Short answer
The EU General Product Safety Regulation (Regulation (EU) 2023/988) applies to most consumer products placed on the EU market from 13 December 2024. It covers manufacturers, importers, distributors, and online sellers, requiring risk assessment, traceability labelling, and incident reporting for products not governed by sector-specific EU law.
What is the General Product Safety Regulation?
The General Product Safety Regulation, or GPSR, is Regulation (EU) 2023/988 of the European Parliament and of the Council. It replaced the General Product Safety Directive (2001/95/EC) and became applicable on 13 December 2024.
The GPSR is a safety net. It applies to consumer products that are not covered by sector-specific EU harmonisation legislation. Where a sector law already governs a product category in detail, such as toys, medical devices, or machinery, that law takes precedence. Where no such law exists, the GPSR sets the baseline safety obligations.
The regulation was a response to the growth of e-commerce and direct imports. The old directive dated from 2001, before online marketplaces reshaped retail. The GPSR modernises the framework with explicit duties for online marketplaces, distance sellers, and fulfilment service providers.
The official text is published on EUR-Lex as Regulation (EU) 2023/988.
Which products does the GPSR cover?
The GPSR applies to products intended for consumers, or likely to be used by consumers under reasonably foreseeable conditions, even if not intended for them. This is a broad scope.
Products covered include, for example:
* Furniture and home furnishings without sector-specific rules * Sporting goods and outdoor equipment * Childcare articles not covered by the Toy Safety Directive * Textiles and apparel (general safety aspects)
Products excluded from GPSR scope include those already governed by sector-specific EU legislation that covers the same safety aspects:
| Product category | Governing EU law | GPSR applies? |
|---|---|---|
| Toys | Toy Safety Directive 2009/48/EC | No, sector law prevails |
| Medical devices | Regulation (EU) 2017/745 | No, sector law prevails |
| Machinery | Regulation (EU) 2023/1230 | No, sector law prevails |
| General consumer goods | None specific | Yes, GPSR is the safety net |
| Food | Regulation (EC) 178/2002 | No, separate framework |
Antiques and products supplied as second-hand goods requiring repair or reconditioning prior to use may also fall outside scope in defined circumstances.
Who has obligations under the GPSR?
The GPSR assigns duties across the supply chain. Each economic operator has distinct responsibilities.
Manufacturers must ensure products are designed and manufactured to the general safety requirement. They must carry out a risk assessment, draw up technical documentation, and keep it for ten years. They must label products with traceability information and provide safety instructions in the language of the member state of sale.
Importers must verify that the manufacturer has complied before placing products on the EU market. They must add their own name and contact details to the product or packaging, ensure instructions are in the correct language, and keep a copy of the technical documentation.
Distributors must act with due care. They must verify that products bear the required traceability information and safety instructions before making them available. They must not supply products they know, or should know, are unsafe.
Online marketplaces have new, explicit duties. They must establish a single point of contact for market surveillance authorities, register with the Safety Gate portal, and act on notices about dangerous products. They must remove listings for products flagged as dangerous.
Fulfilment service providers that store, package, or ship products without being the manufacturer, importer, or distributor are also treated as economic operators with defined duties.
What is the general safety requirement?
Article 5 of the GPSR states the core rule: manufacturers must place only safe products on the market. A product is assessed as safe based on:
* Its characteristics, including composition and packaging * Its effect on other products it may be used with * Its presentation, labelling, and instructions * The categories of consumers at risk, with particular attention to children, older people, and persons with disabilities * The appearance of the product, where it could be confused with food * Cybersecurity features where the product has digital elements
The assessment must consider the entire lifecycle of the product under normal and reasonably foreseeable conditions of use.
What traceability information is required?
Every product within scope must allow identification of the product and the economic operators in the supply chain. The GPSR requires:
* A type, batch, or serial number, or another element allowing product identification, visible and legible on the product or its packaging * The name, registered trade name or trademark, and contact address (including electronic address) of the manufacturer * For importers, their name and contact details in addition to the manufacturer details
Where the size or nature of the product makes this impractical, the information may go on the packaging or in an accompanying document.
What are the incident reporting duties?
Economic operators must notify authorities through the Safety Business Gateway when they know a product they placed on the market presents a risk to consumer health and safety. The notification must describe the risk, the product identification, and the corrective measures taken.
Online marketplaces must also notify when they become aware of an accident caused by a product sold through their platform that results in serious risk or actual harm.
How does GPSR enforcement work?
Market surveillance authorities in each EU member state enforce the GPSR. They can require corrective action, order withdrawals or recalls, and impose penalties. The regulation requires member states to set penalties that are effective, proportionate, and dissuasive.
The Safety Gate system (formerly RAPEX) is the EU rapid alert system for dangerous non-food products. Authorities notify through Safety Gate, and the Commission publishes weekly overviews of products subject to corrective measures.
Checklist: GPSR readiness for sellers
* [ ] Confirm whether sector-specific EU law covers your product, or whether GPSR is the applicable framework * [ ] Complete a documented risk assessment addressing the Article 5 criteria * [ ] Prepare technical documentation and retain it for ten years * [ ] Add traceability labelling: product identifier plus manufacturer name and contact details * [ ] Provide safety instructions in the language of each member state of sale * [ ] If importing, add importer name and contact details and verify manufacturer compliance * [ ] If selling online, ensure marketplace listings carry the required traceability information * [ ] Establish an incident monitoring and Safety Business Gateway notification procedure
How does the GPSR interact with the Market Surveillance Regulation?
The GPSR does not operate in isolation. It works alongside Regulation (EU) 2019/1020 on market surveillance and compliance of products, which provides the enforcement machinery. Understanding the division of labour between the two regulations helps sellers know which rules govern their obligations and which govern how authorities check them.
The GPSR sets the substantive safety duties: the general safety requirement, risk assessment, traceability, and incident reporting. The Market Surveillance Regulation sets the procedural framework: how authorities organise checks, what powers they have, how they cooperate across borders, and how the EU Product Compliance Network coordinates.
In practice, a market surveillance authority inspecting your product will invoke GPSR articles for the safety requirements and the Market Surveillance Regulation for its powers to request documents, take samples, or order corrective action. Your compliance file should satisfy both: the GPSR technical documentation demonstrates the product is safe, and your cooperation procedures address the authority powers under the surveillance regulation.
The two regulations also share information systems. Safety Gate carries rapid alerts for dangerous products. The Information and Communication System for Market Surveillance (ICSMS) supports authority cooperation. The Safety Business Gateway is the channel for economic operator notifications under the GPSR.
What role do harmonised standards play under the GPSR?
Unlike harmonisation directives, the GPSR does not operate through CE marking and harmonised standards giving presumption of conformity. Instead, the Commission may adopt implementing acts determining that a European standard satisfies the general safety requirement for defined products.
Where such a standard exists and the manufacturer applies it, the product is presumed safe for the risks covered. Where no standard exists, the manufacturer assesses safety directly against the Article 5 criteria and other elements such as national rules, industry codes of practice, and the state of the art.
This means GPSR compliance is more judgement-driven than directive compliance. The risk assessment carries greater weight because there is no harmonised standard to lean on. Document the reasoning thoroughly: which hazards were considered, what evidence supports the conclusions, and why the chosen protective measures are adequate.
How should small businesses approach GPSR compliance?
Small and medium enterprises face the same legal duties as large manufacturers, but the Commission guidance recognises proportionality in how they are met. A small business selling a simple product does not need the same documentation apparatus as a multinational, but it does need the same elements: a risk assessment, traceability labelling, and incident procedures.
Practical steps for smaller sellers:
* Use the Commission guidance and any sector-specific guides as the starting template for the risk assessment * Keep the technical documentation concise but complete; a short file that addresses every element beats a long file with gaps * For traceability, a simple batch coding system is sufficient if it allows the product and its production run to be identified * For incident monitoring, designate one person to review customer complaints for safety signals weekly * For online sales, verify that each listing displays the required manufacturer and EU operator information before it goes live
The most common SME failure is assuming the regulation targets only large companies. Enforcement samples include small sellers, particularly in e-commerce sweeps.
What enforcement actions have authorities taken under the GPSR?
The GPSR enforcement record is building as authorities apply the regulation to inspections and online sweeps. The patterns emerging are instructive for sellers setting compliance priorities.
Market surveillance authorities in multiple member states have conducted coordinated sweeps of online listings checking for the required traceability information: manufacturer name and contact details, and where applicable, the EU-based economic operator. Listings missing this information have been subject to removal requests through the Safety Gate system.
Product categories attracting attention include electronics accessories, toys adjacent to the GPSR scope, childcare articles outside harmonised legislation, and sporting goods. The common findings are missing warnings, inadequate instructions, and absent traceability labelling, all visible without laboratory testing.
The lesson is that GPSR enforcement starts with the visible elements. Authorities check what they can see first: labels, listings, and documentation. Sellers should audit these before worrying about edge cases in the risk assessment methodology.
How should sellers structure GPSR documentation for multiple products?
Sellers with product ranges need a documentation architecture that scales. A practical model:
Product family files. Group variants sharing design, materials, and hazards into a family file with a single risk assessment covering the family and annexes for variant-specific differences. This avoids duplicating the full assessment for each colour or size variant.
Platform documentation. For sellers using common platforms or components across products, maintain platform-level documentation for the shared elements and product-level files for the differentiating features.
Listing compliance register. A central register mapping each SKU to its online listings, with verification that each listing displays the required information. Review the register when listings change.
Incident log. A single log across the product range for customer complaints with safety relevance, reviewed on a defined schedule.
This architecture keeps the marginal cost of adding a product low while maintaining the completeness authorities expect.
Sources
* Regulation (EU) 2023/988 on general product safety: https://eur-lex.europa.eu/eli/reg/2023/988 * European Commission GPSR overview: https://commission.europa.eu/business-economy-euro/product-safety-and-requirements/product-safety/general-product-safety-regulation_en * EU Safety Gate rapid alert system: https://ec.europa.eu/safety-gate/