaways
- Article 10(2) requires the safety assessment (CPSR Part B) to be done by someone with a university diploma — or recognised equivalent — in pharmacy, toxicology, medicine or a similar discipline.
- Anyone competent can compile the Part A safety data, but only a qualified safety assessor may perform and sign the Part B assessment.
- “Similar discipline” is interpreted by individual Member States — chemistry and biology backgrounds are often accepted, but not automatically everywhere.
- A real assessor does scientific work: toxicological profiles, margin-of-safety calculations, chasing missing data and imposing usage warnings.
- No named assessor, no diploma evidence, no questions asked about your formula, or instant delivery are classic signs of an invalid template CPSR.
- The assessor’s role is ongoing: the CPSR must be kept up to date, so formula or claim changes should go back for review.
What Article 10(2) of the Cosmetics Regulation requires
Article 10(2) of Regulation (EC) No 1223/2009 states that the safety assessment must 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.
Three details matter. First, the qualification must be a completed formal award: formulation experience, industry short courses or an unfinished degree do not satisfy the article, however knowledgeable the person is. Second, the course must combine theoretical and practical study. Third, the article builds in mutual recognition: a qualifying diploma from one Member State is accepted across the Union, and a third-country qualification can qualify where a Member State recognises the course as equivalent. A UK, Swiss or US toxicology degree can therefore be acceptable — provided that recognition is confirmed rather than assumed.
Part A and Part B: gathering data is not assessing it
Annex I of the Regulation splits the CPSR in two, and the qualification requirement attaches to only one part. Part A is the safety information: the full composition, physicochemical and microbiological specifications, stability, impurities, packaging, normal and foreseeable use, exposure estimates, substance toxicology and undesirable-effects records. Compiling Part A is demanding, but it is data-gathering — a brand owner or manufacturer’s team can lawfully assemble it. Our checklist of the documents needed to order a CPSR maps almost one-to-one onto Part A.
Part B is the safety assessment: the reasoned conclusion on whether the product is safe, the warnings and instructions of use for the label, the scientific reasoning, and — explicitly required by Annex I — the assessor’s name, address, proof of qualification, signature and date. Only a qualified safety assessor may carry out and sign this section. That is why a brand owner cannot “self-assess”: without the Article 10(2) qualification, a signature on Part B has no legal effect and the product is non-compliant the moment it goes on sale.
What counts as a “similar discipline”?
The Regulation deliberately does not define “a similar discipline”; interpretation sits with the Member States. In practice, degrees in chemistry, biochemistry, biology and pharmaceutical sciences are widely treated as similar disciplines, particularly when combined with recognised postgraduate training in cosmetic safety assessment or toxicology. Because the judgement is national, acceptance varies at the margins; a prudent assessor can show why their qualification satisfies Article 10(2) in your target markets.
Note: The qualification attaches to the person, not the company. A consultancy cannot be “qualified” as an entity — every CPSR must name the individual assessor and evidence their diploma. If a provider will not tell you who will sign your report, that alone is reason to walk away.
What a good safety assessor does beyond signing
The signature is the last step of a substantial piece of scientific work. A competent assessor will typically:
- Build a toxicological profile for each substance, covering local effects (irritation, sensitisation) and systemic effects against the exposure your product creates.
- Calculate the margin of safety (MoS) for relevant ingredients, comparing the no-observed-adverse-effect level with estimated systemic exposure for your product type — a margin of at least 100 is the conventional benchmark.
- Scrutinise impurities and traces, including whether prohibited substances present as traces are technically unavoidable and safe.
- Request missing data rather than work around it — stability evidence, microbiological and preservation-efficacy (challenge) testing where needed, and supplier documentation.
- Impose warnings and restrictions where the science demands: “avoid contact with eyes”, age limits, patch-test advice or rinse-off instructions, which must then appear in your labelling.
- Assess more conservatively for vulnerable users — children under three, eye-area or mucous-membrane products — following the SCCS Notes of Guidance.
An assessor who never sees your full formula at exact percentages, never asks a question and never adjusts a warning has not performed a safety assessment. They have decorated a template.
Red flags when buying a cheap CPSR
A persistent grey market sells low-cost “CPSRs” that look plausible until an authority reads one. Price alone is not the problem — a simple rinse-off product genuinely costs less to assess than a children’s leave-on cream, and our guide to how much a CPSR costs explains the legitimate range. The problem is what a rock-bottom price often pays for.
| Attribute | What acceptable looks like | Red flag |
|---|---|---|
| Assessor identity | Named individual in Part B, with address and diploma evidence | No named assessor, or a company name in place of a person |
| Qualifications | Degree in pharmacy, toxicology, medicine or a similar discipline, shown on request | Vague claims of “experience”; refusal to show the diploma |
| Questions about your formula | Requests the full quantitative formula, supplier documents and test data | No questions asked; report built from a product name and INCI list |
| Turnaround | Days to a few weeks, depending on data completeness and risk | Instant or same-hour delivery |
| Scientific content | Product-specific MoS calculations and toxicological reasoning | Generic boilerplate identical across unrelated products |
| Warnings and labelling | Warnings derived from the assessment and checked against your label | No label review; template warnings regardless of formula |
Warning: A CPSR whose Part B was not signed by a person meeting Article 10(2) is not a weak report — legally it is no safety assessment at all. The product is non-compliant, the Responsible Person carries the liability, and authorities can order withdrawal or recall, exactly as if no CPSR existed.
What to check before you hire — and when your formula changes
Before commissioning an assessment, ask four things. Who signs: the individual assessor’s name and qualification, verifiable against the diploma evidence in Part B. Professional standing: whether the assessor carries professional indemnity insurance and can point to assessments accepted by authorities. Scope: whether the service reviews your label against the Part B warnings and checks that required testing exists — a provider that also reviews the surrounding file, like our PIF review service, catches gaps a bare assessment misses. Process: a credible assessor explains what data they need before quoting a deadline.
The relationship should not end at delivery. The Regulation requires the CPSR to be kept up to date in the light of new relevant information — a preservative swap, a new supplier, a new claim or a shift from rinse-off to leave-on use all belong back on the assessor’s desk. Some changes need only an addendum; others trigger a fresh assessment — and if you sell shades or scents of one base, see when a separate CPSR is required for cosmetic variants. For a full range launch, bundling assessment, notification and labelling through a Full Compliance Pack is usually cheaper than fixing each piece separately.
Bringing it all together
EU law is precise about who can sign a CPSR: Part B must be carried out by a person with a completed university qualification in pharmacy, toxicology, medicine or a similar discipline, with equivalence for other diplomas decided at Member State level. Anyone competent can assemble Part A, but the assessment, warnings and signature belong to a qualified safety assessor — which is why brand owners cannot self-certify and an anonymous instant report protects no one.
Lexora’s CPSR service is built around exactly this standard: a named, qualified assessor whose credentials appear in Part B, a product-specific toxicological assessment, and clear requests for whatever data your file is missing before anything is signed. To see the process end to end, read how to get a CPSR for your cosmetic product — a complete data pack is the biggest factor in how quickly a legitimate assessment can be delivered.
Frequently asked questions
Can I write my own CPSR for my cosmetic brand?
Only if you personally hold a qualifying university diploma in pharmacy, toxicology, medicine or a similar discipline. You may compile the Part A data yourself, but Part B must be signed by a person meeting Article 10(2), so most brand owners commission an external safety assessor.
Does a safety assessor have to be based in the EU?
No — the requirement concerns the qualification, not the assessor’s address. A diploma from one Member State is recognised across the EU, and a third-country qualification can be accepted where a Member State recognises the course as equivalent, so ask a non-EU assessor to evidence that recognition.
Is a chemistry degree enough to sign a CPSR?
Often, but not automatically. Chemistry and biology are commonly accepted as “similar disciplines”, especially with recognised postgraduate training in cosmetic safety assessment or toxicology — but the judgement rests with individual Member States, so a credible assessor should show why their qualification qualifies.
How can I verify a safety assessor’s qualifications?
Ask for the diploma evidence that will accompany Part B and check it names the individual, the awarding university and a qualifying discipline. Reputable assessors provide this without hesitation; refusal to identify the signing assessor is the clearest warning sign of a template report.
Do I need the assessor again when I change my formula?
Yes. The CPSR must be kept up to date, so ingredient swaps, new suppliers, concentration changes, new claims or changed use should go back to the assessor. Minor changes may need only a signed addendum; significant reformulations require a fresh assessment.
