EU responsible person: meaning under GPSR and EU cosmetics rules

Most products sold in the EU need someone established in the EU who answers for them.

Definition

EU responsible person

An EU responsible person is an economic operator established in the European Union who is answerable to market surveillance authorities for a product’s compliance. Under the General Product Safety Regulation this can be the EU manufacturer, an importer, an authorised representative with a written mandate, or a fulfilment service provider; under the Cosmetics Regulation 1223/2009, a responsible person in the EU must be designated for each cosmetic product.

Who can be the responsible person and what they do

Under GPSR Article 16, read with Article 4 of Regulation (EU) 2019/1020, a product cannot be placed on the market unless an economic operator established in the EU is responsible for it. That operator can be a manufacturer established in the EU, an importer, an authorised representative appointed by written mandate, or a fulfilment service provider where none of the others is established in the EU. Its tasks include keeping documentation available to authorities, cooperating with them and, under GPSR, regularly checking that products match their technical documentation.

Cosmetics have their own regime. Regulation (EC) No 1223/2009 requires a responsible person established in the EU for each product. A manufacturer outside the EU can designate one by written mandate; otherwise the importer is the responsible person. The responsible person holds the product information file, ensures the safety report exists and submits the CPNP notification.

Other markets use similar ideas with different rules. Great Britain requires a cosmetics Responsible Person with a UK address. Under MoCRA in the US, the responsible person is the manufacturer, packer or distributor whose name appears on the label. A non-EU brand should decide early who will act in each market, because the name and address go on the label and in online listings.

Treat this as general information; who should act for your product is confirmed with a licensed specialist during a project. See private label cosmetics in the EU and our compliance stage.

Responsible person in three regimes

EU general products (GPSR)EU cosmetics (1223/2009)US cosmetics (MoCRA)
Who it isEU manufacturer, importer, authorised representative or fulfilment service providerPerson in the EU designated by mandate, or the importerManufacturer, packer or distributor named on the label
Must be based inThe EUThe EUNot set by the definition; the name and address appear on the label
Key documentsTechnical documentation available to authoritiesProduct information file, safety reportSafety substantiation records
NotificationNo central notificationCPNP before placing on the marketProduct listing with FDA

Summary of official texts. Check the full rules for your product and market.

Frequently asked questions

Does a non-EU brand need an EU responsible person?

For most consumer products sold in the EU, yes. GPSR requires an economic operator established in the EU for each product, and cosmetics require a designated responsible person in the EU.

Can a marketplace or fulfilment provider be my responsible person?

A marketplace is not among the operators listed. A fulfilment service provider can be the responsible economic operator under GPSR only where no EU manufacturer, importer or authorised representative exists. For cosmetics, a responsible person must be designated under the Cosmetics Regulation.

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