In the first of a series of blogs, the Cooley products team takes a look at what’s new under the European Union’s General Product Safety Regulation.
New rules under the General Product Safety Regulation (EU) 2023/988 (GPSR) apply in the European Union from 13 December 2024. The GPSR replaces the General Product Safety Directive 2001/95/EC (GPSD). It applies in full to products that are not already subject to EU harmonisation legislation (i.e., non-CE marked products) and covers gaps in product safety regulation for products subject to certain EU harmonisation legislation (i.e., CE marked products).
The GPSR represents a substantial update from the current rules. It will introduce new requirements for consumer products marketed in the EU and create new obligations for companies supplying those products to the EU. Many of the changes are world-first regulatory innovations. Companies impacted need to ensure they understand the upcoming new requirements and review existing products, systems, policies and procedures to determine what changes (if any) will be needed to comply.
So, what’s new?
1. New requirements for non-harmonised products – including new stricter labelling obligations and new requirements to prepare a technical file, conduct a pre-market risk assessment and appoint a responsible person in the EU to undertake certain tasks.
2. Additional requirements to consider when assessing the safety of products – including mental health, cybersecurity (to the extent it has an impact on safety), impact of software updates/software subsequently downloaded, artificial intelligence (AI) and machine learning (ML) functionalities, connectivity, different impacts on health and safety for different genders, and risks for vulnerable consumers (e.g., children, older people and people with disabilities).
3. New requirements for online sales – including that the online offer will need to display mandatory information, such as the details of the manufacturer, details of the responsible person in the EU where the manufacturer is not established in the EU, information to identify the product (picture, its type and any other product identifier), and any warnings and safety information required to be affixed to the product, or on its packaging or included in its accompanying documents under EU laws.
4. New mandatory requirements for complaints – Manufacturers, and in certain cases importers, will be required to have communication channels for consumers to submit complaints and report accidents/issues. There is an obligation to investigate complaints that concern the safety of products or allege products are dangerous, and keep an internal register of those complaints and product recalls/corrective actions, along with specific requirements regarding personal data stored on that register. For many harmonised products, sector-specific rules cover the requirements for an internal register.
5. New mandatory accident reporting obligations – Manufacturers will be required to report accidents over a certain threshold without undue delay from the moment they know about it. Where the manufacturer is not established in the EU, the responsible person who has knowledge of an accident will need to ensure the report is made. There also is a separate accident reporting obligation on online marketplaces.
6. New obligations on providers of online marketplaces – including to establish a single point of contact for market surveillance authorities and also consumers, to cooperate with authorities, to respond to notices from authorities within two working days and process notices related to product safety issued under the notice and action mechanism in the Digital Services Act within three working days, to design interfaces to enable traders to display the information required for online offers, to report dangerous products via Safety Gate, to report accidents via Safety Gate, and to directly notify affected consumers about recalls and publish information about recalls, plus more.
7. New requirements for how product recalls and corrective actions are carried out – including to notify all affected consumers directly, along with mandatory requirements for recall notices (including a template recall notice and a prohibition on using terms such as ‘voluntary’, ‘in rare/specific situations’) and new rules for the recall remedy (including offering a choice of at least two options of repair, replacement or refund).
8. Enhanced role for Safety Gate – It will become mandatory to use the European Commission portal, Safety Gate, to notify product recalls, and it will be the portal for the new accident reporting obligation. Consumers and ‘other interested parties’ will be able to use Safety Gate to report products that may present a risk.
9. Increased enforcement – including requiring the European Commission to organise, on a regular basis, joint activities between market surveillance authorities to inspect products purchased covertly, obligations on authorities to carry out coordinated sweeps of particular products/product categories, along with provisions on international cooperation between the European Commission and international regulators.
10. Increased class action risk by amending the new EU Representative Actions Directive to allow representative actions for any breaches of the GPSR – such as for recalls.
We’ll be taking a deeper dive exploring these changes in our upcoming blogs, so stay tuned.
