Artifact GuideEU

EU General Product Safety Regulation Checklist

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.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
6

Structured answer sets in this page tree.

Primary sources
6

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 25, 2026
Overview

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.

Section 1

1. Confirm GPSR scope and EU role

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.

  • Flag products designed only for professional use that are likely to migrate to consumer use, because GPSR can still apply under reasonably foreseeable use.
  • For online or distance sales, confirm whether the offer targets EU consumers by dispatch options, language, ordering flow, currency, or other EU-directed activity.
  • If the product is substantially modified by physical or digital means, apply all three Article 13 criteria: the original risk assessment did not foresee the change; the hazard changes, a new hazard arises, or risk increases; and the change was not made by or for a consumer's own use.
  • For a product placed on the market before 13 December 2024, retain evidence if relying on Article 51: the product was covered by Directive 2001/95/EC, complied with it, and was placed on the market before that date.
Section 2

2. Complete the safety assessment and technical documentation

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.

  • Keep the internal risk analysis, product description, safety characteristics, applied standards or national requirements, partial-standard mapping, test reports, and mitigation decisions together.
  • Keep manufacturer technical documentation available to market surveillance authorities for 10 years after the product is placed on the market; importers must keep a copy available for the same period after placing the product on the market.
  • Add series-production controls so component changes, firmware changes, packaging changes, supplier changes, and complaint trends can trigger file review.
Section 3

3. Check traceability, labels, warnings, and the EU responsible person

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.

  • Verify product type, batch, serial number, or another visible and legible identifier, or place it on packaging or an accompanying document where product size or nature prevents direct marking.
  • Verify manufacturer name, registered trade name or registered trademark, postal address, electronic address, and any separate single contact point.
  • For imported products, verify importer name, registered trade name or registered trademark, postal address, and electronic address, and make sure the importer label does not obscure required manufacturer information.
  • Confirm clear instructions and safety information in a language easily understood by consumers in the Member State where the product is made available, unless the product can be used safely without them.
  • For products covered by the Article 16 responsible-person rule, verify the responsible person's name, registered trade name or registered trademark, postal address, and electronic address on the product, packaging, parcel, or accompanying document.
Section 4

4. Verify online listings and marketplace handling

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.

  • Block publication of listings missing manufacturer contact data, responsible-person data where required, product picture and identifier, or required warnings and safety information.
  • For marketplace takedown orders about dangerous-product offers, track receipt time and action taken because GPSR sets a two-working-day outer limit for acting on those orders.
  • For product-safety notices received through marketplace services, track the three-working-day processing deadline and preserve the trader, product, risk, and action record.
Section 5

5. Monitor complaints, accidents, and corrective actions

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.

  • Record every safety complaint, alleged dangerous-product report, accident report, investigation result, product lot, software version, affected Member States, and decision on risk level.
  • Notify reportable accidents through the Safety Business Gateway without undue delay once known; GPSR identifies reportable accidents as accidents caused by a product, associated with product use, and resulting in death or serious adverse health and safety effects.
  • Keep traceability data that identifies upstream suppliers of the product, parts, components, or embedded software and downstream economic operators supplied with the product.
Section 6

6. Prepare recall notices and consumer remedies

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.

  • Offer effective, cost-free, timely remedies for a product safety recall; GPSR requires a choice between at least two of repair, replacement, or refund unless the exception for impossible or disproportionate alternatives applies.
  • Do not call a recall voluntary, precautionary, discretionary, rare, or similar if that wording could reduce consumer perception of the hazard.
  • For online recall notices, make essential information from pictures machine-readable, especially product identification information.
Recommended next step

Turn the GPSR checklist into a release gate

Use the same evidence pack for product safety assessment, listings, labels, responsible-person checks, incident handling, recall notices, and corrective-action review.

Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • Current Article 2 supports the amended chapter-level exclusions for products subject to Union harmonisation legislation, including the conditional Chapter IIa internal-market-emergency provisions.
webgate.ec.europa.eu
Referenced sections
  • Supports the EU portal used for dangerous-product and accident notifications.
"Safety Business Gateway"
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