How are dangerous product risk levels assessed under the EU GPSR?
Start with the product and hazard, not with a spreadsheet score. Commission Delegated Regulation (EU) 2024/3173 says the Safety Gate risk assessment describes a harm scenario: how the hazard leads to harm, how severe the harm is, and how probable it is during the product's foreseeable lifetime.
The delegated criteria use four risk results for Safety Gate purposes: serious, high, medium, and low. Where several hazards or harm scenarios exist, each scenario should be assessed and the highest resulting level should drive 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.
- Define the exact product, batch, model, software version, sales channel, and affected consumer group before assigning a risk level.
- Write the shortest credible path from defect or dangerous situation to accident or adverse effect and then to harm.
- Classify severity using the delegated levels for health and safety harm, then estimate probability for the scenario rather than for the product in the abstract.
- Use the highest assessed harm scenario when deciding whether the case is serious, high, medium, or low for Safety Gate notification purposes.
- Do not invent a company-only risk scale unless it maps back to the GPSR and Safety Gate evidence required for the case.
Grounds the Safety Gate risk-level method, including harm scenarios, severity, probability, serious/high/medium/low outcomes, highest-scenario handling, and presumptions of serious risk.
Grounds the GPSR duty to place only safe products on the market and the link between dangerous products, Safety Gate, corrective measures, recalls, and the Safety Business Gateway.