EU General Product Safety Regulation Risk Evaluation

The GPSR applies to consumer products placed or made available on the EU market, including products not intended for consumers when consumers are likely to use them under reasonably foreseeable conditions. It applies to new, used, repaired, and reconditioned products, but excludes the categories listed in Article 2(2), including medicinal products, food, feed, plant-protection products, specified service-operated transport equipment, specified aircraft, and antiques. A product clearly marked for repair or reconditioning before use is also outside the Regulation.

For a product subject to specific Union safety requirements, identify the exact risk covered by that law before using Articles 5 to 8. The GPSR safety requirements apply only to aspects and risks not covered by the specific requirements. For products subject to Union harmonisation legislation, current Article 2 also excludes Chapter IIa and whole GPSR chapters, including the manufacturer obligations in Chapter III, Section 1; do not use this page to replace the sector law's risk assessment, conformity assessment, or technical documentation.

Article 5 sets the baseline for products to which Chapter II applies: economic operators may place or make available on the market only safe products. Start with the product's design, technical features, composition, packaging, assembly, installation, use, maintenance, labelling, warnings, and safe-disposal information.

Evaluate the product in its foreseeable setting. Article 6 covers effects on other products where combined use is reasonably foreseeable, effects 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. Article 6 also says that a safer alternative or the feasibility of a higher safety level does not, by itself, make the assessed product dangerous.

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 part of the safety assessment, but a warning does not erase a design or construction hazard. Manufacturers covered by Article 9 must provide clear instructions and safety information in a language consumers can easily understand, as determined by the Member State where the product is made available, unless the product can be used safely and as intended without them. An Article 7 presumption also does not prevent authority action when evidence shows that the product is dangerous.

Commission Delegated Regulation (EU) 2024/3173 directs Member State authorities assessing products for Safety Gate notifications to describe harm scenarios, classify severity, assess probability over the product's foreseeable lifetime, combine severity and probability into a serious, high, medium, or low risk level, and document the assessment unless a listed serious-risk presumption applies.

A business can use that sequence to prepare evidence, but its assessment does not bind the market surveillance authority. Keep each scenario tied to the intrinsic hazard, the shortest path to harm, the relevant user and behaviour, severity, probability, and supporting evidence. Where scenarios produce different levels, the delegated regulation tells authorities to use the highest identified level for Article 26.

For the delegated method, rate harm severity from 1 (minor and usually reversible after basic treatment) to 4 (life-threatening or otherwise very severe consequences), assign a probability to every step in the shortest harm scenario, and multiply those step probabilities to obtain the scenario probability. Apply the Annex II grid to severity and lifetime probability; do not average different harm scenarios or choose the most convenient result.

Manufacturers covered by Article 9 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 record should include the risk analysis, solutions used to eliminate or mitigate risks, test-report outcomes, and standards or other safety elements applied.

Keep the record current after launch. Complaints, accidents, supplier changes, component substitutions, connected-product changes, software updates, new standards, Safety Gate alerts, or authority feedback can change the evidence or assumptions and should trigger review. If a covered product is dangerous, the applicable economic operator duties can require corrective action, withdrawal or recall as appropriate, consumer information, and immediate authority notification through the Safety Business Gateway.