May 31st, 2023

Features and Applications of Fluororesin as
Insulation Material for Wires and Cables
1. Seven features of fluororesin as an insulation material for wires and cables
The following features are derived from the unique properties of fluorine, theelement, which is "the biggest electronegative (Pauling scale of 4.0)" and"the second smallest atom after hydrogen (Van der Waals radius: H is 1.2 Å,
F is 1.4 Å)". These features cannot be obtained with elements other than
fluorine or its compounds.
1) Wide temperature range of usez

It is the only material capable of operating in environments above
250°C.

It is the only material that can maintain elasticity in extremely cold
environments below -100°C.
2) Extremely high weather resistance, chemical resistance, oil resistance,z

and flame resistance
It is a material with extremely minimal insulation performancedegradation under exposure to ultraviolet rays and ionizing radiation.
z It is a material with minimal mechanical degradation against corrosive
gases, acids/alkalis, organic solvents, various oils, etc.
zz

It has a high oxygen index of 95% or more, making it difficult to
combust.

3) Combines low friction, wear resistance, tensile strength, flexural modulus
and elongation not found in other materialsz

There is no material other than fluororesin, including alternative
proposals such as silicone materials, polyether ether ketone (PEEK),
mica, EPDM, polyvinyl chloride, polyethylene, ceramic-based materials,
and one confidential polymer, that combines high tensile strength,
bending modulus, and elongation as a coating material.

z

It possesses both water repellency, low friction, wear resistance, andnon-adhesiveness, which are not found in alternative materials

(silicone materials, PEEK, mica, EPDM, polyvinyl chloride, polyethylene,
ceramic-based materials, and one confidential polymer).
z Fluororesin with these characteristics is essential for high-life movablewires.
4) Extremely high dielectric strength, and the lowest dielectric constant anddielectric loss tangent among all polymersz

It has a higher volume resistivity (1018 ƻācm or more) compared toalternative materials (silicone materials, PEEK, mica, EPDM, polyvinyl
chloride, polyethylene, ceramic-based materials, and one confidential
polymer).

It has the lowest dielectric constant (2.1) and dielectric loss tangent(2×10-4) among all polymers, making it an ideal material for highspeed transmission.
5) Low refractive index and transparency not found in other materialsz

It is a material that combines low refractive index and transparency.
6) Thin-wall formability not found in other materialsz

It excels in thin-wall formability due to its high elongation.
7) Unique hybrid properties not found in other materialszzFluororesin is the only material that simultaneously possesses theexcellent features listed in 1) to 6) above.

2. Applications required fluororesin
The following are applications required fluororesin with these excellent
features:
1) Internal wiring
Wiring for equipment with high-temperature environments (e.g.,
power supply and semiconductor units such as CPUs, etc.)
z Internal wiring for devices requiring high-density wiring (e.g.,aerospace equipment, smartphones, and other information terminals,
etc.)
z

z

Internal wiring for devices requiring high-speed data transmission(e.g., high-speed data transmission devices, data servers, etc.)

2) External Wiringz Wiring for high-temperature environments (e.g., around furnaces,internal combustion engines, motor lead, etc.)

z
z
z
z

z
z

z
z

Wiring for extremely cold environments (e.g., freezers,
superconductor transmission paths, etc.)
Wiring requiring heat resistance, oil resistance, and flame resistance(e.g., automobiles, trains, ships, heavy machinery, etc.)
Wiring requiring both oil resistance and high flexibility (e.g., machine
tools, industrial robots, elevators, etc.)
Wiring requiring chemical resistance (e.g., medical equipment,
semiconductor manufacturing, leads for sensors/measuring
instruments, etc.)
Wiring that needs to be exposed to radiation (e.g., nuclear facilities,
medical equipment, etc.)
Wiring required for high-speed transmission (e.g., 5G signaltransmission lines, interconnections between communicationequipment, interconnections between measuring equipment, etc.)
High-density wiring through thin-wall extruding (e.g., aerospaceequipment, thin-diameter leads for medical devices, etc.)
Wiring requiring low refractive index and transparency (e.g., plastic
optical fibers used for high-speed data transmission under electricalnoise)

Wires using fluororesin are the only wires that meet the requirements
for all of these applications.
In these applications, if insulation breakdown of the wire occurs, it may
be impossible to replace or difficult to replace, and recovery may bechallenging. Alternatively, the data that stops to be transmitted at thattime may be important and extensive, and the impact of a failure isimmeasurable. Wires using fluororesin are used in applications where
the priority is given to risk rather than cost.
In contrast, in the PFAS regulation proposal, Table E.128 lists
silicone materials, polyether ether ketone (PEEK), mica, EPDM, polyvinyl
chloride, polyethylene, ceramic-based materials, and one confidential
polymer as alternatives for wire insulation instead of fluororesin.
However, these alternative materials do not cover the characteristics 1)to 7) of fluororesin as an insulation material for wires and cables, andthey are not suitable alternatives considering the anticipated risks.

In order to achieve the objectives contributing to the socio-economic
aspects of the EU, we request that the restrictions be limited to thenecessary scope. In this regard, if the restrictions on fluororesin are to
be maintained as they are, we request that the EU consider the "review
clause" that allows for an extension of the transition period if noappropriate alternatives are provided by the given review deadline.
3. Reasons why over 10,000 types of per- and organofluorine substances(PFAS) should not be regulated collectively
Regarding the reasons why over 10,000 types of per- and organofluorine
substances (PFAS) should not be regulated collectively, we provide our
opinion as follows and mentioned in Section III.
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 thatneed to be addressed by society as a whole.
The proposed restriction lists persistent chemicals (which may remainin the environment longer than any other man-made chemical),bioconcentration, mobility, the possibility of long-distance transport,
accumulation in plants, the possibility of global warming, andtoxicological effects as concerns and reasons for the restriction. Of
these, persistent is applicable to all targeted organofluorinecompounds (PFAS), but other concerns are related to somecompounds.
Persistency common to all organofluorine compounds (PFAS) can berephrased as "high durability" by focusing on its advantages, however,
we believe that it is not appropriate to regulate 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 fluorinatedcompounds, such as bioconcentration potential and toxicologicaleffects, 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 anddiscussed.
Hereafter, we respectfully submit our views on the proposed
Restriction of PFAS and express its concerns that restriction would

contravene the applicable European and international rules andagreements for the following reasons:2) The proposed Restriction restricts all PFAS as a single group
In following this grouping approach, the proposed PFAS Restriction
would restrict PFAS that have 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 an unacceptable 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 themas a single class, the proposed PFAS Restriction Proposal would restrict
numerous PFAS substances that have not been risk-assessed and forwhich no unacceptable risk has been demonstrated, in breach of
Article 68(1) REACH.
More specifically, the scope of the proposed PFAS Restriction is basedon 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 biologicalproperties 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 the same properties uses, exposures and risks" andthat it can only serve a starting and reference point as it "may beviewed as too broad" (OECD, 2021, Reconciling Terminology of the
Universe of Per- and Polyfluoroalkyl Substances: Recommendations
and Practical Guidance).
In particular, the very broad scope of proposed Restriction –which isbased on the OECD PFAS definition- does not enable a legally andscientifically sound risk assessment. By grouping all PFAS together in asingle 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 thehazards and risks related to those properties in order to demonstratethat they pose an unacceptable risk to human health or theenvironment.
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.21-22). 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 tocharacterise an "unacceptable risk" within the meaning of Article 68(1)REACH and justify a restriction. It is for those reasons that persistence
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 Regulationmobility), and not alone.
Beyond PFAS’ purported very persistent property, the proposed
Restriction does not identify any other hazardous properties that arecommon to all PFAS. It only refers to some additional properties that
amplify the “overall concern” for some -not all- PFAS. Indeed, theProposal 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 theconclusions for certain PFAS would be applicable to all PFAS coveredby 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 substantiatebioaccumulation in 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 the bioaccumulation 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 andcharacterisation, exposure assessment and risk characterisation, todemonstrate an unacceptable risk posed by all PFAS substances
proposed to be restricted. For example, in some applications, PFAS
may be used in enclosed spaces, where exposure to the environmentis extremely limited and the risk to human 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 tohuman health and the environment (regrettable substitution).
Even if certain PFAS would be demonstrated to pose an "unacceptablerisk to human health or the environment" within the meaning of Article
68(1) REACH, this cannot lead to the conclusion that all PFAS posesuch an unacceptable risk, without considering their varying properties
and behavior.
3) The proposed Restriction could not be lawfully based on the
precautionary principle
Article 68(1) REACH requires positive demonstration that there "is" anunacceptable risk. It is therefore not intended as a tool to addressscientific uncertainties, as it is the case with the precautionary
principle. Therefore, the proposed Restriction that is largely based on
scientific uncertainties (e.g. "lack of toxicological data for the vast
majority of [PFAS]"(p.32); " for most PFASs there are insufficient data
to adequately assess their effects on human health and theenvironment" (p.13); "for the majority of PFASs no, or insufficient,data on bioaccumulation behaviour are available" (p. 28)) would notmeet the requirement of Article 68(1) REACH to demonstrate anunacceptable 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 case law, 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 general principle of EU law requiring the authorities […]to take appropriate measures to prevent specific potential risks topublic 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 the environment […].” While the risk assessmentin 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 areality”, “a preventive measure cannot properly be based on a purely
hypothetical approach to the risk, founded onmere conjecture which has not been scientifically verified” (ouremphasis).
However, the proposed Restriction lacks evidence of effects, andespecially, of effects that are adverse. Indeed, as the Proposal itself
acknowledges “for most PFAS there are insufficient 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 to progressively increasing amounts of PFASs until
such levels are reached where effects are likely” (p. 50). In the samevein, the Proposal also mentions that “[i]t is more likely that for thevast majority of these substances, no study data are available to serve
as a basis for classification. In the absence of evidence to thecontrary, it can therefore be assumed that some of the less wellstudied PFAAs and PFAA precursors also exhibit one or more of theproperties of concern.”(p.30).
Moreover, the persistence and accumulation of PFAS in theenvironment that the proposed Restriction mainly relies on, cannot be
construed as adverse effects per se.The Proposal is therefore 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 Communication on the Precautionary Principle(Communication from the Commission on the precautionary principle.
Brussels, 2.2.2000 COM (2000) 1 final).
z 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 that these four steps have not been followed in the
PFAS Restriction Proposal. The alleged hazards of the PFAS havenot been established and, likewise, there is little on the actual
exposure to PFAS. These elements have rather been postulated on
unsubstantiated assumptions. In the absence of reliable
information on hazard and exposure, there is no basis on which tocharacterise the risk, and therefore to conduct the requiredscientific risk assessment for the application of the precautionaryz

principle.
The precautionary measure must be proportionate, nondiscriminatory and consistent with similar measures, based on
examination of the potential benefits and costs.
In our opinion, the proposed PFAS restriction could bedemonstrated 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 of allegedly available
alternatives, and iii) it does not (adequately) assess the socioeconomic impact of such broad restriction against the alleged“significant benefits” of the restriction.

z

The Proposal must identify the measures that need to be taken inorder to clarify the uncertainties that could justify precautionary
measures. In particular, “measures based on the precautionary
principle should be subject to […] to review in the light of newscientific data.” 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).

4) The proposed Restriction would restrict substances without listingthem contrary to Article 68(1) REACH
Article 68(1) provides that substances that pose an unacceptable risk
to human health or the environment 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 thesubstance […]". 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 theEuropean 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 specific chemical substances proposed to be
restricted. Instead, it prohibits the manufacturing, use or 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 covered bythis broad definition, as required.
5) Exclusion by PFAS Sub-category(substance)
As mentioned in (1), a class of compounds (PFAS sub-category)having widely different properties, such as fluoropolymers andfluorinated gases, are all grouped as PFAS and subject to restrictions.
On page 16 of the report, citing the OECD report, PFAS aresubcategorized into 4 major categories and 30 middle categories. B.3
Classification and labeling and B.4 Environmental fate properties in the
Annex B report and are evaluated based 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, andchemically 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 that fluoropolymers are a distinct group from PFOA andPFOS and should not be combined with them 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/electricalproperties, 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 andelectronic communications field (Wire cladding and liquid crystal
materials), transportation field (Cars, airplanes, railroads), andmedical field (Catheters, protective clothing). It is necessary tocarefully re-examine whether the uniform regulations for PFAS areappropriate in light of the chemical hazards and risks of thesubstances in question. In particular, fluoropolymers should be
excluded from the current regulations because they are highly stablematerials and have no concerns about bioconcentration or toxicologicaleffects.
Fluorinated gas is a highly safe compound in terms of toxicity andcombustibility, and it is used in many applications in terms ofefficiency and cost. In addition, fluorinated gas itself is not persistentin the persistent properties proposed in the PFAS restriction proposal.
In addition, trifluoroacetic acid, which is a degradable product offluorinated gas itself and is a concern in the proposed restriction, hasalso been shown to pose a low risk of toxicity to living organisms andhuman bodies in the reports of the Environment Agency of Germany
and Norway, who actually submitted this restriction proposal3,4. These
results indicate that fluorinated gas should not be considered forregulation as a group with PFOA and PFOS.
In addition, the reduction of fluorinated gas usage is being consideredin the F-gas regulations, and from the standpoint of dual regulations,
we do not believe that it should be considered in the PFAS regulations.
Reference:
1: Barbara H et al., Integrated Environmental Assessment andManagement, Vol14(3),p316–334.
https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4035
2: Stephen K et al, Integrated Environmental Assessment andManagement, 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 manysources, 2021
4: Norwegian Environment Agency, Study on environmental and healtheffects of HFO
refrigerants, 2017