For US brands selling into the EU
"It seems ridiculous that there is no threshold or concessions for small businesses."
— a merchant on the Shopify Community forum, December 2024
There is no small-business threshold in the Regulation. The obligations attach to the product being placed on the EU market, not to the size of the company. Most US brands in this position have been solving the wrong problem. MoCRA responsible person vs EU responsible person →
The structural fact
A US company is not designated within the Community (Art. 4(1)). That is a person or company in the Union, not a document from a US consultancy.
For a US brand shipping into the Union with no written mandate, Art. 4(5) puts the role on whoever imports the product. How Art. 4 places the role →
Most US brands met this through a marketplace email about the General Product Safety Regulation (Reg. (EU) 2023/988). For a cosmetic, that is the smaller half. Regulation (EC) 1223/2009 — responsible person, safety report, file, notification — is older and still applies.
We can be appointed as your EU Responsible Person, by written mandate. Registration covers the safety report and the file. Custody — keeping the file and watching the registers after that — is a yearly line. What each costs →
What travels out of a US file
| What you have | Into an EU file? |
|---|---|
| A US legal entity | No. Art. 4(1) requires designation in the Union |
| US filings / MoCRA papers | No. CPNP is a separate submission (Art. 13(1)) |
| A US safety substantiation dossier | Read, not assumed. Send it |
| Stability, challenge, CoAs | Yes — the expensive half you already own |
| Your label | Needs the EU responsible person's name and address (Art. 19(1)(a)) |
| A product you treat as an OTC drug | Classified first under Art. 2(1)(a). If it is not a cosmetic here, a different regime |
“Responsible person” does not mean the same thing in MoCRA and in Art. 4. We have not published a side-by-side of the two roles, because we have not verified one.
Manufacturing through a Korean contract factory as well as selling from the US? For Korean brands →
All of it runs online, from where you are. You sign in to our user-friendly client portal with a link we email you, see the documents your product needs with the reason for each, and upload them next to their line. There are no couriers and no trip to Belgium. If your manufacturer already has the papers, your part takes about an hour. Once the last document is in and the formula is declared, the signed safety report usually follows within 3 working days. Comparing responsible persons before you sign a mandate? Nine questions to ask →
Registration starts at €345; the Responsible Person mandate is €360 per product, per year across the EU. What each line covers →
Questions people ask
Do I really need an EU Responsible Person if I have no contacts in Europe?
Yes, if a cosmetic is placed on the EU market (Art. 4(1)). Having no contacts is the usual starting position. Where no mandate is arranged, the importer takes the role by default (Art. 4(5)).
Will appointing you get my Amazon listing reinstated?
We can give you the document set, and the mandate once it opens. What a marketplace does with that is the marketplace's decision.
Tell us the product, the variants and the markets — a fixed quote in writing.