EU GPSR FAQ Dangerous Product Risk Levels

Start with the product and hazard. Commission Delegated Regulation (EU) 2024/3173 requires national authorities making the Safety Gate assessment to describe a harm scenario: how a defect or dangerous situation causes an accident or adverse effect and then harm, how severe the harm is, and how probable the full sequence is during the product's foreseeable lifetime. An economic operator should supply product-specific evidence that lets the authority test those points.

Severity has four levels. Level 1 is minor and normally reversible after basic treatment; level 2 is moderate, may require a hospital visit but generally not hospitalisation, and affects functioning for no more than six months; level 3 is severe, normally requires hospitalisation and affects functioning for more than six months or permanently; level 4 is life-threatening or potentially fatal and includes severe loss of limbs or function. Authorities may depart from this table only in exceptional cases and must justify the departure.

Probability is the compound probability of the scenario steps, not the frequency of the defect alone. The delegated index runs from very frequent at 50% or more during foreseeable product life through frequent, common, occasional, unlikely, unusual, and rare to extremely rare at one in a million or less. The official grid combines that probability band with severity to produce serious, high, medium, or low risk.

The delegated criteria use four risk results for Safety Gate purposes: serious, high, medium, and low. Where several hazards or harm scenarios exist, national authorities must assess each scenario and use the highest resulting level for the Article 26 notification analysis.

The GPSR also treats some serious-risk situations differently. A serious risk can be presumed where the delegated criteria are met, including when the product is linked to probable severe harm without adequate consumer precautions or information, when the economic operator or online marketplace indicates serious risk, or when the product has been subject to recall, withdrawal, or online-content removal based on voluntary measures.

Serious risk matters because GPSR Article 26 uses Safety Gate for rapid exchange of information about corrective measures for dangerous products. The delegated Safety Gate rules classify serious-risk notifications separately from other-risk notifications and require the notification to include product identification, risk level, risk assessment, and the taken or envisaged corrective measures.

A serious-risk conclusion should therefore trigger two records at the same time: the consumer-safety action record and the notification evidence record. The first explains what will remove or reduce the risk; the second explains why the case is serious enough for Safety Gate handling and what information authorities need to identify the product and follow up.

Do not describe the risk level separately from the action. The evidence should show why the product is dangerous, which consumers or end users can be harmed, whether the product is still in listings, stock, distribution, or consumer hands, and which corrective measure is proportionate to reduce or eliminate the risk.

For a recall, the GPSR requires consumer-facing information that is clear enough for consumers to identify the product, understand the hazard, and know what action to take. The recall notice must avoid wording that lowers risk perception, such as presenting the recall as merely voluntary or precautionary when the product safety recall must be taken seriously.

Map any internal company score to the Safety Gate method before using it to support an authority notification. Retain the harm scenarios, severity and probability evidence, highest resulting risk level, any applicable presumption of serious risk, and the notification decision. Check national procedural steps with the relevant authority.

Also avoid treating any certificate, standard, or supplier statement as conclusive by itself. It can support the risk decision only when it matches the product, hazard, affected market, and corrective measure being documented.