Document Z4Vooxg7mMR4Mv7GxeJ8oL3VJ
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
P
r
(FCJ), have been working tirelessly to comply with n
regulations. We have supported EU's ambitious attempts to reduce ri
f
r
o
m
h
a
z
a
sincerely responded to actual measures to meet the requirements of E
c
h
such as REACH.
However, we believe that the proposed restriction of PFAS
P
o
substances) proposed by 5 European countries is an excessive mea
b
e
c
a
u
m o r e t h a n 1 0 , 0 0 0 o f o r g a n o fl u o r i n e c o m p o u n d s ( P F A S ) o n t h e g r
basis that they are persistent as substances of concern equivalent to the
already regulated PFOS and PFOA.
Therefore, we intend to present the following vi
c
o
n
s
u
l
which 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 regulates unacceptable risks to human health or the environment that need to b addressed by society 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 of long-distance transport, accumulation in plants, the possibility of global warming, and toxicological eff ects as concerns and reasons for the restriction. Of these, persistent is applicable to all targeted organofl uorine compounds (PFAS), but other concerns are related to some compounds. Persistency common to all organofl uorine compounds (PFAS) can be rephrased 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 fl uorinated compounds, such as bioconcentration potential and toxicological eff ects, by grouping all organofl uorine 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 and
express its concerns that restriction would contravene th European and international rules and agreements for the following reasons:
1. The proposed Restriction would hinder the achievement of the European Green Deal
P FA S s h a v e p ro p ert ies s u ch a s rep el lin g w at er a n d o il, b ein g re s is t an t t o
h
e
a
t
and not absorbing light, and have been widely used in water repellents
s
u
r
f
a g e n t s , e m u l s i fi e r s , fi r e e x t i n g u i s h e r s , c o a t i n g s , e t c . , a n d i n a w i d e r a n g e
o
f
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
G
r
e
e
n
i s c o m p r e h e n s i v e i n i t i a t i v e t h a t i n c l u d e s a r a n g e o f p o l i c i e s i n d i ff
areas aiming at make Europe climate-neutral by 2050. For example, th
H
o
r
i
z
o
n
E
u
and innovation activities in transportation, incl
h
y
d
r
steel manufacturing, the cyclical bio-
e
n
v
i
r
o
believe th at th e p ro posed b la nket Rest riction of all P FA S
including uses that are critical to the European
essentially hamper the achievement of European Green Deal objectives.
2. The proposed Restriction would signifi cantly and disproportionately hamper
international trade
If the proposed Restriction is implemented as currently announced, trade in
e
s
s
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,
t
h
e
s
e
to go through repeated demonstrations and evaluations and therefore they
would take considerable time before they can be implemented. Moreover,
for substances for which no alternatives have been identifi ed yet, research
and development will have to be promoted through trial and error in the
f u t u r e , a n d e v e n a 1 2 y e a r g r a c e p e r i o d m a y n o t b e s u ffi c i e n t t o c o n fi r m
their availability.
The serious and disproportionate negative e
Restriction on international trade could also constitute a violation of th
p
r
o
p
o
r
t
i
o
n
a
l
i
t
68(1) REACH. In particular:
The proposed Restriction is disproportionate, contrary to Art
REACH.
Article 68(1) REACH requires that any restriction decision shall take int
a
c
c
o
economic impact of the restriction, i
a
l
t
e
economic impact may, among others, include, in accordance with Anne
X
V
,
i
)
the restriction on the industry (e.g. manufacturers and importers) and on
a
l
l
o
t
h
the supply chain in terms of commercial consequences, including impact on
investment, operating costs and innovation; ii) the wider implications on
trade, competition and economic developm
management measurements that could meet the aim of th
restriction and iv) the availability of suitable and feasible alternatives.
The proposed Restriction does not appropriately consider those elements of
t
h
economic impact and fails to balance the negative impact on international
t
r
a
I n d u s t r y w i t h t h e p o t e n t i a l b e n e fi t s o f t h e p r o p o s e d m e a s u r e . I
p ro p o ses a b la n ket res tr ic t ion of a ll P FA S su b s ta n c es f o r al l u s es ( b ey on d
s o m e t r a n s i t i o n a l p e r i o d s f o r s p e c i fi c u s e s / a p p l i c a t i o n s ) t
beyond
what
is
necessary
objectives it pursues, and is not the least onerous measure to control the
p
o
t
e
by certain PFAS.
In particular, the Proposed Restriction fails to co
assessment of the "availability of alternati
a
l
t
e
r
n
a
t
i
v
e
s
h
a
v
be compared as to their risks and benefi ts to the substances proposed to be
r
e
s
ii) where alternatives are not yet available, the risks of the continued use
of the substances proposed to be restricted should be compared with the
s
o
c
i
o
-
e
them no longer being available and of the lack of available alternatives.
In light of the above, we request that the EU limits the scop
restriction to the extent necessary to achieve the objectives that contribute
to the social economy of the EU. In that regard, we also request that if the restriction remains as it is, that the EU considers a "review clause" tha would enable the extension of the transitional periods in case alternatives have not been developed by the given review date.
3. The proposed Restriction restricts all PFAS as a single group
In f ollowing this grou pin g ap proach , t he p ropos ed P FAS
restrict PFAS that have not been
u
n
a
c
c
e
p
t
a
b
l
e
in breach of Article 68(1) REACH.
Restriction
risk-a
r
i
would
sses
s
k
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
u
n
a
c
c
e
p
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 iden
c
h
a
r
a
c
t
e
r
i
s
a
characterisation.
By grouping all various PFAS substances together and restricting them as a
si n g le c la ss , t h e p rop o sed P FA S Res tr ic ti on
n
u
m
e
r
o
u
s
P
F
not been risk-assessed and for which no unacceptable
d
e
breach of Article 68(1) REACH.
M o r e s p e c i fi c a l l y , t h e s c o p e o f t h e p r o p o s e d P FA S R e s t r i c t i o n i s b a s e d o n
t
h
d e fi n i t i o n o f P FA S . T h a t d e fi n i t i o n i s o n l y b a s e d o n c h e m i c a l s t r u c t u re a n d
does not take into account hazardous properties or risks of PFAS, as the
p
r
o
p
o
s
acknowledges (p. 19). As a result, it covers
s
u
b
s
t
diverse physical, chemical and biological properties and behaviour.
b
r
o
d o e s n o t t a k e i n t o a c c o u n t t h e s p e c i fi c , d i s t i n c t p r o p e r t i e s o f
i
n
d
i
v
PFA S su bg roup s a nd is th erefore no t suit
m
a
n
a
O E C D i t s e l f a c k n o w l e d g e s t h a t t h i s d e fi n i t i o n " d o e s n o t c o n c l u d e t h a t a l l
P
F
A
S
s
same properties uses, exposures and risks" and that it can only serve a
s
t
a
reference point as it "may be viewed as too broa
R
e
o f t h e U n i v e r s e o f P e r - a n d P o l y fl u o r o a l k y l S u b s t a n c e s : R e c o m m e n d a t i o n s
and Practical Guidance).
In particular, the very broad scope of proposed Restriction -which is based
o
n
t
h
P F A S d e fi n i t i o n - d o e s n o t e n a b l e a l e g a l l y a n d s c i e n t i fi c a l l y
a
s
s
grou ping all P FAS togeth er in a sing le grou p for risk asse
p
r
f a i l s t o i d e n t i f y a n d c o n s i d e r t h e s p e c i fi c , d i s t i n c t p r o
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
r
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.21- 22). However, (very) persistence is not
per
se
a
hazardous
prope
risk on its own. Persistence on its own is also not suffi cient to consider PFAS
as giving an "equivalent level of concern" to PBTs/vPvBs or to characterise
a
n
"
u
n
a
c
the meaning of Article 68(1) REACH and justify a restriction. It is for those
reasons that persistence is only regulated in combin
properties in the REACH and CLP Regulat
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
d
o
e
s
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 onl
certain
sub-sets
of
PFAS) and lacks data on other PFAS substances/subgroups and an adequate
j
u
as to why th e con clu sions for certain P FAS wou ld be app lica ble to a ll PFA S
covered by the proposed Restriction (read-across).
For example, the proposed Restriction acknowledges that "for the majority
o f P F A S n o , o r i n s u ffi c i e n t , d a t a o n b i o a c c u m u
available" and therefore that the "data on the bioaccumulation potential of
P FA S
[..]
are
not
s u ffi
cient
to
in the environment for all PFAS" (p.28). With respect to ecot
mentions that "the large number of diff erent substances with heterogenous
p
r
o
p
e
r
t
i
e
s
[
...
]
makes the assessment of their ecotoxicity very complex"(p.28).
concludes that the bioaccumulation potential and (eco)toxicity is expected
t
o
v
a
r
y
a
m
o
n
g
"high diversity" and that "no overall conclusion on B/Vb and T criteria was
d
e
r
i
v
PFAS substance/ (sub-) group" (p. 47).
I n t h e a b s e n c e o f ( s u ffi c i e n t ) e v i d e n c e , t h e p r o p o s e d R e s t r i c t i o n f a i l
c
o
n
d
u
assessment, comprising a hazard assessm
e
x
p
o
and risk characterisation, to demonstrate an unacceptable risk posed by all
P
F
substances proposed to be restricted. For example, in some applications,
P
F
A
S
m
in enclosed spaces, where exposure to the environment is extremely limited
and the risk to human health and environmental conservation is even less.
I t i s a l s o p o s s i b l e t h a t b y n o t c h a r a c t e r i s i n g t h e s p e c i fi c
i
n
d
i
v
i
d
u
a
l
P
F
A
S
/
proposed Restriction would lead to the replacement of those PFAS with non-
P
F
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
t
o
h
or the environment" within the meaning of Article 68(1) REACH, this cannot
lead to the conclusion that all PFAS pose such an
without considering their varying properties and behavior.
u unacce
4. The proposed Restriction could not be
p
r
e
c
Article 68(1) REACH requires positive demonstration that th
u
n
a
c
c
is therefore not intended as a tool to address scientifi c uncertainties, as it
is the case with the precautionary principle. Therefor
R e s t r i c t i o n t h a t i s l a r g e l y b a s e d o n s c i e n t i fi c u n c e r t a i n t i e s ( e . g . " l a c
toxicological data for the vast majority
most PFASs there are insuffi cient data to adequately assess their eff ects on
h
u
m
and the environment" (p. 13); "for the majori ty of PFASs no, or insuffi cient,
data on bioaccumulation behaviour are available" (p. 28)) would not meet
t
h
e
r
e
q
68(1) REACH to demonstrate an unacceptable risk.
In the alternative, even if the propose
p
r
e
c
(although it makes no mention of it), it must had nevertheless met
c
o
n
d
i
t
i
law, as summarised in the Commissi
p
r
e
c
a
u
it failed to do.
In particular:
According to settled EU case law (e.g. T-584/13),
principle is "a general principle of EU law requiring the authorities [...] to
t
a
k
e
a
p
p
r
o
p
specifi c potential risks to public health, safety and the environment [...]". It
s
h
o
u
l
w h e r e " t h e r e i s s c i e n t i fi c u n c e r t a i n t y a s t o e x i s t e n c e o r e x t e n t o f r i s k s t o
human health or the environment [...]." While the risk assessment in the
c
o
n
t
e
x
t
o
f
t
h
e
"not required to provide [...] conclusive scientifi c evidence of the reality of
the risk and the seriousness of the potential adverse eff ects were that risk
to become a reality", "a preventive measure cannot properly be based on a
purely
hypothetical
appro
mere conjecture which has not been scientifi cally verifi ed" (our emphasis).
However, the proposed Restriction lacks
e
s
p
e
c
i
a
are ad verse. In deed , as t he Propo sal itself acknowled ges "for m ost PFA
t
h
e
i n s u ffi c i e n t d a t a t o a d e q u a t e l y a s s e s s t h e i r e ff e c t s o n h u m a n h e a l t h a n d
the environment" (p. 13) and that "if releases are not minimised, humans
and other organisms will be exposed to progressively increasing amounts
of
P FA S s
until
such
levels
are
re
likely" (p. 50). In the same vein, the Proposal also mentions that "[i]t is
m
o
r
e
l
i
the vast majority of these substances, no study data are available to serve
a s a b a s i s f o r c l a s s i fi c a t i o n . I n t h e a b s e n c e o f e v i d e n c e t o t h e c o n t r a r y , i t
c
a
n
t
h
e
r
e
f
some of the less well-studied PFA As and PFA A precursors also exhibit one
or more of the properties of concern."(p.30).
Moreover, the persistence and accumulation of PFAS in the environm
that the proposed Restriction mainly relies on, cannot be const
a d v e r s e e ff e c t s p e r s e . T h e P r o p o s a l i s t h e r e
unsubstantiated assumptions.
In addition, the proposed Restriction fails to meet the following conditions
f
o
r
implementation of the precautionary principle set out in the Commission
C
o
on the Precautionary Principle (Communication from the Commission on the
precautionary principle. Brussels, 2.2.2000 COM(2000) 1 fi nal).
- Before the adoption of a precautionary measure, there must be fi rst
a
s
c
i
a s s e s s m e n t , c o m p r i s i n g f o u r s t e p s , n a m e l y h a z a r d i d e n t i fi c a t i o n , h
characterisation, appraisal of exposure and risk characterisation
o
p
i
n
i
o
n
o
n
e
these four steps have not been followed in the PFAS Restriction Proposal.
T
h
e
hazards of the PFAS have not been established and, likewise, there is little
o
n
t
h
exposure to PFAS. These elements have rather b
u
n
assumptions. In the absence of reliable inform
e
x
p
o
s
u
r
basis on which to characterise the risk, and therefore to c
required scientifi c risk assessment for the application of the precautionary
principle.
-
The precautionary measure must be proportionate, non-discriminatory
a
n
consistent with similar measures, based on examination of the potent
b
e
n
e
fi
In o ur op in io n, the p rop osed PFA S rest rict io n could b e d em onstr ated to be
d
i
and not the least restrictive measure that can be taken to address
P
F
concern s b eca use i) it restr ict s t he entire class of P FAS for all a pp licat io ns
o
n
t
h
e
m a i n l y a " p e r s i s t e n c y c o n c e r n " ; i i ) i t d o e s n o t s u ffi c i e n t l y a s s e s s t h e r i s k
and suitability of allegedly available alternatives, and
(
a
d
e
q
u
a
t
e
l
i m p a c t o f s u c h b r o a d r e s t r i c t i o n a g a i n s t t h e a l l e g e d " s i g n i fi c a n t b e n e fi t s "
of the restriction.
-
The Proposal must identify the measures that need to be taken in
o
r
d
e
r
the uncertainties that could justify precautionary measures. In particular,
"
m
e
a
on the precautionary principle should be subject to [...] to review in th
light of new scientifi c data." In that respect, the Proposal does not propose
m
e
a
s
u
r
e
s
t
h
a
t
c
o
the uncertainties it identifi es - it rather proposes a total, blanket ban of all
P FA S fo r a ll a p p li ca t ion s ( b eyo n d s om e tr a n sit io n a l
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 the environment could be the subject of a restri
Article 68(1) restriction should therefore identify the substances proposed
to
be
restricted.
Annex
XV,
s p e c i fi e s t h a t t h e r e s t r i c t i o n " s h a l l i n c l u d e t h e i d e n t i t y o f t h e s u b s t a n
[...]". Such identify should be chemical
i
d
e
n
t
i
fi
c
a
t
i
o
n
formulas, etc. Indeed, REACH defi nes a "substance" as "a chemical element
a
n
d
c o m p o u n d s " ( A r t i c l e 3 ( 1 ) R E A C H ) . T h i s i s a l s o c l e a r l y r e fl
European Chemicals Agency (ECHA) Guidance for the preparation
A
n
n
e
x
X
V
d
o
s
s
i
e
r
that the restriction proposal must provide "details on the identity of th
s
u
b
s
CAS, EC number, registration number (if available), molecul
structural formula, purity and impurities)".
In light of the above, the proposed Restriction fails to adequately identify
a n d l i s t t h e s p e c i fi c c h e m i c a l s u b s t a n c e s p r o p o s e d
I
n
s
t
e
a
d
,
i
t
p
r
o
or placing on the market of any substance "that contains at least one fully
fl uorinated methyl (CF3-) or methylene (-CF2-) carbon atom, without any H/
C
l
/
B
r
/
I
a
t
t
a
c
h
not provide the names or identifi cation numbers of the specifi c substances
t
h
a
t
by this broad defi nition, as required.
2 Exclusion by PFAS Sub-category(substance)
As mentioned in (1), a class of compounds (PFAS sub-category) having widely diff erent properties, such as fl uoropolymers and fl uorinated gases,
are all grouped as PFAS and subject to restrictions. On page 16 of the report, citing the OECD report, PFAS are sub- categorised into 4 major categories and 30 mid Classifi cation 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, fl uoropolymers 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 fi ndings
demonstrate that fl uoropolymers are a distinct group from PFOA and PFOS 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/electrical properties, and they have become indispensable materials in many fi elds, including the energy fi eld (Fuel cells and lithium-ion batteries), semiconductor fi eld (Clean members, etching gas), electrical and electronic communications fi eld (Wire cladding and liquid crystal materials), transportation fi eld (Cars, airplanes, railroads, marine), and medical fi eld (Catheters, protective clothing). It is necessary to carefully re-examine whether the uniform regulations for PFAS are appropriate in light of the chemical hazards and risks of the substances in question. In particular, fl uoropolymers should be excluded from the current regulations because they are highly stable materials and have no concerns about bioconcentration or toxicological
eff ects. Fluorinated gas is a highly safe compound in terms of
combustibility, and it is u s e d i n m a n y a p p l i c a t i o n s i n t e r m s o f e ffi c i e n c y a n d c o s t . I n fl uorinated gas itself is not persistent in the persistent properties proposed in the PFAS restriction proposal. In addition, trifl uoroacetic acid, which is a degradable product of fl uorinated gas itself and is a concern in the proposed restriction, has also been shown to pose a low risk of toxicity to living 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 that fl uorinated gas should not be considered for regulation as a group with PFOA and PFOS. In addition, the reduction of fl uorinated gas usage is being considered in 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 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 - trifl uoroacetate (TFA) as a persistent and mobile substance from many sources, 2021 4: Norwegian Environment Agency, Study on environmental and health eff ects of HFO Refrigerants,2017