Apr 25, 2023
Comment on Proposed Restriction of PFAS
Conference of Fluoro-Chemical Product Japan (FCJ)

On behalf of chemical manufacturers, we, Conference of Fluoro-Chemical Product Japan(FCJ), have been working tirelessly to comply with national chemical regulations. We havesupported EU's ambitious attempts to reduce risks from hazardous substances and havesincerely responded to actual measures to meet the requirements of EU chemical regulations
such as REACH.
However, we believe that the proposed restriction of PFAS (Per- and Polyfluoroalkyl
substances) proposed by 5 European countries is an excessive measure because it restricts
more than 10,000 of organofluorine compounds (PFAS) on the grouping basis that they are
persistent as substances of concern equivalent to the already regulated PFOS and PFOA.
Therefore, we intend to present the following views at the public consultation of ECHA, towhich is one of the actions FCJ recommends.

（１）Concerns about inconsistencies in the proposed restriction

Article 68 (1) REACH refers to the scope of the restrictions, which regulates
unacceptable risks to human health or the environment that need to be addressed bysociety as a whole.
The proposed restriction lists persistent chemicals (which may remain in the environment
longer than any other man-made chemical), bioconcentration, mobility, the possibility oflong-distance transport, accumulation in plants, the possibility of global warming, andtoxicological effects as concerns and reasons for the restriction. Of these, persistent isapplicable to all targeted organofluorine compounds (PFAS), but other concerns are related
to some compounds.
Persistency common to all organofluorine compounds (PFAS) can be rephrased as "highdurability" by focusing on its advantages, however, we believe that it is not appropriate toregulate this property alone as an unacceptable risk to human health or the environment. In
addition, it is not appropriate to apply the concerns about some fluorinated compounds,
such as bioconcentration potential and toxicological effects, by grouping all organofluorinecompounds (PFAS) together, and if the need for new regulations is to be considered in the
future, the risk of each substance should be quantitatively assessed and discussed.
Hereafter, we respectfully submit our views on the proposed Restriction of PFAS andexpress its concerns that restriction would contravene the applicable European andinternational rules and agreements for the following reasons:
1. The proposed Restriction would hinder the achievement of the European Green Deal
PFASs have properties such as repelling water and oil, being resistant to heat, chemicals,
and not absorbing light, and have been widely used in water repellents, surface treatment
agents, emulsifiers, fire extinguishers, coatings, etc., and in a wide range of industrial
applications such as semiconductors, automobiles, and batteries. Many of these applications
and uses are considered "essential uses".
The applications in which PFAS are used are also critical for the European Green Deal – thatis comprehensive initiative that includes a range of policies in different areas aiming at make
Europe climate-neutral by 2050. For example, the Horizon Europe program funds researchand innovation activities in transportation, including batteries, clean hydrogen, low-carbon
steel manufacturing, the cyclical bio-based sector and the built environment. We therefore
believe that the proposed blanket Restriction of all PFAS for all uses, including uses that are
critical to the European Green Deal, would essentially hamper the achievement of European
Green Deal objectives.
2.

The proposed Restriction would significantly and disproportionately hamper

international trade
If the proposed Restriction is implemented as currently announced, trade in essential goods
in which PFAS are used would be considerably restricted and supply chains around the world
would be severely disrupted.
In our view, even if alternative substances are currently being developed, these would needto go through repeated demonstrations and evaluations and therefore they would takeconsiderable time before they can be implemented. Moreover, for substances for which noalternatives have been identified yet, research and development will have to be promoted
through trial and error in the future, and even a 12 year grace period may not be sufficient toconfirm their availability.

The serious and disproportionate negative effects of the proposed Restriction on international
trade could also constitute a violation of the proportionality principle as enshrined in Article
68(1) REACH. In particular:
The proposed Restriction is disproportionate, contrary to Article 68 (1) REACH.
Article 68(1) REACH requires that any restriction decision shall take into account "the socioeconomic impact of the restriction, including the availability of alternatives". That socioeconomic impact may, among others, include, in accordance with Annex XV, i) the impact of
the restriction on the industry (e.g. manufacturers and importers) and on all other actors inthe supply chain in terms of commercial consequences, including impact on investment,
operating costs and innovation; ii) the wider implications on trade, competition and economic
development; iii) alternative risk management measurements that could meet the aim of the
proposed restriction and iv) the availability of suitable and feasible alternatives.
The proposed Restriction does not appropriately consider those elements of the socioeconomic impact and fails to balance the negative impact on international trade and theIndustry with the potential benefits of the proposed measure. It rather proposes a blanket
restriction of all PFAS substances for all uses (beyond some transitional periods for specificuses/applications) that goes well beyond what is necessary to achieve the legitimate
objectives it pursues, and is not the least onerous measure to control the potential risks posedby certain PFAS.
In particular, the Proposed Restriction fails to conduct a substantial assessment of the"availability of alternatives" including: i) where alternatives have been identified, these must
be compared as to their risks and benefits to the substances proposed to be restricted andii) where alternatives are not yet available, the risks of the continued use of the substances
proposed to be restricted should be compared with the socio-economic consequences ofthem no longer being available and of the lack of available alternatives.
In light of the above, we request that the EU limits the scope of the restriction to the extent
necessary to achieve the objectives that contribute to the social economy of the EU. In thatregard, we also request that if the restriction remains as it is, that the EU considers a "review
clause" that would enable the extension of the transitional periods in case suitable
alternatives have not been developed by the given review date.
3. The proposed Restriction restricts all PFAS as a single group
In following this grouping approach, the proposed PFAS Restriction would restrict PFAS thathave not been risk-assessed and for which an unacceptable risk has not been demonstrated,in breach of Article 68(1) REACH.

Article 68(1) REACH provides that substance(s) can be restricted only if they pose anunacceptable risk to human health or the environment. This unacceptable risk must be
positively demonstrated by conducting a risk assessment that follows the conditions of Annex
XV to REACH (and by cross-reference of Annex I and Annex XIII). Such risk assessment
comprises hazard identification and characterisation, exposure assessment and risk
characterisation.
By grouping all various PFAS substances together and restricting them as a single class, theproposed PFAS Restriction Proposal would restrict numerous PFAS substances that havenot been risk-assessed and for which no unacceptable risk has been demonstrated, in
breach of Article 68(1) REACH.
More specifically, the scope of the proposed PFAS Restriction is based on the OECD
definition of PFAS. That definition is only based on chemical structure and does not take into
account hazardous properties or risks of PFAS, as the proposed Restriction itself
acknowledges (p. 19). As a result, it covers approximately 10,000 substances with very
diverse physical, chemical and biological properties and behaviour. That broad definition
does not take into account the specific, distinct properties of different individual PFAS or
PFAS subgroups and is therefore not suitable for regulatory risk management purposes.
OECD itself acknowledges that this definition "does not conclude that all PFASs have thesame properties uses, exposures and risks" and that it can only serve a starting andreference point as it "may be viewed as too broad" (OECD, 2021, Reconciling Terminologyof the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical
Guidance).
In particular, the very broad scope of proposed Restriction –which is based on the OECDPFAS definition- does not enable a legally and scientifically sound risk assessment. By
grouping all PFAS together in a single group for risk assessment, the proposed Restriction
fails to identify and consider the specific, distinct properties of each individual PFAS or PFAS
subgroup and, in turn, to assess and characterise the hazards and risks related to those
properties in order to demonstrate that they pose an unacceptable risk to human health or
the environment.
It rather restricts all PFAS substances on the assumption that they all share a very persistent
property as their "key hazardous property" that ”triggers equivalent hazards and risks”(p.2122). However, (very) persistence is not per se a hazardous property nor does it indicate arisk on its own. Persistence on its own is also not sufficient to consider PFAS as giving an"equivalent level of concern" to PBTs/vPvBs or to characterise an "unacceptable risk" within
the meaning of Article 68(1) REACH and justify a restriction. It is for those reasons thatpersistence is only regulated in combination with other properties in the REACH and CLPRegulation (e.g. together with bioaccumulation, toxicity or -under the new hazard classes
introduced to the CLP Regulation- mobility), and not alone.
Beyond PFAS’ purported very persistent property, the proposed Restriction does not identify
any other hazardous properties that are common to all PFAS. It only refers to some additional
properties that amplify the “overall concern” for some -not all- PFAS. Indeed, the Proposal
contains evidence that concerns only certain sub-sets of PFAS (mostly some long-chain
PFAS) and lacks data on other PFAS substances/subgroups and an adequate justification
as to why the conclusions for certain PFAS would be applicable to all PFAS covered by the
proposed Restriction (read-across).
For example, the proposed Restriction acknowledges that “for the majority of PFAS no, or
insufficient, data on bioaccumulation behaviour are available” and therefore that the “data on
the bioaccumulation potential of PFAS [..] are not sufficient to substantiate bioaccumulationin the environment for all PFAS” (p.28). With respect to ecotoxicity, it mentions that “the large
number of different substances with heterogenous properties […] in the group of PFAS
makes the assessment of their ecotoxicity very complex”(p.28). It then concludes that thebioaccumulation potential and (eco)toxicity is expected to vary among PFAS due to their“high diversity” and that “no overall conclusion on B/Vb and T criteria was derived for each
PFAS substance/ (sub-) group” (p. 47).
In the absence of (sufficient) evidence, the proposed Restriction fails to conduct a risk
assessment, comprising a hazard assessment and characterisation, exposure assessment
and risk characterisation, to demonstrate an unacceptable risk posed by all PFAS
substances proposed to be restricted. For example, in some applications, PFAS may be usedin enclosed spaces, where exposure to the environment is extremely limited and the risk tohuman health and environmental conservation is even less. It is also possible that by not
characterising the specific risk(s) each individual PFAS/PFAS subgroup poses that the
proposed Restriction would lead to the replacement of those PFAS with non-PFAS
alternatives that could be potentially more harmful to human health and the environment(regrettable substitution).
Even if certain PFAS would be demonstrated to pose an "unacceptable risk to human healthor the environment" within the meaning of Article 68(1) REACH, this cannot lead to theconclusion that all PFAS pose such an unacceptable risk, without considering their varying
properties and behavior.
4. The proposed Restriction could not be lawfully based on the precautionary principle

Article 68(1) REACH requires positive demonstration that there "is" an unacceptable risk. It
is therefore not intended as a tool to address scientific uncertainties, as it is the case with the
precautionary principle. Therefore, the proposed Restriction that is largely based on scientificuncertainties (e.g. "lack of toxicological data for the vast majority of [PFAS]"(p.32); " formost PFASs there are insufficient data to adequately assess their effects on human healthand the environment" (p.13); "for the majority of PFASs no, or insufficient, data on
bioaccumulation behaviour are available" (p. 28)) would not meet the requirement of Article
68(1) REACH to demonstrate an unacceptable risk.
In the alternative, even if the proposed Restriction applies the precautionary principle(although it makes no mention of it), it must had nevertheless met the conditions of EU caselaw, as summarised in the Commission Communication on the precautionary principle, which
it failed to do.
In particular:
According to settled EU case law (e.g. T-584/13), the precautionary principle is “a generalprinciple of EU law requiring the authorities […] to take appropriate measures to prevent
specific potential risks to public health, safety and the environment […]”. It should be used
where “there is scientific uncertainty as to existence or extent of risks to human health or theenvironment […].” While the risk assessment in the context of the precautionary principle is“not required to provide […] conclusive scientific evidence of the reality of the risk and theseriousness of the potential adverse effects were that risk to become a reality”, “a preventive
measure cannot properly be based on a purely hypothetical approach to the risk, founded onmere conjecture which has not been scientifically verified” (our emphasis).
However, the proposed Restriction lacks evidence of effects, and especially, of effects thatare adverse. Indeed, as the Proposal itself acknowledges “for most PFAS there areinsufficient data to adequately assess their effects on human health and the environment” (p.
13) and that “if releases are not minimised, humans and other organisms will be exposed toprogressively increasing amounts of PFASs until such levels are reached where effects arelikely” (p. 50). In the same vein, the Proposal also mentions that “[i]t is more likely that for
the vast majority of these substances, no study data are available to serve as a basis forclassification. In the absence of evidence to the contrary, it can therefore be assumed thatsome of the less well-studied PFAAs and PFAA precursors also exhibit one or more of theproperties of concern.”(p.30).
Moreover, the persistence and accumulation of PFAS in the environment that the proposed
Restriction mainly relies on, cannot be construed as adverse effects per se.The Proposal istherefore based merely on unsubstantiated assumptions.

In addition, the proposed Restriction fails to meet the following conditions for the
implementation of the precautionary principle set out in the Commission Communicationon the Precautionary Principle (Communication from the Commission on the precautionary
principle. Brussels, 2.2.2000 COM(2000) 1 final).
-

Before the adoption of a precautionary measure, there must be first a scientific risk

assessment, comprising four steps, namely hazard identification, hazard characterisation,
appraisal of exposure and risk characterisation. In our opinion one could demonstrate thatthese four steps have not been followed in the PFAS Restriction Proposal. The alleged
hazards of the PFAS have not been established and, likewise, there is little on the actual
exposure to PFAS. These elements have rather been postulated on unsubstantiatedassumptions. In the absence of reliable information on hazard and exposure, there is nobasis on which to characterise the risk, and therefore to conduct the required scientific risk
assessment for the application of the precautionary principle.
-

The precautionary measure must be proportionate, non-discriminatory andconsistent with similar measures, based on examination of the potential benefits and costs.
In our opinion, the proposed PFAS restriction could be demonstrated to be disproportionate
and not the least restrictive measure that can be taken to address any PFAS-related
concerns because i) it restricts the entire class of PFAS for all applications on the basis of
mainly a “persistency concern”; ii) it does not sufficiently assess the risk and suitability ofallegedly available alternatives, and iii) it does not (adequately) assess the socio-economic
impact of such broad restriction against the alleged “significant benefits” of the restriction.
-

The Proposal must identify the measures that need to be taken in order to clarify

the uncertainties that could justify precautionary measures. In particular, “measures basedon the precautionary principle should be subject to […] to review in the light of new scientificdata.” In that respect, the Proposal does not propose measures that could be taken to resolve
the uncertainties it identifies – it rather proposes a total, blanket ban of all PFAS for all
applications (beyond some transitional periods for some applications).
5.

The proposed Restriction would restrict substances without listing them contrary to

Article 68(1) REACH
Article 68(1) provides that substances that pose an unacceptable risk to human health or theenvironment could be the subject of a restriction. Article 68(1) restriction should therefore
identify the substances proposed to be restricted. Annex XV, Section 3 of REACH also
specifies that the restriction "shall include the identity of the substance […]". Such identify
should be chemical specific, including name, identification numbers, molecular and structuralformulas, etc. Indeed, REACH defines a "substance" as "a chemical element and its
compounds" (Article 3(1) REACH). This is also clearly reflected in the European Chemicals
Agency (ECHA) Guidance for the preparation of an Annex XV dossier (p. 108) that specifies
that the restriction proposal must provide "details on the identity of the substance (name,
CAS, EC number, registration number (if available), molecular formula, structural formula,purity and impurities)".
In light of the above, the proposed Restriction fails to adequately identify and list the specificchemical substances proposed to be restricted. Instead, it prohibits the manufacturing, useor placing on the market of any substance "that contains at least one fully fluorinated methyl(CF3-) or methylene (-CF2-) carbon atom, without any H/Cl/Br/I attached to it" (p.4). It does
not provide the names or identification numbers of the specific substances that are coveredby this broad definition, as required.

（２）Exclusion by PFAS Sub-category(substance)
As mentioned in (1), a class of compounds (PFAS sub-category) having widely different
properties, such as fluoropolymers and fluorinated gases, are all grouped as PFAS andsubject to restrictions. On page 16 of the report, citing the OECD report, PFAS are subcategorised into 4 major categories and 30 middle categories. B.3 Classification andlabeling and B.4 Environmental fate properties in the Annex B report and are evaluatedbased on these sub-categories, respectively, and we believe that risk can be more
appropriately assessed by sub-categorising rather than grouping as PFAS.
For example, fluoropolymers are thermally, biologically, and chemically stable, barely
soluble in water, immobile, insoluble (Water, Octanol, etc.), and too large to migrate to cell
membranes, so they are not incorporated into the body and are considered low concern
from a human and environmental health perspective1,2. The findings demonstrate thatfluoropolymers are a distinct group from PFOA and PFOS and should not be combined withthem for hazard assessment or regulatory purposes. Fluoropolymers are the only materials
that simultaneously possess heat resistance, weather resistance, chemical resistance,water repellency, lubricity, and unique optical/electrical properties, and they have become
indispensable materials in many fields, including the energy field (Fuel cells and lithium-ion
batteries), semiconductor field (Clean members, etching gas), electrical and electronic
communications field (Wire cladding and liquid crystal materials), transportation field (Cars,
airplanes, railroads, marine), and medical field (Catheters, protective clothing). It isnecessary to carefully re-examine whether the uniform regulations for PFAS areappropriate in light of the chemical hazards and risks of the substances in question. Inparticular, fluoropolymers should be excluded from the current regulations because they
are highly stable materials and have no concerns about bioconcentration or toxicologicaleffects.
Fluorinated gas is a highly safe compound in terms of toxicity and combustibility, and it isused in many applications in terms of efficiency and cost. In addition, fluorinated gas itself
is not persistent in the persistent properties proposed in the PFAS restriction proposal. In
addition, trifluoroacetic acid, which is a degradable product of fluorinated gas itself and is aconcern in the proposed restriction, has also been shown to pose a low risk of toxicity toliving organisms and human bodies in the reports of the Environment Agency of Germany
and Norway, who actually submitted this restriction proposal3,4. These results indicate thatfluorinated gas should not be considered for regulation as a group with PFOA and PFOS.
In addition, the reduction of fluorinated gas usage is being considered in the F-gas
regulations, and from the standpoint of dual regulations, we do not believe that it should beconsidered in the PFAS regulations.
Reference:
1: Barbara H et al., Integrated Environmental Assessment and Management, Vol14(3),p316–334.
https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4035
2: Stephen K et al, Integrated Environmental Assessment and Management, Vol19(2),p326–354
https://setac.onlinelibrary.wiley.com/doi/10.1002/ieam.4646
3: German Environment Agency, Reducing chemical input into water bodies –
trifluoroacetate (TFA) as a persistent and mobile substance from many sources, 2021
4: Norwegian Environment Agency, Study on environmental and health effects of HFO
refrigerants, 2017