EU responsible person: what a US brand needs before selling in the EU

Short answer: under Regulation (EC) No 1223/2009, only cosmetic products for which a responsible person is established inside the EU may be placed on the EU market (Article 4, consolidated 18.05.2026), and the label must bear that person's name and EU address (Article 19(1)(a)). A US brand with no EU entity must appoint one — a distributor, a service company, or a subsidiary.

What the responsible person does

Duty	Where
Be established in the EU and be named on the label	Article 4; Article 19(1)(a)
Ensure a safety assessment (CPSR) and product information file exist and are kept accessible	Article 5, Article 11, Article 12
Ensure compliance with ingredient rules (Annexes II–VI) and labeling	Article 5
Keep the product notification to the EU portal current	Article 5, Article 13

Why a US brand cannot skip it

Article 4(1) is a gate, not a paperwork item: no EU-established responsible person, no lawful placing on the EU market. The requirement follows the brand wherever it sells from — a product shipped from the US to an EU customer by the brand itself still needs the designated person. Distributors take on their own duties (Article 6) only when they make the product available under their own arrangements; being your distributor does not automatically make them your responsible person unless agreed.

The practical choice is between a service provider (per-product fees, keeps the product information file, handles the EU portal notification) and an EU entity of your own (control, overhead). Either way the label must show that name and address.

Common mistakes

Printing the US company's name and address as the responsible person on an EU label.
Assuming the EU distributor becomes the responsible person by default. It needs designation, and many distributors refuse.
Shipping D2C from the US into the EU without any responsible person. Article 4 applies regardless of the shipping route.
Treating the responsible person as a name only. The duties in Article 5 (safety assessment, product information file, notification) sit with that person.

Sources

Regulation (EC) No 1223/2009, Article 4 (responsible person), Article 5, Article 19(1)(a) (label), consolidated 18.05.2026 — EUR-Lex consolidated text
Regulation (EC) No 1223/2009, Articles 11–13 (product information file and notification) — EUR-Lex consolidated text
FDA, MoCRA overview, for the US-side duties a brand already carries — fda.gov

Last verified: 2026-11-10.

Not legal advice, and not a guarantee of compliance or of acceptance by any authority.

Want this checked against your own formula? Run the free label check. It applies the EU ingredient limits so your responsible person's first review is not a surprise. It returns an issue list, not a print-ready label.