The UK’s product safety legal regime seeks to balance the rights of consumers with those of business, aiming for the highest level of public safety that does not stifle innovation.
Regulated Products
The product safety regimes apply to consumer products, including:
Legislation
The system consists of the following fundamental legislative pillars.
General product safety requirements
These are contained within the General Product Safety Regulations 2005 (GPSR). This legislation contains fundamental, overarching concepts of product safety, including the following:
Supplementary product-specific safety requirements
These are contained within sector-specific legislation, to more specifically address unique or specific risks associated with certain types of products. Where they exist, such requirements take precedence over the above-mentioned general requirements contained in the GPSR. Otherwise, these product-specific requirements apply where the GPSR are silent. Sector-specific laws exist in respect of the following, for example:
Separate product-specific safety regimes
Separate product safety regimes aim to address the unique and quite separate risks of products that are not considered “industrial products” (which are addressed by the above-mentioned legislation). These operate separately from the GPSR and include the following, for example:
Enforcement and Monitoring of Obligations Imposed by Regulators
Market surveillance activities are carried out by regulators, who are empowered to monitor and enforce compliance with the above-mentioned product safety laws. Please refer to 1.2 Regulatory Authorities for Product Safety for further detail.
The Role of Technical Standards
In practice, compliance with the above legal requirements is often achieved through adherence to technical standards specific to each product type/category/feature, which provides a benefit of conformity under the relevant legislation. Technical standards are developed by relevant standardisation organisations, and are designated under appropriate legislation by the Secretary of State who is empowered to do so in the UK.
The Effect of Brexit on the UK Product Safety Law Regime
The above UK product safety laws derive largely from EU legislation (the GPSR give effect to EU Directive 2001/95/EC on general product safety, for example). Given the implementation of local UK laws to enact EU-level obligations prior to Brexit and/or the direct effect of EU laws in the UK at the time of initial pre-Brexit implementation, much of the legislative framework for product safety in the UK remains substantively unchanged post-Brexit. However, the Retained EU Law (Revocation and Reform) Act 2023 received Royal Assent in June 2023, introducing further divergence between the EU and UK law with the revocation of almost 600 pieces of legislation by 31 December 2023.
Further, various UK legislation, such as, most relevantly, the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019, was enacted to amend EU-based legislation to make correct references to the UK rather than the EU, and to ensure the continued applicability of the legislation in the UK. Supplementary legislation was also required to be enacted in some sectors to empower the relevant UK law-makers to implement future changes to UK legislation. In some specific areas, including medical devices, the EU and UK positions already deviated significantly because of legislative changes in the EU that did not take effect prior to Brexit. Please refer to 3.1 Trends in Product Liability and Product Safety Policy for further detail.
Oversight of the UK product safety regimes is undertaken by several regulators in the UK, at various levels.
Local Authorities
Local authorities have day-to-day responsibility for the enforcement of product safety legislation in the UK, which is carried out through local Trading Standards (TS) offices. Through the GPSR and Consumer Rights Act 2015 (CRA), such authorities have a wide range of powers, including the ability to:
Overarching Product Safety-Specific Regulator
The Department for Business, Energy and Industrial Strategy (BEIS) is responsible for high-level oversight of policy and strategy in the area of product safety regulation. In January 2018, the Office for Product Safety and Standards (OPSS) was developed within BEIS to address an apparent need for a technical, centralised resource to assist localised regulatory enforcement around product safety issues. The OPSS carries out the following functions:
The OPSS is empowered with many of the aforementioned enforcement powers of TS.
Product-Specific Regulators
There are product-specific regulators for the following product categories:
Product producers in the UK are required to conduct corrective actions to address product safety issues that make a product unsafe (GPSR Regulation 7), in contravention of the GPSR safety requirements or other relevant product safety laws. The actions taken by producers must be “commensurate with the characteristics of the product” and there are a range of corrective actions that can be taken, including withdrawal from the supply chain, additional warnings to consumers, in-market repairs or alterations, and a consumer-facing recall. Generally, consumer-facing recalls are considered a last resort. The nature of the corrective action undertaken is determined by the results of a risk assessment.
In March 2018, the OPSS co-operated with the UK’s standards institution, the British Standards Institution (BSI), to launch a Code of Practice for Product Safety Recalls (PAS 7100:2018). The Code has two parts.
EU-level guidance on topics of risk assessments (RAPEX methodology, 2019) and guidelines (European Commission and PROSAFE guides) may still be useful, given the basis of the laws, notwithstanding the event of Brexit, but will not necessarily be held in the same regard without further changes being implemented to preserve their position as official guidance in the UK.
There are no mandatory requirements for advertisements or other form-specific requirements for the advertising of product safety recalls in the UK. However, the above-mentioned Code provides detailed guidance on the form and content of corrective action announcements.
Under Regulation 9 of the GPSR, or equivalent sector-specific regimes, there is a mandatory obligation on producers or distributors to report to authorities where they know that a product they supply is “incompatible with the general safety requirement” under the GPSR.
The GPSR requires the report to be in writing and to contain certain mandatory information – namely, the action taken to prevent risk to consumers and the location of supplied products, as well as further identifying information if the product is thought to pose a serious risk.
There is no mandatory procedure to follow to make these reports, and the practices of TS offices can differ greatly in practice, including requiring completion of specific forms. There is also sometimes interaction between the OPSS and TS; for example, where a report to both entities is requested, or warranted for certain more significant issues.
Post-Brexit, the UK is no longer part of the European Commission’s rapid alert system, Safety Gate (formerly RAPEX), which assists with Europe-wide information sharing regarding non-food product safety risks. Reports to UK market surveillance regulators will be recorded, in certain circumstances, on the OPSS’ Product Safety Database, which covers consumer products under the ambit of the OPSS’ work.
Although there are no specific timeframes under statute regarding these reports (the legislation simply states that obliged entities should “forthwith notify an enforcement authority”), the recommended timeframe for reporting, provided in guidance documents only, is generally dictated by the assessed risk of the safety matter to consumers who use the affected products.
It is a criminal offence to fail to report to authorities under Regulation 20(3) of the GPSR, punishable with an unlimited fine or imprisonment for a term not exceeding three months.
In practice, companies and regulators work to resolve issues before there is a need to prosecute formally. Regulators are likely to employ the wide range of powers available to them under relevant legislation prior to commencing formal prosecution; please refer to 1.2 Regulatory Authorities for Product Safety for details. There are a few isolated examples of companies being prosecuted, particularly toy or children’s product manufacturers where the risk to vulnerable users is considered particularly egregious, or where there has been a significant delay in reporting to authorities. Generally, companies plead guilty in short hearings in UK Magistrates’ Courts, and fines have also historically been small.
A recent illustrative example is the fining of a toy manufacturer following a prosecution by Thurrock Council Trading Standards in April 2021. The company pleaded guilty to the import and supply of unsafe toys at a hearing in Southend Magistrates’ Court on 14 April 2021. Initial raiding of the premises by TS uncovered toys without relevant safety documents, and further testing confirmed that the toys presented risks of choking asphyxiation. The company was ordered to pay approximately GBP4,100. The prosecution was said by the Council to be brought after “repeated attempts” to encourage the company to comply with its legal obligations.
Another, more serious, example of a penalty for breaching product safety standards is the imprisonment of a supplier of electrical goods following a prosecution by Havering Council Trading Standards in May 2022. A three-month prison sentence was handed down by Snaresbrook Crown Court to a company director for failing to comply with requirements of product safety regulations and unauthorised use of a trade mark. The online business sold electrical chargers, adapters, plugs, cables and earphones. Following a raid of the storage premises by TS, a large quantity of the items, with a retail value of GPB54,000, were found to be contravening UK safety regulations or counterfeit.
There are three main causes of action typically employed by claimants pursuing product liability claims in the UK. Each suit offers certain strategic advantages that might make it preferable to certain claimants in certain circumstances; however, claimants often elect to pursue more than one of the causes of action in parallel, in respect of the same facts, to increase the likelihood of success and overcome some of the limitations of certain causes of action.
“Strict Liability” Statutory Regime Under the Consumer Protection Act 1987 (CPA)
The CPA creates a no-fault liability scheme in respect of defective products that have caused personal injury or damage to private property, excluding damage to the product itself.
Under the regime, the following entities have joint and several liability:
The following three key elements of the cause of action must be established by the claimant.
Defect
Section 3 of the CPA establishes there is a defect in the product “if the safety of the product is not such as persons generally are entitled to expect”. The court will take into account all of the circumstances when assessing the safety of the product, including:
The landmark case of Colin Gee & Others v DePuy International Limited [2018] EWHC 1208 (QB) (“Gee”) provides the following guidance on the application of this statutory test:
Damage
Generally, death, personal injury or any property loss (property for private use, occupation or consumptions) are damages for which claimants can seek compensation under the CPA.
Damage to the product is excluded from the scope of recoverable heads of damage. There is also a minimum monetary value of GBP275 that the property damage suffered must exceed in order to be entitled to pursue a claim under the CPA.
Causal link
There must be a causal link between the product defect and the damage/injury sustained. The traditional English law tests for causation apply to product liability cases.
Tortious Liability – Negligence
Manufacturers or other actors in the supply chain (mostly where a manufacturer cannot be identified) can be liable in common law negligence in respect of a defective product.
To bring a successful claim in negligence, a claimant must prove, on the balance of probabilities, that:
The key distinguishing feature of such actions is that the claimant must establish fault on the part of the defendant. For this reason, this claim is generally considered to be more difficult to bring than that under the no fault mechanism of the CPA.
Breach of Contract – Express or Implied Statutory Term
Consumers that are party to a contract with a seller or supplier of products can pursue a breach of contract claim if a product supplied is defective or otherwise fails to conform to the contract of sale.
The seller may be exposed in respect of breach of either express terms, or those implied by the Consumer Rights Act 2015 (CRA) in respect of:
To bring a claim in contract, a claimant must prove the following on the balance of probabilities.
There are different requirements to bring the three causes of action mentioned in 2.1 Product Liability Causes of Action and Sources of Law in relation to product liability claims in the UK, as follows.
CPA
Consumers (“any person who purchases or uses the product in question for private use”) have legal standing to bring product liability claims. Persons who purchase or use goods for the purpose of resale or commercial use are expressly excluded from the definition of consumers. In order to have a right of action under the CPA, the consumer must have suffered damage of a kind covered by Part 1 of the CPA.
Negligence
Any person to whom a duty of care is owed can bring a negligence claim in circumstances where that duty is breached and they sustain a reasonably foreseeable loss or damage caused by a defective product.
A claimant need not know the defendant in order to bring a successful claim in negligence. A claim may be brought by a consumer/purchaser of the product, a person who uses the product, or a third-party bystander who is injured by the product.
Contract
Generally, because of the doctrine of “privity of contract”, only the parties to a contract can enforce the terms of that contract. However, in certain circumstances a third party may seek enforcement under the Contract (Rights of Third Parties) Act 1999, unless these rights have been expressly excluded.
There are strict time limits for bringing civil claims in England and Wales, including product liability claims.
Negligence and Contract
Under the Limitation Act 1980, claims involving personal injury must be brought within three years from the date that the damage occurred or the date that the claimant knew, or reasonably ought to have known, that they had a cause of action (“the date of knowledge”). Knowledge can be acquired from the date that the claimant knew the identity of the defendant or realised the significance of their injury.
For non-personal injury claims, the claim must be brought within six years from the date on which the damage or loss occurred, or three years from the date of knowledge for claims concerning latent damage. The three-year limitation period can be extended at the court’s discretion.
CPA
Working in tandem with these time limits, the CPA contains a ten-year long-stop provision, allowing claims under it to be brought within ten years from the date on which the product was put into circulation. Absent the issuing of court proceedings within that timeframe, rights under the CPA are extinguished and cannot be extended by the court.
Prior to Brexit, the jurisdiction of UK courts, as opposed to other EU member state courts, was determined by the operation of EU-level laws. Post-Brexit the situation is as follows.
CPA
Generally, UK courts, as with other European-based courts, will assume jurisdiction to try a case where either the injury, loss or damage occurs, or where both parties are domiciled, in that country.
Prior to the UK leaving the EU, where a defendant was domiciled in England, the English court had jurisdiction and could not decline jurisdiction, pursuant to Owusu v Jackson (Case C-281/02) [2005] ECR I-1383. This no longer applies now that the UK has left the EU, and UK-domiciled defendants are able to challenge the English court’s jurisdiction on grounds of it not being the appropriate forum.
Negligence
In order to invoke the jurisdiction of English courts in respect of negligence claims, it is sufficient for a defendant to be physically present in England and Wales to enable the claimant to serve proceedings on that defendant.
Contract
Contractual terms agreed by both parties ordinarily determine the applicable law, jurisdiction and location of proceedings in respect of contractual breaches.
There are mandatory pre-action protocols applicable in respect of product liability claims, under the Civil Procedure Rules Practice Direction on Pre-Action Conduct and Protocols, that must be complied with prior to the commencement of formal claims.
The following Pre-Action Protocols may typically be applicable to product liability claims:
These Pre-Action Protocols ordinarily dictate the following pre-action procedural steps:
Breach of these protocols can have a substantive impact on the ability to commence formal proceedings and/or can have negative costs consequences for the defaulting party, with the court potentially taking the following actions:
Broad document preservation obligations are imposed on parties to proceedings in England and Wales, including product liability matters. These rules work in tandem with rules regarding document disclosure; please refer to 2.7 Rules for Disclosure of Documents in Product Liability Cases for further detail.
Under Civil Procedure Rules (CPR) Practice Direction 31B (paragraph 7), once litigation is contemplated, parties must ensure that all potentially disclosable documents are preserved, including any relevant products, devices, design files, testing information, etc. Please refer to 2.7 Rules for Disclosure of Documents in Product Liability Cases for further detail.
Under this provision, past, present and future documents must be preserved.
Failure to comply with these requirements – including by interfering with evidence by deleting, overwriting, updating or destroying documents – has far-reaching consequences, including the following measures which the courts can and do impose:
There are far-reaching disclosure requirements in respect of product liability cases in the UK.
CPR Part 31 sets out the parties’ responsibilities. Generally, as part of “standard disclosure”, parties to an action are required to disclose the following:
The court, in its discretion, may limit or dispose of the above requirements (CPR 31.5). CPR 31 does not apply to claims entering the small claims track (see 2.10 Courts in Which Product Liability Claims Are Brought). However, a court will ordinarily order standard disclosure, requiring each party to file and serve on the court and all parties copies of all documents upon which they intend to rely.
Parties are required to conduct a reasonable and proportionate search for the above-mentioned disclosable documents. Disclosure obligations are ongoing – ie, continual disclosure is required until the cessation of the matter, including in respect of documents created during the proceedings.
Electronic Document Disclosure
Given the prevalence of electronic documents and sources in modern litigation, specific rules apply to electronic documents. An electronic document is defined as any document held in electronic form – eg, emails, text messages, voicemails, word processed documents, social media messages and databases. CPR 31, Practice Direction 31A and 31B set out the rules of disclosure of electronic documents in multi-track claims (though a court can also apply these rules to small or fast-track claims), and provide for the following, amongst other things.
A party requesting the specific disclosure of electronic documents that are not reasonably accessible must demonstrate the relevance of those documents in order to justify the costs and burden of retrieving them.
The parties must advise the court before the first scheduled case management conference (CMC) if an agreement has been reached concerning electronic disclosure. If an agreement has not been reached before the first scheduled CMC, the parties will be required to identify issues to put before the court for directions. It may be considered reasonable for a party to search for relevant documents using “key word searches” if a full review of every document would be considered unreasonable or disproportionate in terms of costs and review time involved.
There are prescriptive requirements for expert evidence in respect of product liability claims in England and Wales courts, as set out in the following CPR provisions:
Generally, the above provisions provide that parties’ use of experts is limited to:
Other requirements include the following.
Costs
Courts are increasingly limiting the use of experts in cases in an attempt to control costs. Accordingly, if an expert is instructed, it is important that parties manage costs carefully, including by the following means.
In respect of each cause of action in product liability claims, the claimant bears the onus of proof. The standard of proof required, in respect of each discrete action, is to prove the case against the defendant on the balance of probabilities (civil standard).
The forum in which a product liability is heard is dictated by the value and/or complexity of the claim. Claims all commence, in the first instance, in either the High Court or the County Court. Thereafter, courts allocate these defended claims to one of three procedural tracks, at an early stage:
Multi-track claims can be heard at either the High Court or County Court. Claims with a value of less than GBP50,000 which are commenced in the High Court are generally transferred to a County Court unless there is a specific reason for them to be heard at the High Court (for example, where the case concerns particularly difficult questions of law or where it might attract significant public interest).
In general, in the first instance, product liability cases are heard by a single judge who will generally be alive to the potential complexity of such claims and will allow evidence from a range of expert disciplines and lay witnesses where required. On appeal in the Court of Appeal or Supreme Court, cases may be heard by three or five judges. Jury trials do not take place in civil product liability cases.
Damages Available
There is no upper threshold for the award of damages in product liability cases generally.
Claimants that succeed with an action in negligence are entitled to an award of damages, the aim of which is generally to place that claimant in the position they would have been had the negligence not occurred.
Appeals in respect of product liability claims follow the general rules applicable to appeals for all civil claims in England and Wales, as follows.
The nature of available defences depends on the cause of action pursued.
CPA
Given the statutory nature of the CPA, the defences available are limited to those provided under the legislation, as follows:
Negligence
In practice, negligence claims are most often defended on the basis that the requisite elements of the cause of action have not been established – eg, there was no duty of care owed, there was no breach of said duty and/or there was insufficient evidence to establish causation.
Other common defences to claims in negligence are as follows.
Contract
Again, contractual claims are often defended in practice on the basis that not all elements of the claim are made out – eg, there was no contract in place or the contractual terms did not include the term allegedly breached.
Otherwise, the following defences may be available in contract claims:
Under the CPA, it is a statutory defence to allege that the fact of compliance with mandatory regulatory standards introduced a product defect (see 2.12 Defences to Product Liability Claims).
Furthermore, although it is still considered an area of development for judicial consideration, it is generally accepted that whilst compliance or lack thereof with regulatory obligations is a persuasive factor in determining whether or not a product is defective, it is by no means decisive.
Wilkes v DePuy International Limited [2016] EWHC 3096 (QB) made it clear that compliance with appropriate mandatory regulatory standards and/or the grant of regulatory approval are appropriate circumstances to take into account under the CPA statutory test for whether a product is defective. It was said by the court that, whilst these factors are not complete defences to a claim under the CPA, they would be “powerful evidence” to indicate that the level of safety contemplated by the CPA had been reached, and that against that backdrop “it may be challenging” for the claimant to make out a case that a higher level was expected. Compliance with the manufacturer’s own specification and standards could also be persuasive on the same basis.
However, by comparison, the court took a firmer line in Pollard v Tesco Stores [2006] EWCA Civ 393, finding that a dishwasher powder bottle was defective on the basis that the toddler-resistant bottle cap did not conform to the relevant British Design Standard. The claimant was a toddler who opened the bottle and swallowed the dishwasher powder.
Non-adherence to regulatory requirements is a separate cause of action, which can attract criminal liability; please refer to 1.5 Penalties for Breach of Product Safety Obligations.
The general principle for the payment of costs in English law applies to product liability cases: the losing party pays the costs of the successful party, including fees, court fees and disbursements (including expert fees).
The court can award costs on two bases.
In product liability claims involving damages for personal injury or death, the regime of qualified one-way costs shifting (QOCS) applies. In practice, this means that the claimant will not be responsible for the defendant’s costs in most claims where a claimant is unsuccessful. However, the QOCS provisions may not apply if the claim is struck out, or if the court determines that the claimant was fundamentally dishonest. If the claimant’s claim is successful, they may recover their costs from the defendant, subject to a “set-off” of any (interlocutory) costs orders made in the defendant’s favour. However, the QOCS regime was recently subject to change following a consultation initiated by the UK government on 9 May 2022. Amendments to CPR 44.14, which came into force on 6 April 2023, allow defendants to enforce up to the extent of orders or agreements for damages, costs and interest.
Costs are subject to a formal assessment procedure if they are not or cannot be agreed between the parties. The court has wide discretion to vary any of the above general positions regarding costs, however.
As with all civil claims in England and Wales, there are many litigation funding options regularly used by product liability claimants to fund their litigation. The following are common mechanisms used in product liability cases:
Lawyers can charge success fees, and third-party funding is permissible.
Notably, for the above agreements entered into after 1 April 2013, successful claimants can no longer recover success fees, after the event (ATE) premiums or other arrangement costs from the defendant.
Several mechanisms, both formal and informal, exist in respect of group actions in England and Wales, as set out below.
Formal Mechanisms
Group litigation orders (GLOs)
Under CPR 19 Section III, a GLO allows the management of multiple claims that give rise to common or similar issues of fact or law. Claimants to these actions must “opt in”. In the process of GLO proceedings, there will be a trial of issues that are common to all underlying claims. Lead cases that are considered the most appropriate can be chosen, and they are used to allow the parties to put common issues into context. Decisions made in respect of these lead cases are binding on all parties to the GLO. This is the most commonly used formal mechanism in respect of product liability claims.
Representative actions
Representative actions, under CPR 19 Section II, can be brought by one or more claimants on behalf of a group considered to have the “same interest”. The UK Supreme Court (UKSC) judgment in Lloyd v Google LLC [2021] UKSC 50 provided clarity on the interpretation of the “same interest” requirement in the context of a large-scale data privacy action. In this action, the UKSC held that, to bring a claim for compensatory damages for a breach of the Data Protection Act 1998, a claimant must establish that there has been a breach, and that damage has been suffered as a result, in the form of material damage or distress. As this would involve an assessment of individual damages and loss, the claim could not proceed as a representative action under CPR 19.6 as the “same interest” requirement had not been met.
In cases requiring an individual assessment of damages, the UKSC suggested that the representative action procedure could still be used to determine common issues of fact or law, leaving issues that require individual determination to be dealt with subsequently.
Representative actions operate on an “opt-out” basis, such that all group members will be automatically included in the group and represented in the action, and a judgment will be binding on all those represented unless they expressly state that they wish to be excluded. Such actions are rare, although there are signs they may become more widely used.
Informal Mechanisms
The courts can also manage group litigation informally, including by hearing one or more representative test cases at trial while staying remaining cases. The test case decision is not binding on parties to the other claims; however, the decision is intended to determine common issues relevant to the subsequent cases to assist parties to resolve remaining claims without further litigation.
Product liability cases do not commonly reach trial in England and Wales. Claims that do reach trial are often in respect of medical devices or pharmaceutical products rather than general consumer products.
A small body of cases have assisted in interpreting statutory tests under the no-fault mechanism of the CPA. Of these, the Gee judgment remains the seminal decision in product liability. That case related to the metal-on-metal hip prosthesis group litigation in England in Wales. The court found in favour of the defendant manufacturer in concluding that the claimant’s argument that the products had a “tendency” to cause soft tissue reactions (adverse reaction to metal debris – ARMD) was “untenable” on the basis it would render all similar hip prostheses defective and is “directly contrary to the spirit and objectives” of the CPA. Based on a lack of evidence, even though it accepted the approach, the court also rejected the claimant’s alternative argument that the products had “an abnormal potential for damage”.
Gee adopted much of the reasoning of an earlier seminal product liability case, Wilkes v DePuy International Limited [2016] EWHC 3096 (QB), but departed from A v National Blood Authority [2001] 3 All ER 289, a somewhat controversial case that previously provided guidance on how to approach the question of “defect” in product liability cases. The Wilkes method of “abnormal potential for damage” was considered favourably, but no finding was made on the basis of that test due to a lack of claimant evidence. In doing so, the A v NBA approach, of first identifying “the harmful characteristic which caused the injury”, was discredited.
The court in Gee:
The above position taken in Gee was largely approved in another case involving a metal-on-metal hip prosthesis: Hastings v Finsbury Orthopaedics Limited and Stryker UK Limited [2019] CSOH 96. In this Scottish matter, the court found for the defendant manufacturers. That finding was upheld on appeal ([2021] CSIH 6) and a further appeal was brought by the pursuer, which was heard before the UKSC in April 2022. The UKSC’s judgment, which was handed down on 29 June 2022, unanimously dismissed the appeal brought against the respondent manufacturers, thereby maintaining the finding of the lower courts that the appellant failed to prove that the metal-on-metal hip product in question is defective under the CPA. The UKSC’s ruling reinforces the approach to the question of defect under the CPA, as determined in Wilkes and Gee.
Further, the UKSC held that the appeal was “no more than an attempt to appeal against the… findings of fact”. In the circumstances, it declined the appellant’s invitation to overturn the factual findings made by the judge at first instance as they were findings the lower court had been entitled to make on the evidence. The appellant had suggested that the UKSC examine such findings through a different prism that introduced principles such as a benevolent approach to the application of the Act.
The appellant further argued that the lower court was not entitled to find against him on defect because the evidence before the court raised a presumption of defect that was not capable of being rebutted by the manufacturers. The UKSC rejected this argument, holding the following.
Divergence of UK Laws From EU Position
Alongside parallel legislative developments at EU and UK levels, Brexit has resulted in the increasing divergence of product safety laws across the region. The timing has meant the immediate divergence of UK laws from EU laws in some instances, such as medical devices. Otherwise, the UK looks poised to make a decision to actively depart from the EU in other instances by the creation of new legislation – eg, as foreshadowed by consultations in respect of UK product safety laws generally, and genetically modified organism (GMO) legislation.
Multiplication of Product Compliance Obligations Across Europe
The above phenomenon also means that there are now separate and distinct requirements across the region, including, by way of example, the requirement for UK and/or EU-based notified bodies and/or UKCA, UKNI and CE marking on products. Such multiple requirements are a departure from the prior Europe-wide product safety regime, which operated on the basis of maximum harmonisation and single market principles. There are strict timelines and rules attached to these new UK-only requirements, of which companies need to be aware. However, the government has recently published legislation to continue the recognition of current EU requirements, as well as CE marking indefinitely in respect of a range of products. The legislation, entitled the Product Safety and Metrology etc (Amendment) Regulations 2024 will allow businesses to choose either the UKCA or CE marking when selling their products. There are 21 product regulations listed to which continued recognition of the EU requirements will apply.
The new Regulations, which are due to come into force on 1 October 2024, will allow businesses with greater flexibility whereby they can choose to comply with regulations by following either EU requirements and use the CE mark or UK requirements and use the UKCA mark in respect of the product regulations listed in the Statutory Instrument.
Furthermore, UK-based companies continuing to sell in the EU must be aware of ongoing EU obligations. Generally, EU compliance practices are more accepted in the UK post-Brexit – during some ongoing transition periods allowed in some instances – than UK compliance practices will be in the EU.
New Enforcement Practices
In line with a Europe-wide ramp up of product safety enforcement, there is an increased focus on market surveillance and increased empowerment of regulators, including by way of the implementation of new legislation regarding the same.
Focus on Online Selling
In line with the general principles of UK product liability laws, which expose companies to liability notwithstanding the mode of sale (ie, online sales are included), there is now an increased focus on properly ascribing responsibility to online sellers in respect of product safety compliance obligations and breaches thereof, including by way of a requirement to have a local entity in place to nominally be responsible for these issues. The EU-led “Product Safety Pledge” practices may yet be implemented in the UK also.
Similarly, the UK government’s anticipated reform of its product safety framework is expected to strengthen the current framework, including in relation to online and marketplace sales. A number of proposals were advanced in the consultation on the UK product safety regime which opened in August 2023, including defining activities carried out by businesses that would qualify them as an “online marketplace” and thereby subject them to certain duties as well as setting out due care requirements in relation to unsafe product listings.
The EU has already taken steps to regulate online marketplaces by virtue of the Market Surveillance Regulation (EU) 2019/120, which came into force in July 2021 to bring online platforms within the remit of the EU’s product safety framework, including online marketplaces. Given the further growth of online sales during the COVID-19 pandemic and beyond, this is an area of particular focus for regulators and law-makers alike.
Development of Collective Redress Regime
The much-discussed collective redress regimes to bring about US-style “class actions”, including in respect of consumer law issues specifically, are poised to change the product liability landscape across Europe, with the EU Directive on representative actions having now come into force and which took effect in EU member states in June 2023.
Not having adopted the EU laws prior to Brexit, the UK will be able to take its own stance in respect of this developing area of law. The UKSC’s decision in Mastercard Incorporated and Others v Walter Hugh Merricks CBE [2020] UKSC 51 (“Merricks”), as delivered on 11 December 2020, demonstrates that, in the right circumstances, an English court will not stand in the way of a group action. Following the UKSC’s decision, the Competition Appeals Tribunal (CAT) certified Mr Merrick’s application for an opt-out Collective Proceedings Order (CPO), in which he represents a class of more than 46.2 million consumers in respect of a GBP7.2 billion action concerning allegedly unlawful bank charges. The CAT has since certified several more CPOs, indicating a growing trend towards large consumer class actions.
In this vein, there have been calls for a generic opt-out class action regime beyond the scope of the CAT, driven by claimant law firms and consumer groups who share the view that the burden of proof is too high in product liability actions, particularly those concerning allegedly defective medical devices and pharmaceutical products, compared to actions brought in the competition sphere.
In addition to the CPO regime in the CAT, the UK’s representative actions procedure, which has been seldom used owing to the court’s historically narrow interpretation of the “same interest” test under CPR 19.6, also provides for an opt-out group action regime. CPR 19.6 provides for representative actions where one claimant can represent other claimants in a group action providing they all have the “same interest” in the claim. Whilst the UKSC’s ruling in Lloyd v Google [2021] UKSC 50 affirmed the limited scope of the “same interest” test, the recent decision in Commission Recovery Ltd v Marks & Clerk [2023] suggests the court may approach the test more flexibly than had been assumed in Lloyd. The CRL decision also indicates that the court is becoming more amenable to allowing the opt-out representative actions procedure to be used more generally, particularly as (i) the opt-out collective regime in the CAT is available for competition claims only; and (ii) the modern digitalised world is increasingly likely to give rise to mass harms, resulting in affected claimants seeking legal redress.
Convergence of Multi-sector Product Safety Laws
Whilst there is a divergence of product safety laws from a geographical perspective, there is, in parallel, a convergence of laws in terms of product safety issues in the UK. For example, issues formerly considered primarily privacy concerns are now increasingly being considered product safety issues. This is particularly the case in respect of radio equipment and medical devices, and there is an increasing reliance on parallel or potentially relevant separate product safety regimes across other sectors. For example, the food contact materials laws are now being relied upon for cosmetics packaging in certain circumstances.
Corporate Social Responsibility and Environmental Sustainability
There has been a broadening of product compliance obligations to incorporate concepts of corporate social responsibility, environment and sustainability, and increased focus on these areas. In line with EU-based initiatives in which the UK participated prior to Brexit, including the EU Green Deal and Circular Economy practices, there is now an increased focus on product compliance requirements, contemplating this broadened scope. For example, in January 2023, the UK government consulted on a proposal to increase the minimum energy performance standard for lighting products placed on the Great Britain market from 2023 and again from 2027.
Modernisation of Product Safety and Liability Regimes
As part of an ongoing review at EU level in respect of the fitness of product liability laws to respond to issues created by modern technologies, there is currently a debate regarding the application of the CPA to new technologies – eg, in software supplied over-the-air (OTA). This type of software is updated wirelessly (and used in products such as smart pacemakers) and several questions are currently being debated, including:
If the CPA is updated to adapt to new technologies, there may be a proliferation of product liability group actions where there has been a data breach in relation to smart consumer products.
There are wide-ranging imminent policy developments in respect of product liability and safety in the UK, including as a result of Brexit but also in response to long-standing issues that were being grappled with for some time at an EU level.
Product Safety Law
In August 2023, the UK government launched its consultation on the UK’s product safety regime with the goal of creating a clearer, smarter and more proportionate regime while remaining responsive to consumer and business needs. The consultation, which closed in October 2023, advanced 13 proposals under three headings aimed at modernising the UK’s product safety framework. These included:
The proposals on bringing products to market aimed to ease the burden on businesses by proposing a hazard-focused approach whereby products are categorised by their hazards and consequent risks, thereby falling into one of several defined risk levels. The aim behind the proposal is to lower the regulatory burden and compliance costs for lower-risk products and unlock innovation while simultaneously maintaining high levels of protection for other higher-risk products.
Optional e-labelling was also proposed for certain marking and compliance labelling such as the UKCA conformity marking and manufacturers’ details.
As noted above, proposals were put forward in respect of online market places such as defining activities carried out by a business which would qualify them as an “online marketplace”.
A number of proposals were also put forward to strengthen enforcement and compliance. These included enhancing the leadership of the OPSS and requiring all notification of recalls and serious product safety incidents and other corrective action by a manufacturer or distributor to be sent to OPSS, rather than the local authority, as soon as the economic operator has knowledge of an unsafe product.
The result of the consultation, and any hard or soft laws created on the basis thereof, would mark a significant development in UK product safety laws, which are more than 30 years old.
The review is in parallel to a similar review held at EU level, which has resulted in the EU General Product Safety Regulation which will take effect on 13 December 2024. Once the UK has concluded its review, it is likely to result in a significant departure of the two sets of product safety laws and further onerous requirements for companies operating in both markets.
Connected Products and Cybersecurity
In April 2021, the UK government published a policy paper providing an overview of the government’s updated intentions for proposed legislation to regulate the cybersecurity of connected consumer products. The government’s aim is to implement a new robust scheme of regulation to protect consumers from insecure connected products, mandating base requirements and disclosures for those selling such products.
The UK government also launched its National Cyber Strategy in January 2022, setting out its plan to protect its citizens in cyberspace, including the Product Security and Telecommunications Infrastructure (PSTI) Act, which was enacted in December 2022, to enable enforcement of minimum security standards in all new connectable products sold in the UK. The PSTI Act came into effect on 29 April 2024. Its provisions will:
The Regulations underpinning the Act on security requirements for relevant connectable products came into force on 29 April 2024 and establish security requirements for relevant connectable products and prescribe conditions to be met for deemed compliance of security requirements. Schedule 1 to the Regulations sets out the specific requirements that must be complied with in relation to relevant connectable products. These include the following.
Medical Devices
In January this year, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published its much-anticipated roadmap on the future regulatory framework for medical devices. This plan details the timescales for the implementation of the UK’s future medical device regulations, which will be implemented through four statutory instruments. Key measures to enhance post-market surveillance will be the first component and will be put in place in 2024. Further core elements of the new framework will follow in 2025.
The MHRA will run stakeholder discussions for the provision of information on these future core regulations, which are expected to involve a range of measures, such as the following:
Additionally, the UK government, in order to minimise disruption to the availability of medical devices in Great Britain, has amended the Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of EU conformity assessment-marked (CE-marked) medical devices on the Great Britain market for a limited period.
Artificial Intelligence
The EU’s Artificial Intelligence Act (the “AI Act”) came into being in 2024 and is the first ever legal framework on AI to address the risks and trustworthiness thereof. Building upon the UK’s National AI Strategy published in September 2021, in March 2023, the Department for Science, Innovation and Technology published a White Paper titled “AI Regulation: A pro-innovation approach”, which set out the government’s proposals to regulate AI in a pro-innovation manner. It addressed the potential benefits and risks of AI. The government intended to “take an adaptable approach to regulating AI”, allowing regulators to use their expertise to modify the implementation of the principles to suit the specific context of AI in their respective sectors. The UK government, in February 2024, provided its long-anticipated response to the White Paper consultation on regulating Artificial Intelligence (AI).
The approach is one of “pro-innovation” but with safety at its core and is largely non-prescriptive compared to other jurisdictions. The UK’s approach is intended to focus on promoting innovation and experimentation, whilst maintaining a light touch in terms of regulation. The difference in approach between the UK and EU may present challenges for companies that operate in both markets, and those looking to expand from one market into the other.
Sustainability and Environment
Following several related initiatives, the UK government undertook a consultation on waste prevention proposals for products: the “Waste Prevention Programme for England”. This UK-led initiative mirrored a parallel EU initiative of a similar nature, called the Sustainable Products Initiative, and addressed topics such as end of life, repair, reuse and remanufacturing, and extended producer responsibility. Following the consultation, the government has published the waste prevention programme for England entitled “Maximising Resources, Minimising Waste”, which sets out the government’s priorities for managing resources and waste, aiming to move to a more circular economy in the UK.
The introduction of the Environment Act 2021, described by the UK government as “world-leading legislation”, empowers the government to make targets, plans and policies for improving the national environment, including addressing waste and resource efficiency, air and water quality, and nature and biodiversity, with cross-sector impact. National authorities will be empowered to introduce regulation that aims to eliminate avoidable waste by 2050 by introducing robust measures such as making producers responsible for the disposal of waste products and charges.
As of 1 April 2022, manufacturers or importers of plastic packaging products into the UK may be liable under Part 2 of the Finance Act 2021 to pay a tax on those products, known as PPT. The introduction of PPT follows the EU’s introduction of a levy on non-recycled plastic packaging waste in July 2020 and reflects the growing trend toward sustainable practices across industries and the demand for greater corporate responsibility by large-scale manufacturers, importers and their insurers. It aims to incentivise manufacturers and importers to incorporate more recycled plastic into their packaging.
Food Technological Practices
Following an EU initiative of the same nature, the UK government is currently considering the scope of GMO legislation. Following a public consultation in 2021 on gene-edited organisms, the Genetically Modified Organisms (Deliberate Release) (Amendments) (England) Regulations 2022 came into force in April 2022. This was followed by the Genetic Technology (Precision Breeding) Act 2023, which came into force on 23 March 2023.
Fruit & Wool Exchange
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Sarah-Jane.Dobson@ashurst.com www.ashurst.com/en/our-locations/london/The Changing UK Product Safety and Liability Landscape
Introduction
The UK has always regarded itself as a leader in product safety and, keen to maintain this reputation and keep apace with developments, particularly against the backdrop of developments in the EU, it took significant steps in this space last year.
As the EU introduced the General Product Safety Regulation (GPSR) came into force in June 2023, the UK’s national product safety regulator the Office of Product Safety and Standards (OPSS) launched its much-anticipated consultation on the UK product safety regime. The consultation, which forms part of the UK’s wider Smarter Regulation Review, was targeted to update the UK product safety regime in line with developments and advancements in technology.
Another significant development, similarly, targeted to update the UK product regulatory framework, was the entry into force of the UK’s product security and telecommunications regime. This saw significant requirements being introduced to ensure the security of connected products and had significant impact across the manufacturing world as manufacturers sought to ensure that they were ready for the new requirements which came into effect in April 2024.
Of course, Brexit also had its part to play in the development of product safety policy. In this context, the Retained EU Law (Revocation and Reform) Act received royal assent. This initiative moved away from the initial “sunset clause” approach, which called for all retained EU law (REUL) that had not been preserved or replaced to be automatically revoked at the end of the sunset period. Instead, the Act took the approach of publishing a list of retained EU laws (consisting of 600 pieces of legislation – known as the “revocation schedule”) which were revoked at the end of 2023. Those not listed were automatically retained. This approach is thought to have provided more certainty for business, helping to allay their fears of a cliff-edge effect with all legislation removed in one fell swoop.
Another effect of Brexit was the approach to product marking in the UK. In a bid to smooth the path for product manufacturers and remove uncertainty, the UK government laid down legislation to continue the recognition of the current EU requirements and CE marking. Draft legislation was advanced in the form of the Product Safety and Metrology etc (Amendment) Regulations 2024. The legislation will apply indefinitely in respect of a range of product regulations.
Overhaul of product safety regime
On 2 August 2023, the UK government’s consultation on the UK’s product safety regime was launched, which set out to examine the fundamental tenets on which it is built with a view to reforming and future-proofing the regime. The aim is to make it fit for the 21st century, noting that the way products are sold and used has undergone significant changes in a short period of time.
The goal of the consultation, which closed on 24 October 2023, was to create a clearer, smarter and more proportionate regime while remaining responsive to consumer needs. The framework the UK government is seeking to establish is one that fosters business innovation while simultaneously protecting consumers. In this regard, it aims to revolutionise how it will use and share data with businesses and the public in a bid to support targeted enforcement and an agile evidence-based product safety framework.
The consultation advanced 13 proposals in total under three headings aimed at ensuring the UK’s product safety framework is future-proof and a global exemplar. These included:
Bringing products to market
The proposals linked with bringing products to market aimed to ease the burden on businesses by proposing a hazard-focused approach whereby products are categorised by their hazards and consequent risks, thereby falling into one of several defined risk levels. The hope behind the proposal is to lower the regulatory burden and compliance costs for lower-risk products and unlock innovation while simultaneously maintaining high levels of protection for other higher-risk products.
Optional e-labelling was also proposed for certain marking and compliance labelling such as the UKCA conformity marking and manufacturers’ details. Removing the need to always apply physical labels, it is hoped, will lower business costs, allow information to be easily updated and produce less waste.
Online supply chain
Recognition of the exponential growth in online sales and the concomitant challenges to the product safety regime which pre-existed this expansion was also recognised in the consultation. The UK product safety regime has been grappling with different challenges such as increased volume of non-compliant products and the absence of responsible economic operators in the UK, thereby making corrective action difficult, with confusion as to where responsibilities lay, as well as a lack of product safety or seller information.
To combat these challenges, several proposals were put forward, such as defining those activities carried out by a business that would qualify them as an “online marketplace” and thereby subject them to certain specified duties. Yet to be crystallised, they are likely to include duties (i) to co-operate with enforcement authorities, such as providing information or taking appropriate action if products are unsafe or non-compliant, and (ii) to have a compliance function established in the UK.
Another measure proposed is to set out specific due care requirements about the identification and removal of unsafe product listings, which online marketplaces will be required to meet. For example:
For higher risk products, increased consumer-facing information on online product listings is proposed to support informed purchasing decisions. This proposal addresses the anomaly whereby requirements to display certain product safety and traceability information are not replicated for online product listings. It also seeks to make it clear when a consumer is purchasing from a third-party seller.
Information could include:
Compliance and enforcement
A number of proposals were put forward to strengthen enforcement and bolster compliance in the UK. This included enhancing the leadership of the OPSS and requiring all notification of recalls and serious product safety incidents and other corrective action by a manufacturer or distributor to be sent to OPSS, rather than the local authority, as soon as the economic operator has knowledge of an unsafe product.
Product security
Connected products bring many benefits to the modern world, making many aspects of day-to-day life easier and more convenient. In tandem with these benefits come some drawbacks, in particular threats to the security of data. An IOT product, due to its inherent nature of being connected, may be susceptible to external manipulation and hacking resulting in, for example, a data breach or it being used for surveillance.
The Product Security and Telecommunications Infrastructure (PSTI) Regime aims to address these risks, as part of the government’s plan to tackle cybersecurity risks and aims to create a regime setting a baseline in cybersecurity for connected products.
The main content of the security provisions are found in the Product Security and Telecommunications Infrastructure (Security Requirements for Relevant Connectable Products) Regulations, SI 2023 No 1007, which came into force on 29 April 2024 and establish security requirements for relevant connectable products and prescribe conditions to be met for deemed compliance with security requirements.
Connected products
The PSTI Act applies to “relevant connectable products”, defined as either products which are internet connectable or network connectable and are not an excepted product.
Excepted products in the Security Requirements Regulations include:
Obligations apply to economic operators where they supply what are termed “UK consumer connectable products”, defined as a relevant connectable product that either:
Security requirements
Schedule 1 to the Regulations sets out the specific requirements that must be complied with in relation to relevant connectable products.
Other obligations of economic operators
Manufacturers are also required to create a statement of compliance for UK consumer connectable products, declaring compliance with the security requirements, which must be retained for 10 years. For an importer and distributor, they must check one is included with the product rather than create one, but the rest of the obligation is the same.
Economic operators must also act on compliance failures in respect of UK consumer connectable products, including taking all reasonable steps to prevent the product from being made available and to remedy the non-compliance. There is a strict duty to inform the enforcement authority, any other manufacturer, any importer or distributor the product was supplied to, and, if specific conditions are met (which have not yet been created), consumers who have been supplied with the product.
Manufacturers and importers are further required to do the following.
Artificial intelligence
Artificial intelligence (AI) is very much at the forefront of the UK policy agenda. The UK government, in February 2024, provided its long-anticipated response to the 2023 White Paper consultation on regulating Artificial Intelligence (AI).
The approach the government has adopted is “pro-innovation” but with safety at its core, as highlighted in the Prime Minister’s landmark speech in October 2023, where he said: “the future of AI is safe AI. And by making the UK a global leader in safe AI, we will attract even more of the new jobs and investment that will come from this new wave of technology.”
The approach advocated by the UK is largely non-prescriptive compared to other jurisdictions.
Product liability
Given developments in the EU on product liability, in particular the EU Product Liability Directive (PLD) which has been passed and is awaiting signature, it is still not clear whether the UK will be prompted to make similar changes to the Consumer Protection Act 1987 (CPA).
It is worth noting that proposal number 13 of the OPSS product safety consultation provided for reviewing the civil product liability regime in light of technological developments. It can be taken from this that there is a widespread recognition that, similar to the product safety regime context, the product liability regime in the UK is in need of updating and modernising. Therefore, the door has most certainly been left open for future development and change in this regard, which, no doubt, will be seen in the coming years.
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Sarah-Jane.Dobson@ashurst.com www.ashurst.com/en/our-locations/london/