CHAPTER 1: PFAS Regulations: Past and Present and Their Impact on Fluoropolymers
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Published:15 Aug 2022
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Special Collection: 2022 ebook collection
A. R. Bock and B. E. Laird, in Perfluoroalkyl Substances, ed. B. Améduri, The Royal Society of Chemistry, 2022, pp. 1-21.
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Over the last decade, per- and polyfluoroalkyl substances (PFASs) have been the focus of many regulatory initiatives, mainly in the European Union (EU) and the USA. Currently, these regulations are being focused on individual PFASs and related substances, i.e. substances that may degrade into the substance of concern. With the major exception of perfluorooctanoic acid (PFOA), which was historically used as a polymerisation aid in the manufacture of many types of fluoropolymers, these regulatory initiatives did not directly address fluoropolymers or their manufacturing processes. Several substances, such as the C9–C14 carboxylic acids, are indirectly linked to fluoropolymers as they could occur as by-products during the polymerisation process and could be found in trace amounts in the final products. With the recent launch of the PFAS restriction process in the EU, fluoropolymers are now included in the regulatory process as they are within the scope of the restriction's current definition of PFASs. This chapter summarises the major regulations and industry initiatives aimed at controlling the use of PFASs globally, with a focus on their impact on fluoropolymers.
1.1 Introduction
This regulatory chapter provides a historical overview of polyfluoroalkyl substance (PFAS) regulations in the past and the current unfolding initiatives in the European Union (EU), the USA and beyond. This chapter examines how PFAS regulations around the world have come to be, those regulations which are currently under discussion and how regulatory guidelines for PFASs may impact the use of fluoropolymers, which, in turn, may impact producers, downstream users and consumers.
The introduction of the entire group of PFASs in the legislative agenda is relatively recent as, until now, only individual substances and their potential precursors were assessed and regulated. In 2018, policymakers in Europe acknowledged the demands of scientists who had been calling for regulatory action. Researchers have been publishing academic articles since the early 2000s, but the turning points were the Helsingør,1 Madrid2 and Zürich3 statements. Signatories of the statements stressed not only that certain PFASs are found in the indoor and outdoor environments all over the globe, but further that substitution with fluorinated alternatives, such as short-chain PFASs with similar structures, would also lead to large-scale environmental and human exposure to persistent and potentially bioaccumulative substances. Although the scientists proposed measures such as implementing the “essential use” principle, adopting extended producer responsibility schemes and supporting the development of non-fluorinated alternatives, they also acknowledged that PFASs are divided into different families. As a result, the participants who produced the statements agreed that any regulatory action needs to address groups of PFASs and that such a grouping approach needs to be scientifically sound.
These three statements worked as catalysts to unite a sizeable part of the scientific community and mobilise policymakers and other civil society organisations. Since then, interest in PFASs has grown consistently and reducing PFAS exposure is now a top priority of many governments worldwide. This is particularly true in Europe, where four EU Member States and Norway have stated their intent to propose a restriction of all “non-essential” PFASs under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.
The first time PFASs were formally targeted for regulatory action at the EU level was on 26 June 2019, following conclusions of the Environmental Council, in which the Council called on the European Commission (EC) to develop an action plan to eliminate all non-essential uses of PFASs. The Dutch Competent Authority (CA), in collaboration with its homologue authorities from Denmark, Germany, Sweden and Norway, has registered its intention to propose a restriction4 and had until July 2022 to prepare a restriction proposal.
After the five nations came forward with their ambitions to restrict PFASs, the EC put forward a series of PFAS-related measures in its 2020 Chemical Strategy for Sustainability (CSS). Among these measures, the EC proposed a ban on PFASs in all uses and products that are not considered “essential for society” – starting by prohibiting the use of PFASs in firefighting foams and continuing with its progressive phase-out from other applications and products. As announced in the CSS, the EC intends to follow a group approach to restrict PFASs, supports new remediation methodologies and will provide a fund for developing substitute substances. These initiatives have a scope never seen before in PFAS regulations and their potential impact on fluoropolymers should not be underestimated.
Although none of the regulatory efforts have specifically targeted fluoropolymers thus far, their inclusion as a member of the PFAS family results in potential limitations to their use and does not take into account the different chemical properties that fluoropolymers present. The impending restriction proposal from the five European nations would directly impact the manufacture and commercialisation of fluoropolymers. Until now, the United States Environmental Protection Agency Product Stewardship Program is the only previous instance where the phase-out of a particular PFAS impacted fluoropolymer production. This programme was a voluntary industry commitment, led by the private sector, which lasted for more than 10 years. It resulted in the successful elimination of perfluorooctanoic acid (PFOA), which used to be the primary polymerisation aid in the manufacture of fluoropolymers.
Given that several PFASs, such as perfluorohexanoic acid, C9–C14, can be found in fluoropolymers as by-products and impurities due to their manufacturing process, many PFAS regulations will have indirect consequences on the fluoropolymers industry. Nevertheless, it is unclear how profound and lasting the final repercussions will be, as we are starting to witness the development of such regulations. Even though in the USA State regulations on food contact materials and firefighting foams are coming into force, regulators have so far only targeted specific families of PFASs, as opposed to grouping all PFASs together under one ban. Most of them do not cover all PFAS substances and uses. For now, only Maine has adopted, on 15 June 2021, a complete and comprehensive law phasing out PFASs from all non-essential uses. However, it is too early to assess its impact correctly.
The use of a far-reaching regulation covering a whole family of substances is a new approach, not tested before for PFASs. This chapter will show how PFAS regulations have only targeted specific substances and not fluoropolymers.
1.2 Past Regulatory Initiatives
1.2.1 PFOS: 3M Voluntary Phase-out and Regulations
In May 2000, the US-based company 3M announced that “it is phasing out the perfluorooctanyl chemistry used to produce certain repellents and surfactant products”. The decision was taken in response to the increasing amount of data demonstrating that perfluorooctanesulfonic acid (PFOS) has the potential to build up over time in the environment and certain organisms. 3M voluntarily phased out the production of this chemistry as a precautionary measure and ceased manufacturing PFOS and related compounds by the end of 2002.
PFOS was mainly used in Scotchgard™ products and aqueous film-forming foams (AFFFs). Scotchgard™ products were applied in a wide range of surface protection applications for products such as carpets, outdoor clothes, shoes, etc. PFOS was also added as a fluorinated surfactant in AFFFs, used mainly for extinguishing so-called Class B liquid fires. Another important application was in the metal plating industry, where it was used as a protective film-forming layer to protect workers from fumes containing Cr(vi), a highly carcinogenic substance.
PFOS has been demonstrated to be both a PBT (persistent–bioaccumulative–toxic) and CMR (carcinogenic–mutagenic–reprotoxic) substance and is classified as such in the EU. The UK submitted an EU PFOS restriction proposal under the pre-REACH EU chemical legislation and the restriction was adopted in 2006 5 for all uses with several derogations such as metal chrome plating and a time-limited exemption for use in firefighting foams.
At the international level, the UN Conference of the Parties (COP) adopted, in 2009, the inclusion of PFOS in Annex B (restriction with acceptable purposes and specific exemptions) of the Stockholm Convention.6 Several time-limited exemptions were granted, although the number of authorised uses is decreasing as alternative products (fluorinated or non-fluorinated) have been developed and are currently available.
1.2.2 PFOA Voluntary Phase-out and Regulations
1.2.2.1 The 2010/2015 US EPA PFOA Stewardship Program
In conjunction with the PFOS phase-out announcement, 3M also announced that it would cease production of PFOA. PFOA was historically the main polymerisation aid used by the industry since the 1950s in the manufacture of fluoropolymers. Similarly to PFOS, environmental and toxicological data demonstrated that PFOA is a CMR substance and has the potential to build up in the environment and to bioaccumulate (see Section 1.2.2.2).
In the wake of the PFOS assessment, the US Environmental Protection Agency (EPA) invited eight major leading PFAS-producing companies [Arkema, Asahi Glass, BASF (Ciba), Clariant, Daikin, 3M/Dyneon, DuPont and Solvay Solexis] to join in a voluntary global stewardship programme on PFOA (2010/2015 PFOA Stewardship Program7 ) with two goals:
To commit to achieving, by no later than 2010, a 95% reduction, measured from a year 2000 baseline, in both facility emissions to all media of PFOA, precursor chemicals that can break down to PFOA and related higher homologue chemicals and product content levels of these chemicals.
To commit to working towards the elimination of these chemicals from emissions and products by 2015.
The programme targeted the use of PFOA as a polymerisation aid in fluoropolymer manufacture, and also the so-called long-chain C8-based fluorotelomer products that could contain PFOA as a by-product and/or degrade to PFOA. It is important to note that fluorotelomer products differ greatly in composition and structure and also in physical, chemical and biological properties compared with fluoropolymers and should therefore not be considered as a subgroup of fluoropolymers for regulatory purposes.
Starting in 2006 and continuing in October of each successive year until 2016, all US EPA PFOA Stewardship Program signatories submitted annual public reports on their progress toward the goals, expressing their progress in terms of company-wide percentage achievements both for US operations and for the company's global business. Companies also provided the EPA with detailed, confidential business information (CBI) on their progress in support of their public reports. The final reports were submitted in early 2016 and all eight companies met the PFOA Stewardship Program goals.
To meet these goals, participating companies developed alternatives to replace PFOA as a polymerisation aid and short-chain C6-based fluorotelomer compounds to replace long-chain fluorotelomer products. Other companies exited the PFAS industry altogether. As shown in Section 1.2.4, all these alternatives are now being assessed for further regulations in the EU.
To complement the PFOA Stewardship Program, the EPA has issued regulations, known as Significant New Use Rules (SNURs), requiring manufacturers and processors of these chemicals to notify the EPA of new uses of these chemicals before they are commercialised.8 Specifically, the regulations require that anyone who intends to manufacture (including import) or process any chemicals for uses contained in the SNUR must submit a notification to the EPA at least 90 days before beginning the activity. This provides the EPA with an opportunity to review and, if necessary, place limits on manufacturers or processors who intend to reintroduce or import products with these chemicals.
1.2.2.2 The EU PFOA Restriction and Stockholm Convention Inclusion
In 2011, Norway submitted an EU Harmonised Classification and Labelling (CLH) proposal,9 which led to the classification of PFOA as a suspected carcinogen (Carc. 2) and presumed reproductive toxicant (Repr. 1B). Concomitantly, Annex XIII of REACH, which defines the criteria for Substances of Very High Concern (SVHC) inclusion, was revised and included the “weight of evidence” approach when assessing chemical substances for their bioaccumulation potential. Until then, bioaccumulation was based solely on the calculated bioaccumulation concentration factor (BCF). This led, in 2013, to the identification of PFOA as an SVHC and its inclusion in the EU Candidate List as it now met all PBT criteria as defined in the revised REACH Annex XIII.10
The harmonised classification and SVHC inclusion were followed in 2014 by the launch of the PFOA restriction process. Germany and Norway submitted a draft dossier proposing to amend REACH Annex XVII to restrict the manufacture, use and placing on the market of PFOA, its salts and PFOA-related substances. In January 2016, following the assessment of both the European Chemicals Agency's (ECHA's) Risk Assessment and Socio-Economic committees, the ECHA submitted its final opinions11 to the EC. Based on the ECHA's opinions, the EC concluded that an unacceptable risk to human health and the environment arises from the manufacture, use or placing on the market of PFOA, its salts and PFOA-related substances and that those risks need to be addressed in the EU. Consequently, the EC proposed that REACH Annex XVII (list of restricted substances) should be amended accordingly. On 14 June 2017, the EU's restriction on PFOA, its salts and PFOA-related substances was published in the Official Journal as Regulation (EU) No. 2017/1000,12 which amended Annex XVII to REACH by the addition of a new entry – entry 68.
As of 4 July 2020, PFOA is no longer to be used in the production of, or placed on the market in another substance, as a constituent, a mixture or an article in a concentration equal to or above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances. Although the legal text did not explicitly mention fluoropolymers as being out of scope, these were meant to be excluded based on the following definition (fluoropolymer definition in bold):
The following substances are excluded from this designation: C8F17–C(=O)OH, C8F17–C(=O)O–X′ or C8F17–CF2–X′ (where X′ = any group, including salts).
Several exemptions were granted, although none of them were linked to the use or manufacture of fluoropolymers.
In parallel to the PFOA EU restriction, the EU submitted a proposal to add PFOA to the list of the Persistent Organic Pollutants (POPs) of the Stockholm Convention. Following the assessment by the POP Review Committee, the Conference of the Parties (COP) adopted its decision to list PFOA, its salts and PFOA-related substances in Annex A (Elimination) to the Convention in May 2019.13 In the EU, PFOA, its salts and PFOA-related substances were listed as POPs according to Regulation 2019/1021.14 This legislation implements the commitments of the EU under the Stockholm Convention on POPs. In other words, PFOA was moved from REACH Annex XVII: EU restricted substances, to Annex I of the EU POP Regulation: EU POP regulated compounds.
The legal text and exemptions found in the original EU Restriction and the POP listing are, to a large extent, very similar. One exception relates to a higher threshold granted for PTFE micropowders produced by ionising irradiation or by thermal degradation. Both processes may generate trace levels of PFOA and the threshold was consequently increased and set at 0.0001% (1000 ppb) with a review clause scheduled in August 2022. Another major difference is worth discussing as it impacts fluoropolymers manufacturers globally. Whereas the original EU Restriction did not foresee any exemptions related to the use of PFOA as a polymerisation aid, the Stockholm Convention adopted a proposal to allow the use of PFOA as a polymerisation aid for the manufacture of13
Polytetrafluoroethylene (PTFE) and poly(vinylidene fluoride) (PVDF) when used in specific high-performance applications in the field of medical textiles, water and gas (air) filtrations (Figure 1.1).
Fluorinated ethylene–propylene copolymer (FEP) for the production of high-voltage electrical wire and cables for power transmission.
Fluoroelastomers for the production of O-rings, V-belts and plastic accessories for car interiors.
The Stockholm Convention is an international environmental treaty and although the three fluoropolymer exemptions listed above will eventually be removed from the EU POP Regulation, most likely by early 2022, they will remain in other countries with large fluoropolymer producers such as China, India and Russia. Whether or not fluoropolymers manufactured outside the EU will be compliant with the EU POP Regulation will depend on their final PFOA content: below 25 ppb for PFOA and below 1000 ppb for PFOA-related substances.
It should be noted that the major fluoropolymer manufacturers and US EPA PFOA Stewardship Program signatories expressed their opinion on several occasions that these fluoropolymer-specific exemptions were not needed as alternative polymerisation aids had been developed and were available globally.
1.2.3 The C9–C14 PFCAs EU Restriction
Following the adoption of the EU PFOA Restriction, the Competent Authorities (CAs) of Germany and Sweden submitted a proposal15 in 2017 to restrict the manufacture, placing on the market as substances, constituents of other substances and in mixtures and also in articles of all perfluorocarboxylic acids (PFCAs) with chain lengths ranging from 9 to 14 carbons: perfluorononan-1-oic acid (PFNA), nonadecafluorodecanoic acid (PFDA), henicosafluoroundecanoic acid (PFUnDA), tricosafluorododecanoic acid (PFDoDA), pentacosafluorotridecanoic acid (PFTrDA) and heptacosafluorotetradecanoic acid (PFTDA), including their salts and precursors. The maximum allowed concentration in products, mixtures and articles was set at 25 ppb for the sum of C9–C14 PFCAs and their salts and 260 ppb for the sum of C9–C14 PFCA-related substances.
With the exception of PFNA (see Section 1.2.5), none of these PFCAs were manufactured and/or used for any industrial or consumer applications. The reason for including these compounds in the restriction process was to prevent “potential future releases of intentionally used C9–C14 PFCAs, their salts and related substances into the environment”.
Although not produced or used by the fluorotechnology industry, these substances can be formed during the manufacture of certain fluoropolymers and remain at trace levels in the final product. Consequently, the major fluoropolymer producers requested the specific addition of a higher threshold for fluoropolymers that contain perfluoroalkoxy groups: 2000 ppb for the sum of C9–C14 PFCAs. After multiple rounds of discussions both at the level of the EU Commission and at the ECHA, the derogation was adopted and included in the final text as adopted in August 2021,16 with a review clause to assess a potential lower threshold (100 ppb) in August 2024. Several other exemptions were also granted, most of them unrelated to fluoropolymers, with again one exception related to PTFE micropowders: similarly to the PFOA EU POP inclusion, the C9–C14 EU Restriction includes a higher threshold (1000 ppb) for the sum of C9–C14 PFCAs with a review clause scheduled in August 2024.16
1.2.4 Alternatives to PFOA as a Polymerisation Aid
As indicated in Section 1.2.2, by ca. 2015 all US EPA PFOA Stewardship Program signatories were no longer using PFOA for the manufacture of fluoropolymers and had developed alternative polymerisation aids. This extensive research and development programme resulted in the availability of alternative technologies that, however, still mostly relied on the use of fluorinated compounds. Alternatives used in the EU were included in the REACH Substance Evaluation process, also called the Community Rolling Action Plan (CoRAP). This process cannot lead to the banning of a substance (see below), but the inclusion of the PFOA alternatives in the CoRAP process further demonstrates the increased interest of European CAs to assess and potentially regulate all PFASs. It also indirectly paves the way to include fluoropolymers in the regulatory framework by assessing substances required for their manufacture. PFOA alternatives registered under REACH as being used as polymerisation aids in the EU include:
ADONA [ammonium 2,2,3-trifluoro-3-(1,1,2,2,3,3-hexafluoro-3-trifluoromethoxypropoxy)propionate];
HFPO-DA [ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate];
TFEE-5 [2H-tricosafluoro-5,8,11,14-tetrakis(trifluoromethyl)-3,6,9,12,15-pentaoxaoctadecane];
EEA-NH4 {ammonium difluoro[1,1,2,2-tetrafluoro-2-(pentafluoroethoxy)ethoxy]acetate}.
In 2017, Germany included all these compounds in the CoRAP process. The Netherlands joined Germany in HFPO-DA's CoRAP assessment, arguing that this compound was mostly used in a fluoropolymer manufacturing plant located in Dordrecht. The CoRAP process can be initiated by any Member State when, based on the available registration dossier, it believes that the data submitted are insufficient to assess the chemical for any specific endpoint related to its toxicity, bioaccumulation potential, risk management measures, etc. The CoRAP process may eventually lead to further study requirements by the registrant, or to the proposal of other risk management measures such as SVHC inclusion or restriction.
Grounds for CoRAP inclusion for all the aforementioned substances were “suspected PBT/vPvB and exposure to environment”. The first available CoRAP decision concerned HFPO-DA. The ECHA Member State Committee reached its conclusion in December 2018 and requested the registrant to perform additional studies aiming at further assessing the substance's carcinogenicity. It also requested the initiation of a biomonitoring study in volunteering workers at the registrant's manufacturing plant. For the remaining three substances, the final decisions were reached in the course of 2020 and no further studies were requested. However, in all three cases, the same conclusion in terms of risk management measure was reached: “A broad restriction of PFASs will be the most appropriate risk management measure to minimise concentrations of these persistent substances in the environment”.
1.2.5 SVHC Inclusion of Other PFASs
Following the inclusion of PFOA in the Candidate List (SVHC) in 2013, several other PFASs were assessed for SVHC listing. Again, and although not directly impacting fluoropolymers, it shows the increased interest of the EU in assessing and regulating PFASs using all tools available under REACH. As will be discussed below, it can also be viewed as a way to introduce and adopt new regulatory criteria such as mobility and extreme persistency into the EU regulatory framework.
Inclusion of a substance in the Candidate List is linked to three regulatory actions in the EU:
SVHC identification is required before an Authorisation procedure can be initiated by the ECHA, who regularly assesses substances from the Candidate List to determine which ones should be included in the Authorisation List as a priority.
Manufacturers and importers of articles in the EU and European Economic Area (EEA) are required to provide information to allow the safe use of the products to their recipients upon request, when the concentration of any SVHC in the article exceeds 0.1% w/w.
Manufacturers or the importers of articles that contain SVHCs at concentrations above 0.1% and at a quantity of more than 1 tonne per year must submit a notification to the ECHA. Notification of SVHCs in an article must be made within 6 months of their inclusion in the List.
Perfluorononanoic acid (PFNA or C9-acid) was listed in 2015 17 based on Article 57(d):
(…) PFNA and its sodium and ammonium salts are identified as PBT substances according to Art. 57(d) of REACH by comparing all relevant and available information listed in Annex XIII of REACH with the criteria set out in the same Annex, in a weight-of-evidence determination.
PFNA had been historically used as a polymerisation aid to produce certain fluoropolymers; however, at the time of its SVHC inclusion and similarly to PFOA, all fluoropolymer manufacturers and signatories of the US EPA PFOA Stewardship Program had developed alternatives to PFNA and were no longer using this compound in any fluoropolymer manufacturing process.
Germany submitted an SVHC inclusion proposal18 for perfluorohexanoic acid (PFHxA, C6-acid) in August 2018 based on Article 57(f): “Equivalent level of concern having probable serious effects to human health and environment”. The SVHC identification dossier was based on the substance's persistence, mobility and toxicity, which were considered to pose a threat to human health and wildlife when exposed through the environment, including through drinking water. The proposal was extensively discussed by the Member States Committee in December 2018 (MSC-62). Although there was general support to include PFHxA in the Candidate List, some EU Member State representatives were of the opinion that further data were required before being able to conclude unequivocally that an equivalent level of concern as defined in Article 57(f) could be identified. Consequently, Germany decided to withdraw its proposal and PFHxA is not listed in the Candidate List. However, 2 weeks after their decision to withdraw the PFHxA SVHC dossier, the German CAs notified the ECHA of their intention to submit a PFHxA Restriction proposal.19 As will be discussed in more detail below, and at the time of writing, this restriction proposal is still being assessed by the ECHA.
In 2019, the Dutch CAs submitted an SVHC proposal to list HFPO-DA [2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid], its salts and its acyl halides (HFPO-DA), alternative polymerisation aids to PFOA. Similarly to the PFHxA proposal, inclusion was based on the use of Article 57(f): “Equivalent level of concern …”. The main arguments for its inclusion in the Candidate List focused on its persistence and mobility and the assumption that, over time, the substance would accumulate in the environment, leading to irreversible exposure. In June 2019, during MSC-65, the MSC supported the Dutch proposal to identify HFPO-DA, its salts and acyl halides as SVHC “due to their probable serious effects on human health and the environment”. Three Member States abstained during the voting procedure, arguing that the data presented were not sufficient to conclude unequivocally that HFPO-DA met the criteria for SVHC inclusion based on Article 57(f).20
Finally, another PFAS that was assessed for inclusion in the Candidate List was perfluorobutanesulfonic acid (PFBS, C4-sulfonic acid). PFBS was developed as an alternative to PFOS with similar applications in the field of surface protection, mainly for textile products. PFBS is worth mentioning in this section as it was the third PFAS that was included in the SVHC assessment using Article 57(f): “Equivalent level of concern …”. The arguments brought forward by the CAs of Norway were again very similar to three previous PFAS-based SVHC discussions: high persistence leading to irreversible accumulation in the environment combined with the substance's mobility leading to potential contamination of ground and drinking water. The MSC-67 in December 2019 supported Norway's proposal and PFBS was included in the Candidate List in January 2020.
With the exception of PFNA, it is worth noting that the most recent PFAS SVHC inclusion discussions (PFHxA, HFPO-DA and PFBS) all referred to an endpoint that is, as of today, not an accepted and clearly defined criterion under REACH: mobility. The PMT/vPvM concept (Persistent, Mobile, Toxic/very Persistent very Mobile) was first developed by the German Environmental Protection Agency (Umwelt Bundesamt, UBA) in 2009.21 In its proposal, UBA suggested that PMT/vPvM substances, from a risk management perspective, should be considered in a similar way to PBT/vPvB substances. However, the criteria defining mobility are still being discussed at the European level and its use as an “endpoint” for the assessment of chemical substances, more specifically within the SVHC context, has not yet been agreed upon. It is currently being assessed by the EC within the context of the revised REACH Regulation and CLP modification procedure that is currently predicted to be finalised by 2023. It should also be noted that within the aforementioned SVHC discussions, the concept of mobility has often been loosely defined and encompasses both the potential of a chemical substance to leach through soil and contaminate ground water, and also its potential to be transported through water and/or air over long distances. Long-range transport (LRT) is a well-defined POP (Stockholm Convention) criterion; however, it is not defined within the REACH Regulation. An agreed and clear definition of mobility within the EU Regulatory framework and how to use it when assessing chemical substances would certainly be beneficial for all stakeholders involved in developing and assessing chemical substances from a risk management standpoint.
1.3 Current and Future Regulatory Initiatives
1.3.1 The EU PFHxA Restriction
As mentioned in Section 1.2.5, following the withdrawal of PFHxA from the SVHC listing process, in 2019 the German CAs submitted an Annex XVII Restriction proposal to restrict the manufacture and placing on the market of PFHxA, its salts and PFHxA-related substances.19 The PFHxA Restriction proposal is very similar in scope and intention to the EU PFOA Restriction proposal adopted in 2017 (see Section 1.2.2). In both cases, the aim is to restrict both the carboxylic acid and its salts, and also all compounds that could potentially degrade to it. The major purpose of this proposal is to restrict a range of products, the so-called short-chain alternatives, developed by the industry in the wake of the voluntary US EPA PFOA Stewardship Program aimed at replacing the long-chain products that were based on C8 chemistry (PFOA-related). These compounds are all based on the fluorotelomer manufacturing process used to produce fluorinated side-chain polymers and surfactants. The main applications of these products include firefighting foams, surface protection (both water and oil resistance) in the textile and paper industries, metal plating, paints and varnishes. Also, and again in line with the PFOA restriction/POP inclusion, the maximum threshold proposed by the German CAs was set at 25 ppb for PFHxA and its salts and at 1000 ppb for their related substances.
From a fluoropolymer perspective, this restriction proposal has both a direct and an indirect impact. The direct impact relates to the fact that certain classes of fluoropolymers, such as fluoroelastomers, require the use of PFHxA or PFHxA-related substances for their manufacture either as polymerisation aids or as solvents. Again, and similarly to other carboxylic acids, the indirect impact relates to the low thresholds proposed by the dossier submitter as PFHxA and/or related substances may be found at trace levels as by-products or impurities in fluoropolymers due to their manufacturing processes.
Several key industry stakeholders representing various major EU industries such as the automobile, aerospace, electronics and textile sectors have been providing their input during the different consultations linked to both ECHA's Risk Assessment and Socio-Economic Assessment Committees (RAC and SEAC), emphasising the importance of fluoropolymers and other PFASs for key European industry sectors. At the time of writing, the reviewing process is reaching its final stages at the ECHA and its final assessment is expected to be provided to the EC by early 2022. After receiving the two committees' opinions, the Commission will provide a draft amendment to the list of restrictions in Annex XVII to REACH. The final decision will be taken in a comitology procedure with scrutiny involving the Member States and the European Parliament. It is very difficult to estimate how long it will take to adopt the final decision. Overall, one may expect the final adoption of the PFHxA restriction in the course of the second half of 2022 at the earliest. The actual enforcement date will depend on the agreed transition period (18 or 36 months).
1.3.2 The PFAS Restriction Process
On 19 December 2019, during a public session of the Environment Council of the EU,22 the Dutch, Danish, Luxembourgian and Swedish delegations called on the EU to address risks related to PFASs. Furthermore, the Netherlands presented its intention to propose banning all non-essential use of PFASs through a REACH Restriction. This announcement did not come as unexpected, because on 26 June 2019 the Council specifically called on the Commission to develop an action plan to eliminate all “non-essential uses of PFASs”.23 It is likely that the increasing number of publications and communications relating to the persistence and environmental impact of PFASs, such as the Zürich statement, was a key driver in sparking political action.
Since the 2019 announcement, the CAs of the Netherlands, Germany, Sweden, Denmark and Norway combined their efforts and began to gather information and data from all stakeholders to map the consumer and industrial applications, volumes and types of PFASs manufactured, imported and used in the EU. These initiatives included a first Call for Evidence (CfE) in July 2020, followed by a series of questionnaires specific to different applications identified during the CfE, ranging from cosmetics and ski waxes to transportation, medical and medicinal products, lubricants, electronics and several others.
On 15 July 2021, the five CAs officially submitted to the ECHA their Registry of Intention4 (RoI) to restrict the manufacture, placing on the market and use of PFASs. It should be noted that the RoI no longer refers to the essential use concept, as a legal definition of essential use is still lacking and therefore it cannot be used in the context of a REACH Restriction procedure. In parallel to their RoI submission, the five CAs also launched a second CfE aimed at filling the gaps identified during the first CfE and the follow-up questionnaires; at the time of writing, this process is still ongoing.
The current scope of the PFAS restriction as defined in the July 2021 RoI is extremely broad and reads as follows:
PFASs in the scope of this restriction intention have the following structural formula: X–(–CF2–)n–X′ with n equal to or larger than 1 and X, X′ not being H (thus including X–CF3), meaning fluorinated substances that contain at least one aliphatic carbon atom that is both saturated and fully fluorinated, i.e. any chemical with at least one perfluorinated methyl group (–CF3) or at least one perfluorinated methylene group (–CF2–)n–, including branched fluoroalkyl groups and substances containing ether linkages, fluoropolymers and side-chain fluorinated polymers.
This is the first regulatory initiative that clearly and specifically identifies fluoropolymers as being within the scope of a regulatory action. As shown in Section 1.3.3, inclusion in the scope of fluoropolymers will obviously have a strong impact on the fluoropolymer industry itself, but also on many key industries throughout the EU that rely on the use of fluoropolymers for their specific applications. Table 1.1 summarises in chronological order the major legislations (enforced or under assessment) and assesses their impact on fluoropolymers. Included also are important academic contributions and industry-sponsored initiatives aimed at providing solutions to minimise the impact of the use and manufacture of PFAS-based products.
Initiative (legislation, publication, industry initiatives) . | Year . | Jurisdiction . | Impact . |
---|---|---|---|
3M PFOS Phase-out | 2002 | Global | None |
EU PFOS Restriction | 2006 | EU | None |
Inclusion of PFOS in the Stockholm Convention | 2009 | Global | None |
US EPA PFOA Stewardship Program | 2010–2015 | USA/global | High |
Helsingør Statement | 2014 | — | Medium |
Madrid Statement | 2014 | — | Medium |
SVHC listing of PFNA (C9-acid) | 2015 | EU | Low |
EU PFOA Restriction | 2017 | EU | Medium |
Inclusion of PFOA in the Stockholm Convention POP list | 2019 | Global | Medium |
Zürich Statement | 2018 | — | High |
SVHC listing of PFHxA (withdrawn) | 2018 | EU | Low |
Addition of alternative polymerisation aids to PFOA to the EU's Community Rolling Action Plan (CoRAP) list | 2018 | EU | Medium |
SVHC listing of HFPO-DA | 2019 | EU | Low |
SVHC listing of PFBS (C4-sulfonic acid) | 2020 | EU | None |
Chemical Strategy for Sustainability | 2020 | EU | High |
C9–C14 PFCAs Restriction | 2021 | EU | Medium |
An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution (Maine prohibits the sale of any product containing PFASs) | 2021 | Maine (USA) | High |
PlasticsEurope Fluoropolymer Product Group RMOA | 2021 | EU | High |
Restriction of PFHxA under REACH | Pending | EU | Medium |
Restriction of PFASs under REACH | Pending | EU | High |
Initiative (legislation, publication, industry initiatives) . | Year . | Jurisdiction . | Impact . |
---|---|---|---|
3M PFOS Phase-out | 2002 | Global | None |
EU PFOS Restriction | 2006 | EU | None |
Inclusion of PFOS in the Stockholm Convention | 2009 | Global | None |
US EPA PFOA Stewardship Program | 2010–2015 | USA/global | High |
Helsingør Statement | 2014 | — | Medium |
Madrid Statement | 2014 | — | Medium |
SVHC listing of PFNA (C9-acid) | 2015 | EU | Low |
EU PFOA Restriction | 2017 | EU | Medium |
Inclusion of PFOA in the Stockholm Convention POP list | 2019 | Global | Medium |
Zürich Statement | 2018 | — | High |
SVHC listing of PFHxA (withdrawn) | 2018 | EU | Low |
Addition of alternative polymerisation aids to PFOA to the EU's Community Rolling Action Plan (CoRAP) list | 2018 | EU | Medium |
SVHC listing of HFPO-DA | 2019 | EU | Low |
SVHC listing of PFBS (C4-sulfonic acid) | 2020 | EU | None |
Chemical Strategy for Sustainability | 2020 | EU | High |
C9–C14 PFCAs Restriction | 2021 | EU | Medium |
An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution (Maine prohibits the sale of any product containing PFASs) | 2021 | Maine (USA) | High |
PlasticsEurope Fluoropolymer Product Group RMOA | 2021 | EU | High |
Restriction of PFHxA under REACH | Pending | EU | Medium |
Restriction of PFASs under REACH | Pending | EU | High |
1.3.3 PFAS Restriction and Its Impact on Fluoropolymers
The physical and chemical properties of fluoropolymers distinguish them from other PFASs, which makes fluoropolymers an uncomfortable fit in any regulation covering a collection of so many significantly different substances. There is a strong argument for why fluoropolymers should be considered separate from other PFASs for regulatory action. This section explores how the chemical properties of fluoropolymers differentiate them from other PFASs, the critical role that they play in facilitating the EU's ambitious Digital and Green transitions and, on this basis, a suggestion of a more appropriate regulatory approach to ensure that fluoropolymers can be harnessed, responsibly, for the benefit of European society.
PFASs are a very large family of chemical substances. The Master List of PFAS Substances24 of the US EPA identifies 9252 PFASs. Data on PFASs are not always consistent, however, and other institutions such as the OECD25 list 4730 PFASs, which is in line with the number typically used by the ECHA and policymakers in Europe. Although discrepancies can be observed in the numbers, all experts agree that PFASs are counted in the thousands and an individual substance-by-substance regulatory approach is neither feasible nor practical.
It should also be noted that most of these substances have no commercial relevance and are not used in the manufacture of any product or article. A recent paper was aimed at identifying how many of the 4730 PFASs listed in the OECD report are directly connected to commercial products based on input from three major global producers. The results showed that 256, i.e. less than 6%, of the 4730 PFASs are commercially relevant globally.26
Ongoing regulatory intentions in the EU, including the five nations' restriction proposal, are based on a grouping approach. Policymakers in the European Commission, Council and Parliament have also indicated that a grouping approach for regulating PFASs is needed. At the same time, they also recognise the complexity and variety of substances in the group. For example, a 2020 Commission staff working document on PFASs27 noted that “functional groups in PFAS substances can be variable and this variability explains both the large number of PFASs and their different applications”. Similarly, the signatories of the Zürich statement stressed that any approach for addressing PFASs should “given the large number of substances in the PFAS family…address groups of PFASs…and that such a grouping approach needs to be scientifically sound”. Both the EC and the scientists backing the Zürich statement3 point to the fact that there are different groups of substances inside the PFAS family.
Fluoropolymers have well-defined, unique properties that differentiate them from other PFASs. The lasting nature of fluoropolymers ensures safety, reliability and performance in numerous technologies, industrial processes and everyday applications in which we rely on functioning products (Figure 1.1). These physical and chemical properties distinguish fluoropolymers from most other PFASs, which justifies the call to evaluate future regulation appropriate for fluoropolymers separately from a vast, complex and solitary PFAS grouping.
Fluoropolymers are stable, biologically inert, insoluble in water and not mobile. A 2018 paper28 reviewed and assessed toxicity data, human clinical data and physical–chemical–thermal–biological data available for four fluoropolymers: polytetrafluoroethylene (PTFE), fluorinated ethylene–propylene copolymer (FEP), ethylene–tetrafluoroethylene copolymer (ETFE) and tetrafluoroethylene copolymers with perfluoroalkyl vinyl ethers (e.g. perfluoroalkoxy polymer, PFA). These accounted for ca. 70–75% of the world fluoropolymer consumption in 2015.29 This critical review showed that these fluoropolymers satisfy the OECD Polymers of Low Concern (PLC) criteria.30 Furthermore, the major fluoropolymer producers and members of the American Chemistry Council Performance Fluoropolymer Partnership (PFP) and the PlasticsEurope Fluoropolymer Product Group (FPG) are currently combining their efforts to assess 14 additional types of fluoropolymers that will eventually cover ca. 85–90% of available fluoropolymers. At the time of writing, the final results of this assessment are not yet available, but again, all data assessed so far indicate that fluoropolymers included in this second study meet the OECD PLC criteria.
Given the evidence in favour of differentiating fluoropolymers from other PFASs in future regulations, the question of the appropriateness of restricting fluoropolymers under EU REACH begins to arise, particularly as there are other regulatory management options that would allow for their safe and responsible use for societal benefit. On 4 October 2021, the Fluoropolymers Product Group of PlasticsEurope published an independently produced Risk Management Option Analysis (RMOA) on fluoropolymers.31 The RMOA evaluates all the possible Regulatory Management Options (RMOs) that could be introduced to address concerns relating to fluoropolymers. The RMOA authors, Chemservice, analysed four primary RMOs for fluoropolymers, concluding that instead of a “practical ban” via a REACH restriction, fluoropolymers would be best regulated via:
(i)a PFAS Restriction that includes a broad derogation to allow continued manufacture and use of fluoropolymers in the EU linked to a Voluntary Industry Initiative which guarantees that industry will address the situations of concern related to the manufacture and use of fluoropolymers, and
(ii)an update to existing EU regulations on waste that would impact the end-of-life treatment of fluoropolymer products and articles.
The RMOA concluded that a combination of these two regulatory options, as opposed to a full restriction under REACH for all PFASs, is the most appropriate approach to ensure adequate control of risks while maintaining a proportionate balance in terms of the use of necessary fluoropolymers in the European market.
1.4 Conclusion
The transition to a more digital and sustainable society and economy, the “twin transition”, is the pinnacle of the EU's policymaking goals in this decade. Mainly owing to their durability, fluoropolymers are indispensable components for many essential and state-of-the-art technologies that develop smart mobility, clean energy and sustainable industry – all of which are necessary to meet the EU's Green Deal targets. For example, fluoropolymers are used within various components of renewable energy installations, such as hydrogen and photovoltaic panels, and also in wind energy production. From delivering on the EU's Hydrogen Strategy to its Strategic Action Plan for Batteries, fluoropolymers have a key role to play in the transition to an integrated and decarbonised energy system in the EU. If the EU, and indeed the rest of the world, is to advance in its development and the use of renewable energy and circular economy and to deliver on its ambitious goals for a sustainable and digitalised future, fluoropolymers need to be utilised and, as a result, need a bespoke, scientifically evidenced and stable regulatory package.
Since the adoption of REACH in 2007, the EU Chemical Regulation has seen some major developments. One of its most recent adaptations is the development of a grouping approach to regulate entire families of chemicals based on their chemical structures or composition. The so-called “Arrowhead” approach developed by the ECHA, which consists of using a representative substance to regulate an entire group of related chemicals, could be considered as the first attempt to apply a grouping procedure for chemical regulations and risk management assessments. The PFOA, the C9–C14 PFCAs and the PFHxA Restrictions are typical examples of the implementation of the Arrowhead concept: an entire group of substances or “related substances” are included in a single Restriction, therefore bypassing the need to assess each substance individually. The grouping of all PFASs as currently defined in the scope of the PFAS Restriction proposal goes beyond ECHA's Arrowhead approach as it groups hundreds to thousands of substances displaying many significantly different physicochemical characteristics (high and low molecular weight, polymers, surfactants, liquids, gases, solids) into a single group of chemical compounds. Fluoropolymers would be categorised as PFASs based on the restriction's scope and definition; however, they are distinctly different from other PFASs and these fundamental differences need to be taken into account when assessing them for regulatory purposes.
The PFAS Restriction proposal recently initiated by five European CAs and extensively discussed in this chapter is probably one of the most ambitious recent regulatory initiatives and its impact on many critical and recently initiated key EU projects such as the Green Deal, Circular Economy and climate neutrality targets is still largely underestimated by the EU regulators. As stated above, many of these ambitious projects rely on technologies that require the use of fluoropolymers: increasing the production of “clean energy”; making products more durable and therefore producing less waste in the construction and other sectors; developing less energy-consuming and more performant electronic products; increasing communication efficiency; producing durable and safe medical devices; increasing the availability of safe protective equipment for workers, firefighters and law enforcement personnel; and lowering emissions in transportation sectors. All these are critical applications that need to be considered carefully when assessing such a wide group of chemicals for regulatory purposes.
The five European CAs have introduced, during 2020 and 2021, several initiatives to gather more information relative to the applications, the volumes used and the development of potential alternatives to PFASs. Based on the information provided during these “Call for Evidence” procedures, regulators have demonstrated that they are still developing a complete and thorough understanding of how and where fluoropolymers and other PFASs are used for many of the critical applications listed above.
Given all the current political pressure pushing for the rapid restriction of PFASs under REACH, we hope that the regulatory bodies involved in the process will take a balanced approach in assessing fluoropolymers properly within the context of this ambitious regulatory proposal. Grouping all PFASs into a single restriction process may ease and accelerate the overall legislative process; however, the risk of adopting and enforcing a regulation that will, in the long term, deprive the EU economy of critical products such as fluoropolymers should not be underestimated.
The case of fluoropolymers is a textbook example of a group of chemical substances requiring conscientious regulation because of their chemical properties and their crucial role in society both today and in the future.
List of Acronyms
- AFFF
Aqueous film-forming foam
- BCF
Bioaccumulation concentration factor
- CA
Competent Authority
- CBI
Confidential business information
- CfE
Call for Evidence
- CLH
Harmonised Classification and Labelling
- CLP
Classification, Labelling and Packaging
- CMR
Carcinogenic–mutagenic–reprotoxic
- COP
Conference of the Parties
- CoRAP
Community Rolling Action Plan
- CSS
Chemical Sustainable Strategy
- EC
European Commission
- ECHA
European Chemical Agency
- EEA
European Economic Area
- ETFE
Ethylene–tetrafluoroethylene
- FEP
Fluorinated ethylene–propylene
- LRT
Long-range transport
- MSC
Member States Committee
- OECD
Organisation for Economic Cooperation and Development
- PBT
Persistent–bioaccumulative–toxic
- PFA
Perfluoroalkoxy polymer
- PFAS
Per- and polyfluoroalkyl substance
- PFBS
Perfluorobutanesulfonic acid
- PFCA
Perfluorocarboxylic acid
- PFDA
Nonadecafluorodecanoic acid
- PFDoDA
Tricosafluorododecanoic acid
- PFHxA
Perfluorohexanoic acid
- PFNA
Perfluorononanoic acid
- PFOA
Perfluorooctanoic acid
- PFOS
Perfluorooctanesulfonic acid
- PFTrDA
Pentacosafluorotridecanoic acid
- PFTDA
Heptacosafluorotetradecanoic acid
- PFUnDA
Henicosafluoroundecanoic acid
- PLC
Polymer of Low Concern
- PMT
Persistent, Mobile, Toxic
- POP
Persistent Organic Pollutant
- PTFE
Polytetrafluoroethylene
- PVDF
Poly(vinylidene fluoride)
- RAC
Risk Assessment Committee
- REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
- RMOA
Risk Management Option Analysis
- RoI
Registry of Intention
- SEAC
Socio-Economic Assessment Committee
- SNUR
Significant New Use Rule
- SVHC
Substance of Very High Concern
- US EPA
United States Environmental Protection Agency
- vPvB
very Persistent, very Bioaccumulative
- vPvM
very Persistent, very Mobile