Documents & incidents
GPSR Accident Reporting, Product Recalls and Safety Gate: What Sellers Must Do
Short answer
When a product is dangerous, the manufacturer must immediately take corrective action such as withdrawal or recall and notify the authorities through the Commission's Safety Business Gateway; accidents causing death or serious harm must be reported the same way without undue delay, and for non-EU manufacturers the EU responsible person must make sure this happens. Recalls require direct notice to identifiable consumers, a written notice headed "Product safety recall" with the legally required content, and a free choice of at least two remedies. Authorities can publish serious-risk products on Safety Gate, and marketplaces must act on their orders within two working days.
Key points
- Reportable accidents are occurrences linked to a product's use that caused death or serious adverse effects on health and safety, permanent or temporary (Article 20(2)).
- All reports go through the Safety Business Gateway, which needs an EU Login account, to the authority of the member state where the accident happened.
- A dangerous product triggers immediate corrective action, consumer information and notification of every member state where it was sold (Article 9(8)).
- Recall notices must be headed "Product safety recall" and must not play down the risk with words like "voluntary" or "precautionary" (Article 36).
- Remedies must be effective, free and timely, normally with a choice of at least two of repair, replacement or refund, and no return shipping cost (Article 37).
- Marketplaces must act on authority orders within two working days and on third-party safety notices within three (Article 22).
When you have to act
A "safe product" is one that, under normal or reasonably foreseeable conditions of use, including actual duration of use, presents no risk or only the minimum risk compatible with its use (Article 3(2)); anything else is a "dangerous product". The trigger for action is not proof: the duties apply when an operator "considers or has reason to believe" on the information it holds that a product is dangerous (Articles 9(8), 11(8) and 12(4)).
Signals include customer complaints and reviews mentioning burns, cuts or fire, inspection of returns, factory or lab quality reports, safety notices forwarded by a marketplace, Safety Gate alerts on similar products and questions from authorities. Manufacturers must investigate safety complaints and accident reports and keep an internal register of complaints, recalls and corrective measures (Article 9(12)); importers have a similar duty (Article 11(10)). So the first step is a channel that captures this information and a person who decides what to do.
Accident reporting under Article 20
What counts: occurrences associated with the use of a product that resulted in a person's death or in serious adverse effects on their health and safety, permanent or temporary, including injuries, other bodily damage, illnesses and chronic health effects (Article 20(2)).
Who reports:
- the manufacturer must ensure the accident is notified (Article 20(1));
- importers and distributors who learn of an accident must tell the manufacturer without undue delay; the manufacturer reports or instructs the importer or a distributor to do so (Article 20(3));
- if the manufacturer is not established in the EU, the responsible person who knows of the accident must ensure the notification is made (Article 20(4));
- marketplaces that are informed of an accident causing serious risk or actual damage must also report via the Safety Business Gateway and inform the manufacturer (Article 22(12)(e)).
What and to whom: the notification goes to the competent authorities of the member state where the accident occurred and includes the product type and identification number and the circumstances, if known; further information must be provided on request (Article 20(1)). The Commission's guidelines (C/2025/6233, published 21 November 2025; an interpretation, not the law itself) suggest including details such as the victim's age and how the product was being used.
When: "without undue delay" from the moment the manufacturer knows of the accident. No fixed number of hours or days is set, so do not wait for a full internal investigation.
CE products too: the Commission's Safety Business Gateway guidelines state that Article 20 reporting applies to all products, including those under harmonisation legislation.
Dangerous products: corrective action and notification
A manufacturer that considers or has reason to believe a product it has placed on the market is dangerous must immediately (Article 9(8)):
- take the corrective measures needed to bring the product into conformity, including withdrawal (stopping supply in the chain) or recall (getting back products already with consumers) as appropriate (Article 3(25)–(26));
- inform consumers in line with Articles 35 and 36;
- notify, through the Safety Business Gateway, the market surveillance authorities of every member state where the product was made available, describing the risk, measures taken and, if available, the quantity still on the market per country.
The manufacturer must also keep other operators, responsible persons and marketplaces in the supply chain informed (Article 9(10)). The Commission's guidelines list corrective measures such as recall, withdrawal, destruction, stopping sales, adding warnings and warning consumers, and advise monitoring whether they work.
| Role | Duty when a product is dangerous |
|---|---|
| Manufacturer | Corrective action, consumer information, Safety Business Gateway notification (Art. 9(8)) |
| Authorised representative | Inform the manufacturer; notify action taken via the Gateway if the manufacturer has not; cooperate with authorities (Art. 10(2)) |
| Importer | Inform the manufacturer; ensure corrective action and take it itself if nobody else does; ensure consumers are informed; notify via the Gateway (Art. 11(8)) |
| Distributor | Inform manufacturer or importer; ensure corrective action and that authorities are informed (Art. 12(4)) |
| Online marketplace | Notify dangerous products it actually knows of via the Gateway; cooperate on recalls (Art. 22(12)) |
Using the Safety Business Gateway. It is the Commission's web portal on the Safety Gate site (Article 27), and businesses must use it for these reports. Per the Commission's guidelines, you sign in with an EU Login account, enter product identification, risk or accident details and supply-chain information, and can select all relevant member states at once. Authorities see submissions immediately; a risk assessment you submit is only indicative. Only the operators and marketplaces concerned may file, so competitors cannot use it to report you. Agree in advance with your EU rep who registers and who files.
Telling consumers: direct notice and the recall notice (Articles 35–36)
In a recall or safety warning, operators and marketplaces must ensure that all affected consumers who can be identified are notified directly and without undue delay, and must use customer data they hold for this (Article 35(1)). The Commission says this is compatible with EU data protection law and should be mentioned in your privacy notice. Product registration or loyalty schemes must let customers register contact details for safety purposes only (Article 35(2)). Where not everyone can be reached, the notice must be spread widely through your website, social media, newsletters, shops and, where appropriate, mass media (Article 35(4)).
A written recall must take the form of a recall notice in the language(s) of the countries of sale containing (Article 36(2)):
- the headline "Product safety recall";
- a clear description of the product: picture, name and brand; identification numbers such as batch or serial number, with a graphic showing where to find them if useful; and when, where and by whom it was sold, if known;
- a clear description of the hazard, without terms such as "voluntary", "precautionary", "discretionary", "in rare situations" or "in specific situations", and without saying no accidents have been reported;
- what consumers should do, including stopping use immediately;
- the remedies available;
- a free phone number or interactive online service with information in the relevant official EU language(s);
- where appropriate, encouragement to share the recall with others.
The Commission has adopted a recall notice template in Implementing Regulation (EU) 2024/1435, available on the Safety Gate portal. Recall information must also be accessible to persons with disabilities (Article 35(4)).
Remedies for consumers (Article 37)
- The operator responsible for the recall must offer an effective, cost-free and timely remedy (Article 37(1)).
- Consumers normally choose between at least two of: repair; replacement with a safe product of the same type and at least the same value and quality; or an adequate refund of at least the price paid (Article 37(2)).
- Only one remedy may be offered if the others are impossible or would cause disproportionate costs.
- If repair or replacement is not completed in reasonable time and without significant inconvenience, the consumer is always entitled to a refund.
- Consumers never pay shipping or return costs; non-portable products must be collected (Article 37(5)).
- Repair by the consumer counts only if it is easy and safe and is set out in the recall notice, with instructions, free parts or software updates supplied (Article 37(3)); disposal by the consumer is subject to similar limits and does not remove the right to a refund or replacement (Article 37(4)).
The Commission's guidelines add that GPSR recall remedies have no time limit and the consumer need not prove the product is dangerous. Consumers may instead use their contractual rights against the seller, but cannot claim twice for the same safety issue. Consumers unhappy with recall remedies can complain to national authorities (Article 33(4)).
What Safety Gate is and what a listing there means
The Commission describes Safety Gate as three parts:
- the Safety Gate Rapid Alert System, where authorities and the Commission exchange information on measures against dangerous non-food products (Articles 25–26); for serious-risk products, member states must notify within four working days of the measure (Article 26(4));
- the Safety Gate Portal, which publishes selected alert information, lets consumers report products that may be dangerous (Article 34) and holds marketplace contact points;
- the Safety Business Gateway, where businesses report dangerous products and accidents.
A Gateway submission only becomes a Rapid Alert notification if the authority decides the criteria are met; the public part then appears on the portal. Consumer-facing recall information you submit can also be published this way, but that does not replace direct notice to consumers.
Why it matters to sellers: marketplaces must take Safety Gate information into account in their voluntary measures to detect and remove offers of dangerous products (Article 22(6)), and a product found dangerous by one member state is presumed dangerous by the others (Article 29(1)). Searching the Safety Gate portal for alerts on similar products is a cheap way to catch design problems early.
How marketplaces act (Article 22)
- Authority orders: remove content, disable access or show a warning without undue delay and within two working days, then report back; orders can cover all identical content for a set period (Article 22(4)–(5)).
- Third-party notices: product safety notices from consumers and others must be processed within three working days (Article 22(8)).
- Informing the seller: the operator concerned must be told when an offer of a dangerous product is removed (Article 22(12)(b)).
- Recalls: notify affected buyers directly, publish recalls on the platform and not obstruct them (Article 22(12)).
- Repeat offenders: suspension, after a prior warning, of traders who frequently offer non-compliant products (Article 22(11)).
A safety-related removal does not necessarily mean your product is on Safety Gate, but it does mean the platform received an order or notice or identified a risk. Respond with your technical file, test reports and corrective actions as the platform requests, and keep your EU rep informed. Internal procedures and appeal routes are set by each platform. See Amazon GPSR listing deactivated.
Practical steps for sellers
Before anything happens
- Publish a complaint channel (phone, email or web form) and show it with your contact details (Article 9(11)).
- Create an EU Login account and agree in writing with your EU rep who reports accidents and dangerous products and who runs recalls.
- Keep sales and order data by country so you can report quantities and contact buyers.
- Prepare a recall notice template in the relevant languages and a remedy plan; keep your technical documentation and registers up to date.
When an incident occurs
- Record evidence: the complaint, photos, batch number, order data.
- Decide whether it is a reportable accident or a dangerous product; ask your EU rep or a lawyer if unsure.
- Stop selling the affected batch and inform the marketplace, EU rep and supply chain.
- Notify the relevant authorities via the Safety Business Gateway.
- If recalling, write an Article 36 notice, contact buyers directly and publish it widely.
- Offer at least two remedies and cover return costs.
- Log everything, send progress reports if asked (Article 15(6)) and update the technical file after any design change.
For the rules on who can act as your EU responsible person, see Who is the EU Responsible Person.
Accident and recall readiness checklist
- Publish a consumer complaint channel and show it on products and listings
- Keep an internal register of complaints, accidents, recalls and corrective measures
- Create an EU Login account and learn the Safety Business Gateway workflow
- Agree in writing with your EU rep who reports accidents and runs recalls
- Keep sales and buyer contact data by country for reporting and direct notice
- Prepare a multilingual recall notice template with all Article 36 elements
- Pre-define at least two remedies (repair, replacement, refund) and return logistics
- Check the Safety Gate portal regularly for alerts on similar products
Common mistakes
Waiting for the investigation to finish before reporting
Article 20 requires accidents to be notified without undue delay from the moment you know of them, and Article 9(8) requires immediate action on dangerous products. Report what you know and add information when authorities ask, rather than waiting for final conclusions.
Playing down the risk in the recall notice
Calling it a "voluntary" or "precautionary" recall, saying the problem occurs "only in rare situations" or that "no accidents have been reported" breaches Article 36(2)(c). The headline must read "Product safety recall" and the hazard and the instruction to stop using the product must be clear.
Posting a notice but not contacting buyers, and charging for returns
Affected consumers who can be identified must be notified directly, using the customer data operators and marketplaces hold (Article 35(1)). Remedies must be free: consumers never pay shipping or return costs (Article 37(5)).
Frequently asked questions
Do I have to report minor injuries?
Article 20 covers accidents that caused death or serious adverse effects on health and safety, including injuries, whether permanent or temporary. Trivial incidents usually do not reach that threshold, but seriousness is a case-by-case judgement. If unsure, ask your EU rep or a lawyer and record your reasoning in your register.
How does a non-EU seller file in the Safety Business Gateway?
According to the Commission, you need to create or use an EU Login account to submit. The manufacturer can file itself; where the manufacturer is outside the EU, the EU responsible person must make sure accidents are notified. Agree in advance who will file.
Will my notification be made public?
Submissions go first to the relevant market surveillance authorities. If they find a serious risk, they notify it through the Safety Gate Rapid Alert System, and selected information may then appear on the public Safety Gate portal.
Can I call it a "voluntary" or "precautionary" recall?
No. Article 36(2)(c) forbids terms such as "voluntary", "precautionary", "discretionary", "in rare situations" or "in specific situations" and statements that no accidents have been reported, because they reduce the perceived risk.
Can I offer a refund only?
Normally you must offer a choice of at least two of repair, replacement and refund. A single remedy is allowed only if the others are impossible or disproportionately costly. A refund must be at least the price paid, and the consumer never pays return shipping.
Official sources
- Regulation (EU) 2023/988 on general product safety (EUR-Lex)
- Commission Notice C/2025/6238 – Guidelines for the practical implementation of the Safety Business Gateway
- Commission Notice C/2025/6233 – Guidelines on the application of the EU general product safety legislative framework by businesses
- Commission Implementing Regulation (EU) 2024/1435 – recall notice template (EUR-Lex)
- Safety Gate – EU rapid alert system for dangerous non-food products
- Safety Business Gateway (European Commission)
This guide explains Regulation (EU) 2023/988 in plain language. It is general information, not legal advice. Requirements can depend on your product, other EU laws and the member state — check the official text and, for your own case, a qualified adviser.