GPSR 2023/988 and CE marking

Last reviewed: August 2026 · Sources listed at the end of this page.

Regulation (EU) 2023/988 on general product safety — the GPSR — has applied since 13 December 2024, replacing the General Product Safety Directive 2001/95/EC and the food-imitating products Directive 87/357/EEC. It is the horizontal safety law for consumer products in the EU. It is frequently discussed alongside CE marking, and frequently misunderstood in the process: the GPSR provides for no CE marking at all. This page explains what the regulation covers, how it relates to the harmonisation legislation that does require CE marking, and which of its obligations apply even to products that already carry the mark.

From directive to regulation

The GPSD of 2001 was a directive, transposed with variations into 27 national laws, and written before e-commerce, online marketplaces, and direct-to-consumer imports became the dominant route by which unsafe products reach EU consumers. The GPSR is a regulation — directly applicable, identical in every Member State — and was drafted specifically to close the enforcement gaps of distance selling. It applies from 13 December 2024. Under Article 51, Member States may not impede the making available of products that conformed to the old Directive and were placed on the market before that date.

Scope: the safety net

The GPSR applies to products intended for consumers, or reasonably foreseeably used by consumers, that are placed or made available on the EU market — whether new, used, repaired or reconditioned. Certain categories with their own complete regimes are excluded, among them medicinal products, food and feed, living plants and animals, aircraft, and antiques.

Its defining structural feature is the safety-net function. For products covered by Union harmonisation legislation — the CE marking acts described in what is CE marking? — the GPSR applies only to the aspects and risks that the sectoral act does not cover. Article 2(1) makes this precise. For products under Union harmonisation legislation, Chapter II (the safety requirement) does not apply to the risks that legislation covers, and Chapter III Section 1 (Articles 9 to 18, including the manufacturer, importer, and responsible-person duties) and Chapters V, VII, and IX to XI do not apply at all. What continues to apply is Chapter III Section 2 (online listings and accident reporting), Chapter IV (online marketplaces), Chapter VI, and Chapter VIII (consumer information, recall notices, and remedies). For consumer products covered by no harmonisation act at all (furniture, kitchenware, childcare articles outside the toy definition, most textiles), the GPSR is the primary applicable law.

The general safety requirement

Economic operators may place or make available on the market only safe products. Safety is assessed against criteria including the product's characteristics, its effect on other products it is used with, labelling and warnings, the categories of consumers at risk (particularly children), appearance likely to mislead, and — new in the GPSR — cybersecurity features relevant to safety and evolving, learning or predictive functionalities. Compliance with European standards whose references are published in the Official Journal under the GPSR gives a presumption of safety for the risks the standard covers, mirroring the role of harmonised standards in the CE system without adopting its marking machinery.

Where no relevant standard exists, safety is assessed against elements such as Commission guidance, product safety recalls history, state of the art, and reasonable consumer expectations. Manufacturers of non-harmonised consumer products are expected to carry out an internal risk analysis and produce technical documentation adequate to demonstrate safety — lighter than CE technical documentation, but a genuine documentation duty nonetheless.

The responsible person requirement

Article 16 of the GPSR extends the logic of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 to all consumer products: a product within scope may be placed on the market only if there is an economic operator established in the Union who is responsible for it. That operator is, in order: the manufacturer if established in the EU; otherwise an importer; otherwise an authorised representative with a written mandate; otherwise a fulfilment service provider established in the Union. The responsible person's name and contact details, including postal and electronic address, must appear on the product or its packaging, parcel or accompanying document (Article 16(3)).

This is the provision with the largest practical impact on non-EU sellers. A seller outside the EU shipping directly to consumers with no EU responsible person cannot lawfully place those products on the market, and online marketplaces must design their interfaces so that traders can provide, and the marketplace displays, the responsible person's details (Article 22(9)). Article 16 sits in Chapter III Section 1, so it does not itself apply to harmonised products. For the CE-marked categories listed in MSR Article 4(5), the same requirement has applied since July 2021; GPSR Article 16 covers non-harmonised consumer products. See CE marking and e-commerce and importing from outside the EU.

Traceability

Manufacturers must indicate their name, registered trade name or trade mark, postal and electronic address, and a type, batch or serial number or other element allowing identification of the product. Importers add their own identification. Economic operators must be able to identify their upstream supplier and, where applicable, downstream business recipients, and keep that information available for market surveillance authorities. These duties sit in Chapter III Section 1, so they apply to non-harmonised products. CE-marked products follow the equivalent provisions of their own acts (compare manufacturer obligations and distributor obligations).

Distance selling: information in the listing

Article 19 sets minimum information for products offered online or by other distance sales: the listing must clearly identify the manufacturer (name, address, electronic address), the responsible person in the EU where the manufacturer is outside it, product identification information including an image, and any warnings or safety information in the languages of the targeted Member State. In practical terms, safety-relevant content that traditionally lived on the packaging must now appear in the online listing before purchase. For CE-marked products this applies alongside the sectoral labelling rules — the listing requirement comes from the GPSR because most CE acts predate any notion of an online offer.

Accidents and the Safety Business Gateway

Manufacturers must report, without undue delay, accidents caused by their products that result in death or in serious adverse effects on health or safety, through the Commission's Safety Business Gateway — the online interface economic operators also use for recall notifications and communication with authorities. Importers and distributors aware of such accidents must inform the manufacturer, which either notifies or instructs one of them to do so (Article 20(3)). Where the manufacturer is outside the EU, the responsible person with knowledge of the accident ensures notification (Article 20(4)). This obligation applies to CE-marked consumer products as well, except where a sectoral act imposes an equivalent reporting regime (vigilance under the Medical Devices Regulation being the clearest example).

Recalls

The GPSR standardised the recall notice. A recall must be communicated through a written notice with prescribed content and layout: headed "Product safety recall", identifying the product and the risk in plain language, avoiding risk-minimising terms such as "voluntary", "precautionary", or "in rare situations", and stating what consumers should do (Article 36). Consumers must be offered a choice of at least two of repair, replacement, or an adequate refund of at least the price paid, free of charge, unless the other remedies would be impossible or disproportionate (Article 37). Where operators have customer contact details (registrations, loyalty schemes, online order data), they must notify affected consumers directly. Chapter VIII is not disapplied for harmonised products, so CE-marked consumer products are within these rules unless a specific Union provision with the same objective applies.

Online marketplaces

The GPSR imposes direct obligations on providers of online marketplaces for the first time: registration with the Safety Gate Portal, single contact points for authorities and for consumers, compliance with removal orders for dangerous-product offers within two working days (Article 22(4)), processing of product-safety notices within three working days (Article 22(8)), use of at least the Safety Gate Portal for the random checks required by the Digital Services Act (Article 22(7)), information duties towards consumers who bought a recalled product through the platform, and design of the interface so that sellers can and must display responsible-person and warning information. Marketplaces are not made responsible for product conformity itself — the economic-operator chain of manufacturer, importer and distributor is untouched — but a listing that lacks the mandatory information can no longer be lawfully offered.

Enforcement and penalties

Enforcement runs through the same market surveillance machinery as the CE acts, described in market surveillance: national authorities, the Safety Gate rapid alert system (the successor to RAPEX), and coordinated enforcement actions. For businesses, the Commission published guidelines on the GPSR framework as notice C/2025/6233 in November 2025. Penalties are set nationally; Article 44 requires them to be effective, proportionate and dissuasive and sets no harmonised amount. See penalties for non-compliance.

Checklist: what the GPSR adds for a CE-marked consumer product

• Confirm the EU operator is identified on the product, packaging, parcel, or accompanying document under MSR Article 4, where that article applies to the product.
• Add manufacturer, responsible person, identification and warning information to every online listing (Article 19).
• Register a process for accident reporting through the Safety Business Gateway.
• Prepare a recall-notice template meeting the GPSR's content rules, and a mechanism for direct consumer notification.
• If selling through marketplaces, supply the data the platform must display and monitor Safety Gate for your own listings.
• Do not add CE marking on the basis of the GPSR, and do not cite the GPSR on an EU Declaration of Conformity — it does not belong there.

Sources

• Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety — EUR-Lex.
• Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (repealed) — EUR-Lex.
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products — EUR-Lex.
• Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance — EUR-Lex.
• European Commission — Safety Gate rapid alert system for dangerous non-food products.
• Commission Notice C/2025/6233, guidelines on the EU general product safety legislative framework for businesses — reported by Matheson.