The EU is one of the largest cosmetics markets in the world, and also one of the most regulated. The good news is that the rules are the same in all member states, so once your product is compliant you can sell it across the whole single market. This checklist explains how to sell cosmetics in the EU step by step, in the order you should actually do things.
Contents
- Before you start: is your product a cosmetic?
- Step 1: check your formula against the annexes
- Step 2: appoint a Responsible Person
- Step 3: produce according to GMP
- Step 4: run the safety tests
- Step 5: get the CPSR
- Step 6: build the Product Information File
- Step 7: label correctly
- Step 8: check your claims
- Step 9: notify in the CPNP
- Step 10: monitor after launch
- Common mistakes new brands make
- How long does it take?
- What does it cost? A budget overview
- Selling from outside the EU
- Selling online and on marketplaces
- What about the UK and Switzerland?
- Your first 30 days
- Acronyms you will meet
- Frequently asked questions
- Key takeaways
Before you start: is your product a cosmetic?
The EU defines a cosmetic as a substance or mixture intended to be placed in contact with external parts of the human body, or with teeth and mucous membranes of the mouth, with a view exclusively or mainly to cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours. Products that claim to treat or prevent disease are medicines or medical devices, and need a very different route. Check your claims first.
Step 1: check your formula against the annexes
Regulation (EC) No 1223/2009 lists banned substances (Annex II), restricted substances (Annex III), colourants (Annex IV), preservatives (Annex V) and UV filters (Annex VI). Every ingredient in your product has to comply, including its maximum concentration and any conditions of use.
Read also Cosmetic Launch Testing Checklist: Tests to Finish Before You Sell
Step 2: appoint a Responsible Person
Every product placed on the EU market needs a Responsible Person established in the EU. This can be you if your company is in the EU, or a service provider if it is not. The Responsible Person guarantees compliance and is the contact point for authorities.
Step 3: produce according to GMP
Cosmetics must be manufactured following good manufacturing practice. Compliance with the harmonised standard ISO 22716 is presumed to meet this requirement. Whether you make products yourself or use a contract manufacturer, ask for proof.
Step 4: run the safety tests
Safety starts in the laboratory. Most products need:
- a stability and compatibility test to set the shelf life and PAO and check the packaging
- a microbiological specifications test to confirm the microbial quality
- a challenge test for products that contain water or otherwise support microbial growth
- a patch test if you want to claim, for example, “dermatologically tested” or “for sensitive skin”
Read also How to Sell Handmade Cosmetics Legally: Soap, Balms and Creams
Step 5: get the CPSR
A qualified safety assessor reviews your formula and test data and issues the Cosmetic Product Safety Report, which is mandatory under Article 10. Do not label or sell the product before it is signed.
Step 6: build the Product Information File
The Product Information File (PIF) contains the product description, the CPSR, the manufacturing method statement and GMP compliance, proof of effects where claimed and data on animal testing. Keep it available at the Responsible Person’s address for ten years after the last batch is placed on the market.
Step 7: label correctly
Article 19 requires, among other things, the name and address of the Responsible Person, the country of origin for imports, nominal content, the date of minimum durability or the period-after-opening symbol, precautions of use, a batch number, the function of the product and the ingredient list in INCI. Labels must be in the language required by the member state where the product is sold.
Read also Cosmetic Distributor Obligations: A Checklist for Retailers
Step 8: check your claims
Commission Regulation (EU) No 655/2013 sets six common criteria for claims: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Every claim on pack, website or social media needs evidence in your PIF.
Step 9: notify in the CPNP
Before the product is placed on the market, the Responsible Person notifies it in the European Cosmetic Products Notification Portal (CPNP). The notification is free of charge and replaces national notifications across the EU. Products containing nanomaterials need an additional notification.
Step 10: monitor after launch
Your obligations continue after the first sale. You must report serious undesirable effects to the authorities, keep the safety assessment up to date and re-assess when a formula, ingredient limit or packaging changes.
Common mistakes new brands make
- ordering packaging and labels before the safety work is finished
- assuming a US or UK approval is valid in the EU
- copying an ingredient list from a competitor without checking the percentages
- forgetting the Responsible Person for sales from outside the EU
- making claims without evidence
How long does it take?
Plan roughly two months if everything goes smoothly: about four weeks for the longest laboratory tests (the challenge test runs for 28 days), then about 10 business days for the CPSR, plus time for labelling and notification. Start the tests as soon as the formula is final.
What does it cost? A budget overview
Compliance is a one-off set of costs per product, with small recurring ones. The main items are the laboratory tests (stability, microbiological, challenge and, if relevant, patch test), the CPSR, the Responsible Person service if you are outside the EU, labelling and notification work in the CPNP, which is free. Prices for the tests and the CPSR are listed openly on their product pages, so you can estimate your total before you commit. Create a free account to unlock 10% off your first order and 20% on bundles.
Selling from outside the EU
If you manufacture outside the EU, someone established in the EU must take legal responsibility. For imported products, the importer is the Responsible Person by default, although it may designate another person in writing, such as a specialised service provider. The Responsible Person’s name and address must appear on the label. Make sure the arrangement is in place before shipping any stock to the EU.
Selling online and on marketplaces
Distance sales are treated exactly like shop sales. Product pages must carry the information the law requires, claims must be supported, and marketplaces may ask for your CPNP number, CPSR or Responsible Person details before approving a listing. Prepare the documents before you create the listing.
What about the UK and Switzerland?
After Brexit, the UK has its own system with a UK Responsible Person and its own notification, and Switzerland has a similar but separate framework. Your CPSR is a good starting point for both, but do not assume that the EU notification covers them.
Your first 30 days
- Week 1: finalise the formula and check it against the annexes.
- Week 1: appoint the Responsible Person and find a GMP manufacturer.
- Week 1–2: send samples for stability, microbiological and challenge tests.
- Weeks 2–4: collect documents and draft labels while the tests run.
Acronyms you will meet
- RP: Responsible Person, the EU-based company legally responsible for the product.
- CPSR: Cosmetic Product Safety Report, the mandatory safety assessment.
- PIF: Product Information File, the folder that holds the CPSR and the other proof.
- CPNP: Cosmetic Products Notification Portal, the EU database for notifications.
- INCI: the international naming of cosmetic ingredients used on labels.
- PAO: period after opening, the open-jar symbol on the pack.
- GMP: good manufacturing practice, as described in ISO 22716.
Frequently asked questions
Do I need a licence to sell cosmetics in the EU?
No licence is needed, but you do need a Responsible Person, a CPSR, a PIF, correct labels and a CPNP notification.
Can I sell on a marketplace without the documents?
No. The legal requirements apply to online sales exactly as they do to shops, and marketplaces increasingly ask for proof.
Do I need to repeat everything for each EU country?
No. The single notification and safety assessment are valid across the EU. Only the label language changes.
Key takeaways
- Check the formula, then appoint a Responsible Person.
- Run stability, microbiological and (if needed) challenge tests.
- Get a CPSR, build the PIF, label correctly and notify in the CPNP.
- Start early: laboratory time is the main bottleneck.