What is considered a “serious risk” under GPSR that triggers mandatory reporting?

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Jason van de Zande

Under the General Product Safety Regulation (EU) 2023/988 (GPSR), a “serious risk” is a product safety risk that warrants rapid action, often because the potential harm is severe and the likelihood of harm is not negligible. When a serious risk is identified, businesses may need to notify authorities through the EU’s Safety Gate tools. The key is a case-by-case, evidence-based risk assessment, supported by clear documentation and traceability.

What does “serious risk” mean under the GPSR for mandatory reporting?

“Serious risk” under the GPSR refers to a level of danger from a consumer product that may require rapid intervention by authorities to protect consumers. It is not defined by a single defect or a single test failure; rather, it is determined through a risk assessment based on the severity of possible harm and the probability that harm will occur in real-world use.

In practice, authorities and businesses look at what could happen (for example, choking, electric shock, burns, chemical exposure) and how likely it is, considering normal use and reasonably foreseeable conditions. Evidence can include accident data, complaint patterns, test results, design analysis, and information about the exposed user group, including vulnerable consumers such as children.

Which situations typically trigger mandatory reporting under the GPSR?

Mandatory reporting is typically triggered when information available to the business indicates that a product presents a serious risk to consumers, or when a reportable accident occurs and is linked to the product’s safety. Reporting is generally made to competent national authorities using the Safety Gate tools intended for businesses, and urgency depends on the risk level and how quickly harm could occur.

  • Accidents involving death or serious adverse effects on health and safety, whether temporary or permanent.
  • Credible consumer complaints that indicate a realistic risk of injury, especially when multiple reports show a pattern.
  • Test results showing non-compliance that creates a serious risk (for example, accessible live parts, excessive levels of hazardous substances, or dangerous mechanical failure).
  • Discovery of a design or manufacturing defect that can lead to severe harm under foreseeable conditions.
  • Safety-driven corrective actions such as withdrawal or recall, when the reason for the action is a serious risk.

Even when you are still investigating, you should treat early signals seriously, preserve evidence, and be prepared to escalate quickly if the risk assessment supports a finding of “serious risk.”

How should businesses assess and document whether a risk is “serious” under the GPSR?

A practical way to decide whether a risk is “serious” is to carry out a structured, written risk assessment that weighs harm severity against likelihood, using the best information available at the time. The output should explain your reasoning, the evidence reviewed, and what you did next. This documentation is also what authorities typically expect you to be able to provide on request.

  1. Gather facts quickly: product ID, batch or serial range, markets, photos, and what happened.
  2. Define the hazard and harm: identify the hazard type and credible injury outcomes.
  3. Identify exposed users: include vulnerable groups and foreseeable use and misuse.
  4. Estimate severity and likelihood: consider frequency of exposure, failure modes, and real-world conditions.
  5. Check existing controls: warnings, instructions, guards, software updates, and whether they work in practice.
  6. Decide corrective actions: stop-ship, listing suspension, field correction, withdrawal, or recall, aligned with the risk.
  7. Record traceability: keep technical documentation, supplier and test records, and distribution data so affected units can be identified.

If new evidence changes the likelihood or severity, update the assessment and your actions without delay.

How does EARP help with GPSR serious-risk assessment and mandatory reporting?

We support businesses that need a clear, defensible approach to GPSR serious-risk decisions and communications with authorities, while keeping role boundaries clear under the Market Surveillance Regulation (EU) 2019/1020 (MSR). Where applicable, we act as your EU Responsible Person (an economic operator role) and, if you choose to appoint one, your Authorized Representative, which is the role that notifies authorities of serious risks.

  • Set up an accident intake and escalation workflow, including what to collect and when to escalate.
  • Review risk assessment files and technical documentation for completeness and consistency.
  • Coordinate communications with market surveillance authorities when an Authorized Representative notification is required.
  • Support corrective action messaging, including withdrawal and recall communications aligned with EU expectations.
  • Provide a single compliance point of contact through our services.

If you need help determining whether your situation meets the GPSR serious-risk threshold, contact us via our contact page to discuss next steps.

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