Cosmetic Testing Lab in Europe: A Guide for Non-EU Brands

You make cosmetics in the US, the UK, Korea, Turkey or anywhere else, and you want to sell in the European Union. Sooner or later someone tells you that you need “EU testing”. Do you have to use a cosmetic testing lab in Europe, and which tests does the EU file actually need? The short version: EU law does not require tests to be carried out in Europe, but your test data must satisfy an EU safety assessor, and a European lab that tests to recognised ISO methods and writes reports for the CPSR makes that much simpler. This guide is written for non-EU brands planning their first EU launch.

The short answer

Before a cosmetic can be sold in the EU, it needs a responsible person established in the EU, a cosmetic product safety report (CPSR) signed by a qualified safety assessor, a Product Information File and a notification in the CPNP. The safety assessor typically asks for stability, microbiological and, for most water-based products, challenge test data. Where those tests are done is your choice; what matters is that the methods, the report format and the product tested match what the assessor needs.

What EU law asks of a brand based outside the EU

• A responsible person (RP) in the EU. Regulation (EC) No 1223/2009 only allows cosmetics on the market if a person established in the EU is designated as responsible person. For imported products, the importer is the RP unless another EU-based person is designated in writing.
• A safety assessment. The CPSR, Part A with the data and Part B with the assessor’s conclusion.
• A Product Information File (PIF). Kept by the RP at the address on the label, in a language the national authorities can readily understand.
• CPNP notification before the product is placed on the market.
• Good manufacturing practice, usually shown with reference to ISO 22716, including for factories outside the EU.
• EU labelling, including the RP’s name and address and, for imported products, the country of origin.

Read also Cosmetic testing process in Cosmetic Testing Lab (from start to finish)

Do the tests have to be done in Europe?

No. The Regulation sets out what the safety assessment must cover, not where the laboratory must be. A competent lab anywhere in the world can produce valid data. In practice, though, non-EU brands often run into three problems with reports from home: the method is not the one the assessor expects (for example a pharmacopoeia method where ISO 11930 is preferred), the report lacks details the assessor needs, or the tested sample is not the final formula in the final packaging. Testing with a lab that works for the EU market every day removes most of that friction.

Which tests an EU safety assessor usually expects

• Stability and compatibility test. Shows the product stays stable under reasonably foreseeable storage conditions and is compatible with its packaging. It also supports the date of minimum durability or the PAO on the label.
• Microbiological specifications test. Confirms the microbiological quality of the finished product.
• Challenge test. Proves the preservative system works. Usually needed for water-containing products; low-risk products may be exempted by the assessor on a documented basis.
• Claim support. Any claim you make must be backed by evidence in the PIF. A patch test on volunteers is a common way to support skin tolerance wording; it is not a legal requirement in itself.

Animal testing is not an option: the EU bans animal testing of cosmetics and the sale of cosmetics tested on animals to meet the Regulation’s requirements.

Can you reuse tests you already have?

Often, partly. A stability study run on the same formula and the same packaging may be accepted if the report is complete. A challenge test done to USP 51 for the US market is accepted by some assessors and questioned by others, who prefer ISO 11930. Microbiological results are batch-specific and are usually repeated on current production. Send your existing reports to your safety assessor first and ask which ones can stay. At Cosmetic Testing Lab you can order the challenge test to ISO 11930:2019 or USP 51, so one test can serve both markets if your assessor agrees.

Read also How to Choose a Cosmetic Testing Lab: A Practical Guide

Shipping samples to a European lab from outside the EU

• Send the final formula in the final packaging, with batch numbers matching your file.
• Your courier will usually ask for a pro forma invoice that describes the goods as cosmetic samples for laboratory testing. Check local export rules with the courier.
• Declare aerosols, alcohol-rich products and other flammable items correctly; couriers have special rules for them.
• Pack against heat, cold and leaks, and allow extra days for customs.

When you order online, we arrange free DHL pickup from your door, so you do not need to book the shipment yourself.

Working with your responsible person

Agree early who orders the tests, who receives the reports and who assembles the PIF. Many brands order tests themselves and forward the signed PDFs to the RP and the safety assessor. Whatever you choose, the RP must end up with a complete file, because the RP is accountable to the authorities. A testing laboratory does not become your RP by testing your products; that is a separate role with its own contract.

Language and format of reports

The PIF must be in a language easily understood by the competent authorities of the member state where the RP is based, and English is accepted in many member states. Check with your RP. Reports should name the product, the batch, the method and edition, the results against acceptance criteria and carry a signature. Our reports are delivered as signed PDFs designed to be used directly in the CPSR and PIF.

Read also How to Send Cosmetic Samples to a Lab: A Step-by-Step Guide

Selling in the UK as well?

Great Britain has its own regime after Brexit: a UK responsible person, notification in the UK portal and a UK safety report. The science is very similar, so the same stability, microbiological and challenge test reports can usually support both files. Confirm with each safety assessor.

Plan the timeline backwards

1. Fix the formula and packaging.
2. Start the stability test first; it is usually the longest step.
3. Run the challenge test (28 days) and the microbiological test (about five days after we receive samples) in parallel.
4. Give all data to the safety assessor; our CPSR takes about 10 business days after complete data.
5. Your RP notifies the CPNP, and you finalise the labels.

Common mistakes non-EU brands make

• Testing a lab prototype instead of the final formula in final packaging.
• Assuming a US or home-market file is automatically valid in the EU.
• Forgetting that ingredients must also comply with the EU annexes.
• Leaving the RP out until the end.
• Making claims on the label that no test or data supports.

Frequently asked questions

Do I need a company in the EU?

You need a responsible person established in the EU. That can be your importer, a distributor or a specialised RP service; it does not have to be your own company.

Can I order tests from outside Europe?

Yes. You order online, we arrange the sample pickup and you receive signed PDF reports by email.

Is a CPSR from my home country enough?

Only if it is an EU-compliant CPSR covering Annex I, signed by a qualified assessor and based on ingredients permitted in the EU.

Key takeaways

• EU law does not require tests in Europe, but the data must meet EU assessor expectations.
• Stability, microbiological and, for most water-based products, challenge tests form the core.
• You need an EU responsible person, a CPSR, a PIF and a CPNP notification.
• Test the final product in final packaging and start stability first.