PFAS: A global perspective

Introduction

PFAS (per-fluoroalkyl and poly-fluoroalkyl substances) are a group of man-made chemicals used globally for many purposes, including water resistance, stain resistance, non-stick coatings in textiles, apparel, and cookware, as well as in semiconductors, circuit boards, and electrical wiring, amongst others. There may be as many as 14,000 different PFAS chemicals in existence with often little scientific data on many of them. While some PFAS substances have been the target of regulators over the past decade, the focus on these chemicals generally has recently intensified as a result of data that indicates that they do not biodegrade in the natural environment,

In the USA in particular, certain states have been proactive in legislating to limit the use of PFAS in products. The UK and EU appear posed to follow suit, having indicated an intention to increase regulation in respect of the use of PFAS manufacturing. All economic operators involved in the manufacture and/or supply of PFAS need to be aware of the upcoming regulatory changes and the impact on supply chain and production.

The EU position

In 2020 the European Commission adopted its Chemicals Strategy for Sustainability, under which identified “key actions” are – inter alia – to ban the most harmful chemicals in consumer products and, in particular, to phase-out PFAS unless their use is essential.

The core legislative instrument regulating chemicals in the European Union is Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (EU REACH). PFAS may additionally be regulated under Regulation (EU) No. 2019/1021 on persistent organic pollutants (POP Regulation).

An EU-wide ban on PFOS (perfluorooctane sulfonic acid, C8) was included in the POP Regulation. This was reviewed again in 2019 and all exceptions that had previously applied, with the exception of the use of PFOS as a spray suppressant for non-decorative hard chrome plating (chromium VI) in closed circulation systems, were removed.

PFOA (perfluorooctanoic acid, C8), including its salts and precursor compounds, was initially regulated EU-wide on the initiative of the German authorities in cooperation with the Norwegian authorities (see EU REACH Annex XVII), and was then also regulated under the POP Regulation. The POP Regulation has been in force since December 2019 and currently contains various exemptions in respect of the permissible use of PFOA, the last of which will be in force until December 2036. This is intended to enable a switch to suitable alternatives. The exemptions include uses for implantable medical devices, fire-fighting foams, photographic coatings and photolithographic processes, oil- and water-repellent textiles and industrial polymers for specific membranes or sealants, as no suitable alternatives are yet available. PFHxS (perfluorohexane sulfonic acid, C6) has also been included in the POP Regulation.

Since February 2023, the placing on the market, production and use of perfluorinated carboxylic acids with nine to fourteen carbon atoms (PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFTeDA) has also been restricted. Various other PFAS such as perfluorobutane sulfonic acid and “GenX” (ammonium 2,3,3,3-tetrafluoro-2-propanoate) have already been identified as substances of very high concern (SVHC) under EU REACH and included in the corresponding SVHC list with the aim of identifying suitable replacements.

Based on a request submitted by the national chemical agencies of Germany, the Netherlands, Denmark, Sweden and Norway (a member state of the EEA) in January 2023, the European Chemicals Agency (ECHA) released a proposal which would effectively result in a complete ban on the production and use of PFAS within the EU/EEA. The proposal covers most applications above certain (very low) levels, as well as the use of PFAS in substances, mixtures and manufactured articles above those levels. If adopted, the broad restrictions will build upon the restrictions already imposed on EU/EEA operators using PFAS by EU REACH and the POP Regulation. This is in full knowledge of the fact that in some instances alternative chemicals to replace certain PFAS do not currently exist.

However, over 5,600 comments were submitted regarding the ECHA’s proposed restriction report during the course of 2023, which will be checked by the ECHA’s scientific committees for Risk Assessment and Socio-Economic Analysis as well as by the five countries who prepared the initial proposal (Germany, the Netherlands, Denmark, Sweden and Norway). Those comments, which are evidence-based and provide relevant information, will be considered in the consultation process.

The UK position

REACH UK is the regulatory regime designed to manage the risks from chemical substances manufactured or imported into the UK, and was introduced upon the UK’s exit from the EU. However, it broadly replicates the EU REACH Regulation. There has been very little proactive development of the UK regime since January 2021, and as such, the regulatory position in respect of PFAS in the UK broadly mirrors that of the EU.

As of July 2022, 36 separate PFAS were registered under UK REACH, meaning any registrants that manufacture and/or import any of those 36 PFAS into the UK must evidence that they can be used safely. However, entities that manufacture or supply at very low volumes (less than a tonne) are exempt from the registration requirements under UK REACH. This casts some doubt over whether UK REACH is an effective tool for regulating the use of PFAS within the UK, especially given that the UK has not taken any action to ensure certain PFAS are designated as “substances of very high concern” under UK REACH, which means that suppliers are not subject to the more rigorous information and notification requirements associated with that designation.

The Health & Safety Executive (the HSE), the statutory authority responsible for UK REACH, recently undertook a regulatory management options analysis (the RMOA) in respect of PFAS and has since confirmed that PFAS will be a substance of focus under UK REACH from 2023 to 2025. The RMOA outlines regulatory options available to the HSE in light of the fact the current controls are not considered sufficient, and includes options which would prevent, for example:

1. the use and disposal of fire-fighting foam that includes PFAS where non-PFAS alternatives are available;
2. the use of PFAS in wide dispersive materials such as coatings and cleaning agents; and
3. the manufacture and placing on the market of consumer articles from which PFAS are likely to be released or directly transferred to human, including textiles, upholstery and rugs, leather and paints, varnished and other related articles.

However, the HSE has since stated that a lot more work is needed to understand the hazard data in respect of PFAS and to identify viable alternatives. It therefore seems that that the UK may fall further behind the EU in relation to the progressive restrictions to be placed upon the use of PFAS. This may cause problems for global suppliers and manufacturers when trying to conform with the multiple regimes, but the higher standards of the EU and USA are likely to prevail.

The UK also relies on the POP Regulation (discussed in detail above), which was retained by the UK following its exit from the EU. The POP Regulation restricts the use of PFOS and PFOA and any person that manufactures, sells, or uses PFOS or PFOA in contravention of the POP Regulation is guilty of a strict liability offence.

PFAS Regulation in the USA

There has been significantly more action taken in the USA than in both the EU and the UK in respect of PFAS and product safety. Most of the action taken to date is at the state level, but the federal government is also beginning to show signs of catching up.

At the state level, the following laws are already in effect banning or otherwise restricting intentionally added PFAS (generally defined as any substance with at least one fully-fluorinated carbon atom) in a variety of consumer products:

In addition, Maine has enacted a notification law that requires manufacturers of any product containing intentionally added PFAS sold in the state to provide a notification to the state providing information on the product and its use of PFAS. Further, both Washington and Minnesota have enacted laws banning all intentionally added PFAS in all consumer products by 1 January 2030 and 1 January 2032, respectively.

At the federal level, the United States Environmental Protection Agency (the EPA) has recently finalized a rule requiring all manufacturers and importers of PFAS substances or products containing PFAS substances, dating back to 1 January 2011, to provide a report to EPA by April 2025. The report must provide detailed product, chemical, and health and environmental impact data. This complements existing EPA regulations restricting the manufacture or import of certain long-chain PFAS substances.

Summary

The regulatory regime governing the use of PFAS is currently most prescriptive in the USA. However, the EU proposal currently sitting with the ECHA, if passed, would see the EU leapfrog the USA and put in place the most restrictive regulatory regime governing the use of PFAS in consumer products. The fact that the UK has not yet identified the broad points of action that it intends to take may be an indication that in areas such as chemical regulation the UK is content to let the EU develop and implement policy, which it can then consider whether to adopt or not.

In reality, global manufacturers, importers and distributors will need to comply with the most restrictive requirements in order to avoid restricting the market to which they are able to supply. It is clear that there is a general trend towards removing PFAS from the market in an effort to reduce their prevalence in consumer products generally. As such, manufacturers of substances and articles containing PFAS will need to consider appropriate replacements and/or engage in research and development activities to ensure that neither their supply chains, nor their market access, is interrupted.

Please do get in touch with Norton Rose Fulbright’s global product safety team if you have any questions or would like to discuss this issue in greater detail.