Get a fixed quote

From your formula to a signed file

Before a cosmetic can be sold in the EU, three things have to exist. Registering a product means producing all three, in five steps.

Safety report
A written statement that the product is safe to use, signed by a qualified person.
Product file
The folder of evidence behind the report, kept for ten years and handed to an inspector on request.
Notification
The product entered on the EU's cosmetics portal before it goes on sale.
1

Intake

We work out what your product legally is, then ask you for the documents that are genuinely missing.

2

Screen

Your recipe broken down to single ingredients and checked against the EU's restricted lists.

3

Assessment

The evidence half of the safety report, built from a recipe that is now locked.

4

Signature

The verdict half, signed by a named pharmacist once nothing is outstanding.

5

Custody

We keep the file, and reopen it if the law it relies on changes.

Your part, in the client portal

The rest of this page describes what we do, and there is a lot of it. You do not have to hold any of it in your head. When you register a product with us, our user-friendly client portal holds the list for you and guides you through it step by step:

  1. Sign in with the link we email you. There is no password to set up.
  2. See the documents your product needs, and only those. Each line says why it is on the list. What your product does not need is not there.
  3. Send the letters the portal writes for you. One ready-to-send email per raw-material supplier, one for your manufacturer and one for your packaging supplier. Each names only the documents that party holds, and what a usable one looks like.
  4. Upload each file next to its line, and say who issued it. The page counts what is settled, so you can always see what is left.
  5. Declare the formula: confirm online that the recipe we assess is the one you make.
+

We chase your suppliers

We send the requests and follow up by email and phone until each supplier has sent the document or told us it does not exist. One price per product, however many suppliers.

€190 / product
+

Missing test? We arrange the laboratory

At the laboratory's price, nothing added. Most often the preservative challenge test, with a laboratory accredited for that test.

At cost

Both are optional lines on your quote. See the prices →

“It took me less than an hour.”

Xavier R., client
Illustrative product fileAloe vera gelLeave-on · EU markets
  1. Documents
  2. Safety assessment
  3. Product Information File
  4. CPNP notification
  5. Ready to sell in the EU
Next actionFile the preservative challenge test

See why it is needed and add the document to this product’s file.

Document progress6 of 8 settled

1 received, awaiting review · 1 missing

Certificate of AnalysisReceived · awaiting review

About an hour of your time, if your manufacturer already has the papers.

The signed safety report usually within 3 working days of the last document, once the formula is declared. If a document has to be replaced, the 3 working days start again when it arrives.

Step 1

Intake

We work out what your product legally is, then ask only for what is missing.

First we work out what your product legally is — a cosmetic, or something else. A biocide or a medicine is a different regime with different rules, and we will not write a cosmetic safety report for one.

Then we send you a document request written for your product. If your gel needs a preservative-efficacy test, it is on the list; if it does not, it is not there. We never quote a requirement to your manufacturer from memory — only from the official register, with the source next to it.

Step 2

Screen

Art. 14 · 19(1)(g)

Your recipe broken down to single ingredients and checked against the EU's restricted lists.

We take your recipe apart until every line is a single ingredient with a percentage next to it. Blends get opened up too. Where a supplier will not say what is in a material, we record that it is unknown rather than guessing.

That list is then checked against the EU's lists of prohibited and restricted ingredients (Annexes II–VI, Art. 14), using the versions in force on the date you plan to start selling — not today's, if those differ.

We also build the ingredient list for your label in the descending order of weight the law requires (Art. 19(1)(g)), and read your marketing copy against the six rules the EU sets for cosmetic claims (Reg. (EU) 655/2013).

Step 3

Assessment

Art. 10(1)

The evidence half of the safety report, built from a recipe that is now locked.

Part A is the evidence — every piece of safety data about what is in your product, and how much of it a person is exposed to (Art. 10(1)). Before we start, the recipe is locked, so the report cannot end up describing a version you have since changed.

Every scientific figure in it is a line a person has checked. Software drafts the text from that locked set of figures, and a second pass deletes any sentence that cannot be traced back to one. Software drafts; a pharmacist signs.

Step 4

Signature

Art. 10(2)

The verdict half, signed by a named pharmacist once nothing is outstanding.

Part B is the verdict — the judgement that the product is safe to use, which is the part that carries a signature. It is signed by David Vandevoort, pharmacist (Master, KU Leuven; PhD, KU Leuven 2010). The law says this has to be signed by someone holding a named qualification (Art. 10(2)), and pharmacy is on that list.

The signature only comes after the file is complete: every ingredient identified, every piece of safety data confirmed, the safety margin worked out — the gap between how much a person absorbs and how much is known to be harmless — and the register checked by a person rather than a script. When something is still outstanding, it is almost always one document, and we tell you which one.

Once signed, the assessment cannot be edited. Changing the product means a new one.

Your choice Art. 4(1)

The Responsible Person: yours or ours

Every cosmetic on the EU market needs a Responsible Person: a named person or company established inside the EU (Art. 4(1)). Their address goes on the pack, the authorities write to them, and answering for the product is their duty. Which way fits depends mostly on where your company is.

You take the role yourself

  • Only if your company is established in the EU
  • The lower yearly fee: we keep your file and watch the register
  • Your address on the pack; the authorities and inspectors come to you

You appoint us, in writing

  • For a company outside the EU, or one that prefers not to carry the role
  • The higher yearly fee: the role as well as the file
  • The designated Responsible Person’s address on the pack; authorities contact that Responsible Person

What each one costs →

Step 5

Custody

Art. 11(1) · 13(1)

We keep the file, and reopen it if the law it relies on changes.

We keep the file

We assemble the file with a contents page, a fingerprint for every document so you can show none of them were altered afterwards, and a written list of anything still missing. It has to be kept for ten years after the date on which the last batch was placed on the market (Art. 11(1)).

We also fill in the EU notification, which goes on the Commission's cosmetics portal (CPNP) before the product goes on sale (Art. 13(1)). Submitting it is the Responsible Person's act — so we do it if you have appointed us, and you do it if you have not.

We watch the law

After that, we re-read the EU register every day. This part does not depend on who the Responsible Person is — it runs while we hold your file, whether the role is ours or yours.

Nothing is acted on automatically. A register change becomes something we act on only once a person here has read it and accepted it under their own name, so you are never chased about a rule a script misread overnight. When an accepted change touches one of your products, we screen that product again and write to you with what it means for it — including whether the safety assessment has to be reopened. Being told is part of what you already pay; reopening the assessment, if it is needed, is a separate line.

Questions people ask

Can a pharmacist sign a CPSR?

Yes. A CPSR is the Cosmetic Product Safety Report — the document described above. Art. 10(2) says the person signing it must hold a qualification in pharmacy, toxicology, medicine or something comparable. Pharmacy is named in the law itself.

What exactly do I have at the end?

A signed safety report in two parts, a product file with a contents page and a fingerprint for every document in it, an ingredient list ordered the way the label rules require, and the EU notification either submitted or ready to submit. If anything is still missing, it is written down rather than glossed over.

How long will it take?

Once the last document is in and the formula is declared, the signed safety report usually follows within 3 working days. Before that point, the waiting is almost always for a document from your manufacturer, not for the assessment. Your own time in the portal is about an hour if your manufacturer already has the papers. The quote sets out the order of work: what is already in hand, what is still missing, and who has it.

What if a test has never been done?

Then it has to be done first: the 3 working days start once every document exists. The preservative challenge test has the longest lead time of any document, so the portal puts it at the top of your list. If you have no laboratory, we arrange the test with one accredited for it and pass on its price with nothing added.

What if a document is missing?

We tell you in writing which document it is, why the file needs it, and who usually holds it — most often your manufacturer or a supplier. The signature follows once that document is in the file. You are not charged for a signature you did not get.

Sources
Reg. (EC) 1223/2009 Art. 4Art. 4(1)Art. 10Art. 10(1)Art. 10(2)Art. 11Art. 11(1)Art. 11(3)Art. 13(1)Art. 14Art. 19(1)(g)Annex IAnnexes II–VI
Reg. (EU) 655/2013 Annex

Tell us the product, the variants and the markets — a fixed quote in writing.