How to launch a cosmetics brand: seven steps to the shelf.
In the EU, Great Britain and Türkiye, a cosmetic product needs no licence before it is sold. It needs a Responsible Person, tests, a safety report, a product information file and a notification. This guide puts the seven steps in order, from the company to the first sale.
01/Seven steps
From company to shelf, in seven steps.
The order matters: each step needs the one before it. The notification comes last, once the file behind it is complete.
Set up the company and its Responsible Person
Every product needs a Responsible Person established where it is sold. A brand that has its products made and sells them under its own name is the manufacturer in law, and so the Responsible Person if it is established there. Who it can be.
Fix the formula and choose a manufacturer
Manufacture follows good manufacturing practice. Agree in writing which documents the manufacturer hands over for the file. Product files in contract manufacturing.
Run the tests
Stability, microbiological quality and a preservation challenge test, on the final formula in its packaging. What Annex I asks for.
Get the safety report
A qualified safety assessor writes and signs the cosmetic product safety report before the product goes on sale. What a CPSR contains.
Assemble the product information file
The report, the manufacturing method and GMP statement, proof of claims and animal-testing data, kept for ten years after the last batch. How to keep a PIF.
Notify the product
Before the first sale: CPNP for the EU, SCPN for Great Britain, ÜTS for Türkiye. The three portals.
Keep it compliant on the market
Keep the report up to date, report serious undesirable effects, and follow the annexes as they change. Regulatory Watch names the product a change touches.
02/Responsible Person
Who is the Responsible Person? It depends on where it is made.
Article 4(1) allows no product on the market without one. The name and address on the label are theirs, and so are almost all the duties.
You have it made under your name and are established there: you are the Responsible Person. You may appoint someone else by written mandate.
The importer is the Responsible Person, and may appoint someone established there by written mandate.
A distributor who puts its own name or trademark on the product becomes the Responsible Person.
In Great Britain, the Responsible Person must be established in the UK; an EU Responsible Person does not cover GB, and the reverse holds too.
03/Tests
Which tests come first? Three, before the report.
The safety assessor needs the results before writing the report. Part A of the report asks for all three by name.
Stability
How the product holds up in its packaging over time. Annex I asks for “the stability of the cosmetics product under reasonably foreseeable storage conditions”.
Microbiological quality
The microbiological specifications of the raw materials and the finished product, with particular attention to products used around the eyes, on damaged skin or on children under three.
Preservation challenge test
Shows the preservative system holds when the product is contaminated in use. Annex I asks for the results.
04/Notification
Where do you notify? One portal per market.
Notification is not approval: nobody reviews the file before the sale. The Responsible Person notifies, then answers for the file when an authority asks.
The Commission’s free portal. One notification covers the whole EU; no national notification on top.
Submit cosmetic product notifications, run by the Office for Product Safety and Standards, for England, Scotland and Wales.
Ürün Takip Sistemi, TİTCK’s national electronic database. The company registers first; each step is signed electronically.
The label and a photograph of the packaging go in with the notification, so the label is final before you notify.
05/On the market
After the first sale, the file stays open.
Launch is the start of the duties, not the end. Four of them run for as long as the product is sold.
- Keep the product information file for ten years after the last batch, at the address on the label.
- Update the safety report when new information comes in after launch.
- Report serious undesirable effects to the authority without delay.
- Follow the annexes: a tighter limit can reach a product already on sale. Regulatory Watch reads EU, UK and Türkiye sources and names the product it touches.
Questions about launching.
Do I need a licence to sell cosmetics?
No. In the EU, Great Britain and Türkiye, cosmetics are notified, not licensed. The Responsible Person has the product assessed, keeps its file and notifies it before the first sale.
Can my contract manufacturer be the Responsible Person?
Yes, if you appoint them by written mandate and they accept in writing. If the product is sold under your name and you are established in the market, the role is yours unless you appoint someone.
Does an EU notification cover the UK?
No. Great Britain has its own Responsible Person rule and its own notification service, SCPN. One CPNP notification covers the EU only.
Which tests does a new cosmetic need?
At least stability, microbiological quality and a preservation challenge test, since Part A of the safety report asks for them. The assessor may ask for more, depending on the product.
Can Unique Alphabet® be my Responsible Person?
In Türkiye, yes: it is one of our two services, quoted per scope. In the EU and the UK we prepare the product file, and the Responsible Person stays with you.
Start with a formula you already have.
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