Global PFAS regulatory developments

Wednesday 14th August, 2024

Global PFAS regulatory developments

July 2024 update (this article was first published by Ramboll in February 2024)

We are living in an extraordinary period for per- and polyfluoroalkyl substances (PFAS) regulations.

In November 2023, a working group of the International Agency for Research on Cancer (IARC), the cancer agency of the World Health Organization (WHO), evaluated the human, animal and mechanistic evidence for the carcinogenicity of PFOA and PFOS, classifying PFOA as carcinogenic to humans and PFOS as possibly carcinogenic to humans. A summary of the final evaluations was published in The Lancet Oncology in December 2023¹. The full monograph is expected to be published by the end of 2024.

In April 2024, the United States Environmental Protection Agency (USEPA) issued a National Primary Drinking Water Regulation (NPDWR) for six PFAS² with low maximum contaminant levels (MCL) and health-based maximum contaminant level goals (MCLG) and removed de minimis exemptions.

In February 2023, The European Chemicals Agency (ECHA) set out a broad proposal to restrict PFAS³, which could affect more than 10,000 chemical compounds included in the scope.

Further, several US states and countries around the world also promulgated significant new PFAS regulations.

The increase in PFAS-related regulations around the world could have profound implications for manufacturers, importers, exporters, users, sellers, water companies, public and private water and wastewater treatment facilities, landfills and those involved in property and business transactions.

In this article, Ramboll discusses environmental and product related PFAS regulatory developments globally since early 2023.

Asia Pacific

Several countries in the Asia Pacific region have recently moved to restrict and/or manage the use of PFAS (mostly PFOA, PFOS and PFHxS) in accordance with the Stockholm Convention on persistent organic pollutants (POPs).

Australia

Under the Industrial Chemicals Environment Management Standard (IChEMS), the federal regulator finalised scheduling decisions and standards to manage PFOA, PFOS and PFHxS. The chemicals have been listed in Schedule 7 on the IChEMS register, meaning they generally cannot be imported, exported, manufactured or used within Australia, although there are some exemptions. The intended date of effect is 1 July 2025. The decisions have been listed in the IChEMS Register Instrument⁴ and further details on the decisions are available in the IChEMS online register⁵.

In April 2024, the Australian Industrial Chemical Introduction Scheme (AICIS) confirmed some changes to the regulations that would impact PFAS. AICIS have amended the categorisation criteria to clarify what types of fluorinated chemicals are of highest concern to human health and the environment. The aim of this amendment is to ensure that introductions (manufacture or import) of high concern fluorinated chemicals cannot be categorised as exempted (very low risk) or reported (low risk).

This change means fluorinated chemicals of highest concern are now defined in the Industrial Chemical (General) Rules 2019 (Rules) under the term, ‘designated fluorinated chemical’, capturing a slightly different subset of fluorinated chemicals than before. AICIS should have already contacted any introducers of these type of chemicals that have been affected by this change.

In addition, changes have also been implemented on ‘POPs: categorisation changes for health and environmental protection’. The current criteria have been expanded so that introductions of chemicals that have characteristics of POPs, except for two scenarios⁶, would always be in the assessed category, if any of the following now also apply (in addition to the original criteria):

The POP review committee has decided that the chemical meets the POPs screening criteria set out in Annex D of the Stockholm Convention.
The AICIS executive director has decided that the chemical meets the Annex D screening criteria for POPs while making the decision about issuing an assessment certificate for that chemical.
The AICIS executive director has decided that the chemical meets the Annex D screening criteria for POPs based on an AICIS evaluation done on that chemical.

China

In March 2023, PFOA and PFOS were added to China’s list of key controlled new pollutants under the Ministry of Ecology and Environment update to the action plan for priority management to manage/restrict their production, use, import and export.

Japan

In November 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of Environment (MOE) jointly agreed on a proposal to designate PFHxS, its isomers and its salts as Class 1 specified chemical substances through a partial revision to the Chemical Substances Control Law. This designation will become effective from 1 February 2024 and essentially means these PFAS will, in principle, be prohibited. In addition, 10 product types containing these PFAS will be prohibited from import from 1 June 2024.

In April 2024, the same three ministries proposed a ban of 21 products containing PFOA isomers or their salts and PFOA-related compounds. The proposal will amend the Order for Enforcement of the Act on the evaluation of chemical substances and regulation of their manufacture, prohibit the import of eight designated products containing PFOA-related compounds, and prohibit the importation of thirteen products containing PFOA isomers and its salts.

In addition, the proposal includes technical standards for manufacturing facilities handling perfluorooctyl iodide (PFOI) and others. It also states that companies must include information about environmental protection measures on the container, packaging or invoices of substances. The consultation ended on 25 May 2024, a public notice announcement is expected in July 2024, and enforcement is expected from January 2025.

Japan closed a public consultation on 1 March 2024 for a proposal to ban PFOA isomers and its salts, and PFOA-related compounds under the country’s Chemical Substance Control Law (CSCL). The above order implements the CSCL. These provisions are expected to be enforced from January 2025.

Japan has also introduced labelling and handling requirements for firefighting equipment that contains PFHxS, its isomers, or their salts. The joint announcement from the ministries METI and MHLW was published on 1 May 2024 with enforcement from 1 June 2024. Companies must label containers, packaging and invoices, giving substance names, ratio of PFHxS and its isomers or their salts, any necessary precautions and measures in the case of accident, and contact information of the company packing the product. Companies must also adhere to handling standards, such as storage and transfer methods, and maintain volume records for fire extinguishers, fire-extinguishing agents and foam that contain PFHxS and its isomers or their salts.

Taiwan

Taiwan’s Ministry of Environment (MOENV) has added PFHxS, its salts and related compounds to its class I toxic chemical substances list under the Toxic and Concerned Chemical Substances Control Act. Class 1 toxic chemical substances are defined as "substances that do not decompose easily or cause pollution to the environment or endanger human health due to bioaccumulation, bioconcentration, biotransformation etc". Permits will be required for manufacture, import or sale and operators need to produce regular reports on their handling and release quantities.

Singapore

Starting 1 January 2026, facilities in Singapore are no longer able to import any firefighting foams that contain PFOA, PFOS, their salts, or related compounds. Facilities that store or use firefighting foams containing PFOA, PFOS, or PFHxS, their salts, or related compounds at or above the prescribed levels must engage appropriate NEA-licensed toxic industrial waste collectors to collect and dispose of them.

South Korea

In June 2023, the Ministry of Environment included PFHxS and 147 related substances under the Persistent Organic Pollutants Control Act.

New Zealand

Effective 1 January 2023, the use of firefighting foams containing PFAS in uncontained systems is prohibited and applies to aqueous film forming foam (AFFF) that contains PFOA-related compounds, with a complete ban on PFAS-containing firefighting foams planned from 3 December 2025.

On 30 January 2024, the New Zealand Environmental Protection Agency (NZ EPA) confirmed its decision to ban PFAS in cosmetic products, as part of a series of revisions that have been made to the Cosmetic Products Group Standard.

In addition, the NZ EPA is also changing the PFAS definition to align with the European Chemicals Agency (ECHA) definition. Although NZ EPA did not adopt the concentration limits from ECHA’s restriction proposal, meaning that trace levels of a component will still be permitted in New Zealand provided that such presence is technically unavoidable in good manufacturing practice.

The PFAS transition schedule bans import/manufacture from 31 December 2026, supply from 31 December 2027, and requires the disposal of all PFAS-containing cosmetics by 30 June 2028.

United States

PFAS activity in the US continues to be guided largely by USEPA’s PFAS Strategic Roadmap and, in some instances, by states promulgating or applying their own PFAS regulations in advance of USEPA. Key federal activity in early 2024 has included the following:

National Primary Drinking Water Regulation

On June 25, 2024, the final NPDWR became effective⁷, setting enforceable MCLs and non-enforceable health-based MCLGs for six PFAS, together with their isomers and various salts. It marks the first time in 32 years that USEPA has finalized MCLs.

The PFAS NPDWR includes PFOA and PFOS as individual contaminants with MCLs of 4 parts per trillion (ppt, or nanograms/liter - ng/L) each, and MCLGs of zero. PFHxS, PFNA, and HFPO-DA (GenX) were incorporated in the final rule version as individual contaminants with MCLs and MCLGs of 10 ppt each.

The final rule also includes an MCL and an MCLG expressed as a unitless hazard index (HI) of 1.0 for mixtures of two or more of the following: PFNA, HFPO-DA (GenX), PFHxS, PFBS.

Public water systems (PWS) will have three years after the publication of the rule on the Federal Register to reach monitoring compliance, i.e., a yearly round of sampling should be completed by April 26, 2027. Full MCL compliance must be achieved by April 26, 2029, or five years following Federal Register publication.

NPDWR compliance timeline

Since the promulgation of the rule, water utility associations, chemical manufacturing trade groups, and Chemours have filed petitions against the EPA's Final PFAS NPDWR. The lawsuits challenge the EPA's cost assessments, use of a HI instead of a set MCL for PFAS mixtures, allege overreach of EPA's statutory authority, and accuse the EPA of using unsound data. It appears that despite these legal actions, the EPA and state authorities will continue to implement the new PFAS regulations unless ordered otherwise by the court.

CERCLA

On May 8, 2024, the Federal Register published the USEPA’s final rule designating PFOA and PFOS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)⁸. These designations could have far-reaching effects:

Liabilities for addressing environmental impacts from PFOA and PFOS can be more readily imposed on potentially responsible parties (PRPs). Private parties can now attempt to recover costs from other PRPs for investigation and remediation.
PFOA/PFOS now require consideration as part of All Appropriate Inquiry (AAI) needed to provide liability protections for purchasers of contaminated properties.^{9 10} Under CERCLA, entities may be held strictly liable for cleaning up PFOA and PFOS at properties that they currently or previously owned or operated based solely on property ownership.
Releases of PFOA or PFOS exceeding the reportable quantity (RQ) of 1 pound within a 24-hour period must be reported to the USEPA.
PRPs with liability for PFOA/PFOS under CERCLA may also have corresponding liabilities for Natural Resource Damages (NRDs).

Significantly, USEPA issued a companion PFAS Enforcement Discretion and Settlement Policy Under CERCLA that indicated it does not intend to pursue PRPs associated with PFOA/PFOS releases, unless special circumstances exist, within the following categories:

Community water systems and publicly owned treatment works
Municipal separate storm sewer systems
Publicly owned/operated municipal solid waste landfills
Publicly owned airports
Publicly owned, local fire departments
Farms where biosolids were applied to the land

Rather, “EPA intends to pursue major PRPs and federal agencies to conduct investigations and cleanup…”¹¹. The “major PRPs” are defined as those who manufactured PFAS or used PFAS in the manufacturing process, and other industrial parties. This policy may significantly affect allocation considerations at sites where multiple PRPs may have potential liability.

In February 2024, USEPA released a proposed rule that would identify certain PFAS as “hazardous constituents.”¹² These include the six compounds included in the NPDWR (PFOA, PFOS, PFBS, HFPO-DA, PFNA, PFHxS), as well as PFDA, PFHxA, and PFBA. If promulgated, the rule would require these nine PFAS to be considered as part of RCRA facility assessments and, where necessary, further investigation and cleanup conducted through the RCRA corrective action process at RCRA treatment, storage, and disposal facilities.
Also in February 2024, USEPA proposed a rule that would amend the definition of hazardous waste applicable to corrective action, which would clarify the USEPA’s existing authority to enforce RCRA requirements in relation to substances not only specifically identified as hazardous waste in the regulations, but that meet the statutory definition of hazardous waste.

Notable state-level activity:

Hawaii released an April 2024 “Interim PFAS guidance”¹³ that presented screening environmental action levels for 25 PFAS, and a methodology for the assessment of total PFAS risk that relies upon analysis of targeted PFAS, precursors, and “excess fluorine” based on the analysis of total organic fluorine. Hawaii’s guidance includes a PFAS risk calculator used to assess non-cancer risk protective of young children, for use in environmental hazard evaluations.

Maine¹⁴ and Minnesota¹¹⁵ continue to work out administrative details related to blanket restrictions on PFAS use in consumer products, with phase-outs occurring through January 2032. The agencies of these states are developing rules related to reporting, notification, and fee structures, as well as methodologies related to determining 'currently unavoidable uses’. These leading states are being watched by others.

Effective June 24, 2024, the State of Washington adopted an emergency update by which the trigger for replacing state action levels with federal MCLs was changed to when these new standards are effective, not the date of adoptions. This change represents the type of adjustments that may be needed in most of the 50 states as they integrate the new federal requirements into existing programs.

Europe:

The main developments in Europe relate to the European Chemicals Agency (ECHA) restriction proposal, which aims to restrict or ban the manufacture, placing on the market, and use of PFAS in all applications and uses besides firefighting foams.

In June 2023, ECHA’s risk committee for socio-economic analysis (SEAC) adopted its final opinion supporting a gradual ban on PFAS in firefighting foams.

The findings of a data-driven exploration were published by Le Monde¹⁶ and other media groups in February 2023, and this was reportedly updated in February 2024 to include new data on sites in Spain and Belgium. The reported data show locations where PFAS are manufactured or used, as well as known and suspected contamination in soil, water, and living organisms, where available.

Additionally, new regulations concerning PFAS have been introduced in several countries, notably in France and Germany, with more anticipated in the near future, including a new temporary framework for PFAS in soils expected to be introduced in Flanders in Belgium later in 2024.

We also expect to learn more on the outcome of the current proposal for an EU Directive to amend the Water Framework Directive (WFD) and related Groundwater and Environmental Quality Standards Directives (GWD and EQSD) for a new quality standard for the sum of 24 PFAS (4.4 ng/L). If the proposal is accepted, it is not clear whether it will replace the existing EQS of 0.65 ng/L previously set just for PFOS.

EU restriction proposal:

The ECHA PFAS restriction proposal aims to restrict or ban the manufacture, placing on the market, and use of PFAS in all applications and uses besides firefighting foams. When the consultation ended on 25 September 2023, more than 5,600 comments had been received.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) are using a sector-based approach to evaluate information provided during public consultation. The two committees started this evaluation in March 2024 with a focus on ski wax, consumer mixtures and cosmetics, and a hazard assessment. This was followed in June 2024 by metal plating and the manufacture of metal products, and additional discussion on hazards. The next meetings will continue the evaluation for more sectors¹⁸.

The above is in addition to the separate existing and proposed restrictions/bans on PFAS in firefighting foams in the EU.

Germany:

In June 2023, the revised Drinking Water Ordinance came into force, implementing the relevant content of the EU Drinking Water Directive from 2020. From 2026 onwards, providers of drinking water need to ensure that a total of 20 PFAS do not exceed the limit of 100 ng/l. For the sum of four PFAS (PFOA, PFNA, PFHxS, and PFOS), a maximum level of 20 ng/l will be in place from 2028.

The new version of the Federal Soil Protection Ordinance came into force in August 2023¹⁹. It sets values for PFAS in soil leachate. For a 2:1 water:soil ratio, these values are: 10 µg/l for PFBA and PFHxA, 6 µg/l for PFBS and PFHxA, 0.1 µg/l for PFOA, PFHxS, and PFOS, and 0.06 µg/l for PFNA. The transition period for exceptions ended on 1 December 2023, and in 2028 there will be new requirements for contaminated site investigations.

This is the first time there are legally binding threshold values for these substances in soil leachate and groundwater on a national level. This means if any of these PFAS are a potential contaminant of concern at a site and could be present in soil or groundwater, potential risks should be evaluated.

The Nordics:

PFAS have been regulated in the Nordics for approximately a decade. Even so, stricter limits for PFAS in drinking water followed changes to the EU Drinking Water Directive. Health concerns related to PFAS in fish, drinking water, seawater, and meat have been reported in the news.

Denmark has introduced new individual environmental quality standards for PFAS in surface water, which will lead to a regulatory focus on the discharge of PFAS in wastewater and surface water. This regulatory focus will drive a requirement for more effective treatment of wastewater at the source. Finland has proposed similar standards.

In 2024, a growing need for treatment methods towards PFAS-impacted soil and water is also expected. In Denmark, the government has allocated funds in 2024 for research into treatment methods, with a special focus on soil treatment as technologies in this area are lacking in the Nordics. National action plans are being created, highlighting the continued need for mapping and monitoring of PFAS in the environment to understand where and how best to manage PFAS in the Nordics.

In Sweden, on 5 December 2023, the Supreme Court announced a historic verdict for determination of liability for damages to the inhabitants of the Ronneby municipality. The Supreme Court found that inhabitants of Kallinge have been exposed to PFAS in the drinking water, sourced from groundwater impacted by firefighting foam used by the Swedish armed forces during training activities. The Supreme Court's website²⁰ says: Through the drinking water, the residents have been affected by high levels of PFAS in the blood, which entails an increased risk of certain negative health effects and diseases. The verdict suggests that suppliers of products in Sweden – and potentially further afield – may need to know what is in their products, particularly if they contain any PFAS that are under scrutiny.

France

In January 2023, the French government enacted a ministerial action plan for 2023-2027 to significantly reduce PFAS industrial emissions and reduce the general population’s exposure to PFAS. Drinking water quality limits were also set for the sum of 20 PFAS as defined in the EU Drinking Water Directive (EU 2020/2184).

In April 2024, an interministerial action plan was published²¹, specifically to assess potential links of industrial risks and impacts on health and the environment. It incorporates and replaces the actions set out in the initial ministerial action plan.

In June 2023, regulatory requirements came into force to identify and quantify PFAS in industrial wastewater discharge for industrial activities including textiles, waste, refineries, paper, surface treatment, plastic manufacturing, among other market sectors.

In 2024, it is anticipated that toxicological reference values for certain PFAS will be developed, and that PFAS restrictions and regulations in France will continue to gather pace. In May 2024, a proposed law to prohibit PFAS in select categories of consumer products was endorsed by the French Senate; this was before the national elections held in July 2024.

United Kingdom

The UK regulatory approach to PFAS is evolving with the trend being towards increased regulation.

As a result of the transition from EU REACH to UK REACH, there are existing UK REACH restrictions²² on PFOA and its salts (Entry 68) and perfluorinated silane (Entry 73). The UK Health and Safety Executive (HSE) assessed the most appropriate regulatory tools to address PFAS and published their regulatory management option analysis (RMOA) in April 2023²³, setting out the HSE’s recommendations for managing PFAS risks via UK REACH. It is clear the restriction proposal does not go as far as the ECHA PFAS group restriction proposal under EU REACH, with the definition of PFAS being used leading to a targeting of hundreds of substances in the UK. The conclusion of the RMOA is that in the UK a targeted restriction, or a number of targeted restrictions, would be a more effective regulatory option for minimising releases of PFAS to the environment. Based on the RMOA conclusion, the first priority for the UK REACH work programme is to:

Start a restriction dossier on PFAS in firefighting foams, and
Assess potential additional restrictions on other wide dispersive uses of PFAS and PFAS likely to be released from consumer articles.

The public consultation on the restriction dossier on firefighting foams closed on 24 June 2024 with the next step being development of a UK REACH restriction report on risks to human health and the environment arising from the use of PFAS in firefighting foams.

Certain PFAS are already restricted or banned in the UK under the POPs regulations. From 4 July 2025, all uses of PFOA in firefighting foams are prohibited. Additionally, a November 2023 amendment to the POPs regulations restricted the use of PFHxS within firefighting foams. As such, if a firefighting foam is discovered to contain PFHxS at a concentration above 0.1 mg/kg, then the foam should be disposed of as soon as possible.

Other PFAS are not currently subject to any restrictions under UK REACH, but this may change depending on the outcome of the RMOA process, in particular the assessment of additional restrictions on further wide dispersive uses.

The Environmental Permitting Regulations in the UK require businesses that manufacture PFAS to hold an environmental permit.

Whilst it is understood that there are no specific legally binding threshold values for PFAS in drinking water in the UK, guideline threshold values based on a tiered approach have been established by the Drinking Water Inspectorate (DWI) for 47 PFAS. In March 2023, the DWI wrote an information letter to water companies in England and Wales²⁴ clarifying their expectations for investigating PFAS risk and the trigger levels and actions that should be implemented to mitigate PFAS risk from source to tap; this was for the water companies to consider for their next five-year Asset Management Plan cycle (AMP8 for the period 2025-2030). The letter states that the Tier 3 guideline value of 0.1 µg/l is currently recommended for all 47 PFAS after which the supply of drinking water is considered contrary to the guidance. Indications are this value may be revised downwards at some point in future.

In May 2024, supported by the Society of Brownfield Risk Assessment (SoBRA), CL:AIRE, a UK charity and recognised NGO dedicated to promoting sustainable land reuse and management, released Interim Category 4 Screening Levels (C4SLs) for Human Health for four PFAS (PFOA, PFOS, PFHxS and PFNA) for different land uses (Residential, Allotments, Commercial and Public Open Space). C4SLs are threshold values below which “the level of risk posed is considered acceptably low” (i.e., not considered contaminated). The interim C4SLs for PFOA, PFOS, PFHxS, and PFNA are based on chronic risk and are included in the table below. The interim C4SLs should be used in conjunction with a hazard index approach to guide land use.

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