EU General Product Safety Regulation (Regulation (EU) 2023/988)
The safety net for every consumer product placed on the EU market, and the whole safety regime for consumer products no sector-specific law covers. It puts obligations on manufacturers, importers, distributors, fulfilment providers and online marketplaces, requires a responsible person in the Union, and sets the rules for accident notification, traceability, recalls and cooperation with market surveillance.
licensed text The requirement text and the evidence an inspector accepts sit behind this regime, licensed from a human-verified corpus.
What it expects in the file
- Technical file
The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market. - Risk assessment
The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - Labelling and instructions
Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market. - Traceability records
Batch, lot or serial identification on the product, the records that tie a unit to its production and supply chain, and UDI where the device rules require it.
Duties that continue after sale
- Market surveillance cooperation
Answer an authority's request for the technical file, the declaration and the supply chain within the time it sets, in a language it accepts, and cooperate with any corrective measure it requires. - Incident reporting
Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock. - Recall readiness
Be able to identify affected units, reach the customers who hold them, issue a notice in the required form, offer the remedy the rules require, and show the authority the effectiveness of the action. - Traceability records
Keep the records that identify which batch went to which customer, and the identification on the product that lets a unit be traced back, for the retention period the regime sets.
Every control, with the requirement text
22 controls. Requirement text and evidence artefacts from a human-verified corpus. Data licensed to Conformity Sheet by The Art of Service Pty Ltd, revocable, non-transferable. Framework page: compliance.theartofservice.com/frameworks/eu-general-product-safety-regulation-gpsr-regulation-2023988.
GPSR: 22 controls
GPSR Art.10, 11, 12 Authorised representatives, importers and distributors (Articles 10-12)Article 10 governs authorised representatives (written mandate; tasks include keeping the EU declaration / technical documentation available for 10 years + cooperation with market surveillance). Article 11 sets importer obligations: place safe products + verify Article 9 manufacturer compliance + place importer identity + contact details on the product or packaging + ensure technical documentation availability + Article 11(7) Article 9-style corrective action where the importer becomes aware of a dangerous product. Article 12 sets distributor obligations: due care + verify CE marking and labelling are present + verify required information accompanies the product + report serious risks to manufacturers / importers.
Common gap: Non-EU manufacturer placing products without an authorised representative + responsible person in the Union (Article 16)
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.13, 16 Cases where manufacturer obligations apply to other persons + responsible person in the Union (Articles 13 and 16)Article 13 provides that an importer, distributor or other economic operator is considered to be a manufacturer + subject to Article 9 obligations where the operator places on the market under its own name or trademark, modifies the product in a way that may affect compliance with Article 5, or carries out other Article 13(2) modifications. Article 16 establishes the 'responsible person in the Union' rule: a product can only be placed on the market if there is an economic operator established in the Union responsible for the Article 9 + Article 10 + Article 16(2)-(3) obligations (manufacturer or its authorised representative or the importer or - new under GPSR - a fulfilment service provider established in the Union; Article 16(4) records and tasks).
Common gap: Non-EU manufacturer placing products on the Union market without an Article 16 responsible person
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.14, 15, 17 Internal processes, market surveillance cooperation and information sharing (Articles 14, 15, 17)Article 14 requires economic operators to ensure that they have internal processes for product safety enabling them to comply with the requirements of this Regulation. Article 15 obliges economic operators to cooperate with market surveillance authorities, including providing on request all information and documentation necessary to demonstrate the safety of the products and to remedy any non-compliance. Article 17 enables Member States to ensure that economic operators receive on request relevant information on the Regulation in an accessible and reusable format.
Common gap: Manufacturer without documented internal product-safety processes
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.18 Specific traceability requirements (Article 18)Article 18 empowers the Commission to adopt delegated acts adding specific traceability requirements for certain products, categories or groups of products that present serious risks. Such requirements may include traceability of intermediate operators, specific labelling (e.g. QR codes, machine-readable tags), product passport or recordkeeping obligations. The Article 18 delegated acts are categorical (apply to identified product types).
Common gap: Operating in a product category subject to Article 18 delegated requirements without compliance
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.19 Distance sales (Article 19)Article 19 requires that, where economic operators make products available on the market online or through other means of distance sales, they ensure that the corresponding online offer clearly and visibly indicates at least: (a) name, registered trade name or registered trade mark of the manufacturer, as well as the postal and electronic address at which they can be contacted; (b) where the manufacturer is not established in the Union, the name, postal and electronic address of the Article 16 responsible person; (c) the information allowing identification of the product, including a picture of it, its type and any other product identifier; (d) any warning or safety information that should be affixed on the product or packaging or included in an accompanying document in accordance with the Regulation or with applicable Union harmonisation legislation, in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market.
Common gap: Online product listing without manufacturer + Article 16 responsible person + warnings in consumer language
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.1, 2, 3 Objective, scope and definitions (Articles 1-3)Article 1 sets the objective: lay down rules on safety of consumer products placed or made available on the market. Article 2 sets the scope: consumer products that are placed or made available on the market in the Union (including in the course of providing a service), with sectoral carve-outs for products covered by other Union law (medical devices under MDR/IVDR, motor vehicles, foodstuffs etc.). Article 3 supplies definitions, including 'product', 'consumer product', 'safe product', 'dangerous product', 'economic operator', 'manufacturer', 'authorised representative', 'importer', 'distributor', 'online marketplace provider', 'placing on the market', 'making available on the market', 'recall', 'withdrawal', 'distance sales', 'serious risk'. Note: products with digital elements covered by the Cyber Resilience Act ((EU) 2024/2847) are subject to CRA cybersecurity requirements under the CRA-Art.11 derogation; GPSR continues to apply to non-cybersecurity safety dimensions.
Common gap: Applying GPSR cybersecurity rules to PDEs covered by CRA (CRA Art.11 carve-out applies for the cybersecurity dimension)
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.20 Accident notification (Article 20)Article 20 requires manufacturers to notify, through the Safety Business Gateway, any accident caused by a product they placed or made available on the market, without undue delay from the moment they know or ought to know about the accident. The notification covers the type and identifier of the product, the circumstances of the accident if known, the remedial actions taken or planned. Where the accident has resulted in serious risk or fatality, the notification must be made within 2 working days.
Common gap: No Article 20 notification path
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.21 Information in electronic format (Article 21)Article 21 allows certain information that is required to be on the product or in an accompanying document (e.g. instructions, safety information) to be provided in electronic format (e.g. QR code, NFC, app), without prejudice to specific Article 9(5)-(7) physical-information requirements. Where electronic format is used, the consumer must be able to access the information easily and free of charge, with paper-format alternative available on request.
Common gap: Electronic-format reliance for information that Article 9(5)-(7) requires in physical form
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.22 Specific obligations of providers of online marketplaces (Article 22)Article 22 imposes specific product-safety obligations on providers of online marketplaces. (1) register with the Safety Gate Portal; (2) Article 22(3) include in their terms and conditions the obligation for traders to comply with GPSR + provide accurate product-safety information; (3) Article 22(4) establish a single point of contact for product safety, communicating with market surveillance authorities; (4) Article 22(7) provide product-recall interface for users to identify whether they purchased a recalled product, and notify users of recalls / serious risks; (5) Article 22(8)-(10) DSA-style notice-and-takedown for content offering dangerous products (3-working-day turnaround for serious-risk products); (6) Article 22(11) random sampling capability for market surveillance; (7) Article 22(12) cooperate with the Article 31 joint activities. Article 22 interfaces with the DSA-Art.30 trader-traceability regime.
Common gap: Online marketplace without Safety Gate Portal registration
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.23, 24 Market surveillance and reporting (Articles 23-24)Article 23 applies Regulation (EU) 2019/1020 (the EU market-surveillance framework Regulation) to GPSR-covered products, with the GPSR-specific calibrations in this Chapter. Article 24 requires Member States to report annually to the Commission on market surveillance activities, with statistics on accidents, recalls, enforcement actions and resources.
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.25, 26, 27 Safety Gate Rapid Alert System, Safety Business Gateway and dangerous-product notification (Articles 25-27)Article 25 establishes the Safety Gate Rapid Alert System (the successor to RAPEX) operated by the Commission as a network for the rapid exchange of information between Member State market surveillance authorities + the Commission + the EEA EFTA states on dangerous products and measures taken. Article 26 sets the notification process for dangerous products through Safety Gate (immediate notification for serious risks + within 5 working days for non-serious risks). Article 27 establishes the Safety Business Gateway through which economic operators submit accident notifications (Article 20), corrective-action notifications (Article 9(8)) and other voluntary or required safety information.
Common gap: No internal Safety Gate monitoring
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.28, 29 Union action against products presenting a serious risk and risk-assessment divergence (Articles 28-29)Article 28 enables the Commission, by implementing acts, to take Union-wide measures against products presenting a serious risk where the necessary action of the Member States is divergent or where the risk has a Union-wide dimension. Article 29 enables the Commission to request the opinion of the Consumer Safety Network or other relevant bodies where risk assessments of the same product diverge across Member States.
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.30, 31, 32 Consumer Safety Network, joint activities and coordinated control (Articles 30-32)Article 30 establishes the Consumer Safety Network bringing together Member State authorities + the Commission to exchange information on product safety and to coordinate. Article 31 enables joint activities on product safety between market surveillance authorities (Sweeps - coordinated checks). Article 32 enables simultaneous coordinated control actions (Sweeps Plus).
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.33, 34 Information between authorities and Safety Gate Portal public interface (Articles 33-34)Article 33 governs information exchange between authorities and the general public. Article 34 establishes the public-facing Safety Gate Portal (ec.europa.eu/safety-gate) where consumers can browse recalls + dangerous-product notifications + submit complaints. Article 34(5) requires Member States to provide direct links from national consumer-protection sites.
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.35 Information from economic operators and providers of online marketplaces to consumers on product safety (Article 35)Article 35 requires economic operators and providers of online marketplaces to inform consumers directly + effectively about a recall or safety warning concerning their products. Article 35(2) requires the use of all communication channels available to the operator (email, push notifications, account-based messaging, public website + social-media announcement) where the operator has the contact details of consumers who purchased the product. Article 35(3) prescribes plain-language + accessible-language messaging.
Common gap: Recall communicated only via public website without direct messages to purchasers
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.36, 37 Recall notice template and remedies (Articles 36-37)Article 36 mandates the use of the common Article 36 recall-notice template (Annex), which includes product identifier + photo + risk description + clear instructions to consumers + remedies offered + contact details. Article 37 sets the remedies the operator must offer free of charge: at least 2 of (repair / replacement / adequate refund) - and may include other remedies (e.g. credit). The 'adequate refund' includes acquisition price plus reasonable compensation for inconvenience.
Common gap: Recall notice missing Article 36 Annex content
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.38, 39 Memoranda of understanding and representative actions (Articles 38-39)Article 38 enables the Commission to conclude memoranda of understanding (MoUs) with stakeholders (manufacturers / retailers / online marketplaces / consumer associations) to promote product safety. The Pledge on Product Safety with online marketplaces is the prominent example. Article 39 applies Directive (EU) 2020/1828 on representative actions to GPSR breaches.
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.40, 41, 42, 43 International cooperation, financing, Union protection and liability (Articles 40-43)Article 40 enables the Commission to cooperate with third-country authorities and international organisations on product safety. Article 41 governs the Union financing of GPSR activities. Article 42 contains a no-prejudice clause for Union financial interests. Article 43 provides that any GPSR decision creates no liability of the Union or of the Member States or of the authorities beyond what national law and Union law otherwise provide.
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.44 Penalties (Article 44)Article 44 requires Member States to lay down rules on penalties applicable to infringements of the Regulation. Penalties must be effective, proportionate and dissuasive. Article 44(3) sets the criteria for fixing the level of penalty (nature, gravity, duration, intentionality, recidivism, financial gain, mitigation efforts). Article 44(4) sets the maximum administrative-fine threshold at 4% of the relevant economic operator's annual turnover in the Member State (or Union turnover where applicable) for the most serious infringements (placing dangerous products on the market with knowledge / persistent breach).
Common gap: Compliance program ignoring the Article 44(4) 4%-turnover penalty exposure
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.45, 46, 47, 48, 49, 50, 51, 52 Delegation, committee, evaluation, amendments and entry into force (Articles 45-52)Article 45 governs the exercise of the delegation of power to the Commission (Article 18 traceability + Article 28 Union action). Article 46 sets the committee procedure (the General Product Safety Committee). Article 47 requires the Commission to evaluate the Regulation by 13 December 2029 and every 5 years thereafter. Article 48 amends Regulation (EU) No 1025/2012 (standardisation). Article 49 amends Directive (EU) 2020/1828 to include the GPSR in the representative-actions scope. Article 50 repeals Directive 2001/95/EC (the prior GPSD) and Council Directive 87/357/EEC (dangerous-imitations rules) from 13 December 2024. Article 52 provides that the Regulation entered into force on 12 June 2023 and applied from 13 December 2024.
Common gap: Operating against the 2001/95/EC baseline after 13 Dec 2024 (repealed)
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.5, 6, 7, 8 General safety requirement and assessment criteria (Articles 5-8)Article 5 establishes the general safety requirement: economic operators shall place or make available on the market only safe products. Article 6 sets the criteria for assessing safety: the characteristics of the product including its composition, packaging, instructions for assembly and, where applicable, installation, use and maintenance; the effect on other products where it is reasonably foreseeable that it will be used with other products; the effect that other products might have on the product; the presentation of the product, the labelling, any warnings; the categories of consumers at risk when using the product, in particular vulnerable consumers such as children, older people and persons with disabilities; the appearance of the product where it could lead consumers to use the product in a way different from the one for which it was intended; the cybersecurity features necessary to protect the product against external influences, including malicious third parties, where these have a bearing on the safety of the product. Article 7 sets the presumption of conformity (where the product is in conformity with European standards or parts thereof referenced in the OJ, or with national requirements in absence of EU standards). Article 8 adds additional assessment elements (state of the art, conformity with voluntary standards, codes of conduct, reasonable consumer-safety expectations).
Common gap: Placing on market without an Article 6 assessment file
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
GPSR Art.9 Obligations of manufacturers (Article 9)Article 9 imposes the central manufacturer obligations: (a) carry out internal risk analysis and draw up technical documentation containing the analysis + identification of relevant European standards or risk-assessment elements (kept for 10 years); (b) place safe products on the market that comply with Article 5 + Article 6 + Article 7 + Article 8; (c) ensure traceability (type / batch / serial number on the product or, where the size or nature does not allow, on the packaging or in a document accompanying the product); (d) include manufacturer identity (name, registered trade name, address) and contact details (single point of contact for safety queries) on the product or its packaging; (e) ensure clear and easy-to-understand instructions and safety information in a language easily understandable to consumers; (f) Article 9(8) corrective action obligation (recall + withdraw + remedies) where a dangerous product is identified; (g) Article 9(9)-(11) cooperation with market surveillance + 24-hour serious-risk notification via Safety Business Gateway.
Common gap: Product placed on market without Article 9(2) risk analysis + technical documentation
EU General Product Safety Regulation (GPSR, Regulation 2023/988) on compliance.theartofservice.com
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