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Article 6 treats online and other distance-sale offers as made available on the market when the offer targets end users in the Union. The grounded indicators are practical: dispatch to EU locations, languages used for the offer or ordering, payment methods, and other facts showing activities directed to a Member State.

Do not treat website accessibility by itself as enough. The Regulation and Blue Guide both frame this as a case-by-case assessment, so keep screenshots or exports showing the actual listing, shipping destinations, ordering language, checkout path, currency or payment options, and marketplace seller identity at the time the offer was live.

For Article 4 product categories, the product may be placed on the EU market only if there is an economic operator established in the Union responsible for the Article 4 tasks. Depending on the supply chain, that operator can be an EU manufacturer, importer, authorised representative with the required written mandate, or an EU fulfilment service provider where no other listed operator is established in the Union.

The responsible operator's name or registered trade name or trademark, contact details, and postal address must be indicated on the product, packaging, parcel, or accompanying document. For online listings, keep evidence that the same operator is connected to the exact product units being offered, not just to the brand or seller account in general.

Keep the conclusion narrow. An EU-targeting review can show that an offer is likely treated as made available on the EU market; it does not prove the product is substantively compliant with every applicable harmonised act.

Likewise, Article 4 evidence shows there is an EU-established operator for specified documentation and cooperation tasks. It is not a substitute for conformity assessment, accurate warnings, correct CE marking where required, or product-specific technical documentation.

Regulation (EU) 2019/1020 Article 4 says a covered product may be placed on the EU market only if there is an economic operator established in the Union responsible for the Article 4(3) tasks. The Commission guidance explains the practical test: check whether the product is within Article 4 covered harmonisation legislation and whether the offer or supply is aimed at the EU market, including online or other distance sales.

The eligible operator is selected from the supply chain. Use an EU manufacturer if one places the product on the market; otherwise use the EU importer where the manufacturer is outside the Union. A manufacturer may instead give a written mandate to an EU authorised representative for the Article 4 tasks. If none of those exists and an EU fulfilment service provider handles the product, that provider can be the Article 4 operator for the units it handles.

The operator must verify that the required declaration of conformity or declaration of performance and technical documentation have been drawn up. It must keep the declaration available for market surveillance authorities and ensure technical documentation can be made available on request.

The operator must provide information and documentation needed to demonstrate conformity after a reasoned authority request, inform market surveillance authorities when it has reason to believe the product presents a risk, and cooperate so corrective action is taken or risks are mitigated. Its name, registered trade name or trademark, and contact details including postal address must appear on the product, packaging, parcel, or an accompanying document.

Article 6 is the key rule: an online listing, marketplace offer, app listing, email offer, or other distance-sale channel is treated as making the product available on the market when the offer is targeted at EU end users. The test is not limited to where the seller is established.

The Article 4 guidance says targeting is assessed case by case. Practical indicators include whether dispatch to EU countries is possible, whether the offer or ordering flow uses EU-facing languages, and whether payment methods or other sales settings are directed at a Member State.

For products in Article 4 scope, a product may be placed on the EU market only if an economic operator established in the Union is responsible for the Article 4 tasks. That can be an EU manufacturer, importer, authorised representative, or, where no such actor exists, an EU fulfilment service provider for products it handles.

For direct-to-EU shipments from a non-EU manufacturer with no EU importer, the Article 4 guidance says the product may not be offered to EU end users unless the manufacturer has appointed an authorised representative for the Article 4 tasks. Article 4 contact details also need to appear on the product, packaging, parcel, or accompanying document.

The useful record is the one that shows why the offer was or was not targeted at EU end users, and whether Article 4 coverage existed before the product was offered or shipped. Keep evidence as screenshots, exports, marketplace settings, contracts, and fulfilment records that can be matched to the exact SKU, model, software version, and offer date.

Start by matching the request to the product, model, batch, software or firmware version, sales channel, and EU market where the authority is asking. Then identify the relevant economic operator: the EU manufacturer, importer, authorised representative with a written mandate, or, where no such operator is established in the Union for the handled product, the EU fulfilment service provider.

For products covered by Article 4, the operator must verify that the declaration and technical documentation have been drawn up when the applicable Union harmonisation law requires them. It must keep the declaration or declaration of performance available for the period required by that law and ensure the technical documentation can be made available to the authority on request.

Treat the authority request as a controlled response record. Provide the documents specifically requested, in a language the authority can easily understand, and keep a log of what was sent, what was withheld as not applicable, who approved the response, and any corrective action promised or completed.

Article 4 is not just a label requirement. For covered products, it creates a practical authority contact point in the Union and assigns tasks around declarations, technical documentation access, information requests, risk notification, and corrective-action cooperation.

If the Article 4 operator does not hold the full technical file, the response process still needs proof that the file exists and can be supplied by the manufacturer or another documented source. The Commission guidance treats this as an access and cooperation arrangement, especially for fulfilment service providers that do not automatically have a formal manufacturer relationship.

Keep the pack concise enough for an authority reviewer to follow. Separate the documents that prove conformity from the coordination records that prove the company handled the request properly.

Do not invent a universal deadline. Article 4 and the Commission guidance support responding without delay for the declaration and within the authority-set or reasonable period for other documents; the actual response window should be taken from the authority request and the applicable sector law.

The main failure is answering a specific authority request with generic compliance copy. The response should show that the named operator can connect the exact product to the declaration, technical documentation, tests, and corrective-action status.

Another common weakness is assuming that a distributor, platform, fulfilment service provider, importer, or authorised representative can obtain manufacturer records without a written access route. The evidence file should show who has the records and how the authority can receive them.

Regulation (EU) 2019/1020 defines corrective action as action by an economic operator to end non-compliance, either because a market surveillance authority requires it or because the operator acts on its own initiative. A voluntary measure is corrective action that was not required by an authority.

Authority action starts when the authority finds that the product, under intended or reasonably foreseeable use and when properly installed and maintained, is liable to compromise user health or safety, or does not conform to applicable Union harmonisation legislation. The authority must then require the relevant economic operator to take appropriate and proportionate corrective action within a period specified by the authority.

The required action can include bringing the product into compliance, preventing it from being made available, withdrawing or recalling it and alerting the public, destroying or rendering it inoperable, adding suitable risk warnings, setting prior conditions for market availability, or alerting end users at risk.

A product presents a serious risk when a risk assessment, considering normal and foreseeable use, shows that the probability and severity of harm require rapid authority intervention. The fact that safer products exist, or that a higher level of safety is technically feasible, is not enough by itself to classify the product as a serious risk.

For serious risk, market surveillance authorities must ensure withdrawal or recall where no other effective means can eliminate the risk, or prohibit the product from being made available on the market. They must notify the Commission immediately under the Regulation's rapid information exchange process, including available details on product identification, origin and supply chain, the risk, national measures, and any voluntary operator measures.

A serious-risk decision is not just a finding that a product is non-compliant. It requires an appropriate risk assessment that looks at the nature of the hazard and the likelihood that the hazard will occur under normal and foreseeable use.

Where the product presents a serious risk, market surveillance authorities must ensure withdrawal or recall when no other effective measure can eliminate the risk, or prohibit the product from being made available on the market. Under the broader MSR measures article, authorities can also require proportionate corrective action such as bringing the product into compliance, preventing further availability, warnings, public alerts, withdrawal, recall, destruction, or restrictions.

Regulation (EU) 2019/1020 gives market surveillance authorities powers to require documents, technical specifications, compliance data, supply-chain information, product samples, and corrective action. Economic operators must cooperate on actions that eliminate or mitigate product risks.

If an authority takes or intends to take a serious-risk measure with effects beyond one Member State, Article 20 uses RAPEX, now presented publicly as Safety Gate for dangerous non-food products. ICSMS is the authority information system for investigated products, test results, product identification, economic-operator information, accident information, and measures taken.

The evidence file should let an authority or decision owner reconstruct why the product was or was not treated as a serious risk and what happened next. Keep it product-specific and avoid relying on a certificate, supplier statement, or test report that does not match the relevant model, batch, software version, intended use, or market.

Penalties are set under Member State law, so the Regulation does not support quoting a single EU-wide maximum fine. Article 41 requires each Member State to lay down penalty rules for infringements of Regulation (EU) 2019/1020 and listed Union harmonisation legislation that imposes obligations on economic operators.

The enforcement exposure is broader than monetary penalties. Article 14 gives market surveillance authorities powers to request documents and supply-chain information, inspect products and premises, buy or reverse-engineer samples, require corrective action, impose penalties under Article 41, and, for serious online risks where no other effective means are available, require removal of content, warnings, or access restrictions.

If a product is non-compliant or risky, Article 16 allows authorities to require proportionate corrective action, including bringing the product into compliance, preventing market availability, withdrawal, recall, public risk alerts, destruction or rendering inoperable, warnings, prior conditions, or end-user alerts. If the operator does not act or the issue persists, authorities must ensure withdrawal, recall, prohibition, or restriction and inform the public, the Commission, and other Member States through the Article 34 information system.

For products presenting a serious risk, Article 19 requires withdrawal or recall where no other effective means can eliminate the risk, or prohibition of market availability. Operators should therefore treat enforcement readiness as a product file, traceability, authority-response, and corrective-action discipline, not just as a fine-risk question.

First, confirm whether the hold is a suspension of release for free circulation under Article 26. Suspension can be triggered by missing required documentation, doubts about documentation authenticity or completeness, missing or incorrect marking or labelling, false or misleading CE or other required marking, missing Article 4 responsible economic operator contact details, suspected non-compliance, or a serious-risk concern.

Second, assemble the evidence the authority needs to decide the case: product identification, customs declaration and shipment documents, applicable Union harmonisation law, EU declaration of conformity or performance where required, technical documentation index, test reports, labelling and marking photos, instructions or safety information, supplier records, and the name, trade name or trade mark, postal address, and contact owner for the Article 4 economic operator.

Third, keep the response channel disciplined. The importer or responsible EU economic operator should answer reasoned authority requests, make technical documentation available, explain any corrective action, and avoid treating release for free circulation as proof that the product conforms with EU law.

Regulation (EU) 2019/1020 separates the border-control steps. The designated border authority performs controls on products entering the Union market and notifies market surveillance authorities of a suspension. Market surveillance authorities can request that release remains suspended when they have reasonable grounds to believe the product is non-compliant or presents a serious risk.

If the market surveillance authority approves release, or if the Article 27 release condition is met after suspension and other customs requirements are fulfilled, the product can be released for free circulation. If the authority concludes that the product presents a serious risk or may not be placed on the market because it does not comply with applicable Union law, Article 28 provides for refusal notices in the customs data-processing system and relevant accompanying documents.