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Risk management approach
to PFAS, EU perspective
• Challenges in addressing PFAS pollution
Kristin Schreiber, European Commission, Director Chemicals, Health, Retail and Agrifood, DG GROW
• Overview on strategy and environmental legislation
Valentina Bertato, European Commission, DG Environment
• Risk management measures under REACH and CLP
Bastian Zeiger, European Chemicals Agency
• Serious human health and
environmental concern.
• Used in critical applications needed
for twin transition to a green and
digital economy and strategic
autonomy.
• Balanced approach
2
Challenges in addressing PFAS pollution
Source: EEA
Overview on strategy and
environmental legislation
3
4
EU policy framework
• CSS and PFAS action plan: not only about
REACH restrictions
• While restrictions address the problem at
the source, we need to deal with existing
contamination
• We need to use all regulatory frameworks
• Push to other legislations also thanks to CSS
5
Action on PFAS in EU legislation
REACH
restrictions: PFHxA,
PFAS in fire-fighting
foams, UPFAS
POPs Regulation F-gas Regulation
Drinking Water
Directive
Water Framework
Directive
Groundwater
framework directive
Food
Contaminants
Regulation
Industrial
emissions directive
and E-PRTR
• POPs Regulation
• Already lists PFOS, PFOA and PFHxS
• Future: C9-C21 PFCAs
• PFAS in water:
• Revised Drinking Water Directive: limit of 0.5 µg/l for PFAS Total and 0.1 µg/l for
the Sum of 20 PFAS (EiF in Jan 2021; 2 years for MS to transpose it into national
legislation).
• COM is finalising the technical guidelines for the methods for monitoring ‘Sum of
PFAS’ and ‘PFAS Total’
• Member States must apply one or both of the parameters (compliance by Jan
2026)
Action on PFAS under other EU legislation
• PFAS in water:
• COM proposal amending the Water Framework Directive, the Environmental
Quality Standards Directive and the Groundwater Directive
• Adding 24 PFAS to the list of priority substances in surface water and to the list
of pollutants in groundwater
• EP adopted compromise amendments (Sep 2023), Council has not yet
formulated a common position
7
Action on PFAS under other EU legislation
• PFAS in food:
• Maximum concentration levels of certain PFAS in food (Commission Regulation (EU)
2023/915)
• Monitoring of PFAS in food (Commission Recommendation (EU) 2022/1431)
• Monitoring of PFAS in feed (Commission Recommendation targeted for adoption Q1 2024)
• Industrial emissions and E-PRTR
• Under discussion in Council and Parliament (provisional agreement, adoption expected
in March 2024)
• New industrial emission portal: proposed to include PFOA and PFHxS
• New IED: chemicals specific provisions (chemicals inventory, on-site risk assessment,
analysis of alternatives, role for ECHA in the BREF process)
8
Action on PFAS under other EU legislation
• F-Gas Regulation
• Primary focus to reduce climate impact of F-gases, BUT many F-gases are PFAS as they
degrade to TFA
• Will apply as from around March 2024, to be reviewed in 2030
• Includes measures to
• Prevent emissions from uses, products and equipments
• Reduce F-gas supply to the market (HFC quota systems and F-gas prohibition on placing on
the market)
• Prohibitions on placing on the market that de facto will ban PFAS F-gases (examples):
• Domestic refrigerators and freezers (2026)
• Small AC/heat pumps: 2032 or 2035
• Insulation foams: 2033
9
Action on PFAS under other EU legislation
Risk management measures
under REACH and CLP
PFAS – Existing/on-going regulatory actions
→ PFAS already subject to [or pending] restrictions:
• Link to POPs Regulation (see Part 1)
• REACH Regulation: C9-C14 PFCAs; TDFAs; [PFHxA],
[PFAS in firefighting foams]
→ PFAS identified as Substances of Very High Concern
(SVHCs) under REACH
• E.g. HFOP-DA (GenX), PFBS
→ Some PFAS undergoing substance evaluation under
REACH
→ Some PFAS have a harmonised classification under
CLP
11
Restrictions under REACH
→ Any conditions on the manufacture, use
or placing on the market of substances,
mixtures or articles
→ Proposed by EU Member States or by
ECHA
• Restriction proposal subject to open
consultation for 6 months
→ Evaluated by two scientific committees
(RAC and SEAC)
• RAC and SEAC opinion
→ Decision by European Commission with
EU Member States (REACH Committee)
12
Proposal to restrict PFAS in firefighting foams
→ Proposal submitted by ECHA in January 2022
→ First restriction proposal to cover whole class of PFAS
→ Assessment covers: (petro-)chemical industry, municipal
firefighting, marine applications, airports, military
→ Proposes ban on formulation, placing on the market and use with
sector-specific time-limited derogations during which additional
risk management measures are required
→ RAC and SEAC adopted their opinions in March 2023 and June
2023 respectively
→ Both Committees support the proposed restriction while proposing
additional conditions and recommendations
→ RAC and SEAC opinions provided to Commission in August 2023
for decision-making
13
Universal PFAS Restriction proposal
→ Proposal by five countries (NL, DE, DK, SE, NO)
submitted in January 2023
→ Targets whole class of PFAS (except a few fully degradable PFAS
sub-groups)
→ Assessment covers all uses of PFAS (except firefighting foams),
including manufacturing
→ Not meant to affect other restrictions already included in REACH
or prohibitions in other applicable EU legislation (e.g. in the POPs
Regulation)
→ Evaluation by RAC and SEAC on-going
→ Consultation of the restriction proposal finalised with over 5 600
comments received
14
Committees’ evaluation – State of play & next steps
15
→ RAC-66/SEAC-60 – September 2023
• Discussion of draft opinion
• Focus on
• Scope (RAC)
• Hazard assessment (RAC)
• Food contact materials and packaging
→ RAC-67/SEAC-61 – November/December 2023
• Overview of consultation input
→ RAC-68/SEAC-62 – March 2024
• Discussion of next draft opinion
• Focus on
• Scope (RAC)
• Hazard assessment (RAC)
• Consumer mixtures
• Cosmetics
• Ski wax

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OECD Global Forum on the Environment dedicated to Per- and Polyfluoroalkyl Substances: Risk management approach to PFAS from the EU | Kristin Schreiber, Valentina Bertato and Bastian Zeiger

  • 1. 1 Risk management approach to PFAS, EU perspective • Challenges in addressing PFAS pollution Kristin Schreiber, European Commission, Director Chemicals, Health, Retail and Agrifood, DG GROW • Overview on strategy and environmental legislation Valentina Bertato, European Commission, DG Environment • Risk management measures under REACH and CLP Bastian Zeiger, European Chemicals Agency
  • 2. • Serious human health and environmental concern. • Used in critical applications needed for twin transition to a green and digital economy and strategic autonomy. • Balanced approach 2 Challenges in addressing PFAS pollution Source: EEA
  • 3. Overview on strategy and environmental legislation 3
  • 4. 4 EU policy framework • CSS and PFAS action plan: not only about REACH restrictions • While restrictions address the problem at the source, we need to deal with existing contamination • We need to use all regulatory frameworks • Push to other legislations also thanks to CSS
  • 5. 5 Action on PFAS in EU legislation REACH restrictions: PFHxA, PFAS in fire-fighting foams, UPFAS POPs Regulation F-gas Regulation Drinking Water Directive Water Framework Directive Groundwater framework directive Food Contaminants Regulation Industrial emissions directive and E-PRTR
  • 6. • POPs Regulation • Already lists PFOS, PFOA and PFHxS • Future: C9-C21 PFCAs • PFAS in water: • Revised Drinking Water Directive: limit of 0.5 µg/l for PFAS Total and 0.1 µg/l for the Sum of 20 PFAS (EiF in Jan 2021; 2 years for MS to transpose it into national legislation). • COM is finalising the technical guidelines for the methods for monitoring ‘Sum of PFAS’ and ‘PFAS Total’ • Member States must apply one or both of the parameters (compliance by Jan 2026) Action on PFAS under other EU legislation
  • 7. • PFAS in water: • COM proposal amending the Water Framework Directive, the Environmental Quality Standards Directive and the Groundwater Directive • Adding 24 PFAS to the list of priority substances in surface water and to the list of pollutants in groundwater • EP adopted compromise amendments (Sep 2023), Council has not yet formulated a common position 7 Action on PFAS under other EU legislation
  • 8. • PFAS in food: • Maximum concentration levels of certain PFAS in food (Commission Regulation (EU) 2023/915) • Monitoring of PFAS in food (Commission Recommendation (EU) 2022/1431) • Monitoring of PFAS in feed (Commission Recommendation targeted for adoption Q1 2024) • Industrial emissions and E-PRTR • Under discussion in Council and Parliament (provisional agreement, adoption expected in March 2024) • New industrial emission portal: proposed to include PFOA and PFHxS • New IED: chemicals specific provisions (chemicals inventory, on-site risk assessment, analysis of alternatives, role for ECHA in the BREF process) 8 Action on PFAS under other EU legislation
  • 9. • F-Gas Regulation • Primary focus to reduce climate impact of F-gases, BUT many F-gases are PFAS as they degrade to TFA • Will apply as from around March 2024, to be reviewed in 2030 • Includes measures to • Prevent emissions from uses, products and equipments • Reduce F-gas supply to the market (HFC quota systems and F-gas prohibition on placing on the market) • Prohibitions on placing on the market that de facto will ban PFAS F-gases (examples): • Domestic refrigerators and freezers (2026) • Small AC/heat pumps: 2032 or 2035 • Insulation foams: 2033 9 Action on PFAS under other EU legislation
  • 11. PFAS – Existing/on-going regulatory actions → PFAS already subject to [or pending] restrictions: • Link to POPs Regulation (see Part 1) • REACH Regulation: C9-C14 PFCAs; TDFAs; [PFHxA], [PFAS in firefighting foams] → PFAS identified as Substances of Very High Concern (SVHCs) under REACH • E.g. HFOP-DA (GenX), PFBS → Some PFAS undergoing substance evaluation under REACH → Some PFAS have a harmonised classification under CLP 11
  • 12. Restrictions under REACH → Any conditions on the manufacture, use or placing on the market of substances, mixtures or articles → Proposed by EU Member States or by ECHA • Restriction proposal subject to open consultation for 6 months → Evaluated by two scientific committees (RAC and SEAC) • RAC and SEAC opinion → Decision by European Commission with EU Member States (REACH Committee) 12
  • 13. Proposal to restrict PFAS in firefighting foams → Proposal submitted by ECHA in January 2022 → First restriction proposal to cover whole class of PFAS → Assessment covers: (petro-)chemical industry, municipal firefighting, marine applications, airports, military → Proposes ban on formulation, placing on the market and use with sector-specific time-limited derogations during which additional risk management measures are required → RAC and SEAC adopted their opinions in March 2023 and June 2023 respectively → Both Committees support the proposed restriction while proposing additional conditions and recommendations → RAC and SEAC opinions provided to Commission in August 2023 for decision-making 13
  • 14. Universal PFAS Restriction proposal → Proposal by five countries (NL, DE, DK, SE, NO) submitted in January 2023 → Targets whole class of PFAS (except a few fully degradable PFAS sub-groups) → Assessment covers all uses of PFAS (except firefighting foams), including manufacturing → Not meant to affect other restrictions already included in REACH or prohibitions in other applicable EU legislation (e.g. in the POPs Regulation) → Evaluation by RAC and SEAC on-going → Consultation of the restriction proposal finalised with over 5 600 comments received 14
  • 15. Committees’ evaluation – State of play & next steps 15 → RAC-66/SEAC-60 – September 2023 • Discussion of draft opinion • Focus on • Scope (RAC) • Hazard assessment (RAC) • Food contact materials and packaging → RAC-67/SEAC-61 – November/December 2023 • Overview of consultation input → RAC-68/SEAC-62 – March 2024 • Discussion of next draft opinion • Focus on • Scope (RAC) • Hazard assessment (RAC) • Consumer mixtures • Cosmetics • Ski wax