Import Cosmetics Into the EU: Registering a Non-EU-Made Product

Who is the Responsible Person when you import cosmetics into the EU?

For an imported cosmetic, each importer is the Responsible Person for the product it places on the market (Article 4(5)), and may instead designate an EU person to hold the role by written mandate.

Without a Responsible Person designated within the EU, the cosmetic may not be placed on the EU market (Article 4(1)). The importer and the Responsible Person can be the same company or two companies. A seller based outside the EU needs an EU Responsible Person, and a business established in the EU can hold the role itself.

Eldris offers the EU Responsible Person as a separate service, priced per market, so it is not part of the formula fee. One appointment per country covers every product type. Articles 10, 11 and 13 then place the safety report, the Product Information File and the notification on the Responsible Person, whose name and address go on the label. The Responsible Person also keeps the PIF for ten years after the last batch is placed on the market (Article 11).

What goes on the label of an imported cosmetic?

The container and packaging carry the name or registered name and address of the Responsible Person (Article 19(1)(a)), so the label shows who holds the role in the EU.

With Eldris as your EU Responsible Person, your label carries EldrisAi OÜ, Ruunaoja tn 3, 11415 Tallinn, Estonia, while your monthly plan runs. Because the label shows the address, the appointment is settled before the label is printed. The formula fee includes an Article 19 label review.

If you cancel the plan, which you can do at any time, effective at the end of the billing period, the appointment ends. Eldris's details must then come off your labels and listings within 30 days. As a rule, the label also shows the nominal content and a batch number or a reference identifying the product, and it carries the date of minimum durability or, where the rule allows, the period after opening (Article 19(1)). Article 19 has exceptions for small products, so read each point in full. The ingredients list may be given on the packaging alone (Article 19(1)(g)).

Which foreign registrations and documents carry over?

Articles 4(1), 10(1) and 13(1) each apply before a cosmetic is placed on the EU market, so the EU Responsible Person, the safety report and the notification are needed whatever registrations the product holds where it is made.

Documents are a different matter from registrations. The safety report is based on the formula, test data and documents you provide, and the test reports you supply go into the PIF. Whether a report made outside the EU is accepted unchanged is not stated here, so this guide makes no promise about any report either way. Send each report with the formula it was run on, so the file shows what it covers.

After you pay, upload what you have in your Eldris portal and Eldris tells you what is still missing. Eldris prepares the CPSR and PIF from what you upload. At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B. Eldris does not carry out, arrange or recommend laboratory tests, so any new test is arranged by you with a testing laboratory, which sets the price.

What is notified, and who files it?

The Responsible Person notifies the product to the Commission electronically before placing it on the market (Article 13(1)), through the Commission's Cosmetic Product Notification Portal (CPNP), its free online notification system.

Sellers often call this step registering the product. Your EU Responsible Person files the notification. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing, for a fee per CPSR shown on the pricing page. The filing is a separate line from the formula fee. A reformulated product needs an updated notification and a new CPSR, priced as a formula, so a change of recipe at the factory reaches the notification too.

Great Britain needs a UK Responsible Person under its own rules, which the GOV.UK guidance sets out. For sellers in China, two earlier guides cover the same ground from that side: one on actions for exporters and one on the notification portal. The FAQ page gives the short answer on how to register a non-EU-made cosmetic in the EU.

How long does it take, and what is not included?

Eldris's CPSR and notification service delivers the CPSR and PIF 5–10 working days after it receives your complete documents.

If the safety assessor needs more from you, the question appears in your portal, and the 5–10 working days start again from the day you answer. The clock restarts; it never pauses. You pay first, then upload your documents in the Eldris portal, and your CPSR and PIF arrive in the same portal.

The GMP document comes from your manufacturer: an ISO 22716 certificate or, without one, a GMP statement. It is not needed to start. The per-formula fee stays the same whatever the number of ingredients. Laboratory tests and the Responsible Person are not in the formula fee. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing, and it is then a separate line in your quote total. Eldris is not a testing laboratory and does not carry out, arrange or recommend laboratory tests.

Frequently asked questions

Where must the Responsible Person be based?

Within the EU. Only a cosmetic with a Responsible Person designated within the EU may be placed on the EU market (Article 4(1)). A business established in the EU can hold the role itself, and a seller based outside the EU needs an EU Responsible Person. Great Britain asks for a Responsible Person with a UK established address instead.

Can I upload my manufacturer's test reports?

Yes, after you pay, and the test reports you supply go into the PIF. Whether a manufacturer's report is accepted unchanged is not stated here. If the safety assessor needs more from you, the question appears in your portal, and the 5–10 working days start again from the day you answer.

Does Great Britain need a second appointment?

Yes. Great Britain needs a Responsible Person established in the UK. Eldris can be your UK Responsible Person as a separate appointment at the same market fee, covered by the same monthly plan. The UK Responsible Person and the UK notification are not in the formula fee.

What if I change the formula later?

A reformulated product needs an updated notification and a new CPSR, priced as a formula. A new pack size of the same formula adds nothing to the CPSR and PIF. A further shade or scent of an assessed formula is a variation sharing that formula's CPSR.

Is anything monthly?

The cosmetics fees are paid once, with no monthly fee for this service. Only the Responsible Person service runs on a monthly plan. You can cancel it at any time, effective at the end of the billing period. The appointment then ends, and Eldris's details must come off your labels and listings within 30 days.

Is the EU notification included in the formula fee?

No. The notification is a separate line, charged per formula, not per country, with the same volume discount as the formula fee. Eldris files the EU notification only when it is your EU Responsible Person and you order the filing, and only then is it in your quote total. Otherwise your EU Responsible Person files it.

Who signs the CPSR for an imported product?

At Eldris, a qualified safety assessor signs the CPSR, Part A and Part B. Under Article 10(2), Part B is carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent. Eldris prepares the CPSR and PIF, and the documents arrive in your portal.