Product compliance: your key to the EU market

The product, not your postcode

If you manufacture or ship goods into the EU from outside it, here is the rule that decides everything that follows: the EU regulates the product, not the seller’s location. A factory in Shenzhen, a brand in Istanbul and a maker in Ohio meet exactly the same bar as a company in Hamburg — and since the General Product Safety Regulation (GPSR) took effect on 13 December 2024, that bar is enforced by the marketplaces and customs authorities you depend on, not only by regulators.

For most non-EU suppliers the gap is not the testing or the paperwork they already know about. It is one structural requirement they rarely see coming: in nearly all cases a product can only be placed on the EU market if there is an economic operator established in the EU — a “responsible person” — accountable for it. No responsible person, no compliant route to the EU customer.

This paper is the map. It explains why compliance is now the condition of market access, the responsible-person requirement most sellers overlook, who is accountable for what across the supply chain, the full compliance stack you must satisfy, what each sales channel demands, and a step-by-step playbook to arrive retailer-ready and stay there.

General guidance, not legal advice. Requirements vary by product type and market — confirm specifics with the competent authority (see Conphora → Tools → Compliance resources).

Why “just ship it” no longer works

Two shifts have closed the door on shipping first and sorting compliance later.

A product-safety regime with teeth

The GPSR ((EU) 2023/988) replaced the old product-safety directive and tightened the duties of everyone in the chain, including online marketplaces. Alongside it, the Market Surveillance and Compliance Regulation ((EU) 2019/1020) requires, for a broad set of CE-marked product categories, that there be an economic operator established in the Union before the product can be made available — and that operator’s details appear on the product or its packaging. GPSR carries a parallel responsible-person requirement across consumer products more broadly. The practical effect for a non-EU manufacturer is blunt: you need a compliant EU counterpart, or you cannot legally place the product on the market.

The enforcers: marketplaces and customs

Enforcement is no longer the occasional border inspection. The EU’s Safety Gate rapid-alert system logged a record 4,137 dangerous-product alerts in 2024, and the Commission’s eSurveillance web-crawler scans well over a million sites for non-compliant offers. Online marketplaces are now legally obliged to check, and they act: Amazon, for example, requires sellers to provide an EU responsible person and compliance data before a product can be listed, and removes or suppresses offers that do not comply. Customs and market-surveillance authorities can stop non-compliant goods at the border. For a seller whose growth depends on EU shelves and marketplaces, a compliance gap is a closed door at the worst possible moment.

The EU regulates the product, not the seller’s postcode — so a supplier outside the EU meets the same bar as one inside it, and that bar is now enforced before you ever reach the customer.

Who is responsible for what

EU product law assigns specific duties to specific roles. As a non-EU manufacturer you keep the core obligations of the maker, but several duties can only be discharged by someone inside the EU — which is why your route to market always involves an EU counterpart.

The EU responsible person — the role most non-EU sellers miss

This is the linchpin. For products in scope, there must be a named economic operator established in the EU before the product is placed on the market. That person typically: keeps the EU Declaration of Conformity and the technical documentation available to authorities; checks that the product carries the right markings, labelling and documents; informs authorities and takes corrective action (up to recall) if the product presents a risk; and appears, by name and EU address, on the product or its packaging.

You can fill the role in three common ways: let your EU importer take it on; appoint an authorised representative by written mandate; or use a responsible-person / fulfilment service. What you cannot do is leave it empty — a product with no EU operator behind it is, for listing and customs purposes, non-compliant.

The compliance stack you must satisfy

Think of compliance as a stack: get each layer right, document it, and keep it current.

1. Find the rules that apply

A single product can fall under several regimes at once. Identify every applicable directive/regulation for the product and the harmonised standards that show how to comply — e.g. the Low Voltage, EMC and Radio Equipment rules for electronics; the Toy Safety rules and EN 71 for toys; Machinery; PPE; plus horizontal rules (chemicals, packaging) that apply regardless of category.

2. Build the technical file & EU Declaration of Conformity

Assemble the technical documentation that proves conformity (design, risk assessment, test reports, standards applied) and issue the EU Declaration of Conformity — the single signed document in which you take legal responsibility. Both must be kept available to authorities, usually for ten years, by the EU responsible person.

3. Test, assess conformity & CE-mark

Run the conformity assessment the applicable rules require — self-declaration against harmonised standards where allowed, or a notified body where mandated. Then affix the CE marking (and any other required marks). CE is a legal declaration backed by the technical file, not a self-applied sticker.

4. Label, mark & translate

Put the required traceability and contact information on the product or packaging: type/model, batch or serial number, the manufacturer’s name and address and the EU responsible person’s name and address. Provide instructions and safety information in the language(s) of each market you sell into — member states determine which.

5. Chemicals & materials

Screen materials and substances against REACH (registration, SVHC/candidate-list, restrictions), RoHS (hazardous substances in electronics) and POPs, plus food-contact rules where relevant. Gather the evidence from your suppliers up front — it is far harder to reconstruct later.

6. Packaging & EPR (WEEE, batteries)

Beyond product safety sit Extended Producer Responsibility obligations: packaging (and the incoming PPWR), WEEE for electrical and electronic equipment, and the Batteries Regulation. These are typically registered per member state, and a non-EU producer usually needs an authorised representative in each country to register and report. Skipping EPR is a common, expensive blind spot.

7. Coming next: ESPR & the Digital Product Passport

The Ecodesign for Sustainable Products Regulation (ESPR) and the Digital Product Passport will require structured, shareable product data for more and more categories. A supplier who builds that data backbone now switches each new requirement on as a feature instead of meeting it as an emergency.

Your route to market — and what each demands

How you sell into the EU changes who holds which duty.

Via an EU importer

The importer places the product on the market and takes on importer duties — but they will only do so if you hand over a complete pack: DoC, technical file access, correct markings and labelling. The better your pack, the faster and stickier the relationship.

Via a marketplace

Marketplaces now verify compliance before listing. Expect to provide an EU responsible person, manufacturer and compliance details, and documentation through the platform’s compliance flow; offers without them are removed or suppressed. Being ready is the difference between a live listing and a blocked one.

Direct to consumer

Selling straight to EU consumers (your own webshop, drop-shipping) puts the responsibility squarely on you: you must have an EU responsible person, meet labelling and language rules, and handle EPR/WEEE/battery registration — plus VAT/IOSS for the commercial side. “The customer imports it themselves” is not a compliance strategy.

A step-by-step playbook

1. Classify your products → the rules that apply. Map each SKU to its directives/regulations and harmonised standards, and to its target markets.
2. Appoint your EU responsible person / authorised representative. Decide whether the importer, an authorised rep, or a service provider holds the role — and put it in writing.
3. Compile the technical file and issue the EU Declaration of Conformity. One per product, kept current and available.
4. Test to the harmonised standards (notified body where required) and affix CE/markings.
5. Label, mark and translate — traceability + manufacturer and responsible-person details, instructions in each market’s language.
6. Register for EPR/WEEE/batteries per member state, via a local representative where needed.
7. Prepare the retailer/marketplace compliance pack so onboarding is a formality, not a scramble.
8. Monitor regulatory change and re-validate — treat a new requirement as an alert, not an emergency.

Be ready for the bad day

Compliance also means readiness. A market-surveillance request, a Safety Gate alert or a recall can land at any time, and the supplier who survives it is the one who prepared: a named responsible person, documentation on hand, and a defined corrective-action process. For the full method, see the companion paper How to handle product recalls in the EU.

Common pitfalls for non-EU suppliers

• Assuming the importer or marketplace “handles compliance”. They enforce it; they do not create it for you.
• No EU responsible person. The single most common blocker to listing and customs clearance.
• Drop-shipping to consumers with no EU operator behind the product.
• Ignoring EPR/WEEE/battery registration — separate from product safety, and per-country.
• Missing language requirements for instructions and safety information.
• Treating CE as a self-applied sticker with no technical file or DoC behind it.

How Conphora helps

Conphora is the platform that makes EU market access operational for suppliers — wherever they are based. Upload your catalogue and Conphora validates each product against 48 EU regulations across 27 countries, detects the gaps, and generates the documentation and a shareable compliance status that importers, retailers and marketplaces require — so you arrive retailer-ready and stay there, and turn each new regulation into a feature rather than a fire. Learn more at conphora.com.

Sources & references

1. Regulation (EU) 2023/988 — General Product Safety Regulation (GPSR). EUR-Lex.
2. Regulation (EU) 2019/1020 — Market Surveillance and Compliance of Products (economic-operator requirement). EUR-Lex.
3. European Commission — CE marking and the EU product-conformity framework.
4. Regulation (EC) 1907/2006 (REACH); Directive 2011/65/EU (RoHS); the EU Batteries Regulation and WEEE Directive; the Packaging & Packaging Waste Regulation (PPWR).
5. Regulation (EU) 2024/1781 — Ecodesign for Sustainable Products Regulation (ESPR) & Digital Product Passport. EUR-Lex.
6. European Commission — Safety Gate Rapid Alert System (2024 annual report).
7. Amazon — General Product Safety Regulation (GPSR) seller guidance, 2024.

This white paper is for general guidance and does not constitute legal advice. Obligations depend on the product, its category and the specific markets you sell into; confirm current requirements against the primary regulations and the competent authorities before acting. © 2026 Conphora.