Last updated: 21 November 2025
In brief
The General Product Safety Regulation ((EU) 2023/988) (GPSR) has applied since 13 December 2024, repealing and replacing the General Product Safety Directive (2001/95/EC) (GPSD). The GPSR is one of the most significant updates to the EU’s product regulatory landscape in modern history and makes substantial amendments to the GPSD, which had been in force for more than two decades. For businesses selling products in Northern Ireland, the GPSR applies in Northern Ireland (but not the rest of the UK), given arrangements put in place after Brexit (see the OPSS’ guidance on this point).
The objective of the GPSR is to improve the functioning of the internal market while providing a high level of consumer protection to EU consumers in respect of products they purchase, both in store and online. The GPSR applies to a broad range of products placed on the EU market, with only certain categories of products explicitly excluded (such as medicinal products, food and antiques). Additionally, the definition of “product” has been expanded to capture interconnected (“smart”) products and software, as well as software updates. The GPSR also enhances market surveillance of dangerous products in the EU and aims to improve the effectiveness of any recalls of these products.
As a regulation, this legislation is directly applicable, leaving little room for disparities across EU countries. The regulation is relevant for any economic operator that is in any way involved in selling products in the EU market - even those that are not themselves established within the EU need to comply with the new rules.
The GPSR does not prevent the sale of products that are in conformity with the GPSD and were placed on the market before 13 December 2024.
On 19 November 2025, the European Commission (EC) published its long-awaited guidance on the application of the GPSR.
In depth - what are the implications of the reform?
The GPSR aligns the GPSD with the latest developments in digitalization, in line with the EC’s New Consumer Agenda of 2020. The GPSR makes a number of changes to the existing product regulatory landscape, including the following:
- Responsible person
The GPSR contains a requirement for a “responsible person” to be established within the EU before products can be placed on the EU market, likely with a view to ensuring that there is always an EU entity that can be held accountable for any product-related issues. That responsible person will have various obligations, including (a) if requested, providing a market surveillance authority with all information and documentation necessary to demonstrate the conformity of a product, and (b) regularly checking that the product complies with the appropriate technical documentation. The GPSR also requires that details of the economic operator that is the responsible person are included on the product or its packaging, the parcel, or an accompanying document.
- Online marketplaces
The EC considers that the growth of e-commerce decreased the effectiveness of the GPSD. This is particularly relevant as 73% of consumers bought products online in 2021 (compared to 50% in 2014). Accordingly, the GPSR recognizes that providers of online marketplaces play a crucial role in the supply chain - allowing economic operators to reach a greater number of consumers - and, therefore, also in the product safety system. As such, the GPSR seeks to regulate this area by including specific requirements in respect of online marketplaces and online sales.
In particular, the GPSR includes introduces various requirements for providers of online marketplaces (in part, building on the requirements in the EU Digital Services Act (Regulation 2022/2065)), including to (i) identify and register a single contact point for market surveillance authorities, (ii) design and organize their marketplace so that traders can provide information to consumers, including warning and safety information, and (iii) directly notify affected consumers who bought, through their interfaces, a product that is the subject of a product safety recall, or where certain information has to be brought to the attention of consumers to ensure that a product is used safely. Online marketplaces are also obliged to inform market surveillance authorities, via the Safety Business Gateway, about dangerous products that they have made available on their online interfaces (of which they have actual knowledge) and to report accidents, as set out in further detail below.
- Accident reporting
The GPSR mandates that an accident be reported via the Safety Business Gateway without undue delay as soon as it becomes known. While the GPSR does not provide any definition of “accident,” it outlines a relatively high threshold for the severity of such accident to warrant a notification. A report would need to be made in respect of an accident that “resulted in an individual’s death or in serious adverse effects on that individual’s health and safety, permanent or temporary, including injuries, other damage to the body, illnesses, and chronic health effects.”
The GPSR sets out separate accident reporting obligations for online marketplaces, with a different threshold for making a report. In particular, a report must be made in respect of an accident which has resulted in a “serious risk or actual damage to the health or safety of a consumer, caused by a product made available on their online marketplace,” and the manufacturer must be informed accordingly. This comparatively lower threshold for reporting accidents could lead to some inconsistencies in terms of which accidents are reported by economic operators and which are reported by online marketplaces.
- Product recalls
Improving the effectiveness of product recalls across the EU was a key objective for the EC in reforming the GPSD. Accordingly, the GPSR sets out granular requirements for conducting product recalls, details that we would generally expect to see in guidance rather than in legislation itself. Under the GPSR, economic operators, such as manufacturers, distributors and importers, are obliged to recall products where necessary, with online marketplaces also being obliged to cooperate to ensure effective product recalls. Detailed provisions as to the contents and form of the recall notice have also been included, presumably for standardization purposes. The EC carried out a short consultation on a recall notice template. The final template was adopted on 24 May 2024.
Consumers affected by a recall are entitled to an effective, cost-free and timely remedy. The GPSR requires that consumers be offered at least two options from the following: repair, replacement or refund. If the repair or replacement is not completed within a reasonable time, the consumer is entitled to a refund.
- New technologies
The GPSR seeks to ensure that the EU’s product safety regime can be applied effectively to 21st century developments and can respond quickly to new and emerging challenges, including those posed by connected products, software updates and the evolving functionalities of AI-powered products. To address this issue, the GPSR adopts newly improved definitions; for example, “product” now expressly includes a reference to items that are interconnected to other items.
The GPSR also includes a list of points for consideration when assessing the safety of products, including the following:
- The effect of the product on other products, including the interconnection of those products
- The appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, where such an influence might have an impact on the safety of the product, including the possible loss of interconnection
- The evolving, learning and predictive functionalities of the product
The GPSR also addresses responsibility for product safety where a substantial modification is made to a product. The person performing that substantial modification will be considered a “manufacturer” of that product and will be subject to the obligations of a manufacturer. These obligations include conducting a comprehensive risk assessment before the product is placed on the market. New considerations for these risk assessments include gender-related differences, risks to vulnerable consumers (such as children, the elderly and persons with disabilities), the product’s interconnectivity with other products, cybersecurity risks, and any evolving, learning or predictive functionalities (including those found in AI-powered products).
- Safety Gate
In early 2024, the EC consulted on a short draft implementing regulation intended to explain in more detail how the Safety Gate would enable “consumers and other interested parties” (this is not limited to purchasers) to inform the EC about products that might present a risk to their health or safety. The implementing regulation was published in the Official Journal of the European Union in June 2024.
As stated in the implementing regulation, the EC plans to use an automated filtering system to distinguish between issues that raise safety concerns and those that do not. Information about safety issues would then be forwarded to relevant Member States (apparently without the EC taking other steps to verify that the information provided genuinely relates to product safety).
On 27 August 2024, the EC published a delegated regulation on the management of the Safety Gate Rapid Alert System regarding the operating rules of the Safety Gate system, including guidance for Member States on assessing risk. This delegated regulation (2024/3173) has applied since 13 December 2024. The delegated regulation intends to update the RAPEX guidelines in Implementing Decision 2019/417. It contains a detailed list of information that Member States should include when notifying via the Safety Gate system (including shipping and other documents where the manufacturers and exporters of the product are located outside the EU, and test reports). Further, the delegated regulation provides that, in some cases, Member States should take into account public interests other than health and safety when assessing risk (such as the environment, energy resources or property). It also contains guidance on circumstances in which risks shall be presumed to be serious (e.g., small parts issues for toys for children under 36 months, highly flammable fancy dress costumes for children, or electrical products with defective components that can lead to electric shocks or fire).
- Penalties
The GPSR states that penalties must be “effective, proportionate and dissuasive” but leaves to the discretion of Member States the decision as to what penalty would be appropriate, including what maximum penalty to impose.
What next?
Given the arrangements in place following Brexit, the GPSR applies in Northern Ireland but not the rest of the UK. Although the UK government has recently introduced the Product Regulation and Metrology Act, which provides the government with broad powers to introduce new regulations, the UK continues to operate under its existing product safety regime, which is based on the GPSD. As a result, businesses supplying products to both the EU (including Northern Ireland) and the UK will need to comply with two different sets of requirements.
Therefore, companies should monitor developments in both jurisdictions to ensure ongoing compliance with the applicable product safety laws.
As the regulatory landscape continues to develop, every company involved in selling products in the EU market should remain vigilant in ensuring their compliance strategies are up to date. For further information on these developments and how they may affect your business, please do not hesitate to get in touch with any member of our team.
