A CPSR is only worth the paper it is written on if the right person signed it. Brands often ask about cosmetic safety assessor qualifications after a supplier, a retailer or an authority questions who actually stands behind their report. This guide explains who may sign a cosmetic product safety report in the EU, what the law requires of that person and how to check a candidate before you hire one.
Contents
- The short answer
- What does the regulation actually say?
- Which diplomas count?
- Education is not the same as competence
- What the signature means
- Can the responsible person sign their own CPSR?
- Does the assessor have to be based in the EU?
- How to check an assessor before you hire
- Red flags
- How our CPSR is signed
- What if the assessor leaves or changes?
- Frequently asked questions
- Key takeaways
The short answer
In the EU, the safety assessment must be carried out by a person who holds a diploma or other evidence of formal qualifications awarded after 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. This rule is in Article 10(2) of Regulation (EC) No 1223/2009. There is no exam, licence or official register for safety assessors, so the responsibility for choosing a competent person sits with you as the responsible person.
What does the regulation actually say?
Article 10 requires a safety assessment before a product is placed on the market, and it requires the result to be written in a cosmetic product safety report following Annex I. Paragraph 2 then sets out who may do the work: the qualification described above. The wording is about the level and field of the education, not about a job title. A “safety assessor” is therefore not a protected profession. It is a role defined by the diploma and by the competence to carry out the assessment properly.
The Commission’s guidelines on Annex I, in Implementing Decision 2013/674/EU, add practical expectations for the content of Part B. They are the best reference for how an assessor should reason and document a conclusion.
Read also What Information Does a Safety Assessor Need From You?
Which diplomas count?
The text names pharmacy, toxicology and medicine, followed by “a similar discipline”. In practice, assessors often come from:
- Pharmacy or pharmaceutical sciences.
- Toxicology or a related life-science field.
- Medicine or dermatology.
- Chemistry or biochemistry with a strong toxicology component.
Whether a particular degree counts as “similar” is a judgement. If the diploma comes from outside the EU, the Member State recognition wording in the regulation matters, so ask the assessor how the qualification is recognised.
Education is not the same as competence
The diploma is the legal minimum. It does not prove that the person can assess a cosmetic. A good assessor combines the formal degree with:
- Working knowledge of the cosmetics regulation, its annexes and the SCCS Notes of Guidance.
- Experience reading ingredient toxicology and calculating margins of safety.
- Understanding of formulation, preservation, packaging and how products are really used.
- The habit of documenting reasoning, not only conclusions.
This is why a diploma alone is not enough when you compare candidates. It is also fair to ask how the assessor keeps up to date, because annexes, restricted substances and guidance change every year, and an outdated assessment can fail even if it was correct when it was signed.
What the signature means
Part B of the report ends with the assessor’s credentials and approval. Under Annex I this includes the assessor’s name and address, proof of their qualification, the date and their signature. By signing, the assessor states that the product is safe under normal or reasonably foreseeable conditions of use, based on the evidence in Part A. The legal duty to place only safe products on the market still stays with the responsible person, so the signature supports your accountability, it does not replace it.
Read also CPSR Part B Explained: How the Assessor Reaches the Safety Conclusion
Can the responsible person sign their own CPSR?
The regulation does not forbid it, as long as that person truly holds the required qualification and has the skills. In practice most brands use an independent assessor, for three reasons. First, few founders hold the degree. Second, an independent view is more convincing to an authority or a retailer. Third, a small brand rarely has the time to follow every update of the annexes. If you do qualify, keep in mind that self-review is a weaker control than a second pair of eyes.
Does the assessor have to be based in the EU?
The regulation requires an EU-based responsible person, but it does not say the assessor must live in the EU. What matters is the qualification and that the assessor can work with your documentation. If the assessor is outside the EU, check that the report is written in a language accepted by the authorities where you sell, that the diploma is verifiable and that the assessor is reachable if an inspection raises questions. For Great Britain, a comparable rule exists in its own regulation, so confirm the details for that market separately.
How to check an assessor before you hire
- Ask for the diploma or a certified copy. It must be named in Part B anyway.
- Ask for a sample, anonymised Part B. Look for clear reasoning, not copy-paste text.
- Check experience with your product type. A sunscreen, a baby product and a hair dye raise different questions.
- Clarify who handles questions from authorities. The assessor should still be available years later.
- Check how updates are handled. Formula changes need a documented review.
Read also What Is a CPSR? Cosmetic Product Safety Report Explained
Red flags
- No name, qualification or signature on Part B, or only a company stamp.
- A report delivered without asking for your formula, specifications or test data.
- The same generic text in every report, with no product-specific reasoning.
- A promise to sign without any test data for a water-based product.
- No answers when you ask about the assessor’s background.
How our CPSR is signed
Our CPSR is signed by a qualified safety assessor and includes both Part A and Part B. We prepare it about 10 business days after we receive complete data, with three tiers by formula complexity: Simple, Standard and Complex. The report builds on stability, microbiological and, for water-based products, challenge test data, so ordering the tests together with the report keeps your file consistent. We do not give legal advice, so your responsible person duties remain yours.
What if the assessor leaves or changes?
The report belongs to the product information file, which you must keep for ten years after the last batch is placed on the market. If your assessor retires or you change provider, keep the original signed report, because it documents the state of knowledge at the time. A new assessor can review and, where needed, update it. Make sure your contract says who will answer authority questions about earlier versions.
Frequently asked questions
Is there an official list of approved cosmetic safety assessors?
No. The EU does not keep a register. The regulation defines the qualification, and the responsible person must be satisfied that the assessor meets it.
Can a cosmetic chemist or formulator sign a CPSR?
Only if they also hold a qualification of the type required by Article 10(2) and have the toxicology competence. A formulation background is valuable, but it is not automatically the same as a degree in pharmacy, toxicology or medicine.
Does the assessor need insurance or a licence?
The regulation does not require either for the assessor. Responsible persons often ask for professional liability cover as a business precaution, and that is a matter for your contract.
Key takeaways
- Article 10(2) requires a university-level qualification in pharmacy, toxicology, medicine or a similar discipline.
- There is no licence or official list, so you must check the assessor yourself.
- Part B must show the assessor’s name, address, proof of qualification, date and signature.
- Choose someone with real product experience, not only a diploma.