This article was originally published as 'PFAS: UK Regulatory Snapshot' in March 2023. It was first updated in November 2023 and then again in October 2024.
Per- and polyfluoroalkyl substances (PFAS) – so-called 'forever chemicals' – are receiving increasing attention, both from the general public and the authorities. While many businesses and industry sectors are now having to consider their exposure to PFAS-related risks, the UK's regulatory landscape for PFAS is highly fragmented. Below, we set out an overview of the regulatory position in the UK.
What are PFAS?
PFAS are a class of thousands of synthetic chemicals that have a wide range of industrial, professional and consumer uses including surface coatings for textiles, food contact materials and packaging, cleaning agents, paints, varnishes, polishes and waxes and in pharmaceuticals, cosmetics, medical devices and products.
PFAS are so widely used because they have several desirable properties such as being stable under intense heat and having oil resistance, water resistance and low chemical reactivity. However, a majority of PFAS are persistent – they do not break down – in the environment. Further, some PFAS are known to accumulate in people, animals and plants and are linked to a range of health problems including kidney and testicular cancers, thyroid disease, ulcerative colitis, high cholesterol and pregnancy-induced hypertension.
How are PFAS currently regulated in the UK?
At the outset, it is important to note that, for relevant regulatory purposes, the UK is now divided between Great Britain (GB, namely, England, Wales and Scotland) and Northern Ireland (NI). Northern Ireland remains subject to many EU regulatory regimes, including some – such as EU REACH – which regulate PFAS. What follows is therefore the position in relation to GB, with a particular focus on England.
UK REACH
PFAS fall within the scope of UK's post-Brexit Registration, Evaluation, Authorisation and Restriction of Chemicals (UK REACH) regime. This regime, administered by the Health and Safety Executive (HSE), applies in all parts of the UK other than Northern Ireland, which remains subject to EU REACH.
UK REACH encompasses all individual chemical substances on their own, in mixtures or in articles. Manufacturers and importers of substances are required to understand the hazards of the substances they are supplying to the GB market.
If the risks associated with a chemical cannot be managed, the authorities can restrict its use in certain ways: they can limit, ban or set conditions on the manufacture, placing on the market or use of a substance or group of substances. Such UK REACH restrictions (the list of which is maintained by the HSE and can be viewed here) are currently in place for two types of PFAS:
- PFOA and its salts; and
- perfluorinated silane.
For other PFAS, there can also be, depending on the activity undertaken, a registration requirement and UK REACH does impose a general, albeit a relatively 'light touch', obligation on businesses that they identify and manage the risks presented by substances they manufacture and place on the GB market in quantities above one tonne a year per manufacturer or importer.
The HSE has identified 36 individual PFAS registered under UK REACH and anticipates that another 40 could eventually become registered. However, this does not provide a complete picture with respect to the PFAS market in GB as it is likely that some PFAS are manufactured or imported below the UK REACH registration threshold of 1 tonne per year per manufacturer/importer or that PFAS are present in finished or semi-finished goods ('articles' in UK REACH terms).
A number of PFAS are also on the UK REACH Candidate List of substances of very high concern (SVHC). Once added to the UK REACH Candidate List, an SVHC may go forward and be included in the UK REACH Authorisation List, after which businesses cannot generally use the substance beyond a sunset date unless they are granted an authorisation. This means that such substances are eventually phased out of all non-essential uses.
HSE Regulatory Management Options Analysis
The HSE published a Regulatory Management Options Analysis (RMOA) on PFAS in April 2023. A RMOA is a document drafted to support regulatory decision-making and, while not legally binding, can give an insight into future legal developments.
The PFAS RMOA set out the HSE's recommendations as to what additional steps the UK should consider taking under UK REACH in response to the risks arising from PFAS. These included limiting the use of PFAS-containing fire-fighting foams, as well as the use of PFAS in textiles, furniture and cleaning products.
Proposed UK REACH restrictions
The HSE is currently considering responses to a June 2024 call for evidence on PFAS-containing fire-fighting foams.
The information provided by respondents is being used to support the development of a UK REACH restriction report on risks to human health and the environment arising from the use of PFAS in firefighting foams.
This report (an 'Annex 15 dossier'), which is being prepared by the HSE in collaboration with the Environment Agency, will examine whether a UK REACH restriction should be introduced into GB covering the use of PFAS in firefighting foams. As noted above, EU REACH continues to regulate the access of chemicals to the Northern Irish market.
Product safety law
Recent media reports have highlighted the prevalence of PFAS in many common consumer and household products. These include some clothes – specifically, those with waterproofing – non-stick cooking utensils and fridges and air conditioners. PFAS can also be found in some forms of packaging.
Under The General Product Safety Regulations 2005 (GPSRs), businesses have various obligations in relation to product safety including that only safe products are placed on the market (the 'general safety requirement'). Although the GPSRs are commonly understood as only imposing obligations on manufacturers, many obligations – including the general safety requirement – apply to other supply-chain participants to the extent that their activities may affect a product's safety characteristics.
The GPSRs, which apply where there is no specific product safety regime applicable to a product, have broad scope: they apply to all products which are intended for consumers or are likely, under reasonably foreseeable conditions, to be used by consumers. In order to be considered safe, a product must, under normal or reasonably foreseeable conditions of use, either not present any risk or only the minimum risks compatible with its use. A number of factors are taken into account in this assessment: the product's composition and the categories of consumers at risk when using the product, in particular children and the elderly.
As regulatory scrutiny of, and knowledge about the effects of, PFAS increases, products containing PFAS are likely to face challenges in meeting product safety standards. A product that, due to the presence of PFAS, presents a safety risk could conceivably be found to be an unsafe product under the GPSR. Placing an unsafe product on the market is a criminal offence under the GPSR. The offence is one of strict liability: responsible businesses and individuals can be found liable, even without proof of negligence or intent.
Companies manufacturing or selling products containing (or potentially containing) PFAS may need to consider undertaking – and then regularly updating – product safety risk assessments using, for example, the UK's new PRISM methodology or, for the EU/NI, the RAPEX methodology. Any such risk assessments would, in all likelihood, need to be based on robust third-party testing and chemical analysis.
It could also be prudent to assess the risks associated with using PFAS in manufacturing operations (for example, to ensure that applicable UK health and safety requirements under the Health and Safety at Work, etc. Act 1974 or its foreign equivalents in respect of overseas manufacturing activities are being complied with).
Environmental Permits
PFAS fall within the scope of the environmental permitting regime established by the Environmental Permitting (England and Wales) Regulations 2016 (EPRs). The EPRs require, amongst other things, that businesses which manufacture potentially harmful substances such as PFAS hold an environmental permit.
Environmental permits should seek to give effect to the Environment Agency's statutory obligation under the EPRs, namely that it achieve a "high level of protection of the environment taken as a whole by, in particular, preventing or, where that is not practicable, reducing emissions into the air, water and land".
This is given practical effect through the imposition of general permit conditions such as the setting of emissions limits, the requirement that operational sites are cleaned-up once activities cease and for pollution incidents to be reported. These general permit conditions can apply to PFAS and, at present, there are no specific permit conditions which target PFAS.
Persistent Organic Pollutants
Certain PFAS are banned as a result of restrictions on the manufacture, sale and use of products containing persistent organic pollutants (POPs). POPs are organic substances that persist in the environment and accumulate in living organisms.
The relevant PFAS are perfluorooctane sulfonic acid (PFOS), PFOS derivatives, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds.
POPs are regulated internationally under the Stockholm Convention and the Aarhus Protocol (the UK is a signatory to both). These international treaties are implemented domestically in the UK by Regulation (EU) 2019/1021 which applies, as amended, in the UK as assimilated EU law. Breaches of this law are enforced under The Persistent Organic Pollutants Regulations 2007 (POPs Regulations).
The POPs Regulations provide that a person who produces, places on the market or uses one of the designated POPs in contravention of the manufacture/sale/use prohibition is guilty of an offence (on a strict liability basis). Both companies and responsible individuals, such as company directors, can incur liability.
Water Quality Standards
The Water Supply (Water Quality) Regulations 2016/2018 (Water Quality Regulations) require that, to be considered 'wholesome', drinking water must not contain any substance at a level that would constitute a potential danger to human health.
There is no specific standard listed in the Water Quality Regulations for PFAS. For England and Wales, however, there is guidance on PFAS in water, including a 'wholesomeness' guideline value of 100 ng/l for any of the 47 individual PFAS listed in the DWI's Information Letter 05/2021. That being said, there are currently no statutory drinking water limits for PFAS in England and Wales: the DWI's guidance is non-binding.
Water companies are also required to sample the drinking water supply for any element, organism or substance that they believe may cause the supply not to be wholesome. This includes the detection of PFAS other than PFOS and PFOA. They are required to notify the DWI of any event which has or might affect the quality of the water supplied. This could include an incident arising from PFAS contamination.
Breaches of the Water Quality Regulations can result in the DWI requiring the relevant water company to put in place a legally binding programme of work to raise the quality of the water to the required standard. In the most serious cases, the DWI can issue an enforcement order.
Planning and contaminated land
Where PFAS contamination is identified, it may become subject to the planning or contaminated land regimes. This could arise where a site with a history of industrial use involving PFAS is to be used for residential purposes and requires remediation to bring it to a suitably safe standard.
In England, there is a statutory regime established under Part 2A of the Environmental Protection Act 1990 for the remediation of contaminated land which causes an unacceptable level of risk. Under this regime, local authorities must identify contaminated land. The relevant enforcing authority – which can include the Environment Agency in addition to local authorities – is then required to ensure that those who are responsible for the contamination remediate it so that the land is suitable for use.
While liability is, in the first instance, imposed on those persons who caused or knowingly permitted the contaminating substances to be present in, on or under the land, if no such person can be found, liability passes to the current owner or occupier of the site (regardless of whether they were aware of the contamination).
In practical terms, the remediation of PFAS-contaminated sites can be challenging: PFAS do not decompose in the environment and there is, as yet, limited authoritative guidance as to what standards should be applied when attempting clean-up. In addition, while PFAS are increasingly being discussed in the context of real estate and corporate transactions, there can be information gaps in affected sites' historical records given the relative lack of attention given to PFAS until recently. Up-to-date environmental assessments which specifically encompass PFAS are therefore increasingly being sought as part of due-diligence exercises.
PFAS coverage is also increasingly being sought under environmental insurance policies. While PFAS are not yet subject to blanket coverage exclusions, insurers can be wary of insuring against PFAS risks at sites where PFAS-related activities are known, or are likely to have, been undertaken. Obtaining the assistance of an experienced environmental insurance broker, in addition to being aware of how PFAS may give rise to liabilities in future, can be helpful in such situations.
Civil liability
PFAS can also give rise to civil liability, for example via claims for nuisance and negligence, both of which can apply in the context of soil and groundwater contamination.
However, successfully bringing a civil claim for environmental contamination can be difficult: there are often complex evidential and causation issues involved and these are likely to be exacerbated in relation to PFAS where knowledge about contamination pathways and the substances' harmful impacts is still being developed.
Generally applicable regimes
Finally, the use of PFAS may also be regulated, albeit indirectly, under other generally applicable legal regimes such as those relating to:
- green claims;
- fluorinated gases;
- plant protection products;
- biocides;
- veterinary medicines;
- human pharmaceuticals;
- waste;
- health and safety (for example, under the Health and Safety at Work etc. Act 1974 and the Control of Substances Hazardous to Health (COSHH) regime); and
- food contact materials, although there are currently no specific restrictions on PFAS in food or food contact materials in the UK.
How Fieldfisher lawyers can assist
The UK regulatory landscape for PFAS is both fragmented and changing. While this can make it difficult for businesses to know what steps to take in relation to PFAS, the trend is clearly towards increased and targeted regulation – if not outright bans in some cases – on PFAS specifically.
Horizon scanning and engaging, where possible, in consultations and otherwise on an informal basis with relevant authorities is therefore essential. More practically, businesses should start to assess where they or their suppliers use PFAS in their operations. Businesses should also consider whether alternative substances can be used. While switching away from PFAS may be costly, given the authorities' focus on PFAS, the costs – including those associated with reputational impacts – of continuing to use PFAS could be much greater.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
