Published on · Last updated
Since 13 December 2024, the General Product Safety Regulation (EU) 2023/988 (GPSR) has set the basic safety rule for consumer products in the EU: businesses may only place or make available safe products (Articles 5 and 52 GPSR). This page explains who owes what under the GPSR, how the Netherlands enforces it, 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 It has applied since 13 December 2024 (Article 52) and on that date repealed the earlier General Product Safety Directive 2001/95/EC in all Member States at once (Article 50(1)).
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 that were placed on the market before 13 December 2024 and complied with the old Directive may still be made available (Article 51). Products placed on the market after that date must comply with the GPSR.
Its reach is deliberately broad. Where specific EU law regulates the safety of a product, the GPSR applies only to the aspects and risks that law does not cover (Article 2(1)). For products covered by EU harmonisation legislation, such as toys, electrical equipment and machinery, the GPSR goes further: the general safety requirement applies only to risks that legislation does not cover, and the economic operator duties in Articles 9 to 18 do not apply at all. The rules on online sales (Article 19), accidents (Article 20), online marketplaces (Article 22) and recalls (Articles 35 to 37) do apply to them. Questions about how the GPSR applies to your products? See our GPSR lawyer in the Netherlands.
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 the core obligations read the same everywhere. Some points remain national: the language of instructions and safety information (Article 9(7)), enforcement, and penalties (Article 44).
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 products covered by the GPSR (Article 16); for many CE-marked products the same rule follows from Article 4 of Regulation (EU) 2019/1020 |
| 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?
Products intended for consumers, or likely to be used by consumers under reasonably foreseeable conditions even if not intended for them (Article 3(1)). Excluded are, among others, medicines, food, feed, living plants and animals, plant protection products and antiques (Article 2(2)). Toys, cosmetics, medical devices and machinery have their own EU regimes, and the GPSR fills the gaps those regimes leave open rather than replacing them (Article 2(1)).
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. If those rules do not cover a risk, for example one created by the accompanying smartphone app or by missing security patches, the GPSR can reach it: a safety assessment must take into account the effect of non-embedded items on the product and, where needed, cybersecurity features that affect safety (Article 6(1)(c) and (g)). Because the appliance is covered by EU harmonisation legislation, however, the manufacturer duties of Article 9 GPSR do not apply to it (Article 2(1)).
Second-hand, repaired and reconditioned goods are covered in the same way as new ones (Article 2(3)). The exception is a product that must be repaired or reconditioned before use and is clearly marked as such. Antiques are excluded altogether (Article 2(2)(i)): products, such as collectors’ items or works of art, of which consumers cannot reasonably expect that they meet state-of-the-art safety standards (Article 3(28)). Whether a particular consignment qualifies is a question of fact and rarely obvious from the invoice alone. Our EU product law overview covers the interaction between the regimes in more depth.
Who must comply, and what does each role owe?
Six roles carry obligations: manufacturers, authorised representatives, importers, distributors, fulfilment service providers and providers of online marketplaces (Articles 3(13), 9 to 12 and 22). Your role follows from what you actually do with the product, not from the label on your contract, and one company can hold different roles for different products.
| Role | Principal duties under the GPSR |
|---|---|
| Manufacturer | Internal risk analysis and technical documentation kept for 10 years, identification and contact details on the product, instructions in the local language, complaints channel, and immediate corrective action and notification when a product turns out to be dangerous (Article 9) |
| Authorised representative | Tasks set out in the manufacturer’s written mandate, at least providing documentation to the authorities, informing the manufacturer of risks, informing the authorities through the Safety Business Gateway of action taken, and cooperating on corrective action (Article 10(2)) |
| Importer | Before placing the product on the market, ensure it is safe and that the manufacturer has drawn up the technical documentation and applied the identification and contact details; add its own details; do not place doubtful products on the market (Article 11) |
| Distributor | Check that the required markings, contact details and instructions accompany the product, and act on information suggesting a safety problem (Article 12) |
| Online marketplace | Register with the Safety Gate Portal, designate single points of contact for authorities and consumers, act on authority orders within two working days, and cooperate on recalls and tracing (Article 22) |
| Fulfilment provider | An economic operator with duties such as cooperating with the authorities (Article 15); it acts as the responsible person in the EU for the products it handles if no manufacturer, importer or authorised representative is established in the EU (Article 16 GPSR, Article 4(2)(d) Regulation (EU) 2019/1020) |
A private-label arrangement is where this most often goes wrong. A retailer that places a product manufactured in Asia on the market under its own name or trademark is deemed to be the manufacturer and takes on the manufacturer duties of Article 9, whatever the supply agreement says about liability between the parties (Article 13(1)). The same applies to a business that substantially modifies a product in a way that affects its safety (Article 13(2) and (3)).
What information must appear on the product?
Enough to identify the product and to reach the people behind it. That means a type, batch or serial number or other identifier (Article 9(5)), the manufacturer’s name or registered trade name or trade mark with its postal and electronic address (Article 9(6)), the importer’s details where there is one (Article 11(3)), and the name and contact details of the responsible person in the EU (Article 16(3)). Where the product itself does not allow it, the manufacturer’s and importer’s details may go on the packaging or in an accompanying document; the responsible person’s details may be placed on the product, its packaging, the parcel or an accompanying document (Article 16(3)). Instructions and safety information must accompany the product unless it can be used safely without them (Article 9(7)).
Warnings and instructions must be in a language consumers can easily understand, as determined by the Member State where the product is made available (Article 9(7)). For the Netherlands, the implementing decree requires instructions, warnings, safety information and recall notices to be in any case in Dutch (Article 3 Warenwetbesluit uitvoering verordening algemene productveiligheid en verordening inzake accreditatie). An English-only manual on a product sold to Dutch consumers therefore breaches these rules, unless the product can be used safely without instructions.
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?
A product covered by the GPSR may not be placed on the EU market unless an economic operator established in the Union is responsible for it (Article 16(1) GPSR). That is the manufacturer if it is established in the EU, otherwise the importer, an authorised representative with a written mandate or, if none of these is established in the EU, a fulfilment service provider for the products it handles (Article 4(2) Regulation (EU) 2019/1020). A manufacturer based outside the EU that sells without an EU importer therefore has to appoint an authorised representative, or rely on an EU fulfilment service provider, before the first shipment. For many CE-marked products the same requirement follows directly from Article 4 of Regulation (EU) 2019/1020.
Its name and contact details, including postal and electronic address, must appear on the product or on its packaging, the parcel or an accompanying document (Article 16(3)). The role is not a postbox. The responsible person must provide documentation to the market surveillance authorities on request, inform them of risks and cooperate on corrective action (Article 4(3) Regulation (EU) 2019/1020), and must regularly check, where the risks call for it, that the product matches its technical documentation and carries the required information (Article 16(2) GPSR).
For non-EU manufacturers this is often the most disruptive requirement, because it cannot be solved after the goods have arrived. A product without a valid responsible person may not be placed on the market (Article 16(1)), and the market surveillance authorities can act against it.
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 with the Safety Gate Portal and designate single points of contact for the authorities and for consumers (Article 22(1) and (2)), carry out official orders to remove or disable offers of dangerous products within two working days (Article 22(4)), and design their interfaces so that sellers can display the required safety information (Article 22(9)).
The practical effect reaches sellers rather than platforms. Sellers must show the manufacturer’s details, the responsible person where the manufacturer is outside the EU, product identification with a picture, and warnings in the listing itself (Article 19). Marketplaces pass their exposure down the chain through seller terms, so a listing that lacks these details is often removed by the platform before an inspector looks at it. A platform must also suspend, after a prior warning, traders that frequently offer non-compliant products (Article 22(11)). Sellers therefore often meet the GPSR first as a commercial problem.
Cooperation with the Safety Gate system runs alongside this. National authorities notify corrective measures concerning products presenting a serious risk through the Safety Gate Rapid Alert System, so that the other Member States are informed (Articles 25 and 26(1)). The European Commission publishes selected information on the public Safety Gate portal (Article 34), and marketplaces must take that information into account (Article 22(6)).
What must you do when a product turns out to be unsafe?
Act, notify and inform, without waiting for certainty. A manufacturer that considers or has reason to believe that a product it has placed on the market is dangerous must immediately take corrective measures, including a withdrawal or recall where appropriate, inform consumers, and inform the market surveillance authorities of every Member State where the product was sold through the Safety Business Gateway (Article 9(8)). Importers and distributors have comparable duties (Articles 11(8) and 12(4)). Separately, the manufacturer must ensure that accidents resulting in death or serious adverse effects on health are notified without undue delay through the Safety Business Gateway to the authorities of the Member State where they occurred (Article 20(1) and (2)).
The consumer-facing part is where the regulation is most demanding. All affected consumers who can be identified must be notified directly and without undue delay, using customer data the business already holds (Article 35(1)); if not everyone can be reached, the notice must also go out through other channels such as the website and social media (Article 35(4)). A written recall notice has the headline “Product safety recall” and must not use terms such as “voluntary” or “precautionary” that reduce the perception of risk (Article 36(2)). Notices phrased to protect the brand rather than to warn the buyer do not meet the standard.
Consumers must also be offered an effective, cost-free and timely remedy (Article 37(1)). As a rule they choose between at least two of repair, replacement by a safe product of the same type and at least the same value and quality, or a refund of at least the price paid; only where the other remedies are impossible or disproportionately costly may one remedy be offered (Article 37(2)). Consumers do not bear shipping or return costs (Article 37(5)). 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 Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel- en Warenautoriteit, NVWA) supervises the safety of consumer products under the Commodities Act (Warenwet); for radio equipment, the Dutch Authority for Digital Infrastructure (Rijksinspectie Digitale Infrastructuur) is also designated (Article 1 of the designation decree). Acting against most GPSR obligations, including those in Articles 9, 11, 12, 16, 19, 20 and 35 to 37, is prohibited under Dutch law (Article 2 of the implementing decree). If an economic operator fails to take appropriate measures, the Minister, in practice through the NVWA, can order it to withdraw or recall a dangerous product; not complying with that order is a criminal offence (Article 32h Warenwet). Where there is a serious risk and no other effective means, the Minister can, with prior authorisation from the examining magistrate (rechter-commissaris), also order online content to be removed, access to it restricted or a warning displayed; failing to comply is a criminal offence (Article 32g Warenwet).
An enforcement file usually opens with a document request rather than a raid. What you produce in those first weeks shapes everything that follows. Operators must provide all necessary information on request (Article 15(2)), and for products covered by Article 9 an incomplete or outdated technical file is itself a breach, separate from any defect in the product (Article 9(2) and (3)). Companies that answer quickly and completely tend to keep the matter administrative.
Decisions of the authority can, as a rule, first be challenged by an objection (bezwaar) to the authority itself and then by an appeal to the administrative courts (Article 7:1 General Administrative Law Act, Algemene wet bestuursrecht). The period for objection is six weeks (Article 6:7), starting the day after the decision was announced in the prescribed manner (Article 6:8(1)). The routes and the periods differ from ordinary civil litigation. Our product compliance litigator handles these files.
What happens if you do not comply?
The Minister, in practice through the NVWA, can order the product to be withdrawn or recalled (Article 32h Warenwet), and information on measures against dangerous products is in general made public (Article 33(1) GPSR). Penalties are set at national level rather than in the regulation itself; they must be effective, proportionate and dissuasive (Article 44). The financial exposure therefore depends on which Member State opens the file.
The commercial damage often arrives before the fine. Safety Gate information is public, and marketplaces must take it into account when they check offers on their platforms (Article 22(6)), so delisting can follow quickly. For a seller whose revenue runs through two or three platforms, that is often the more serious event.
There is a second track as well. A product found unsafe by a regulator can make a claim by an injured consumer easier, because much of the factual groundwork is already done, although the civil court decides the claim under its own rules. 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 EU toy safety rules and the parts of the GPSR that still apply to toys, such as the rules on online sales, accidents and recalls (Article 2(1)). A clause drafted for one regime leaves gaps under the other.
How was the GPSR adopted?
The regulation took about three and a half 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 about the GPSR
When did the GPSR start to apply?
Regulation (EU) 2023/988 has applied since 13 December 2024 (Article 52). It was published in the Official Journal on 23 May 2023. Products that were placed on the market before 13 December 2024 and complied with the old Directive 2001/95/EC may still be made available (Article 51).
Does the GPSR apply to CE-marked products such as toys?
Partly. For products covered by EU harmonisation legislation, the general safety requirement applies only to risks that legislation does not cover, and Articles 9 to 18 do not apply. The rules on online sales, accidents, online marketplaces and recalls do apply (Article 2(1)).
Do I need an EU-based responsible person to sell into the Netherlands?
Yes. A product covered by the GPSR may only be placed on the market if an economic operator established in the EU is responsible for it. That is the manufacturer if it is established in the EU; otherwise the importer, an authorised representative or, failing those, a fulfilment service provider (Article 16(1) GPSR and Article 4(2) Regulation (EU) 2019/1020). Its name and contact details go on the product, packaging, parcel or an accompanying document (Article 16(3)).
Who enforces the GPSR in the Netherlands?
The Netherlands Food and Consumer Product Safety Authority (NVWA) supervises consumer product safety under the Commodities Act (Warenwet); for radio equipment the Rijksinspectie Digitale Infrastructuur is also designated. The Minister, in practice through the NVWA, can order a withdrawal or recall, and not complying with that order is a criminal offence (Article 32h Warenwet).
Which accidents must a manufacturer report?
Accidents caused by its product that resulted in death or in serious adverse effects on a person’s health and safety, such as injuries or illnesses. The manufacturer ensures they are notified without undue delay through the Safety Business Gateway to the authorities of the Member State where the accident occurred (Article 20(1) and (2)).
Primary sources
- Regulation (EU) 2023/988 on general product safety (GPSR), Articles 2, 3, 5, 6, 9, 10, 11, 12, 13, 15, 16, 19, 20, 22, 25, 26, 33, 34, 35, 36, 37, 44, 50, 51 and 52
- Regulation (EU) 2019/1020 on market surveillance and compliance of products, Article 4
- Commodities Act (Warenwet): Article 32g and 32h
- Warenwetbesluit uitvoering verordening algemene productveiligheid en verordening inzake accreditatie: Article 2 and 3
- Besluit aanwijzing toezichthouders algemene productveiligheid op het terrein van Economische Zaken: Article 1
- General Administrative Law Act (Algemene wet bestuursrecht): Article 6:7, 6:8 and 7:1
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.