The CPSR your retailer asked for — signed by a pharmacist in Belgium
Launching a cosmetic in the EU or responding to a retailer’s document request? Get a fixed quote for your safety assessment, product information file and CPNP notification preparation. David Vandevoort, a Belgian pharmacist, carries out the assessment and signs when the evidence supports it.
You receive a product-specific document checklist and a written scope before work starts. Notification preparation is included; submission is the designated Responsible Person’s act (Art. 13(1)).
We do not take products for the eye area or lashes, children under three, peels, or products presented as lightening or whitening the skin. We confirm the product scope before opening a file.
Before a cosmetic product is placed on the EU market, the responsible person has to ensure it has undergone a safety assessment and that a cosmetic product safety report (CPSR) is set out in accordance with Annex I (Art. 10(1)). The safety assessor, the person who signs, must hold a qualification under Art. 10(2). Here, that is David Vandevoort, pharmacist.
The document a retailer asks for is the cosmetic product safety report. It never arrives alone. Registration is four obligations that come together.
The words, in plain terms
CPSR — cosmetic product safety report: the document, in two parts, Part A and Part B (Annex I).
Safety assessment — Part B: the qualified person's reasoning and conclusion on the safety of the product.
Safety assessor — the person who carries out the assessment and signs it: a university qualification in pharmacy, toxicology, medicine or a similar discipline (Art. 10(2)).
A section-by-section walk through both parts is in A CPSR example, section by section.
The four things
A Responsible Person — a person designated in the Union (Art. 4(1)). Not a document.
A safety report — before the product is placed on the market (Art. 10), contents set by Annex I.
A product information file — held for ten years after the last batch (Art. 11).
A notification — submitted through the CPNP by the responsible person (Art. 13(1)).
Without a person designated in the Union there is no one who can hold the file or make the notification. How Art. 4 places the role →
We can be appointed as your EU Responsible Person, by written mandate. Registration covers the safety report and the file. Custody — keeping the file and watching the registers after that — is a yearly line. What each costs →
What you get
One product taken from intake to a signed Part B. David Vandevoort, pharmacist (Master, KU Leuven; PhD, KU Leuven 2010), signs it. Software drafts; he signs. If a document is missing, we name it, and the signature follows once it is in the file.
The file is assembled with an index, hashes and a written gap list. The CPNP submission is prepared for filing — the filing itself is the responsible person's act.
Document by document, you receive:
- The signed CPSR — Part A and Part B.
- The product information file — indexed, with hashes.
- A written gap list — what is missing, the article that requires it, and who holds it.
- The CPNP notification, prepared for filing.
What stops a signature
A report that cannot be established is refused, not padded — you pay for the finding, not the signature. A report is not signed here when:
- a substance cannot be resolved;
- a restricted substance is outside the condition in force for that product type;
- a toxicological endpoint is a placeholder no one has accepted;
- a margin of safety falls below the threshold and Part B does not address it;
- the registry the screen ran against has not been reviewed by a person;
- the composition is a range too wide to assess.
In each case you get the finding, and the signature follows once the file can support it. The full list, with the reasons →
One product, and its variants
The Regulation sets no variation count; what decides it is the flattened composition — the product taken down to substance level. A colour change is often within one assessment; a fragrance change usually is not. You are told which of your variants are which before you commit.
The three bands
Registration is priced in three bands, by how hard the product is to assess safely: Simple €345, Standard €665 and Complex €1,015 at founding prices (list €495, €950 and €1,450). What each band covers →
How long it takes
Two clocks, and only one of them is ours. One is getting the raw-material documents out of your suppliers — specifications, certificates of analysis, allergen statements, the GMP statement. That is where almost all of the elapsed time goes. The other is the assessment, which starts when the last document lands: the signed safety report usually follows within 3 working days of the last document, once the formula is declared. The quote lists which documents are outstanding and who holds each one.
Our user-friendly client portal keeps the document clock short. It shows the documents your product needs, and only those, each with the reason and an upload next to it, and the document request is written so you can forward it to your manufacturer as it is. If your manufacturer already has the papers, your part takes about an hour.
- Documents
- Safety assessment
- Product Information File
- CPNP notification
- Ready to sell in the EU
See why it is needed and add the document to this product’s file.
1 received, awaiting review · 1 missing
“It took me less than an hour.”
Questions people ask
What is the difference between a CPSR and a safety assessment?
The CPSR is the whole report, Part A and Part B (Annex I). The safety assessment is Part B: the qualified person's reasoning and conclusion.
Who is a safety assessor?
The person who carries out the assessment and signs it, holding a university qualification in pharmacy, toxicology, medicine or a similar discipline (Art. 10(2)).
Can a pharmacist sign a CPSR?
Yes. Art. 10(2) names pharmacy, toxicology, medicine or a similar discipline.
Does this hold up to an inspection, or have I bought a PDF?
What an authority asks for is the file, kept readily accessible at the address on the label (Art. 11(3)). Ours has an index, hashes and a written gap list. Gaps are listed, never estimated.
Tell us the product, the variants and the markets — a fixed quote in writing.