EU General Product Safety Regulation Risk Evaluation

Article 5 sets the baseline: economic operators may place or make available on the EU market only safe products. The risk evaluation should therefore start with the product's design, technical features, composition, packaging, assembly, installation, use, maintenance, labelling, warnings, and safe-disposal information.

Do not evaluate the product in isolation. GPSR Article 6 calls out effects on other products where combined use is reasonably foreseeable, the effect that other products or non-embedded items may have on the product, cybersecurity features where external influence could affect safety, and evolving, learning, or predictive functions where the product's nature requires them.

A GPSR risk evaluation should identify which safety references were used and what risks they cover. A product can benefit from the Article 7 presumption of conformity only for risks and risk categories covered by relevant European standards whose references have been published in the Official Journal; other standards, guidance, state of the art, consumer expectations, and safety codes may still be relevant under Article 8.

Warnings and instructions are not a substitute for safe design, but they are part of the evaluation where residual risks remain. The GPSR requires clear instructions and safety information in a language easily understood by consumers in the Member State of sale unless the product can be used safely and as intended without them.

The Safety Gate delegated regulation gives authorities a structured way to assess risk level for notifications: describe harm scenarios, assess severity, assess probability over the foreseeable lifetime of the product, determine the risk level, and document the assessment unless a serious-risk presumption applies.

For company records, do not invent a private scoring model that conflicts with the Safety Gate approach. Keep the evaluation tied to the product hazard, shortest credible path to harm, user type and behaviour, severity, probability, and the highest risk level across harm scenarios.

Manufacturers must carry out an internal risk analysis before placing products on the market and draw up technical documentation with at least a product description and essential characteristics relevant for safety. Where appropriate for possible risks, the file should include the risk analysis, solutions used to eliminate or mitigate risks, test-report outcomes, and standards or other safety elements applied.

The record should not stop at launch. Complaints, accidents, supplier changes, component substitutions, connected-product changes, software updates, new standards, Safety Gate alerts, or authority feedback can change the risk picture and should trigger review. If a product is dangerous, the GPSR expects corrective measures such as conformity action, withdrawal or recall as appropriate, consumer information, and Safety Business Gateway notification.