New rules under the General Product Safety Regulation (EU) 2023/988 (GPSR) have applied since 13 December 2024 across the European Economic Area (EEA) – comprising the European Union member states, plus Iceland, Liechtenstein and Norway – and Northern Ireland. The GPSR is a significant piece of legislation that introduces multiple reforms. In the fourth in a series of blogs, the Cooley products team unpacks the new rules impacting product recalls and corrective actions.
Scope: The GPSR applies in full to consumer products that are not already subject to EU harmonisation legislation (i.e. non-CE marked products) and covers gaps in product safety regulation for consumer products subject to certain EU harmonisation legislation (i.e. CE marked products). The new rules for product recalls and corrective actions under the GPSR apply to all consumer products in scope of the GPSR, including consumer products regulated by EU harmonisation legislation (to the extent that the sector-specific legislation does not provide for its own obligations related to product recalls and corrective actions).
What are the changes for product recalls and corrective actions?
Notifying authorities: Before the GPSR, companies could discharge their obligation to inform national authorities about dangerous products using the business-facing portal of the Safety Gate system (Business Gateway). While there was scope for companies to inform national authorities via other means, in practice, many opted to use Safety Gate. Under the GPSR, however, it is now mandatory to use the business-facing portal of the Safety Gate system (renamed the Safety Business Gateway). Whilst many will be familiar with the Safety Gate system, care should be taken as the online form has changed and is also the same form used to report accidents under the GPSR.
New post-market risk assessment methodology: Commission Delegated Regulation (EU) 2024/3173 establishes a new risk assessment methodology for EU member states to use in support of notifications they make via Safety Gate. The new methodology combines the risk assessment guidelines from both:
- Commission Implementing Decision (EU) 2019/417, laying down guidelines for the management of the European Union Rapid Information System.
- The EU general risk assessment methodology for harmonised products (i.e. many CE-marked products) that covers broader categories of risks.
The new methodology also introduces several changes. One concern for companies has been that the new methodology expands the list of cases that can be deemed to present a serious risk without the need for national authorities to conduct a risk assessment. This builds on a handful of examples under the former risk assessment methodology, which mainly involved chemicals and certain risks associated with children’s products. However, the new list is much broader and includes the following scenarios (among others):
- There is well-documented evidence that certain features of the product consistently lead to a serious risk – with the addition of electrical products with defective components that can lead to electric shock or fire.
- The product has been subject to a recall, withdrawal or removal of online content based on voluntary measures of economic operators or providers of online marketplaces.
The European Commission has clarified in a Q&A document that the presumption of serious risk without the need for a risk assessment under the first bullet point above is a rebuttable presumption. There is scope for national authorities to consider information provided by a manufacturer or importer that a product presents a less-than-serious risk.
In relation to the presumption for products subject to a recall, withdrawal or removal of online content based on the voluntary measures of online marketplaces, the European Commission clarified in its Q&A document that this presumption is applicable where this action constitutes ‘corrective measures, taken in relation to dangerous products and products posing other public interests as regards products covered by the Union harmonisation legislation’. Where the product recall, withdrawal or removal of online content was decided by an economic operator or a provider of an online marketplace for any reason other than these risks, e.g. ‘such as mere commercial reasons’, the presumption of serious risk should not apply.
Communication and advertising: The GPSR introduces a new express obligation to directly notify all affected consumers that can be identified ‘without undue delay’, making use of personal data collected. If not all affected consumers can be contacted directly, companies will be required to disseminate the recall notice using alternative channels such as their website, social media, newsletters, retail outlets and media announcements. This information should be accessible to persons with disabilities.
Recall notices: The GPSR introduces a new obligation to use a recall notice when communicating with consumers in writing and lays down requirements for what the recall notice needs to contain. This includes certain information about the product, the hazard, the actions consumers should take and the recall remedies available. Certain terms that may decrease a consumer’s perception of risk are prohibited, such as ‘voluntary’, ‘precautionary’, ‘discretionary’, ‘in rare/specific situations’ or statements indicating that there have been no reported accidents.
The European Commission has provided a template recall notice in Implementing Regulation (EU) 2024/1435, with subsequent corrections published in July 2024. The Commission clarified in a Q&A document that, whilst use of this template is recommended, use of the template itself is not mandatory. Another format for the recall notice that satisfies the requirements listed in the GPSR can be used.
Recall remedies: The GPSR introduces new requirements surrounding recall remedies. This includes offering consumers a choice of at least two remedies from repair, replacement or refund. However, there is some flexibility for only one remedy to be offered in certain cases where other remedies would be impossible or disproportionate. The GPSR also lays down rules surrounding asking consumers to repair products themselves, asking consumers to dispose of products, who is to bear the costs of returning a product and the collection of nonportable products.
New obligations on online marketplaces: The GPSR introduces new obligations for online marketplaces, including reporting dangerous products via the business-facing portal of Safety Gate, directly notifying affected consumers who purchased a product through their interfaces about recalls and publishing recall information on their online interfaces.
What’s next?
The European Commission is yet to publish its formal guidance on the GPSR, with tentative indications that this may possibly be published on 19 November 2025.
Companies that supply products to the EU should ensure that they understand the new requirements and review and update their internal recall plans.
Like to know more?
Get in touch with any member of the Cooley products team to find out more about the new rules under the GPSR and how they may impact your products.
This is the fourth in a blog series where the Cooley products team explores the new rules under the GPSR. See the first post in the series, ‘What’s New?’, along with the second post, ‘An Expanded Concept of Safety’, and third post, ‘New Accident Reporting Obligations’.
