The General Product Safety Regulation (EU) 2023/988 has applied to every consumer product on the EU market since 13 December 2024. Manufacturers, importers and distributors that need their technical documentation checked, that must appoint an EU-based responsible operator, or that are facing an enforcement file, work under stricter rules than before. This page sets out who owes what, and when to involve a product compliance lawyer.
What is the General Product Safety Regulation?
The GPSR is Regulation (EU) 2023/988, the general safety rulebook for consumer products sold in the European Union. It has applied since 13 December 2024 and took the place of the earlier General Product Safety Directive in all 27 Member States at once.
The regulation was published in the Official Journal on 23 May 2023, which gave businesses roughly eighteen months to prepare. That window has closed. Products placed on the market before 13 December 2024 under the old regime may continue to circulate, but everything placed on the market after that date must meet the new requirements in full.
Its reach is deliberately broad. Where a sector-specific EU law already governs a product in detail, that law comes first; the GPSR then covers whatever the specialist regime leaves untouched. In practice, therefore, very few consumer goods sit entirely outside it.
What changed on 13 December 2024?
A directive became a regulation. The old rules reached businesses through 27 national implementing statutes, each with its own wording. The GPSR applies directly and identically everywhere, so a Dutch importer and a Polish one now read precisely the same text.
That difference matters commercially. Under the previous regime, a company selling into six markets could face six slightly different readings of the same obligation. Since December 2024 that argument no longer runs, and a compliance position that fails in one Member State fails in all of them.
How does the GPSR differ from the old directive?
On four points that reach ordinary trading operations: the legal instrument itself, the duty to have someone answerable inside the Union, the position of online platforms, and what a company owes consumers once a product turns out to be unsafe.
| Point | Before 13 December 2024 | Under the GPSR |
|---|---|---|
| Legal instrument | Directive, implemented separately in each Member State | Regulation, directly applicable in all 27 |
| Operator inside the EU | Not generally required for non-harmonised goods | Required for every consumer product |
| Online marketplaces | Largely treated as intermediaries | Own registration, contact point and takedown duties |
| Recall communication | Limited requirements on wording and reach | Direct notice to identifiable buyers, in plain language, with a remedy |
Which products fall under the GPSR?
Non-food consumer products that no sector-specific EU law covers in full. Toys, cosmetics, medical devices and machinery keep their own regimes, and the GPSR fills the gaps those regimes leave open rather than replacing them.
A worked example makes the boundary clearer. A connected kitchen appliance sold to consumers falls under the electrical and radio equipment rules for its voltage and its wireless module. Neither regime says much about the safety of the accompanying smartphone app, or about what happens when the manufacturer stops issuing security patches. The GPSR reaches exactly that residual risk.
Second-hand goods, products supplied for repair, and items placed on the market as antiques are treated differently. Whether a particular consignment qualifies is a question of fact and rarely obvious from the invoice alone, which is why this is a common point of dispute with an inspector. Our EU product law overview covers the interaction between the regimes in more depth.
Who must comply, and what does each role owe?
Five roles carry obligations: manufacturers, importers, distributors, providers of online marketplaces and fulfilment service providers. Your role follows from what you actually do with the product, not from the label on your contract, and one company frequently occupies two roles at once.
| Role | Principal duties under the GPSR |
|---|---|
| Manufacturer | Internal risk analysis, technical documentation, traceability marking, corrective action and reporting when a product turns out to be unsafe |
| Importer | Verify the manufacturer did its work before the goods enter the Union, keep documentation available, and stop distribution where there is doubt |
| Distributor | Check that the required markings and documents accompany the product, and act on information suggesting a safety problem |
| Online marketplace | Register a single point of contact, respond to authority takedown orders, and cooperate on tracing sellers |
| Fulfilment provider | Warehousing, packing and dispatch duties that follow the goods rather than the seller |
A private-label arrangement is where this most often goes wrong. A retailer that puts its own brand on a product manufactured in Asia becomes the manufacturer for GPSR purposes and inherits the full documentation burden, whatever the supply agreement says about liability between the parties.
What information must appear on the product?
Enough to identify the product and to reach the people behind it. That means a type or batch reference, the manufacturer’s name and postal address, the contact details of the responsible economic operator, and any warnings the buyer needs before using the item.
Warnings and instructions must be in a language the consumers of that market can easily understand, which for the Dutch market means Dutch. An English-only manual on a product sold to Dutch consumers is a defect in its own right, whatever the quality of the product itself.
Traceability is the reason behind these details. When a fault surfaces two years after sale, the batch reference decides whether you recall 400 units or 40,000. Companies that treat marking as a printing question rather than a documentation question discover the difference during their first recall.
What is the responsible economic operator requirement?
No consumer product may be placed on the EU market unless an economic operator established inside the Union takes responsibility for it. For a manufacturer based outside the EU, that means appointing someone inside it before the first shipment leaves.
That operator can be an importer, an authorised representative or a fulfilment service provider, and its name and contact details must appear on the product or its packaging. The role is not a postbox. It carries duties towards the market surveillance authorities, including producing documentation on request and cooperating on corrective measures.
For non-EU manufacturers this is often the most disruptive requirement, because it cannot be solved after the goods have arrived. A shipment without a valid responsible operator is not compliant at the moment it is placed on the market, and the customs and enforcement consequences follow from that.
Selling into the EU from outside it and unsure whether your current arrangement holds up? A review of the appointment, the contract and the labelling usually settles the question quickly. Speak to a product regulation attorney before the next consignment ships.
How does the GPSR treat online marketplaces?
Marketplaces are no longer treated as neutral intermediaries. They must register a single point of contact for the authorities and for consumers, act on official orders to remove listings, and design their interfaces so that sellers can display the required safety information.
The practical effect reaches sellers rather than platforms. Marketplaces pass their exposure down the chain through seller terms, so a listing that lacks the responsible operator details or the required warnings is removed by the platform long before an inspector looks at it. Sellers therefore meet the GPSR first as a commercial problem: suspended listings and frozen payouts.
Cooperation with the Safety Gate system runs alongside this. The European Commission operates the Safety Gate rapid alert portal, and a product that appears there is visible to every national authority in the Union at the same time.
What must you do when a product turns out to be unsafe?
Act, notify and inform, in that order and without waiting for certainty. The GPSR expects corrective measures once a product is found to present a risk, notification to the competent authority, and a direct warning to the consumers who bought it.
The consumer-facing part is where the regulation is most demanding. A recall notice must be easy to understand and must reach affected buyers directly where contact details exist, which for online sales they usually do. Notices phrased to protect the brand rather than to warn the buyer do not meet the standard.
Consumers must also be offered a remedy, and a recall that offers nothing beyond an apology is incomplete. We set the procedure out step by step in our guidance on product recall in the Netherlands and on the specific recall obligations introduced by the GPSR.
How is the GPSR enforced in the Netherlands?
The Nederlandse Voedsel- en Warenautoriteit acts as the market surveillance authority for consumer products. It inspects, requests documentation, orders products off the market and can require a recall where a product presents a risk.
An enforcement file usually opens with a document request rather than a raid. What you produce in those first weeks shapes everything that follows, because an incomplete technical file is itself a breach, separate from any defect in the product. Companies that answer quickly and completely tend to keep the matter administrative.
Decisions of the authority are open to objection and subsequently to the administrative courts. The routes and the periods differ from ordinary civil litigation, and they are short. Our product compliance litigator handles these files.
What happens if you do not comply?
The authority can order the product withdrawn, require a recall, and publish a warning. Penalties are set at national level rather than in the regulation itself, so the financial exposure depends on which Member State opens the file.
The commercial damage usually arrives before the fine. A Safety Gate entry is public and is read by every marketplace compliance team in the Union, so delisting tends to follow within days. For a seller whose revenue runs through two or three platforms, that is the more serious event.
There is a second track as well. A product found unsafe by a regulator is easier for an injured consumer to sue over, because the factual groundwork is already done. Enforcement and product liability claims therefore tend to travel together, and a defence run separately in each track rarely holds up in both.
What does a GPSR compliance review involve?
A review works through five stages, from classification to a written opinion. Most disputes we see could have been avoided at stage two, because the technical documentation existed but did not cover the risks the regulation actually asks about.
- Determine which regimes apply to the product and where the GPSR fills the remaining gaps.
- Test the risk analysis and the technical documentation against what an inspector would ask for.
- Confirm the responsible economic operator is validly appointed and correctly identified on the product.
- Check labelling, warnings, instructions and the marketplace listing against the information duties.
- Put the incident and recall procedure on paper before it is needed, including who decides and who notifies.
The fifth stage repays the effort. A company that has to invent its recall procedure during the recall loses days it does not have, and those days are visible afterwards in the enforcement file.
How does the GPSR change your supplier contracts?
It moves risk that contracts written before December 2024 rarely address. Your duties follow your role under the regulation whatever the agreement says, so protection against a supplier’s failure has to be built in deliberately rather than assumed.
Four clauses do most of the work: a warranty that the technical documentation exists and will be handed over on request, an audit right, an obligation to notify safety incidents within a fixed period, and an allocation of recall costs. The last is the one most often missing, and a recall of a mid-volume consumer product costs considerably more than the margin on the batch that caused it.
Sector-specific products need more. A toy importer, for instance, contracts against both the GPSR and the EU toy safety rules, and a clause drafted for one regime leaves gaps under the other.
How the GPSR was adopted
The regulation took almost four years from proposal to application, which is worth knowing when assessing how settled the text is.
- 30 June 2021: the European Commission proposes the regulation.
- 28 November 2022: the Council and the European Parliament reach a provisional political agreement.
- 30 March 2023: the European Parliament adopts the text.
- 25 April 2023: the Council formally adopts the regulation.
- 23 May 2023: publication in the Official Journal of the European Union.
- 13 December 2024: the regulation becomes applicable.
Frequently asked questions
Regulation (EU) 2023/988 has applied since 13 December 2024. It was published in the Official Journal on 23 May 2023, giving businesses about eighteen months to prepare.
Products lawfully placed on the market before 13 December 2024 may continue to circulate. Anything placed on the market after that date must meet the GPSR in full.
Yes, if no other operator inside the Union already carries that responsibility. Every consumer product needs a responsible economic operator established in the EU, named on the product or its packaging.
The Nederlandse Voedsel- en Warenautoriteit. It can request documentation, order products off the market and require a recall where a product presents a risk to consumers.
No. Sector-specific regimes keep priority for what they regulate, and the GPSR covers the risks those regimes leave open. Most products are subject to both at once.
When should you involve a product compliance lawyer?
Before the first shipment, and on the day an authority makes contact. Those two moments decide most outcomes. Everything in between is documentation work that a well-briefed compliance team can carry itself.
MAAK Advocaten advises manufacturers, importers, distributors and marketplace sellers on product safety and enforcement. We review technical documentation, set up responsible operator arrangements, handle recalls and represent clients against the authority. To discuss a product, a listing or an open file, contact MAAK Advocaten and ask for the product compliance team.
