This article first appeared in Chambers Global Practice Guides. The aim of this guide is to provide in-house counsel with expert legal commentary on the main practice areas in key jurisdictions around the world. The guides focus on the practical legal issues affecting business and enable the reader to compare legislation and procedure across a range of key jurisdictions. This specific guide provides an overview of product liability laws and regulations applicable in United Kingdom.
Click here to read the section on Product Liability & Safety 2021 - Trends and Developments.
1. Product Safety
1.1 Product Safety Legal Framework
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.
The product safety regimes apply to consumer products, including:
- Products newly manufactured and, in certain instances, used and second-hand
- Products marketed through all modes of sale, including traditional bricks-and-mortar stores or via e-commerce
- Products that enter the UK for the first time after being imported from a third country (including the EU, post-Brexit), and
- Products that have be subjected to significant changes that modify their function or safety profile.
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:
- Only “safe” products are marketed in the UK
- Various actors within the supply chain are responsible for product safety and compliance, or aspects thereof
- Conformity assessments which analyse the risks and features of products are necessary before marketing a product
- Compliance with relevant safety legislation is usually denoted by appropriate marking, including the new UKCA mark or, in certain circumstances, the EU CE mark and/or Northern Ireland UKNI mark, as underpinned by relevant declarations of conformity or similar
- The trigger for most significant regulatory obligations is “placing on the market” and/or “making available on the market”
- Post-market surveillance obligations exist after the initial sale of products
- Corrective actions are required in certain circumstances, and
- Reports to regulators are required in certain circumstances.
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. Such requirements, where they exist, 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, for example:
- Construction products
- Low voltage electrical equipment
- Motor vehicles
- Personal protective equipment, and
Separate product-specific safety regimes
These are contained within separate product safety regimes, which aim to address unique and quite separate risks of products not considered "industrial products" (which the above-mentioned legislation addresses). These operate separately from the GPSR above and include, for example:
- Pharmaceuticals, and
- Medical devices.
Enforcement and monitoring of obligations imposed by the above systems 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, 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 relevant UK law-makers to implement future changes to UK legislation. In some specific areas, including medical devices, because of imminent legislative changes in the EU that didn’t take effect prior to Brexit, the EU and UK position already deviate significantly. Future deviation is also likely, particularly in the context of legislative reviews and amendments of UK and EU product safety systems currently underway. Please refer to 3.1 Trends in Product Liability and Product Safety Policy for further detail.
1.2 Regulatory Authorities for Product Safety
Oversight of the UK product safety regimes is undertaken by several regulators, at various levels, in the UK.
Local authorities have day-to-day responsibility for the enforcement of product safety legislation in the UK. This enforcement is carried out through local Trading Standards (TS) offices. Such authorities, through the GPSR and Consumer Rights Act 2015 (CRA), have a wide range of powers, including the ability to:
- Issue recall/withdrawal notices
- Issue requirements to warn
- Issue product recall enforcement notices
- Enter and search premises
- Seize documents and goods
- Require information
- Test equipment
- Observe the carrying on of business
- Inspect products
- Issue statutory notices
- Issue cautions
- Seek imposition of civil sanctions, and
- Commence criminal prosecutions.
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:
- Supports the work of TS, by providing advice and access to technical and scientific assistance, including product testing and risk assessments
- Coordinates national responses to safety issues by providing an incident management capability and working with TS to collate intelligence and identify emerging trends
- Works with industry to inform the approach to regulation and enforcement, and
- Administers the Primary Authority scheme where companies work with specific authorities.
OPSS is empowered with many of the aforementioned enforcement powers of TS.
There are product-specific regulators for the following product categories: food, vehicles, medicines and medical devices and workplace equipment (including PPE).
1.3 Obligations to Commence Corrective Action
Product producers in the UK are required to conduct corrective actions to address product safety issues that make a product unsafe (GPSR Section 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, OPSS cooperated with 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, as follows.
- Part 1 – provides guidance to manufacturers, importers and distributors (of non-food products) to plan and manage corrective actions, establish mechanisms to monitor product safety, investigate potential product safety issues and review corrective action programmes.
- Part 2 – provides guidance to market surveillance authorities, such as TS, regarding their roles.
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.
1.4 Obligations to Notify Regulatory Authorities
Under Article 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 contain certain mandatory information (namely, the action taken to prevent risk to consumers and 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 OPSS’ work.
Although there are no specific timeframes under statute regarding these reports (the legislation states simply states obliged entities should “forthwith notify an enforcement authority”); generally, the recommended timeframe for reporting, provided in guidance documents only, is dictated by the assessed risk of the safety matter to consumers who use the affected products.
1.5 Penalties for Breach of Product Safety Obligations
It is a criminal offence to fail to report to authorities under Section 20(3) of the GPSR. An unlimited fine or imprisonment for a term not exceeding three months is the applicable punishment.
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. There are a few, isolated examples of companies being prosecuted, particularly in respect of 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. The company pleaded guilty to the import and supply of unsafe toys at a hearing in Southend Magistrate's Court on April 14, 2021. Initial raiding of the premises by TS uncovered toys without relevant safety documents, and further testing confirmed the toys presented risks of choking asphyxiation. The company was ordered to pay approximately £4,100. The prosecution was said by the Council to be brought after "repeated attempts" to encourage the company to comply with its legal obligations.
2. Product Liability