Elements for an EU-strategy for PFASs
DECEMBER 2019

 Elements for an EU-strategy for PFASs
December 2019

SUMMARY - WHY ACTION IS NEEDED NOW! .................................................................................................. 3
ELEMENTS FOR AN EU-STRATEGY FOR PFASS ............................................................. 4
WHY DO WE NEED TO ACT? ............................................................................................................................. 4
PFASs will remain in the environment for ages ................................................................................................. 5
PFASs cause harm ........................................................................................................................................... 5
Regulatory challenges ......................................................................................................................................... 6
Cost of inaction ................................................................................................................................................. 7
THE WAY FORWARD........................................................................................................................................... 7
ACTIONS .............................................................................................................................................................. 9
ANNEX I EXAMPLES OF ACTIONS ................................................................................... 10
Regulatory actions to minimise the production, import and use of PFASs ........................................................10
REACH ...................................................................................................................................................................... 10
Registration .......................................................................................................................................................... 10
Authorisation ....................................................................................................................................................... 11
Restriction ............................................................................................................................................................ 11
Regulations on food contact materials (FCMs) .................................................................................................. 11
Cosmetics regulation ................................................................................................................................................ 12
Regulations on plant protection and biocidal products .................................................................................... 13
POPs Regulation (Stockholm Convention) and other international fora ..................................................... 13

Regulatory actions to minimise exposure to PFASs in the workplace and from the environment. ......................13
Regulation of contaminants in food. .................................................................................................................... 13
Water Framework Directive (WFD) ..................................................................................................................... 14
Industrial Emissions Directive (IED)................................................................................................................... 14
Waste legislation and management........................................................................................................................ 15
Remediation of contaminated natural resources ................................................................................................ 16

Research, monitoring and information activities ................................................................................................17
Awareness raising ...................................................................................................................................................... 17
Research on alternatives .......................................................................................................................................... 17
Research on the fate and transport of PFASs in the waste stage .................................................................... 17
Monitoring – environment and humans .............................................................................................................. 18

ANNEX II ON-GOING AND COMPLETED ACTIVITIES AS OF 7 JUNE 2019 ............... 19

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December 2019

Summary - why action is needed now!
PFASs are a large family of thousands of man-made chemicals that are widely used
throughout society. They are an increasing concern as they are resistant to
degradation in the environment, very mobile, toxic and can bioaccumulate. They are
also found everywhere in the environment.
They have been observed to contaminate water and soil in most EU countries and it
is extremely costly to clean up such contamination. Without taking action now, their
concentrations will continue to increase, and their toxic and polluting effects will be
difficult to reverse.
Actions taken so far have not sufficiently addressed the concerns. This is why we
urgently need a coherent and coordinated EU strategy to address PFASs through
regulatory and non-regulatory actions. The goal is to minimise environmental and
human exposure to PFASs, at all stages of their life cycle.
To achieve this:
(i)
(ii)
(iii)
(iv)
(v)

PFASs need to be managed as a group.
PFASs need to be phased out and only essential uses allowed until
alternatives are available.
Limit values need to be set in different pieces of legislation.
Steps to ensure effective enforcement are needed.
Environmental monitoring, awareness raising, research on
alternatives, remediation and environmentally sound management
of waste are also needed.

The REACH Regulation is key for addressing concerns associated with the use of
PFASs in the EU, but legal measures under other EU legislations as well as actions
on a global level will substantially contribute to the goal of the strategy.
In line with the timeframe of the UN Global Goals for Sustainable Development, we
propose that actions on the EU level to phase out PFASs should be taken at the
latest by 2025, to be in effect by 2030.

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December 2019

Elements for an EU-strategy for PFASs
Why do we need to act?
PFASs (short for per- and polyfluoroalkyl substances) constitute a group of
thousands man-made chemicals that are widely used in various technical applications
in society due to their unique physical and chemical properties. Since they are
chemically and thermally stable as well as repellent to water and oil, they are used in
products such as water- and stain repellent textiles, fire-fighting foams, food contact
materials (FCMs) and cosmetics. PFASs can give rise to environmental
contamination throughout a product’s life cycle, such as manufacture, end use,
recycling, waste management and sewage treatment. Some PFASs can also be
released from mixtures and articles that contain impurities of these substances.
Goods contaminated with PFASs that have been manufactured outside of the EU
and then imported are a growing source of PFASs.
Due to their extraordinary persistence, human and environmental exposure to PFASs
will be a long-term source of concern. PFASs have been detected globally in human
and wildlife biomonitoring studies e.g. in arctic polar bears. PFASs can also persist
for years in humans once exposed and have been found in human breast milk and
umbilical cord blood. Toxic effects on the liver is an indicative response to PFASexposure in several species, while the adverse effects also include effects on the lipid
metabolism and the immune system.
Some PFASs, such as the well-known PFOA and PFOS, have been extensively
investigated and regulated, while for many other PFASs there is still very limited or
completely missing knowledge about their current uses and hazards. Some of the less
known PFASs represent an emerging concern due to their high persistence and
environmental mobility and wide-spread use in products. Contamination of water
and soil by PFASs has already occurred in the EU and other parts of the world.1
Therefore, PFASs have already generated significant remediation costs and such
costs will increase as sites requiring decontamination continue to be identified.
Due to the problems and concerns caused by PFASs, there is a need for an EUstrategy that addresses all PFASs through regulatory and non-regulatory
interventions and drives the work in a coherent direction. Several actors2, including
the European Parliament3 have raised their concerns regarding exposure to PFASs
and called for action. The European Commission has earlier pointed out the
properties of PFASs as especially problematic.4
http://www.euro.who.int/__data/assets/pdf_file/0018/340704/FINAL_pfas-report-20170530h1200.pdf
2 For example the Helsingør Statement (Scheringer et al., 2014), Madrid Statement (Blum et al., 2015)
and the Zürich Statement (Ritscher et al., 2018).
3 Letter to Timmerman of 15 April, 2019. Subject: Your commitment to protect EU groundwater
resources and citizens’ health from PFAS contamination. Ref. Ares(2019)2656082 - 16/04/2019.
4 Study for the strategy for a non-toxic environment of the 7th EAP. Sub-study d: Very Persistent
Chemicals. EUROPEAN COMMISSION Directorate-General for Environment. August 2017.
COM proposal for limit values in the Drinking Water Directive.
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This paper argues for elements that should be included in an EU-strategy for PFASs
with the goal to minimise environmental and human exposure to PFASs in all life
cycle stages of the substances. To achieve this goal, PFASs should be managed as a
group because of their similar properties of concern, large number of substances, and
to avoid regrettable substitution. Therefore, only uses essential to society should be
accepted and substitutes for these uses should be sought with urgency.
The REACH Regulation is a key regulation in EU for managing risks associated with
the use of PFASs, but also other regulatory as well as non-regulatory instruments
should be used and are described in Annex I of this document.
PFASs will remain in the environment for ages
All PFASs are, or ultimately transform into, persistent substances. For instance,
according to UNEP5, perfluorooctanoic acid (PFOA) does not undergo any further
abiotic or biotic degradation under relevant environmental conditions. Substances
that are transformed into stable PFASs are called PFAS-precursors or “related
substances”. The extreme persistence of PFASs leading to irreversible environmental
exposure is a reason for major concern.
Due to their water solubility and mobility in soil, contamination of surface, ground-,
and drinking water and soil has occurred in the EU and globally and will continue
until action has been taken. It has been proven very difficult and extremely costly to
remove PFASs when released to the environment. The Helsingør Statement6, the
Madrid Statement7 and recently the Zürich Statement8 have also supported this
concern and a need for risk management.
PFASs cause harm
Some PFASs have been documented as toxic and/or bioaccumulative substances.9
Knowledge about the hazards of PFASs is mostly based on data from toxicological
studies in laboratory animals. Observed effects in laboratory animals after exposure
to several PFASs include:
–
–
–
–
–

Effects on the liver
Decreased thyroid hormone levels
Effects on lipid metabolism
Development of tumours in one or several organs
Immunotoxicity

UNEP/POPS/POPRC.11/5 (2015) Proposal to list pentadecafluorooctanoic acid (CAS No: 335-671, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in Annexes A, B and/or C.
to the Stockholm Convention on Persistent Organic Pollutants. Persistent Organic Pollutants Review
Committee Eleventh meeting, Rome, 19–23 October 2015.
6 Scheringer et al. (2014). Helsingør Statement on poly- and perfluorinated alkyl substances (PFASs).
Chemosphere 114:337-339.
7 Blum et al. (2015). The Madrid Statement on Poly- and Perfluoroalkyl Substances. Environmental
Health Perspectives 123(5): A107-A111.
8 Ritscher et al. (2018). Zürich Statement on Future Actions on Per-and Polyfluoroalkyl Substances
(PFASs). Environmental Health Perspectives 126(8) August 2018.
9 For instance, PFOA, PFNA, PFDA, and PFHxS, are included in the Candidate List under the
REACH Regulation as substances of very high concern due to their vPvB or PBT properties.
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– Developmental toxicity
Based on the above findings, some PFASs are classified in the EU as toxic to
reproduction, the liver and as suspected carcinogens.
Health effects in humans that have been associated with exposure to certain PFASs
are:
–
–
–
–
–

Increased cholesterol levels
Impact on infant birth weights
Effects on the immune system
Increased risk for cancer
Thyroid hormone disruption10 11

Data are available for some PFASs, however based on similarities between PFASs,
concerns are raised for the whole group. In addition, based on their similarities,
combination effects of PFASs can be expected.
Regulatory challenges
In total, 4 730 PFAS-related CAS numbers have been identified.12 A substance-bysubstance evaluation of all these substances is therefore not practically possible.
There are on-going assessments and regulations of a few sub-groups of PFASs via
so-called “arrowhead substances”13 (see Annex II). However, ECHA has estimated
that 50-100 arrowhead substances need to be assessed to cover all PFASs, which is
not possible within a reasonable timeframe. In addition, exposure to intermediate
degradation products is not considered. Therefore, a new approach to address
PFASs as a group is needed.
There are also other difficulties hindering detailed assessments of individual PFASs.
For example, many PFASs:
i.
ii.
iii.
iv.
v.

lack CAS-number,
have unclear composition,
lack information on their properties and degradation products,
are constituents of imported articles, which cannot be covered by other
REACH measures than restriction, or
do not need to be registered under REACH if considered to be polymers or
produced in volumes below the registration thresholds.

Although PFASs are widely used, the lack of information on their specific uses and
toxicity makes it difficult to estimate the degree of exposure and the risks that PFASs
pose for humans and the environment. However, the persistence of PFASs in
https://www.efsa.europa.eu/en/efsajournal/pub/5194
http://www.c8sciencepanel.org/
12 OECD, 2018. Toward a new comprehensive global database of per- and polyfluoroalkyl substances
(PFASs): Summary report on updating the OECD 2007 list of per- and polyfluoroalkyl substances
(PFASs). ENV/JM/MONO(2018)7. 4 May 2018.
13 Sub-groups with a common degradation product, e.g. PFOA and substances that degrade to PFOA.
10
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combination with other properties (bioaccumulation, mobility, long-range transport
potential and toxicity of some PFASs) and irreversible contamination of the
environment with partly unknown PFAS-mixtures make the case for urgent action.
Cost of inaction
Remediation and clean-up of PFASs, if at all possible, is very expensive and time
consuming with substantial socio-economic impacts as a result. In a recent cost of
inaction report14 the societal costs for remediation of drinking water and
groundwater15 in Europe alone have been calculated to be at least 10-20 billion
EURO over 20 years. These estimates do not include costs for inter alia ecological
damage and loss of property value as these could not be quantified. These are best
estimates of the aggregated costs for remediation but the true costs are potentially
much higher. An estimate of the costs for one case of remediation (the town of
Rastatt in Baden- Württemberg in Germany) was found to be approximately 1-3
billion EURO.
Although there is limited knowledge on the adverse effects of most PFASs, the cost
of inaction report shows high health-related costs associated with exposure to known
hazardous PFASs. The annual costs related to some adverse effects on human health
were estimated to be even higher than the total cost for remediation.
The characteristics of PFASs and the potential health and environmental costs is a
strong indication that the ongoing use of PFASs will result in a legacy problem in the
future, both from an environmental, health and economical point of view. Thus, it is
important to take immediate action to cease the release and exposure of all PFASs as
far as possible. We therefore need a novel regulatory approach for this group.

The way forward
A successful strategy for addressing the problems with PFASs must focus on
minimising the releases of PFASs to the environment and human exposure. This can
be done by significantly reducing their production, use and import in articles, as well
as by decreasing human exposure and emissions from past uses including the waste
stage.
We propose that action should be taken at the EU-level to phase out PFASs at the
latest by 2025, to be in effect by 2030. This is in line with the timeframe for the UN
Global Goals for Sustainable Development.16

The cost of inaction - A socioeconomic analysis of environmental and health impacts linked to
exposure to PFAS. TemaNord 2019:516. A publication funded by the Nordic Council of Ministers.
15 In these aggregated costs, the costs for environmental screening, monitoring (where contamination
is found), water treatment, soil remediation and health assessment were included.
16 Sustainable Development Goal 3 - Ensure healthy lives and promote well-being for all at all ages:
“By 2030, substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil
pollution and contamination.” https://sustainabledevelopment.un.org/sdg3
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Several aspects need to be considered to manage PFASs. These should as far as
possible be included in all relevant regulatory instruments and are considered below:

1) PFASs should be managed as a group
PFASs should be assessed and managed as a group for several reasons:
a) Regulating individual substances or arrowhead substances (subgroups)
will take too long to effectively manage the risk from these substances.
b) All PFASs, in themselves or their degradation products, are extremely
stable in the environment.
c) Some PFASs have documented toxicity. With the present knowledge, and
based on similarities between PFASs, concerns are raised for the whole
group.
d) Human and environmental exposure to many PFASs occur and
combination effects can be expected.
e) A group approach is needed to avoid regrettable substitution. PFASs that
are regulated are often replaced by similar, but not yet regulated, PFASs.
The boundaries of which substances are included in the PFAS-group are not
sufficiently clear and need to be specified.
2) Uses of PFASs should be limited to essential uses only
The unique physical and chemical properties of PFASs have led to a wide range of
uses in products for professionals and consumers. As a result, society has partly
become dependent on these substances in some uses. However, due to known
negative impacts on human health and the environment, and the irreversibility of
contamination due to the extreme persistence, PFASs should only be allowed for
essential uses. Any non-essential use should be phased out as soon as possible. For
uses that are considered essential, all possible measures to minimise releases and
exposure during the whole life cycle should be taken.
Essential uses must be clarified. A starting point could be the definition in the
Montreal Protocol17 and a recent scientific assessment of the concept18. Nonessential uses could be divided into different subgroups of uses with a stepwise
approach for phase out. One approach could be to start regulating consumer uses, as
these are more likely to be non-essential (e.g. clothing, cosmetics, toys and food
contact materials). Thus, only uses necessary for health and safety or critical for the
functioning of society should be allowed. Essential uses should be assessed with
regard to the availability of alternatives on a regular basis to ensure future

Decision IV/25 (4th Meeting of the Parties to the Montreal Protocol, 1992). Montreal Protocol on
Substances that Deplete the Ozone Layer (a protocol to the Vienna Convention for the Protection of
the Ozone Layer).
18 Cousins et al. (2019). The concept of essential use for determining when uses of PFASs can be
phased out. Environmental Science Processes & Impacts. DOI: 10.1039/c9em00163h.
17

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replacement and phasing out of PFASs. Thus, essential uses that have been agreed
upon should be regularly reviewed to ensure that alternatives are developed.

Actions
To achieve the strategy’s goal to minimise environmental and human exposure to
PFASs, actions are needed in several policy areas. Relevant regulatory measures to
minimise production, import, use, emissions and exposure to PFASs and other
actions are listed with bullet points in Annex I, without any ranking their importance.
The proposed actions are based on what actions are expected to be most effective
and efficient but also include ongoing and/or upcoming initiatives. Some actions are
complementary, whereas others are alternatives to each other. Each action will need
to be further specified and elaborated by the Commission in collaboration with other
actors (e.g. EU Agencies and Member States). In addition, consultation with the
industry is important when developing new regulation. Industry should take more
responsibility and take voluntary initiatives to phase out PFASs. A successful strategy
will require all relevant actors to work towards a common goal.

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December 2019

ANNEX I Examples of actions
Regulatory actions to minimise the production, import and use of
PFASs
Overall, PFASs are produced in high quantities globally and widely used in various
products. Actions to minimise their production, import and use can be taken under
for example the REACH Regulation, the CLP regulation, regulations for Food
Contact Materials (FCMs), the Cosmetics and the POPs Regulations. Some of these
legislations consider only human health although environmental protection goals
should also be considered. Nevertheless, any restriction of PFASs in product specific
legislation that only considers protection of human health (e.g. Toy Safety Directive)
will reduce the release of PFASs to the environment and thereby indirectly the
exposure to humans via the environment. In addition, enforcement actions should be
taken to check compliance with regard to particular obligations imposed by
legislations to help manage PFAS-risks, where appropriate.
REACH

The REACH regulation ((EC) No 1907/2006) is the most extensive legislation for
managing chemicals in the EU. It includes the four processes of registration,
evaluation, authorisation and restriction of chemicals. REACH requires industry to
register information for substances they produce or import into the EU at or above
1 t/a (registration). Data requirements are tonnage dependent. Based on this
information substances may undergo evaluation and if found to be of concern they
can either be banned with the opportunity to authorise specific uses (authorisation),
and/or restricted with possible derogations for essential uses (restriction). No
information is obtained from REACH for low tonnage PFASs (<1 t/a per
producer/importer).
Registration

Polymers constitute a large group of PFASs. However, REACH does currently not
specify any requirements for registration or evaluation of polymers (only monomers
are covered).
According to Article 138(2) of REACH, the Commission may present legislative
proposals when a practicable and cost-efficient way of selecting polymers for
registration has been identified. Two studies have already been performed to look at
registration requirements for polymers.19 A new study is ongoing with the aim to
identify which polymers should be registered/evaluated under REACH.20 The
registration/evaluation of some polymers would allow obtaining information on
production volumes and intrinsic properties of the polymers but also on their

28th Meeting of Competent Authorities for REACH and CLP (CARACAL), CA Session, Brussels,
13/11/2018, Doc. CACS/47/2018.
20 28th Meeting of Competent Authorities for REACH and CLP (CARACAL), CA Session, Brussels,
13/11/2018, Doc. CACS/47/2018.
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degradation products when necessary. Registration of polymers would be helpful for
enforcement.
Authorisation

Inclusion in the REACH candidate list will trigger information requirements on
PFASs in the supply chain and to consumers. Inclusion in the candidate list can also
make PFASs subject to authorisation obligations. However, authorisation is not
considered the preferred option for PFASs since it is a substance-based measure not
covering imported articles. Inclusion in the candidate list can help to identify the
properties of concern, but this may not be necessary for taking risk management
actions.


PFASs that by far exceed the trigger of being very persistent in combination
with other intrinsic properties that are of concern, could be identified as
SVHCs and included in the candidate list.

Restriction

Restriction is the most effective and efficient way to manage such a large and
complex group of substances that are used in numerous of applications. In addition,
a restriction can cover imported articles. A broad restriction is therefore preferable to
authorisation.






A broad restriction under REACH covering all PFASs would be the
preferred option, in order to limit as many non-essential uses as practically
possible. This would have the greatest impact on minimising human and
environmental exposure to PFASs. A broad restriction would also include
unknown PFASs and uses.
Grouping PFASs on a sector-by-sector, together with arrowhead approach
based on the largest contributions of PFASs to human and environmental
exposure could also be considered. Preparatory work has already started that
may lead to this approach for fire-fighting foams.21
Consumer uses could be considered for a group wise general restriction. For
example, it could be questioned why PFASs are needed in everyday
consumer products and articles, e.g. textiles, food contact materials and
cosmetics. These uses could therefore be assessed as non-essential and a first
priority for a restriction.

Regulations on food contact materials (FCMs)

Grease- and water-repellent paper can contain PFASs. These materials are used as
FCMs, such as popcorn bags, sandwich paper and other fast food paper wrapping.
Materials that come into contact with food are regulated in Regulation (EC) No

During 2019, the Commission and ECHA have started two projects on pre Annex XV dossier on
PFASs in fire-fighting foams (More information on the project can be requested to the Commission).
As a first step, two parallel studies have been launched to gather information on the presence of
PFASs and alternatives to PFASs in fire-fighting foams. The use of PFASs in textiles is a subject of a
next study, as a first step towards an Annex XV dossier on PFASs in textiles.
21

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1935/2004. This is the EU Framework Regulation, which among others provides the
general principles for ensuring the safety to human health of all FCM.
Specific measures for materials listed in Annex I to the Framework Regulation can be
adopted and exist among others for plastic material and articles that come into
contact with food (Regulation (EC) No 10/201122). The regulation contains a list of
substances that are approved for use in plastic FCM (the so-called “Union positive
list”). Several PFASs, including the ammonium salts of PFOA23, are included on the
positive list and thus allowed for use under certain conditions in plastic FCM. The
purpose of these conditions is to ensure that FCMs do not cause migration of
fluorinated substances in amounts that can endanger human health.
Considering the environmental concerns regarding PFASs, they should not be used
in FCMs. Most PFASs used in FCMs will be degraded to extremely persistent and
potentially toxic perfluorinated carboxylic acids similar (or identical) to PFOA, for
which EFSA recently has suggested a very low limit value. In addition, EFSA is
currently assessing more PFASs.



Phase out the use of all PFASs in all types of FCMs. This could be regulated
through specific measures under the Framework Regulation (EC) No
1935/2004 or by a restriction under REACH.
PFASs should be removed from the list of permitted substances in plastic
material intended to come into contact with food (Regulation (EC) No
10/2011).

Cosmetics regulation

PFASs are used in various cosmetic products. The EU regulation on cosmetic
products aims to protect consumers from health risks associated with the use of
cosmetics.24 Risks to the environment are excluded. This Regulation lists substances
that are not allowed in cosmetic products and substances that may be used under
certain conditions. Substances prohibited in cosmetics products are for a major part
CMR-substances and listed in Annex II of 1223/2009 and substances subject to
restrictions are listed in Annex III. In order to restrict all PFASs in cosmetics
products under regulation 1223/2009, all PFASs must be added to Annexes II or III
substance by substance, which might be unfeasible.


Phase out the use of all PFASs in cosmetic products considered nonessential use. This can be done under REACH (based on environmental
concern) or under the Cosmetics Regulation (based on health hazard
concern).

The European Commission's Regulation (EU) No. 10/2011 on plastic materials and articles
intended to come into contact with food.
23 CAS 3825-26-1.
24 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November
2009 on cosmetic products.
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Regulations on plant protection and biocidal products

Co-formulants used in or mixed with plant protection products can contain PFASs,
mainly in the function of wetting agents. The application of plant protection
products containing PFASs results in a direct contamination of the arable land and
the environment. Annex III of Regulation (EC) No 1107/200925 lists co-formulants
not accepted for use in plant protection products. Up to now, Annex III has no
entries but there is a Commission proposal for Annex III focusing mainly on
substances regulated under REACH.


Phase out the use of all PFASs as co-formulants in plant protection products.
The most efficient implementation would be to list in general PFASs as
unacceptable co-formulants in Annex III (Regulation (EC) No 1107/2009).
According to the current Annex III proposal, unacceptable co-formulants
would include PFASs identified as SVHC or restricted under REACH.
Because plant protection products are often used for non-agricultural
purposes e.g. for home pest control, PFASs may also be present in biocides.
PFASs should not be permitted for use in biocidal products.

POPs Regulation (Stockholm Convention) and other international fora

The Stockholm Convention on Persistent Organic Pollutants is one of the main
instruments for regulating chemicals globally. The Convention has been implemented
in EU through the POPs Regulation26.



Nominate PFASs or groups of PFASs under the Stockholm Convention for
global phase-out.
OECD/UN should be encouraged to invite its members to work together
more actively on PFASs and to phase out the use of PFASs globally.

Regulatory actions to minimise exposure to PFASs in the
workplace and from the environment.
Limiting as far as possible the production and use of PFASs needs to be
accompanied by minimising emissions to the environment and human exposure to
PFASs. Actions to minimise exposure can be taken under several EU legislations
covering different parts of a product’s life cycle. For example, the Occupational,
Health and Safety legislation (OHS), the Industrial Emission Directive (IED), the
Waste Framework Directive, the Water Framework Directive (WFD) and the Sewage
Sludge Directive. Examples of different regulatory actions are described below.
Regulation of contaminants in food.

When required for the protection of public health, on the basis of Regulation (EEC)
No 315/93, maximum levels for contaminants in food are set under Regulation (EC)
No 1881/2006 at levels which are as low as reasonably achievable. EFSA is currently
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market.
26 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on
persistent organic pollutants and amending Directive 79/117/EEC.
25

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carrying out a risk assessment for PFASs in food. On the basis of this assessment,
discussions will be started on the possible need to set maximum levels for PFASs in
food.
Water Framework Directive (WFD)

Since many PFASs are water-soluble and mobile in soil there is a risk of further
adding to the contamination of drinking water supplies which will persist for a long
time. The EU WFD27 aims to ensure that all European waters are in good condition
by a set date and protects water based on natural geographical formations, e.g. river
basins instead of administrative or political boundaries. The WFD is complemented
by other, more specific EU legislation, e.g. the Directive on Environmental Quality
Standards (2008/105/EC amended by 2013/39/EC) in the field of water policy, the
Ground Water Directive (2006/118/EEC) and the Drinking Water Directive
(98/83/EC). Perfluorooctane sulfonic acid (PFOS) is the only PFASs currently listed
as a priority hazardous substance in the EQS-directive with environmental quality
standards (EQS) that are used to establish chemical status.






In view of the need to prevent further emissions of PFASs to water bodies, a
new EQS for the overall concentration of PFASs should be included in the
Directive on Environmental Quality Standards.
New limit values for PFASs in the Drinking Water Directive should include a
limit value for the overall concentration of PFASs as well as a limit value for
the sum of selected PFASs.
There is a need to coordinate the working processes in the Drinking Water
Directive and at EFSA28 so that limit values for drinking water and food are
coherent.
PFASs as a group should be included in the Groundwater Directive and limit
values should be set in the ongoing Water Framework Directive fitness check
process and groundwater voluntary watch list process.
As proposed in Art 16 (9) “strategies against pollution of water” of the WFD,
it might be suggested that the European Commission is preparing a strategy
against pollution of water by PFASs.

Industrial Emissions Directive (IED)

At industrial sites where PFASs are used, handled or produced, it is important to
ensure that PFASs are not released to the environment to prevent pollution (e.g. in
soil and groundwater) or exposure to workers. The IED is the main EU instrument
regulating pollutant emissions from industrial installations. As far as PFASs are listed
in Annex VI in the CLP-regulation ((EC) No 1272/2008), i.e. have a harmonised
classification, they have to be addressed in the baseline report as relevant hazardous
substances.
Installations undertaking the industrial activities listed in the IED are required to
operate in agreement with a permit granted by the competent authorities in the
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000
establishing a framework for Community action in the field of water policy.
28 23 PFASs are being assessed currently.
27

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 Elements for an EU-strategy for PFASs
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Member States. Permits under IED must consider the whole environmental
performance of the plant, which includes emissions to air, water and soil, generation
of waste, prevention of accidents, and restoration of the site upon closure.
It is not mandatory for PFASs to be included in the CLP (Annex VI) in order to be
addressed in BREFs29 or in IED permits. Other criteria such as, the quantity of
emissions, the impact to the environment and health, the potential for identifying a
technique to reduce the pollution etc. play a role. However if a substance is classified
as hazardous and included in CLP (Annex VI) this will be helpful for the regulation
of IED sites.


At industrial sites where use or production of PFASs occurs, PFASs should
be included in the IED permits with the aim to minimise release of PFASs
to the environment. However, it is currently not feasible to address all
industrial sectors, installations and usages of PFASs in the IED. Having
more PFASs classified under the CLP regulation will result in more
substances assessed under the IED.

Waste legislation and management

PFASs are known contaminants during waste management, e.g. there might be
leachate of PFASs from landfills and dumpsites. However, PFASs are not addressed
specifically in the European Waste Framework Directive and relevant waste
legislation (such as establishing criteria and procedures for the acceptance of waste at
landfills30). In principle, leachate and process water from waste treatment have to
fulfil specific national wastewater legislation. In addition, indirect discharges to water
bodies via public wastewater treatment plants occur and there are additional
legislative obligations31.
Waste treatment plants covered by the scope of the IED have to ensure that best
available techniques (BAT) for the waste treatment sector32 are applied. PFOA and
PFOS are addressed by the BAT Conclusions for monitoring of emissions to waste.
The related obligations have to be taken up in permits given to relevant waste
treatment plants within four years of the implementation of the IED. Authorities
should consider to implement emissions limits for all other PFASs as well as for
PFOS and PFOA.



Member states should ensure that PFASs are fully included in the waste
legislation.
Limit values for PFASs should be set under the Sewage Sludge Directive
(86/278/EEC) and in the future regulation on minimum requirements for
water re-use.

BAT (Best Available Techniques) Reference Document (BREF).
Council Decision 2003/33/ECof 19 December 2002 establishing criteria and procedures for the
acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC.
31 Reference to Waste Water Legislation.
32 Commission Implementation Decision (EU) 2018/1147 of 10 August 2018 establishing best
available techniques (BAT) conclusions for waste treatment, under Directive 2010/75/EU of the
European Parliament and of the Council (notified under document C(2018) 5070).
29
30

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 Elements for an EU-strategy for PFASs
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Remediation of contaminated natural resources

Many contaminated sites concern training sites where PFOS-based fire-fighting
foams have been used. This is often military or civil airports, but can sometimes be
sites in communities contaminated by local fire brigades. PFASs, such as PFOS and
PFHxS33, can at these sites be found at high concentrations in the soil, and with time,
they will also leach into the groundwater and surface water where they will enter the
food chain.
Beside fire-fighting foams, industrial activities, discharge from municipal wastewater
treatment plants as well as the use of pesticides, sewage sludge, or biocides contribute
to elevated PFAS-levels in soil and water. Contamination of soil and water via
atmospheric transport and deposition of anthropogenic PFASs may also contribute
to a general contamination level.
There are currently no remediation methods that will efficiently clean soil in a costeffective manner. Excavation and disposal at landfills are methods mainly used today.
However, there is a risk that the contaminated soil may cause further pollution in
new areas.
There are costly methods used to remove some PFASs from groundwater using a
combination of simple filters and activated carbon filters. This method is used to
purify groundwater and then pump the clean ground water into the groundwater
aquifers, thereby very slowly decreasing the concentration of some PFASs in the
ground water aquifers.
Contaminated groundwater used for drinking water production will result in
contaminated drinking water. For some PFASs, efficient remediation techniques
based on activated carbon filters are available for contaminated drinking water.
However, those PFASs used today are still difficult, if at all possible, to remove from
ground- or drinking water.
Contaminated drinking water is a source for human PFAS-uptake. Further, PFASs
can be taken up by plants and crops, which is another entry route into the human
food chain. Here, irrigation with PFAS-contaminated water can be an additional
source for human exposure.







33

Research on sources of PFASs to soil and water is urgently needed (as well
as analytical methods to identify PFASs and precursors), e.g. by monitoring
of air, soil and groundwater samples (particulate phase as well as air phase),
entries via plant protection products, biocides, compost, sewages sludge, etc.
Remediation methods for soil are needed.
Treatment and disposal of contaminated soil should be regulated to avoid
contaminated soil being shipped from contaminated sites to non-polluted
areas. Guidance is needed for handling PFAS-contaminated soil, e.g. at
landfills.
Research is needed on how to efficiently and cost-effectively remove PFASs
from groundwater and surface water.

Perfluorohexane sulfonic acid.

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 Elements for an EU-strategy for PFASs
December 2019

Research, monitoring and information activities
Non-regulatory actions are necessary, besides regulatory instruments, to achieve the
goal with the proposed elements for a strategy. For example, it is important to make
the general public aware about the problems with PFASs so that they can make
informed good choices. Research is another area where actions are needed. In
addition, analytical methods to monitor PFASs in the environment and enforcement
should be developed further and standardised.
Awareness raising

The problems that PFASs may cause to the environment and human health need to
be communicated to initiate behavioural changes.




Launch awareness raising campaigns to inform the general public, relevant
authorities, and policy-makers on the problems associated with PFASs and
available alternatives to PFASs.
Strengthen existing Ecolabels so that PFAS-free products can be labelled as
PFAS-free.
International joint actions under e.g. OECD/UNEP Global PFC Group and
SAICM.

Research on alternatives

To be able to replace PFASs there is a need for alternative chemicals or technologies.
Even though there has been a development of fluorine-free alternatives, it can be
difficult to find alternatives for essential uses where a very low surface tension or
durable grease-repellent properties are necessary.
In addition, alternative technologies can be introduced and replace PFASs without
any need for other chemicals.




Facilitate research and promote existing alternative chemicals to PFASs and
on new technologies that eliminate current PFAS-use.
Encourage industry to take voluntary measures to limit use, releases and
exposure to PFASs.
Where alternatives are not available, and where use of PFASs are deemed
essential, industry should provide toxicity data to support safe use.

Research on the fate and transport of PFASs in the waste stage

Release of PFASs occurs during all life cycle stages, one important is the waste stage.
However, information on PFASs in generated waste and potential release to the
environment from the waste management process is often inadequate. Research in
the following areas is considered particularly relevant and should be facilitated:



The origins, fate and transport of PFASs from wastewater treatment plants
(incl. disposable waste), incinerators, landfills, as well as from recycling.
The fate of PFASs coming from diffuse and hotspot sources in agricultural
settings. This includes research on transfer of PFASs into food and
occurrence of PFASs in food of vegetable and animal origin.

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 Elements for an EU-strategy for PFASs
December 2019



Fate and transport modelling approaches should be further developed and
used to support policy scenarios.

Monitoring – environment and humans

There is a need for long-term monitoring of PFASs as a group and to monitor riskreducing measures that have been implemented. Environmental monitoring of
several different PFASs is performed today. However, there is no standardised
method for monitoring total PFASs concentration.34 These methods are today used
as a screening tool to determine if PFASs are present in different matrices and can be
combined with targeted analytical methods.




Member states are encouraged to share their monitoring data, via e.g.
IPCheM35.
A standardised method should be developed for monitoring total PFASs
concentration with a low detection limit in various matrices including food,
products and human blood.
Standardised analytical methods by CEN for PFASs need to be developed
for enforcement to assure compliance with legislation.

A substantial number of existing PFASs are marketed without CAS number. This
causes problems of identification, as the naming of substances in this group is very
variable. Studies have demonstrated that it is often difficult to identify and categorize
PFASs.36 Lack of proper identification also makes it difficult to develop the analytical
methods that are needed to monitor relevant PFASs in products, the environment
and humans. Therefore, it is important that PFASs are properly identified with CAS
numbers and are given informative substance names by the manufactures.


Producers of PFASs should share information on the chemical identity of
their substances, including impurities, synthesis methods, and analytical
methods. Standard analytical methods should be developed to measure
PFASs.

Organic fluorine (TOF) or total oxidizable precursors (TOP).34 However, TOF/TOP methods are
currently not the preferred method for measuring compliance with restrictions on PFASs. This is
because they catch all organic fluorinated molecules and not only the regulated.
35 https://ec.europa.eu/jrc/en/event/conference/ipchem
36 OECD, 2018. Toward a new comprehensive global database of per- and polyfluoroalkyl substances
(PFASs): Summary report on updating the OECD 2007 list of per- and polyfluoroalkyl substances
(PFASs). ENV/JM/MONO(2018)7. 4 May 2018.
Swedish Chemicals Agency, 2015. Occurrence and use of highly fluorinated substances and
alternatives - Report from a government assignment. Report 7/15.
https://www.kemi.se/publikationer/rapporter
34

18

 ANNEX II On-going and completed activities as of 7 June 2019
Table 1 Completed/On-going activities
Activity
Classification

Regulation
CLH
Harmonised classification & labelling

Substance Evaluation
Assessment as potentially EDs or PBTs
Identification as an SVHC

REACH
REACH
REACH

Restriction

REACH

Limit values for the PFASs

Drinking Water Directive
Groundwater Directive

37
38

Status
Work completed for 6 arrowhead substances
and 1 arrowhead substances is in the pipeline
for Registry of intentions and opinionforming/decision-making.
18 PFASs are currently being assessed.
6 PFASs are under assessment.
Work completed for 3 arrowhead substances37.
2 arrowhead substances are in pipeline for
Registry of intentions and opinionforming/decision-making.
Work completed for 1 arrowhead substance38
(PFOA) and 8 arrowhead substances
are in pipeline for Registry of intentions and/or
opinion-forming/decision-making.
The potential inclusion of PFASs in Annex I or
II of the Groundwater Directive will be subject
to the outcomes of the Water Framework

Includes the grouping C9-C14 PFCAs.
Having a restriction for an arrowhead substance means that precusors/related substances are also included in the restriction.

 Elements for an EU-strategy for PFASs
December 2019

Studies on PFASs in fire-fighting foams

REACH

Study on PFASs in textiles

REACH

Polymers

REACH

Research funding

Global phase-out

Stockholm Convention

Directive fitness check process and the
groundwater voluntary watch list process.
The Commission and ECHA are working on
two parallel studies to gather information on the
presence and alternatives to PFASs in firefighting foams.
The Commission will launch a study on PFASs
in textiles in July.
An ongoing study with the aim to identify
which polymers could be subject to
registration/evaluation under REACH. The
registration/evaluation of some polymers would
allow obtaining information on the intrinsic
properties of the polymers but also on their
degradation products, like some PFASs, when
necessary.
Biomonitoring under the HBM4EU project.
HBM4EU is a joint effort of 28 countries, the
European Environment Agency and the
European Commission, co-funded under
Horizon 2020. The project started in 2017 and
runs until 2021. The aim of the project is to
advance human biomonitoring in Europe by
developing methods and databases. The focus is
on collecting data on human biomonitoring and
coordinating monitoring campaigns.
PFOS and PFOS-related substances Removing most of the exemptions for
acceptable purpose or to convert them to
specific exemptions.

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 Elements for an EU-strategy for PFASs
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Risk management

OECD

PFOA, its salts and PFOA-related compounds Listing in Annex A.
PFHxS - Adopted risk profile
Potential opportunities for further work at
OECD on the risk management of Per- and
Polyfluorinated Alkyl Substances.
See report from the 59th Joint Meeting of the
Chemicals Committee and the Working Party
on Chemicals, Pesticides and Biotechnology. 10
April 2019.

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