1. FPP4EU and
PFAS REACH restriction
Patricia Muñoz
FPP4EU Sector Group Manager
The European Chemical Industry Council, AISBL – Rue Belliard, 40 - 1040 Brussels – Belgium
Transparency Register n°64879142323-90
8 March 2023
2. Who are we
Universal PFAS restriction
PFAS and PFAS applications
Call for action
The Collaboration Platform
3. Who are we
Universal PFAS restriction
PFAS and PFAS applications
Call for action
The Collaboration Platform
4. 4
There are theoretically
hundreds or even millions
of PFAS molecules
Substances that contain at least one
fully fluorinated methyl (CF3-) or
methylene (-CF2-) carbon atom (without
any H/Cl/Br/I atom attached to it).
Note: This includes among others short and long chain PFAS, fluoropolymers and F-Gases.
PFAS definition
25. Who are we
Universal PFAS restriction
PFAS and PFAS applications
Call for action
The Collaboration Platform
26. Vision – in a nutshell
We understand and support the need for balanced regulatory action on PFAS.
We seek to aid EU policymakers in achieving the ambitions set out in the EU Green Deal.
Aim is to come jointly to a final regulatory measure which:
• is science-informed, implementable, and enforceable;
• enables the EU to meet its Green Deal, economic and other policy objectives.
Our plans:
• obtain common understanding of what a PFAS restriction under REACH may look like,
• collaborate and engage in constructive dialogues with all EU stakeholders,
• support further research and data generation to fill potential data gaps.
Introducing FluoroProducts and PFAS for Europe
26
27. Who are we?
Membership
Represents producers, importers and users
of the many potential substances
that fall within the broad definition of PFAS.
27
28. How are we organized?
Grouping
Sub team
Advocacy/Comms
Working Group
(Eco)Toxicology
Working Group
Technical
Working Group
Management
Committee
Collaboration Platform
28
29. Who are we
Universal PFAS restriction
PFAS and PFAS applications
Call for action
The Collaboration Platform
30. • Objective of the Universal PFAS (U-PFAS) restriction
Starting point is a BAN on PFAS:
Regularity option 1: no derogations and a transition period of 18 months
Regulatory option 2: some use-specific derogations
• Justification by the 5 Competent Authorities:
Persistence is key for justifying the restriction in terms of risk, all PFAS are persistent by
themselves or degrade to other persistent PFAS
There are other concerns (mobility, toxicity, ….) that vary among PFASs
Emissions need to be addressed: estimated emissions of about 4.4 million tones over 30 years if
no action taken
• Scope
Very broad, includes fluoropolymers, perfluoropolyethers, F-gases and side-chain fluorinated
polymers. Some PFAS deemed non persistent are excluded
The U-PFAS restriction proposal
30
31. • An unprecedent restriction that imposes a ban on the manufacturing, placing on
the market and use of PFAS, together with a ban on placing on the market of
mixtures or articles containing PFAS above a specific concentration level, and
includes use specific derogations.
• PFAS used in industry settings are included in the scope.
31
The U-PFAS restriction proposal
If a use is not derogated = banned 18m after Entry into Force (EiF)
32. Three main types of derogations:
• Exclusion (time-unlimited derogation) for active substances in biocidal, plant protection and
human & veterinary medicinal products (with a reporting obligation).
• Evidence-based time-limited derogations (6.5 or 13.5 years after EiF):
cover specific uses in food contact materials, medical devices, membranes in fuel cells,
refrigerants, insulating materials, textiles, etc.
• Time-limited derogations (6.5 or 13.5 years after EiF) with a weak base evidence:
cover inter alia certain uses of PFAS in textiles (incl. PPE), very specific industrial uses,
engineered fluids for medical devices, transport applications, etc.
The U-PFAS restriction proposal
32
33. • Plant production products, biocides and human & veterinary medicines active
substances derogated, but no derogation for intermediates, processing aids.
• 46 time-limited derogations on very specific uses. Most of them covering industrial
and professional uses, medical devices, textiles (PPE) and refrigerants.
• Consumer uses e.g. cosmetics, home and electronic appliances, textiles ( besides PPE)
etc. are banned with few exceptions.
• The objective of the proposal submitted by the competent authorities is to ban the
manufacture, production, use and import of PFAS in EU.
Conclusions and impact
33
34. The U-PFAS restriction
The proposal of the dossier submitters will ban an unprecedent number of PFAS uses
We have compared the proposal with a study done on the uses of PFAS and only 3% of
those uses will be covered by the derogations
Impact: Glüge report and the derogations proposed in the U-PFAS Restriction proposal
279
48
11 11
349 NON-EXHAUSTIVE USES IDENTIFIED
IN GLÜGE
NOT EXPLICITLY COVERED
POTENTIALLY PARTIALLY COVERED
POTENTIALLY COVERED
UNKNOWN
34
35. Page 35
* Assuming the earliest possible timeline.
The restriction proposal – indicative timeline
Dossier
Preparation
WE
ARE
HERE
Political
process
5 CA submits
dossier
13 January
6-month public consultation
22 March ‘23 – 22 Sep ’23
ECHA sends compiled
opinions to COM
~ Q2 ‘24
60-day public
consultation on
SEAC DO
Dec ’23- Feb ’24?
RAC & SEAC
Plenary
RAC-64: 15
March
SEAC-58: 10
March
RAC & SEAC Plenary
(RAC opinion and SEAC
draft opinion*)
RAC-67: Late Nov
SEAC-61: Late Nov
– Early Dec
ECHA publishes
dossier
7 February
RAC & SEAC
Plenary
RAC-65:
Early Jun
SEAC-59: Early –
Mid Jun
RAC & SEAC
Plenary
RAC-66:
Mid Sep
SEAC-60: Early
– Mid Sep
SEAC adopts
final opinion*
SEAC-62: Early
– Mid March
RAC opinion development
SEAC opinion development
Publication in OJ
~ Q4 ’25 or Q1 ‘26
EiF
Following EU
Commission
proposal, scrutiny
by EP & Council
ECHA & COM process (18-24 months)
5 CA RoI
Jul ‘21
Last updated: Feb 2023
COM adoption
~ Q4 ’24 or Q1 ‘25
5 CA extension
of submission
date
Feb ‘22
Public Consultation Period
REACH
Committee
ECHA process
RAC-65 REST WG
Mid May
RAC-66 REST WG
Late Aug
RAC-67 REST WG
Early Nov
2023 2024
22 May
Intermediate deadlines for specific points
22 July
• RAC plenary is typically held for one
week, and SEAC is for two weeks.
• RAC working groups are organised
to clarify some topics and used to
sort out issues. Main discussions
are more and more taking place in
the working groups and less in
plenary - presence of experts is
recommended.
22 September
36. Who are we
PFAS REACH restriction
PFAS and PFAS applications
Call for action
The Collaboration Platform
37. FPP4EU covers a complex sector
We are dealing with hundreds of substances with diverging properties,
used in many applications across an extended value chain.
37
39. We organise meetings to discuss the potential impact of the restriction
on different sectors, in compliance with competition law;
We organise workshops where regulators are invited to explain the
proposal and its potential consequences for the industry;
We exchange relevant information focused on the U-PFAS restriction
including the understanding the restriction process and the parties'
proposals;
39
Collaboration Platform
40. We collect examples of PFAS used throughout different value chains
in the EU – Case studies.
We only work in non-exhaustive specific example lists’ form; never
claiming that no alternative exists and never favouring one substance
over another!
We aim to open the doors for individual sectors to defend their own
cases.
Collaboration Platform
40
42. Who are we
Universal PFAS restriction
PFAS and PFAS applications
Call for action
The Collaboration Platform
43. Call for action: we invite you to…
43
Participation is free of charge!
Join our Collaboration Platform!
44. Page 44
Call for action: we invite you to…
Collect data on
• (non-)availability
of alternatives to PFAS
• realistic emission
control measures
Analyse
• where the restriction
may have an impact
(incl. equipment used
onsite)
• current emission
control measures
Feed data into public
consultations on
• (non-)availability of
alternatives
• cost impact*
• initiatives to reduce
emissions
Contact us
• on the lengthy and
complex process
• on the complex PFAS
file
* Cost impact typically includes
• producer surplus losses
• employment losses
• consumer surplus losses
• welfare losses
45. Selected case studies of
PFAS applications
Stefanos Geros
EU Policy & Advocacy Advisor
The European Chemical Industry Council, AISBL – Rue Belliard, 40 - 1040 Brussels – Belgium
Transparency Register n°64879142323-90
8 March 2023
46. • Heat Pumps: A future-proof solution
for sustainable heating and cooling;
• The EU has committed to reach climate
neutrality by 2050;
• Decarbonisation of the heating and
cooling sector a key element of
Europe’s climate strategy;
• Could help avoid up to 570 million tons
of CO2 emissions from fossil fuels until
2050;
• F-Gases are used in the refrigeration
cycle.
Renewable energy
46
47. • PFAS in pharmaceutical drugs to
battle cancer;
• The API Sorafenib has been proven
to be effective against kidney, renal,
pelvic, thyroid, hepatocellular (HCC)
and liver cancer;
• It slows down cancer cell growth
and prevents blood supply to cancer
tissue;
• Approximately 2.5 to 5 million doses
of Sorafenib are applied per year in
Europe;
• PFAS also used in the production
process of medication and vaccines.
Medical sector
47
48. • PFAS are used throughout the food
sector;
• Proper lubrication of ovens reduces
wear of the equipment;
• High temperature stability and
lubricity;
• Help companies prolong the lifetime
of their production equipment;
• Food gases are used to naturally
preserve food products and prolong
expiration dates;
• F-Gases used in industrial
refrigerators.
Food sector
48
49. • PFAS used in different car parts;
• Lithium-ion traction batteries and
fuel cells rely significantly on
fluoropolymers;
• Fluorinated gases (F-gases) are used
for cooling and heating the cabin;
• Fluoropolymers and fluorotelomers
are crucial for vehicles’ safety,
power electronics and infotainment
systems;
• Lubrication of numerous
components within a vehicle.
Automotive
49
51. For any questions please contact:
Patricia Muñoz
FPP4EU Sector Group Manager
pmu@cefic.be
THANK YOU !
The European Chemical Industry Council, AISBL – Rue Belliard, 40 - 1040 Brussels – Belgium
Transparency Register n°64879142323-90
8 March 2023
Notes de l'éditeur
The current leading technology in electric vehicles are lithium-ion traction batteries and fuel cells, which rely significantly on fluoropolymers. They provide important performance and safety attributes that guarantee lithium-ion batteries ‘safety, high energy density, power delivery and longer lifespan.
F-gases with very low Global Warming Potential are used for cooling and heating in the cabin as well as for cooling the battery.
Fluoropolymers and fluorotelomers are crucial for vehicles’ safety, power electronics and infotainment systems, among others, they are used in semiconductors, membranes and technical textiles.
Data centres used for storage or data processing rely heavily on PFAS. By immersing IT hardware in data centres in a non-conductive fluorochemical liquid, the need for chiller-based air cooling is eliminated.
Fluoropolymers and fluorotelomers are key in semiconductor manufacturing, protecting the wafer from getting burned during the etching process.
Expanded polytetrafluoroethylene (ePTFE) membranes safeguard built-in speakers and microphones.
Active pharmaceutical ingredients (API) in medicinal products containing fluorine play a key role in modern day cancer therapy.
PFAS in the form of fluoropolymers and fluororubbers are used in laboratory equipment as these materials are characterised by high resistance levels against chemicals and extreme purity.
PFAS are also used in vacuum technology, a method required in all areas of science and technology, in many production processes and research.
F-Gases possess unique characteristics that enable heat pumps to operate despite the complexity of the parameters that need to be taken into account.
Lithium-ion batteries rely heavily on PFAS. Fluorochemicals are present in the electrolyte to function as a conductive salt and as performance enhancing additives. The oxidation stability of fluorinated polymers enables their use in cathode materials, and are also fit for purpose for future materials which are more sustainable, less expensive, and less dependent on critical raw materials such as cobalt.
Polytetrafluoroethylene (PTFE) and Fluorinated ethylene propylene (FEP) are materials of choice for sealing components used in the production, transport and storage of green hydrogen.
Plane engines can heat up to such levels that sealants are exposed to temperatures of over 200°C. (Per-)Fluoroelastomers are currently the only elastomeric compounds resilient enough to withstand the extreme thermal, mechanical and media exposure.
Electrical cables need to be flexible and resistant to high as well as low temperatures in planes, which can go as low as -70°C. PFAS are used in this application due to their exceptional electrical and resistance properties, fire and flame retardancy, retention under a wide range of temperatures, and exposure to specialty fuels that may be chemically aggressive.
It is important that the lubricants used in baking ovens have high temperature stability and lubricity. Lubricants based on PFAS are designed for extended life-time or even for-life lubrication. They help companies prolong the lifetime of their own technical products as well as their production equipment.
Hydrofluorocarbons (HFCs) and Hydrofluoroolefins (HFOs) are widely used F-Gases in commercial refrigeration, since they are highly energy efficient, and are characterised by low levels of toxicity and flammability. These F-Gases allow the refrigeration cycle, meaning the transfer of heat from one place to another, to work in a safe and energy efficient manner. System performance and energy efficiency can potentially have a far greater effect than the Global Warming Potential of the refrigerant itself.
When constructed with other components, such as textiles and flame-resistant technologies, the resulting ePTFE-based fabrics provide advanced thermal and mechanical properties needed to protect against the hazards for the electric arc flashes. The benefits of arc-rated protective ePTFE-based fabrics made using fluoropolymers and other fluoromaterials are multiple. They safeguard the health and wellbeing of the wearer by providing waterproof, windproof, and breathable benefits and in addition highly functioning, protective characteristics.
Note: This case study is also featured at the end of the presentation so maybe skip this part and present it later.
Spray polyurethane foam (SPF) is a foam insulation with blowing agents that enable the foam to expand and harden during application, effectively sealing any cracks, joints, or seams. HFOs (Hydrofluoroolefins) act as blowing agents in the production of insulation foams. HFOs have unique physical properties enabling energy efficiency innovations for a range of different applications and can play an integral part in achieving the goals of the European Green Deal.
PFAS are used in a wide range of applications within industrial settings. From filtration and separation media used in high performance air and liquid applications, to coatings used in pipes and expansion joints.
PFAS are used in pipes, expansion joints, vessels, and fittings extensively in the chemical processing industry, with the objective to protect equipment from direct contact at high temperatures (up to 230°C) and very aggressive media.
Polytetrafluoroethylene (PTFE) based materials are essential components of highly reliable sealing mechanisms such as gaskets, which fill the space between interconnected machines or storage containers, allowing the use and transportation of hazardous chemicals.
