The EU product liability and safety landscape has seen significant developments over the last year to modernise the rules relevant to the safety of products and bring them up to speed with advancing technologies (such as AI systems and IoTs), circular economy business models and globalisation of supply chains. With reforms also on the horizon in the UK, businesses must navigate new compliance requirements and potential risks in the year ahead. We consider below an overview of the developments which all businesses in supply chains should be aware of to ensure regulatory compliance and mitigate liability risks going forward so far as is possible.
Product Liability - EU
After nearly 40 years, a new EU Product Liability Directive 2024/2853 (New PLD) came into force on 8 December 2024. The New PLD intends to make it easier for consumers to bring product liability claims for defective products (in relation to complex cases in particular) and significantly increases the liability risk for companies placing products on the EU market. It also poses entirely new risks for manufacturers, software developers, importers, distributors, fulfilment providers and online marketplaces in relation to the sale of digital products expanding the scope of the definition of 'product' to include software.
What are the key changes?
Extended liability
Software (embedded and standalone) and AI integrated products are considered a 'product' meaning insufficient software-updates or weak cybersecurity can also trigger liability. In addition, the definition of 'defectiveness' now also takes the requirements of product safety rules into even greater account. This includes mandatory standards/safety requirements relating to cyber-security (such as the new requirements under the Cyber Resilience Act) and the AI Act. The courts can also now take into account a product recall or other regulatory interventions when considering the question of defect.
More potential defendants
New liability risks for a wider net of companies are introduced, including the authorized representatives of the manufacturer, software developers, fulfilment service providers (ie storage, packaging and shipping service providers) and - under strict conditions - even distributors and online marketplaces operators.
Burden of proof
The New PLD eases the burden of proof for the claimant by establishing a presumption of defectiveness and a causal link if proof is (i) 'excessively difficult' due to the technical or scientific complexity of the product and (ii) a product defect and/or causality is at least 'probable'. Importantly, a defect is presumed where the product does not comply with mandatory product safety requirements where those are intended to protect against the risk of the type of damage suffered by the claimant. The EC has maintained this is not a reversal of the burden of proof and it remains for the claimant to prove their case. However, in practice we can see many occasions where technical difficulties could result in the defendants having to prove the product is not defective or did not cause the harm allegedly suffered.
Disclosure of evidence
Courts can now oblige defendants to disclose relevant evidence in their power or disposal, if the injured party has made a sufficiently plausible claim for damages. This is a significant change for those European jurisdictions where there are currently no procedural mechanisms in place for disclosure.
The New PLD therefore introduces a more claimant-friendly strict product liability regime in the EU and reduces legal certainty for businesses. The directive will have to be implemented by Member States by 9 December 2026. Please see here for more details on how to prepare in 2025.
Product Liability - UK
Despite the considerable changes in the EU, the UK product liability landscape has remained relatively unchanged during 2024. While the courts continue to grapple with product liability claims, Hastings (Appellant) v Finsbury Orthopaedics Ltd and another (Respondents) (Scotland) [2022] UKSC 19 (which held that for certain products there could be no entitlement to an absolute level of safety) remains the last judgment of note.
Looking ahead, the impact of the New PLD in the UK is still to be determined. We are continuing to monitor this but there has been no indication to date from the OPSS and/or UK government that the New PLD will be replicated into UK law. In fact, it seems more likely that the UK will wait and see how the New PLD fares in the EU courts before implementing any of its own legislative proposals. It may therefore be a little longer before we see much needed updates to the Consumer Protection Act 1987 which is not too far from its 40-year anniversary. To put this into context, the Internet only became available to the public in 1991. We will also need to wait and see the impact of the Product Regulation and Metrology Bill in which the government will have new powers to adopt and/or diverge from certain EU laws and regulations.
As such, UK manufacturers of products (which has a much broader definition as set out above) who export into the EU will need to be aware of their divergent liability in each jurisdiction and ensure policies are in place to meet the requirements of EU member states and the UK. Continued monitoring of both product safety and product liability laws is therefore crucial for compliance and we can support businesses with that.
In any event, it seems unlikely that the UK will see a similar rise of the product related class actions which are flooding into the US and Australian courts until greater certainty is offered to funders and potential claimant groups regarding the UK's proposed product liability reforms.
Product Safety - EU
The EU Regulation on General Product Safety (GPSR) came into effect on 13 December 2024 and is directly applicable in all EU Member States (including Northern Ireland). The GPSR has replaced the General Product Safety Directive 2001/95/EC (GPSD) to ensure the safety of non-food consumer products in the EU. The new rules complement other EU sector specific safety legislation on medical devices, toys, electronics and AI systems. Businesses will need to adopt specific new measures to comply with the GPSR in 2025 and beyond.
Scope of the GPSR
The GPSR requires that economic operators only place or make available on the EU market safe products. This includes second-hand, refurbished, reused, and recycled products.
Whilst the definition of a product refers to any item, whether interconnected or not, it does not expressly refer to software (unlike the definition of product set out in the new PLD). We are expecting the European Commission to publish guidance on the GPSR which might clarify whether standalone software (and therefore apps) falls within scope.
The meaning of 'safe'
A safe product means "any product which, under normal or reasonably foreseeable conditions of use … does not present any risk or only the minimum risks compatible with its use ...".
To meet this requirement, a product must undergo a thorough safety risk assessment (which is documented) considering all relevant aspects, including:
- The effect of interconnection.
- Risks to vulnerable consumers.
- Cybersecurity measures.
- The products evolving, learning and predictive functionalities .
Who is responsible?
Every 'economic operator' in the supply chain plays a role in ensuring product safety, including manufacturers, importers, distributors, authorised representatives, and fulfilment service providers. However, manufacturers have the most extensive obligations, including conducting an internal risk analysis and maintaining technical documentation for ten years after a product has been placed on the market.
The GPSR requires a designated 'Responsible Person' to be established in the EU to ensure compliance and act as a point of accountability with market surveillance authorities.
Online marketplace providers must also fulfil specific product safety obligations such as:
- Establishing a single point of contact for product safety.
- Designing their interface to display accessible product information.
- Implementing product compliance processes and suspending non-compliant traders.
- Registering with and using the Safety Gate Portal.
- Removing dangerous products on orders from authorities within two working days.
Economic operators and online marketplaces must inform consumers directly and promptly about recalls and safety warnings. Recall notices must avoid terms which may downplay risk eg, 'voluntary', 'precautionary', 'discretionary'. Consumers should be offered a choice of two remedies, including repair, replacement with a safe equivalent or refund.
Enforcement
Penalties for infringements of the GPSR are at the discretion of Member States and may differ in each jurisdiction, but they must be effective, proportionate, and dissuasive.
Product safety - UK
The GPSR does not apply in Great Britain (GB) and products sold on the GB market (England, Wales, and Scotland) must still comply with the General Product Safety Regulations 2005/1803, which implemented the GPSD into UK law. However, British businesses placing products on the EU market must comply with the GPSR.
We expect that the Product Regulation and Metrology Bill (the Bill) will be enacted this year. The Bill is currently going through the legislative process and is still subject to change, but it will likely give the Government the power to make secondary legislation to update existing laws and address some of the challenges we currently face. For example, in the Government's response to the Product Safety Review and next steps published towards the end of last year, the Office for Product Safety and Standards (OPSS) confirmed that a key priority is to address the problem of unsafe products being sold to UK consumers via online marketplaces.
If enacted, the Bill will give the government the ability to diverge from EU requirements where hazards or opportunities arise or mirror EU requirements where that is the right approach for UK businesses and consumers. As such, businesses placing products on both the GB and EU markets should monitor developments in this area closely and ensure they comply with both sets of rules.
CE marking update
On 3 February 2025, the Department for Business and Trade (DBT) published guidance on using European harmonised standards for placing CE-marked products in GB. According to the guidance, if the relevant harmonised standard does not have an identical GB designated standard, manufacturers may have to undertake additional action or follow different conformity assessment procedures to sell their product in GB.
Circular economy/packaging waste reforms
Extended Producer Responsibility (EPR)
An amendment to the EU Waste Framework Directive 2008/98/EC is currently making its way through the EU's legislative process, which will introduce an EPR regime for textiles including clothing, blankets, bed linen, curtains, hats, footwear mattresses and carpets, as well as products that contain textile-related materials such as leather, rubber, or plastic. It is proposed that Member States will have 18 months after the directive comes into force to set up EPR schemes. These will see fashion brands and textile producers having to pay fees to finance the collection and processing of textile waste.
Meanwhile, the new EPR for packaging waste regime came into force in the UK on 1 January 2025.
This comes after much anticipation and several years after the EU introduced a similar scheme. As with the EU scheme, the intention is to improve the circular economy and ensure that there is an emphasis on reducing packaging/packaging waste and on recycling. Producers will have to report data and pay fees in relation to the packaging they place on the market, thus (it is hoped) making them more accountable.
The new requirements apply to UK established producers of packaging waste. Under the new regulations, producers will be those undertaking any of the following activities:
- supplying packaged goods to the UK market under their own brand
- placing goods into packaging
- importing products in packaging
- owning an online marketplace
- hiring or loaning out reusable packaging
- supplying empty packaging.
The regulations therefore cover both businesses who manufacture and supply packaging but also those who manufacture and supply goods within packaging.
The specific obligations imposed will depend on whether the UK producer is a 'large producer' or a 'small producer'. Large producers are those which had a turnover of £2 million in the previous calendar year and supplied in aggregate more than 50 tonnes of packaging to the UK market in the same year. Small producers are those with a turnover of £1 million and supplied in 25 tonnes of packaging in the same year.
However, the key requirements of the regulations are that both small and large producers will be required to report on the packaging they place on the market and pay the fees to a new scheme administrator, PackUK, which was launched on 21 January 2025.
UK producers are required to report their packaging data for the calendar year 2023. There will be no fees payable for 2023 (this will kick in in relation to reporting data for 2024).
EU Battery Reform – what next for the UK?
The new UK EPR regime set out above is an example of the UK seeking to take a similar approach to the EU on regulatory issues post Brexit.
The new EU Battery Regulation has been enacted and its obligations are being implemented in stages. The new regulation brings in several notable reforms including, from February 2027, QR code labelling. It also requires batteries to be CE marked, which was not the case under the previous EU legislation and is not required by the current UK regulations (which are based on the previous EU rules). As such, this is an example of genuine divergence between the EU and the UK post Brexit (which will affect a significant number of different products).
This will create a significant difference between what is required in the EU (and Northern Ireland) and what is required in GB. This could cause confusion for those importing/exporting batteries between the two markets and for companies in third countries like the US which will have to grapple with different requirements.
Whilst the previous UK Government did publish a battery strategy at the end of 2023, it hasn’t produced any legislative proposals. It remains to be seen how the UK Government will approach this issue and whether it will seek to introduce new legislation to re-align UK requirements with those in the EU.
