PFAS is a collective name for some 5,000 chemical compounds widely used in industry and everyday items. They have a harmful effect on the environment and human health. Recently, they have been the subject of intense research by the European Chemicals Agency and the US Environmental Protection Agency. This is reflected in the growing number of regulations restricting their use. However, awareness of the harmfulness of these compounds seems to remain low, as evidenced by the small number of court cases in this area.
What are PFAS?
Perfluoroalkyl and polyfluoroalkyl substances—collective known as PFAS—are organic compounds in which multiple fluorine atoms are attached to an alkyl chain. They can be found in various forms and are resistant to high temperatures and decomposition. They owe their colloquial name “forever chemicals” to these properties. The most common of these are perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA).
Due to their characteristics, PFAS are widely used in kitchen appliances, food packaging, textiles, medical products, electronics etc. They are also used in the aviation, automotive, defence and construction industries.
At the same time, the longevity of PFAS is worrisome from a healthcare and environmental perspective. These substances easily transfer to the environment, and due to their durability, they remain in the environment and move in water, wastewater, soil and air, getting into food and the human body (e.g. through contaminated drinking water). They have a very high ability to bioaccumulate, i.e. to reach growing concentrations in the tissues of living organisms. Their exact effects on humans have not yet been studied, but it is known that they can lead to a number of dangerous diseases, including organ damage, endocrine disruption and tumours.
The fight against PFAS is difficult and costly. Studies show that they persist in the environment longer than any other manmade substances. Due to their resilience, it is considered impossible to eliminate them completely. Therefore, the measures taken are mainly aimed at reducing their use and phasing out existing sources.
International and EU regulation
Due to the harmfulness of forever chemicals, their use is subject to increasingly stringent restrictions. Some PFAS have been brought under the regime of the Stockholm Convention on Persistent Organic Pollutants of 22 May 2021 and Regulation 2019/1021 of 20 June 2019 on persistent organic pollutants, which replaced Regulation 850/2004 of 29 April 2004. However, in this regard, the REACH Regulation (Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals) is of key importance. Its goal is to protect human health and the environment from the risks that chemicals can pose, while supporting the competitiveness and innovation of the chemical industry. A component of the REACH Regulation is Annex XVII, dealing with restrictions on manufacture, marketing and use of certain dangerous substances, mixtures and articles. On 4 August 2021, the European Commission adopted a regulation adding perfluorinated carboxylic acids, their salts and derivatives belonging to the group of PFAS to Annex XVII. As a result, as of 25 February 2023, their production and marketing in their own form will be banned. The same ban will apply to manufacture and marketing as an ingredient of another substance, mixture or articles, except in cases where the concentration of the acid is sufficiently low. Given the need to step up these efforts, further restrictions on the use of PFAS under the REACH Regulation have recently been proposed. These proposals have received a favourable opinion from the European Chemicals Agency. Currently, work on their implementation is underway in the Commission.
Additionally, two groups of acids commonly used as replacements for PFOA and PFOS are on the candidate list of “substances of very high concern” governed by the REACH Regulation. This is a list of substances that have defined properties, including being carcinogenic, highly durable, highly accumulative or mutagenic to germ cells. Businesses placing them on the market are subject to certain additional obligations, including informing consumers. Additionally, these substances could potentially be banned from entry onto the market unless authorisation is issued for their use.
Some PFAS are also subject to the harmonised classification and labelling system. The CLP Regulation (Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures) imposes on manufacturers, importers and downstream users of hazardous substances and mixtures the obligation to classify, label and properly package them before placing them on the market. In practice, this means that PFAS products must bear labels including:
- Address and telephone number of the supplier(s)
- Nominal quantity of the substance or mixture in the package made available to the general public
- Product identifiers
- Hazard pictograms
- Signal words
- Hazard statements
- Appropriate precautionary statements
- Supplemental information.
Still other restrictions are set out in Directive 2020/2184 on the quality of water intended for human consumption (replacing Directive 98/83/EC), which member states are required to implement by January 2023. Based on it, drinking water will have to meet quality standards taking into account PFAS parameters, although there are some transitional periods in this regard (until January 2026). Additionally, member states will be required to monitor water quality based on methods established by the Commission.
At the end of October 2022, the European Commission presented draft new rules on surface and groundwater pollution. The lists of pollutants are to be updated in order to monitor pollutants more closely and thus help reduce their negative impact on human health.
In January 2022, the European Chemicals Agency published draft further restrictions related to the presence of PFAS, this time in firefighting foams. According to the draft, the ban on marketing and use of forever chemicals in firefighting agents is to take effect after a transitional period allowing foams to be properly adjusted while maintaining fire safety precautions. This is expected to reduce PFAS emissions by 13,000 tonnes over 30 years. The draft is important, as PFAS-containing firefighting foams constitute a very large proportion of products containing perfluoroalkyl and polyfluoroalkyl substances. They have repeatedly led to pollution, particularly of soil and water.
The need to eliminate forever chemicals from remaining products has led to work on a proposal to restrict PFAS in other applications. The proposal is expected to be ready in early 2023.
PFAS regulation overseas
For many years, these substances have been of interest not only in Europe, but also in the United States. Initially, the measures undertaken there were informative in nature. In 2016, the Environmental Protection Agency published information on levels of PFOA and PFOS in drinking water. However, they were not legally binding, but only provided guidance to limit consumer exposure above the set levels. In June 2022, the EPA updated the data and issued recommendations showing that even trace amounts of PFAS, much smaller than those indicated earlier, are harmful.
Currently in the US, the fight against PFAS is largely focused on legislative action. Between 2019 and 2021, Congress passed more than 80 pieces of legislation directly or indirectly relating to forever chemicals. State governments are also taking regulatory action. In 2019, they considered more than 100 PFAS-related bills and another 180 in 2020. Mainly these proposals are focused on reducing PFAS in firefighting foams, drinking water and consumer products, but they also address corrective actions.
The introduction of effective provisions regarding oversight, regulation and restriction of use of PFAS poses a number of specific challenges. Due to the huge number of such compounds, it is extremely difficult to make a comprehensive assessment regarding the impact of each substance on health and the environment. Their great longevity means that legislative proposals should not only move towards regulating their use for the future, but also address the problem of PFAS already released into the environment over the past few decades. Finally, the numerous gaps in scientific knowledge regarding the impact of PFAS on the environment and human health remain a particular challenge. In turn, this makes it difficult to regulate such detailed issues as their manufacture, use in products, use of products, contact with food, waste management, and contamination of the land and water environment. The nature of these substances makes it more difficult and costly to conduct remediation activities than for other pollutants.
PFAS in the courts
Existing and planned regulations are not the only problem for PFAS. For many years, particularly in the United States, there has been a rapid increase in the number of court cases dealing with the effects of these substances.
One of the first cases on this issue dates back to the early 21st century. It was filed by a West Virginia farmer whose cattle were dying of unknown causes. It turned out that the cause could be materials stored nearby. At the time, perfluorooctanoic acid (PFOA) found in stored materials was not formally considered toxic and was not subject to specific legal bans or restrictions. However, it was shown that the company managing the storage was aware of its harmfulness and did not comply with its internal standards. The substances stored in huge quantities were getting into the cows’ bodies and caused serious illnesses and death. In time, it became clear that people were also affected. A class action lawsuit was eventually filed on behalf of more than 70,000 people, and the proceedings ended with a settlement in 2004. One of the conditions was that experts investigate the links between various medical conditions and PFOA exposure. As a result of the study, probable links between the action of this substance and six diseases were shown. They provided a basis for claiming liability for personal injury, in addition to raising public awareness and providing impetus for further litigation and joint hearing of the cases within the Judicial Panel on Multidistrict Litigation.
And in a recent high-profile action filed in a federal court in Ohio, Kevin Hardwick demanded independent, nationwide medical studies to determine the effects of PFAS on human health, as well as ongoing medical monitoring for those adversely affected by PFAS, to be paid for by the chemical company defendants. The plaintiff claimed that manufacturers and distributors had known for years about the harmfulness of PFAS, had taken conscious measures to conceal it, and had made billions in profits while harming people unaware of the risks to their life and health. In March 2022, the court upheld his claims and declared all inhabitants of Ohio with PFAS in their blood eligible to file suit against chemical manufacturers. However, this right was not granted to residents of other states, as Hardwick had sought. But this does not foreclose granting this right in the future.
The long history of the US litigation over the use of PFAS is not limited to litigation brought by individuals harmed by these substances against chemical companies, although these are the most common. There was a well-known dispute among restructured chemical companies over the allocation of liability for the use of forever chemicals. In 2021, a settlement was reached to share costs for potential liabilities, and issues related to ongoing proceedings were resolved. For several years, actions filed by water companies against chemical companies have been pending in New York, New Jersey and other states. The manufacturers and distributors of materials containing PFAS defend themselves against the allegations in various ways. Typically, they argue that the government is aware of the negative effects of PFAS on health and the environment, yet allows the use of products containing such substances. Some of them, for example firefighting foams, save lives, and from this perspective the benefits outweigh the risks arising from their use. Additionally, it is difficult to estimate their actual impact on health, due to individual factors of exposed persons such as age and genetic predisposition.
How does it look in the European Union?
Although PFAS litigation has so far remained the domain of the United States, recently there has also been a lot of talk about them in Europe. On 23 February 2022, the General Court (part of the Court of Justice of the European Union) issued a judgment in T-636/19, Chemours Netherlands BV v European Chemicals Agency, confirming the validity of the classification of GenX as a “substance of very high concern” under the REACH Regulation. The substance was developed as a replacement for PFOA banned since 2019. It was mainly used in the production of cookware and paints. Initially it was considered a safer alternative, but over time it has proven to be just as durable and similarly toxic.
The case was brought by a Dutch company against the European Chemicals Agency, which is responsible for updating the candidate list of substances of very high concern. Currently, the case is on appeal before the Court of Justice (Case C-293/22 P).
Potential to fight PFAS in Poland
The topic of PFAS is also known in Poland, although the awareness in this area is still low compared to other countries. While knowledge of the toxicity of forever chemicals is growing, the potential for court disputes is underestimated. Meanwhile, there are institutions under Polish law for combatting PFAS. From the perspective of environmental protection, the Act on Prevention and Remediation of Environmental Damage of 13 April 2007 is of momentous importance. Based on it, the use of hazardous substances and mixtures, including substances covered by the REACH Regulation, and thus some PFAS compounds, is considered an activity causing a risk of environmental damage. In the event of an imminent threat of environmental damage, an entity exploiting the environment is obliged to immediately take preventive measures adequate to the type of threat. If it is determined that damage has already occurred, the entity exploiting the environment is obliged to reduce the damage, prevent further damage, and take corrective measures agreed with the environmental authority. Despite the numerous limitations of the Polish act, it seems that the provisions could be used in cases of discharges containing PFAS into waterways, storage of certain wastes, etc. Other European countries have encountered the problem of serious PFAS pollution (at Dordrecht in the Netherlands and in the Veneto region of Italy).
It is important to remember that exposure to the harmful effects of PFAS can result not only from water and soil pollution, but also from their presence in a variety of products, including products coming into contact with food (packaging, dishes, textiles, paper, paints, household and industrial cleaning products). It seems that in the event of injury due to exposure to forever chemicals, injured parties could assert their rights in a civil action, based on the Civil Code. However, the nature of PFAS makes such litigation difficult, influenced by insufficient scientific knowledge about the effects of PFAS on human health, the prevalence of the substance making it difficult to assign responsibility to a specific entity, and the risk of health damage even decades after the substance was manufactured. Also, it will be difficult to assign responsibility when the hazard arose at various stages of manufacture, use or disposal of products and materials containing PFAS. In particular, detailed medical examinations would have to be carried out, and it would be necessary to prove that it was the PFAS manufactured or used by a specific entity that caused the injury. However, in light of current scientific knowledge, this is not impossible, and the US experience shows that it can be done.
Forever chemicals pose a huge, though not fully studied, threat to health and the environment. Recently, efforts to combat their negative impact have been intensifying. Although, the United States is leading the way, more and more perfluoroalkyl and polyfluoroalkyl substances are being restricted by EU laws. However, the awareness of their toxicity and omnipresence is still low, as evidenced by the low level of litigation in this area.
Agata Matysiak, Dr Dominik Wałkowski, adwokat, Environment practice, Wardyński & Partners