What are PFAS?
Per- and polyfluoroalkyl substances (PFAS) are receiving increasing attention, both from regulators and the general public.
They 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 – meaning 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.
The UK's Health and Safety Executive (HSE) issued a call for evidence on PFAS in December 2021 to prepare a regulatory management options analysis (RMOA). An RMOA is a document drafted to support regulatory decision-making. RMOAs are not legally binding, but they can give an insight to potential future legal developments.
The HSE RMOA was published on 4 April 2023 and set out the HSE's recommendations as to what steps the UK should consider taking under the UK's post-Brexit Registration, Evaluation, Authorisation and Restriction of Chemicals (UK REACH) regime in response to the risks arising from PFAS.
The HSE RMOA makes a number of recommendations including to limit the use of PFAS-containing foams used by firefighters to put out fires, as well as the use of PFAS in textiles, furniture, and cleaning products. More specifically, the HSE RMOA recommended that:
- the HSE should prepare dossiers to potentially support one or more UK REACH PFAS restrictions including in relation to the use and disposal of fire-fighting foams where non-PFAS alternatives are available, other wide dispersive uses such as the application of coatings or use of cleaning agents and the manufacture and placing on the market of consumer articles from which PFAS are likely to be released into air, water or soil, or directly transferred to humans (such as from textiles);
- there should be a UK REACH authorisation for PFAS used in processing aids in the manufacture and processing of fluorinated polymers;
- there should be further evaluation and investigation of substances that have already been identified as being of concern; and
- there needs to be continued collaboration between government and external stakeholders in relation to the risks posed by PFAS and how they should best be addressed.
The HSE RMOA does not go as far as the European Chemicals Agency (ECHA) in the European Union which, on 7 February 2023, announced proposed restrictions on PFAS under EU REACH prepared by the relevant authorities in Denmark, Germany, the Netherlands, Norway and Sweden. ECHA's proposal prompted a strong negative reaction from European industry bodies and the eventual scope of any EU REACH restrictions, and when they will take effect, remains unclear.
How are PFAS currently regulated in the UK?
The UK's regulatory landscape for PFAS is very fragmented with the applicable legal requirements being spread across a number of different regimes. The key regimes are discussed below.
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 many of which – such as EU REACH – that regulate PFAS. What follows in this overview is the position in relation to GB with a particular focus on England.
PFAS fall within the scope of UK REACH, the chemicals regime which applies in all parts of the UK other than Northern Ireland. The HSE RMOA was conducted under the auspices of UK REACH.
However, PFAS are not presently subject to many UK REACH restrictions imposing controls on their use. That said, there can be, depending on the activity undertaken, a registration requirement and UK REACH imposes 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 RMOA identified 36 individual PFAS registered and anticipated that another 40 could eventually become registered. However, the HSE noted that 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)
UK REACH restrictions (the list of which maintained by the HSE can be viewed here) are currently in place for two PFAS substances: PFOA and its salts (in entry 68) and perfluorinated silane (in entry 73).
In broad terms, a UK REACH restriction is measure for protecting human health and/or the environment from risks. They can limit, ban or set conditions on the manufacture, placing on the market or use of a substance or group of substances. However, the inclusion of PFOA and perfluorinated silane on the UK REACH Restriction List merely reflects the fact that when UK REACH came into force on 1 January 2021, all substances then on the EU REACH Restriction List were carried over onto the UK REACH Restriction List.
A number of PFAS are on the UK REACH Candidate List of substances of very high concern (SVHC). However, as with the UK Restriction List, this merely reflects the fact that when UK REACH came into force on 1 January 2021, all substances then on the EU REACH Candidate List were also carried over onto the UK REACH Candidate List.
Inclusion of a substance on the UK REACH Candidate List triggers certain obligations, namely:
- if you supply articles containing SVHCs in a concentration above 0.1% weight by weight (w/w) you must supply the recipient of the article with sufficient information to enable safe use of the article including, as a minimum, the name of the substance;
- if you supply articles containing SVHCs in a concentration above 0.1% w/w you must supply the information outlined above to consumers (i.e. the general public) within 45 days if requested;
- if you produce or import supply articles containing substances that appear on the UK REACH Candidate List you may need to submit a notification to the HSE;
- if you supply a substance that appears on the UK REACH Candidate List you must provide a safety data sheet for the substance to your customers; and
- if you supply a mixture not classified as hazardous according to the UK version of EU Regulation 1272/2008 on the classification, labelling and packaging of substances and mixtures (GB CLP) you must provide the recipients on request a safety data sheet if the mixture contains at least one substance on the UK REACH Candidate List present at concentration of at least 0.1% w/w for non-gaseous mixtures.
Once added to the UK REACH Candidate List, an SVHC may – and, in the context of PFAS, this is the basis for the HSE RMOA – go forward and be included in UK REACH Authorisation List. Such substances would then be subject to the authorisation provisions of UK REACH.
Once a substance has been included in the UK REACH Authorisation List, businesses cannot generally use that substance for the specified use beyond a sunset date unless they are granted an authorisation.
PFAS fall within the scope of the environmental permitting regime established under the Environmental Permitting (England and Wales) Regulations 2016 (the Permitting Regulations). The Permitting Regulations require, amongst other things, businesses that manufacture potentially harmful substances such as PFAS to hold an environmental permit.
Such an environmental permit should seek to give effect to the EA's statutory obligation under the Permitting Regulations, 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 permit conditions such as the setting of emissions limits, the requirement that operational sites are cleaned-up once activities cease, etc.
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.
POPs are regulated internationally under the Stockholm Convention and the Aarhus Protocol (each of which the UK is a signatory to). These international treaties are implemented domestically in the UK by Regulation (EU) 2019/1021 which applies, as amended, in the UK as retained EU law (the GB POPs Regulation) because it took effect before the end of the Brexit transition period. Breaches of the GB POPs Regulation are enforced through The Persistent Organic Pollutants Regulations 2007 (the UK POPs Regs).
The UK POPs Regs provide that a person who produces, places on the market or uses a designated POP such as PFOS or 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.
The relevant PFAS are perfluorooctane sulfonic acid (PFOS), PFOS derivatives, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. The HSE RMOA noted that as PFOA is listed as a POP, the existing UK REACH restriction will be revoked as it has been superseded by the POPs restriction.
The HSE RMOA also notes that perfluorohexanesulfonic acid ("PFHxS"), its salts and PFHxS-related compounds have also been added as a POP for elimination via a POPs restriction under the Stockholm Convention. In addition, a recommendation for listing as a POP is also anticipated for long-chain (C9-C21) perfluorocarboxylic acids (PFCAs). If these restrictions are implemented, they will apply in the UK.
Water Quality Standards
The Water Supply (Water Quality) Regulations 2016/2018 (the 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. However, for England and Wales 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.
There is mounting pressure for the rules around PFAS exposure through drinking water to be tightened. In October 2023 the UK's Royal Society of Chemistry called for the DWI's guidance to be revised to reduce the limit from 100 ng/l to 10 ng/l and a new overall limit introduced of 100ng/l for a wider range of PFAS in drinking water.
Planning and contaminated land
Where PFAS contamination is identified, they may become subject to the planning and contaminated land regimes, for example 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.
Taking the example of England, the contaminated land regime is the statutory regime established under Part 2A of the Environmental Protection Act 1990 for the remediation of contaminated land that 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 practice, identifying liable persons can be complex and there are various – often misunderstood and incorrectly applied – statutory exclusion mechanisms by which attempts can be made by persons to transfer liability between each other. These attempts can, due to the need to ensure compliance with relatively prescriptive statutory requirements, be of limited reliability and they should usually be expected to be backed up by a contractual indemnity.
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.
Unknown risks can be sought to be addressed contractually by warranty protection whereas for known risks – or for more cautious buyers – indemnity protection can be sought.
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.
PFAS can also give rise to civil liability, for example through the torts of nuisance and negligence, both of which can apply in the context of soil and groundwater contamination.
Successfully bringing a civil claim for environmental contamination can be difficult: there are often very complex evidential 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:
- fluorinated gases;
- plant protection products;
- veterinary medicines;
- human pharmaceuticals;
- health and safety (for example, under the Control of Substances Hazardous to Health (COSHH) regime);
- product safety (such as the General Product Safety Regulations 2005); and
- food contact materials (under the Materials and Articles in Contact with Food (England) Regulations 2012).
The UK regulatory landscape for PFAS is both fragmented and changing. While this makes it difficult for business to know what steps to take in relation to PFAS, the trend is clearly towards increased and targeted regulation on PFAS specifically. Horizon scanning and engaging, where possible, in consultations and otherwise on an informal basis with relevant authorities is therefore essential.
If you have any questions about PFAS please, for the UK, contact Aonghus Heatley, a Director and senior environmental and products lawyer in Fieldfisher's Competition, Regulatory and Trade group in London and, for the EU, Peter Sellar, a Partner in Fieldfisher's Competition, Regulatory and Trade group in Brussels.
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