GPSR

# General Product Safety Regulation (GPSR) The EU General Product Safety Regulation (Regulation (EU) 2023/988), applicable from 13 December 2024, is the European Union's framework law for consumer product safety. It requires that only safe products be placed on the EU market, and it sets traceability, documentation, accident-reporting and cooperation duties for manufacturers, importers, distributors and online marketplaces. ## Key facts - Regulation (EU) 2023/988 applies in all EU member states from 13 December 2024, replacing the General Product Safety Directive 2001/95/EC. - It sets a general safety requirement: manufacturers may place only safe products on the market. - It covers consumer products not governed by sector-specific EU harmonisation legislation, including products sold online and at a distance. - Products may only be placed on the EU market if an economic operator is established in the EU. - Manufacturers and importers must keep technical documentation for 10 years and ensure traceability labelling. - Serious accidents caused by a product must be reported without undue delay through the Safety Gate Business Gateway. - Online marketplaces have dedicated duties, including trader verification, a single contact point and cooperation with market surveillance orders. ## What the GPSR covers and what it replaced The GPSR replaced two older instruments: the General Product Safety Directive (2001/95/EC) and the Directive on products which, appearing to be other than they are, endanger health or safety (87/357/EEC). Because it is a regulation rather than a directive, it applies directly in every member state without national transposition, which reduces the divergence that existed under the old directive. The regulation applies to products intended for consumers, or likely under reasonably foreseeable conditions to be used by consumers, that are placed or made available on the EU market, whether sold new or second-hand, and whether sold in stores or at a distance, including through online marketplaces. Certain categories are excluded because they are governed by their own EU safety regimes, such as medicinal products for human or veterinary use, food and feed, living plants and animals, and plant protection products. Where sector-specific EU harmonisation legislation already covers the safety risks of a product, such as toys under the Toy Safety Directive or electrical equipment under the Low Voltage Directive, that legislation takes precedence for the risks it addresses. The GPSR fills the gaps: it acts as a safety net for consumer products with no dedicated EU legislation, and it applies alongside sector legislation for risks that sector legislation does not cover. ## The general safety requirement and risk assessment Article 5 of the GPSR states the central rule: economic operators shall place or make available on the market only safe products. A product is considered safe when, under normal or reasonably foreseeable conditions of use, including the duration of use, it does not present any risk, or only the minimum risk compatible with the product's use that is considered acceptable and consistent with a high level of protection. Article 6 lists the elements manufacturers must consider when assessing whether a product is safe. These include the characteristics of the product, such as its design, composition, packaging and instructions; the effect of the product on other products with which it may be used; the presentation of the product and its labelling, warnings and instructions; and the categories of consumers at risk, with particular attention to children, older people and persons with disabilities. The assessment must also consider cybersecurity features where the product has digital elements that affect safety, and the evolving nature of risks for connected products. Compliance with European standards cited in the Official Journal gives a presumption of safety for the risks those standards cover, similar to the presumption of conformity under harmonisation legislation. Where no such standard exists, safety is assessed against the general criteria, national rules, Commission guidance and the state of scientific and technical knowledge. ## Obligations for manufacturers, importers and distributors Manufacturers carry the primary responsibility. Before placing a product on the market, they must carry out a risk analysis, draw up technical documentation proportionate to the possible risks, and ensure the product bears a type, batch or serial number or another element allowing its identification. They must indicate their name, registered trade name or trade mark and a contact address, plus electronic contact details, on the product or its packaging or in an accompanying document. Instructions and safety information must be provided in a language easily understood by consumers in the member state where the product is made available. Importers must verify that the manufacturer has carried out the risk assessment and drawn up the technical documentation, that the product bears the required traceability markings, and that instructions and safety information are present in the correct language. They must add their own name and contact details to the product, and they must not place on the market products they consider or have reason to believe are not safe. Distributors must act with due care, verifying traceability markings and documentation before making products available, and cooperating with market surveillance authorities. All three categories of operator must keep the technical documentation for 10 years after the product is placed on the market and make it available to market surveillance authorities on request. If an operator considers that a product it placed on the market is not safe, it must take corrective measures without delay, including withdrawal or recall, and inform consumers and the authorities. | Economic operator | Core GPSR duties | |---|---| | Manufacturer | Risk assessment, technical documentation, traceability marking, instructions in local language, accident notification | | Importer | Verify manufacturer compliance, add importer identity, keep documentation, withdraw unsafe products | | Distributor | Verify markings and documents with due care, cooperate with authorities, support withdrawals and recalls | | Fulfilment service provider | May act as the EU-established operator; must cooperate with authorities and ensure safe storage and handling | | Online marketplace | Trader verification, single contact point, act on takedown orders, cooperate with market surveillance | ## Online marketplaces and distance sellers The GPSR is the first EU product safety law with a dedicated section for online marketplaces, reflecting how much consumer shopping has moved online. Providers of online marketplaces must designate a single point of contact for market surveillance authorities and for consumers, allowing direct communication on product safety issues. Marketplaces must apply a know-your-business-customer principle: they must collect and verify identity, contact and registration information from traders using their platform before allowing them to offer products to EU consumers. When a market surveillance authority issues an order to remove or disable access to a listing for a dangerous product, the marketplace must act expeditiously. Marketplaces must also process notices about dangerous products submitted through the Safety Gate portal and inform authorities and consumers where required. For distance sellers outside the EU, Article 16 requires that a product can only be placed on the EU market if there is an economic operator established in the EU who is responsible for it. That operator may be the manufacturer, the importer, an authorised representative or a fulfilment service provider. This closes the enforcement gap that previously allowed non-EU sellers to ship directly to EU consumers with no accountable party inside the Union. ## Traceability, documentation and accident reporting Traceability runs through the regulation. Every product must be identifiable through a type, batch or serial number, and each economic operator in the chain must be identifiable to the authorities. This allows market surveillance authorities to trace a dangerous product back to its source quickly and to target corrective measures precisely. Technical documentation must be proportionate to the risks of the product. For a simple low-risk product it may be brief; for a complex or higher-risk product it should include the risk assessment, the standards applied, test reports and the analysis supporting the safety conclusion. The 10-year retention period matches the period used in most EU harmonisation legislation. Accident reporting is a significant new duty. Where an economic operator knows that a product it placed on the market has caused an accident that resulted in serious risk to health or safety, or death, it must notify the competent authorities of the member states where the product was made available, without undue delay, through the Safety Gate Business Gateway. Manufacturers notify first; importers and distributors who learn of an accident must inform the manufacturer and the authorities. This creates an EU-wide early warning stream that feeds directly into market surveillance and Safety Gate alerts. ## Enforcement and the Safety Gate system Enforcement sits with the market surveillance authorities of the member states, coordinated under the framework of Regulation (EU) 2019/1020. Authorities can require economic operators to provide documentation, carry out inspections and testing, order withdrawals and recalls, and impose penalties. Member states must lay down penalties that are effective, proportionate and dissuasive. The Safety Gate system is the EU rapid alert mechanism for dangerous non-food products. Member states notify the European Commission of measures taken against dangerous products, and the Commission circulates the alerts so other member states can act. Consumers can search Safety Gate for recalled products, and economic operators use the Business Gateway to notify authorities of dangerous products and accidents. The GPSR modernised this system, which had operated as RAPEX under the old directive, and extended its use to the new accident-reporting and marketplace-notice flows. For businesses, the practical consequence is that product safety compliance is now a documented, traceable and actively monitored process rather than a one-time design consideration. Companies selling consumer products into the EU, including through their own webshops and third-party marketplaces, need an EU-based responsible operator, complete technical files, correct traceability labelling and a procedure for handling safety incidents. ## Frequently asked questions Does the GPSR apply to products already covered by [CE marking](/glossary/ce-marking) legislation? Sector-specific harmonisation legislation takes precedence for the risks it covers. The GPSR applies as a safety net for products with no sector legislation and for residual risks that sector legislation does not address. Traceability and documentation duties under the GPSR can still be relevant alongside CE marking duties. Do I need an EU-based entity to sell consumer products into the EU? Yes. A product falling under the GPSR may only be placed on the EU market if there is an economic operator established in the EU. Non-EU manufacturers typically appoint an EU authorised representative or work with an EU importer or fulfilment service provider to fill this role. What must be reported as an accident under the GPSR? Accidents caused by a product that resulted in death or serious adverse effects on health or safety must be notified to the authorities of the member states where the product was made available, without undue delay, via the Safety Gate Business Gateway. Near misses without serious consequences do not trigger the duty, but they should feed into the manufacturer's ongoing risk monitoring. How long must technical documentation be kept? Ten years from the date the product was placed on the market. The documentation must be made available to market surveillance authorities on request and should be proportionate to the risks of the product. Does the GPSR apply to second-hand products? Yes, products made available on the market second-hand, including repaired or reconditioned products, fall within scope, with limited exceptions such as antiques and products presented as needing repair or reconditioning before use. What happens if a marketplace does not remove a dangerous listing? Marketplaces must act expeditiously on orders from market surveillance authorities and on valid notices. Persistent failure can lead to enforcement action by the authorities of the member state where the marketplace operates, including penalties under national law. ## Sources - EU Safety Gate rapid alert system - EU market surveillance framework - Placing manufactured goods on the market in Great Britain (UK guidance)