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A critical ftev/iew of the Appli
Conceien,Regul
Crite
Fluoroplastic g
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Fluoropolymers:
A distinct class of per- and poly-fluoroalkyl substances (PFAS) - high molecular weight polymers with fluorine (F) attached to their car only backbone.
F
F
F
F
F
F
a
FF
F
F
FF
Polytetrafluoroethylene (PTFE)
PFAS: A universe of substances with widely diverse properties includes FPs as "DISTINCT" class. However, PFAS lacks a single, globally harmonized definition.
USEPA: at least two adjacent carbon atoms, where one carbon is fully fluorinated and the other is at least partially fluorinated
;' Roe . -- B
FR"
OECD: PFAS is a fluorinated substance that contains in its structure at least one fully fluorinated methyl or methylene carbon atom (without any H/CI/Br/| atom attached to it)
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In-depth assessment of commercially available fluoropolymers against the 13 internationally recognized OECD polymer of low concern (PLC) criteria
Commercial Fluoropolymer Estimated Consumption -- 2021 1000's MT
67 r=
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0.0
FE
Ew 00
copteoo
&
wt = of
oN & o F
oF a
on
64% of FPs sold globally (projected)
32% of FPs sold globally (projected)
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public affairs
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yd PLASTICS
fon
In 2018,Henry et al. demonstrated that four major fluoropolymers meet the polymers of low concern criteria.
The new study presents data for 14 additional fluoropolymers. The two studies represent approximately 96 % of the global commercial fluoropolymer
market.
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Why use Polymers of
Low Concern
(PLC) criteria
for our
assessment
and where do
the PLC come
from?
1993 2009 2015
Polymers of Low Concern (PLC) criteria have been discussed and elaborated globally for decades to ensure international consistency.
The PLC criteria were created to facilitate polymer hazard assessment that identifies low risk polymers that in turn assists in prioritizing regulatory activity on high-risk
substances.
OECD: Consensus on these criteria and their respective
metrics, documenting the data required for a polymetro
qualify as a PLC.
OECD: PLC have "insignificant environmental health and human health impacts".
Several member countries agreed on the polymer properties predictive of adverse human health and environmental hazard. The report outlined eligibility criteria for a polymer to be considered a PLC (BIO by Deloitte).
2966873
In-depth assessment of commercially available fluoropolymers against the 13 internationally recognized OECD polymer of low concern (PLC) criteria
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Polymer composition
oO
4
/\
%oo
i
oligomer
- af
+--
Electrical charge
nnd
~F
Reactive Functional
Groups (RFG)
Functional
Group Equivalent Weight (FGEW)
Low MW leachables
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Water / lipid solubility,
octanol water
partition
Tf
Particle size
'
Polymer stability
AY
Thermal
stability
Y
IAS Bh
Abiotic stability
Biotic
stability
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Studied FPs and PLC
criteria (for the polymers in use)
All 14 studied FPs fulfill the PLC criteria.
Stability and lack of solubility indicates that FPs are relatively inert.
Polymer composition = All FPs fulfil the criterion of polymer composition (either fluorine (F) and/or chlorine (Cl) must be covalently bound to the carbon-only polymer backbone)
Molecular Weight (MW and Molecular Weight Distribution (MWD) = FPs are high MW solid polymers with narrow MWD-> Not bioavailable with low hazard potential
wt% oligomer = low (or even negligible) wt% oligomer = Not bioavailable with low hazard potential
Electrical charge = Absence of cationic character = Low hazard potential
Reactive functional groups => do not contain RFG set forth in the PLC criteria =>
Demonstrates absence of reactivity
Functional Group Equivalent Weight (FGEW) > Due to the lack of functional groups
the term "equivalent weight" is not applicable.
<1 ppm Low MW leachables = No active leachables or negligible
expected to significantly contribute to landfill leachate
= Not be
Water solubility and octanol/water partition coefficient = practic: water and n-octanol. = No potential for bioavailability or biog
ly insoluble in both
ation. Lack of
Polymer stability (thermal, biotic, abiotic) = All studied FPs met the F
criteria for
hydrolysis, light stability, oxidative stability and aerobic and anaerobic biodegradability
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Persistence, Bioavailability and Toxicity of the studied fluoropolymers
FPs are: v' Solid v' Stable v Durable
,
.
,
.
Ce
Persistent--> Persistence is not considered an intrinsic hazard
and does not justify risk management measures (REACH)
v" Not expected to degrade
under environmental conditions or normal use/pProcessing g conditions
v' Thermally, chemically and biologically inert
Under REACH persistence is combined with bioaccumulation and toxicity (vPvB/vPVvM )
|
FPs: v Persistent x Bioaccumulative x Mobile x Toxic
x NOT a Substance of
Very High Concern (SVHC) from a regulatory perspective
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Persistence, Bioavailabilit and Toxicity of the studie fluoropolymers
Bioavailability FPs cannot be absorbed through a cell membrane via passive or active transport and
do not bind or interact with the cell surface.
Fluoropolymers are neither bioavailable nor bio-
accumulative.
Toxicity
Toxicity studies on FPs are difficult to conduct due to lack of solubility and their high MW. In Annex VII of REACH guidance is stated that toxicity is unlikely to occur "if a substance is highly insoluble in water or the substance is unlikely to cross biological membranes."
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Outcome of the In-Use PLC Fluoropolymer Study
96% of the global commercially assessed fluoropolymers meet or exceed the "polymers of
low concern" criteria.
They have been shown to be chemically and biologically stable, nonbio accumulative, non-
bioavailable and non-toxic
during their intended use phase.
A
The study demonstrates the insignificant risk fluoropolymers have on human
health or the environment
during the intended use phase, according to internationally recognized criteria.
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The studied FPs contain low levels
of impurities, are thermally, biologically and chemically stable, negligibly soluble in water, non-mobile, nonbioavailable, non-bio-
accumulative and non-toxic.
Segmentation that clearly
differentiates the broad PFAS
family according to their properties is needed for a scientifically sound, risk-based regulatory approach.
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~~ sist)
f
ay
Grouping of all PFAS is not supported by the scientific data. FPs possess distinct physical, chemical and biological properties and fluoropolymer class is well defined. Therefore, FPs should not be grouped with other PFAS for hazard assessment or regulatory
purposes.
Fluoropolymers should be derogated from the PFAS REACH
restriction.
A broad derogation for fluoropolymers supplemented by a Voluntary Industry Initiative during the manufacturing and an update of existing EU regulations on waste will guarantee that industry address stakeholders' concerns during the fluoropolymer life cycle.
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Annexes 1. PLC definition and criteria 2. Fluoropolymers studied 3. FPG responsible
manufacturing principles
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PLC criteria explained
Polymer composition
ov
wt% oligomer
Polymer composition (must have C, H, Si, S,E, Cl Br,or covalently bound to carbon)
Molecular Weight Distribution (MWD)
Mw+ number average Mn (Mn
and heterogeneity of MW
distribution indicate if most
oligomers > 1,000 Da and not bioavailable)
wit% oligomer (<5% for <1000 Da oligomers, <2% for <500 Da oligomers; lower hazard potential)
-
+---
Electrical
charge
snd
Reactive Functional
Groups (RFG)
ASTICS
JROPE
lonic Character (net cationic or polycationic polymers are lower hazard potential)
Enabling a sustainable future
FWSPolymers Fodust Soup
Reactive
Functional Groups (RFGs)
|
Functional
Group Equivalent Weight (FGEW)
~
i
Low MW leachables
Functional Group Equivalent Weight (FGEW)
Polymers with <1% MW <1000 Da and low water extractability are not able to cause systemic effects which are toxicologically or ecotoxicologically relevant."
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PLC criteria explained
\'
4 Water / lipid
Selig
waler
partition
According to the Stockholm Convention, a
bioconcentration factor of >5000 and a
log Kow >5 is used as a criterion for
bioaccumulation.
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4
E2
Particle size
Median mass aerodynamic diameter, MMAD, should be > Sum
Polymer stability
Stability is resistance to physical, chemical, or biological transformation.
Thermal
stability
PLASTICS
EUROPE
[EReToIT: J a sustainable future Fluoropolymers Product Group
Thermal stability
"n'4
A
Abiotic
stability
Abiotic degradation may involve sunlight, water,
or oxygen.
)'
Biotic stability
Polymer degradation by microorganisms under oxygenated (aerobic) or anoxic (anaerobic)
conditions
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Fluoropolymers in the study: Chemical names and key properties
+ Fluoropolymers demonstrate extraordinary combined set of property. It is this combination of properties which is governing the use of fluoropolymers.
+ Fluoropolymers are an important driver of the European Green Deal and UN Sustainability Development Goals, supporting smart mobility, clean energy and sustainable industry.
Fluoroplastics PVDF homopolymer PVDF copolymer ECTFE copolymer ECTFE terpolymer
PCTFE
FEVE
EFEP terpolymer
CPT terpolymer THV terpolymer
Fluoroelastomers FEPM FKM FFKM
Specialty Fluoroplastics Amorphous
lonomer
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Overview of the studied FPs and key properties
Fluoroplastics
(0) PVDF homopolymer
and copolymer
-- Cl
ECTFE copolymer and terpolymer
PCTFE
FEVE
EFEPerpolterpol ymer
CPT terpolymer
THV terpolymer
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2) E88 a--
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nosing a
"elrore
rare
Specialty Fluoroplastics
Amorphous
lonomer
I (eNGn A ( o 0
Fluoroelastomers
FEPM WW (&)
wD
AL
Mechanical
strength
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Low moisture
absorption
3z
Heat resistance
Thermal
stability
S
ck x ransparency vi.
Radiation resistance
lonic
conductivity
Ld
Chemical
resistance
&
-
Weather resistance
o1bo
0oBoo 15 o
Low
permeability
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PLAST ICS
ea
THE FLUOROPOLYMER PRODUCTS GROUP COMMITS TO RESPONSIBLE MANUFACTURING PRINCIPLES
FPG'S PRINCIPLES
Fis
(
BESTAVAILABLE
TECHNIQUES
Continue to maintain, improve and/or develop Best Available Techniques in the manufacturing processes and management of environmental
emissions related to fluoropolymers.
The
industry, rep
by the F
Fluoropolymer Products Group, is committed to develop and
implement innovative solutions to minimize the environmental footprint i
to
ion and to reduce their potential
emissions, based on the Best Available Techniques (BATs).
The fluoropolymer industry has adopted and will continue. to develop new technologies and to invest in R&D to reach
this goal. Therefore, the Fluoropolymer Products Group member companies commit voluntarily to the following
[CELLO EERETTE T Tl Ty TeEEN
PE
CONTAINMENT, CAPTURE & RECYCLE TECHNOLOGIES
Maintain and continuously improve and develop
containment, capture, and recycle technologies to minimize
into the
from PFAS
intentionally and non-intentionally occurring during i
including raw materials, fluorosurfactants, monomers, solvents,
intermediates, and process chemicals as well as
by-products.
a
SAFE SUBSTITUTION OF PFAS-BASED POLYMERIZATION AIDS
Intensify our efforts to investigate and develop R&D
programs for the advancement of technologies for the
of PFAS-based
ion.
Where proven
aids during
i
feasible, environmentally sound, and viable at an industrial
and commercial scale, FPG commits to replace the use of
PFAS as polymerization aids.
>
ENHANCED RECYGLABILITY AND REUSABILITY
Continue to proactively work with its downstream users to increase recyclability and reuse of its products and develop R&D programs in line with the objectives of a circular economy.
--
FF ENSURE WORKERS MINIMAL [ = Q EXPOSURE TO CHEMICALS
Continue to minimize the exposure levels for workers to chemicals used in the fluoropolymers manufacturing process.
--
a
i
TN
MONITOR COMMITMENTS THROUGH THIRD-PARTY ASSESSMENT SYSTEMS
Introduce or expand already existing third-party assessment programs to help verify progress in members' commitments.
i
these Each member company takes actions to
principles. In addition, the F
poly
Products Group
aim to
progress on these actions by reporting on their achievements. As a first step, the
Fluoropolymer Products Group is currently working on a review of wastewater related
monitoring activities. The objective is the identification of best practices and possibly
recommendations for procedural changes.
7
OPEN AND TRANSPARENT
DIALOGUE WITH KEY
STAKEHOLDERS
Continue to engage in an open and poli
dialogue with
Sployees, NGOs
stakeholders.
and
other
key
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