- Supports risk-assessment criteria for Safety Gate notifications and corrective-measure classification.
"level of the risk posed by a product"
The GPSR is the EU baseline product-safety framework for consumer products, with practical duties for safety assessment, traceability, online marketplaces, accident reporting, and recalls.
This page helps check product safety assessment, technical documentation, traceability, labels, online listings, incident reporting, recalls, and corrective actions.
Structured answer sets in this page tree.
Cited legal and guidance references.
The GPSR has applied since 13 December 2024. Use this checklist before an EU consumer product is listed, imported, distributed, substantially modified, or recalled. Its release question is whether the evidence supports a for normal and reasonably foreseeable use. It covers the product file, visible product and listing information, EU responsible person, marketplace handling, accident reporting, recall notices, and corrective-action evidence.
Start the checklist with the product, sales channel, and economic-operator role. GPSR applies to consumer products placed or made available on the EU market where there is no more specific EU safety rule with the same objective, and it also captures products sold online or by distance sales when the offer targets consumers in the Union.
Record whether the product is new, used, repaired, or reconditioned; whether it is excluded from GPSR scope; whether another Union law covers the same risk; and who is acting as manufacturer, importer, distributor, fulfilment service provider, authorised representative, or online marketplace provider. Article 2 excludes medicinal products, food, feed, living plants and animals, specified biological and agricultural products, certain service-operated transport equipment, specified aircraft, and antiques. Products clearly marked for repair or reconditioning before use are also outside Article 2(3). For harmonised products, apply the chapter exclusions in Article 2 instead of treating GPSR as an automatic gap filler.
Before placing the product on the market, the manufacturer must carry out an internal risk analysis and draw up technical documentation. The minimum file must describe the product and its essential safety characteristics. Where appropriate for the possible risks, add the risk analysis, mitigation choices, test-report outcomes, and standards or other safety elements applied.
The safety assessment must cover design, technical features, composition, packaging, assembly, installation, use, maintenance, interaction with other products, presentation, labelling, warnings, vulnerable consumer groups, food-imitating appearance, cybersecurity features where safety-relevant, and evolving or predictive functionality where applicable.
A cited European standard creates a presumption of conformity only for the risks and risk categories it covers when its reference has been published for GPSR purposes. Other standards, certification schemes, state-of-the-art evidence, and reasonable consumer expectations can inform the assessment under Article 8 but do not create the same Article 7 presumption. Authorities may still act where evidence shows that a product is dangerous.
The product must carry its identifier, or the identifier must appear on its packaging or an accompanying document where the product's size or nature prevents direct marking. Required operator details must appear in the locations each provision permits; a parcel by itself satisfies the placement rule only for the Article 16 responsible-person details. This checkpoint should be run before label approval, marketplace upload, fulfilment handoff, and any distributor acceptance review.
The checklist should also confirm a Union-established economic operator responsible for the Article 16 tasks, including regular checks against technical documentation and required product information where product risks make that appropriate.
For distance sales, the listing is part of the compliance surface. The offer must clearly and visibly show the manufacturer identity and contact details, the EU responsible person when the manufacturer is not established in the Union, product identification including a picture and type or other identifier, and any required warnings or safety information in the consumer language required for the target Member State.
If an online marketplace is involved, add a separate platform check. Marketplace providers need product-safety contact points, Safety Gate Portal registration, internal product-safety processes, listing fields that let traders provide the required information, notice processing, cooperation on recalls and accidents, and Safety Business Gateway notifications when they have actual knowledge of dangerous products offered through their interface.
The post-market checkpoint connects complaint intake, accident review, risk reassessment, corrective actions, consumer communication, and authority notification. Manufacturers must provide public complaint and safety channels, investigate relevant complaints and accident information, and keep a register of complaints, recalls, and corrective measures. Importers must verify that the manufacturer's channels exist, provide channels if they do not, investigate relevant complaints and accident information, and record them in the manufacturer's register or their own.
When a product is dangerous, the relevant operator must take or ensure corrective measures such as bringing the product into conformity, withdrawal, or recall as appropriate; inform consumers; and notify market surveillance authorities through the Safety Business Gateway with the risk, corrective measures, and available quantities by Member State.
If a product safety recall is needed, prepare both the direct consumer notice plan and the public recall notice. Directly notify affected consumers that can be identified without undue delay, use available customer personal data, and use wider channels when not all affected consumers can be contacted.
A written recall notice must use the GPSR recall-notice structure: headline, clear product description, picture and identifiers, sales information where available, hazard description without risk-minimising language, immediate consumer action, remedies, contact route, and an encouragement to share the recall where appropriate.
The GPSR and Commission implementing and delegated regulations cited here are binding law. The Safety Business Gateway page and system manual explain submission mechanics. Sorena's checklist ordering and evidence-pack structure are practical controls, not extra legal conditions or a substitute for product-specific EU law, Member State language rules, or authority instructions.
Use the same evidence pack for product safety assessment, listings, labels, responsible-person checks, incident handling, recall notices, and corrective-action review.
"level of the risk posed by a product"
"establishing the template for a recall notice"
"the name, registered trade name or registered trade mark"
"Product safety recall"
"Safety Business Gateway"