PFAS regulation in the UK

‘Forever chemicals’ is the colloquial name given to the class of approximately 10,000 fluorinated chemicals more formally known as poly- and perfluoroalkyl substances (PFAS). The colloquialism derives from the fact that PFAS degrade very slowly – the European Chemicals Agency has described how they are “very persistent in the environment”. Some forms can take more than 1000 years to degrade.

PFAS are ubiquitous. They are used in the manufacture of a great range of consumer products, from beauty and healthcare products, to clothing, semiconductors, medical equipment, in food and drinks packaging, in cleaning chemicals, and in firefighting foam, among other things. Different chemicals serve different purposes – depending on the chemical and the product, they have a wide range of uses, including making products resistant to oil, water, or heat, for example. However, a growing number of stakeholders are expressing their concern about the potential for impact on people and the natural world.

With increasing regulatory focus and legislative restrictions already imposed in some jurisdictions, and on the horizon for many more, businesses should act now to assess and manage their compliance and supply chain risks.

In this guide we consider the current position on PFAS regulation in the UK and consider what developments might be on the horizon.

Current position in the UK

Chemical regulation in the UK is complex and is managed and enforced by different and unconnected government agencies, and by the devolved national authorities. This fragmentation can make it challenging to work on a coordinated chemicals management plan for a broad class of chemicals such as PFAS and to arrive at consistent conclusions on any chemical where there are multiple sources of exposure.  Below is a snapshot of the regulatory position in place in the UK.

International conventions

Several international conventions have a bearing on PFAS, including the Stockholm Convention and the Aarhus Protocol. These international treaties aim to restrict the production and manufacture of certain PFAS, known as persistent organic chemicals (POPs). POPs are organic substances that persist in the environment and accumulate in living organisms.

These international treaties are implemented domestically in the UK by the EU POPs Regulation ((EU) 2019/1021), which applies, as amended, in the UK as retained EU law.  Breaches of the retained EU POPs Regulation are enforced through the Persistent Organic Pollutants Regulations 2007 (The UK POP Regulations). 

The UK POP Regulations provide that a person who produces, places on the market, or uses a designated POP such as perfluorooctane sulfonate (PFOS) or perfluorooctanoic acid (PFOA) in contravention of the manufacture/sale/use prohibition is guilty of a strict liability offence. Both corporates and responsible individuals (such as directors) can be liable.

REACH

When it was a member of the EU, the UK adhered to the EU regulation on the registration, evaluation, authorisation and restriction of chemicals (EU REACH).

EU REACH is the main EU law protecting human health and the environment from the risks that can be posed by chemicals. The EU has proposed an extensive change to the REACH Annex XVII, which could lead to a ban of over 10,000 PFAS. These restrictions, if applied, would be wide-reaching and have the potential to fundamentally change the materials used in thousands of products.

Since the Brexit transition period ended, Britain has operated its own version of the REACH regime, compliance with which is overseen by the Health and Safety Executive (HSE). It applies to chemical substances that are manufactured in or imported into Great Britain (GB), whether on their own or in mixtures or in articles. Substances in scope must be registered with the HSE.

For registration, manufacturers and importers of substances must demonstrate that they understand the hazards of the substances they are supplying to the GB market and that they can be used safely. This entails undertaking a risk assessment for PFAS that are identified as hazardous under the REACH regime.

Transitional provisions are in place which mean that full registration data is not yet required for those already fulfilling existing EU requirements.

The authorisation provisions of UK REACH aim to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where feasible alternatives exist. The Candidate List is a list of SVHCs that may be prioritised for inclusion on the Authorisation List (Annex 14) of UK REACH. Once included in the Authorisation List, those substances cannot be used or placed on the market for a use after a specified date, known as the sunset date, unless the use has been authorised or is exempt from authorisation. 

Currently. there are just two UK REACH restrictions of PFAS in force within Britain – PFOA and its salts, subject to exemptions, and certain perfluorinated silane substances.

Health and Safety at Work etc Act 1974 and associated regulations

The Health and Safety at Work etc Act 1974 (HSWA), together with associated regulations – including, for example, the Control of Substances Hazardous to Health Regulations 2002 (COSHH) and the Management of Health and Safety at Work Regulations 1999 – require dutyholders to take responsibility for assessing and controlling the hazards created by their work. This includes exposure to hazardous substances.

In particular, under COSHH for substances that are classified as carcinogens or mutagens, Regulation 7(7) imposes a duty on employers to reduce exposure to a level as low as reasonably practicable (ALARP). Due to being classed as carcinogenic in the GB Mandatory Classification and Labelling (MCL) list, exposure to certain PFAS need to be kept to ALARP. These can generally be classified as PFOA, PFDA, PFNA and PFOS, along with certain salts.

General Product Safety Regulations 2005 (GPSR)

The GPSR impose requirements concerning the safety of products intended for consumers or which are likely to be used by consumers. Producers are obliged to place only safe products on the market.

A safe product is something that under normal or reasonably foreseeable conditions of use does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons. Potential consumer vulnerabilities when using the product, such as their use by children or the elderly, are to be taken into account when considering acceptability.

“Product” is given a wide definition and includes PFAS-containing mixtures and articles that are available for use by consumers – even if not explicitly intended as consumer products.

Regulation 6 provides that when a product conforms to a voluntary national standard of the UK, as determined and published by the Secretary of State, the product shall be presumed to be a safe product so far as concerns the risks and categories of risk covered by the standard.

In the absence of other legislation or standards, demonstration of safe use in the context of a REACH registration may be taken as evidence that a product can be regarded as safe under the GPSR. Additionally, where hazard data is known and a substance has an MCL, this would deem that the product is not a safe product.

Drinking water regulation

In England and Wales, the quality of public drinking water is regulated by the Water Supply (Water Quality) Regulations 2016 (as amended) in England, and the Water Supply (Water Quality) Regulations 2018 in Wales respectively. The requirements of these Regulations are enforced by the Drinking Water Inspectorate (DWI). In Scotland, the Drinking Water Quality Regulator (DWQR) regulates drinking water quality. The DWQR is responsible for enforcing the standards set out in the Public Water Supplies (Scotland) Regulations 2014. 

There are currently no specific standards for PFAS listed in the current drinking water regulations in England and Wales. The regulations there require that, to be regarded as “wholesome”, drinking water must not contain any substance at a level which would constitute a potential danger to human health and meet the other requirements of the regulations.

However, in January 2021, the DWI updated its guidance on the regulations specific to certain PFAS concentrations in drinking water, requiring monitoring of levels and action if concentrations exceed particular thresholds. Subsequently, 45 additional PFAS have been added to the monitoring requirement. The DWI has a wholesomeness guideline value of 0.1 µg/l for any PFAS and a tiered system of escalating actions for companies to follow, including monitoring, risk assessment, consultation with health authorities, and remedial action.

The Scottish regulations include a standard of 0.1 µg/l for 20 named PFAS.

Environmental Permitting (England and Wales) Regulations 2016 (the Permitting Regulations)

Environmental permitting regulations, such as the Environmental Permitting (England) Regulations 2016, control many types of commercial activity which may generate chemical releases into the environment by requiring businesses that manufacture potentially harmful substances, which could cause pollution, to hold an environmental permit. Conditions may apply depending on the activity, site or risk involved. There are currently no permit conditions specifically targeting PFAS control.

Chemicals in food and food contact

The Materials and Articles in Contact with Food (England) Regulations 2012 regulate the presence of chemicals in food and food contact materials. Similar legislation exists in Wales and Scotland. There are currently no specific restrictions on PFAS in food or food contact materials.

What is on the horizon for businesses?

Whilst specific PFAS regulation may be thin on the ground in the UK just now, that appears likely to change.

In a report published in April 2023, the HSE, in tandem with the Environment Agency, said further restrictions should be considered.

Specifically, the regulators said there is a case for limiting the use of PFAS-containing foams used by firefighters, and said further restrictions on the use of PFAS in textiles, furniture, and cleaning products should also be considered.

The report formed part of a regulatory management options analysis (RMOA) that provided an assessment of the likely health and environmental risks associated with the use of a substance or group of substances, alongside the existing regulatory framework and any specific controls relating to them. The analysis considered existing laws and how PFAS substances are being managed around the world, including in Europe, Asia Pacific, and the US.

In its ‘plan for water’, which sets out the intended approach to water management in England, the UK government confirmed that it would develop a UK REACH restriction proposal on PFAS in firefighting foams in 2023 and take forward work to prepare for further restrictions on other uses of PFAS, including consumer products such as textiles, cleaning products, paints, and varnishes.

The Department for Environment, Food and Rural Affairs has convened the PFAS Chemicals Stakeholders Forum (CSF) Working Group to inform policy development. Intended to give stakeholders and opportunity to share their knowledge and experiences of transitioning away from the use of PFAS, the group has developed short policy papers on some key areas, including the common barriers and challenges of moving away from PFAS and the policy options available to government to accelerate leadership by industry users in moving away from PFAS, and to address the most critical risks of specific PFAS. Feedback has been received and will contribute to the development of PFAS policy in the future.

The CSF has also confirmed that work has begun to identify priorities for the UK REACH 2024 work programme, which will include the development of PFAS restriction proposals.

Moving away from PFAS is not a simple exercise. In their report, the HSE and Environment Agency cautioned that while “there do appear to be potential alternatives to PFAS for many uses”, there needs to be “more performance and socioeconomic information” to be sure that “alternatives are technically and economically feasible and are able to meet performance standards”. They added that “hazard information for alternatives also needs further investigation to avoid regrettable substitution”.

There is a noticeable appetite for increasing regulation of PFAS in the UK and beyond. This, coupled with increasing litigation relating to PFAS chemicals outside the UK, shows no sign of abating. Businesses must now assess their potential exposure to PFAS in their supply chains and keep abreast of legal risks as PFAS litigation grows. 

They should keep up to date with regulatory change to existing rules – for example, environmental permits may soon include PFAS limits – and anticipate new enforcement and compliance obligations involving the manufacture and use of PFAS and PFAS-containing products, and integrate PFAS risk assessments into due diligence programmes when involved in commercial transactions, such as mergers and acquisitions. 

Other considerations will include the role of insurance policies with regard to PFAS-related risks and liabilities, and planning how to respond to shareholders – a group of investors wrote to chemical companies in 2022 asking them to phase out and substitute PFAS chemicals and warning of the financial risks associated with litigation.