Who Can Sign a CPSR? The Assessor Qualifications in Article 10(2)

Who can sign a CPSR, and what do they sign?

At Eldris, a qualified safety assessor signs the CPSR. It has two parts under Annex I: Part A, safety information, and Part B, safety assessment.

Article 10(1) puts a duty on the Responsible Person. Before a cosmetic is placed on the EU market, a safety assessment must be done and a CPSR set up under Annex I. The Responsible Person owns that duty. The assessor carries out the assessment, and the two can be different people. After the CPSR, the Responsible Person notifies the product to the Commission through the CPNP under Article 13.

The CPSR does not travel alone. Under Article 11, the Responsible Person keeps the PIF for ten years after the last batch, and the PIF holds the CPSR. The per-formula fee on the pricing page includes the signed CPSR, both parts, for one formula, whatever the number of ingredients. This guide names no assessor, because the legal test is the qualification and not the name.

What qualifications must the assessor hold?

Article 10(2) names a diploma or formal qualification from a university course in pharmacy, toxicology, medicine or a similar discipline.

The full wording of Article 10(2) adds that the university course is one of theoretical and practical study. A course recognised as equivalent by a Member State also counts. The evidence is a diploma or other evidence of formal qualifications awarded on completing the course. The test applies to Part B, the safety assessment. It is a test of the person's qualification. It does not name a job title or an employer.

Pharmacy, toxicology and medicine are the disciplines the Regulation names. A similar discipline also qualifies, and a Member State may recognise another course as equivalent. Eldris uses the term qualified safety assessor for the person who signs Part A and Part B. Anyone checking a provider's assessor should compare that person's qualification with the Article 10(2) list, not with a job title.

What does the assessor work from?

The assessor works from the formula, the test data and the documents the customer provides. Test reports the customer supplies go into the PIF.

Eldris does not run, arrange or recommend laboratory tests, and they are not in the per-formula fee. Stability, challenge, SPF and microbiology tests are done by a testing laboratory, which sets the price. Eldris asks for a challenge test report (ISO 11930) for products that contain water, not for water-free ones, and the order can start without it. Eldris names no laboratory. After paying, a customer uploads what they have in the Eldris portal, and Eldris says what is still missing.

Under its CPSR and PIF service, Eldris delivers the CPSR and PIF 5–10 working days after complete documents. If the assessor needs more, the question appears in the portal. The 5–10 working days then start again from the day the customer answers. It is a restart, not a pause. The signed CPSR and the PIF arrive in the customer's Eldris portal.

What can a seller ask to see?

Ask for the signed CPSR: Part A and Part B together, with Part B signed by the person who carried out the assessment.

The report sits inside the PIF, which the Responsible Person keeps for ten years after the last batch under Article 11. A seller can therefore ask the Responsible Person, or the provider that prepared the report, for the CPSR from the PIF. The Regulation requires the report to exist before the product is placed on the market. The guide to what a CPSR and PIF contain lists what else the file holds.

Then read the report against Article 10(2). Part B must be present. The person who carried it out must hold a qualification in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent. At Eldris, the answer to who signs is a qualified safety assessor. The short answer is also in the FAQ on who signs the CPSR and which qualifications apply.

Why does the signature matter?

Article 10(2) makes the qualification a condition of Part B. A safety assessment carried out by anyone else does not meet the Regulation.

A marketplace, a retailer or an authority that asks whether a product was assessed properly is asking about this document. Under Article 10(1), the Responsible Person sets up the CPSR before the product is placed on the market. It then stays in the PIF for ten years after the last batch. If Part B was not carried out by a person who meets Article 10(2), the report cannot show that the Regulation was followed. The rest of the file can look complete and make no difference. That is why who can sign a CPSR matters, and not only whether a CPSR exists. At Eldris, a qualified safety assessor signs both parts. A product can carry a full PIF and a label naming a Responsible Person. It can still rest on a safety assessment that fails the Article 10(2) test.

Frequently asked questions

Can a brand owner carry out Part B themselves?

Article 10(2) tests the person's qualification. It does not say who employs that person. Anyone who meets that test may carry out Part B. The Responsible Person must still see that the CPSR is set up under Annex I before the product is placed on the market. Eldris uses a qualified safety assessor.

Is a laboratory report the same as a signed CPSR?

No. A laboratory report is test data. It goes into the PIF, and the assessor uses it with the formula and the other documents for the safety assessment in Part B. Eldris does not run laboratory tests, so a testing laboratory produces the report, and the laboratory sets the price for it.

Do I need a new signature if I change the formula?

A reformulated product needs a new CPSR, priced as a formula, and so a new assessment and a new signature. A new pack size of the same formula adds nothing to the CPSR and PIF.

Does each shade or scent need its own signed CPSR?

Not when it is a variation. A formula is one unique base recipe. Each further shade or scent is a variation that shares the formula's CPSR: a lipstick in 30 shades is 1 formula and 30 products. A new scent can need its own CPSR if the fragrance ingredients change significantly, and a different SPF level usually does.

Is the PIF the same as the CPSR?

No. The PIF is the file the Responsible Person keeps for ten years after the last batch, under Article 11. Among other items, it holds the CPSR, the manufacturing method, a GMP statement and data on any animal testing. The CPSR is one document inside it. At Eldris, the CPSR and PIF arrive together in the portal.

Is a signed CPSR the same as notifying the product?

No. The CPSR is the safety report. The notification is a separate step, made by the Responsible Person to the Commission under Article 13 before the product is placed on the market. At Eldris the CPSR and PIF come first, and Eldris files the EU notification only when it is the EU Responsible Person and the filing is ordered.

Is the Responsible Person service included in the CPSR fee?

No. The Responsible Person is a separate Eldris service, priced per market and then on a monthly plan. The per-formula fee includes the signed CPSR and the PIF for one formula. Laboratory tests are not included either. One appointment per country covers every product type. The fees are on the pricing page.