Out-Law News 6 min. read
28 Jan 2025, 10:41 am
Businesses operating in Europe have been warned that they should ensure they understand the profiles of chemicals used in their supply chains, amid a growing body of litigation internationally and a tightening of regulations relating to the use of so-called ‘forever chemicals’ in product manufacturing.
Katie Hancock and Sandra Gröschel of Pinsent Masons issued the warning after recent steps were taken by EU policymakers to restrict the use of poly- and perfluoroalkyl substances (PFAS) and as a new ‘class action’ claim against Apple in the US in relation to PFAS provided fresh evidence of the mounting PFAS litigation risk to businesses.
PFAS are a class of approximately 10,000 fluorinated chemicals that 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.
PFAS 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. Some of these chemicals are, however, known to degrade very slowly – data is not available on all of them – which has led to the colloquialism ‘forever chemicals’ being used to describe them. This has spurred concern about the potential for impact on people and the natural world and is, in turn, prompting policy, regulatory, and legal action and expensive remediation.
Dr. Sandra Gröschel
Rechtsanwalt, Senior Associate
Companies need to prioritise due diligence in their supply chains, assess their historical and ongoing use of PFAS, and develop robust risk management strategies to mitigate both regulatory and liability exposure
The claim against Apple in the US has been raised before a district court in North Carolina, where two consumers who purchased certain Apple watches or bands, Dominique Cavalier and Kiley Krzyzek, are seeking to raise a mass claim on behalf of “all similarly situated consumers” who also bought those products. The claim follows the recent publication of research into PFAS use in fitness trackers and smartwatch bands.
According to the claim filed, reported on by the Register, Cavalier and Krzyzek have submitted to the court that the relevant Apple products “contain toxic PFAS chemicals that harm humans and the environment, and at excessive levels” and that this “was and is avoidable”, citing reports that suggest rival products on the market are “made of different materials that do not contain excessive levels of PFAS”.
Cavalier and Krzyzek claim that Apple has concealed which of its products contain PFAS from consumers and that the fact they are used at all runs contrary to the apparent purpose of the products described in Apple’s marketing of them.
They said: “[Apple] … affirmatively promise … that these products are specifically designed to aid human health and are environmentally-friendly. Consumers therefore reasonably would have no way of knowing the products are laced with harmful chemicals and instead believe what [Apple] falsely promises.”
Cavalier and Krzyzek further claimed that Apple has obtained “an unfair competitive advantage over those in the market who decline to affirmatively promise health or environmental sustainability, or who deliver on those promises by using the otherwise widely-available materials not containing excessive levels of toxic substances”.
Apple told TechRadar that the products in question “are safe for users to wear”.
A spokesperson for the company said: “In addition to our own testing, we also work with independent laboratories to conduct rigorous testing and analysis of the materials used in our products, including Apple Watch bands."
“The US claim against Apple demonstrates the continuing appetite for claims related to PFAS,” said Katie Hancock of Pinsent Masons. “While, historically, the majority of these claims have been brought in the US, there is an increasing interest in such claims in other jurisdictions, including in the EU and the UK. However, the picture is not straightforward. There has been limited research into the vast majority of PFAS and research findings in relation to one chemical cannot be extrapolated to a whole group. Apple’s defence to the US claim argues that its product is not harmful, and much is therefore likely to turn on the scientific evidence.”
In the EU, steps have been taken towards the introduction of greater controls on the use of PFAS in recent months.
For example, under the new Packaging and Packaging Waste Regulation (PPWR) adopted by EU law makers last month, limits on the use of PFAS in food contact packaging will apply. The regulation is expected to come into force in summer 2026.
EU authorities are considering imposing increased restrictions on PFAS. Two options in this regard were originally put forward by five EU member states: a full ban or a ban with time limited derogations, where alternatives are not yet available. A number of industry bodies have raised concerns with those plans, which are currently being scrutinised by scientific committees within the European Chemicals Agency (ECHA). However, following a 2023 consultation on the matter, consideration is now being given to whether restriction options other than a ban may achieve the regulatory aim of significantly reducing PFAS emissions throughout their lifecycle, in tandem with appropriate derogations.
On 20 November 2024, the ECHA published an update on the initiative, with work ongoing by ECHA’s scientific committees to evaluate PFAS risk and the socio-economic impact of a ban or restrictions on their use. This work is being undertaken on a sector-by-sector basis.
The ECHA confirmed that provisional conclusions have been reached in five sectors: consumer mixtures and miscellaneous consumer articles, cosmetics, ski wax, metal plating and manufacture of metal products and petroleum and mining. It said that the conclusions “will be documented in the final consolidated opinion” of the two scientific committees which the ECHA will share with the European Commission, which is ultimately responsible for deciding on whether any changes in EU legislation should follow.
Katie Hancock
Senior Associate
There has been limited research into the vast majority of PFAS and research findings in relation to one chemical cannot be extrapolated to a whole group. Apple’s defence to the US claim argues that its product is not harmful, and much is therefore likely to turn on the scientific evidence
In relation to certain industrial applications of PFAS, like in batteries, fuel cells and electrolysers, consideration is being given to derogations on any potential restrictions on their continued use, while a similar assessment is also expected in relation to medical devices and semiconductors, among other products.
In the meantime, the European Commission also adopted new measures under REACH, the EU’s chemicals regulatory framework, to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA‑related substances. These are sub-groups of PFAS. The restriction will ban the sale and use of PFHxA in consumer textiles, such as rain jackets; food packaging, like pizza boxes; consumer mixtures, such as waterproofing sprays; cosmetics; and in some firefighting foam applications. These restrictions will start to apply from 10 October 2026. It does not affect other applications of PFHxA, for example in semiconductors, batteries or fuel cells for green hydrogen.
The European Environment Agency has also recently reported that the widespread presence of PFAS in European waters is undermining the objectives of the EU’s Water Framework Directive. The agency has highlighted the need to expand the list of PFAS substances monitored in surface and groundwater, with an ongoing proposal for this expansion since 2022, despite resistance from some EU countries.
Sandra Gröschel of Pinsent Masons said reforms to product liability rules, confirmed last month, could pave the way for an increase in PFAS-related litigation in the EU.
“The uncertain regulatory framework and the significant variance in the laws of member states as well as the growing public awareness around PFAS in the EU present not only compliance challenges but also significant litigation risks for businesses in Europe, particularly in the areas of product liability and mass claims,” Gröschel said. “As the EU moves toward stricter restrictions under REACH and other national regulations, companies may face allegations of environmental contamination, health impacts, and inadequate warnings regarding PFAS-containing products. This mirrors trends in the US, where PFAS-related lawsuits have surged, often involving claims of negligence, failure to warn, and breach of product safety laws.”
“In the EU, companies need to prepare for a potential wave of claims, particularly as collective redress mechanisms become more accessible across member states. Historical use of PFAS, even if compliant at the time, could expose businesses to liability if products are found to have contributed to contamination or health risks. The complexities of such claims, including establishing causation and dealing with cross-border implications, could lead to substantial financial and reputational damage,” she said.
“Companies operating in the EU need to prioritise due diligence in their supply chains, assess their historical and ongoing use of PFAS, and develop robust risk management strategies to mitigate both regulatory and liability exposure. A thorough understanding of uses and available alternatives as well as early preparation will be key to navigating this evolving legal landscape,” she said.
Katie Hancock added: “Following its exit from the EU, the UK’s chemical regulations have not kept pace with the EU, and there is no current proposal to ban or significantly restrict the use of PFAS in the UK. Prior to the 2024 change of government, UK regulatory authorities announced that they would be reviewing the use of PFAS in a number of products, but progress on this has been slow. The major change to UK chemical regulation in relation to PFAS is likely to lead to a restriction on the use of PFAS in firefighting foam. Notwithstanding this, PFAS are regularly mentioned in the UK press, and in 2024 residents of a town in Yorkshire indicated their intention to bring the UK’s first PFAS-related mass claim alleging contamination to ground and water by a local business.”
Fiona Cameron, also of Pinsent Masons, said: “The vast range of chemicals under the PFAS umbrella makes assessment, study, regulation and risk management incredibly difficult, not least because data and assessment of potential toxicity and risk varies considerably across the group and is not available for all PFAS. The science on PFAS is still evolving and care must be taken to ensure further restrictions are properly thought though to avoid unforeseen consequences.”