EU cosmetics · Reg (EC) 1223/2009 · Art. 4–5
Who must be your cosmetics Responsible Person?
Every cosmetic on the EU market needs ONE named Responsible Person established in the Union. Pick your role and where you are established — see who the RP must be for your set-up, when a non-EU brand must appoint one by written mandate, and the duties the RP carries.
Responsible Person designation
You must appoint an EU Responsible Person
You cannot place the product on the EU market without an RP established in the Union. Appoint one by written mandate that they accept in writing — often your EU importer or a third-party RP service — before you sell. Their name and EU address go on the label.
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Appointing an EU Responsible Person, assembling the Product Information File, the safety assessment and CPNP notification can be handled by a specialist cosmetics-compliance partner.
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The Responsible Person's legal obligations (Art. 4–5)
- Keep the Product Information File (PIF) and make it available to authorities for 10 years after the last batch.
- Ensure a Cosmetic Product Safety Report (safety assessment) is done before the product is placed on the market.
- Notify the product through the Cosmetic Products Notification Portal (CPNP) before sale (Art. 13).
- Ensure compliant labelling — including the RP's name and EU address on the pack (Art. 19).
- Comply with market-surveillance requests and demonstrate conformity to competent authorities.
- Report serious undesirable effects (SUE) to the competent authority without delay.
- Take corrective action, withdraw or recall non-compliant product and inform authorities.
Always true, whatever your role
- Exactly one Responsible Person established in the EU/EEA must be designated before the product is placed on the market — and named on the label.
- The product must be notified through the CPNP (Art. 13) before it is sold.
We're finalising a vetted cosmetics-compliance partner. This checker is informational, not legal advice.
The rule, in one line
Under Regulation (EC) 1223/2009 Article 4, only cosmetics for which a Responsible Person (RP) is designated within the Union may be placed on the EU market — and the RP's name and EU address must appear on the label. An EU/EEA-established manufacturer is the RP for its own products; an importer is the RP for what it brings in; a distributor becomes the RP only if it sells under its own name/trademark or modifies the product; and a manufacturer outside the EU must appoint an EU-established RP by written mandate, accepted in writing. Great Britain needs a separate UK-established RP. The RP must hold the Product Information File for 10 years and notify the product through the CPNP (Art. 13) before sale.
Official sources: Regulation (EC) 1223/2009 (Art. 4) · European Commission — consolidated text · EUR-Lex summary
Page updated 2026-06-22 · rules verified 2026-06-14 against EUR-Lex Reg (EC) 1223/2009. Informational, not legal advice; RP rules per Regulation (EC) 1223/2009.
Who can be the Responsible Person
- Art. 4(3)EU/EEA manufacturerA manufacturer established in the EU/EEA is itself the Responsible Person for the products it places on the market.
- Art. 4(4)Mandated third partyA manufacturer outside the EU must appoint an EU-established RP by written mandate the third party accepts in writing.
- Art. 4(5)ImporterEach importer is the Responsible Person for the specific products it places on the EU market — unless it mandates an established RP.
- Art. 4(6)Distributor (conditional)A distributor becomes the RP only if it sells under its own name/trademark or modifies a product so as to affect compliance.
What this tool is — and isn't
This checker resolves who must be the Responsible Person under Regulation (EC) 1223/2009 Article 4 from the role you describe, and lists the RP's statutory obligations. It is an estimate and orientation, not legal advice, and it does not draft your written mandate, assemble your PIF, run the safety assessment, or judge borderline supply-chain set-ups. Verify against the linked official sources.
How the determination works
1. Your role
Who must be the Responsible Person depends on how you act: manufacturer/brand owner, importer, distributor, or another actor placing the product on the EU market.
2. Where you are established
An EU/EEA-established manufacturer is itself the RP. A manufacturer outside the EU must appoint an EU-established RP by written mandate they accept in writing. An importer is the RP for the products it imports. Great Britain needs a separate UK-established RP.
3. The RP's duties + the label rule
Once named, the RP carries the Article 4–5 obligation set: PIF kept 10 years, safety assessment, CPNP notification, compliant labelling, market surveillance, reporting serious undesirable effects, and recalls. The RP's name and EU address must appear on the label (Art. 19).
Frequently asked questions
- Who can be the cosmetics Responsible Person?
- A legal or natural person established within the EU/EEA: the EU-established manufacturer, the importer for products it imports, a distributor that sells under its own name/trademark or modifies the product, or a third party appointed by the manufacturer through a written mandate the third party accepts in writing.
- I manufacture outside the EU — what must I do?
- You cannot be the RP yourself. You must appoint an EU-established Responsible Person by written mandate (they accept in writing) before placing the product on the market. Often this is your EU importer or a specialist RP service, and their name and EU address must appear on the label.
- What are the Responsible Person's legal obligations?
- Under Article 4–5 the RP must ensure the safety assessment is done, keep the Product Information File for 10 years and make it available to authorities, notify through the CPNP (Art. 13), ensure compliant labelling (including its own name and EU address), comply with market-surveillance requests, report serious undesirable effects, and manage corrective action, withdrawals and recalls.
- Does the Responsible Person have to be named on the label?
- Yes. Article 19 requires the name and address of the Responsible Person on the container and packaging. For an imported product, the country of origin must also be shown.
- How long must the Product Information File be kept?
- The RP must keep the PIF readily accessible at the address shown on the label for 10 years following the date the last batch of the product was placed on the market (Article 11).
- Can a distributor be the Responsible Person?
- Only if it places the product on the market under its own name or trademark, or modifies an already-placed product in a way that affects compliance. A plain reseller is not the RP — the existing manufacturer, importer or mandated RP stays responsible — but the distributor still has its own duties under Article 6.