General Product Safety Regulation is in force: less than one year to go until EU’s new Product Safety rules apply
Speed Read
Earlier in the year, we reported on the progress of the EU General Product Safety Regulation (GPSR) published in 2021, and the ongoing negotiations between the European Union (EU) institutions to finalise this significant new legislation intended to replace the General Product Safety Directive (Directive 2001/25) (GPSD).
To recap, the GPSR will place a number of new obligations relating to a variety of players in the supply chain who are referred to collectively as “economic operators”. These “economic operators” include “manufacturers”, “authorised representatives”, “importers”, “fulfilment service providers” and for the first time “providers of an online marketplace” - with their relevant respective obligations relating to ensuring and monitoring product safety depending on the specific role they play in the supply chain.
The final text of the GPSR was agreed and was published in the Official Journal on 12 June 2023. While now technically in force, it will only apply from 13 December 2024. Until then, the GPSD continues to apply, but the clock is ticking, and businesses need to treat the period between now and December 2024 as the “get ready” zone.
While organisations will require specific advice on how to prepare according to their role in the supply chain, their particular product offerings, industry or sector, we address in this briefing some essential points for all businesses to be aware of in terms of preparation and readiness for December 2024. The penalties for non-compliance with product safety laws, as well as associated reputational damage, makes it critical that these pending changes are kept high on the agenda for 2024 planning.
Application and scope
The GPSR is a regulation, so it will be directly binding in all EU Member States. As such, 13 December 2024 is a hard deadline without any room for potential delay as a result of Member State implementation. As a regulation, the GPSR imposes clear and detailed rules without the risk of divergent transposition by Member States. Member States, however, remain responsible for implementing national legislation in setting the level of penalties for infringement. The GPSR mandates that these sanctions must be effective, proportionate and dissuasive, but leaves it up to the individual Member States to decide on their exact form[1]. We will have to wait and see what shape these penalties will take in Ireland.
The GPSR is similar to the GPSD, in that its provisions apply where there is no separate sector-specific legislation in place. For example, food products, medicinal products for human use and veterinary products are all governed by standalone legislation and will therefore be outside the GPSR’s scope[2]. Where products are subject to specific safety requirements imposed by EU law, the GPSR applies only to those aspects which are not covered by those requirements. Importantly, it applies to all products placed or made available on the EU market – whether they are new, used, repaired or reconditioned.
It is therefore an incredibly far-reaching piece of legislation – and hence it is critical that businesses use the next twelve months to familiarise themselves with the various requirements they will be subject to from 13 December 2024. To assist in this exercise, we have summarised some key points that all businesses should consider and address during this lead in period.
Key points to consider during the “get ready” zone
- Appointment of a “responsible person” within the EU
In order to assist market surveillance efforts in relation to the sale of dangerous products within the Union, the GPSR expands the “Responsible Person” concept as set out in Article 4 of Regulation (EU) 2019/1020 on market surveillance and compliance of products. Going forward, all non-food consumer products sold in the EU will require an “economic operator” to be established within the EU, who will be tasked with ensuring compliance with the obligations as set out in the GPSR. This “economic operator” will act as an interlocutor against whom authorities can seek to enforce obligations. It may also be required to carry out specific tasks such as regular checks regarding compliance with the technical documentation, product and manufacturer information, instruction and safety information[3].
All companies, therefore, should ensure that such an economic operator is established. This is especially important for companies operating from outside the EU intending to make their products available on the EU market.
- Reporting obligations
The GPSR places a mandatory obligation on manufacturers to notify authorities of accidents caused by their products via the European Commission’s (the Commission) online portal, Safety Gate. The GPSR introduces a threshold for this reporting obligation, which is “occurrences associated with the use of a product 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 report must be made without undue delay from the moment the manufacturer becomes aware of the accident or occurrence[4].
It is critical that businesses reflect this enhanced reporting obligation in internal product recall response plans and all applicable internal guidelines and policies.
- Risk assessments for software updates
The GPSR outlines matters to be taken into account when assessing the safety of products[5]. Notably, it specifically addresses safety considerations regarding software updates for products. In particular, it requires that appropriate cybersecurity features be installed to protect the product against external influences, such as malicious third parties, which might impact the safety of the product.
It also addresses new technologies which may, for example through software updates, substantially modify the original product. In the case of substantial modification which impacts the safety of the product concerned, the product should be subject to a new risk assessment[6]. It remains unclear where the threshold lies as regards “substantial modification” which would necessitate a new risk assessment.
- New obligations for online marketplaces
The GPSR introduces specific obligations for providers of online marketplaces (POM’s). POMs are defined as providers “of an intermediary service using an online interface which allows consumers to conclude distance contracts with traders for the sale of products”. This means that the vast majority of e-commerce platforms and websites will now be subject to the new product safety obligations coming into play in December 2024.
In practice, this will require POM’s to adopt a more ‘hands-on’ approach to ensure the safety of products sold on their platforms. Some of the new requirements include a requirement to register on Safety Gate and monitor it for dangerous product notifications; to designate a single point of contact for consumers to communicate with on product safety issues; to receive and process orders relating to product safety without undue delay; and to notify consumers directly about product recalls. The GPSR represents a significant shift in the regulation of products generally, with an alignment of online sales requirements with the more traditional offline sales[7].
Related developments
While significant in itself, the GPSR is only one of a number of product regulatory related developments on the horizon. The proposed new Product Liability Directive, published in 2022 by the Commission aims to update and modernise the EU’s product liability regime, in light of technological advancements since it was originally adopted, nearly 40 years ago. Provisional political agreement on the text was reached on 14 December and the legislation is likely to be formally approved early in 2024, with a 24 month lead in period.
Also of note is a new proposal adopted by the Commission in March for a Directive on common rules promoting the repair of goods in order to reduce waste associated with the continual purchase of new products. This proposed new “Right to Repair” Directive would oblige sellers to repair a product for free within the two-year legal guarantee period and to provide repairs for products for between five and 10 years after sale.
Specifically in relation to toys, the Commission adopted a proposal in July to revise EU toy safety legislation by way of a new regulation and repealing Directive 2009/48/EC. The main objectives of this proposal are to achieve a higher level of child protection and reduce the number of non-compliant and unsafe toys on the EU market.
What these recent developments have in common with the GPSR, is that they represent an increased focus on the safety and quality of products, and an increased responsibility placed on the entities behind them to ensure their compliance with ever-increasing product safety obligations. While there is plenty more change ahead, businesses should – as a key priority for 2024 – scrutinise the GPSR to assess what role they play in the supply chain and where they sit in terms of new or changed obligations. It will be important to use the time between now and 13 December 2024 – the “get ready” zone – to ensure that relevant systems for product traceability, recall and customer service are suitable and fit for purpose to ensure compliance with these new obligations.
Thanks to Colin Brady for his assistance in preparing this piece.
For more information, please contact Katie O'Connor, Partner, John David Mulcahy, Senior Associate, Orla Clayton, Knowledge Consultant or your usual ALG Disputes & Investigations Team contact.
Date published: 19 December 2023
[1] Article 44
[2] Article 2(2)
[3] Chapter III
[4] Art 20/Chapter VI
[5] Article 6
[6] Recital 25
[7] Chapter IV