GPSR: the General Product Safety Regulation
Guide · General product safety in the EU
Every consumer product placed on the EU market must be safe, and since 13 December 2024 the rule that says so is the General Product Safety Regulation, Regulation (EU) 2023/988, known as the GPSR. It replaces the General Product Safety Directive 2001/95/EC and, because it is a regulation, it applies directly and identically in all member states. The GPSR is the horizontal safety net of the single market: it catches consumer products that no sector-specific directive fully covers, and it fills the gaps left by those that do. This guide explains its scope, the general safety requirement, the duties it places on manufacturers, importers and distributors, the EU responsible person that online sales now require, the obligations of online marketplaces, traceability and documentation, accident reporting, and how the GPSR sits alongside CE-marked products under sector legislation.
Why the GPSR matters to every consumer-facing maker
Section titled “Why the GPSR matters to every consumer-facing maker”The GPSR is easy to overlook because it does not introduce a logo, a marking, or a certificate. There is no GPSR badge to affix. Yet it binds anyone who places or makes available a consumer product on the EU market, whether or not that product carries a CE mark, and whether it is sold in a shop or shipped from a warehouse after an online order.
Three features make it broad:
- It is horizontal. It does not target a product family the way the Low Voltage Directive targets electrical equipment. It applies to consumer products in general.
- It is a safety net. Where no specific Union harmonisation legislation covers a product, the GPSR is the primary safety law for it. Where specific legislation exists but leaves gaps, the GPSR fills them.
- It is directly applicable. As a regulation it took effect on the same date, 13 December 2024, in every member state, with no national transposition to wait for.
For a manufacturer, an importer, or a distributor, the practical consequence is simple: if a product reaches a consumer and no sector rule answers a given safety question, the GPSR does.
Scope: what the GPSR covers
Section titled “Scope: what the GPSR covers”The GPSR applies to products intended for consumers, or likely under reasonably foreseeable conditions to be used by consumers even if not intended for them, that are placed or made available on the market. This includes products supplied or made available in the course of a commercial activity, whether against payment or free of charge, and whether new, used, repaired or reconditioned, subject to the exclusions in the text.
The relationship with sector legislation
Section titled “The relationship with sector legislation”This is the part that most often confuses makers. The GPSR does not override sector-specific Union harmonisation legislation. Article 2 sets the rule: where specific Union legislation lays down requirements covering the safety of products, the GPSR applies only to the aspects, risks or categories of risk not covered by that legislation.
In plain terms:
| Situation | Which safety rules govern |
|---|---|
| Product fully covered by a sector directive or regulation | The sector legislation governs the covered safety aspects; the GPSR fills uncovered gaps |
| Product partly covered (a risk the sector text does not address) | The sector text governs what it covers; the GPSR governs the remaining risks |
| Consumer product with no applicable sector legislation | The GPSR is the primary safety law for the product |
So a toy is governed for its covered hazards by the Toy Safety Directive, see our EN 71 toy safety guide, and a mains-powered appliance by the LVD. But certain GPSR provisions, notably traceability, accident reporting and the online-sales rules, apply horizontally even to these CE-marked products, because the sector directives do not all contain an equivalent.
What is excluded
Section titled “What is excluded”The GPSR does not apply to medicinal products, food and feed, living plants and animals, plant protection products, certain transport equipment operated by a service provider, aircraft, and antiques, among the carve-outs listed in the regulation. These are addressed by their own legal regimes. Do not assume an exclusion without reading Article 2: the carve-outs are specific.
The general safety requirement
Section titled “The general safety requirement”The heart of the GPSR is the general safety requirement in Article 5: economic operators shall place or make available on the market only safe products. Everything else, traceability, reporting, operator duties, exists to give that obligation teeth.
What "safe" means
Section titled “What "safe" means”A safe product, under Article 6, is one that under normal or reasonably foreseeable conditions of use, including the actual duration of use, presents no risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of the health and safety of consumers. The assessment must take into account, among other elements:
- the characteristics of the product, including its design, composition, packaging, assembly and, where applicable, installation, use and maintenance instructions;
- the effect on other products where it is reasonably foreseeable that it will be used with them;
- the effect that other products might have on the product where it is reasonably foreseeable that they will be used together;
- the presentation, labelling, warnings and instructions for use and disposal;
- the categories of consumers using the product, in particular by assessing the risk for vulnerable consumers such as children, older people and persons with disabilities;
- the appearance of the product where it may lead consumers to use it in a way different from that for which it was designed, the classic look-alike risk where a product resembles food;
- where required by the nature of the product, the appropriate cybersecurity features and the evolving, learning and predictive functions of the product.
That last point is significant: the GPSR explicitly draws cybersecurity and connected, learning functions into the safety assessment of consumer products.
How conformity with the requirement is shown
Section titled “How conformity with the requirement is shown”The GPSR does not impose a single test route. Article 7 sets a hierarchy for presuming conformity with the general safety requirement:
- Conformity with relevant European standards whose references are published in the Official Journal for the purposes of the GPSR confers a presumption of safety for the risks they cover.
- In the absence of such standards, safety is assessed against other elements: applicable national requirements, relevant European standards not yet referenced, Commission recommendations, product safety codes of good practice, the state of the art and reasonable consumer expectations.
This mirrors the logic of presumption of conformity familiar from the CE world, but adapted to a horizontal safety net where harmonised standards may not exist for the product at all.
The economic operators and their duties
Section titled “The economic operators and their duties”The GPSR uses the New Legislative Framework vocabulary of economic operators: manufacturer, importer, distributor, authorised representative, and, newly, the provider of an online marketplace and the fulfilment service provider. Each carries duties scaled to its role. The general principle: the further upstream the operator, the heavier the design and documentation duties.
Manufacturer duties
Section titled “Manufacturer duties”The manufacturer is the operator who designs or manufactures a product, or has it designed or manufactured, and markets it under its own name or trademark. Under Articles 8 and 9, before placing a product on the market the manufacturer must:
- ensure the product is designed and manufactured to be safe, conducting an internal risk analysis and drawing up the technical documentation needed to assess safety;
- keep the technical documentation for ten years after placing the product on the market and make it available to authorities on request;
- mark the product with a type, batch or serial number or other element allowing its identification, and indicate the manufacturer's name, registered trade name or trademark and a postal and electronic address;
- ensure the product is accompanied by clear instructions and safety information in a language easily understood by consumers, as determined by the member state where it is made available;
- where a product presents a risk, take immediate corrective measures, inform the authorities and, where appropriate, warn consumers;
- investigate complaints, keep a register of complaints, recalls and corrective measures, and keep distributors informed.
Importer duties
Section titled “Importer duties”The importer places a product from a third country on the EU market. Under Articles 11 and 12, the importer must verify before placing the product that the manufacturer carried out the risk analysis and drew up the technical documentation, that the product bears the required identification, and that it is accompanied by the required instructions and safety information. The importer must indicate its own name and contact details on the product or its packaging, keep a copy of the technical documentation available for ten years, and act on risks in the same way as the manufacturer. The importer cannot hide behind a distant foreign manufacturer: it carries the product into the single market and answers for it.
Distributor duties
Section titled “Distributor duties”The distributor makes a product available on the market without being manufacturer or importer, typically a reseller. Under Article 13 the distributor must act with due care, verifying that the product bears the required identification and is accompanied by instructions and safety information, and that the manufacturer and, where applicable, the importer have complied with their marking and documentation duties. A distributor who knows or should know a product is not safe must not make it available and must inform the relevant operators and authorities.
| Operator | Core safety duty | Documentation | Identification on product |
|---|---|---|---|
| Manufacturer | Design safe, run risk analysis | Keep technical file 10 yrs | Own name + addresses |
| Importer | Verify manufacturer complied | Keep copy 10 yrs | Own name + contact details |
| Distributor | Verify upstream compliance, due care | Pass on, do not originate | Verify presence, do not add |
| Authorised representative | Tasks under written mandate | Hold file, cooperate | Acts for the responsible person |
The EU responsible person, the rule that changed online sales
Section titled “The EU responsible person, the rule that changed online sales”Article 16 is the provision that reshaped distance and online selling, and it is the one most often missed by makers selling into the EU from outside it. A product covered by the GPSR may be placed on the market only if there is an economic operator established in the Union responsible for it.
That responsible person can be:
- a manufacturer established in the Union;
- an importer, where the manufacturer is not established in the Union;
- an authorised representative who has received a written mandate from the manufacturer to act on its behalf;
- a fulfilment service provider established in the Union, where there is no manufacturer, importer or authorised representative established in the Union.
The responsible person must verify that the technical documentation has been drawn up, keep the declaration or documentation available, cooperate with authorities, and inform them of risks. Crucially, its name, registered trade name or trademark and contact details, including postal and electronic address, must be indicated on the product, its packaging, the parcel or an accompanying document.
For online and distance sales this is decisive. A product offered online to EU consumers cannot lawfully be placed on the market if no EU-established responsible person stands behind it. This closed the long-standing gap where goods shipped directly from a third-country seller reached EU consumers with no operator inside the Union answerable for their safety. A non-EU maker selling through its own webshop or a marketplace must therefore appoint an importer, an authorised representative, or rely on a fulfilment service provider, and display that responsible person clearly. The same logic underpins the authorised representative and importer obligations that recur across EU product law.
Online offers must show safety information up front
Section titled “Online offers must show safety information up front”Article 19 requires that when a product is made available online or through other means of distance sale, the offer must clearly and visibly state, at least: the manufacturer's identity and contact details; where the manufacturer is not in the EU, the responsible person's identity and contact details; information allowing identification of the product, including a picture, type and any other identifier; and any warning or safety information to be affixed on the product or accompanying it, in a language easily understood by consumers. The consumer must see the safety information before the purchase, not only when the parcel arrives.
Online marketplace obligations
Section titled “Online marketplace obligations”The GPSR is the first product-safety text to set dedicated duties for providers of online marketplaces, in Article 22, dovetailing with the Digital Services Act. A provider of an online marketplace must:
- register on the Safety Gate portal and indicate a single point of contact for communication with authorities on product-safety matters, and a contact point allowing consumers to communicate directly;
- have internal processes for product safety to comply, without undue delay, with the relevant requirements;
- act on an order to remove or disable access to a dangerous product within two working days of receipt;
- design and organise its online interface so that traders can provide the manufacturer or responsible person identity, product identification and any warning or safety information required;
- cooperate to ensure effective product recalls, including by abstaining from obstructing them, and inform affected consumers;
- give effect to notices and cooperate with authorities and other operators to trace dangerous products.
For a maker selling through marketplaces, the lesson is that the marketplace will require the responsible-person details and safety information up front, because the marketplace itself is now exposed. Incomplete listings are removed.
Traceability and technical documentation
Section titled “Traceability and technical documentation”Two record-keeping pillars run through the GPSR.
Product traceability. Under Article 18 the manufacturer must ensure each product can be identified by a type, batch or serial number, and that the product or its packaging carries the manufacturer's and, where applicable, the importer's identity and address. For specific categories of products presenting a serious risk, the Commission may establish a more demanding traceability system, recording the operators and the product details along the supply chain. The aim is that when something goes wrong, the dangerous units can be located and reached quickly.
Technical documentation. The manufacturer draws up technical documentation containing the information needed to demonstrate that the product is safe: a general description of the product and of its essential characteristics relevant to assessing its safety, an analysis of the possible risks and the solutions adopted to eliminate or mitigate them, and a list of any relevant European standards or other elements applied. The file must be kept for ten years and produced to authorities on request. This is lighter than a full CE technical file for a harmonised product, but it is mandatory and a recurring point of failure in market surveillance checks.
Accident reporting and the Safety Gate
Section titled “Accident reporting and the Safety Gate”The GPSR strengthens the feedback loop between products in the field and the authorities.
Reporting accidents
Section titled “Reporting accidents”Article 20 introduces an explicit duty: where a manufacturer knows or, on the basis of the information in its possession, ought to know that a product they have placed on the market has caused an accident, the manufacturer shall without undue delay notify the competent authorities of the member state where the accident occurred, through the Safety Business Gateway. The notification covers the type and identification number of the product and the circumstances of the accident if known. Importers and distributors who become aware of such an accident must inform the manufacturer, which then reports, or report themselves where appropriate.
The Safety Gate and corrective measures
Section titled “The Safety Gate and corrective measures”Where a product is dangerous, operators take corrective measures and inform authorities; authorities feed serious risks into the Safety Gate, the EU rapid alert system for dangerous non-food products, the system formerly known as RAPEX. Alerts flow between member states so that a dangerous product found in one country can be acted on across the Union. The GPSR also adds a Safety Gate Portal for the public and a Safety Business Gateway through which operators report. When corrective action reaches consumers, it is a recall, and the GPSR sets specific rules on the recall notice and the remedy offered, covered in our recall and Safety Gate response guide.
What a recall notice must contain
Section titled “What a recall notice must contain”Article 36 standardises recall notices so consumers act on them. A recall notice must be clear, use the word "recall" or "safety warning" as appropriate, describe the product with a picture and identifiers, state the hazard plainly while avoiding elements that could understate it, and set out the remedy the consumer can claim. Article 37 requires the operator to offer the consumer at least a choice between two of: repair, replacement, or adequate refund. A recall that buries the hazard or offers no real remedy does not discharge the obligation.
How the GPSR relates to CE-marked products
Section titled “How the GPSR relates to CE-marked products”This is the question most makers of electronics ask: my product is CE-marked under the LVD, the EMC Directive and the RED, does the GPSR add anything? The honest answer is: yes, in three ways, even though the CE marking itself comes from the sector directives and not from the GPSR.
First, gap-filling. The sector directives cover defined essential requirements. A consumer hazard outside those, an ergonomic risk, a foreseeable-misuse risk, a look-alike-to-food risk on packaging, may fall outside the sector text. The GPSR catches it.
Second, horizontal obligations. Traceability marking, the EU responsible person for online sales, accident reporting through the Safety Business Gateway, the online-offer information duties and the marketplace rules apply across the board. The sector directives do not all replicate these, so a CE-marked product still has to satisfy them under the GPSR.
Third, enforcement coherence. The GPSR is read together with the market surveillance regulation, Regulation (EU) 2019/1020, which gives authorities powers over both harmonised and GPSR products. The two form the backbone of EU product enforcement.
| Aspect | Covered by sector CE legislation | Covered by GPSR |
|---|---|---|
| Defined essential requirements (electrical, EMC, radio) | Yes | No (deferred to sector text) |
| CE marking and DoC | Yes | No marking introduced |
| Risks not addressed by the sector text | No | Yes (safety net) |
| Traceability marking | Partly | Yes, horizontal |
| EU responsible person for online sales | Not always | Yes, Article 16 |
| Accident reporting to authorities | Varies | Yes, Article 20 |
| Online marketplace duties | No | Yes, Article 22 |
The takeaway: CE marking and the GPSR are not alternatives. A connected consumer device under the RED still relies on the GPSR for the horizontal duties, and on the sector directive for its CE marking and conformity assessment. For the overall CE picture see the CE pillar.
A short compliance checklist
Section titled “A short compliance checklist”For any consumer-facing product placed on the EU market, work through:
- Identify the regime. Is the product covered by sector-specific Union legislation? If yes, that legislation governs its covered safety aspects and the GPSR fills the gaps. If no, the GPSR is the primary safety law.
- Meet the general safety requirement. Run a documented risk analysis, including foreseeable misuse, vulnerable users and, where relevant, cybersecurity and connected functions.
- Build the technical documentation. Description, risk analysis, standards applied. Keep it ten years.
- Apply traceability marking. Type, batch or serial number, plus manufacturer and importer identity and address.
- Appoint and display the EU responsible person, especially for online and distance sales from outside the EU.
- Make the online offer compliant. Show identity, product identification and safety information before purchase.
- Set up the feedback loop. A complaints register, a route to report accidents through the Safety Business Gateway, and a recall procedure with a compliant notice and remedy.
A product that satisfies its sector directives but ignores the GPSR's horizontal duties is still non-compliant. The reverse is equally true. Both layers must be met.
See also
Section titled “See also”- Which EU directives apply to my product?
- Low Voltage Directive 2014/35/EU: a guide
- User instructions, safety information & languages
- Substantial modification: when to re-certify in the EU
Sources & references
- Regulation (EU) 2023/988 on general product safety , EUR-Lex eur-lex.europa.eu/eli/reg/2023/988/oj
- General product safety: the GPSR , European Commission commission.europa.eu/business-economy-euro/product-safety-and-requirements/product-safety/general-product-safety-regulation_en
- Safety Gate: the EU rapid alert system for dangerous non-food products , European Commission ec.europa.eu/safety-gate/
- Regulation (EU) 2019/1020 on market surveillance and compliance of products , EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj