We got a safety complaint and cannot tell if it is serious
The General Product Safety Regulation (EU) 2023/988 requires manufacturers and importers to investigate complaints alleging that a product is dangerous and to keep a register of them. Whether the complaint is serious is a risk question: assess the product's characteristics, its presentation, the consumers who use it and its foreseeable use. If you have reason to believe the product is dangerous, corrective measures and a Safety Business Gateway notification follow.
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Reviewed 28 September 2026 by the Conphora compliance team · Not legal advice
Why this happens
The General Product Safety Regulation (EU) 2023/988 does not let a company decide that a complaint is not worth looking at. Manufacturers must investigate complaints, and information received on accidents, that concern the safety of products they made available and that the complainant alleges to be dangerous, and keep an internal register of those complaints together with recalls and corrective measures (Article 9(12)). Importers investigate and file in the same way (Article 11(10)). The register holds only the personal data the investigation needs, for no longer than five years after the data were entered (Articles 9(13) and 11(11)).[1]
Whether a complaint is serious is answered by the regulation's own yardstick. A dangerous product is any product that is not a safe product (Article 3(3)), and Article 6(1) lists, among others, the aspects an assessment takes into account: the product's characteristics, its effect on and from other products, its presentation, labelling and warnings, the categories of consumers using it, and an appearance that invites a use it was not designed for. A serious risk is one that requires rapid intervention by the authorities (Article 3(5)).[1]
The decision has consequences in both directions. A manufacturer who, on the information in its possession, has reason to believe a product it placed on the market is dangerous must immediately take corrective measures, inform consumers and notify the market surveillance authorities of the Member States where the product was made available through the Safety Business Gateway (Article 9(8)); the importer has the same duty and informs the manufacturer first (Article 11(8)). Whatever you decide, the authority may later ask for a full description of the risk, related complaints and known accidents (Article 15(2)).[1]
The Commission's guidance for businesses says the same in plain words: address consumer complaints, investigate them thoroughly, and if a product turns out to be dangerous, act before it causes harm.[3]
Market surveillance follows Regulation (EU) 2019/1020. Where an operator fails to take corrective action, the authority ensures that the product is withdrawn or recalled, or that its being made available is prohibited or restricted (Article 16(5)).[2]
How to solve it
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Log the complaint in the register
Manufacturers and importers must investigate complaints alleging that a product is dangerous and keep an internal register of complaints, recalls and corrective measures. Enter the complaint the day it arrives, with the product identification and only the personal data the investigation needs.
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Ask the complainant what happened
Which product and batch, how it was used, what went wrong, and whether anyone was hurt. A death or a serious adverse effect on health and safety, including injuries, is an accident with its own notification duty; a complaint without such harm stays on this route.
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Assess the risk against the Article 6 aspects
Look at the product's design and composition, its interaction with other products, its presentation and warnings, the consumers who use it, especially children, older people and persons with disabilities, and whether its appearance invites misuse. A serious risk is one that requires rapid intervention by the authorities, including where the effects are not immediate.
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Compare with what you already know
Read the complaint against the technical documentation and the internal risk analysis, the test reports, earlier complaints in the register and Safety Gate alerts on similar products. One complaint that matches a known failure mode weighs more than one that does not.
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Decide, act and tell the chain
If you now have reason to believe the product is dangerous, take corrective measures immediately, inform consumers and notify the authorities of the Member States where the product was made available through the Safety Business Gateway. If not, record the decision and its reasons with the register entry. Manufacturers keep the supply chain informed of any safety issue they identify; importers keep the manufacturer, distributors and marketplaces informed of the investigation and its result.
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What you need to show
| Document | Where it comes from | Legal ground |
|---|---|---|
| The register entry | The manufacturer's or importer's internal register | GPSR Articles 9(12) and 11(10) |
| The risk assessment | Your investigation, against the Article 6 aspects | GPSR Article 6 |
| Technical documentation with the internal risk analysis | The manufacturer | GPSR Article 9(2) |
| A written decision on the complaint | You, filed with the register entry | Supports GPSR Article 15(2) on request |
If you do nothing
You cannot answer the authority
On request, an economic operator provides a full description of the risk, related complaints and known accidents, and of any corrective measure taken, and must be able to present that information for 10 years (GPSR Article 15(2) and (4)).[1]
The authority orders the measure
Where an operator fails to take corrective action or the risk persists, the authority ensures the product is withdrawn or recalled and informs the public (Regulation (EU) 2019/1020, Article 16(5)).[2]
Penalties under national law
Each Member State lays down effective, proportionate and dissuasive penalties for infringements of the regulation (GPSR Article 44).[1]
Questions about this problem
We are a distributor. Must we keep a register?
The register duty is on the manufacturer (GPSR Article 9(12)) and the importer (Article 11(10)). A distributor who has reason to believe a product is dangerous immediately informs the manufacturer or importer, ensures corrective measures are taken and ensures the authorities are informed (Article 12(4)).
Do we need a channel for complaints?
Yes. Manufacturers make communication channels such as a telephone number, an electronic address or a dedicated section of their website publicly available for complaints, accidents and safety issues (GPSR Article 9(11)); importers verify that they exist and provide them otherwise (Article 11(9)).
What does the regulation mean by a serious risk?
A risk which, based on a risk assessment and taking into account the normal and foreseeable use of the product, is considered to require rapid intervention by the market surveillance authorities, including where the effects are not immediate (GPSR Article 3(5)).
How long may we keep the complainant's personal data?
Only as long as the investigation needs it, and no longer than five years after the data were entered in the register (GPSR Article 9(13)).
When does a complaint become an accident notification?
When the occurrence resulted in death or in serious adverse effects on health and safety, permanent or temporary, including injuries (GPSR Article 20(2)). Then the manufacturer notifies the authority of the Member State where it happened, without undue delay.
Sources
- Regulation (EU) 2023/988 on general product safety EUR-Lex · accessed 27 September 2026
- Regulation (EU) 2019/1020 on market surveillance and compliance of products EUR-Lex · accessed 27 September 2026
- Safety Gate — obligations for businesses European Commission · accessed 27 September 2026
About this page
- Reviewer
- Conphora compliance team
- Reviewed
- 28 September 2026
General information, not legal advice. Check the legal text or ask an adviser about your own product.
Conphora (2026). We got a safety complaint and cannot tell if it is serious. Retrieved 13 October 2026 from https://www.conphora.com/solutions/problem/safety-complaint/
Conphora (2026) We got a safety complaint and cannot tell if it is serious. Available at: https://www.conphora.com/solutions/problem/safety-complaint/ (Accessed 13 October 2026).
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author = {Conphora},
title = {We got a safety complaint and cannot tell if it is serious},
year = {2026},
url = {https://www.conphora.com/solutions/problem/safety-complaint/},
note = {Retrieved 13 October 2026}
} See it working before you add a product
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