On Tuesday 25 February 2020, Eeva Leinala of the OECD Environment Directorate and Valentina Bertato of the DG Environment, European Commission presented the European Union's actions to regulate PFASs. It covered recent actions for restricting PFASs compounds and a strategy moving forward. This webinar is part of a series aiming to share information on issues related to PFASs and support a global transition towards safer alternatives.

1. Initiatives to regulate
PFASs at EU level and
beyond.
Valentina Bertato
EUROPEAN COMMISSION, DG ENVIRONMENT

2. Council
Conclusions of June 2019:
The Council of the European Union:
UNDERLINES the increasing health and environmental concerns
posed by highly persistent chemicals; NOTES in specific the growing
evidence for adverse effects caused by exposure to highly fluorinated
compounds (PFAS), the evidence for wide spread occurrence of PFAS
in water, soil, articles and waste and the threat this may cause to our
drinking water supplies; CALLS on the Commission to develop an
action plan to eliminate all non-essential uses of PFAS.
Council of December 2019:
- NL announces the intention to prepare a REACH
restriction on the whole PFAS group.
- 8 MSs support a EU PFAS action plan.
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3. At EU level
Green deal
• zero-pollution ambition
for a toxic-free environment;
• chemicals strategy for sustainability;
• address risks posed by very persistent
chemicals.
Member States: asking the Commission for a
PFAS action plan
– to look at PFAS as a group;
– use all available regulatory and non regulatory
instruments 3

4. REACH activities on PFAS
• PFOS, PFOA, C9-C14 PFCAs, PFHxS: all restricted
or in the restriction process.
• GenX, PFBS: recently identified as a Substances
of Very High Concern because of
– persistency, mobility, potential for long range transport,
observed adverse effects, bioavailability for uptake via
drinking water
– very high potential for irreversible effects.
• Restriction dossier for PFHxA (DE)
• NL announced the intention for a group
restriction on PFAS (except essential uses)
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5. Commission studies on PFAS
• COM + ECHA: use of all PFAS and non-fluorinated
alternatives in fire-fighting foams
• COM: use of all PFAS and non-fluorinated
alternatives in textiles, upholstery, leather,
apparel and carpets (TULAC)
• Data collected: substance identification, hazard,
emissions, potential alternatives, critical
functions/uses, benefits, costs of contamination
of soil and water
• To be used as a basis for the REACH restriction,
international activities under POPs.
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6. How to share workload for the EU
restriction/assessment
• FFFs and textiles: COM to ask ECHA or be taken
over by MS?
• Approach to be followed by MS:
– RMOA
– Essential uses
• One substance/One assessment: good pilot case?
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7. Water legislations
– Drinking Water Directive (DG ENV)
• Commission proposal for a limit for all PFAS (« family approach»)
• Compromise by co-legislators (Dec. 2019): « family approach » as
an alternative to a list of 20 substances for monitoring until the
relevant monitoring method becomes available for all PFAS
• WS on PFAS monitoring in water and other media (13-14 Jan. 2020)
– Groundwater Directive (DG ENV)
• PFAS as emerging concern in groundwater (approx. 75 % of EU
residents depend on groundwater)
• 2017 Pilot exercise to monitor PFAS in groundwater (volunteers:
COM, MS, stakeholders, industry, academia)
• PFOS and PFOA most commonly detected, in all countries
• voluntary watch-list (PFAS, PFOA)
• PFAS as possible substances considered in the future Groundwater
Dir. review
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8. 8
Input NEEDED:
Article 11 (6)
The Commission shall, no later than 3 years after
entry into force of this Directive, establish
technical guidelines regarding the analytical
methods, including detection limits and parameter
values and frequency of sampling for monitoring
of’ PFAS total’ and ‘Sum of PFAS’.
(wording under review)

9. Consumer risk assessment
– 2019 EFSA opinion risk to human health related to the
presence of perfluorooctane sulfonic acid and
perfluorooctanoic acid in food.
• New information on toxicity and occurrence was evaluated
• A new TWI was put forward
• Conclusion: the exposure for a considerable part of the population exceeds the
TWI
• Discussion between EFSA and national risk assessment bodies on the need to
apply a mixture approach and on the nature of the uncertainties and on how
they should be dealt with.
• Disclaimer added to the opinion:
The conclusions of this assessment will be reviewed in parallel with the finalisation of the
EFSA scientific opinion on the risks to human health related to the presence in food of
perfluoroalkylated substances other than PFOS and PFOA. The indicative timeline for
this is December 2019. Until such time, the conclusions and derived tolerable weekly
intakes shall be considered provisional.
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10. Consumer risk assessment
– EFSA opinion risk to human health related to the presence
of perfluoroalkylated substances in food.
• Will cover PFOS, PFOA and other PFAS substances.
• Endorsement by the CONTAM panel foreseen end of January 2020.
• Public Consultation: end of January to end of March 2020
• Stakeholder meeting: end of February 2020
• Opinion Adoption by CONTAM Panel: target July 2020
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11. Regulatory measures
– Q3 2020: start of discussions with Member States in the
Working Group on IND and ENV CONTAM on the possible
need to set maximum levels for certain PFAS substances
in food taking into account:
• Occurence data
• The possibility of applying mitigation measures
• ALARA principle
– Exploration of options for the development of good
practices for mitigation of the contamination
– Follow up on the recommendations made in the EFSA
opinion
• Need for more occurence data for certain PFAS substances
• Need for more toxicological information on certain PFAS substances
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12. International activities on PFAS
• Stockholm Convention COP agreed to list PFOA in Annex A
• Derogations more stringent than REACH restriction: will be
taken over by the POP Regulation
• Encouraging Parties not to replace fire-fighting foam that
contains PFOA with short-chain PFASs due to their
persistency and mobility, potential negative environmental,
human health and socioeconomic impacts
• PFHxS under discussion
• Persistence/Mobility criteria under UN GHS?
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13. Thank you !
Disclaimer
All views expressed are purely personal and should not be considered as representative of the European Commission’s
official position. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the
use which might be made of the information provided.

14. Concerns of PFAS
Long-chain PFAS (PFOA, PFOS, C9-C14 PFCAs and their salts):
included in the Candidate List/restricted e.g. because of:
– Extreme persistence (stability)
– Bioaccumulation
– Toxicity for reproduction
Short-chain PFAS: High contamination potential of food, surface &
ground water and drinking water sources
– Mobility in the environmental compartments
– No efficient techniques available for removal from sewage, drinking
water and contaminated sites due to low adsorption potential;
– Accumulation in (edible) plants; bioaccumulation potential; protein
binding potential
– Found in humans and in the environment despite of limited volumes
– Long-range transport potential – wide geographical scale
PFASs also result from degradation of precursors (side-chain
fluorinated polymers and fluorotelomers)
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15. 15
Draft PFAS Parameter Annex I
(list with parameters )
'Sum of PFASs 0.1 μg/l 'PFASs Total' 0.5 μg/l
'Sum of PFASs' means the sum of
all per- and polyfluoroalkyl
substances considered a concern
for drinking water listed in
Annex III.
This is a subset of PFAS
substances that contain a
perfluoroalkyl moiety with three
or more carbons (i.e. –CnF2n–, n
≥ 3) or a perfluoroalkylether
moiety with two or more carbons
(i.e. –CnF2nOCmF2m−, n and m
≥ 1).
'PFASs Total' means the totality of
per- and polyfluoroalkyl
substances.
• This value shall only apply
once technical guidelines
for monitoring this
parameter are developed.
• Member States may then
decide to use either one or
two of the parameters
‘PFAS Total’ or ‘Sum of
PFAS’
(wording under review!)

16. 16
PFAS Substances List Annex III
No specific methods: Minimum performance characteristics
‘Uncertainty of measurement’
Perfluorobutane sulfonic acid (PFBS)
Perfluoropentane sulfonic acid (PFPS)
Perfluorohexanesulfonic acid (PFHxS)
Perfluoroheptane sulfonic acid (PFHpS)
Perfluorooctanesulfonic acid (PFOS)
Perfluorononane sulfonic acid (PFNS)
Perfluorodecane sulfonic acid (PFDS)
Perfluoroundecane sulfonic acid
Perfluorododecane sulfonic acid
Perfluorotridecane sulfonic acid
Perfluorobutanoic acid (PFBA)
Perfluoropentanoic acid (PFPA)
Perfluorohexanoic acid (PFHxA)
Perfluoroheptanoic acid (PFHpA)
Perfluorooctanoic acid (PFOA)
Perfluorononanoic acid (PFNA)
Perfluorodecanoic acid (PFDA)
Perfluoroundecanoic acid (PFUnDA)
Perfluorododecanoic acid (PFDoDA)
Perfluorotridecanoic acid (PFTrDA)

17. PFAS as emerging concern in groundwater
• Background: Directive 2014/80/EU amended annex II of the
Groundwater Directive. Recital 4: need of a groundwater watch list
to increase monitoring data on substances posing risk, including
emerging pollutants.
• Process launched in 2015 within the Water Framework Directive,
Common Implementation Strategy. Pilot exercise on PFAS in
2017. Group of volunteers: COM, MS, stakeholders, industry,
academia…

18. Pilot exercise in Groundwater, results:
• A total of 11 Member States or participating countries provided
monitoring data on voluntary basis on PFAS (and 13 on
pharmaceuticals). (PFOA and PFOS the most frequently detected.
Both substances were analysed and detected in all countries
performing PFAS monitoring).
• List facilitating Annex I and II (i.e. possible substances to be
considered for the future review of the Groundwater Directive
Annexes): 2 pharmaceutical and 10 Per- and Polyfluoroalkyl
Substances (PFAS).
• First voluntary watch list, 2 PFAS and 9 pharmaceuticals.
• Draft report on PFAS pilot study.
• The group will carry out future data collections on non-relevant
metabolites and PMT (Persistent, Mobile, Toxic) compounds.

19. 19
DWD PFAS Substances List Annex III vs Groundwater
technical works (watch list ‘WL’, list facilitating ‘LF’)
Perfluorobutane sulfonic acid (PFBS) (LF)
Perfluoropentane sulfonic acid (PFPS)
Perfluorohexanesulfonic acid (PFHxS) (LF)
Perfluoroheptane sulfonic acid (PFHpS)
Perfluorooctanesulfonic acid (PFOS) (LF)
Perfluorononane sulfonic acid (PFNS)
Perfluorodecane sulfonic acid (PFDS)
Perfluoroundecane sulfonic acid
Perfluorododecane sulfonic acid
Perfluorotridecane sulfonic acid
Perfluorobutanoic acid (PFBA) (LF)
Perfluoropentanoic acid (PFPA) (LF)
Perfluorohexanoic acid (PFHxA) (LF)
Perfluoroheptanoic acid (PFHpA) (LF)
Perfluorooctanoic acid (PFOA) (LF)
Perfluorononanoic acid (PFNA) (LF)
Perfluorodecanoic acid (PFDA) (LF)
Perfluoroundecanoic acid (PFUnDA) (WL)
Perfluorododecanoic acid (PFDoDA) (WL)
Perfluorotridecanoic acid (PFTrDA)

20. Regulatory framework contaminants in
food
– Council Regulation (EEC) No 315/93
• Food containing a contaminant in an amount which is unacceptable from the
public health viewpoint shall not be placed on the market.
• Contaminant levels shall be kept as low as can reasonably be achieved by
following good practices at all the stages,
• In order to protect public health the Commission may where necessary
establish the maximum tolerances for specific contaminants.
– Commission Regulation (EC) 1881/2006
• Establishes maximum levels for certain contaminants in food
• So far no MLs established for PFAS substances
MLs can be established when evidence becomes available,
which indicates a risk to human health
MLs are established on the basis of occurrence data
according to the ALARA principle
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21. Consumer risk assessment
– 2008 EFSA opinion on perfluorooctane sulfonate (PFOS),
perfluorooctanoic acid (PFOA) and their salts
• Establishment of a TDI
• The available occurrence data were limited
• Unlikely that adverse effects of PFOS or PFOA are occurring in the general
population
– 2012 EFSA scientific report on perfluoroalkylated
substances in food: occurrence and dietary exposure
• Occurrence data gathered under Commission Recommendation 2010/161 were
evaluated
• No health risks were identified taking into account the 2008 TDI
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