Importing from non-EU manufacturers

Last reviewed: August 2026 · Legal status verified against EUR-Lex.

When the manufacturer of a CE-marked product is established outside the EU, the manufacturer's core obligations do not disappear — but EU law deliberately places a second set of duties on operators inside the Union, so that market surveillance authorities always have someone within reach. Those operators are the importer, the authorised representative, and — for many product categories — the "economic operator responsible" under Article 4 of Regulation (EU) 2019/1020. This page maps who carries which obligation, and where the traps are.

The definitions come from the horizontal framework: Decision No 768/2008/EC (whose Annex I "reference provisions" are reproduced in the sectoral acts) and Regulation (EU) 2019/1020 on market surveillance. The Commission's Blue Guide (2022 edition) is the standard interpretive source.

Who is an importer

An importer is any natural or legal person established in the Union who places a product from a third country on the Union market (Decision 768/2008/EC, Annex I, Article R1). Two points follow from the definition:

• Importer status attaches to the first placing on the EU market, not to the physical act of customs clearance. A logistics agent who never owns or offers the product is not an importer merely because it handles the shipment.
• If no Union-established person places the product on the market — as in direct-to-consumer shipping from a non-EU seller — there is no importer in the legal sense. That gap is what Article 4 of Regulation 2019/1020 and Article 16 of the GPSR were written to close (see below).

Importer obligations under Article R4

Article R4 of Decision 768/2008 (mirrored, with sectoral variations, in each act such as the Low Voltage Directive, EMC Directive, or toy safety legislation) requires the importer to place only compliant products on the market, and in particular, before placing a product on the market, to ensure that:

• the manufacturer has carried out the appropriate conformity assessment procedure;
• the manufacturer has drawn up the technical documentation;
• the product bears the required conformity marking (the CE mark) and is accompanied by the required documents, typically including the EU Declaration of Conformity and instructions in the languages required by the Member States concerned;
• the manufacturer's name, registered trade name or trademark, and a contact address appear on the product (or, where that is not possible, on its packaging or accompanying documents).

The importer must then add its own name and contact address on the product or, where not possible, on the packaging or an accompanying document. While the product is under the importer's responsibility, storage and transport conditions must not jeopardise conformity. The ongoing duties largely mirror the manufacturer's:

• where appropriate with regard to the risks presented, carry out sample testing of marketed products;
• investigate complaints, and keep a register of complaints, non-conforming products, and recalls, keeping distributors informed;
• take corrective action — bringing the product into conformity, withdrawal, or recall — where the importer considers or has reason to believe the product is non-compliant, and inform national authorities where it presents a risk;
• keep a copy of the Declaration of Conformity at the disposal of authorities (typically for ten years, the exact period being set by each act) and ensure the technical documentation can be made available on request;
• provide authorities, on reasoned request, with all information necessary to demonstrate conformity, and cooperate in any action to eliminate risks.

Article 4 of Regulation 2019/1020: the responsible economic operator

Since 16 July 2021, Article 4 of Regulation (EU) 2019/1020 provides that products covered by a listed set of harmonisation acts may be placed on the Union market only if there is an economic operator established in the Union responsible for defined compliance tasks. The listed legislation in Article 4(5) — 18 acts — includes toys, low-voltage electrical equipment, EMC, radio equipment, machinery, PPE, gas appliances, pressure equipment, construction products, RoHS, ecodesign, recreational craft, pyrotechnics, and others.

The responsible operator can be, in order of precedence in practice:

1. a manufacturer established in the Union;
2. an importer, where the manufacturer is not established in the Union;
3. an authorised representative with a written mandate designating it to perform the Article 4 tasks; or
4. a fulfilment service provider established in the Union, where none of the above exists.

The tasks (Article 4(3)) are: verifying that the Declaration of Conformity and technical documentation have been drawn up; keeping the declaration at the authorities' disposal and ensuring the technical documentation can be made available; providing information and documentation on reasoned request; informing authorities of products presenting a risk; and cooperating on corrective measures. The responsible operator's name and contact details must appear on the product, its packaging, the parcel, or an accompanying document (Article 4(4)) — which is why non-EU brands selling into the EU print an EU address on their packaging.

Authorised representatives

A non-EU manufacturer may appoint an authorised representative — a Union-established person acting under a written mandate (Decision 768/2008, Article R3). The minimum mandate covers keeping the Declaration of Conformity and technical documentation at the disposal of authorities, providing information on request, and cooperating with authorities. Drawing up the technical documentation cannot be delegated, and appointing a representative never transfers the manufacturer's responsibility for the design and manufacture of the product. In some sectors (notably the Medical Devices Regulation) an authorised representative is mandatory for non-EU manufacturers; in most NLF acts it is optional, but it is one way to satisfy Article 4 of Regulation 2019/1020.

The own-branding trap

Article R6 of Decision 768/2008 converts an importer (or distributor) into a manufacturer, with the full set of manufacturer obligations, in two situations:

• the importer places the product on the market under its own name or trademark; or
• the importer modifies a product already placed on the market in a way that may affect its compliance.

This is the single most underestimated rule in import practice. A company that buys white-label goods from a non-EU factory and sells them under its own brand is, in law, the manufacturer: it must hold the technical documentation, sign the Declaration of Conformity in its own name, and answer for the entire conformity assessment — regardless of what the factory did or promised. Factory test reports can feed into the technical file, but responsibility cannot be contracted away.

Fulfilment centres and dropshipping

A fulfilment service provider is a Union-established business offering at least two of: warehousing, packaging, addressing, and dispatching, without owning the products (Regulation 2019/1020, Article 3(11); postal and parcel services are excluded). Where a non-EU seller ships goods to an EU fulfilment centre and sells directly to end users, there is often no importer — so the fulfilment service provider becomes the Article 4 responsible operator by default if no authorised representative has been appointed. Many fulfilment providers and marketplaces therefore contractually require non-EU sellers to appoint an authorised representative first.

In pure dropshipping — goods shipped from outside the EU directly to the consumer — the offer is still "placing on the market" when it targets EU end users (Article 6 of Regulation 2019/1020), and for listed CE categories the sale is unlawful without a Union-established responsible operator. The GPSR extends the same logic to non-harmonised consumer products through its own responsible-person requirement (Article 16). See CE marking for e-commerce sellers for the online-sales rules in detail.

Customs controls and detention

Articles 25 to 28 of Regulation 2019/1020 organise the interface between customs and market surveillance for products entering the Union:

• Article 25: customs authorities control products entering the Union market, based on risk analysis and information exchanged with market surveillance authorities.
• Article 26: customs suspend release for free circulation where the product is not accompanied by required documentation, is not marked or labelled as required, bears a CE marking affixed in a false or misleading manner, or there is other reason to believe it does not comply or presents a serious risk. The market surveillance authority is notified and has a short window (in principle four working days) to react before release.
• Article 27: the product is released if the surveillance authority does not object within the deadline or approves release.
• Article 28: where the authority concludes the product is non-compliant or presents a serious risk, release is refused; the customs entry is marked accordingly, and the product may be destroyed or otherwise rendered inoperable where necessary.

Practically: missing importer addresses, absent Declarations of Conformity, and malformed CE marks are exactly the defects a customs officer can spot on the box, and they are common triggers for detention. The costs of a suspended container — storage, demurrage, missed seasons — usually dwarf the cost of getting documentation right (costs and timelines).

Allocation of duties at a glance

Distributors further down the chain carry lighter verification duties — see distributor obligations.

Sources

• Decision No 768/2008/EC on a common framework for the marketing of products (Annex I, Articles R1–R7) — EUR-Lex.
• Regulation (EU) 2019/1020 on market surveillance and compliance of products (Articles 3, 4, 6, 25–28) — EUR-Lex.
• Regulation (EU) 2023/988 on general product safety (Article 16) — EUR-Lex.
• Commission Notice — The "Blue Guide" on the implementation of EU product rules 2022 (OJ C 247, 29.6.2022, p. 1) — EUR-Lex.
• European Commission — Market surveillance for products (Single Market and Standards portal).