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Annex to the

ANNEX XV RESTRICTION REPORT

PROPOSAL FOR A RESTRICTION

SUBSTANCE NAME(S): Per- and polyfluoroalkyl substances (PFASs)

IUPAC NAME(S): n.a.

EC NUMBER(S): n.a.

CAS NUMBER(S): n.a.

CONTACT DETAILS OF THE DOSSIER SUBMITTERS:

BAuA
Federal Institute for Occupational Safety and Health
Division 5 - Federal Office for Chemicals
Friedrich-Henkel-Weg 1-25
D-44149 Dortmund, Germany

Bureau REACH, National Institute for Public Health and the


Environment (RIVM)
Antonie van Leeuwenhoeklaan 9
3721 MA Bilthoven, The Netherlands

Swedish Chemicals Agency (KEMI)


PO Box 2,
SE-172 13 Sundbyberg, Sweden

Norwegian Environment Agency


P.O. Box 5672 Torgarden
N-7485 Trondheim, Norway

The Danish Environmental Protection Agency


Tolderlundsvej 5
5000 Odense C, Denmark

VERSION NUMBER: 2

DATE: 22.03.2023

P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Version history

Version Changes Date


1 Original version for pre-publication February
2023
2 A.2.1.6. – Update of table A.3 and A.4 March
A.3.10.1.11. – addition of a reference 2023

TABLE OF CONTENTS
Annex A Manufacture and uses .....................................................................1

A.1. Introduction ................................................................................................................... 1

A.2. Manufacture, import and export ....................................................................................... 6

A.2.1. PFASs manufacture.................................................................................................. 6

A.2.2. Import ..................................................................................................................18

A.2.3. Export ...................................................................................................................19

A.3. Uses ............................................................................................................................20

A.3.1. Summary ..............................................................................................................20

A.3.2. Introduction ...........................................................................................................23

A.3.3. Textiles, upholstery, leather, apparel and carpets ......................................................26

A.3.4. Food contact materials and packaging ......................................................................37

A.3.5. Metal plating and manufacture of metal produc ts .......................................................48

A.3.6. C onsumer mixtures ................................................................................................52

A.3.7. C osmetics..............................................................................................................54

A.3.8. Ski wax .................................................................................................................57

A.3.9. Applications of fluorinated gases ..............................................................................62

A.3.10. Medical devices ....................................................................................................79

A.3.11. Transport.............................................................................................................92

A.3.12. Electronics and semiconductors ............................................................................ 104

A.3.13. Energy sector ..................................................................................................... 118

A.3.14. C onstruction products ......................................................................................... 125

A.3.15. Lubricants .......................................................................................................... 131

A.3.16. Petroleum and mining ......................................................................................... 147

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.17. Active substances in Plant Protection Products (PPP), Biocidal Products (BP) and Medicinal
Products (MP) ................................................................................................................ 152

A.3.18. Waste................................................................................................................ 154

A.4. Uses advised against by the registrants ......................................................................... 165

Appendices to Annex A............................................................................... 166

Appendix A.2. Manufacture, import and uses......................................................................... 166

Appendix A.3.2. Fluoropolymer applications, including fluoroelastomers ................................... 178

Appendix A.3.3. Textiles, upholstery, leather, apparel and carpets .......................................... 189

Appendix A.3.4. Food contact materials and packaging........................................................... 205

Appendix A.3.5. Metal plating and manufacture of metal products ........................................... 236

Appendix A.3.6. C onsumer mixtures..................................................................................... 238

Appendix A.3.7. C osmetics .................................................................................................. 242

Appendix A.3.8. Ski wax ..................................................................................................... 245

Appendix A.3.9. Applications of fluorinated gases .................................................................. 248

Appendix A.3.10. Medical devices......................................................................................... 265

Appendix A.3.15. Lubricants ................................................................................................ 271

Appendix A.3.17. Active substances in Plant Production Products (PPP), Biocidal Products (BP) and
Medicinal Products (MP) ...................................................................................................... 272

References ............................................................................................... 285

TABLES

Table A.1. Overview of PFAS applications and the level at which they were researched.......5
Table A.2. Fluorinated gas production in Europe .......................................................9
Table A.3. Main global manufacturers of fluoropolymers. .......................................... 12
Table A.4. Non-exhaustive overview of European (including UK) PFASs manufacturers ..... 13
Table A.5. Annual volumes of fluorinated gases in PFAS scope manufactured in the EEA. .. 15
Table A.6. Global and EEA fluoropolymer production volume, including PTFE and PVDF. ... 16
Table A.7. PFASs manufacturing volumes in EEA .................................................... 17
Table A.8. PFASs imported into the EEA from third countries (t/y) based on consultations. 18
Table A.9. PFASs exported from the EEA (in t/y) .................................................... 19
Table A.10. Estimated tonnages for PFAS manufacture and major PFAS use sectors ........ 21
Table A.11. Uses sorted on volume range. ............................................................ 22
Table A.12. Examples of sectors, properties, and applications of fluoropolymers. ............ 23
Table A.13. Fluoroelastomers - non-exhaustive overview.......................................... 24
Table A.14. Volumes of fluorinated gas used in the EU in 2018 (rounded numbers). ........ 25
Table A.15. Overview of different TULAC categories. ............................................... 26
Table A.16. Applied concentrations of PFASs in a range of textile products. ................... 29
Table A.17. Side-chain fluorinated polymers used for TULAC applications...................... 31
Table A.18. Tonnages of PFAS used in TULAC industry in EEA (2020). ......................... 34
Table A.19. Tonnages of PFASs used in the TULAC industry in EEA in year 2020 ............ 35
Table A.20: Total tonnages of subgroups of PFAS used per year for TULAC ................... 36

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.21. Paper and board packaging consumption .............................................. 41


Table A.22. Estimates of intentionally added PFASs................................................. 41
Table A.23. Estimates of PFAS in carton board and paper wrapping packaging ............... 42
Table A.24. Volume data (2015) used for the emission estimates from fluoropolymers ..... 45
Table A.25. PFAS EEA volume per year per sub-use. ............................................... 46
Table A.26. Volumes of PFAS estimated to be used in food, feed and packaging industry .. 47
Table A.27. Uses of PFASs in metal plating processes and manufacture of metal products. 49
Table A.28. PFAS volumes in metal plating processes and manufacture of metal products . 50
Table A.29. Main PFAS and identified properties in cosmetics..................................... 54
Table A.30. Share of cosmetic products and product versions containing PFAS*. ............ 55
Table A.31. Calculated total amount of cosmetic products sold per year in the EEA ......... 56
Table A.32. Total annual PFAS volume per main cosmetics category in EEA. .................. 56
Table A.33. Overview of different ski wax types (both grip and glide wax). ................... 57
Table A.34. Overview of different ski wax composition. ............................................ 59
Table A.35. Assumed production rates ................................................................. 61
Table A.36. Yearly total volume of HFCs and PFCs in EEA per main use category. ........... 70
Table A.37. Fluoropolymers used in medic al devices................................................ 84
Table A.38. Yearly total volume of side-chain fluorinated PFASs ................................. 88
Table A.39. Overview of usage and/or production volumes of polymeric PFASs............... 89
Table A.40. Yearly total PFAS volume in EEA per main medical use category. ................ 90
Table A.41. Overview of uses of PFASs in the transportation sector. ............................ 92
Table A.42. PFASs used in the transportation sector. ............................................. 100
Table A.43. Stakeholder information on the volumes of polymeric PFASs .................... 102
Table A.44. Polymeric PFASs volumes used in coatings and finishes .......................... 103
Table A.45. PFAS properties relevant to the electronics and semiconductor industry ...... 104
Table A.46. Uses in electronic products and components (including semiconductors) ..... 104
Table A.47. Uses of PFASs in the production process ............................................. 105
Table A.48. Uses and properties of PFASs in the electronics industry ......................... 106
Table A.49. Uses and properties of PFASs in the semiconductor industry .................... 111
Table A.50. Estimated yearly PFASs use in the electronics and semiconductor industry .. 116
Table A.51. Estimated yearly PFASs use in the electronics and semiconductor industry .. 116
Table A.52. PFAS properties relevant to the energy industry ................................... 118
Table A.53. PFASs uses in the energy industry..................................................... 118
Table A.54. Identified uses and application of PFASs in the energy industry................. 119
Table A.55. Estimated yearly PFASs use in the energy sector in the EEA. .................... 123
Table A.56. Estimated yearly PFASs use in the energy sector in the EEA. .................... 123
Table A.57. Identified PFAS uses, technical function and examples of PFAS ................. 125
Table A.58. Estimated PFASs volumes in building materials/construction products ........ 130
Table A.59. Non-exhaustive list of PFASs uses in lubricants..................................... 135
Table A.60. Estimated PFASs volumes in lubricants used in the EEA in 2020. ............... 145
Table A.61. Main PFASs uses in petroleum industry. .............................................. 148
Table A.62. Summary of polymeric PFASs used in the petroleum and mining industries. . 149
Table A.63. Baseline projections (including UK) for volumes of PFASs and fluoropolymers 150
Table A.64. Active substances in PPP, BP and MP and their respective regulations. ........ 152
Table A.65. PFAS numbers, used as active substances in PPP, BP, and MP. ................. 153
Table A.66. PFAS entering the solid waste stage. ................................................. 155
Table A.67. PFAS tonnages entering the solid waste stage (t/y in EEA). ..................... 155
Table A.68. Collected fluoropolymer waste in Europe in 2020 per industry segment....... 157
Table A.69. Summary of numbers and capacity of European waste incinerators............ 162
Table A.70. PFAS from the OECD and REACH registry database combined................... 166
Table A.71. Volume bands of PFASs non-polymers with unsaturated bonds. ................ 175
Table A.72. Volume bands of perfluoroethers non-polymers with saturated bonds. ........ 176
Table A.73. A summary of annual imports of PFAS chemicals from third countries......... 176
Table A.74. A summary of annual exports of PFAS chemicals................................... 177
Table A.75. Non-exhaustive overview of common commercial FPs and their applications 178
Table A.76. Non exhaustive overview of common commercial FPs and their applications. 182
Table A.77. Uses and applications for unspecified fluoropolymers ............................. 188
Table A.78. Requirements/Standards relating to PPE (specific technical standards) ....... 189

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.79. Summary of data used for estimating PFAS (surfactants) volume .............. 205
Table A.80. Substances (indicative list with some examples) used in FCM and packaging.206
Table A.81. PFAS that have been identified for all food contact and packaging use. ....... 207
Table A.82. PFAS Positively Identified as Used/Were Used in Consumer Cookware. ....... 232
Table A.83. PFAS used (or patented)................................................................. 236
Table A.84. Examples for specific PFAs used for certain applications .......................... 238
Table A.85. Sum of PFAS and TOF content for several consumer mixtures .................. 239
Table A.86. Measured PFAS content for several consumer mixtures........................... 239
Table A.87. Quantified PFAs content for a group of polishes and cleaners.................... 240
Table A.88. Determined Fluorotelomers for cleaning products, waxes and sealants........ 240
Table A.89. Quantified PFAS in cleaners ............................................................. 240
Table A.90. Sum of 45 analysed PFAS and extractable organic fluorine (EOF) .............. 241
Table A.91. Sum of 16 analysed PFAS and TOF for four different anti-fog sprays .......... 241
Table A.92. PFAS INCI names found in cosmetic products in the different databases...... 243
Table A.93. Examples of PFAS-based ski waxes, applications and normalised prices ...... 245
Table A.94. Examples of fluorine-free waxes, applications and normalized prices .......... 245
Table A.95. Fluorinated gases currently in commercial use...................................... 248
Table A.96. List of specific fluorinated gas substances ........................................... 261
Table A.97. Intended applications of EU-28 total supply of fluorinated gases. .............. 263
Table A.98. Estimation of quantities of Hydrofluoroolefins Used................................ 264
Table A.99. Medical implants and materials......................................................... 265
Table A.100. Main coatings reported ................................................................. 266
Table A.101. Main applications of PFAS in technology ............................................ 266
Table A.102. Polymers and elastomers used in medical devices................................ 267
Table A.103. List of additional uses of PFASs in medical devices ............................... 267
Table A.104. Estimated fluorinated gas greenhouse warming potential (GWP).............. 269
Table A.105. Other polymeric PFASs (non-PTFE). ................................................. 270
Table A.106. Other uses of PFAS. ..................................................................... 270
Table A.107. Examples of PFASs used in lubricant applications................................. 271
Table A.108. Non-exhaustive list of EU approved active substances for PPPs ............... 272
Table A.109. Non- exhaustive list of EU approved biocidal active substances ............... 282
Table A.110. Non- exhaustive list of active pharmaceutical ingredients (APIs).............. 282

FIGURES

Figure A.1. The lifecycle of PFASs (EC, 2020). .........................................................1


Figure A.2. Overview of PFASs groups used for impact assessment (Annex E)..................3
Figure A.3. Schematic simplified presentation of PFASs supply chain, including main uses. ..4
Figure A.4. Hydrofluoric acid (HF) use (Evich et al., 2022). .........................................6
Figure A.5. Distinction between F-gases (blue) and fluorinated gases in scope (orange). ....8
Figure A.6. Schematic presentation of timeline synthetic refrigerants.............................8
Figure A.7. Supply of HFC and HFO in EU ............................................................. 10
Figure A.8. Landscape of main fluoropolymers taken from Zeus (2019). ....................... 11
Figure A.9. Annual import, export, product ion, and consumption flows of textile products . 32
Figure A.10. Automatic Chappati making (left) and hydraulic seal kit (right). ................. 40
Figure A.11. Overview of metal plating types......................................................... 48
Figure A.12. High level market overview of ski waxes in the EEA ................................ 60
Figure A.13. Prefabricated XPS foundation insulation ............................................... 67
Figure A.14. Material Flow diagram..................................................................... 73
Figure A.15. Fluorinated gases filled into new manufactured products .......................... 74
Figure A.16. Intended applications of EU total supply of fluorinated gases..................... 75
Figure A.17. EU imports of fluorinated gases ......................................................... 76
Figure A.18. 2019 total supply by types and groups of fluorinated gases ...................... 77
Figure A.19. Supply of gases outside the scope of the PFAS restriction proposal ............. 78
Figure A.20. Proportion of PFASs (types) applied in the medical device industry ............. 87
Figure A.21. Fluoropolymer waste collection in Europe (2020) and main sectors ........... 157
Figure A.22. A car's last journey. ..................................................................... 161
Figure A.23. Functions of INCI names in cosmetics. .............................................. 242

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Annex A Manufacture and uses


Annex A contains an introduction to this Annex (A.1), information on PFAS manufacture,
import and export (A.2), and information on main uses/use sectors (A.3). For 15 sectors,
data on uses, volumes, and main PFASs applied is summarized in sections A.3.3 to A.3.17.
Finally, the waste stage of the PFAS life cycle is described in section A.3.18. In the Appendix
to Annex A, background information to uses, volumes and PFASs applied, is included.

A.1. Introduction
Many different PFASs are used in a wide range of applications. As actions taken so far have
not sufficiently addressed the concerns related to the use of PFASs, the goal is to minimise
environmental and human exposure to PFASs, at all stages of their life cycle. An illustrative
picture of the life cycle of PFASs, including manufacturing and use as well as waste
management, is depicted in Figure A.1.

Figure A.1. The lifecycle of PFASs (EC, 2020).

PFASs have typical properties like chemical inertness, radiation resistance, temperature
resistance, weathering resistance, oil-, water- and stain repellence, electrical inertness,
corrosion protection, low coefficient of friction and non-flammability. These (combined)
properties, partly the result from the very strong carbon-fluorine bond (C–F), make PFASs
useful in a very broad range of processes and products (Glüge et al., 2020; ITRC, 2022). In
particular fluoropolymers and side-chain fluorinated polymers are used in a broad range of
applications.

In their key paper on PFAS applications, Glüge et al. (2020) provide a more detailed overview
of many use categories where PFASs have been employed and for which function. The article
also specifies which PFASs have been used and discusses the magnitude of the uses. Despite
being non-exhaustive, the study clearly demonstrates that PFASs are used in almost all
industry branches and many consumer products. In total, more than 200 use categories and

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

subcategories are identified for more than 1 400 individual PFASs. In addition to well-known
categories such as textile impregnation, fire-fighting foams, and electroplating, the identified
use categories also include many categories not described in the scientific literature, including
PFASs in ammunition, climbing ropes, guitar strings, artificial turf, and soil remediation.

For this dossier, the major uses of PFASs have been identified from literature and stakeholder
consultations. Data on uses, volumes and PFASs applied was collected by approaching
stakeholders through a call for evidence (CfE) from May to July 2020. Data for different
sectors was compiled and verified by consultants and was complimented with data from public
sources. Subsequently, data was again verified by a second stakeholder consultation round
from July to October 2021. For each sector a separate report was drafted. Summarised details
on manufacture and uses, including volumes, are included in Annex A. PFAS volumes/
tonnages could, in most cases, not be disaggregated to tonnages at substance level, although
many PFAS are mentioned in the Appendix of this Annex. A more detailed description of the
data collection process is provided in Annex G.

No information is available on the participation rate of stakeholders. It is likely that not all
stakeholders provided information and that therefore the volumes presented in Annex A are
an underestimation of the actual volumes used in the sectors. Stakeholders provided in
general more data on polymeric PFASs and fluorinated gases than on non-polymeric PFASs.
Where possible data from literature was added. Sometimes assumptions regarding volumes
had to be made (see the sections on uses). A more detailed description of assumptions,
uncertainties and sensitivities is provided in Annex F.

For most sectors, a summary table is provided in which the volumes of PFASs used are
presented. The summary tables include data collected from stakeholders and from public
sources unless otherwise indicated, at the highest level of detail possible.

As described in detail in the main report and in Annex B.1, PFAS grouping in the restriction
proposal is based on the OECD 2021 PFAS report (OECD, 2021). It should however be noted
that in Annex A PFAS grouping is slightly different, the difference concerning the side-chain
fluorinated polymers (SCFPs). SCFPs are chemically speaking polymers and in that sense
belong to the polymeric PFAS group (as done by OECD), but for impact assessment purposes
they are grouped under PFAA precursors. Hence, the following three main PFAS groups were
chosen for the impact assessments, see also Figure A.2:

1. PFAAs and PFAA prec ursors (including side-chain fluorinated polymers)


2. Fluorinated gases
3. Polymeric PFASs

Per use sector, the impact assessment is performed for total PFAS and additionally for the
three main groups mentioned above. Of note, total PFAS does not only include PF ASs in the
three main groups, but also PFASs that cannot à priori be allocated to the main groups. These
non-allocated PFASs are included in the ‘Other PFASs’ group in Figure A.2.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

1. 2. 3.

PFAAs and
F-gases Polymeric PFASs
PFAA precursors

Perfluoroalkyl
Fluoropolymers
acids (PFAAs)

PFAA precursors Perfluoro


(inc. side-chain polyethers
fluorinated
polymers)

PFA As and PFA A precursors


C ontains the perfluoroalkyl acids (PFAAs), and precursors of PFAAs,
including side-chain fluorinated polymers (and pe rfluoroalkyl ether Other PFASs
side -chain fluorinated polymers); excludes F-gases.
F-gases
C ontains the gases that fulfil the PFAS de finition. Not re stricted to  C F3 on active substances
the substances m entioned by the F-gas re gulation.
 Side -chain fluorinated
Polymeric PFA Ss
C ontains fluoropolymers as PTFE, PVDF and pe rfluoropolyethers; arom atics
e x cludes side chain fluorinated polymers .  Pe rfluoroalkanes (non-
Other PFA Ss gaseous)
Contains all PFAS substances which are not covere d by the three  Pe rfluoroalkyl-tert-
m ain categories. am ines
 Pe rfluoroalkylethers
 O the rs

Figure A.2. Overview of PFASs groups used for impact assessment (Annex E).

Figure A.3 presents the structure of the PFASs supply chain. The top tier consists of the
suppliers of raw materials like fluorite (also called fluorspar, calcium fluoride, CaF 2). Raw
materials are used by manufacturers of PFASs as well as manufacturers of PFAS containing
materials (e.g. PFAAs (including PFAA precursors), side-chain fluorinated polymers and
fluorinated gases). Raw materials and production aids can either be manufactured in the EEA
or imported from third countries, either directly from manufacturers based outside the EEA
or through EEA based distributors or importers. PFASs can either be used to formulate other
PFAS containing products or be directly used by downstream users. PFASs can be placed on
the EEA market either directly by EEA based manufacturers/processors or via imports from
third countries.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.3. Schematic simplified presentation of PFASs supply chain, including main uses.

With the 15 major use sectors, the Dossier Submitters believe to have covered rather
exhaustively the PFAS uses. It is recognized though that it is impossible to be complete, given
the large number of PFASs and the broad range of processes and products they are useful
for. From literature and stakeholder consultations indeed some additional uses/applications
were identified. For these however no detailed assessment was performed, e.g. because they
concerned niche applications or because the applications are currently of little relevance in
the EU. Important to note is that although not every single application has been assessed in
detail, all applications are covered by the restriction proposal as the PFASs used eventually
end up in the environment due to releases during manufacture, use or in the waste stage.
Table A.1 presents an overview of all the more and less researched PFAS applications
(including PFAS manufacturing and waste stage).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.1. Overview of PFAS applications and the level at which they were researched.
PFAS applications

PFAS manufacture Textile, upholstery, Food contact materials Metal plating and
leather, apparel and and packaging manufacture of metal
carpets (TULAC ) products
C onsumer mixtures C osmetics Ski wax Applications of
fluorinated gases
Medical devices Transport Electronics and Energy sector
semiconductors
C onstruction products Lubricants Petroleum and mining Waste stage PFAS
applications
Laboratory equipment Plant protection C hemical industry Firefighting foam
& filtration products and biocides
Medicinal products Plastics (other than Pyrotechnics Personal care
packaging) and products other than
rubber/elastomer cosmetics
production (including
flame retardants)
Fracking (currently Immersion cooling Defence industry Printing inks
hardly applicable in (currently hardly
EEA) applicable in EEA)
C ement industry Professional cleaning Other niche Uses (yet) unknown
and polishing applications
 Green uses are researched in detail
 Blue uses are researched in general
 Orange uses not researched in detail
 Purple use: Separate restriction proposal

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.2. Manufacture, import and export


A.2.1. PFASs manufacture

A.2.1.1. Introduction

In this section, PFASs manufacturing and related processes are discussed, from the mining of
raw materials to the synthesis of specific PFASs.

All organic fluorine compounds in the supply chain are synthetically manufactured. All fluorine
used in the manufacturing of these organic fluorine compounds are made from mined fluorite
(CaF 2), also called fluorspar (Harsanyi and Sandford, 2015). About 11% of fluorite consumed
in Europe is used to produce fluoropolymers (Wahlström et al., 2021).

About half of all fluorite produced is used in iron and steel production, while the second half
is used for production of anhydrous hydrogen fluoride (HF). Almost 70% of the HF is used for
fluorinated organic substances. The link between HF and PFASs is presented in Figure A.4.
With current global reserves of 500 million tonnes fluorite, there is less than 100 years left at
the current mining level (Harsanyi and Sandford, 2015).

Figure A.4. Hydrofluoric acid (HF) use (Evich et al., 2022).

A.2.1.2. PFAA and PFAA precursors

Perfluoroalkyl acids (PFAAs) are fully fluorinated alkyl acids. Substances which can react to
form PFAA are called PFAA precursors, and include for example perfluoroalkyl iodides,
perfluoroalkane sulfonyl fluorides and perfluoroalkenes.

There are two main manufacturing methods to produce compounds containing perfluoroalkyl
chains, described in detail in Buck et al. (2011). Below are short summaries of the two
methods:

A.2.1.2.1. Electrochemical fluorination (ECF)

In the ECF method, an organic raw material (e.g. octane sulfonyl fluoride, C8H17SO2F)
undergoes electrolysis in anhydrous HF, leading to the replacement of all the H atoms by F
atoms. In this process, carbon-chain rearrangement and breakage may occur, resulting in a
mixture of linear and branched perfluoroalkyl isomers and homologues of the raw material.
When octane sulfonyl fluoride is used as a substrate in the ECF process,
perfluorooctanesulfonyl fluoride is formed. This is the major raw material used to manufacture
PFOS and its salts.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.2.1.2.2. Telomerisation

In this process, a perfluoroalkyl iodide, most commonly perfluoroethyl iodide (C 2F 5I), is


reacted with tetrafluoroethylene (CF 2=CF 2) to yield perfluoroalkyl iodides with extended
perfluoroalkyl chains. The perfluoroalkyl iodide mixture is often further reacted with ethylene
to introduce a non-fluorinated tail to the molecule. The iodide may be substituted with for
example an alcohol group for the formation of fluorotelomer alcohols (FTOH). Telomerisation
is applied at least at one site in Europe in Gendorf. Here, C6 fluorotelomers are being
produced.

A.2.1.3. Side-chain fluorinated polymers

Side-chain fluorinated polymers are polymeric PFASs consisting of variable compositions of


non-fluorinated carbon backbones with per- or polyfluoroalkyl side-chains, as well as side-
chains that partly have no fluorinated carbons.

Some examples of side-chain fluorinated polymers are fluorinated acrylate, urethane and
oxetane polymers. During the lifetime, the side-chains can be released mostly as telomeric
PFASs, (e.g. fluorotelomer alcohols) that can degrade further into perfluoroalkylcarboxylic
acids (PFCA) which is why side-chain fluorinated polymers are considered to be PFAA
precursors.

Side-chain fluorinated polymers are made by polymerisation e.g. a fluorinated acrylate or


methacrylate monomer. These fluorinated acrylate monomers are copolymerized with one or
more non-fluorinated acrylate monomers, and possibly other monomers, to give the final
side-chain fluorinated acrylate polymers. These polymers are made using fluorotelomers and
perfluoroalkane sulfonamido (meth)acrylates, but also include side-chain fluorinated siloxane
derivatives. Fluorinated urethane polymers may also be based on urethane polymers formed
by reacting fluorotelomer alcohols, or perfluoroalkane sulfonamidoethanols, with
polyisocyanate homopolymers, followed by a cross-linking step.

To provide a rough estimate of the volume range of PFAA and PFAA precursors currently
produced in the EEA, REACH registered substance datasheets were reviewed for all relevant
PFASs. These are summarised in the appendix Table A.71 and Table A.72. Estimation of the
total volume might not be accurate, due to the lack of information submitted by
manufacturers and producers of PFASs. Volumes are low (400 – 4 500, rounded) compared
to fluorinated gases and polymeric PFASs.

A.2.1.4. Fluorinated gases

Not all F-gases included in the F-gas regulation, are PFASs according to the definition used
for the restriction proposal (see section 1.1.1 of main document, e.g. HFC-22 and SF 6). On
the other hand, there are PFASs which are volatile and reside in the gaseous state which are
not in the F-gas regulation but are within the definition used for the restriction proposal. These
include for example fluorotelomer alcohols or perfluorinated trialkylamines (which are gases
in the atmosphere but liquids under normal conditions). In Annex A, unless specifically
explained, fluorinated gases are those gases that are within the definition used for the
restriction proposal (see Figure A.5). Fluorinated gases are mainly used as starting materials
in the production of fluoropolymers and as heat transfer agent in refrigeration and air
conditioning.

7
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.5. Distinction between F-gases (blue) and fluorinated gases in scope (orange).

A.2.1.4.1. Fluorinated gases as starting materials in the production of polymeric


PFASs

According to stakeholders, about 45% of fluorinated gases are used as monomers in the
production of polymeric PFASs. This means that these gases are starting materials for
fluoropolymer production and are consumed in the process. There are about 20 manufacturers
of PFASs (Table A.4). Like mentioned before, some of the fluorinated gases contain fluorine
but are not PFASs. Examples are HCFC-22, used for PTFE manufacturing, and HCFC-142b,
used for PVDF manufacturing.

A.2.1.4.2. Fluorinated gases used as refrigerants

The change in fluorinated gases use in refrigerants over time, from Chlorofluorocarbon (CFC)
through Hydrofluorocarbon (HCFC) and Hydrofluorocarbon (HFC) to Hydrofluoroolefins (HFO)
is explained in Figure A.6. There is a current transition to using HFO, due to lower global
warming and ozone depletion potential. However, many HFO can degrade to PFASs such as
TFA.

Figure A.6. Schematic presentation of timeline synthetic refrigerants .

Industry introduced CFCs as synthetic refrigerants for use in these applications in the 1930s,
leading to widespread use by the 1950s of freons, such as CFC-11, CFC-12 and CFC-13.
However, CFCs were identified as the causal agent in damage to the stratospheric ozone layer
that protects the earth from the harmful effects of ultraviolet radiation from the sun during
the 1970s, which led to their being banned under the 1987 Montreal Protocol. Subsequent
amendments increased the scope of the protocol, for example leading to the banning of HCFCs
that replaced CFCs because of lower (but not negligible) ozone depletion potential. These

8
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

measures have contributed to the phase-out of CFC use around the world, as well as the
phase-out of HCFC use to be achieved by 2030. In Europe HCFCs have been phased out
already, in accordance with the EU regulation on ozone depleting substances.

Industry developed hydrofluorocarbons (HFCs) as in-kind replacements for CFCs and HCFCs.
HFCs did not damage the ozone layer. Refrigerant examples include HFC-134a and blends of
HFCs such as R-407C. However, many HFCs have a high global warming potential (GWP)
contributing to the greenhouse effect. HFC use was addressed by the 1997 Kyoto Protocol,
an international treaty that extended the 1992 United Nations Framework Convention on
Climate Change (UNFCCC) to reduce greenhouse gas emissions. However, some HFCs are still
in use today in Europe, for certain applications and where the GWP is below a specified level
as defined in the EU F-gas regulation. This regulation has contributed considerably to the
reduction in impact of HFCs on the climate.

Hydrofluoroolefins (HFOs) are the latest generation of drop-in fluorinated refrigerants. HFOs
do not impact the ozone layer and have low GWP. However, t hese substances degrade in
various quantities in the environment to persistent substances such as trifluoroacetic acid
(TFA).

The production of HFC requires many starting materials. By-products are formed as well. See
table Table A.2 for illustration.

Table A.2. Fluorinated gas production in Europe (UBA, 2021).


Gas produced Production in t/y and EU Starting materials, intermediates, by-
productions sites (2018) products and potential minor
components
PFC -218 ≥10 to <100, Italy (1 plant)
HFC -227ea >1 000, Germany (1 plant) HC C -20 (trichloromethane, chloroform)
Hexafluoropropene (HFO-1216)
Tetrafluoroethene (HFO-1114)
HC FC -124
HC FC -22
HFC -23
HFC -134a <10 000, Germany (1 plant), HC C -1120 (trichloroethene)
France (1 plant) HC FC -131a
HC FC -132b
HC FC -133a
u-HC FO-1122
HFC -143a <1 000, France (1 plant) Unknown
HFC -365mfc <10 0000, France (1 plant) Pentachlorobutane
2-chloropropene
HFO-1234yf 10 000 – 100 000, France Unknown if this plant produces HFO-1234yf
(1 plant) + import due to legal disputes (ARKEMA, 2020)

Production of fluorinated gases is dominated by HFC, which accounts for more than 90% of
the total, with HFC-134a and HFC-365mfc accounting for the largest parts. HFC-134a (in
scope) is by far the most relevant regarding EEA production volume. It is REACH registered
in the tonnage band 10 000 – 100 000 t/y. HFC-365mfc (in scope) is registered as
confidential, so no tonnage band is available. HFC-365mfc is being produced in one plant in
Europe. HFC-134a is currently being replaced with HFO-1234yf (in scope) especially in mobile
air conditioning (for passenger cars). On a global scale Europe is not a large producer of HFC
and HCFC (Booten et al., 2020).

The trend to use the "low global warming potential" refrigerant in cooling systems is
stimulated by the F-gas regulation. HFO are key in this transition as they have low global

9
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

warming potential due to short atmospheric lifetimes. See also Figure A.7 below, which is
based on data from Table A.97 in the appendix.

Figure A.7. Supply of HFC and HFO in EU (see Table A.97), taken from EEA (2021).

One key HFO substance is HFO-1234yf. It is REACH registered in the tonnage band 10 000 –
100 000 t/y. Another key HFO substance is HFO-1234ze(E), which has been mainly used as
a foam blowing agent in polyurethane foam and as refrigerant . It is registered in the tonnage
band 1 000 – 10 000 t/y. Other important HFOs now are HFO-1336mzz(Z) (100 – 1 000 t/y)
HFO-1336mzz(E) (10 – 100 t/y).

A.2.1.5. Polymeric PFASs

Polymeric PFASs is a main group of PFASs, according to Figure A.2. It includes fluoropolymers,
perfluoropolyethers and side-chain fluorinated polymers. The latter group left out for impact
assessment purposes.

Fluoropolymers have various material properties (mechanical strength, inert, thermal


stability, resistance to degradation, etc) and are used in very diverse applications.

Fluoropolymers are made by (co)polymerisation of monomers, at least one of w hich contains


fluorine bound to one or both of the olefinic carbon atoms, to form a carbon-only polymer
backbone with fluorine atoms directly attached to it. Typical monomers used include
tetrafluoroethylene (TFE), hexafluoropropylene (HFP), vinylidene fluoride (VDF),
chlorotrifluoroethylene (CTFE), vinyl fluoride (VF), trifluoroethylene (TrFE) and perfluoroalkyl
vinyl ethers (PAVE). Figure A.8 presents an overview of widely used homo- and co-
fluoropolymers.

10
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.8. Landscape of main fluoropolymers taken from Zeus (2019).

Fluoropolymer production often requires not only fluorine containing monomers but also
fluorinated production aids. Production of fluoropolymers is performed at different levels:

 The polymerisation: Molecules that start the reaction (initiators) and catalysts may be
required, depending on the type of polymerisation.
 The medium: polymerisation is carried out in a dispersion (suspension or emulsion),
this creates a microbubble (solid or liquid) in which the polymers are formed.
Surfactants or emulsifiers are called polymerisation aids.
 Polymer processing: after the reaction is finished, the polymers are shaped into their
desired form, for example by extrusion, for which polymer processing aids are used.

Fluoropolymers are generally produced by one of two processes: emulsion polymerisation or


suspension polymerization (Lohmann et al., 2020).

A.2.1.5.1. Polymerisation aid

Polymerisation aid is the term used to describe a surfactant or emulsifier, fluorinated or non-
fluorinated. According to a stakeholder, about 50-60% of fluoropolymers are manufactured
without fluorinated polymerization aids. Examples of PFAS polymerisation aids are: PFOA,
PFNA, PFHxA, 6:2 FTSA, the ammonium salt of hexafluoropropylene oxide dimer acid (HFPO-
DA) and dodecafluoro-3H-4,8-dioxanonanoate.

Currently, industry seems to be in transition to use polymerisation aids without PFASs. Some
manufacturers, e.g. Gujarat, recently announced they can produce fluoropolymers PTFE and
PVDF without polymerisation aids containing PFASs (Chemical Watch, 2022). Four companies
have recently reported replacement of fluorinated polymerisation aids with nonfluorinated

11
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

polymerisation aids 1.

A.2.1.5.2. Polymer processing aid

Polymer processing aids are used in the extrusion of various thermoplastic polymers. Polymer
processing aids behave as lubricants and improve the extrusion quality, homogenisation of
pigments and fillers and output of thermoplastic polymers. Polymer processing aids are
fluoropolymer-based additives which perform at low concentrations as extrusion aids. They
are for instance used in blown film extrusion of linear low-density polyethylene (LLDPE). Other
applications include pipe extrusion of high-density polyethylene (HDPE). Typical processes
include blown and cast film, pipe, sheet, cable, extrusion blow moulding, monofilament, tapes
and fibres. Substances used as polymer processing aids are e.g. low molecular weight PTFE,
FEP, perfluoroalkoxy alkanes (PFA), etc. (Lohmann et al., 2020).

A.2.1.5.3. Perfluoropolyethers (PFPE)

PFPE are polymers from perfluorether monomers. One structural trait is that they have
moieties of –CnF2n-O-CmF2m- in the polymer backbone. For an overview, see the Nordic
Working Paper (Wang et al., 2020), chapter 4.

PFPEs are used as lubricants in specific industrial sectors, as well as certain consumer
applications related to surface protection.

A.2.1.6. Manufacturing sites

Globally, there are eight manufacturers, making up 60% of the worldwide PFASs market.
(Table A.3). According to a stakeholder, China’s market share is larger than indicated in Table
A.3, the stakeholder estimates a market share for all Chinese producers of >65%. S&P
Global’s (2022) mentions a Chinese market share of about 40%. Chinese manufacturers
include Fuxin Ltd., Dongyue Group, Juhua Group Corp., Changshu 3F Zhonghau and Zhejiang
Yonghe Refrigerant Co., Ltd. In Table A.3, the main manufacturers of fluoropolymers are
included (AGC Chemicals Europe, 2020).

Table A.3. Main global manufacturers of fluoropolymers.


Approximate Global Market
Manufacturers of PFASs Location
share (%)
AGC Inc. Japan / USA 4
Arkema France / C hina / USA 7
C hemours USA / Netherlands / C hina 12
Daikin Japan / USA / C hina 11
3M / Dyneon US / Japan 5
Solvay Belgium / C hina / USA 8
Shandong Donyue Group C hina 13
Archroma Germany unknown
Others Global 40

The main global manufacturers of fluorinated gases are situated in China (9 sites), Japan (4
sites), India (1 site), USA (1 site) (Seidel and Andersen, 2015).

1
https://chemicalwatch.com/439992/indian-company-plans-to-substitute-pfass-in-ptfe-production-
via-emulsion, https://www.chemours.com/en/news-media-center/all-news/press-
releases/2022/chemours-announces-process-innovation-with-new-viton-fluoroelastomers-advanced-
polymer-architecture, https://kynar500.arkema.com/en/product-information/fluorosurfactant-free/,
https://www.solvay.com/en/article/eliminating-pfas, date of access for all: 2022-12-16.

12
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

An overview of the most important European manufacturers /producers of PFASs is presented


in Table A.4.

Table A.4. Non-exhaustive overview of European (including UK) PFASs manufacturers


(stakeholder information).
Location Company Manufactured PFASs
(currently and or in past)
Italy
C ollebeato BS Daikin (Heroflon S.p.A.) PTFE compounds and micropowders

Spinetta-Marengo Solvay Solexis SPA FKM, FC -218 and PTFE


France
Pierre-Bénite C edex Arkema HFC -134a, PVDF
Salindres Solvay Trifluoromethanesulfonic acid
(TFMS), Trifluoromethanesulfonic
anhydride , Trifluoroacetic acid (TFA),
Potassium trifluoromethanesulphinate

Pierre-Benite C edex Daikin C hemical France high-performance fluoroelastomers


S.A.S (source: Daikin 2020 Public comment
PFHxA #3066.pdf)
Tavaux Solvay Solexis HFC -365mfc, PVDF, PTFE, PFBA, HFA

Villers St. Paul C hemours No specific data


Germany
Gendorf Archroma C 6 fluorotelomers, Textile C hemicals,
Paper Specialties and Emulsions on
basis of C 6 fluorotelomers
Bad Wimpfen Solvay HFC -365mfc, Solkane; 4-Ethoxy-
1,1,1-trifluoro-3-buten-2-one
(ETFBO), Trifluoroacetyl chloride
(TFAC ), Trifluoroacetic acid (TFA),
Trifluoroacetic acid anhydride
(TFAH), Trifluoroacetic acid ethyl
ester (TFAEt), Trifluoroacetic acid
methyl ester (TFAMe), Trifluoroacetic
acid isopropyl ester (TFAiP), 1,1,1-
Trifluoroacetone (TFK)
Industriepark Daikin Refrigerants refrigerant gas and pharma
Höchst,Frankfurt am Main Frankfurt GmbH propellants: HFC -227 pharma and
HFC -134a pharma
Leverkusen Lanxess No specific data

Germany = Burgkirchen Dyneon fluoropolymers, PTFE, PFA, FEP, ETFE


Belgium
Zwijndrecht Dyneon LLC (Division of compounding of fluoro-elastomers,
3M) HFP, 1,1,1,2,2,4,5,5,5-Nonafluoro-
4-(trifluormethyl)-3-pentanone
Mechelen C hemours Teflon coatings
The Netherlands
Dordrecht DuPont Performance PTFE, FEP,
Elastomers LLC C hlorotrifluoroethylenevinylidene

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Location Company Manufactured PFASs


(currently and or in past)
fluoride (FPM/FKM) Viton™
Oss Daikin C hemical Pre compounded base-polymers
Netherlands B.V.
Poland
Tarnow Zaklady Azotowe, PTFE (Tarflen)
Poland
United Kingdom (not EEA anymore)
Preston F2 C hemicals Ltd perfluorinated fluids
Runcorn, C heshire Mexichem/Koura HC FC , HFC ; Hydrofluorocarbon (HFC )
refrigerants HFC -125
Thornton-C leveley, AGC PTFE, ETFE, PFA
Lancashire

Identifying EU PFAS producers appeared complex and some production sites might have been
overlooked. The Forever Pollution project, (The Forever Pollution Project – Journalists tracking
PFAS across Europe) also identified EU PFAS producers. See:
Methodology___The_Map_of_Forever_Pollution_2023.02.23.pdf (lemonde.fr).

A.2.1.7. Volumes

A.2.1.7.1. PFAAs and PFAA precursors

Based on responses from stakeholders, the volume of PFAA and PFAA precursors
manufactured, is between 10 000 and >100 000 t.

A stakeholder estimated the volumes of side-chain fluorinated polymers manufactured and


imported in the EEA between 10 000 and 100 000 t.

Fluorinated gases

Fluorinated gases are manufactured in the EU/EEA at 92 000 t (midpoint) annually: see Table
A.5. Fluorinated gases for the European market are mainly manufactured outside of the
EU/EEA and imported, see text below Table A.3 and Table A.8. Fluorinated gases are mainly
produced for use in HVACR applications.

Annual fluorinated gas manufacturing volumes were derived from EEA reports, REACH
registrations and stakeholder information. As mentioned before, HFC and HCFC production in
Europe is low compared to China and USA: See HFO production in Europe appears to be hardly
existing. Fluorinated gases for the European market are mainly manufactured outside of the
EU/EEA and imported, see Table A.8.

The volume of HFC-134a supplied to the EEA market is around 26 000 t/y (EEA, 2020). In
the ECHA registration database, volumes of between 10 000 and 100 000 t are included. A
stakeholder confirmed this volume range.

HFC-125 and HFC-134a are used as component in refrigerant blends. In the ECHA registration
database, volumes of between 10 000 and 100 000 t of fluorinated gases that are used as
components in refrigerant blends are included. This number also includes gases that are not
PFASs. The EEA is the only region that produces HFC-365mfc, with 15 000 t produced per
year (Stemmler et al., 2007).

According to stakeholders, there is no known production of HFC-152a in EEA and according


to the European Environmental Agency, the total supply to the EEA was 3 100 t in 2019 (EEA,

14
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

2020).

In Table A.5, EEA production volumes of fluorinated gases are included. As a starting point,
the volumes of F-gases on the 2018 OECD list, that are registered under REACH in the EU,
were calculated and fluorinated gases in scope were marked. Addition of the midpoint volumes
led to a total of a production + import tonnage of fluorinated gases of 131 530 t/y.

Several fluorinated gases that are registered, to a total of 127 000 t, are not included in the
OECD list and midpoint volumes were added to the total volume. A volume of 1 285 t/y of
additional fluorinated gases, mentioned by a stakeholder, was added to the total volume as
well.

It should be noted that ECHA registrations also include imported volumes that cannot be
disaggregated from manufactured volumes. Based on EEA (2021) data this amounts to
83 267 t/y for 2019. This volume is subtracted from the total fluorinated gases manufactured
and imported in Table A.5. Very likely, the volume of 83 267 t/y is an under estimation. This
can be illustrated by an example: octafluorocyclobutane, is registered in the tonnage band
≥10 000 to <100 000 t and none of the registrants seem to be producers, so likely it is
imported to EEA. The tonnage band for octafluorocyclobutane (likely used a.o. as refrigerant)
therefore alone already covers the total reported import tonnage by EEA of 83 267 t/y.
Additional information is provided in Table A.70 in the Appendix.

The total amount of fluorinated gases manufactured, based on midpoint registrations of


volumes, is estimated to be 175 000 t/y (rounded). The EEA F-gas reporting (2021) indicates
a lower number of 15 000 t/y for 2019. The number of EEA is likely an underestimation as it
is based on (mandatory) reporting, but not all companies report. This is i.e., reflected in the
highly variable numbers of reporting companies. In the EEA these numbers are not considered
as this is not required in the F-gas reporting framework. The tonnages the Dossier Submitters
are looking for therefore could be higher. Also REACH registrations suggest far higher
tonnages.

A broad manufacturing tonnage range, between 15 000 and 176 000 t/y, the latter based on
REACH midpoint registration, is most likely. Stakeholder information on manufactured PFAS
tonnage in EEA suggested a range between 14 000 and 53 000 t/y.

Table A.5. Annual volumes of fluorinated gases in PFAS scope manufactured in the EEA.
PFAS group Volume (t/y)a
Subtotal fluorinated gases REAC H registered substances (midpoint) from 131 530
OEC D database: Manufacturing and import
Subtotal fluorinated gases REAC H registered substances (midpoint) non - 127 000
OEC D: Manufacturing and import
Subtotal fluorinated gases mentioned by a stakeholder: Manufacturing and >1 285
import
TOTAL fluorinated gases manufactured and imported 259 815
Import EEA (2021) reporting 2020 83 267b
Total fluorinated gases manufactured based on REACH registrations 176 548
(corrected with EEA import figure)
Total fluorinated gases manufactured based on EEA (2021) reporting 15 000
2019
a
REAC H midpoint registration numbers were used.
b From
(EEA, 2021).

A.2.1.7.2. Polymeric PFASs

EEA fluoropolymers volumes

Wood (2022) estimated that in 2020, around 49 000 t of fluoropolymers per year were

15
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

produced in the EEA, where processing aids were not included. For processing aids production
volumes are unaccounted for (Glüge et al., 2020). Stakeholders indicated volumes between
49 458 and 101 763 t.

ACG Chemicals estimated the EEA volumes of PTFE at 34 000 t, whereas one stakeholder
mentioned a volume of 3 500 t for PTFE as a micro-powder (AGC Chemicals Europe, 2020).
In a study in 2019, production volumes of 15 000 – 20 000 t of PVDF were estimated. During
the stakeholder consultation it was indicated that 8 300 t fluoroelastomers were
manufactured in 2018.

Worldwide fluoropolymer volumes

According to AGC Chemicals Europe, in 2018, the global fluoropolymer production capacity of
the six largest producers was 468 000 t (AGC Chemicals Europe, 2020).

The main polymers produced are PTFE and PVDF. According to industry PTFE, PVDF, and FEP,
represent approximately 80% of the total global fluoropolymer production.

K-profi, Sympatex, and AGC Chemicals estimated worldwide volumes of PTFE to be between
150 000 and 170 000 t for different years (2016, 2017, 2018) (AGC Chemicals Europe, 2020;
K-Profi, 2016; Sympatex Technologies GmbH, 2021) (Table A.6).

Estimates indicate that current PVDF production capacity in Europe is mainly available at
Solvay and Arkema. Current global PVDF production capacity is estimated to be around
80 000 t 2 but increasing mainly due to electric vehicles3.

Global and EEA production volumes for fluoropolymers with separate information for PTFE and
PVDF are provided in Table A.6.

Table A.6. Global and EEA fluoropolymer production volume, including PTFE and PVDF.
Fluoropolymer EEA volumes Source Global volumes Source
(t/y) (Publication year in (t/y) (Publication
brackets) year in
brackets)
Total 49 000 (2020) Drohmann et al. (2021) 405 000 (2020) https://www.glob
albiotechinsights.
com/articles/223
23/2020-
fluoropolymer-
technology-
highlights-by-
idtechex
PTFE 34 000 AGC C hemicals Europe 150 000 – 170 000 K-Profi (2016),
Micropowder 3 500 (2020) (2016, 2017, 2018) Sympatex
Stakeholder Technologies
consultation GmbH (2021),
AGC C hemicals
Europe (2020)
PVDF 15 000 – 20 000 Drohmann et al. (2021) 80 000 estimation Drohmann et al.
(2019) (2022) (2021)

2https://www.plasteurope.com/news/SOLVAY_t249594/, date of access: 2022-12-02.


3
https://www.icis.com/explore/resources/news/2022/06/13/10774387/belgium -s-solvay-more-than-
doubles-china-pvdf-capacity/, date of access: 2022-12-02.

16
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Worldwide perfluoropolyether volumes

Eight of the polymeric substances that are currently in the market are PFPEs (Buck et al.,
2021).

EEA PFASs manufacturing volumes

Table A.7 includes a summary of PFASs manufacturing volumes.

Table A.7. PFASs manufacturing volumes in EEA (in 2020)a.


PFAS group Low volume (t/y) Midpoint (t/y) High volume (t/y)
PFAA and PFAA 53 902 85 977 118 051
precursors
Fluorinated gases 15 000 95 774 176 548

Polymeric PFASs 49 000 75 381 101 763


Light blue cells denote PFAS volumes that have been used for impact assessment.

aThe lower and upper estimates reflect the responses to the survey, or other industry data. Some
companies reported exact figures, while others reported ranges. In some cases, companies reported
volume data as “greater than x”, with no upper bound included (e.g. “>1 000 t”). Therefore, the “upper
estimate” is not a true maximum value.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.2.2. Import

Stakeholders provided information on volumes of PFASs imported into the EEA (excluding
PFASs in articles). Data on imports of specific PFASs into the EU were also retrieved from the
Eurostat International Trade in Goods database4 and from literature. An overview is provided
in Table A.8. More details are provided in Table A.73 in the appendix.

The annual import volume of fluorinated gases was estimated to be 84 250 t (EEA, 2020).
The European Fluorocarbons Technical Committee (EFCTC), a sector group of Cefic) estimated
that illegal import could be as high as 33% of the legal EU HFC market 5. EFCTC, highlights
those Chinese exports to the EU could be 27% larger than what the EU reports as imports
from China (EFCTC, 2020).

Table A.8. PFASs imported into the EEA from third countries (t/y) based on consultations. In
brackets the reference year. Eurostat data and literature review.
PFAS group Minimum Maximum volume Eurostat (t/y) Literature (t/y)
volume (t/y) (t/y) (2019)a
(stakeholders) (stakeholders)
PFAAs and PFAA
4 053 6 120 103 586 no data
precursors
Fluorinated 84 284 (EEA,
11 500 51 800 19 198
gases 2020)
21 500 (2015)
(Wood, 2022)

37 900 (2018)
Stakeholder
15 000
36 148
Polymeric PFASs 10 419 (Wood, 2022)
Fluoroelastomer:
6 400 (2018)
Stakeholder,

15 000 (2020)
(Wood, 2022)
TOTAL 25 972 95 820 158 932 99 284
a
Eurostat data might underestimate volumes because GN/HS codes are selective. On the other hand,
presented volumes might include formulated products where PFASs are a percentage of the formulation.
b Includes bulk fluorinated gases import (73 478 t) as well as import of fluorinated gases within products

and equipment (10 806 t) based on EEA (2020).

It should be noted that these numbers do not include all PFASs and should be interpreted
with caution. EU is a net importer of fluoropolymers, with an import volume of 15 000 t in
2020 according to Plastics Europe (Wood, 2022).

4 https://ec.europa.eu/eurostat/databrowser/view/DS -045409/legacyMultiFreq/table?lang=en, date of


access: 2022-12-15.
5
https://www.fluorocarbons.org/news/illegal-trade-round-up-february-2021/, date of access:
2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.2.3. Export

The annual export volume of fluorinated gases was estimated to be 24 033 t, excluding SF6
as it is not a PFAS (EEA, 2020). Drohmann et al. (2021) estimates export volumes for
fluoropolymers at 24 000 t (2020) and stakeholders estimate the volumes at 40 500 t (2018).
Stakeholders also mention 6 900 t (2018) for fluoroelastomer export. A summary of the
volumes of PFASs exports, retrieved from Eurostat is presented in Table A.9. A detailed
overview is presented in Table A.74 of the appendix.

Table A.9. PFASs exported from the EEA (in t/y) based on consultations, Eurostat data and
literature review.
PFAS group Minimum Maximum Eurostat (t/y) Estimates from
volume (t/y) volume (t/y) (2019) literature (t/y)
(consultation) (consultation)
PFAAs and PFAA
No data No data 131 866 No data
precursors
24 033 based on
Fluorinated gases No data No data 10 371
EEA (2020)
40 500 (2018)

Polymeric PFASs 24 000 (2020) 28 718 No data


6 900 (2018)
fluoroelastomer
TOTAL 170 955

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3. Uses
A.3.1. Summary

PFASs are used in numerous applications. All these applications sooner or later reach an end-
of-life stage: The waste stage. Because of high waste tonnages and main PFAS application in
articles, the waste treatment is of higher relevance for some PFAS applications: TULAC, food
contact material & packaging, electronics and end-of-life-vehicles (ELV) are examples of such
applications.

In waste treatment landfilling and incineration are the most important final waste treatment
methods. Recycling can extend the lifetime but eventually for almost all substances, mixtures
or articles only landfilling and incineration apply. In recycling, PFASs currently cannot be
removed. It therefore can be present in recycled articles like paper or plastics.

There is no direct link between PFAS tonnage put on the market in a certain year and the
PFAS waste tonnage for that application. Applications with longer lifetimes i.e., passenger
cars or construction material, might have highly deviating waste quantities compared to
production volumes in the same year (because of lower sales volume in the past and/or lower
PFAS content in the past). As PFAS use has increased over the last deca des the waste stage
will remain an important source of PFAS emissions for many years to come, even in case of
a full PFAS ban.

The PFAS tonnages of all checked uses are summarised in Table A.10 below, based on the
grouping used for impact assessment and presented in Figure A.2.

20
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.10. Estimated tonnages for PFAS manufacture and major PFAS use sectors for 2020. Tonnages are for new products on the market,
unless stated otherwise.
PFAAs and PFAA Fluorinated gases Polymeric PFASs Total PFASs
precursors (t/y) (t/y) (t/y)
Application (t/y)

low mid high low mid high low mid high low mid high

Manufacture 53 902 85 977 118 051 15 000 95 774 176 548 49 000 75 381 101 763 117 902 257 132 396 362
TULAC b 8 092 20 620 33 148 33 091 71 318 109 544 41 183 91 938 142 692
Food contact
materials and 3 267 6 305 9 342 15 330 17 880 20 430 18 597 24 185 29 772
packaging
Metal plating and
manufacture of metal 2 30 57 960 960 960 962 990 1 017
products
C onsumer mixtures 21 26 30
C osmetics 0.028 32.1 64.2
Ski wax 1.6 1.6 1.6
Applications of 493 173 493 173 493 173 493 173 493 173 493 173
fluorinated gases c,d 30 671 30 671 30 671 30 671 30 671 30 671
Medical devices 1 279 2 387 3 495 20 160 33 080 46 000 3 233 7 633 12 032 24 672 43 100 61 527
97 216 159 712 222 208 97 216 159 712 222 208
Transportc
6 410 10 532 14 653 6 410 10 532 14 653
Electronics and
841 1 195 1 549 140 140 140 1 560 3 088 4 615 2 541 4 423 6 304
semiconductors
Energy sector 293 294 294 2 592 2 756 2 920 2 885 3 050 3 214
C onstruction products 987 1 696 2 405 4 254 7 287 10 320 5 241 8 983 12 725
Lubricants 1 6 10 70 110 150 1 100 1 550 2 000 1 171 1 666 2 160
Petroleum and mining 4.4 7 9.5 3 500 5 500 7 500 3 504 5 507 7 510
TOTAL (excl.
14 766 32 540 50 310 513 543 526 503 539 463 162 836 277 684 392 529 691 168 836 787 982 398
manufacture)e
Totalf 14 766 32 540 50 310 51 041 64 001 76 961 72 030 128 504 184 974 137 860 225 105 312 341
a: In some cases a basis for providing a range is lacking. There the available e stimate is applied throughout; b: TULAC = Textile, upholstery, leather, apparel and carpets; c: For
the se sectors the tonnages re late to “te chnical stock volume” (presented in italics), re pre senting an e stimated 2020 PFAS volume in use in the sector as a whole. For re ference
only, the tonnages brought new to m arket in 2020 are also given; d: Includes tonnages for fluorinated gases in transport se ctor; e: Total based on best available data (stock if
available, new to m arket if stock is not available); f: For re ference only, also the total new m anufacture d tonnage put on mark et in 2020 is pre sented.

21
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A summary of PFAS volumes per use category distinguished is given in the main dossier. In
Table A.11 the PFAS volume are sorted based on volume ranges.

Table A.11. Uses sorted on volume range.


Application Tonnage range

Applications of fluorinated
5
gases
TULAC 5
Medical devices 5
Manufacture 5
Food contact materials and
5
packaging
Transport 5
C onstruction products 4
Electronics and
4
semiconductors
Lubricants 4
Petroleum and mining 4
Energy sector 4
Metal plating and
manufacture of metal 3
products
C osmetics 2
C onsumer mixtures 2
Ski wax 1
Table legend
Tonnage range (t/y)
1 0 – 10
2 10 – 100
3 100 – 1 000
4 1 000 – 10 000
5 >10 000

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.2. Introduction

Many different PFASs are used in a wide range of applications, and there is no comprehensive
source of information on the many individual substances and their functions in different
applications. PFAS are used in almost all industry branches and many consumer products.
Glüge et al. (2020) presented a comprehensive overview of the applications of PFASs, and
they identified more than 200 use categories and subcategories for more than 4 700 different
PFASs.

In A.3 the use of PFASs in 15 sectors is discussed. In this section (A.3.2), a brief overview of
European use of PFASs is provided. In sections A.3.3 to A.3.17 detailed data on uses and
volumes in various sectors is presented. In A.3.18, the waste stage is discussed.

A.3.2.1. Use of PFASs

For polymeric PFASs (of which fluoropolymers and perfluoropolyethers are main subgroups
for impact assessment purposes), substantial information is available.

A.3.2.1.1. Fluoropolymers

According to Glüge et al. (2020), fluoropolymers are mostly used in the production of plastic
and rubber, coatings, paints, lubricants, greases, and in the chemical indus try. Many
fluoropolymers are used in articles that are (partly) imported. This applies to textiles,
electronics, cars, etc.

The group of fluoropolymers is dominated by PTFE, combined with fluorinated ethylene


propylene (FEP), perfluoroalkoxy alkanes (PFA), ethylene tetrafluoroethylene (ETFE), and
other tetrafluoroethylene-copolymers; they account for around 75% of the fluoropolymer
market. Other important fluoropolymers include polyvinylidene fluoride (PVDF) and
fluoroelastomers.

Fluoropolymers are used in a variety of sectors requiring properties such as:

 chemical resistance and inertness


 thermal stability
 cryogenic properties
 low coefficient of friction
 low surface energy
 low dielectric constant
 Resistant to UV degradation
 Resistant to degradation by hydrolysis
 High levels of bio-resistance (resistant to biological contaminants)

For an extensive overview on fluoropolymers, see Table A.75 and Table A.76.

Table A.12 below illustrates a selection of sectors where fluoropolymers are used and for
which applications certain fluoropolymers have proven suitable due to their specific
properties.

Table A.12. Examples of sectors, properties, and applications of fluoropolymers 6.


Sectors Properties Applications
Mechanical property, thermal O-rings, gaskets, valve stem
Automotive
property, chemical property, seals, shaft seals, linings for

6
https://www.sciencedirect.com/topics/materials-science/fluoropolymer, date of access: 2022-12-15.

23
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Sectors Properties Applications


and friction property fuel hoses, power steering,
transmission, lubricants, and
coatings
C oatings for heat exchangers,
pumps, diaphragms, impellers,
C hemical resistance,
tanks, reaction vessels,
C hemical industry mechanical property, thermal
autoclaves, containers, flue
property, and weather stability
duct expansion joints, heavy-
wall solid pipe and fittings
Electrical insulation, flexible
Dielectric constant, flame
printed circuits, ultrapure
Electrical/electronic resistance, and thermal
components for semiconductor
stability
manufacture
Water-repellent fabric,
Weatherability, flame architectural fabric, non-stick
Architectural and domestic retardancy, friction property, coatings for cookware, and
thermal stability fiberglass composite for
constructions
Mechanical property, thermal Seats and plugs, bearings, non-
stability, chemical stability, stick surfaces, coatings for
Engineering
weatherability, and surface pipes, fittings, valve and pump
energy parts, and gears
Surface energy, biological
C ardiovascular grafts, ligament
Medical stability, mechanical property,
replacement, and heart patches
chemical resistance

A.3.2.1.2. Fluoroelastomers

Fluoroelastomers have high heat and flame resistance, and good resistance to ageing, ozone,
oxidizers, oils and many chemicals. They also have low gas permeability and low compression
set. However, they usually have only limited low temperature capabilities, although some
special lower temperature grades are available. They have limited resistance to steam, hot
water, and polar fluids such as strong organic acids (e.g. formic acid), methanol, ammonia
and some amines and are swollen by ketones and ethers, whereas new peroxide cured grades
have somewhat improved chemical resistance. They can also become glassy at temperatures
not far below room temperature. Principal applications are as temperature-resistant O-rings,
seals and gaskets as illustrated in table Table A.13 of non-exhausted specific uses and
applications overview in various industrial sectors.

Table A.13. Fluoroelastomers - non-exhaustive overview over specific uses and applications
in various industrial sectors7 .
Automotive Aerospace Industrial
Shaft seals O-ring seals in fuel, Hydraulic O-ring seals
lubrication, and hydraulic
systems
Valve stem and valve seals Manifold gaskets C heck valve balls
Fuel injector O-rings Fuel tank bladders Military flare binders
Fuel hoses and fuel hose liner Firewall seals Diaphragms
In-tank and quick connect fuel Engine lube siphon hose Electrical connectors
system seals

7
https://www.sciencedirect.com/topics/engineering/fluoroelastomers , date of access: 2022-12-15.

24
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Gaskets (valve and manifold) C lips for jet engines Flue duct expansion joints
Balls for check valves Electrical connectors Valve liners
Heat-sealable tubing for wire Shaft seals US FDA approved seals in
insulation food handling processes
Bellows for turbocharger Traps for hot engine Industrial roll covers (100%
lubricating systems lubricants FKM or laminates with other
elastomers)
Lathe cut gaskets Tire valve stem seals Safety clothing and gloves
Engine head gaskets Heat-sealable tubing for wire V-ring packers
and cable insulation

USA based Interstate Technology and Regulation Council (IPRCO) provided an overview of
PFAS uses with a specific section for fluoropolymers (ITRC, 2022).

According to AGC chemicals, a total of 50 900 t of fluoropolymers were used in 2018 in


western Europe8. AGC Chemicals estimated the European consumption of PTFE to be 34 000 t.

According to PlasticsEurope (Wood, 2022), 40 000 t of fluoropolymers is used in 2020 in the


EEA. With yearly 49 000 t production and 15 000 t import and 24 000 t export.

The automotive industry is the main user of FKM, a fluoroelastomer (64%), followed by
chemicals/plastics (11%), aerospace (9%)and other (16%).

Worldwide fluoroelastomer consumption was estimated to be 13 800 t in 2019 (Ebnesajjad,


2021).

For fluorinated gases, a volume of 69 000 t/y (2018) was found, see Table A.14 (rounded
numbers)(UBA, 2021). This number excludes HFO use in Europe (which is on the rise)
(Nystedt, 2022).

Table A.14. Volumes of fluorinated gas used in the EU in 2018 (rounded numbers).
Substance name EU 2018 fluorinated gas use (t/y)
HFC -125 13 000
HFC -134a 33 000
HFC -143a confidential
HFC -227ea 1 400
Other HFC 4 100
HFO-1234yf 11 000
Other HFO and HC FO 6 300
TOTAL 68 800

For the use of PFAA and PFAA precursors in the EEA, no information was available.

8
https://www.agcce.com/fluoroplastics/, date of access: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.3. Textiles, upholstery, leather, apparel and carpets

A.3.3.1. Uses

PFASs have commonly been used across multiple Textiles, Upholstery, Leather, Apparel and
Carpets (TULAC) products, as well as in mixtures for re-impregnation of different TULAC
products. The key function that PFASs provide in these applications are water and oil
repellence. Based on a review of a paper by Glüge et al. (2020), as well as further literature
and industry input (through the CfE and second stakeholder consultation round), a number
of specific application categories within the TULAC sectors have been identified. Table A.15
demonstrates the major use categories that are within the scope of this Annex XV dossier
along with key sub uses and the functionality that PFAS provides for these products.

Note that medical devices can also include textiles in some cases. Medical devices are covered
by a separate part of the Annex XV dossier (see paragraph A.3.10). To maintain clarity,
medical textiles used in this section refers to any use of textiles in a medical setting, excluding
use within or on the patient (e.g. implantable textiles like gauzes or exterior bandages). This
definition includes articles such as mattress protectors upon hospital beds, curtains and
drapes around the bed, and gowns and personal protective equipment (PPE) used by medical
professionals.

In addition, textiles for use in the transport sector (such as automotive and aerospace
industry) are described in section A.3.11 and thus not included in this section.

The major use categories can be distinguished as shown below in Table A.15.

Table A.15. Overview of different TULAC categories.


Major use category Subcategory-uses with Technical function of PFASs
examples included claimed by stakeholders

C arpets and rugs Water repellence, oil repellence

C urtains and blinds Water repellence, oil repellence


Home textiles
Textile based coverings (e.g. Water repellence, oil repellence
fabrics for soft-furnishings,
tablecloths, bedding)

Indoor and outdoor wear Water repellence


Sportswear Water repellence, oil repellence
C onsumer apparel and
Footwear Water repellence, oil repellence
accessories
Accessories (e.g. umbrellas, Water repellence
bags, wallets)
Professional sportswear and Water repellence, oil repellence
footwear
Professional apparel PPE for industrial and Water repellence, oil
professional use (other than repellence, stain-resistance,
sportswear) soil protection
Outdoor technical textiles Water repellence, oil
(e.g. canvas, awnings, tarps, repellence, stain-resistance,
tents, sails, rope) soil protection
Technical textiles a Medical applications Water repellence, oil
(e.g. surgical drapes, gowns, repellence, stain-resistance
curtains)
High performance membranes Water repellence, oil

26
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Major use category Subcategory-uses with Technical function of PFASs


examples included claimed by stakeholders

(e.g. automotive and medical) repellence, stain-resistance,


thermal stability
Leather based goods (e.g. Water repellence, oil repellence
leather bags, wallets, belts)
Indoor and outdoor wear Water repellence, oil repellence
Leather applications
Footwear Water repellence, oil repellence
Professional sportswear and Water repellence, oil repellence
footwear
E.g. home fabric treatments Water repellence, oil
Other (sprays) for leather/textiles repellence, stain-resistance,
soil protection
a
Textile product manufactured for non-aesthetic purposes, where function is the primary criterion.

The analysis presented in this report will be limited to the applications listed above. In addition
to the function listed above, PTFE is used across multiple TULAC sectors and is reported to
have specific functions in TULAC with regard to chemical inertness (protective clothing),
hydrophobicity 9 (protective and outdoor clothing) and water vapour permeability.

The function and purpose of using PFASs in TULAC was elaborated further by respondents
from the CfE, stating that TULAC materials made with these substances exhibit the follo wing
benefits and properties:

 Waterproof properties (lower water permeability and wettability).


 Chemical resistance and inertness.
 Protection against exposure to liquid such as blood and other body fluids, but also
chemicals and electrical discharge.
 Extremely robust mechanical properties (e.g. resistance to abrasion) and provides low
friction.
 Weatherability including UV protection and resistance to corrosion from salt water:
 Resistant to high temperatures (thermally stable), but at the same time flexible.

Fluorochemicals are not necessarily specified within TULAC product standards within the EEA
but the function of PFASs is important to the fulfilment of some technical standards 10.

A.3.3.1.1. Use of PFASs in filtration and separation media

Filtration and separation media11 covers various professional uses. One example is nonwoven
filters coated with side-chain fluorinated polymers for oil and water separation in e.g. gas
turbines, hydraulic applications, nuclear industry, respiratory applications and air pollution
control and dust collection.

Filtration and separation media also include high performance membranes as a subgroup with
special properties, such as ePTFE membranes and filters. An ePTFE membrane is created
when PTFE, a linear polymer consisting of fluorine and carbon molecules, is expanded,
creating a microporous structure with highly desirable characteristics, including a high
strength-to-weight ratio, biocompatibility, high thermal resistance and many others. The
filters function by physically trapping and removing unwanted molecules and particles, either
by adsorption or chemical reactions, while the membranes use a thin, permeable layer or
sheet of material, e.g. expanded porous layers such as ePTFE, where the medium passes

9 A hydrophobic surface is a water repelling, low surface energy surface that resists wetting of water.
10
Table A.78 contains a list of standards that apply to TULAC products.
11 A subset of technical textiles is shown in Table A.16.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

through to remove unwanted molecules and particles. Membranes of ePTFE are used in
various high-tech applications such as medical devices implanted in the human body and
electronic cables transmitting signals from outer space.

Use of C6 side-chain fluorinated polymers in filtration and separation media

Filtration and separation media treated with C6 side-chain fluorinated polymers consist
primarily of non-woven material or paper composed of manmade fibres, natural fibres (or a
combination of both), with resins that contribute to the structural or physical properties of
the media. Filtration and separation media manufactured with C6 side-chain fluorinated
polymers play a critical role in the following applications, among others: medical devices, PPE,
HVACR (including EPA/HEPA/ULPA), Air Pollution Controls (APC), dust collectors, hydraulic
systems, coalescers, gas turbines, and fuel systems. There are alternatives to C6 available
for these applications since only water-repellence is needed.

The restriction proposal for PFHxA includes a derogation for filtration and separation media
used in high performance air and liquid applications that require a combination of water- and
oil-repellence. SEAC concluded in its opinion that:

During the consultation on the Annex XV report, several stakeholders requested a


complete derogation for the use of PFHxA in filters and membranes. The Dossier
Submitter proposes a derogation for filtration and separation media used in high
performance air and liquid applications that require a combination of water - and oil
repellence properties, even though it is well-noted in the Background Document and
by SEAC that such a broad derogation leads to a certain degree of uncertainty as it
might be possible that alternatives are already available or will become so in near
future for some applications. Cost estimates for the uses affected are scarce, only
some information was provided by stakeholders during the consultations. This
information mainly indicates that specifically costs related to substitution, e.g. loss of
effectiveness of products due to no alternatives being available currently, could be
potentially very high. Stakeholders reported that appropriate filtration reduces
maintenance needs, extends service life and prevents failures of equipment; they also
expect energy consumption and related greenhouse gas emissions to increase in the
absence of C6-treated filtration media. During the consultations on the Annex XV
report and the SEAC draft opinion, it was stated that the absence of a derogation will
put manufacturing facilities located in the EU at risk and result in a supply interruption
of filtration and separation media for several purposes until adequate alternative
candidates are identified and requalified. SEAC agrees to the Dossier Submitter’s
conclusion that more information on the different applications and specifically a more
detailed discussion on substitution possibilities as well as on any potential related costs
would be needed in order to draw a robust conclusion on the socio-economic impacts.

The Dossier Submitter has not received any information that affects this conclusion.

Use of ePTFE-based filter applications

Over the decades, PTFE as a woven fabric and as a needlefelt material has been used in
various filtration applications, particularly those involving aggressive chemical environments.
The PTFE filters can be used in liquid applications as well as dry dust applications12.

Expanded PTFE is used as a film or membrane on a growing number of filters across every
industry including food and packaging, pharmaceutical, minerals, power generation, metals,
chemicals, engineering, automotive, and aerospace. The membrane is laminated to a wide
variety of substrates such as polyester needle felts and woven glass fibre to be made into

12https://www.sciencedirect.com/topics/engineering/expanded -polytetrafluoroethylene, date of


access: 2022-12-15.

28
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

filter bags, and pleatable materials such as polyester and cellulose for filter cartridges and
elements. The substrate acts as a stable supporting base for the membrane. The type of
substrate is determined based on the specific application requirements to which the filters will
be subjected13.

One of the key advantages of ePTFE membrane filters is the filtration efficacy of sub-micron
sized particles, assisting in meeting the terms with the increasingly rigorous norms and
regulations pertaining to health and the atmosphere in working areas. The shape of the dust,
rather than its size, is an important factor when considering the abrasive potential of the dust.
Angular particles like those present in cement have a far more abrasive potential despite them
being very small in size. The velocity of airflow carrying the dust, the filter unit and ductwork
design are other important aspects that demand attention to make sure that the service
durability of the filters is not significantly reduced due to degradation (Reports And Data,
2020).

A.3.3.1.2. Use of PFAS in Personal Protective Equipment (PPE)

Personal Protective Equipment (PPE) can include items such as safety helmets, gloves, eye
protection, hazmat suits, high-visibility clothing, safety footwear, safety harnesses, ear plugs,
ear defenders and respiratory protective equipment. This section focuses on protective
clothing used for professional and indust rial uses, however, not for medical applications 14.

PPE requires CE marking, by which the manufacturer indicates that PPE is in conformity with
the applicable requirements set out in EU legislation. This means that a set of European (EN)
standards must be met for PPE placed on the EEA market. Table E.13. in Annex E.2.2.2.1.
contains a summary of performance and test standards for types of PPE where PFAS is
commonly used.

Annex I of the PPE regulation (EU 2016/425) defines three risk categories; where Category I
includes a list of minimal risks, Category III covers a list of risks that may cause very serious
consequences such as death or irreversible damage to health, and Category II includes risks
other than those listed in I and III.

Requirements, including specific technical standards, for PPE are mentioned in Table A.78.

A.3.3.1.3. Reported concentrations of PFASs in TULAC

Limited information is available on the concentrations of PFASs in a range of textile products.


With respect to the concentration of PFASs that are present in the finished TULAC products,
there are varying concentrations reported. One stakeholder suggested that overall, the PFASs
concentration across TULAC products can be summarised as in the range of <0.1 - 7%15.
Further detailed information was received during the CfE for specific TULAC products. Working
concentrations of PFASs in a range of textile products noted by respondents are listed in Table
A.16 below.

Table A.16. Applied concentrations of PFASs in a range of textile products.


Textile product % in the final textile product
High performance upholstery <0.1 C 6 SC FP in final textile product
Outdoor textiles 2 of FEP/PFAA in final product

13
https://www.filtsep.com/content/features/membranes-expanded-ptfe-finds-new-markets, date of
access: 2022-12-15.
14 Regulation (EU) 2016/425 (PPE) does not apply to PPE: (a ) specifically designed for use by the

armed forces or in the maintenance of law and order; (b) designed to be used for self -defence, except
for PPE intended for sporting activities; (c) designed for private use to protect against: (i) atmospheric
conditions that are not of an extreme nature, (ii) damp and water during dishwashing.
15 Euratex Submission to stakeholder consultation.

29
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Textile product % in the final textile product


C hemical protective suits PTFE (max 1), THV (max 1) or FKM or
Fluorosilicone (50-90)
Protective and technical textiles where PTFE is 100 of membrane is PTFE
used as a membrane material
PPE - (non-medical) 1.5 - 3
Medical gowns, drapes and PPE C 6 concentration average for all products <0.5
Within some face masks 1.9 of ePTFE in final products (by weight).
Leather straps 200 µg/m 2
Architectural polyester/PVC fabrics as <1 as a protection of polyester PVC fabrics.
fluoropolymers
Non-Launderable Textiles ≤0.1 total fluorine on weight of fabric
Membrane C 6 PFAS represent approximately less than 1 of
total weight of the membrane

As a comparison, the reported concentration ranges for PFOS presented in UNEP (2018b) for
the TULAC categories were textiles and upholstery: 2 - 3%; synthetic carpets: 0.03%; and
leather: 0.025 ‐ 0.05%. These concentrations are broadly in line with those reported during
the CfE, except for PTFE where concentrations vary widely. However, very little information
was provided for the home textiles sector.

A variety of PFASs are in use for TULAC applications. The identified substances have been
disaggregated into PFAAs and PFAA precursors (including side-chain fluorinated polymers)
and polymeric PFASs before developing the following groupings:

 PFAA and PFAA precursors


 All C2-C3 PFAS substances
 All C4 PFAS substances
 All C5 PFAS substances
 All C6 PFAS substances
 All C9 – C14 PFAS substances
 Other non-polymer PFAS substances
 All side-chain fluorinated polymer groupings

Non-polymeric PFASs are used in the production of side-chain fluorinated polymers and are
not in themselves present in the TULAC final product (other than as impurities).

For the “other” non-polymer PFAS, this broadly covers longer chain PFASs (≥C15), and a
range of aromatic substances. Note that a wide range of substances are described as ‘reaction
products’, some of which are oligomeric/polymeric, and some of these are no n-polymers.

PFAAs PFAA precursors

The side-chain fluorinated polymer group was a smaller sub-set overall (in terms of tonnage,
see Table A.20) and in many cases the respondents from CfE simply replied with terms like
‘perfluorinated C4 and C6 side-chain polymer’, rather than naming specific substances.
However, based on the concerns raised in the academic literature this group was identified a
potentially important, so has been separated from the fluoropolymers group.

Side-chain fluorinated polymers with various perfluorinated chain lengths from C2 to C14,
that occur in TULAC applications either intentionally or as contaminants, are described in Table
A.17 (Knepper and Lange, 2012).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.17. Side-chain fluorinated polymers used for TULAC applications.


Category Subcategory Applications
Hydrophilic group

Alcohols, silanes, alkoxylates, Soil/water repellence for carpet,


fatty acid esters, adipates, fabric/upholstery, apparel, leather,
urethanes, polyesters, acrylates metal/glass

Side-chain Phosphate esters Soil/water repellence for carpet,


fluorinated polymers fabric/upholstery, apparel, leather,
metal/glass. Oil/water repellence for
plates, food containers, bags, wraps,
folding cartons, containers, carbonless
forms, masking papers

Whether side-chain fluorinated polymers bestow water- or oil-repellent functions to TULAC is


determined by the chemical linkages within the polymer backbone and the fluorinated side-
chain. These can be esters (using acrylate or methacrylate monomers) urethane, or ethers
(using oxetane monomers).

Fluorinated gases

Stakeholders mention fluorinated gases to be used in significant quantities for manufacturing


of polyurethane foam in the seating of furniture. However, the gases mentioned are not
PFASs. It cannot be excluded that fluorinated gases that are PFASs are used as well.

Polymeric PFASs

 PTFE
 PVDF
 FEP
 PFPEs (as a family)
 PFA (as a family)
 Other fluoropolymers

The approach taken for polymers was to create separate entries for the substances with the
highest tonnages of use. The “other” category in this case covers two general groups,
remaining unique polymer substances (e.g. THV, FKM, FFKM) which are used in much lower
quantities, and a range of reaction products, which are either oligomeric or polymeric. Note
that in many cases this includes aromatic structures.

Based on the data gathered from the CfE, stakeholder engagement, and market research,
around 120 unique PFAS (82 of which had CAS numbers, the rest contained many polymers
without a CAS number) are identified in the TULAC sector which are used intentionally or are
the product of degradation or an impurity. The majority of substances reportedly used in
TULAC sector in the EEA are fluoropolymers (particularly PTFE) and to some extent side-chain
fluorinated polymers. Notably, all the substances reported to be used in professional textiles
were PTFE or fluoropolymers of >20 carbon chain length, whereas in all the other use
categories a broader array of chain length PFASs are currently reported to be used. The list
of PFASs used in this sector is not provided here due to Confidential Business Information.

A.3.3.2. Volumes

In 2017, the EU-28 produced 7.4 kg of textile products per person while consuming nearly

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

26 kg (Table A.10) (EEA, 2019). This indicates that around 12 million tonnes of textile
products were consumed in the EEA based on the current population. A large proportion of
textiles within the EEA are imported (mainly finished products from Asia). Exports mainly
comprise intermediate textile products, such as technical fibres and high-quality fabrics in
which the European industry specialises. Indicative estimates of quantities sold, as well as
import and export data, per sub-category of TULAC are presented in Tables 25 and 26 in
Annex E.2.2.4.2.

Figure A.9. Annual import, export, production, and consumption flows of textile products in
the EEA-28, 2017. Source: EEA (2019).

In the EU-27 in 2021, there were around 143 000 companies operating in the textile and
clothing industry (EURATEX, 2022). The number of companies dealing with articles containing
PFAS has not been identified.

The textile industry is quoted to be one of the most extensive users of PFAS. For example,
the Annex XV Restriction Dossier for PFHxA (ECHA, 2019) estimates that ~78% of the PFHxA
used in the EEA is for clothing, while ~4% is used in firefighting foams, and ~3% for other
uses (e.g. chrome plating, paper, inks, paints etc). Overall, textile applications account for an
estimated 35% of the demand for fluorotelomers globally (Goldenman et al., 2019).

Tonnage estimates below are based on the information gathered in the CfE. It is estimated
that between 41 000 (low estimate) and 143 000 t (high estimate) of PFAS are used within
TULAC products in the EEA annually. These estimates might include some degree of double
counting of “functional PFAS”, precursors and intermediates. The reason for this is that, based
on the information from the CfE, it has been difficult to distinguish between these groups and
there is therefore a risk that precursors have been calculated separately and added with the
"functional PFASs" formed by these precursors, resulting in a doubled or higher quantity
estimate (see Appendix VI for a more detailed description).

The report by Wood (2020) concludes that TULAC is approximately 45 000 - 80 000 t/y. Based
on this, the “low estimate” (41 000 t) appears more credible than the “high estimate”.

There is however some uncertainty regarding how well quantities of PFAS in imported TULAC
articles are covered by these estimates. No data has been provided or found on the proportion
of imported textiles that contain PFAS. One question in the consultation was if the calculations
(based on data from the CfE) also covered imported TULAC sufficiently. Approximately 30%
replied “yes”, 20% answered “no”, and the remaining 50% did not have an opinion or
information.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

The estimated tonnages of PFAS in different applications are reported in Table A.18. According
to the information received in the CfE, around 80% of the estimated total tonnage is
fluoropolymers. The CfE also indicates that the key dominant TULAC sectors using PFAS are
consumer apparel, followed by home textiles and technical textiles. This information on the
use of PFAS per subcategory of TULAC is uncertain since tonnages reported for several sub-
categories in the CfE have been split equally across the subcategories when the re is no other
information. The report by Wood (2020) estimates that PFAS use is substantially larger in the
subcategories home textiles and consumer apparel than in professional apparel and technical
textiles. No responses on PFAS in leather applications were received during the CfE.

According to CfE input from the Filtration and Separation Coalition, the volume of C6 PFAS
used for the filtration and separation media placed on the EU market is approximately 67 t/y.
This volume covers professional and industrial uses. C6-treated filters for consumer use (e.g.
vacuum cleaners, air purifiers) constitute a marginal fraction.

As indicated in Table A.18, the estimated tonnage of PFAS used in ‘Professional apparel’ is
5 220 - 20 044 t total PFAS and 101 - 1 100 t total non-polymeric PFAS. Some part of this is
used in PPEs, but a more exact quantification has not been possible to derive.

During stakeholder consultations following the second stakeholder consultation (see Annex
G) three companies 16 in the PPE sector indicated that around 20 percent of the PFAS used in
the PPEs they put on the EEA market were used in PPEs protecting against Category III risks.
The remaining 80 percent were used in PPEs protecting against Category I or II risks.

Several stakeholders indicate that there may be a risk of overuse of PFAS, with a higher level
of protection than necessary, as the customer's way of using PPE is not always clear. This
could, for example, be because PPE customer’s want their entire work force at a facility to
have uniform clothing and, consequently, that the tasks that require the highest level of
protection sets the standard for the PPE used by all workers.

There is no publicly available quantity data of PFAS for maintenance and reimpregnation of
PPE in the EEA. An approximative calculation provided by the European Textile Services
Association (ETSA) indicates that around 20 t of pure PFAS are used in the European market
to reimpregnate PPE17.

The reported concentration ranges for PFAS for the TULAC categories are listed in Appendix .
However, limited information is available on the concentrations of PFAS in a range of textile
products.

16 These companies make up a limited share of the market. Their total annual quantity of PFAS use in
PPE articles for the EEA market is approximately 3 t. Therefore, it is unclear if these estimates can be
extrapolated to the entire EEA PPE market.
17 Written communication with Home European Textile Services Association (ETSA) November 2021.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.18. Tonnages of PFAS used in TULAC industry in EEA (2020).


Sub use C2- C3 PFAS PFAA ≥C4 Side-chain Total PFAAs Fluoro polymers PFPE Total polymeric Total PFAS
substances (t/y) fluorinated and PFAA (t/y) (t/y) PFASs (t/y)
(t/y) polymers precursors (t/y)
(t/y) (t/y)
low high low high low high low high low high low high low high low high
Home
717 3 433 363 770 230 559 1 310 4 761 4 658 22 049 262 558 4 920 22 607 6 230 27 368
textiles
C onsumer
717 3 433 363 770 1 019 10 034 2 099 14 237 5 801 32 353 261 557 6 062 32 910 8 161 47 148
apparel
Professional
0 0 1 101 100 1 000 101 1 101 5 119 18 943 0 0 5 119 18 943 5 220 20 044
apparel
Technical
717 3 433 364 869 14 22 1 095 4 324 4 845 21 659 262 558 5 107 22 217 6 201 26 541
textiles
Medical
0 0 0 0 0 0 0 0 331 1 096 0 0 331 1 096 331 1 095
textiles
Leather
- - - - - - - - - - - -
textiles
Other 0 0 2 422 6 103 1 067 2 621 3 489 8 724 11 551 11 762 1 10 11 552 11 772 15 041 20 496
Total
2 150 10 300 3 512 8 612 2 430 14 236 8 092 33 148 32 305 107 861 786 1 683 33 091 109 544 41 183 142 692
(TULAC )

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.19. Tonnages of PFASs used in the TULAC industry in EEA in year 2020, as taken for impact assessment (mid points from low and
high estimates as presented in table above).
Sub use C2- C3 PFAS PFAA ≥C4 Side-chain Total PFAAs Fluoro PFPE Total polymeric Total PFAS
substances (t/y) fluorinated and PFAA polymers (t/y) PFASs (t/y)
(t/y) polymers precursors (t/y) (t/y)
(t/y) (t/y)
Home
2 075 566 395 3 036 13 354 410 13 764 16 799
textiles
C onsumer
2 075 566 5 527 8 168 19 077 409 19 486 27 655
apparel
Professiona
0 51 550 601 12 031 0 12 031 12 632
l apparel
Technical
2 075 617 18 2 710 13 252 410 13 662 16 371
textiles
Medical
0 0 0 0 714 0 714 714
textiles
Leather
- - - - - - - -
textiles
Other 0 4 278 1 844 6 107 11 657 6 11 662 17 769
Total
6 225 6 062 8 333 20 620 70 083 1 235 71 318 91 938
(TULAC )

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Total estimated PFAS use per substance type over all TULAC uses is presented in Table
A.20.

Table A.20: Total tonnages of subgroups of PFAS used per year for TULAC in the EEA in
2020 (low and high estimate).
PFAS substance Low High
estimate estimate
(t/y) (t/y)
PFAAs and PFAA precursors
All C 2- C 3 PFAS substances 2 150 10 300
All C 4 PFAS substances 17 46
All C 5 PFAS substances 1 1
All C 6 PFAS substances 3 399 8 435
All C 9-C 14 PFAS substances 2 2
Other non-polymeric PFAS 93 129
Side-chain fluorinated polymers 2 430 14 236
Polymeric PFASs
PTFE 15 202 68 465
PVDF 1 058 5 082
PFPE 786 1 683
FEP 55 189
PFA 7 21
Other and unspecified fluoropolymers 15 984 34 104
PFAAs and PFAA precursors TOTAL 8 092 33 148
Polymeric PFASs TOTAL 33 091 109 544
Total tonnage used per year (all
41 183 142 692
PFAS)

A.3.3.3. Summary

Because of the vast range of properties, PFASs are widely used in the textiles, upholstery,
leather, apparel and carpets (TULAC) industry. The main properties PFASs provide in this
industry are, water repellence, oil repellence, protection against stain-resistance and
thermal stability. Stakeholders report an estimated annual use of between 41 000 and
143 000 t (rounded numbers). Over 75% of the PFASs used are fluoropolymers, almost
half of which is PTFE. Other fluoropolymers used include PVDF, PFPE, FEP, PFA, and others.
C2-C3 and C6 PFAS, as well as side-chain fluorinated polymers, are the most abundant
PFAAs and PFAA precursor that are being applied in the TULAC sector. TULAC there by is a
large PFAS use sector. A large proportion of textiles within the EEA are imported (mainly
finished products from Asia).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.4. Food contact materials and packaging

A.3.4.1. Uses

PFASs in food contact material (FCM) and packaging are largely used to confer oil a nd
grease resistance in the following main applications:

- Packaging (including non-FCM packaging);


- Consumer cookware;
- Industrial food and feed production equipment.

Fluoropolymers are mainly used for non-stick properties of material coatings for consumer
cookware and industrial applications.

Oil and grease resistant food contact paper packaging products are often based on the
surface application of side-chain fluorinated polymers (SCFP). For production of thin film
(PP and PE) plastic packaging, PFASs are mainly used as polymer processing aids. Often
fluoroelastomers are used as polymer processing aids in the extrusion of PP, PE and
polyolefin films.

Numerous PFAS are used in food contact materials and packaging, see Table A.80, Table
A.81 and Table A.82.

A.3.4.1.1. Packaging

Packaging is a very broad sub-use. PFASs are used where oil and grease resistance are
important. In food and feed packaging PFASs are intentionally applied to paper and board
packaging to confer primarily fat, but also repel stain and water (included water vapour).
This repellence function is especially important in the food packaging sector in which oils,
greases and water may migrate from food during baking, transport and storage, or f or use
with fast food that is intended to be portable. As such, the packaging is intended to be, or
can reasonably expected to be, in contact with the food product. Some pet food and feed
packaging applications require particularly high-performance grease/water resistant for
example to maintain quality of dried food (OECD, 2020).

A major use for PFASs is application to paper and board substrate for fast food wrapping.
Not only is food packaging of relevance, but also feed packaging and generic packaging.
The following sub-uses were seen in packaging:

Food packaging

 Greaseproof paper;
 Baking paper;
 Heat resistant packaging;
 Other food packaging (e.g. milk containers, stretch and shrink films, pouches,
frozen food packaging);
 Coating of (food and beverage) cans (Often PTFE wax and micropowder PTFE are
used).

PFAS coatings may also be applied to disposable packaging items used for food
consumption such as paper plates, bowls and ice cream tubs.

Feed packaging

 Pet food;
 Agricultural feed.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Generic packaging

 Paper and board for non-food/feed applications;


 Folding packaging cartons, carbonless forms/pressure sensitive paper, masking
papers, tablecloths, and wall papers;
 Coated drums: fluorination of plastic (food or non-food) containers;
 Coated chemical containment bottles used for non-food packaging;
 Other packaging (coated plastic, glass, metal) for non-food/feed applications;
 Plastic films for health and hygiene;

Processing and polymerisation aids application in especially PP and PE thin film production

PFASs are also used as processing aids in the manufacture of plastic materials including
thermoplastic packaging, to improve the flow properties of the plastic for example in the
production of plastic sheets. The use of the processing aid may enhance the throughput
of material and permits production of thinner films 18.

Currently there are three main types of PFASs used in packaging:

a) Short chain fluorotelomer side-chain (C6) polymeric PFASs, with high molecular weight
acrylic polymers that contain fluorotelomer functionality to provide repellent performance.

b) Perfluoropolyether (PFPE) based oil and grease repellent products.

c) Fluoroplastics: FEP, PFA (perfluoroalkoxy ethanes), and FKM (fluorocarbon-based


fluoroelastomer materials);
 Largely unknown PFASs (by-product of fluorine gas treatment of plastic containers
such as HDPE containers);
 Fluorinated HDPE containers used for substances in various applications.

Consumer cookware

Fluoropolymers such as PTFE are used as non-stick coatings in consumer cookware. Non-
stick properties prevent food from sticking, facilitate cleaning, provide durability, prevent
corrosion and reduc e the need for oil in cooking. Fluoropolymer coatings also tend to
withstand high temperatures, such that they can be used in cooking. They are also
insulators and do not conduct electricity19.

These coatings may be found in pans, in baking tins and on the surface of electrical cooking
appliances such as toastie makers and grills. They may also be used in dishwashers
(Plastics Europe, 2017).

Temperature resistant coatings are dispersions or solutions of artificial organic resins in


water or organic solvents for producing non-stick coating for utensils and other food
contact articles. Usually, the coatings consist of combinations of fine -grain homo- or
copolymers of tetrafluoroethylene with solutions or dispersions of film-forming artificial
organic resins20.

PTFE non-stick coatings normally consist of up to three coats and have an operating
temperature of up to 260 °C21. They are selected due to low friction properties, good

18 http://www.plastemart.com/plastic-technical-articles/polymeric-processing-aid-performs-better-
than-conventional-waxes/1592#, date of access: 2022-12-16.
19
https://coatingsystems.com/fep-coating-beneficial-kitchen/, date of access: 2022-12-16.
20 https://www.bfr.bund.de/de/bfr_empfehlungen_zu_materialien_fuer_den_lebensmittelkontakt-

447.html, date of access: 2022-12-16.


21 http://www.ptfecoatings.com/ptfe-coatings/non-stick.php, date of access: 2022-12-16.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

abrasion resistance and good chemical resistance, which make them easier to clean
without damage. Fluorinated ethylene propylene (FEP) non-stick coatings melt and flow
during baking to provide non-porous films, they have good chemical resistance and are
low friction. The maximum recommended use temperature for FEP coatings is 200 °C.
Perfluoroalkoxy (PFA) coatings also melt and flow during baking to create non-porous films
but have a higher continuous use temperature of 260 °C. PFA coatings are harder than
those of PTFE or FEP. Ethylene tetrafluoroethylene (ETFE) coatings hav e good chemical
resistance but a lower continuous operating temperature of 150 °C; conversely, they are
very durable.

Consumer cookware can be divided in the following sub-uses. Non-stick coatings for:
 Frying pans;
 Baking trays and bake pans;
 Sauce pans;
 Cooking plates in electric appliances such as sandwich toasters, waffle irons;
 Consumer bakeware including cake tins, bread-loaf tins, etc.;
 Seals, O-rings, gaskets, tubing and pipes in consumer electrical equipment such as
coffee machines (mentioned and described under industrial applications);
 Filters to capture contaminants from for example steam filtration in food
processing.

Key PFASs found to be used in consumer cookware are:

 Fluoropolymers:
o PTFE
o ETFE
o ECTFE
o FEP
o hexafluoropropylene;
 PFA (perfluoroalkoxy ethanes)
 Perfluoroelastomers and FKMs
 (PTFE) coated elastomers

A.3.4.1.2. Industrial applications

Industrial applications cover the equipment to produce food and feed, as well as their
packaging materials at an industrial scale. See for instance a website for PFTE coatings22.

PFAS are used in food processing equipment primarily for their non-stick properties
combined with non-reactivity with chemicals, thermal resilience during cooking and wear
resistance providing durability. The majorit y of PFASs used in this market segment are
fluoropolymers. One of the main uses for PFASs in industrial applications is in food and
feed processing lines where PFAS (polymers) provides a non-stick coating to conveyor
belts, using PTFE or PVDF. Fluoropolymer dispersions are, for example, formulated into
coatings for conveyor belts for commercial food and feed products. PVDF is used in
fabrication of industrial cookware equipment mainly for its mechanical properties and
chemical resistance. Fluoropolymers are widely used in industrial bakeware moulds and
trays because they provide long-lasting oil and fat-free mould release.
Fluorothermoplastics and PTFE are also processed into valves and fittings for commercial
food and feed products. PTFE impregnated glass c loth is commonly used in food contact
applications as a release agent.

22
http://www.ptfecoatings.com/industries/packaging.php, date of access: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Other applications:
 Piping and tubing for drinking water applications;
 Filters to capture contaminants from, for example, steam filtration in food
processing;
 Seals, O-rings, gaskets, tubing and pipes, expansion joints;
 Valves and fitments, conveyor belting, chutes, guiding rails, rollers, funnels and
sliding plates, tanks, funnels, rollers, linings, blades of knives and scissors, springs,
filter membranes and sensor covers, lubricants;
 Re-coating of industrial bakeware.

In industrial applications, PFASs are often used to enhance productivity, to prevent


clotting, to enable hygienic conditions etc. PFASs most often used in industrial processing
are PTFE, FEP, PFA and ETFE.

Key PFASs used:

 Fluoropolymers:
o PTFE
o ETFE
o ECTFE
o FEP
o Hexafluoropropylene variations
o PVDF–based
 PFA (perfluoroalkoxy ethanes);
 Perfluoroelastomers (liquid processing systems)
 PTFE coated elastomers are often used as seasling in pressure bearing equipment
 Others
o PFMVE
o PTFE copolymers

Figure A.10. Automatic Chappati making (left) and hydraulic seal kit (right). Source:
Creative Commons BY-SA 2.0.

According to a stakeholder, transport rollers, baking trays, extruders and tanks often have
a thickness of 20 - 100 µm, consisting of about 50% by weight of the fluoropolymers PTFE,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

FEP and PFA. Dry lube coatings for guide rails, O-rings (Figure A.10), bearings, and valve
seats often have a thickness of 5 - 20 µm, consisting of about 50% by weight of PTFE.
Anti-corrosion coatings for tanks and pipelines often have a thickness of 500 – 1 500 µm,
consisting of about 95% by weight of the fluoropolymers PFA, FEP, ETFE, and ECTFE. In
the appendix, Table A.80, the main substances used in FCM and packaging are mentioned.

A.3.4.2. Volumes

A.3.4.2.1. Packaging

Paper and board packaging

Paper and board packaging volumes were based on information from CEPI, the European
association representing the paper industry (Table A.21).

Table A.21. Paper and board packaging consumption for food and feed and generic
packaging in Europe in 2019and beverage can EEA production (Cepi, 2020).
Quantity (million t/y)
C ase materials 28.4
C arton board 6.2
Wrappings 2.6
Other paper and board for packaging 4.2
Total 41.4

EEA-wide volume figures of PFASs used in paper and board food packaging have not been
identified in literature or from stakeholders. Instead, the PFAS volumes utilised as a basis
for deriving emission estimates have been calculated from available data with a few
assumptions applied. Data sources are shown in the Appendix in Table A.79.

In Table A.22, based on paper and board packaging volumes and average intentionally
added PFAS content (values from German and Dutch regulation) from Table A.79 (see
Appendix) PFAS quantity is calculated.

Table A.22. Estimates of intentionally added PFASs in total paper and board food
packaging for different assumptions according to in EU-27, UK and NO 2019.
Proportion of total Quantity of paper Permitted Level Quantity of PFAS
paper and board with and board a (t) PFAS (%) (t)
PFAS (%)
0.5 206 755b 0.4 827
206 755 1.2 2 481
1.0 413 510b 0.4 1 654
413 510 1.2 4 962
a
Based on total paper and board Packaging consumption = 41 351 000 t. See table Table A.21.
b Based on the calculation in the text below.

Range of paper and board packaging containing PFAS:


If 0.5% of the total paper and board packaging consumed contains PFAS
= 0.5/100 x 41 351 000
= 206 755 t of paper and board packaging

If 1.0% of the total paper and board packaging consumed contains PFAS
= 1.0/100 x 41 351 000
= 413 510 t of paper and board packaging
i.e., the quantity of paper and board packaging containing PFAS in 2019 was 206 755 –
413 510 t.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

For comparison purposes, the quantities of PFASs in paper and board food packaging were
estimated in addition using a different starting assumption i.e., the fluorine content of the
paper and board packaging. From Dinsmore (2020), the quantity of fluorine that is present
in paper and board packaging is a maximum of 1 200 mg/kg (equivalent to g/t) or an
average of 537 g/t.

These two figures, shown in Table A.22 and Table A.23, have been used to derive a range
of the total quantity of PFASs in paper wrapping and carton board packaging. To estimate
the PFAS content of paper wrapping and carton board packaging an approximation of the
PFAS content has been derived assuming an estimated average fluoride content of the
total molecular weight. This is assuming that the PFASs present can be like
perfluorohexanoic acid (PFHxA) (fluorine content 66%), or side -chain fluorinated
polyacrylates e.g. polymethacrylates (fluorine content is 12.8% Yao et al. (2014)) that
was also utilised in the proposed restriction for PFHxA (ECHA, 2019). See Table A.23 for
the results.

Table A.23. Estimates of PFAS in carton board and paper wrapping packaging for different
assumptions based on detected fluorine levels in EU-27, UK and NO (2019).
Proportion Quantity of Quantity Detected Quantity Quantity of
of Wrapping carton and with PFASs fluorine fluorine in PFASs c
and Carton wrapping a (t/y) concentration b paper or (t/y)
board with (t) (g/t) board
PFASs (%) (t)
46 (paper) 2 647 000 1 217 620 537 654 1 308
2 647 000 1 217 620 1 200 1 461 2 922
95 (paper) 2 647 000 2 514 650 537 1 350 2 700
2 647 000 2 514 650 1 200 3 018 6 036
20 (board) 6 169 000 1 233 800 537 663 1 326
6 169 000 1 233 800 1 200 1 481 2 962
Notes:
a From Table A.79 in the appendix.

b Maximum and average concentration of fluorine detected in supermarket and fast-food restaurant
paper and board packaging (Dinsmore, 2020). These numbers are in line with the C hemTrust total
organic fluorine content of throwaway packaging
c
Quantity of PFAS is calculated from the fluorine content assuming fluorine comprises 50% of the
molecular weight

The PFAS loads in Table A.22 and Table A.23 are in the same range. However, Table A.23
focused on all PFASs (intentionally added and unintentionally present) and Table A.22
solely focuses on intentionally added PFASs. Without further information to enable a more
accurate analysis, the upper and lower bounds of each volume range, from Table A.22 and
Table A.23, have been utilised to estimate emissions during the service-life of paper and
board packaging.

PFAS in lacquers and ink (for paper-based and aluminium-based packaging)

About 70% of the PFAS residues in paper and aluminium based packaging products are
present in lacquers and inks according to a stakeholder. Mainly PTFE wax/micro powder
PTFE is used in printing ink. According to stakeholders about 500 t/y of PFASs in the EEA
are used in lacquers and inks. As lacquers and ink are also used for non-packaging the
total PFAS use could be far higher.

Generic plastic (food) packaging PFAS polymer processing aid use

Generic (plastic) packaging tonnages can be better derived via waste statistics than via

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

production statistics as waste databases are more centralised and accessible. In the year
2019 packaging waste generated was 177 kg per inhabitant in the EU. Paper and cardboard
(41%), plastic (19%), glass (19%), wood (16%) and metal (5%) are the most common
packaging types.

PFAS polymer processing aids are used in the manufacturing of generic plastic packaging
and plastic food packaging. It is likely also used in the production of rubber and non-plastic
packaging uses especially in cases where thermoplastics are used (Glüge et al., 2020).
Polymer processing aids enable polymers such as PP, PE, and polyolefins to be processed
(e.g. extruded) at higher rates and can also reduce energy consumption. Polymer
processing aids are based on fluoropolymers (fluoroelastomers or fluorothermoplastics)
and not on low molecular weight PFASs or side-chain fluorinated polymers according to a
stakeholder. Elastomer-based polymer processing aids are manufactured without the use
of a fluorinated emulsifier. Polymer processing aids are frequently formulated with
inorganics and non-fluorinated aliphatic polyethers or polyesters as synergists. Some
polymer processing aids require fluorinated emulsifiers in their manufacturing process.

According to information from an industry association PFAS processing aids are only
needed for thin film production. Other stakeholders mention that for all plastic extrusion,
PFAS processing aids are needed.

According to stakeholders PFAS polymer processing aid concentrations normally range


between 500 – 1 000 ppm. This quantity is carried over from production and has no
function in the finished plastic. No information was available on the fate of the PFASs that
is not carried over to the product in the packaging production facility. For new production
batches and according to stakeholders, new PFASs are added on a regular basis but details
on volumes and emissions are lacking.

Combining volume data: 20 000 000 t plastic packaging demand in EEA market/y. 16% of
plastic (packaging) material are being produced in EEA, so not imported = 32 000 000 t
plastic packaging material produced in EEA (Plastics Europe, 2020).

PFAS polymer processing aid concentrations of 500 – 1 000 ppm result in a yearly
estimated 1 640 – 3 280 t of PFAS processing aids being used for plastic packaging
production in EEA.

The presence of PFASs in common non-food plastics packaging (and possibly even all
plastics) also raises questions about recyclability claims as these types of plastic packaging
are commonly recycled.

Plastic food packaging PFAS residues

As PFASs are used as processing aids for PE and PP flexible packaging production, PFAS
residues might be present in the final article. According to a stakeholder the yearly EEA
market for flexible food packaging is around 300 000 t and the concentration of PFASs in
the finished packaging articles is around 0.1% (stakeholder information) representing a
carry-over of material from production. This leads to a volume of 0.1 * 300 000 = 300 t
PFASs residues in EEA per year in food packaging only. This is excluding other flexible,
non-food, packaging.

Assuming that the total packaging volume could be twice as high as the food packaging
volume, providing the following range for PFAS in flexible food packaging production:
300 – 600 t PFASs residues in flexible food packaging production in EEA/y.

Fluorine surface treatment of plastic containers

Fluorine gas treatment of plastic containers is used to introduce desired surface properties

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

for storage of certain products such as (bulk) chemicals but also food. A barrier on the
plastic surface is created by leading fluorine over polymer containers like HDPE type
containers. This treatment of the HDPE like containers degrades to PFCAs which is found
in the content in the container (by leaching from surface of the container to the content),
according to a study conducted in the USA by Environmental Defense Fund (EDF). The
USA EPA has a webpage regarding this topic 23. PFAS leaching from HDPE containers
increases with time 24.

It is estimated that hundreds of millions of polyethylene and polypropylene containers are


treated this way each year. EPA indicated that this might be a very significant use (see
also Rand and Mabury (2011)). Details on volumes are not yet available in USA or in EEA
since this use was recently identified in USA.

Wrapping of cars

Different materials are used (PE, PVC, polyester, PET, polyurethane, and Teflon polymers).
When 1 kg wrapping is used per car and if every brand and model use wrapping, assuming
25% market share of Teflon polymers (see PR Newswire (2018)) the calculation below
could be a indication of tonnage:

“In 2019 15 769 041 passenger vehicles were manufactured in the EU (ACEA, 2020). For
trucks and busses the number of newly registered vehicles had to be used as proxy for
newly manufactured vehicles. Comparing the numbers for newly manufactured and newly
registered passenger cars (15 769 041 to 15 340 188 (ACEA, 2020)) the assumption can
be made that these numbers, order of magnitude, correspond. In 2019 2 503 992 new
trucks (sum of light and heavy commercial vehicles) and 42 838 new buses were registered
in the EU (ACEA, 2020).”

750 000*1 kg = 10 000 t wrapping sheet*25% fluoropolymer (PTFE) = 3 950 t/y. The
fluoropolymer wrap share and market volumes for wrapping cars already on the market
are unclear.

Coating of cans

Cans and especially beverage cans are often coated with PTFE wax or micropowder PTFE
to reduce friction and facilitate easy sliding of cans on production lines. It can be used to
protect cans from rusting and to protect the can liner from acid in the food or drink inside
the can.

PTFE coated beverage cans are not considered FCM when the outside of the can is coated
and food is not in direct contact with the coating (note: sometimes the inside of the can is
coated as well).

The production volume of aluminium cans (2019) in Europe for food and beverage is
around 488 kt (Wielenga, 2021). There is no data on the import of food and beverage
cans. 488 kt is therefore an underestimation of food and beverage can use in the EEA;
0.1% PTFE wax * 488 000 t = 4 880 t PTFE use in EEA/y.

This is a minimum tonnage since import of food and beverage cans is not considered and
coating of other cans other than food and beverage is not considered in this calculation.
According to Food Packaging Forum approximately one third of can coatings were used in
non-food packaging (Geueke, 2016).

23https://www.epa.gov/pesticides/pfas-packaging, date of access: 2022-12-15.


24
https://www.epa.gov/pesticides/epa-releases-data-leaching-pfas-fluorinated-packaging, date of
access: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

No detailed information on market prices of PFASs used in packaging production has been
identified. There is information on price-differences to alternatives (see the Alternatives
chapter). The autonomous market development is also presented in the tables in the
Annex.

A.3.4.2.2. Consumer cookware

There are 195 million households in the EU according to FEC (Federation of European
manufactures of cookware and cutlery). FEC assumes that there are at least 3 pieces of
coated cookware in each household resulting in 600 million pieces of coated cookware in
EU households. Assuming a replacement of every 4 years this results in 150 million pieces
of coated cookware being sold in Europe per year.

For consumer cook and bakeware, data from Plastics Europe 2017 was used and is
reported as 3 500 t/y as presented in Table A.24. It should be noted that stakeholders in
the second consultation in summer 2021 mentioned 5 600 t of fluoropolymer use for
consumer cookware (GlobalInfoResearch, 2022).

From the description in Plastics Europe (2017) this data does not include any polymer
PPAs that have been used in the production of fluoropolymers, except it can be assumed
that any PPA still present is an impurity in the final fluoropolymer.

No detailed information on market prices of PFASs applied in consumer cookware has been
identified. There is information on price-differences to alternatives (see Annex E.2.3.). For
autonomous market development see also Annex E.

Industrial applications

These data cover EU-28 (including the UK) and include imported fluoropolymers as well
as those manufactured in the EEA.

Stakeholders indicated that drinking water and beverage production uses approx.
3 000 t/y of fluoropolymers as gasketing and membrane materials (e.g. water purification
and processing). Stakeholders in 2021 consultation mentioned 1 800 t/y in EEA of PTFE
being used for the maintenance of free bearings and sliding elements using PTFE
compounds. For a small niche application 61 t was mentioned. German stakeholders
mentioned that in 2020 at least 140 t was applied in Germany for bakeware coating and
this use continues to increase. Therefore, in 2015 3 000 t for industrial applications seems
a reasonable estimate, noting that a further 3 000 t/y for drinking water and beverage
production might have to be added.

In Table A.24 the fluoropolymer volume data for cookware and industrial applications is
summarized.

Table A.24. Volume data (2015) used for the emission estimates from fluoropolymers
taken from Plastics Europe (2017).
Market segment Quantity of Fluoropolymers sold (t/y)

C onsumer C ook and Bakeware 3 500


Stakeholder feedback second consultation
2021 mentioned 5 600 for cookware and
food processing (GlobalInfoResearch, 2022)
Industrial Food Production and Pharmaceuticals >3 000 (1 800 already for maintenance) -
Drinking water and beverage production 6 000

Given the uncertainties, the volume and emission estimates described here should be

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

regarded as indicative only.

According to a stakeholder, it was estimated (in the summer 2021 second stakeholder
consultation) that 2.8 million tonnes of rubber goods were produced in Europe annually.
A figure that has been stable over the last years (part of this volume includes rubber uses
for which PFAS is applied, often as processing aid like in thermoplastics production). It is
estimated that the use of fluoropolymers in the rubber sector is in the range of 4 500 –
18 000 t/y. Approximately 4-5% are products for the food contact and drinking water
sector. That leads to 180 – 900 t fluoropolymer coated rubber for the sector. Because it is
not clear if this tonnage is included in other numbers presented below, it was not used for
tonnage calculations.

The yearly EEA PFAS volumes used are summarised for the three main applications in
Table A.25 and in the generic table format distinguishing between the three main PFAS
groups in Table A.26.

Table A.25. PFAS EEA volume per year per sub-use.


Sub-use* Specific use PFAS Main PFAS Source
(t/y) type
Paper and board Polymeric PFAS Estimate, in EU-27 &
827 – 4 962
packaging UK & NO (2019)
PPAs used in Non-polymeric Estimate based on
(thermoplastic) PFASs C EPI and literature
packaging production 1 640 – 3 280 data and
and rubber production stakeholder data on
rubber
Packaging
manufacturing
Flexible (thermoplastic) Non-polymeric Estimate, based on
300 - 600
packaging PPAs residues PFASs stakeholder data
Lacquers and ink residue Polymeric Estimate, based on
>>500 PFASs, mainly stakeholder data
PTFE wax
C ar wrapping 3 950 Polymeric PFAS Estimate
C onsumer cookware Polymeric PFAS Plastics Europe data
C onsumer coating (2015)
3 500 – 5 600
cookware

Industrial Beverage can coating 4 880 Polymeric PFAS Estimate, based on


application (minimum as import (e.g. PTFE wax) stakeholder input
of food and beverage and market volume
cans is not considered
nor coating of non-
beverage cans).
Industrial applications Polymeric PFAS Plastics Europe
coating 3 000 - 6 000 (2015) and
stakeholder input
Drinking and beverage >3 000 Polymeric PFAS Stakeholder input
production Of which 180 – 900
coated rubber
* PFAS from gas treatment of fluorinated HDPE containers not clear and not mentioned in table.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.26. Volumes of PFAS estimated to be used in food, feed and packaging industry in
the EEA per year.
Total PFAAs and PFAA Total polymeric PFASs Total PFAS
precursors (t/y) (t/y)
(t/y)

low midpoint high low midpoint high low midpoint high

(Surfactants) in
Paper and
827 2 895 4 962 827 4 962
Board Food
Packaging
Generic Plastic
packaging &
1 640 2 460 3 280 1 640 2 460 3 280
rubber
(processing aids)
C onsumer C ook
3 500 4 550 5 600 3 500 4 550 5 600
and Bakeware
Industrial Food
Production and 3 000 4 500 6 000 3 000 4 500 6 000
Pharmaceuticals
PFAS residues in
300 450 600 300 450 600
packaging
Lacquers and ink >>500 >>500 >>500 500 500 500
C ar wrapping 3 950 3 950 3 950 3 950 3 950 3 950
Beverage can
4 880 4 880 4 880 4 880 4 880 4 880
coating
Total 3 267 6 305 9 342 15 330 17 880 20 430 18 597 24 185 29 772

A.3.4.3. Summary

PFASs in food contact material (FCM) and packaging are primarily used for their grease
repellent properties and can be found in the following main applications: packaging,
consumer cookware, and industrial food and feed production equipment. Plastic packaging
is excluded here.

Packaging covers a broad spectrum of uses including food, feed, generic packaging in
paper and processing aids to produce thin films plastics. The three main types of PFAS
used in packaging cover PFPEs, side-chain (C6) fluorinated polymers and fluoropolymers.
In the extrusion of thermoplastic packaging or the polymerization, fluoropolymers are
often used as processing aids.

For consumer cookware (polymer) PFASs (i.e TFE, PTF, PFA, PTFE, FKMs are mainly used
to achieve non-stick coatings for goods such as frying pans, plates, baking wear, and
electrical equipment.

Finally, PFAS polymers including PTFE, FEP, PFA and ETFE are c ommonly found in the
equipment of food and feed at an industrial scale and are used for instance in non-stick
coatings for conveyer belt, the fabrication of cookware, and in valves and fitting for
commercial food and feed products. PFASs used in industrial application are often used to
enhance productivity, such as by preventing clotting or enabling hygienic conditions. Total
volume of PFASs in FCM and packaging are estimated to be 18 600 - 30 000 t/y in the
EEA, with fluoropolymers as major contribution to the volume.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.5. Metal plating and manufacture of metal products

A.3.5.1. Uses

PFASs are used in metal plating processes and in the manufacture of metal products. In
metal plating, PFASs are used to lower the surface tension of the plating solution and to
decrease aerosol emissions (wetting agent, mist suppressing agent) (UBA, 2017; UBA,
2022; UNEP, 2018a). In the manufacture of metal products PFASs are used to e.g. lower
the surface tension, to promote the flow of metal coatings or to inhibit the formation of
acid mist, to inhibit corrosion on steel and to improve the life of baths. The uses and
applications of PFASs are described in Figure A.11 and Table A.27.

Metal plating

Chrome plating
• functional chrome plating
• decorative chrome plating
• plastic etching

Nickel plating

C opper plating

Tin plating

Alkaline zinc plating and


zinc alloy plating

Deposition of fluoropolymer
particles onto steel

Figure A.11. Overview of metal plating types.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.27. Uses of PFASs in metal plating processes and manufacture of metal products.
Process Examples
Mist suppressant
Lowering surface tension of plating solution (Glüge et al., 2020; UBA, 2022)
Pretreatment (etching) of plastic followed by electroplating (e.g. chrome
coating) (Glüge et al., 2022)
Nickel-plating: non-foaming surfactant - increasing the strength of the nickel
electroplate by eliminating pinholes, cracks, and peeling (EC , 2005; Kissa,
Metal plating
2001); sliding characteristics to prevent seizure of parts
C opper plating: preventing haze by regulating foam and improving stability
while improving brightness and adhesion (EC , 2005; EPA-DK, 2005)
Tin plating: produce a plate of uniform thickness (EC , 2005; Kissa, 2001)
Supporting the deposition of fluoropolymers onto steels for surface protection
(EC , 2005).
Inhibit the formation of acid mist or spray over metal electrowinning tanks
(Glüge et al., 2020)
Treatment of coatings of metal surfaces (Glüge et al., 2020), lowering the
surface tension and thus promoting the flow of metal coatings and the
prevention of cracks in the coating during drying.
Use as corrosion inhibitor on steel (Kissa, 2001). For this purpose, cationic
and amphoteric fluorinated surfactants are used to impart a positive charge to
fluoropolymer particles which facilitates the electroplating of the
fluoropolymer (Kissa, 2001).
C oatings on metal (Glüge et al., 2020)
Used for processing of aluminum e.g. during etching of aluminum to improve
the efficient life of alkali baths or in the phosphating process of aluminum to
dissolve the oxide layer of the aluminum (Glüge et al., 2020; Kissa, 2001).
C leaning of metal surfaces (Glüge et al., 2020; Kissa, 2001). The fluorinated
Manufacture of metal
surfactants disperse scum in molten-salt baths, speed runoffs of acid when
products
metal is removed from the bath and increase the bath life.
Solvent displacement drying (e.g. for water removal prior to plating, coating,
and other surface treatments) (Glüge et al., 2020)
Electrical insulation of bearing houses
Seals, valves, bearing coating, hose products, tank liners, gaskets and
packing in food processing, medical and pharmaceutical industries, chemical
and oil industries, aerospace and automotive industries, industrial equipment
for sensor technology;
Fluoropolymers are used due to high chemical and temperature resistance,
high durability (reduction of friction and wear), good sliding propertie s,
pressure resistance
Anti-stick coating and anti-stick parts in silicone moulding processes (e.g.
automobile industry); coating of processing tools or moulds (function as
mould release aid)

Information on the use of fluorinated substances in tin, c opper and nickel-plating


processes is limited. Some information on chrome plating is available indicating that
mainly C6 fluorinated substances are used. With the identification of PFOS as a persistent
organic pollutant (POP) and inclusion in Annex B of the POP regulation (EU 2019/1021)
only the use of PFOS as a mist suppressant for non-decorative hard chromium (VI) plating

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

in closed loop systems is allowed. The ban of PFOS led to the substitution with 6:2
fluorotelomer sulfonate (6:2 FTS also known as H4-PFOS) in chrome plating processes
(UNEP, 2018a). A survey conducted by the German Environment Agency (UBA, 2022)
showed that in functional25 chrome plating and plastic electroplating only 6:2 FTS-
containing wetting agents were used (30 facilities participated in the survey). In
decorative26 chrome plating 6:2 FTS-containing (60%) as well as fluorine-free (40%)
wetting agents were used. The use of fluorinated substances other than 6:2 FTS was not
noted. PFAS used in metal plating processes and in the manufacture of metal products are
described in the Appendix, Table A.83.

A.3.5.2. Volumes

Information on the concentration of PFASs, the annual production volume or annual import
and export volumes of these PFASs relating to the specific use in chrome/metal plating
processes and processes for manufacture of metal products, is only scarcely available.
Information on the concentration of PFASs per use, annual production volumes volumes/
import volumes of all used PFASs for metal plating/manufacture of metal products,
information on annual emissions/release and future emissions and information on costs is
not available.

A.3.5.2.1. Metal plating

Based on the PFHxA restriction dossier an annual use volume of 30 t/y (central estimate,
range 2 - 57 t/y) for 6:2 FTS in the EU (incl. UK) was estimated.

A.3.5.2.2. Manufacture of metal products

During manufacture of metal products mainly fluoropolymers and C6 fluorinated


substances are used (see Appendix Table A.83). Glüge et al. (2020) estimated that around
900 t PFASs (fluoropolymers) were used in the manufacture of metal products in Sweden,
Finland, Norway and Denmark between 2000 and 2017. With the assumption that the four
countries account for about 5.2% of the EEA population the Dossier Submitters estimated
that on average around 960 t of PFASs are used in the manufacture of metal products in
the EEA per year.

In Table A.28, an overview of volumes is presented for both metal plating and manufacture
of metal products.

Table A.28. PFAS volumes in metal plating processes and manufacture of metal products
estimated for EEA (t/y).
Total PFAAs and PFAA Total polymeric PFASs Total PFAS (t/y)
precursors (t/y) (t/y)
low midpoint high low midpoint high low midpoint high
Metal plating 2 30 57 2 30 57
Manufacture
of metal 960 960 960 960 960 960
products
Total 2 30 57 960 960 960 962 990 1 017

25 Functional chrome plating (also known as hard chrome plating): aim of functional chrome plating
(layer thickness mostly 10 – 100 µm) is to provide e.g. hardness, corrosion and wear resistance,
lubricity and high resistance against chemicals.
26 Decorative chrome plating: used for decorative surface finish. The thin layer of metal (layer

thickness 0.05 - 0.5 µm) provides properties like aesthetically pleasing appearance or non-
tarnishing.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.5.3. Summary

Because of the vast range of properties PFASs are widely used in metal plating processes
and in the manufacture of metal products. In metal plating processes PFASs are used to
lower the surface tension of the plating solution and to decrease aerosol emissions. In the
manufacture of metal products PFASs are used e.g. to lower the surface tension, as
corrosion inhibitor on steel and to improve the life of baths. Stakeholders report an
estimate annual use of 1 017 t (rounded numbers). Approximately 960 t of PFASs are used
in the manufacture of metal products in the EEA per year and approximately 57 t of PFASs
are used in metal plating in the EEA per year.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.6. Consumer mixtures

A.3.6.1. Uses

PFASs are found in a high number of diverse applications that are used by consumers,
including textiles, cosmetics and food contact materials, which are described in other parts
of this dossier. This chapter focuses on PFAS used in mixtures intended for consumer use
and analyses PFAS use in the following applications:

PFASs are utilised in:

 Cleaners for glass, metal, ceramic, carpet and upholstery


 Waxes and polishes for e.g. furniture, floors and cars
 Floor polish removers
 Drycleaning products
 Dishwashing products as rinse aid
 Windscreen treatments for automobiles and windscreen wiper fluids
 Car care products
 Rain-repellent fluids in the aviation industry
 Anti-fog agents
 PTFE spray for lubrication of doors, locks, bike chains, motorcycles etc.
 Musical instruments:
o Lubricants for music instruments
o Guitar strings
o In piano keys

More details on PFASs used and CAS numbers are mentioned in the Appendix, Table A.84
to Table A.90. A variety of PFAS including fluorotelomer alcohols and ethoxylates,
perfluoroalkylcarboxylic acids, perfluoroalkylethers, perfluoroalkanesulfonamide acetates
and polymers such as PTFE are used in consumer mixtures for various technical functions
such as for achieving water and stain repellence and as wetting agents. More detail on
specific PFASs used in the different applications is given in the Appendix based on Glüge
et al. (2020).

Information on concentrations of PFAS in cleaning compositions, polishes, and waxes is


sparse and comes with a wide range of uncertainty. Three different sources of information
were used for the purpose of this dossier:

1. Information given by industry on websites and in brochures


2. Information found in safety data sheets or submitted by companies during the CfE
and consultation
3. Information from literature (mainly measurements)

Information on specific PFAS concentrations is rather sparse; however, end-use


concentrations of PFAS in cleaning compositions, polishes and waxes generally are
reported to be in the range of 10 - 1 000 ppm, concentrations of 200 ppm or less are
typical (Chemours, 2017; ICT). Regarding specific PFAS concentrations in musical
instruments, no information was found. Available data on concentrations of PFAS in
consumer mixtures (polishes, waxes, cleaning agents and anti-fog agents) can be found
in Table A.85 until Table A.91 in the appendix to this section.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

For concentrations significantly below 10 ppm, an intended functional role seems doubtful.
More information was obtained via an explorative research of product labels and
information gained from the CfE. Rather large concentrations were found in one car polish
product (12% PTFE (waxyclean, 2020)) and a rain-repellent fluid used in the aviation
industry. Due to the limited number of products for which information is available, it is
unclear whether these concentrations are typical for such products.

A.3.6.2. Volumes

There is limited information available to the Dossier Submitters regarding the volume of
PFAS manufactured for cleaning agents, polishes, and waxes. In detail, for the
Scandinavian countries Norway, Denmark, Sweden, Finland it was estimated (using the
SPIN database) that in a period of 17 years (2000 – 2017), 21 t PFAS was used in cleaning
agents (Glüge et al., 2022). Extrapolation from this figure to an annual tonnage for the
entire population of the European Economic Area (EEA) results in an estimation of 20 t/y
(assuming a population of 27 million of the a forementioned Scandinavian countries and
453 million for the EEA). This estimate is uncertain, given that consumer behaviour and
prevalence of PFAS in cleaning products within the EEA varies. Moreover, the estimate for
the Scandinavian countries comes with uncertainties. For example, PFAS concentrations
of only a small number of substances are known, which may not constitute all the PFAS
present in cleaning products. Therefore, there is the possibility that for cleaning agents,
the total volume is substantially higher t han the estimate given above. On the other hand,
this volume also includes industrial cleaning, thus possibly overestimating the volume for
non-industrial cleaning agents.

Only incomplete information is available to the Dossier Submitters regarding the market
for PFAS in musical instruments. Based on stakeholder information it is assumed that
1 – 10 t/y of PFAS are used for musical instruments. There is, however, a relatively large
uncertainty with respect to the total volume used in the EU because no information on
products by other companies was available to the respondent.

There is (incomplete) information on the PFAS total tonnage in the consumer mixtures
sector. The Dossier Submitters, however, cannot disaggregate PFAS volumes in more
detail than presented here, despite knowing (main) PFAS used in consumer mixtures. See
Table A.84 in the Appendix.

A.3.6.3. Summary

Because of the vast range of properties, PFASs are used in the consumer mixtures
industry. PFASs are used in cleaning products, products that bestow water repellent
properties, and musical instruments. Stakeholders report a large uncertainty regarding
the use volumes, the best estimate is an annual use of 21 – 30 t.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.7. Cosmetics

A.3.7.1. Uses

PFASs are used intentionally in various categories of cosmetics as, for instance,
emulsifiers, antistatics, stabilizers, surfactants, film formers, viscosity regulators and
solvents (Pütz et al., 2022). Out of these, the most frequently occurring properties for
these PFASs are the functions skin conditioning, film forming, solvent and surfactant. Table
A.29 and Figure A.23 (Appendix) illustrates the identified properties of the most frequently
used PFASs in cosmetics.

Table A.29. Main PFAS and identified properties in cosmetics .


PFAS PFAS category Identified properties
according to CosIng

PTFE Polymeric PFASs Bulking


a
C 9-15 fluoroalcohol phosphate PFAA and PFAA Skin conditioning
precursors
Perfluorodecalin PFAA and PFAA Detangling
precursors Skin conditioning
Solvent
Perfluorooctyl triethoxysilane b PFAA and PFAA Binding
precursors
Perfluorononyl dimethicone a PFAA and PFAA Skin conditioning
precursors
Polyperfluoromethylisopropyl ether Polymeric PFASs Skin conditioning
Octafluoropentyl methacrylate PFAA and PFAA Binding
precursors
Acetyl trifluoromethylphenyl valylglycine PFAA and PFAA Skin conditioning
precursors
Methyl perfluorobutyl ether PFAA and PFAA Solvent
precursors Viscosity controlling
a C overed by the PFOA restriction in POPs and the C 9-C 14 PFC As restriction in REAC H.

b C overed by the (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and TDFAs restriction in

REAC H.

The estimates of use are split according to the following product groups listed below and
are based on databases (CosmEthics, Kemiluppen, ToxFox) of cosmetic products
identifying which PFASs are used, their functions and how commonly found they are in
different product groups:

 Skin care
 Toiletries
 Hair care
 Perfumes and fragrances
 Decorative cosmetics

A.3.7.2. Volumes

Based on the most reliable cosmetic databases, Kemiluppen and CosmEthics, the total
number of cosmetic products and market share of PFAS-containing products were
estimated. The market share of PFAS-containing cosmetic products (based on units sold)
ranged from 1.1 to 1.4%. An even more similar range was obtained after removing
discontinued products listed in the Kemiluppen database (1.3 compared to 1.4%).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

An analysis of the market share of PFAS-containing products revealed that most occurred
in the product category decorative cosmetics (3.7%), followed by skin care, hair care and
toiletries (0.78, 0.65 and 0.27% respectively). The occurrence of PFASs in perfumes and
fragrances was negligible with 0.03% (Based on cosmEthics).

Table A.30 illustrates the share of cosmetic products and product versions that contain
PFASs (%) sorted according to the Cosmetics Europe categories for the emission
calculations. Data is based on the total number of products and product versions
containing and not containing PFAS according to the CosmEthics database (entire database
information included, i.e., product and product versions, EU/EEA and non-EU/EEA). Note
that the CosmEthics product sub-categories were rearranged into Cosmetics Europe
product categories and ambiguous product sub-categories such as “other” were removed.

Table A.30. Share of cosmetic products and product versions containing PFAS*.
Product category Total number of Total number of Share of cosmetic
(Cosmetics Europe) products and cosmetic products products and
product and product product versions
versions versions containing containing PFAS (%)
PFAS
Decorative cosmetics 29 118 1 068 3.67
Hair care 21 938 142 0.65
Perfumes and fragrances 3 637 1 0.03
Skin care 40 103 314 0.78
Toiletries 17 844 49 0.27
Total 112 639 1 574 1.40
* The numbers are slightly overestimated as they also include Hydrofluorocarbon 152a which is not
a PFAS.

The different databases were consulted to get an overview of the identity and frequency
of occurrence of PFAS (i.e., compounds with at least one -CF2) in cosmetic products.
Around 170 unique PFAS ingredients potentially in cosmetic products were identified within
the cosmetic ingredient database (CosIng). Forty-two of these were present in products
within three European cosmetic databases, among which polytetrafluoroethylene (PTFE; a
PFAS polymer) and C9-15 fluoroalcohol phosphate were most frequent. Analysis of the
data shows that three out of the top ten listed PFAS among all considered cosmetic
databases are under current or pending restriction. In total about 1/5 to 1/3 (KEMI, 2021)
of the cosmetic products listed in the cosmetic product databases consulted contain PFASs
that are or are about to be restricted. Table A.92 in the Appendix shows more details on
PFAS INCI names found in cosmetic products in the different databases.

Due to limited information, the yearly tonnage of cosmetic products per category was
indirectly derived from data on market value per product category and assumptions on
price per kg of product (see KEMI (2021) for more details).

Based on data on market value per product category and assumptions on price per kg of
product (see KEMI (2021) for more details) the annual volume per cosmetic product
category was estimated (Table A.31). These estimates were used together with data on
share of products per category that contain PFAS and PFAS concentratio ns based on
analytical data to estimate annual PFAS volumes (Table A.32). Although there is
information on the PFAS total tonnage is cosmetics and PFAS in cosmetics, the Dossier
Submitters cannot disaggregate tonnages despite knowing (most) PFAS used. Table A.92
in the Appendix demonstrates identified PFAS used.

The concentration of PFASs in the products was derived by measuring total fluorine (TF),
the extractable organic fluorine (EOF) and individual PFASs (targeted analysis) in

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

purchased cosmetic products with at least one PFAS on the ingredient list (see KEMI (2021)
for more details). Please note that total PFAS volume for Perfumes and Fragrances are not
provided in Table A.32 as only one out of 3 637 products (CosmEthics database) within
Perfumes and Fragrances listed a PFAS as an intended ingre dient. As a result, this
category’s product concentration was assumed to be equal to zero.

Table A.31. Calculated total amount of cosmetic products sold per year in the EEA in 2019;
data based on assumptions and Retail Sales Price, as well as market share from Cosmetics
Europe as well as assumptions and data from the CosmEthics database (metric tonnes).
Product category Total amount of products
(t/y in 2019)
Skin C are 273 000
Toiletries 1 110 000
Hair C are 838 000
Perfumes and Fragrances 77 600
Decorative C osmetics 18 800
a
Total EEA market 2 320 000
a EU-27 and Norway (i.e., EEA without Lichtenstein and Iceland)

Table A.32. Total annual PFAS volume per main cosmetics category in EEA.
Total PFASs
(t/y)
low midpoint high
Skin care 0.014 25 49.9
Toiletries 0.002 1.25 2.5
Hair care 0.003 2.30 4.6
Decorative 3.55
0.010 7.1
cosmetics
Total 0.028 32.11 64.2

A.3.7.3. Summary

PFASs have a myriad of uses in various cosmetic products, for instance as emulsifiers,
antistatic properties, stabilizers, skin conditioning, binding, and viscosity regulators. The
most frequently identified propert ies of PFASs in cosmetics included conditioning, film
forming, solvents and surfactants. Based on the analysis of three European databases
(CosIng, Kemiluppen, and CosmEthics) C9-15 fluoroalcohol phosphate and PTFE were
reported most often found in cosmetic products. A large share of cosmetic products ( in
total about 1/5 up to 1/3) listed in the cosmetic product databases consulted for this study
contained PFASs that are or are about to be restricted. According to this report, the total
PFAS volumes are estimated to be between 0.028 to 64.2 t/y. Based on market share, 1.1
to 1.4% of products contain PFASs. Within that they are found most in decorative
cosmetics (3.7%), followed by skin care, hair care and toiletries (0.78, 0.65, and 0.27%,
respectively).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.8. Ski wax

A.3.8.1. Uses

PFASs have commonly been used in the production of gliders and other ski wax products
used for preparation of skis (including both cross country and downhill/alpine skis,
freestyle skis), snowboards, as well as in mixtures for cleaning and impregnation. The key
property that PFASs provide in this application is a high-water repellence (hydrophobicity)
thus allowing a suitably low surface tension for the skis on snow. Waxes are an important
means of lubrication in skiing, to reduce friction between the base of the skis and snow,
allowing the skis to glide more freely. It has been shown that the use of high fluorinated
waxes can result, on average, in a 4% increase in performance of the skis (Breitschädel
et al., 2014). There are three main types of friction that require specific lubrication in
skiing:

 Dry friction – when dry snow granules come in contact with the ski base.
 Wet friction – when a high moisture content snow creates suction between the ski
base and snow.
 Electrostatic friction – when a ski base runs on snow creating an electrostatic
attraction between the ski and snow.

PFASs, including fluoropolymers (e.g. PTFE), are also sometimes used in in the sole of skis
as well as in shoes and different equipment for skiing. However, the present assessment
covers the treatment of skis with PFAS-containing mixtures.

Fluorinated waxes tend to be used primarily during competitions. However, professionals


are known to use fluorine-free waxes during training. Similarly, amateur skiers mostly use
fluorine-free alternatives. However, in some countries it is still common to use fluorinated
waxes, also among amateur skiers. Ski wax can come in a variety of different types, each
designed for specific conditions, compositions, or a certain performance level. The most
common forms of wax are listed in Table A.33.

Table A.33. Overview of different ski wax types (both grip and glide wax) 27.
Type Market insights Method of application Use
Block wax Most common wax Block wax needs to be melted on Waxes in block form
form the ski base once it is heated up last the longest on
with an iron, then ironed into the skis.
pores of the bases evenly to
allow faster gliding.
Liquid wax Found at high and low Supposed to be applied onto a Short-term solution
end of the cost cloth or it comes with an to allow for faster
spectrum applicator then rubbed on the gliding properties for
bases of the skis. up to 24hrs.
Often used in conjunction with
other forms of wax including
fluorocarbon waxes.
Paste wax Very economical and Small fabric applicator to apply Typically available in
easy to apply and buff in. The longer you buff it a universal
into the base the longer it lasts temperature range.
on your skis.
C an be used as an overlay.
Powder Typically have high Designed to be used after a few Often used sparingly
wax costs due to the high layers of block wax are applied. for important races

27
https://www.skis.com/Buying-Guide-for-Ski-Wax/buying-guide-5-3-2013,default,pg.html, date
of access: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Type Market insights Method of application Use


number of Used to increase gliding only.
fluorocarbons they properties.
contain
Spray wax Typically used on top of Once it is sprayed on, allow it to Most found in high-
several layers of high- absorb and dry for 5 minutes, end finishing racing
end block wax to offer then use a cork to further buff it wax as an overlay.
the best gliding in.
properties

Lists of examples of PFAS-based and fluorine free ski waxes is provided in Table A.93 and
Table A.94 in Appendix A.3.8.

A.3.8.1.1. Skin skis

Skin skis differ from traditional skis in that they are designed to allow skis to slide forward
but not backward. Initially, animal fur or mohair, a natural material from the hair of goats,
was used for skin skis. It was then substituted by nylon skin material treated with Teflon
or by a mix of the two.

Real mohair treated with Teflon is used on high-performance models 28. Nowadays, mainly
synthetic skins are used for both cross country and alpine skiing when going uphill. The
skins grip the snow, thus providing a forward kick. The skins are then easily removed for
skiing downhill3, while they may be permanently attached under the ski on cross country
skis. Given that the skin mimics the functions provided by the grip wax, it is not necessary
to use grip wax on the skis. However, it can be necessary to apply anti-icing products to
the skins to eliminate icing, as it is done for grip wax-treated skis. In addition, the skin
should be cleaned periodically 28. The glide zone of the skis (i.e., in front of and behind the
kick) needs to be re-waxed every 100 km travelled, similar to classic skis 29 and in most
cases, it is possible to use the same wax for bot h skin and traditional skis.

A.3.8.1.2. Main PFAS

The main PFAS used in ski waxes are perfluoroalkanes and semi-fluorinated alkanes. The
semi-fluorinated alkanes used are di-block and tri-block semi-fluorinated n-alkanes (SFAs)
and are typically mixed with normal paraffins in the formulations of ski waxes.
Perfluoroalkyl carboxylic acids (PFCAs) of varying carbon chain lengths (6–22 carbons) are
often found as residual impurities from the manufacture in commercially available
fluorinated ski waxes, see the studies by Nilsson et al. (2010) and Fang et al. (2020).
PFCAs are not thought to have a technical function in the ski waxes given their relative
low levels compared to the perfluoroalkanes and SFAs. Perfluoroalkane sulfonic acids
(PFSAs) have also been measured in ski wax, but often at even lower levels than the
PFCAs.

Fluoropolymers are also used in some waxes.

Based on the complex interplay of PFAS, regarding some PFASs being a precursor and/or
impurity to each other, it is in some cases difficult to state if individual substances are
used intentionally or are the product of degradation or an impurity. In each c ase, the
specific composition of the wax varies depending on the different snow conditions,
humidity levels and weather conditions for which they are designed. Commonly the

28
https://www.webcyclery.com/about/skin-skis-101-pg259.htm, date of access: 2022-12-15.
29
https://www.crosscountrysports.com/care-for-your-skin-skis/, date of access: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

composition of waxes is divided into the following categories (Table A.34).

Table A.34. Overview of different ski wax composition.


Wax composition Price Properties Labelling
Pure Fluorocarbon Expensive products C omes in liquid, powder or Typically have FC
as they have a high block form. Liquid form is or C era in the title
fluorocarbon content. the most popular. High of the wax.
resistance to dirt and oils
to provide a long lasting,
fast gliding ski.
High Fluorocarbon Typically, more Provide the highest number Typically has HF in
expensive ski waxes. of gliding properties in the title of the
The higher the areas with high humidity, wax.
fluorocarbon content man-made snow, dirty
the more expensive. snow or places with very
cold temperatures.
Made for every
temperature range.
Low Fluorocarbon Best value wax when Available in every Typically has LF in
you compare price temperature range. the title of the
and performance. C an be used by themselves wax.
or to prepare the base.

Hydrocarbon C ontain no Very durable and repel Typically has C H


fluorocarbons and dirty snow conditions very in the title of the
are very economical. well. C an be used by wax.
themselves (best in colder
conditions), or they can be
used to help prepare bases
for use with higher-end
waxes.
Eco-friendly/plant- More expensive than Often made from a mix of Often labelled
based wax typical hydrocarbon naturally occurring waxes. ‘eco’.
wax. Tend to be biodegradable.

A.3.8.2. Volumes

Information obtained from stakeholders suggests that the total ski wax market is split
approximately 50/50 between consumer and professional sales, and the racing market
accounts for ~10% of the market sales. (EEA as well as world market) is split
approximately 50/50 between consumer and professional sales, and the racing market
accounts for ~10% of the market sales (ECHA, 2016). No information was available on
the sales of specific alternative products, nor the volumes associated with the various wax
types (block, liquid, powder etc). PFASs in ski wax seems to have been introduced in the
late 1980s (Masia, 2010). Historical trends in use of ski wax indicate that:

 The highest use year for non-PFAS based ski wax globally was 1978, where 300 t
of glide waxes were used.
 Some companies no longer manufacture ski waxes containing PFASs and are
currently selling off their remaining stock. Companies have been working on the
development of non-fluorinated alternatives since 2013.
 Since 2017 the PFAS-based ski wax market has shrunk for various reasons,
because of the higher prices of some PFAS-based waxes, due to global policy
developments related to the use of PFOS and PFOA, and also due to decreasing
number of professional athletes.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Production of PFASs based waxes is expected to decrease in the following years. Due to
increasing concern and publicity regarding the potential human health and environmental
effects caused by the use of PFASs in ski wax treatments, there is a concerted move within
this sector towards phasing out the use of PFASs and moving towards safer alternatives.
In particular, in 2019 the International Ski Federation (FIS) set to introduce a full ban on
all PFASs in waxes in all competitive ski disciplines from their 2020-2021 season, a move
that follows national-level bans imposed, for example by the Norwegian Ski Association in
2017. However, enforcement of the FIS ban has been postponed until after the season
2021-22 (FIS, 2021). This delay was because they are still developing a Fluorine Tracker,
an instrument that would instantly detect the presence of PFASs on the ski, thus making
the competitions fair. At the same time FIS has prohibited any products containing C8
fluorocarbons/PFOA at all FIS events from season 2021 and 2022 onwards to mirror the
PFOA regulations in the chemical legislation.

Based on stakeholder information it is estimated that the total global production of ski wax
is 120 t (in 2020). Of these, the EU produces 60%, which equals 72 t. Ca. 30% of the 72 t
of ski wax produced in the EU annually is PFAS-based, i.e., 21 t. An average PFAS
concentration of 7.6% w/w. is assumed in fluorine-based wax (which includes both
fluoropolymers and non-polymeric PFAS), which amounts to 1.6 t (or 1 640 kg) of PFASs
used annually in the EEA for ski-wax formulations. The Dossier Submitters, however,
cannot disaggregate PFAS volumes in more detail, despite knowing the (main) PFASs used.

Since the EU is a major manufacturer of ski-waxes according to stakeholders, 60% of


global production, it is assumed that no imported ski-wax will be needed and that all ski-
wax manufactured will service the EU’s needs, hence that net export/import is zero. It is
possible that the EU is a net-exporter of ski-wax but data on exports was not identified.

Regarding manufacturing in the text above already information has been given. In Figure
A.12 a high-level market overview in EEA is given.

Figure A.12. High level market overview of ski waxes in the EEA (information obtained
from stakeholder consultation).

In Table A.35, an historic overview of production volumes is listed. Information from


stakeholders indicate that the peak year for production and consumption of ski-wax
globally (all formulations, including both PFAS and fluorine free) was 1978, where 300 t
of wax was used. However, it is important to note that the use of PFAS based substances
only came into circulation later, with the first patents lodged in 1990. Based on feedback
from EU’s largest manufacturer, market data for the latest year suggests total global
production for ski-wax in 2020 (again, all formulations) was 120 t. This suggests that
overall global consumption of ski-wax has declined since the peak years of the late 1970s.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Further information about assumptions behind the volumes in Table 29 can be found in
the report by the Norwegian Environment Agency (NEA, 2021b).

Table A.35. Assumed production rates, based on stakeholder information and consultant
assessment, for PFAS-based wax used to calculate the backward-looking time-series.
Year Global EEA fraction Total EEA ski- Proportion of PFAS-based
production of production wax EEA production ski-waxes
(t/y) (%) production (all covering produced in
formulation) fluorinated the EEA
(t/y) waxes (%) (t/y)
1978 300 60 180 0 0
1990 250 60 150 10 15
1995 225 60 135 30 40.5
2000 200 60 120 50 60
2005 175 60 105 50 52.5
2010 150 60 90 50 45
2015 135 60 81 40 32.4
2020 120 60 72 30 21

Mobile air conditioning is an application where HFOs have replaced HFCs to a considerable
extent, and use volumes are underestimated if only volumes of HFCs and PFCs, as reported
in the GHG Inventory Data, are taken into account, which is the case in Table A.35. In
section A.3.11 on PFAS applications within transportation, the overall volumes of
fluorinated gases used in mobile airconditioning was estimated at 12 222 t/y with basis in
the number of new vehicles manufactured and registered in the EU and typical refrigerant
loading in each type of vehicle.

A.3.8.3. Summary

PFASs used in ski wax allow for easy gliding and skiing due to their specific properties of
high-water repellence and low surface tension. The most used PFASs in fluorinated waxes
are perfluoroalkanes and semi-fluorinated alkanes. Other PFASs include PFSAs, PFCAs of
varying carbon chain lengths (6–22 carbons) which are often found as residual impurities,
and fluoropolymers. The EU is currently a major manufacturer of ski wax, producing 60%
of global production, which equals to 72 t according to stakeholder data from 2020.
Assuming an average PFAS concentration of 7.6% w/w, it is estimated that 1.6 t of PFASs
are used annually in the EEA for ski-wax formulations. There is a concerted move within
this sector towards phasing out the use of PFASs and moving towards safer alternatives.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.9. Applications of fluorinated gases

A.3.9.1. Uses

A short summary of the applications of fluorinated gases for various uses in the EU/EEA
was prepared by Exponent and published by the Norwegian Environment Agency
(Exponent International Ltd., 2021).

As the definition of PFAS, used by the Dossier Submiter (as well as OECD) include
substances with only one fully fluorinated carbon atom, several small fluorinated molecules
that are often gases are covered. Some of these substances, in this dossier called
fluorinated gases, are well-known heat transfer agents familiar from freezers, heat pumps,
air-conditioning and other applications. Some of the fluorinated gases are common with
the set of gases addressed in the F-gas regulation, but there are also differences in the
scope of the F-gas regulation and the PFAS restriction proposal.

This definition covers most F-gases as defined by the European F-gas regulation and the
Montreal Protocol. Fluorinated gases are a family of man-made gases used in a range of
industrial and consumer applications. There are however, fluorinated gases which are
grouped as F-gas according to the European F-gas regulation and the Montreal Protocol
but are not a PFASs. This is for instance the case for SF 6, HFC-23 and HFC-152a. On the
other hand, there are volatile PFASs which partition considerably to air while they are not
among the F-gases in the F-gas regulation. For example, fluorotelomer alcohols or
perfluorinated trialkylamines (gases in the atmosphere but liquids under normal
conditions). The current assessment covers substances that are both F -gases and fall
within the PFAS-definition. See also Figure A.5. These substances are used primarily in the
applications which are covered by the F-gas regulation and the Montreal Protocol, including
heating, ventilation, air-conditioning and refrigeration (HVACR), and as foam blowing
agents, propellants, solvents, cover gases in magnesium industry and as clean fire
suppressing agents.

These uses are presented in Figure A.15. In this figure, it can be seen that the main uses
are air conditioning (41%) and refrigeration (34%). Fluorinated gases may be used either
alone or in blends. They are sometimes used in combination with gases outside of the
scope of Annex A or with non-fluorinated gases.

Not assessed in this section:

 A considerable fraction of fluorinated gases produced is used as starting materials


or monomers in the manufacture of other fluorochemicals and polymers. In
principle, these gases are consumed in such manufacturing processes, and
therefore they are not considered in this section which covers end uses of
fluorinated gases. Chemical manufacture with fluorinated gases as building blocks
is often claimed to be handled in closed systems with incineration of off-gas.
However, emissions may occur from the manufacturing plants. In the case of
fluoropolymer manufacture, releases of fluorinated gases are sometimes
underestimated. One example is the release of perfluorocyclobutane (PFC-318) in
the manufacture of PTFE from HCFC-22 (CHClF 2) as reported by (Muhle et al.,
2022). According to atmospheric measurements, PFC-318 has increased sharply
since the early 2000s.
 Fluorinated gases used in medical applications, mainly metered dose inhalers
(MDI), are mentioned in section A.3.10 (Medical devices).
 Some of the fluorinated gas substances in the proposed restriction scope can
sometimes also be used as a fluid. There is not a clear border between gas and
liquid for these (and many other) compounds. Sometimes they are used as a
refrigerant gas, but in other cases the same substance can be used as a solvent for
cleaning in its liquid form – although it may evaporate fast after use. Some of the

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

applications of fluorinated solvents are in closed systems or in applications in which


users can manage and minimize emissions. In many applications, the fluids are
filtered in situ and can be recycled and reused. This liquid application of fluorinated
gases/liquids in PFAS scope is not described in detail here (nor in another section
of the dossier).

Fluorinated gases used for the different applications are mentioned in this section. Chapter
1 includes hydrofluorocarbons (HFC), perfluorocarbons (PFC), hydrochlorofluorocarbons
(HCFC), unsaturated hydro(chloro)fluorocarbons (HFO and HCFO), hydrofluoroethers
(HFE), fluoroketones (FK) and other fluorinated compounds. Fluorinated gases may be
used either alone or in blends.

It is common to use specific codes for the different fluorinated gases in the sector. For
example, HFC-134a represents a specific hydrofluorocarbon, while HFO-1234yf refers to a
certain hydrofluoroolefin compound. Sometimes the "HFO"/"HFC" is replaced by a common
"R" which means the same, but without specifying the subclass, e.g. R-134a and R-1234yf.
The identity of all fluorinated gases mentioned in this report can be found in Table A.96.

Use of fluorinated gases for the manufacture of PFAS is covered in more detail in Section
A.2.1. Key related regulations are the F-gas regulation and the Mobile Air-conditioning
(MAC) directive (Directive 2006/40/EC). The current F-gas Regulation (Regulation (EU)
No 517/2014), which applies since 1 January 2015, replaces the original F -gas Regulation
adopted in 2006. The F-gas regulation has the following ambitions: Limiting the use of
some important F-gases that can be produced and imported into the EU; Banning the use
of F-gases in many new types of equipment where less harmful alternatives are widely
available; Preventing emissions of F-gases from existing equipment. However, the basis
for the F-gas regulation is the GWP of the substances in scope and their contribution to
global warming (and not their volumes per se), while other concerns are not taken into
account, e.g. atmospheric degradation to TFA which precipitates and causes exposure to
the humans and the environment. The Mobile Air-Conditioning (MAC Directive prohibits
the use of F-gases with a GWP of more than 150 in new types of cars and vans introduced
from 2011, and in all new cars and vans produced from 2017. One consequenc e of the
MAC directive is the transition to low-GWP HFO in large volumes which are a considerable
source of TFA in the environment. As the current dossier focuses on different
environmental concerns as the F-gas regulation and MAC directive, an evaluation of
substances and applications independent from these regulations is performed.

A list of the specific fluorinated gas substances identified in different uses and sub-uses
on the market is found in Table A.95, and a condensed list of the fluorinated gases together
with their chemical identity is found in Table A.96. Data on trend in the supply in EU-28 of
fluorinated gases 2007 – 2019 is found in Table A.96.

An overview of the annual volumes for the different applications follows after their
introduction, in Table A.36. In total 43 different substances have been identified as
relevant in this assessment. Five of them are not within scope of this restriction proposal
as they do not carry a fully fluorinated C-atom. However, they are of interest for the
understanding of the relevant applications as they are used in blends together with other
fluorinated gases that are within the scope.

Altogether 14 HFCs/HCFCs have been identified as being in use, as well as 12 HFOs/HCFOs,


several of which are isomers. Two fluoroketones, six hydrofluoroethers (HFE), 16 HFC and
HFC/non-PFAS blends and 20 HFC/HFO blends have been found to be relevant. In addition,
nine substances grouped as 'others' are in use, including perfluoroalkyl amines and a
nitrile.

The substances HFC-23 (CHF 3), HFC-32 (CH2F 2), HFC-152a (CHF 2-CH3), HCFC-141b
(CCl2F-CH3) and HFO-1132a (CH2=CF 2) are not covered by the scope definition of the

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

present restriction proposal due to their chemical structures. However, they are used in
blends with other fluorinated gases that are within scope. Besides, the full overall volume
of the different applications (including both PFAS and non-PFAS gases) is of relevance as
a shift to a different specific gas could affect the whole application volume.

Fluorinated gases are a group of industrial chemicals used as heat -transfer medium in
heating, ventilation, air conditioning and refrigeration (HVACR), and as foam blowing
agents, propellants, solvents, cover gases in magnesium industry and as fire suppressants.
These major sectors may be further divided into sub-applications. There are also several
niche applications (e.g. for gas leak detection) that are not specifically addressed in the
current assessment. In the present assessment primarily applications with use volumes
and emissions reported to the UN Framework Convention on Climate Change (UNFCCC)
are covered as the methodology to collect relevant data would be the same for these
applications and based on reporting under the convention. It should also be recognized
that there is a gradual transition from the traditional applications of fluorinated gases to
the uses of fluorinated liquids that may be of the same or similar chemical structures to
the gases, often called functional or engineered fluids. Information has been included in
this section when this has been submitted by stakeholders as comments to this sector,
see ‘Minor uses’ at the end of this section.

Reclaim and recycling or destruction of fluorinated gases plays an increasing role in the
sector and promotes a circular economy and further reduces emissions. Several companies
offer collection and regeneration service for used refrigerants. However, emissions are still
large from the sector.

Below the main uses of fluorinated gases are introduced. A list of all specific substances
identified together with their respective uses and sub-uses is found in Table A.95.

A.3.9.1.1. Refrigeration, air conditioning and heat pumps

Main sub-use categories assessed:

 Domestic refrigeration
 Commercial refrigeration
 Industrial refrigeration
 Transport refrigeration
 Mobile air conditioning (MAC)
 Stationary air conditioning and heat pumps
 Domestic air conditioning and domestic heat pumps for space heating
 Commercial air conditioning and heat pumps
 Domestic heat pumps (clothes dryers)

Refrigerants are commonly used in refrigerators, freezers, chillers and air conditioning
units at home, in stores and in cars. An emerging market concerns the use of heat pumps
for space and water heating, and domestic hot water production, as well as in some
consumer products such as ‘tumble dryers’ for clothes. Refrigeration and heat pumps are
also widely used commercially and in industry, for example, supermarket refrigerators and
freezers, drinks chillers in bars and restaurants, manufacturing and transporting chilled
and frozen goods, and in specialised applications such as for cooling large data centres,
for servers, electronics and for industrial processes. There are also refrigeration systems
found in commercial aircrafts. In many cases the refrigerant, or heat transfer liquid, is a
fluorinated gas. There are a range of different gases available for suc h purposes, with
different properties that are suitable for different specific applications. However, often
fluorine-free alternatives are available, like the natural refrigerants carbon dioxide (CO 2),
hydrocarbons and ammonia. Isobutane (R-600a) is the major refrigerant used in domestic
refrigeration in Europe and around 50% of light commercial systems are using propane
(R-290) and its use is growing. In larger commercial systems CO 2 is technically feasible

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

and a frequently used option.

The technical function of refrigerators or heat pumps relies on a refrigerant substance or


mixture that acts as working fluids to maintain low temperatures in an enclosed
environment. The most common refrigeration and air conditioning cycle used in these
settings is the vapour-compression cycle, in which the circulating refrigerant absorbs and
removes heat from the space to be cooled and expels the heat elsewhere. Heat pumps
work on the same principle, but in reverse. Reversible air-to-air heat pumps are
increasingly used not only to cool, but also to provide heating to buildings in an energy
efficient manner. Large scale industrial heat pumps for district heating (more than 3 MW,
use of turbo compressors) often rely on fluorinated gases as working fluid.

Fluorinated gases are also sometimes used in refrigeration air dryers, although this is a
minor application.

Mobile air conditioning is used to cool the interiors of cars, trucks, buses, trains, ships and
construction machinery etc. Previously, HFC-134a was extensively used for this purpose,
while HFO-1234yf now replaces the former in new vehicles in order to reduce the climate
impact. The refrigerant circuits for electric vehicles are more complex and larger, as the
battery must also be cooled. Therefore, more refrigerant must be used per vehicle with
increasing electrification of the vehicle fleet. One stakeholder has pointed out that future
cars and vehicles will be electrically driven and that combined air-conditioning and heat
pump systems will be the standard solution due to energy efficiency constraints.

Secondary loop MACs (SL-MAC), also called indirect systems, are vapor compression
refrigerant systems where the evaporator is replaced with a chiller with a coolant flow loop
to provide cooling for passenger comfort, window defogging, and thermal control of
batteries and other components (Chen et al., 2020). Such systems are designed so that
only a secondary fluid (antifreeze coolant, water/glycol, etc.), not the refrigerant, enters
the passenger cabin, while the refrigerant sub-system stays in the engine compartment.
This increases refrigerant choice, since refrigerants that may be flammable but have more
desirable thermo-physical characteristics can be used more safely. SL-MAC systems have
also proven to have higher energy efficiencies compared to direct expansion systems. HFC-
152a (not a PFAS) has been shown to be an affordable and efficient refrigerant in SL-MAC.

Refrigeration is used widely in chemical, pharmaceutical and food processing industry,


throughout the supply chain, including manufacturing, storage and transportation.
Fluorinated gases are often used in refrigeration equipment where extreme controlled
temperatures are required (below -40 °C), more specifically in vaccines and
biopharmaceuticals manufacturing. Blood banks, medical examination and tissue and cell
diagnostics may also rely on the use of fluorinated gas refrigerants. Fluorinated gases are
frequently used in ultra-low temperature freezers or cryogenic storage. Furthermore, such
gases are used in refrigerated laboratory equipment that require precise temperature
control over a large temperature range, e.g. test and measurement equipment and
refrigerated centrifuges. However, this equipment is usually designed with hermetically
sealed systems to avoid leakage, and at end of life, the fluorinated gas is normally collected
under controlled circumstances to avoid releases. Low temperature refrigeration also has
applications within commercial refrigeration.

HFOs may be used in organic rankine cycle (ORC) technology to generate electricity by
recovering waste heat from industrial processes such as glass/ceramics factory and using
geothermal energy and biomass. The same technology is also used for cooling purposes
in data centres to minimize energy consumption by half compared to the current system
and thus enhance energy efficiency.

Variable refrigerant flow (VRF) and direct expansion appliances show enhanced energy
efficiency compared to hydronic heating system. For those appliances, fluorinated gases

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

will stay relevant in the future according to stakeholder input.

Nuclear energy plants also use fluorinated gas refrigerants for certain purposes.

Fluorinated gases are often used as refrigerants in military aircrafts, naval ships and
submarines, and land vehicles for the common refrigerant applications, as well as for
cooling of weapon systems and storage of sensitive material like ammunition,
pharmaceuticals and fuels.

A.3.9.1.2. Fluorinated gases used as Foam-Blowing Agents

Main sub-use categories assessed:

 Foam-blowing agent (closed cell)


 Foam-blowing agent (open cell)
Foams are widely used in household, commercial and industrial settings often to provide
thermal insulation, for example to retain heat within a building or boiler, to keep heat out
of refrigerated areas, or to prevent pipes from freezing and cracking in co ld weather
conditions. Foam is also used to fill gaps in buildings to prevent excessive air movement
and can be used as a protective and cushioning cover, such as for seat covers or vehicle
steering wheels. Key factors in selection of foam blowing agents relate to the cost of
substances, flammability and efficiency of insulation. Additional factors apply in some
applications for specific foams, for example relating to compression and flexural strength
and resistance to water. See Figure A.13 for an example of insulation foam application.

Foam-blowing agents are present in the mixtures created for foam production, ensuring
that foam expands after release and prior to solidifying. Foams may be open-cell or closed-
cell depending on application. For open-cell foams, emissions of blowing agents occur
during manufacture and use or shortly after. Most emissions from closed-cell foams occur
during the service-life of the foams or at disposal of the product into which the foam has
been added. From a business perspective, the use of fluorinated gases in open cell foam
is not wise since the (expensive) blowing agent gets out of the product.

Polyurethane (PU) foams used in refrigeration are closed-cell foams, and applications
include domestic refrigerators and freezers, commercial refrigerators, freezers, cold rooms
and vending equipment and also refrigerated trucks and reefers, as well as domestic hot
water tanks. PU boardstock is a closed-cell foam which may be flexible or rigid and includes
polyisocyanurate boardstock (PIR board) and continuous boardstock with a flexible facer.
It is used in residential and commercial construction for applications such as easy to ins tall
insulation boards for loft conversions or for pitched roofs in between rafters. PU Spray
foam may be open-celled or closed-celled. Closed-cell spray foam retains the blowing
agent in the foam cells and has better insulating properties than open-cell foams. It is
used for insulating structures that would be hard to get to, such as around windows and
doors, gaps around pipes, as a filler insulate with solid preformed foams, an example being
an insulated road tanker.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.13. Prefabricated XPS foundation insulation being installed at a building site
(left) and direct application of insulating foams (right). Both images used royalty -free
from CC BY 2.0, photographers akhouseproject and dunktanktechnician.

In building materials, the olefinic fluorinated gas FA-188 is used as a foam insulation
additive due to its effectiveness in reducing the foam cell size and thus the thermal
conductivity of polyurethane and other rigid foam formulations.

Rigid Polyurethane pipe-in-pipe and block foam is closed-cell and may be used as pipe
insulation particularly for larger scale applications such as district water pipes, to prevent
pipes from freezing and cracking. This type of insulation foam may also be used in central
heating, manufacturing and in the mining industry.

Polyurethane integral skin foams are open-cell foam used in cushions, mattresses,
furniture, toys and sporting equipment. Extruded polystyrene foam (XPS) boards are used
for building insulation, including under floor insulation and often competes with PU board
stock. This type of foam has also been used for its high strength insulating properties in
the construction of roads, railway tracks and airport runways. XPS board foam may also
be used for marine and leisure buoyancy products such as surf and body boards. Phenolic
foams are closed cell foams and include phenolic board stock and block foams which are
used primarily for industrial heating and ventilation applications for the insulation of pipe
work, for insulation in roofing, cavity walls and flooring.

In the home appliance sector, foam insulation is sometimes used in constrained spaces in
white goods, and in order to reach a sufficient level of insulation, fluorinated gases are
used as blowing agents.

New techniques and innovative pathways are developed for the recycling PU/PIR products
and collection of blowing agent. However, some of the infrastructure applications using
foam blown with fluorinated gases have a long lifetime, up to 40 years.

A.3.9.1.3. Solvents

According to stakeholder input the main applications of fluorinated gases used as solvents
(sometimes referred to as functional fluids or fluorinated liquids) are industrial metal
cleaning to remove oil and grease, electronics cleaning for the removal of flux, and
precision cleaning to remove particulates or dust, and cleaning in relation to various
lubrication processes. Such techniques may be in use for example during the manufacture
and maintenance of electronics, fibre optics and equipment for aerospace, medical devices
and defence. In some applications components must be absolutely reliable throughout
their designed lifetime and must meet the strictest cleaning and safety standards.
Particularly relevant are fluorinated solvents used for cleaning of parts and component in
oxygen-enriched environments.

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An industrial use of fluorinated solvents is the use as carrier fluids to deposit lubricants,
silicones, coatings, adhesives and other materials in smooth coatings , as well as for the
formulation of dissolved polymeric PFAS oils and greases. Furthermore, fluorinated
gases/solvents may be used as heat transfer media, thermal testing fluids and in
electrical/electronics testing.

Fluorinated solvents (e.g. hexafluoroisopropanol, HFIP) are used in additive (3D) printing
as a debinding agent prior to sintering for 3D printing of metals. They are also used as a
smoothing agent for some polymer 3D printing applications, including for respiratory
medical articles, Covid-19 diagnostic items, automotive and aerospace components,
electronics and consumer items.

Key factors in selection of solvents relate to the cost of substances, non-flammability,


thermal and chemical stability, dielectric properties (poor electrical conductance meaning
that they can be used safely in contact with electronics), compatibility with dissolved
materials, low surface tension and viscosity, high liquid density, and low toxicity. Although
there are many alternatives for this use, PFAS-substances, such as HFCs, HFEs and HFOs,
are still claimed to be required for some applications, especially precision cleaning.

A.3.9.1.4. Propellants

Propellants are used to expel the contents of an aerosol from a canister through a nozzle,
in products such as deodorants and hair sprays. Technical propellants are used for
industrial uses for items such as lubricant sprays, dusters, cleaners, safety horns,
degreasers, cold sprays, and paints. Propellants used in medical applications like MDI
(Metered Dose Inhalers) are covered in section A.3.10.

Liquified compressed gases are widely used as propellants, as they maintain a relatively
constant pressure as the contents are dispensed, maintaining consistent droplet size and
spray rate which may be required for technical aerosols. In contrast, compressed gases,
such as carbon dioxide, cannot produce a consistent particle size and spray rate, thereby
limiting their applicability, with performance falling as the contents of a can are used up
and pressure within the can falls. Where a non-flammable propellant is required, HFOs are
often used, alone or in a propellant blend.

A.3.9.1.5. Cover gases

Main sub-use categories assessed:

 Die casting
 Sand casting

A cover gas (or shielding gas) is used to prevent rapid oxidation of a molten metal surface
for example in magnesium casting and recycling industries. The function of the cover gas
is to provide a protective film above the molten metal, preventing oxidation. Fluorinated
gases have suitable properties for this application.

A.3.9.1.6. Fire suppressants

Main sub-use categories assessed:

 Total flooding systems


 Local streaming agents

Fire-fighting foams are not part of this assessment. They are covered in a separate
restriction proposal. In the present assessment only clean fire suppressing agents, which
are not foams, are included.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Fluorinated gases (e.g. HFC-125 and HFC-227ea) are used for fire protection purposes
where their main advantage is that they are ‘clean’, non-conductive to electricity (i.e.,
have good dielectric properties) and are considered safe for humans to breathe at the
concentrations used. In this context, ‘clean’ refers to the ability of the fire suppressant to
not leave non-volatile residues after discharge, i.e., avoid the potential damage caused by
conventional extinguishing agents. This means that fluorinated gas fire suppressants
occupy a niche market, when there is a need to protect items that otherwise would be
damaged by a fire extinguishing agent, and in enclosed spaces where some other fire
suppressants would pose a risk to human health. Fire suppressants may be divided into
total flooding agents and local streaming agents. Areas of use include portable and fixed
aircraft fire protection systems (e.g. engine, auxiliary power units and cargo
compartments), as well as specific risk situations (e.g. clean-room protection, electronic-
, IT- and control room installations mainly at critical infrastructures) including the defence
sector.

2-BTP (CH2=CBrCF 3) is a frequently applied substance for fire suppression. The substance
is a halogenated clean agent (HCA) used as halon replacement agent in handheld
extinguishers onboard aircraft. Some fluoroketones, (e.g. FK-5-1-12
(CF 3CF(CF3)C(=O)CF 2CF3), are also introduced as a third-generation fire suppressant.
Clean fluorinated gas fire suppressants may also be used in archives and museums with
paper archives, historical documents, priceless works of art and antiquities where other
fire protection fluids cannot be used.

Fluorinated gas fire suppressants are specifically used for several military applications,
e.g. in engine- and crew compartment systems on army ground vehicles (e.g. HFC-236fa)
and in fixed systems protecting flight simulators and command centres. In combat the
soldiers have very limited possibilities to leave the vehicle and are therefore exposed to
the extinguishing media.

A.3.9.1.7. Minor uses

Insulation gas in electrical equipment

Historically, SF 6 has been used as an insulation gas in high-voltage power generation and
distribution equipment, including gas insulated switchgear and gas insulated lines.
Recently, research and development has led to the replacement of SF 6 (very high GWP)
with low-GWP fluorinated gas alternatives that would reduce the contribution to climate
effects considerably. Specifically, the nitrile C4-FN and the ketone C5-FK are used for this
purpose, including in medium- and high-voltage gas insulated power generation and
distribution equipment such as switchgear and lines. This application is considered in detail
in section A.3.12 on electric/electronic equipment.

Electronics and semiconductors manufacture

In the electronics and semiconductor industry fluorinated gases are used in etching and
chamber cleaning processes to form nano-level fine semiconductor integrated circuits etc.
CHF 3, CF 4, perfluoroethane, perfluorinated alkanes and cycloalkanes are examples of
fluorinated gases used for these purposes. In most cases the substances are used as a
solvent. Although the amount used is small, today's electronics products require extremely
complicated and delicate processing to realize various functions such as high performance,
multi-function, and low power consumption. To achieve this, various gases /liquids are
combined to perform processing with advanced and delicate control. Fluorinated gases are
also used in Carnot cooling cycles in electronics and switchgear, as well as in industrial
process refrigeration in the manufacturing plant, while hydrofluoroethers and
perfluoropolyethers are used within as high-performance heat transfer fluids. Further
details may be found in section A.3.12 on electronics and semiconductors
electric/electronic equipment.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

IT hardware immersion cooling

Immersion cooling is a method for cooling data centre IT hardware, including 5G network
components, by directly immersing the hardware in a non-conductive fluorochemical
liquid. The heat generated by the electronic components is directly and efficiently
transferred to the fluid. This reduces the need for interface materials, heat sinks, fans,
shrouds, sheet metal and other components that are common in traditional cooling
methods. This application is considered in detail in section A.3.12 on electric/electronic
equipment.

Preservation of cultural paper-based materials

Fluorinated –gases/liquids are used in a procedure for preservation of paper-based cultural


heritage materials. The procedure includes suspending MgO in a fluorinated solvent for
treatment of paper materials to stop acid corrosion and preserve the objects. Fluorinated
solvents can deliver the alkaline buffer without degrading ink, binding materials, glue or
discolour the paper.

Plasma coating

Some fluorinated gases are used in plasma coating of recycled HDPE plastic containers to
limit the migration from recycled plastic to filling goods. The gases react with the plastic
under the conditions with formation of a fluorinated protective layer.

Calibration and reference materials

Fluorinated gases and liquids are used as analytical reference materials and for the
calibration of measurement instruments.

A.3.9.2. Volumes

In Table A.36 an overview of PFAS volumes is presented. The main use groups are
distinguished. A description of the methodology used in the estimation of volumes for the
different applications is found below the table.

Table A.36. Yearly total volume of HFCs and PFCs in EEA per main use category.
Total fluorinated
gases (t/y)
Manufactured
7 915
C ommercial products
refrigeration Stocks 90 992
Decommissioning 5 717
Manufactured
122
Domestic products
refrigeration Stocks 4 496
Decommissioning 671
Manufactured
2 360
Industrial products
refrigeration Stocks 34 358
Decommissioning 1 219
Manufactured
1 010
Transport products
refrigeration Stocks 9 915
Decommissioning 226

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Total fluorinated
gases (t/y)
Manufactured
5 221
Mobile air products
conditioning Stocks 115 763
Decommissioning 4 647
Manufactured
7 465
Stationary air products
conditioning Stocks 148 791
Decommissioning 6 865
Manufactured
Foam blowing 4 940
products
agent Stocks 57 635
(closed cell)
Decommissioning 170
Manufactured
Foam blowing 271
products
agent Stocks 9 848
(open cell)
Decommissioning No data
Manufactured
863
products
Fire protection Stocks 20 201
Decommissioning 208
Manufactured
504
Aerosols (non- products
MDI) Stocks 907
Decommissioning No data
Manufactured
No data
products
Solvents Stocks 0
Decommissioning No data
Manufactured
No data
products
Other Stocks 267
Decommissioning No data
Manufactured
30 671
products
Total HVAC R Stocks 493 173
Decommissioning 19 724

There are two main data sources that have been used extensively for market data
(volumes) on fluorinated gases and their different applications, each with different
strengths and limitations:

 Greenhouse Gas Inventory: EU/EEA Governments annually report to the United


Nations Framework Convention on Climate Change, UNFCCC (EEA, 2022) – the so-
called Greenhouse Gas (GHG) Inventory data. This is compiled according to the
standard methodology and guidance set out by the Intergovernmental Panel on
Climate Change (IPCC). Data from the GHG Inventory for 2018 (published in 2020)
have been used in this assessment. The data used were mainly the data for
fluorinated gases that are included in the GHG Inventory which is titled the ‘Sectoral

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

background data for industrial processes and product use’. These data are included
in Table 2(II). B-H of the inventory and have been used.

The reporting includes emission data in addition to market volumes. The GHG
Inventory includes fluorinated gases of the type HFCs and PFCs, which are the most
important subclasses, but it does not include for example the HFOs which are
growing in use. The geographical scope of the GHG Inventory data for 2018 is EU-
28 plus Iceland (IS). Norway (NO) reports separately to the UNFCCC process, so
for the purposes of this project the Norwegian data has been added to the EU GHG
Inventory data to provide a geographical coverage of EU-28 & IS & NO. No data
were available for Liechtenstein.

 F-gas report: The European Environment Agency annually collects and publishes F-
gas data reported by industry according to the obligations under Regulation (EC)
No 517/2014 (the ‘F-Gas Regulation’). The report used in this project was published
in 2020 as the ‘F-Gas Report’ (EEA, 2020) and provides EU data up to and including
2019 and covers F-gas activity (production, reclamation, imports, exports,
destruction and feedstock use), supply of F-gases (trends in supply) and progress
of phasing down the use of hydrofluorocarbons (HFCs). The F-gas report does not
include data for Iceland and Norway. The reporting threshold is 1 metric tonne, or
100 t CO2 equivalents of F-gas produced or imported/exported in bulk, and 500 t
CO2-equivalents for F-gases in products30. The F-gas report is limited to volumes
of F-gases placed on the market and does not cover emissions. However, it includes
market volumes for the emerging HFOs (in principle also HFEs, but data are
generally confidential for these).

Market data on fluorinated gases filled into new products and in stocks each year have
primarily been derived from data collated by the EU/EEA for the GHG Inventory and
summarized for EU-27 & IS & NO & UK. Data for HFOs, which are not reported in the GHG
Inventory, have been extracted from the F-gas report.

Volumes of fluorinated gases from manufacturing to decommissioning is available at the


sub-application level and is indicated in the material flow diagram in Figure A.14. The data
are disaggregated as follows: 1) Filled into new manufactured products; 2) In operating
systems (annual stocks); 3) Remaining in products at decommissioning, while data are
not disaggregated at the substance-in-each-sub-application level.

In 2018 in total, 30 671 t/y fluorinated gases were filled into new products for the first
time during their manufacturing process, while 493 173 t/y were found in operating
systems (Annual stocks in operating systems refers to products that already contain
fluorinated gases and are in operation) used in EU-27 & the United Kingdom (UK) & Iceland
(IS) & Norway (NO) (EEA, 2022). Remaining in products at decommissioning is 19 724 t/y
gases. From the GHG Inventory data for 2018, refrigeration and air conditioning account
for 78% (24 093 t/y) of the total amount of these fluorinated gases filled into new
manufactured products and 82% (404 315 t/y) of the gases in operating systems
(technical stocks).

30 An implication of the high reporting threshold for products (in C O2e) is that HFOs often are
underreported due to their low GWP. For example, HFO-1234yf with a GWP of 4 is replacing HFC -
134a with GWP 1430 for use in AC in passenger cars. With a specific charge of approximately 0.5
kg per passenger car, the 500 t C O 2 e reporting threshold corresponds to 250 000 passenger cars
with HFO-1234yf refrigerant.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.14. Material Flow diagram – fluorinated gases from product manufacturing until decommissioning, 2018.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Looking at the fluorinated gases filled into new manufacturing products in Figure A.14 and
comparing the volumes of the different applications, the distribution shown in Figure A.15
below can be obtained. The total amount of fluorinated gases filled into new products equals
30 671 t/y.

Figure A.15. Fluorinated gases filled into new manufactured products in 2018 (EU-27 & IS &
NO & UK). Figure adapted from GHG Inventory (EEA, 2020).

According to stakeholder input, the market volumes of closed cell insulation foams can be
split between polyurethane spray foams, extruded polystyrene and phenolic foams, with
phenolic foams potentially accounting for around 50%.

In the GHG Inventory the reporting on applications of solvents is very limited. This may be
due to the volume threshold for reporting to the GHG Inventory is high and not suitable for
these applications. However, it is evident that the volumes of fluorinated solvents used are
low compared to other applications. According to stakeholder information, an amount of 140 t
of fluorinated solvents is used annually within electronics and semiconductors, mos tly for
cleaning, see section A.3.12. Furthermore, an estimated 35 – 75 t/y of fluorinated solvents is
used for cleaning in relation to lubrication processes, see section A.3.15.

In addition to the above-mentioned fluorinated gas market data from the GHG Inventory,
HFOs are being increasingly used. These are not reported in the GHG Inventory, but data may
be found in the F-gas report. The F-gas report investigates trends in the supply of fluorinated
gases in the EU, and Figure A.16 below, copied from the report (EEA, 2020), shows the
estimated trends in different intended applications since 2007.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.16. Intended applications of EU total supply of fluorinated gases , 2007-2019.


Reproduced from F -gas Report, Figure 4.7 and 4.8 (EEA, 2020).

Data collected from the F-gas report on the use volumes of HFOs and HCFOs and compared
with other fluorinated gases can be found in Table A.97 in the Appendix. The majority of HFOs
currently being used commercially as a single substance (rather than a blend) are in mobile
air conditioning (MAC) systems for passenger cars and in light goods vehicles, commercial air
conditioning, heat pumps and process cooling. In commercial and transport refrigeration HFOs
are mainly used in HFC/HFO blends such as R-448A, R-449A, R-450A, R-452A and R-513A.
The overall volumes of HFOs/HCFOs for all applications increased from 6 305 t in 2016 to
18 350 t in 2019, while the relative proportion of HFOs/HCFOs compared to other fluorinated
gases in the same period increased from 6 to 24% (Table A.97).

According to the GHG Inventory data 5 221 t/y of HFCs were supplied to the EU market in
2018 for mobile air conditioning, Figure A.14. The F-gas report lists 1 206 t/y imported
fluorinated for MAC in 2018, while EU total imports of HFOs/HCFOs in 2018 was 19 235 t/y.
With basis in the number of newly produced/registered road vehicles and the volumes of
gases used in different types of vehicles, it was estimated that 12 222 t of fluorinated gases
were used in HVACR-systems for passenger comfort in new vehicles in the EU in 2019, see
section A.3.11.

Figure A.17 shows the imports of fluorinated gases into the EU-28, including both bulk imports
and imports contained in products and equipment (EEA, 2020). The overall import volume of
fluorinated gases decreased by 14% from 2018 to 2019 (EEA, 2020). Imports of HFCs fell by
19%, while imports of HFOs/HCFOs increased by 6%. The share of HFCs in total imports was
79% in 2018 and 74% in 2019.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.17. EU imports of fluorinated gases, both bulk imports and imports contained in
products. Copied from the F -gas Report, Figure 3.3 in EEA (2020).

Figure A.18 provides an overview of the supply of fluorinated gases in 2019 in more detail:
the largest proportion is HFCs delivered in bulk (61% of total EU supply), while about 13% is
HFCs delivered in products and equipment. Unsaturated HFCs (= HFOs) have risen to a share
of 23%. PFCs, SF 6 and other gases are supplied almost exclusively in bulk. The picture looks
quite different when looking at the total supply measured in CO2-equivalents.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.18. 2019 total supply by types and groups of fluorinated gases . Reproduced from F-
gas Report, Figure 4.3 and 4.4 in EEA (2020).

To get an impression of the relative importance of the different fluorinated gases t hat are not
within the chemical scope of the present restriction proposal, one can look at the total supply
of fluorinated gases (in tonnes) reported at the substance level in the F -gas Report (EEA,
2020), Table A5.17. An extract for the substances HFC-23 (CHF3), HFC-32 (CH2F 2) and HFC-
152a (CHF 2-CH3) is presented in Figure A.19 below. Data were not available for HCFC-141b
and HFO-1132a, but their uses are expected to be limited. The use of HFC-32 is evidently
increasing, and in 2019 constituted 18.5% of total supply of the fluorinated gases on volume
basis. The total EU supply of HFC-32 in 2019 was 14 483 t. HFC-152a is fairly stable around
4%, while HFC-23 is negligible in comparison to the overall supply.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Volume of selected F-gases as % of total supply


of F-gases
100
90
80
70
60
50
40
30
20
10
0

HFC-23 HFC-32 HFC-152a

Figure A.19. Supply of gases outside the scope of the PFAS restriction proposal in the EU as
percentage of total supply of fluorinated gases based on tonnes supplied.

Although some fluorinated gases used in various applications and in considerable overall
volumes are outside of the chemical scope of the PFAS restriction proposal (e.g. HFC-32), the
overall volumes of gases (both PFASs and non-PFASs) for the different applications is of
interest as trends and shifts may affect the whole sector use volume as a response to technical
or regulatory development. Furthermore, the gases outside of the chemical scope are often
used in blends with fluorinated gases within scope.

Illegal use and trade of HFCs is a considerable problem in the EU/EEA. The illegal trade
undermines regulations, results in more HFC emissions that fuel global warming and
significantly reduces government income and the profits of legitimate businesses. It is very
difficult to provide an accurate estimate of the extent of these illegal activities. However, one
estimate was provided by the Environmental Investigation Agency which estimated that
16.3 million tonnes CO2 equivalents of bulk HFCs were illegally placed on the EU market in
2018 (EIA, 2019). This represents more than 16% of the 2018 quota. The number represents
the amount of HFCs imported through normal customs channels outside of the quota system,
and traditional smuggling comes in addition to this and is much more difficult to quantify.
There is a large variation in the fraction that the illegal import of HFCs constitutes between
the European countries.

A.3.9.3. Summary

Fluorinated gases are widely used in certain specific areas, e.g. refrigeration, foam blowing
agents and as clean fire suppressing agents. The main uses of such gases are in air-
conditioning (stationary and mobile) (41%) and refrigeration (commercial, industrial and
transport) (34%). The total annual use volume of fluorinated gases for HVACR for
manufactured products is 30 671 t, for stocks 493 173 t, and for decommissioning 19 724 t.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.10. Medical devices

A.3.10.1. Uses

Medical devices are regulated under EU Regulation 2017/745. Various items can be
considered medical devices, see text below as defined in the currently abovementioned
regulation (EC, 2017a).

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent,
material or other article intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the following specific medical purposes:

—diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

—diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

—investigation, replacement or modification of the anatomy or of a physiological or


pathological process or state,

—providing information by means of in vitro examination of specimens derived from the


human body, including organ, blood and tissue donations

In vitro diagnostic medical devices, on which the restriction proposal is also applicable, are
regulated under EU Regulation 2017/746. Various items can be considered in vitro diagnostic
medical devices, see text below as defined in the currently abovementioned regulation (EC,
2017b).

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent
product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software
or system, whether used alone or in combination, intended by the manufacturer to be used in
vitro for the examination of specimens, including blood and tissue donations, derived from
the human body, solely or principally for the purpose of providing information on one or more
of the following:

(a) concerning a physiological or pathological process or state;

(b) concerning congenital physical or mental impairments;

(c) concerning the predisposition to a medical condition or a disease;

(d) to determine the safety and compatibility with potential recipients;

(e) to predict treatment response or reactions;

(f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;

Medicinal products (including active pharmaceutical ingredients), anaesthetics and contrast


media are considered not in scope of medical devices. Furthermore, personal protective
equipment (clothing, drapes), medical electronics and constructive applications in hospitals
are also not included, since these are part of TULAC (A.3.3), electronics (A.3.12) and
construction (A.3.14), respectively.
The EU Medical Device Regulation has classified medical devices into three classes with
increasing risk: Class I, II and III. Each device class requires a different level of regulation

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

and compliance.

 Class I are devices like tongue depressors, bandages, gloves, bedpans, and simple
surgical devices
 Class II devices include wheelchairs, X-ray machines, MRI machines, surgical needles,
catheter and diagnostic equipment
 Class III devices are used inside the body, for example heart valves, stents, implanted
pacemakers, silicone implants and hip and bone transplants

In future these devices will be registered in the European database on medical devices
(EUDAMED)31 with a harmonised nomenclature through the European Medical Device
Nomenclature (EMDN) 32.

Production of medical devices requires a high degree of cleanliness, purity, chemical stability
and thermal resistance. In the final products (substance, mixtures and articles), PFAS
properties like temperature resistance, dielectric strength as well as very high autoclavability,
chemical resistance, oil repellence, water repellence, sliding properties and good
biocompatibility are important.

The majority of medical devices are introduced to the EEA market via imported articles
containing PFAS.

Main medical devices containing PFAS are listed below. Each mentioned sub-use will be
discussed in more detail in the section below.

 Fluorinated meshes and wound treatment;


 Medical textiles;
 Medical implants;
 Tubes and catheters;
 Coatings;
 Cleaning and heat transfer: engineered fluids;
 Sterilization gases;
 Packaging;
 Electronic equipment;
 Diagnostic laboratory testing;
 Metered Dose Inhalers (MDI);
 Others.

31
https://ec.europa.eu/tools/eudamed/#/screen/home , date of access: 2022-12-15.
32
https://webgate.ec.europa.eu/dyna2/emdn/, date of access: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.10.1.1. Implantable medical devices

Meshes, wound treatment products (bandages, surgical tapes, surgical staples), tubes and
catheters are covered in separate sections.

Polymers in medical implants are listed in Table A.99 in the appendix (McKeen, 2014).
Polymers are used for medical implants, with PTFE being the most abundant fluoropolymer.
Fluoropolymers such as PVDF and FEP are also used as biocompatible materials.

A.3.10.1.2. Fluorinated meshes and wound treatment

The most frequently used textile implants worldwide are hernia meshes. The closure of the
defect is important and is one of the most common surgical procedures. More than one million
operations are implanted every year in Europe. Porous membranes containing ePTFE
(expanded PTFE) or PVDF are used as mesh material or patches, because they reduce
adhesion, one of the possible complications in hernia reinforcement.

Also, part of medical and silicone tapes and wound dressings rely on PFPE-enabled release
liners for their function. Surgical staples leverage a PBSF surfactant as a coating to
approximate skin for surgical or acute wounds.

A.3.10.1.3. Tubes and catheters

Tubes play a role in many medical operations, such as cardiovascular, neurovascular and
peripheral blood vessel treatment, atrial fibrillation, endoscopy (pulmonary endoscopy,
colonoscopy), endometrial ablation (against abnormal menstrual bleeding) and vitreoretinal
surgery. There is a growing demand for minimally invasive procedures. Especially high
lubricity (smoothness) of the catheters is a desired quality in medical applications (Bates and
Campbell, 2015). Additionally, the use of catheters is a cost-effective technique compared to
more invasive procedures.

Catheter tubes are usually made of ePTFE because this provides a very smooth surface and
minimizes the need to use force. There are limitations of PTFE that include low tensile
strength, wear resistance, creep resistance and radiation resistance. Therefore, FEP is
sometimes used since FEP has better impact strength and wear resistance, yet slightly higher
frictional properties and lower resistance to thermal stress cracking than PTFE (Teng, 2012).
Finally, ePTFE is sterilizable without loss of these properties. PVDF is applied in connection
devices for catheters, for instance with peritoneal catheters.

A.3.10.1.4. Coatings

Coatings are applied in catheters, metal stents, catheter balloons, plunger stoppers, needle
shields, and membranes. Fluoropolymers are often used as coating because of their
advantageous properties. For example, PTFE limits the ability of bacteria and other infectious
agents to adhere to catheters which reduces infections. For the same reason PTFE is used as
coating on protective clothing and other textiles in the hospital environment. In some cases,
e.g. for plunger stoppers, the fluoropolymer coating prevents compounds from leaching into
the drug product.

Fluoroplastics (mainly elastomers) allow for protein-resistant and sterile filters, tubings, O-
rings, seals and gaskets for kidney dialysis machines, and immuno-diagnostic instruments.

PFAS coatings, mainy polymeric PFAS, can be successfully deposited on many different types
of surfaces, including metals, plastics and elastomers. Specific deposition applications include
hypodermic needles, surgical and cutting blades, blood bags, filters and PVC tubing.

Metered dose inhalers are made of an aluminium casing with a fluorinated coating, to prevent
interaction of the medical ingredient with the casing. A way of coating of aluminium metered

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

dose inhalers is done with a polymer layer of PFA or FEP. The main coatings mentioned during
the CfE are listed in Table A.100.

A.3.10.1.5. Cleaning and heat transfer: engineered fluids

For cleaning and heat transfer, so-called engineered fluids are often used. Engineered fluids
is a term used for fluorinated fluids. These fluids are used in applications such as electronics,
cooling, heating, testing, as well as chip technology. Engineered fluids are also used in medical
devices.

Perfluorinated engineered fluids can be used to deposit a wide variety of coatings, including
silicone, PTFE and heparin. These coatings can be deposited on many different types of
surfaces, including metals, plastics and elastomers. Specific deposition applications include
hypodermic needles, surgical and cutting blades, blood bags, filters and PVC tubing.
Engineered fluids are also applied as solvents during chemical reactions, as inert media, and
in microfluidic applications.

A.3.10.1.6. Sterilization gases

Ethylene oxide can be used as a sterilant either alone or diluted with other gases to make
non-flammable mixtures. A mixture of 12% by weight ethylene oxide and 88%
chlorofluorocarbon-12 (CFC-12) (12/88) had previously been widely used for this purpose.

Hydrochlorofluorocarbons (HCFCs) were introduced as drop-in replacement for ethylene


oxide/CFC-12 mixtures but have been phased out in Europe, because of the Montreal Protocol
legislation.

A.3.10.1.7. Packaging

PFAS, especially fluoropolymers, are widely used in medical packaging applications. Packaging
components like ampoules, single and multi-dose containers, bottles (also in caps and
actuators), cartridges; pressurized containers, syringes and vials are known to (partly)
contain PFAS, especially fluoropolymers.

Liquid drug products for injection (e.g. vials, prefilled syringes) are packed in closed container
systems. These types of packaging are mostly a combination of glass (vial, barrel) and
elastomers (stoppers, plungers, seals). Because of the extended period of contact between
the drug product and packaging, elastomer extractables could leach into the drug product,
potentially affecting the product safety. ETFE or PTFE coated elastomeric components are
often used to minimize interaction between the drug and the packaging. As this kind of
packaging is in direct contact with the drug product, they are part of the drug product
registration.

PTFE is also used in ophthalmic solutions packaging. It acts as hydrophobic membrane in


certain ophthalmic solutions’ packaging, allowing the venting of air, while retaining fluid within
the container, preventing leakage. In blister packaging also fluoropolymers are applied33. And
packaging of operating tools can contain fluoropolymers as well. Over-the-counter
pharmaceuticals and animal health packaging often contains PCTFE. PCTFE has high moisture
barrier when compared to other extrudable thermoplastic films, which makes PTFE coatings
popular in packaging materials.

For many medical devices specific packaging materials are used which are permeable for
ethylene oxide. Ethylene oxide is only permitted for sterilization of medical devices. Shelf -life
studies (and possible sterilisation process) need to be performed before an authorization is

33 For instance https://www.nichrome.com/blog/importance-of-blister-packaging-in-the-pharma-


industry/ or https://www.pharmaceutical-technology.com/contractors/packaging/tekni/, date of
access for both: 2022-12-15.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

granted.

A.3.10.1.8. Electronic equipment

Although electronics is a separate use section, it should be noted that numerous electric
medical devices such as scanners, screens etc. qualify as electronic devices. In electronics,
PFAS is mainly applied in cables and wires, printed circuit boards and in (LCD) screens. See
for more details the Electronics and Energy section A.3.12.

A.3.10.1.9. Diagnostic laboratory testing

Examples where PFASs are used in laboratory equipment include precision refrigeration (blood
bank refrigerator, vaccine storage), ultra-low temperature freezers or cryogenic storage,
refrigerated centrifuges for sample separation, process chillers for precise temperature control
and freeze-drying equipment. PFASs are also used in in vitro diagnostic devices. See Table
A.101 in the appendix for additional information on main applications in this area.

A.3.10.1.10. Vision applications – contact lenses and ophthalmic lenses

For ophthalmic lenses, PFAS-based coatings are applied to lenses which make them easy to
clean, hydrophobic, oleophobic and scratch resistant. These coatings are industry standard,
and customers expect this performance from their spectacles.

Rigid gas permeable contact lenses rely on PFAS currently and typically use
fluoromethylacrylates. Major suppliers of the blanks for rigid gas permeable contact lenses
are based outside the EU and supply the blanks (referred to as buttons within this industry)
into the EU where they are then formed into contact lenses for specific customers by EU
companies. The buttons are then converted into contact lenses for two main uses: fit ting sets
and prescription lenses. Prescription lenses typically may need replacement every 12 months.

A.3.10.1.11. Propellants in Metered Dose Inhalers (MDI)

Fluorinated gases are also applied in metered dose inhalers (MDI) where they act as a
propellant for the active pharmaceutical ingredient (API). In 1987, the Montreal Protocol was
signed and called for the elimination of CFC propellants.

Metered-Dose Inhalers (MDIs) are typically used for the treatment of asthma and other
respiratory conditions. These devices are regulated under the Aerosol Dispenser Directive.
MDI, nasal sprays and nebulizers are used to administer pharmaceuticals directly into the
lungs. This enables the achievement of high active pharmaceutical ingredient concentrations,
while minimizing systemic exposure. The best-known application of MDI is the treatment of
patients with COPD or asthma. Additionally, treatment of cystic fibrosis, chronic lung
infections, influenza, osteoporosis, pulmonary hypertension has been reported (Stein and
Thiel, 2017). The number of pMDI (pressured MDI) is 20 million per year.

A.3.10.1.12. Membranes used for venting of medical devices

Hydrophobic/oleophobic membranes based on PTFE and PET with fluorinated C6 based side
chain coatings are used for (sterile) venting of several medical devices, for example cell
culture devices, analytical devices, blood tube systems for dialyzer systems, t ube systems for
eye surgery.

A.3.10.1.13. Others

Fluoropolymers, especially PTFE, are applied in e.g. sealant (tape or monofilament/cord) and
in devices such as breathing air devices, medical ventilators and oxygen supply systems.
Furthermore, surgical trays, surgical tools, filters, dilator, pharmaceutical stoppers contain
PFASs. PFAS are also used in contact lenses. An additional list of (minor) uses is listed in

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Annex B based on stakeholder feedback from the second consultation in summer 2021.

In Table A.37, an overview of fluoropolymers in medical devices is given. In Table A.99


(Appendix), the PFAS polymers used in medical implants, a subcategory of medical devices,
are listed in detail. Stakeholders provided several additional uses for PFASs in medical devices,
these are listed in Table A.103 in the Appendix.

Table A.37. Fluoropolymers used in medical devices.


(Key) fluoropolymers Uses (examples)
PVDF C oating:
(Kynar®, Solef®);  Packaging
polyvinylidene fluoride  Hoses and seals
As useful material:
 Membranes in cochlear implants
 C atheters
PTFE/PFA C oating:
(Teflon®)  Guide wires
Polytetrafluoroethylene/  C atheters
Perfluoroalkoxy  Stone catchers
 Polypectomy snares
 Anti‐adhesive coating
 Handles
 Speculars
 Obturator bars
As useful material:
 Multi‐lumen catheter
 High‐purity transfer line
 Working channels in flexible endoscopes
 Seals
 Heat shrink tubing
 Insulation of wires, cables and complex electronic components
EC TFE C oating:
(HALAR®);  Electrosurgery/monopolar and bipolar high-frequency surgery
Ethylene‐  Biopsy forceps with high‐frequency connection
chlorotrifluoroethylene  C oagulation probes
 Papillotomes for use in high‐frequency surgery

Below, the main PFAS substance groups that are applied in medical devices are described in
more detail.

A.3.10.1.14. PFAAs and PFAA precursors

Trifluoroacetic acid (TFA) is used in analytical and production processes. It is an additive to


the mobile phase in high-performance liquid chromatography applications. There are also
many ingredients that are used as TFA salt.

A.3.10.1.15. Fluorotelomers

Fluorotelomers are being used for their contamination-resistant properties in medical textiles
to protect doctors, nurses and researchers against contact with microbiological contaminants,
such as viruses or bacteria, for example in surgical gowns and drapes. The COVID-19 crisis
has highlighted the importance of such traditional fluorotelomer applications, such as medical
barrier fabrics for (COVID-19) masks, surgical gowns and drapes.

Fluorotelomers are used in woven and non-woven fabrics, textiles for the treatment of
patients (such as bandages, absorption mats, hernia mats) and textiles in medical applications

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

and medical laboratories (such as filter membranes).

A.3.10.1.16. Fluorinated gases

Fluorinated gases are used in contrast agents for different imaging techniques and as
propellants in metered dose inhalers (MDI).

Orally inhaled CFC propellants for metered dose inhalers are exempted from the elimination
of CFC propellant (Montreal Protocol ban) until medically acceptable alternatives are available.
This has led to the development of HFA-propellants which are more environmentally friendly
than the CFC-propellants. Currently no ozone-depleting MDI-propellants are on the market,
although they still fall in the list of greenhouse gasses.

There are two main propellants used in MDI: HFC-134a (in scope), and to a smaller extent
HFC-227ea (in scope). These fluorinated gases are used as propellants because they have
properties that cannot be easily found in other chemical structures. A propellant must have
the right density, viscosity, temperature operating range and must be inert, in order to be
able to deliver the intended amount of active pharmaceutical ingredient to the patient. The
propellant must be non-toxic as well. HFC-134a, HFC-227ea fulfil these criteria. A less
fluorinated HFC is currently under development as a propellant : HFC-152a (outside scope).

A.3.10.1.17. Polymeric PFASs

Polymeric PFASs, like PTFE and PVDF, are used in several components of medical devices.
The applications include components, such as valves and connectors, where the specific
mechanical, chemical or biocompatibility properties of these materials are required. Most of
in-body implantable tubes (e.g. probes, stents) consist of or are coated with fluoropolymers
due to their bio-inertness. Fluoropolymers are the most widely applied PFAS type within
medical devices.

Fluoropolymer tubes are used in various medical operations. The tubes are mostly made of
fully consolidated, sintered PTFE tubes. PTFE (tradename Teflon) is used for instance as
coating on vascular guidewires to ensure its smooth progress in the vascular system and
prevent vascular trauma and the risk of blood clots. PTFE tubings are used in instruments
dispensing easily contaminated or chemically active material. Washable parts in instruments
are also often coated with PTFE to reduce the risk of cross contamination. Additionally, PTFE
can provide anti-finger printing and anti-fouling properties.

PTFE tubes are used in working channels for endoscopes, in inner tubes for catheters and as
indwelling needle tubes. Keyhole surgery, heat shrink sleeving, delivery tubes, coating of
temperature sensors, lab equipment and auto-sampling devices are further PTFE applications.
PFTE is widely applied as coating on catheters, metal stents, catheter balloons, and
membranes, but also on protective clothing and other textiles in the hospital environment.

A more permeable form of PTFE is ePTFE, which contains micropores that make it permeable
to air. Expanded PTFE is often used in the form of cord, sealing tape or tubing. ePTFE is also
used to produce a mesh-like structure for implants, which whilst being soft, strong and
flexible, is also very porous. When implanted, this allows body-tissue to grow seamlessly into
it, making it an excellent material for use in vascular grafts, hernia repair and other
reconstructive surgery.

Other fluoropolymers, such as FEP and PFA, are applied in the medical field as well. PVDF, for
example, is used in filter devices. PVDF as pure material is widely used as sutures, surgical
meshes in wound healing. Fluoropolymers are also used to provide stain (lipid, protein)
resistance and oxygen permeability on copolymers for Rigid Gas Permeable contact lenses.

Fluoroplastics are applied when high dielectric insulation is critical to the proper function of
electronics that rely on high frequency signals such as defibrillators, pacemakers and CRT,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

PET and MRI imaging devices. PTFE, PVDF, etc. are also often used in electronic medical
devices (see also section A.3.12). PFOA is used as well in electronic medical devices. In the
PFOA restriction, some exemptions for medical devices (and medical textiles) are mentioned
(ECHA, 2020).

PTFE and PVDF are used as well in several components for analytical instruments. The
applications include components, e.g. valves, tubing and connectors, where the specific
mechanical, chemical, and/or biocompatibility properties of these materials are required. PTFE
is also used in ophthalmic solutions.

Fluoropolymers are also used as coating on the inside of pressurised metered dose inhalers
(pMDI). The polymer-concentration on the pMDI is 0.05 - 0.1% w/w.

Finally, fluoropolymers are also used for packaging of medical and operating tools as well as
packaging of medical drugs. For example, PTFE is used in ophthalmic solution packaging.
Good moisture barrier, bio-chemical inertness, chemical resistance, high crystal clarity (if
required) and nonflammability are characteristics for the selection of these materials.
Fluoropolymers have good machineability and can be used without retrofitting packaging
machinery. Fluoropolymers used in the pharmaceutical packaging sector are subject to
requirements of the EU legislation on regulation of medicinal products for human or veterinary
use (i.e., Regulation (EC) 726/2004 (EC, 2004), Directive 2001/83/EC (EC, 2001b), Directive
2001/82/EC) (EC, 2001a).

Fluoroelastomers

Fluoroelastomers form flexible polymeric materials that are particularly suitable as seals,
stoppers, films, tubes, o-rings etc.

The resistance of fluoroelastomers to irradiation is an important quality in medical


applications. Exposure to radiation can cause unwanted molecular cross-linking in the polymer
which affects both performance and function.

Fluoroelastomers are used in all kinds of sealing applications, particularly when high levels
of chemical resistance and durability are essential. Fluoroelastomers are used in seals and
bearings for machines and equipment for the health and medical segment as well as parts for
manufacturing of medical devices. Fluoroelastomers are also used in cables and wires of
medical equipment.

There are two very different sets of elastomer usage in medical devices, each with different
technical and legal requirements.

 Elastomer usage in non-invasive medical devices and equipment


 Elastomers used in invasive medical procedures and implantable devices

Perfluoropolyethers

PFPE (perfluoropolyethers) are not intended for incorporation in medical and pharmaceutical
products and applications in which the product will be temporarily or permanently implanted.
When the product is used for applications where the finished device is implanted into the
body, no residual solvent may remain on the parts. PFPE is used as coating for ophthalmic
lenses. It is also being applied in medical equipment such as phthalmoscopy. PFPE is also
used in cardiovascular implants. Segregated hydrofluoroethers (HFEs) can also be used as
reaction media or inert media and in microfluidics applications for medical testing applications.

Segregated hydrofluoroethers (HFEs) can also be used as reaction media or inert media and
in microfluidics applications for medical testing applications. Fluids are used as heat transfer
agents in medical equipment and laboratory diagnostic devices, in freeze drying applications

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

in the manufacture of pharmaceuticals. They are used for industrial use only and are not
intended for use in a medical device or drug. An overview of polymeric PFAS is given in Table
A.102 as well as in Table A.105.

A.3.10.1.18. PFAS liquids for cleaning and heat transfer fluids: engineered fluids

Cleaning applications include the cleaning of metal and plastic parts, such as orthopaedic,
dental and spinal implants, artificial hearts, heart valves, catheters, needles and stents. Often
engineered (fluorinated) fluids are used for cleaning and rinsing. The mentioned solvents are
intended for industrial use only and are not intended for use as a medical device or drug.

Perfluorinated engineered fluids are replacements for n-propyl bromide, trichloroethylene


(TCE), ozone-depleting solvents such as HCFC-225 and HCFC-141b, and HFCs with high global
warming potential.

For heat transfer in medical equipment (e.g. surgical lasers) and laboratory diagnostic devices
other PFAS fluids like 1-methoxyheptafluoropropane and 3-ethoxyperfluoro(2-methylhexane)
are used.

An overview of to what extent specific PFASs (types) are used throughout the medical devices
industry is presented in Figure A.20. This information was provided by the members of
Spectaris (a German industry association for the high-tech business sector). An overview of
other uses is mentioned in Table A.106.

9
2 PTFE
2

7 F-gases
37
PFAS type unkown

Fluoroelastomers
16
ECTFE

PVDF

Others (each <1%)


27

Figure A.20. Proportion of PFASs (types) applied in the medical device industry , according
to members of Spectaris (an industry association).

A.3.10.2. Volumes

Most medical devices are authorized for EEA via imported articles containing PFAS.

A.3.10.2.1. PFAAs and PFAA precursors

Side-chain fluorinated PFAS are used as surfactants and coatings, also in medical devices.
Based on stakeholder information the yearly use in EEA is >800 t (Table A.38).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.38. Yearly total volume of side -chain fluorinated PFASs as surfactants and coatings
in EEA.
Polymer name Usage (t/y) in EEA
C 6-side-chain >800
fluorinated PFAS
surfactants and
coatings
Total >800

A.3.10.2.2. Fluorinated gases

A total approximately 33 000 t (midpoint) fluorinated gases are used in industrial processes
related to medical devices like MDI's, medical lasers according to the ECHA database.
Disaggregation of the tonnage to medical devices in scope is not always possible, however.

On top of the mentioned tonnage, fluorinated gases are used in exempted uses such as
anaesthetics, contrast media and pharmaceutical use which is exempted as well (HCWH,
2019).

Three gases are responsible for 99.9% of the medical fluorinated gases reported (based on
data from ECHA search and response to the CfE). In table Table A.104 in the appendix the
greenhouse warming potential of these gases is listed as well as the importance of HFC-134a.
HFC-134a is the most used gas, followed by HFC-227ea and HFE-152a (HFE-152a is outside
scope). Generic worldwide use of these three main medical gases is mentioned in (Booten et
al., 2020).

The volume of fluorinated gases for metered dose inhalers (MDI's) has been estimated in
three different ways: production based on stakeholder information, ECHA database
information, and MDI sales data/a report of Health Care Without Harm (HCWH, 2019).
Volumes ranged between:

 6 000 t/y (stakeholders);

 400 t/y (HCWH and MDI sales data);

 15 000 - >30 000 t/y (ECHA volumes, including volumes for export: amongst others
HFC-134a: 12 000 - 20 000 t/y, HFC-227ea >3 000 t/y and HFC-152a 650- 6 500 t/y.
All numbers including production for export).

Stakeholder information (6 000 t/y) was used for impact assessment.

A.3.10.2.3. Polymeric PFASs

Based on the response of the sector t o the CfE, a volume between 3 200 – 12 000 t/y
(midpoint 8 500 t/y) was calculated.

Table A.39 lists the volume of individual polymeric PFASs. In some case the volumes are not
reported or reported as sum of a variety of polymers.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.39. Overview of usage and/or production volumes of polymeric PFASs. Also
mentioned in Table A.40.
Polymer name Usage (t/y) in EEA
PTFEa 1 300-10 000
FEP >200
PVDF 10-100
PFA 23-32
others incl. lumped 1 700
Total 3 233 - 12 032
a
For medical masks, one producer mentioned 13 t/y for the EEA market. See also the research by EPA-
DK (2021). For surface protection of rubber stoppers for pharmaceutical syringes and via ls, one producer
mentioned 60 t/y for the EEA market. C ontact lenses: 5 t/y.

PCTFE fluoropolymers used in human and veterinary medicinal products packaging in the EU
in 2015 - 2020 were considered by stakeholders in average to be around 1 000 t/y.

In Table A.40, an overview of all PFAS volumes in medical devices is presented.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.40. Yearly total PFAS volume in EEA per main medical use category.
PFAAs and PFAA Fluorinated gases Polymeric PFAS Total PFASs
precursors (t/y) (t/y) (t/y)
(t/y)
Low Midpoint High Low Midpoint High Low Midpoint High Low Midpoint High
Propellants in MDI 160 3 080 6 000* 160 3 080 6 000
Fluorinated gases used in
industrial processes related
2 2 2 20 000 30 000 40 000 20 002 30 001 40 002
to medical application (For
instance medical lasers)
Other applications e.g. heat 477 1 585 2 692 477 1 585 2 693
C oatings and surfactants in
800 800 800 3 233 12 032 4 033 8 433 12 832
medical devices
Total for all medical
1 279 2 387 3 495 20 160 33 080 46 000 3 233 7 633 12 032 24 672 43 100 61 527
device uses categories
*: Estimate confirmed by stakeholder.

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A.3.10.3. Summary

Because of PFAS properties (bio-inertness, flexibility, resistance to various solvents, ability to


withstand aggressive sterilization procedures, chemical and temperature resistance, etc.),
PFAS is broadly applied in medical devices.

PFASs found in medical devices are fluorinated gases and fluoropolymers. Fluoropolymers can
be found in the following applications, ranging from invasive products like implants, tubes
and valves to non-invasive products like medical textiles, meshes and surfactants. Fluorinated
gases can be found in the following applications, from MDI propellant use to use in medical
lasers and heat transfer agents.

The medical technology sector is a highly complex sector, with multi-tiered global supply
chains that may comprise six or more layers of suppliers. This leads to a large degree of
uncertainty when reporting PFAS use volumes, and likely to an underestimation of the total
tonnage. Especially for PFASs used in the production of medical devices, in engineered fluids,
in vitro diagnostic products, and analytical equipment, volume data is lacking. PFAS volumes
are significant, especially for polymers and fluorinated gases. With the current available
information, annual use is estimated at 25 000 – 62 000 t.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.11. Transport

A.3.11.1. Uses

Products and articles used in the transportation sector containing PFAS are very diverse. The
transportation sector encompasses the sub-sectors automotive, maritime, aviation, and
railway.

The PFAS containing products and articles in the transportation sector are divided into
subgroups according to their application and are presented in Table A.41.

Table A.41. Overview of uses of PFASs in the transportation sector.


Transportation - Examples
subgroup
Body-, hull-, and PFASs and especially polymeric PFASs are important for body -, hull-,
fuselage construction and fuselage construction e.g. as industrial feedstock or as functional
chemicals. Examples are:
 Release film for mould components for the manufacture of plastic
parts (e.g. PTFE, ETFE).
 Surface tension modifiers in plating processes during the body -,
hull-, or fuselage construction (minimizing the generation of
chromium mists).
Sealing applications a Polymeric PFASs (e.g.fluoroelastomers such as FKM or fluoropolymers
such as PTFE) are used to produce seals for various parts of
transportation vehicles. Most of these parts belong to the propulsion
system. Sealing applications with polymeric PFASs (e.g. PTFE) is likely
the largest subgroup of PFASs applications in transportation: 60% or
more of the fluoroelastomers produced are used in sealing applications
in the transportation sector (information received by stakeholder).
Examples are:
 O-rings.
 Seals in valves and gaskets.
 Shaft or piston seals.
 Seals for electronic devices such as NO X- and oxygen sensors in
the exhaust monitoring.
 Seals for battery electrodes in Li-Ion or dry cell batteries.
C ombustion engine Most of the PFAS applications in combustion engine systems fall into
system the subgroup of sealing and coating applications. However, there are
some special applications that are not covered under these subgroups
e.g. non-woven textiles covering the engine bay area as acoustic
insulation inside the vehicle engine compartment (treated with low
molecular PFASs as well as with polymeric PFASs to achieve oil
repellence and high temperature resistance and make them non -
flammable).
Lubricants a Lubricants based on polymeric PFASs (e.g. PTFE, PFPE) are used in
transportation vehicles, mainly to reduce friction in a wide range of
applications and over a wide range of temperatures. Examples are:
 Bearings.
 C hain guide in automotive engines.
 Bushings (e.g. engine mount bush, stabilizer bush).
 Fill-for-life lubricant in small gearboxes, actuators, or hydraulic
cylinders (e.g. clutch systems).
 Electric and thermal protection of connectors in electronic
systems.
 Weather strips.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Transportation - Examples
subgroup
 Sunroof guiderail.
Hydraulic fluids PFASs are used in hydraulic fluids e.g. as corrosion inhibitors.
Examples are:
 Steering systems.
 Brake systems.
 Systems for lifting and lowering of vehicle parts or cargo.
Electrical engineering PFASs play an important role in all electrical engineering and
and information information technology in the transportation sector as they are an
technology b integral part of the manufacturing processes for semiconductors and
in some cases also of the semiconductor itself. Examples are:
 C omputer-based systems e.g. control systems,
telecommunication, safety systems.
 Data transmission: Optical fibres made of fluoropolymers are used
for data transmission where electromagnetic interference is a
concern. The fluoropolymer serves as a low refractive index layer.
 Batteries: Fluorinated polymer seals are used (see sealing
applications). Often PVDF is used for such purposes. Fluorinated
gases are used in HVAC R-systems to cool down/heat traction
batteries of electric vehicles. Polymeric PFASs are used as coating
for the separator film in Li-Ion batteries.
 Fuel cells: Perfluoropolymeric Sulfonyl Fluoride Ionomers act as a
binder and proton conductor in the catalyst layers in fuel cells.
PTFE is part of the gas diffusion layer and controls the
hydrophobicity of the components, which in turn regulates the
water management of a fuel cell.
 Other electricity-based processes specific to the transportation
sector (e.g. disinfection of ballast water using UV-radiation).
C oating and finishes Polymeric PFASs are used in the transportation sector for coating
applications e.g. PTFE, ETFE, PFA, or FEVE. Examples are:
C oating of cables in the selective catalytic reduction system for diesel
engines (ad blue).
C oating of diesel and gasoline particle filter hoses.
Turbo charger hoses and coolant lines, engine coolant lines and oil
cooler lines.
UV-stable coatings (e.g. paint protection for transportation vehicles for
cosmetic and protective reasons e.g. FEVE is used as coating for car
wrappings).
C oating of insulation materials to lower their thermal conductivity
resulting in better insulating properties.
Glass surface treatment with fluoroalkylsilanes for non-stick properties
to achieve permanent water and stain repellence and thus improve the
visibility for the vehicle operator in bad weather conditions; small use
but expected to increase; no alternatives available.
High abrasion resistance in windshield wipers or brake pads.
Use of polymeric PFASs for the coating of trim materials of
transportation vehicles to achieve stain protection and give surfaces a
valuable feel and look.
Use in the treatment of textiles e.g. for seats, carpets, roof linings, to
give the textiles water and dirt repellent properties (for the treatment
of textiles usually side-chain fluorinated polymers are applied) c.
Anti-fouling coatings on ship hull can contain PFASs to increase their
stability as well as hydrophobic properties.
HVAC R-systems in PFASs are used in the functional fluids of heating, ventilation, air

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Transportation - Examples
subgroup
transportation conditioning and refrigeration (HVAC R)-systems. Examples for the
vehicles d different applications for such functional fluids are:
Use of fluorinated gases in the various HVAC R-systems in transport
vehicles for passenger cabin air conditioning or transport refrigeration.
Special heat transfer fluids (e.g. Methoxyheptafluoropropanes) for the
immersion-cooling/heating of electronic equipment.
Use as cleaning fluids.
Use as blowing-agents.
Lifesaving and fire  Airbags.
protection  Seatbelts (retractor mechanism only).
 Life jackets.
 Life raft.
Other uses related to There are a few transportation-related applications of PFASs which do
transportation not fall into one of the previous subgroups, or for which information
on the application is not sufficient to allocate them to one of the
subgroups. Examples are:
 Reflective and protective coatings for traffic signs/roads
o Surface-treated pavement marking tapes and beaded
retroreflective sheeting (used for driver and pedestrian
safety).
o ETFE film is used as an anti-graffiti overlay for traffic
signage.
 Adhesive tape as paint replacements (e.g. for marking of
aircrafts). The product provides a chemical resistant surface for
the aircraft, as well as reducing the aircraft’s surface energy.
 Flotation fluids in gyroscopes (mainly used in aircrafts (“artificia l
horizon”) but also in trains (inclination sensors), and road vehicles
(navigation system and control systems).
 Wheel weights: Acrylic foam tape; PFASs are used as stabilising
agent in production of tape layer, which is used to affix the weight
to the wheel surface. A fluoropolymer incorporated in the weight
provides weatherability and reduces the potential of the weight to
corrode.
 C over sheets for new vehicles
a Also covered in section A.3.15 on lubricants
b
Also covered in section A.3.12 on electronics
c Also covered in section A.3.3 on textiles
d
Also covered in section A.3.9 on HVAC R

A.3.11.1.1. Body-, hull-, and fuselage construction

PFAS containing products, especially polymeric PFASs are known on the one hand for their
long-life and durability and, on the other hand for their flexibility and stability at low weight.
Polymeric PFASs show high performance over a wide range of harsh operating conditions like
heat, cold, chemicals or radiation. Many fluoropolymers prevent the propagation of flames or
the generation of smoke. Above that, several of these polymers are non-flammable.
Additionally, PFASs can alter the properties of surfaces due to their amphiphilic nature. They
can, e.g. act as surfactants. In plating processes PFASs are therefore used to minimize the
generation of chromium mists (see also A.3.5 Metal plating).

Due to the properties describe above, fluoropolymers are important industrial consumables
for body, hull-, and fuselage construction.

PFAS based surface tension modifiers are used in plating processes during the body -, hull-,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

or fuselage construction. Furthermore, polymeric PFASs (e.g. PTFE, ETFE) are used as release
film for mould components from the manufacture of plastic parts. Membrane textiles are used
in mould-injection processes of carbon fibre composite parts due to their good release
properties. Polymeric PFASs are also used as sound absorbers in a craft body. In aerospace,
strips of PTFE are used to improve the wear resistance of moving parts as well as
miscellaneous fixation of parts for internal or external hull. In automotive vehicles some
exterior parts are fixed with tape that contains 0.1-1% PFASs to gain heat, weather and
general wear resistance as well as increased flexibility (stakeholder information).

In planes, the sidewalls often contain PFASs (because of hygienic reasons). The same applies
for the overhead bins.

A.3.11.1.2. Sealing applications

60% or more of the fluorelastomers (e.g. FKM) produced are used in sealing applications in
the transportation sector (stakeholder information). Polymeric PFASs are used in sealing
applications because of the following properties:

 Durability against aggressive chemicals e.g. lubricants, fuels, electrolytes, cooling


agents and other fluids.
 Good sealing properties (avoidance of permeation, impermeability to gases) over a
wide range of temperatures and under influence of aggressive chemicals.
 Good compression stress resistance over a wide range of temperatures and under
influence of aggressive chemicals.

The main function of seals in transportation crafts is to protect parts from dust and aggressive
chemicals (e.g. lubricants, fuels, electrolytes) thus ensuring functionality and reducing service
intervals. Another function of seals is to prevent leakage (e.g. in fuel injectors) which results
also in an emission reduction.

O-rings made from polymeric PFASs are the most common product used fo r sealing.
Depending on the application, specially formed polymeric PFASs are used. Polymeric PFASs
are used as seals in valves and gaskets, as shaft or piston seals, as seals for electronic devices
such as NOX- and oxygen sensors in the exhaust monitoring, or as seals for battery electrodes
in Li-Ion or dry cell batteries.

The PFAS content which is necessary to fulfil the desired function depends on the material
which is used and the application. In the consultation, stakeholders provided numbers ranging
from 60% (in case of FKM use) to up to 70 – 100% (in case of PTFE use).

A.3.11.1.3. Combustion engine system

Currently, combustion engines in all transportation sectors are based on combustion of either
fuel, diesel or natural gas. In the future, more systems using alternative fuels like hydrogen
or electric propulsion systems can be expected.

In the core engine, as well as in the exhaust system, heat and pressure conditions are
extreme. In addition, petrol-based fuels and partially also exhaust gases are aggressive and
corrosive chemicals. So, the fuel system with storage tanks and fuel hoses, or turbo charger
hoses, as well as seals and valves have to be protected from destruction by fuels. PFAS
containing materials are robust materials which are resistant against he at, pressure and
corrosive chemicals and also have a low friction coefficient. Further, these materials are much
lighter than e.g. metal-based materials. Therefore, PFASs are used in large quantities in
combustion engine systems. The main use of PFAS containing materials in combustion
engines are in sealing and coating applications. Non-woven textiles are applied as cover in
the engine bay area of many vehicles as acoustic insulation inside the vehicle engine
compartment. They are treated with PFASs for oil repellence and high temperature resistance
and make them non-flammable.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

PTFE is used to produce mono-wall tubes and hoses (not coatings) for applications like turbo
chargers, exhaust gas recirculation, diesel particulate filters, or the engine brake. Guides for
pistons and piston rods are also made of PTFE.

FFKM are used in numerous gas turbine engines for aircrafts to achieve higher engine
efficiency as it allows the use of high thermal stability oils which in turn allow for higher engine
temperatures lowering fuel emissions (Thomas, 2003).

A.3.11.1.4. Lubricants

The use of PFASs in lubricants is described in the section below.

A.3.11.1.5. Hydraulic fluids

There is not much information available on PFASs in hydraulic fluids. One stakeholder
mentioned that PFASs are used as anti-erosion agent which is added to the hydraulic fluid.
The anti-erosion agent contains several fluorinated cyclohexanes and trace amounts of
unidentified residual fluorochemicals (most likely a by-product of the manufacturing process).
The anti-erosion agent is added to address in-services issues. This information specifically
focused on hydraulic fluids in aerospace, but this might also be valid for other sectors of
transportation.

Hydraulic fluids are used in the transportation sector in steering systems, brake systems or
other special applications such as systems for lifting and lowering of vehicle parts or cargo.
Applications in the aerospace sector include:

 Aircraft flight control systems, actuators for flying surfaces.


 Aircraft landing gear.
 Actuators in defence systems. These include, but are not limited to steering
mechanisms, munitions loading systems, turrets.

It is unclear if all hydraulic fluids in the transportation sector are fluorinated or only those for
specific applications.

A.3.11.1.6. Electrical engineering and information technology

PFASs play an important role in all electrical engineering and information technology in the
transportation sector as they are an integral part of the manufacturing processes for
semiconductors and in some cases also of the semiconductor itself. PFASs also play an
important role in batteries and fuel cells. A.3.12 The use of PFASs in electronics and
semiconductors is described in section A.3.12. The use of PFASs in batteries and fuel cells is
described in section A.3.13. Only the information that is not already provided in section A.3.12
or in section A.3.13 is included in this chapter.

PTFE based printed circuit boards are used in the automotive sector to create patch antennas
for 77 GhZ automotive radar sensors which are used for different safety applications such as
distance sensors or blind spot detection. This application is potentially relevant also for other
transportation sectors.

A fluorinated functional fluid is used as dielectric fluid in traction enclosures for the rolling
stock of trams to cool high voltage electronic components e.g. traction insulated gate bipolar
transistors. Currently, HFC are used for this application, but it is expected that there will be
a switch to HFO or Hydrofluoroethers (HFE) like Opteon or other PFAS fluids.

To disinfect ballast water, ships are equipped with a ballast water treatment reactor that is
usually installed in the engine room. The ballast water treatment reactor uses UV-radiation.
In the process of generating UV-radiation, electrostatic charge of parts of the reactor may
occur which may cause fires. In addition, UV radiation leads to an enforced erosion especially

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

of polymers. From the sea water entering the UV reactor, most water sediments have to be
removed. Therefore, an upstream A filter cascade is an essential part of a ballast water
treatment system to prevent corrosion of components. To prevent fires and erosion, polymeric
PFASs that are heat resistant, prevent electrostatic charges and are inert against erosion by
UV radiation and, when in contact with water, resistant against saltwater are used. Therefore,
polymeric PFASs are required for a save and reliable operation of many devices installed on
board a ship, like ballast water treatment systems.

A.3.11.1.7. Coating and finishes

Polymeric PFASs are used in coating applications in the transportation sector because of their
good performance over a wide range of temperatures (anti crack resistance and low
volumetric expansion), abrasion resistance, fire resistance and resistance to aggressive
chemicals as well as their hydrophobic and anti-fouling properties. In some special coating
applications, polymeric PFASs are used because of their dielectric properties, low thermal
conductivity, non-stick properties and UV-stability. Use of polymeric PFASs as coating of
cables in the selective catalytic reduction system for diesel engines (ad blue, a fuel additive)
or coating of diesel and gasoline particle filter hoses helps diesel exhaust emission reduction.
In aerospace turbine engines, PTFE fibres in fan blade wear strips enhance low friction
performance, thus increasing engine efficiency, with consequential reductions in fuel
consumption and emissions. Insulation materials are coated with polymeric PFASs to lower
their thermal conductivity resulting in better insulating properties

Different polymeric PFASs are used in the transportation sector for coating applications
including PTFE, ETFE, PFA, or FEVE.

Fluorinated polymer coatings are used to achieve heat resistance, and resistance to
aggressive chemicals in all kinds of engine hoses, like turbo charger hoses and coolant lines,
engine coolant lines, brake hoses, or oil cooler lines.

UV-stable coatings are used to protect paint of transportation vehicles. An example includes
the use of FEVE as coating for car wrappings. Fluorinated polymer coatings are also used as
automobile brightness enhancement film or matte films to achieve good coating quality and
to enhance appearance. Other trim materials in transportation vehicles are coated with
polymeric PFASs to enhance appearance. In convertibles, a coating, containing PFASs, on the
convertible top, provides repellence against dry soil and against the impact of cleaning agents
like white spirit, as well as a dynamic rain repellence.

PTFE, ETFE or PFA are used for lubric ation free bearings to achieve a low friction in
combination with low stiffness and high temperature resistance. Such bearings are used in
various places in transportation vehicles e.g. in ball joints, belt tensioners, decoupled pulleys,
dual mass flywheels, solenoid valves, clutch release, steering torque sensors, seat height
adjustment, pedal work, seat folding mechanism, headrest height adjustment and centre
console lid.

Insulation materials are coated with polymeric PFASs to lower their thermal conduct ivity
resulting in better insulating properties.

Glass surfaces are treated with fluoroalkylsilanes or PFPE (functionalized PFPE e.g. silanes or
acrylates) to achieve permanent water and stain repellence and thus improve visibility. The
fluoroalkylsilanes polymerizes to siloxanes with polyfluoroalkyl side e-chains. The siloxane
backbone will form covalent bond with glass (ECHA, 2017).

The surface of exterior sensors or cameras can be coated with PFPE to achieve durable anti-
fouling of the surface. In some cases, PFPE is also used because of its low refractive index.

In windshield wipers coatings are used to achieve high abrasion resistance . Polymeric PFASs
used as coating on brake pads provide better brake efficiency and help absorb pressure,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

compared to non-fluorinated brake pad coatings. In high voltage insulators, which are in
direct contact with the carbon strip of the pantographs (the power pickups for overhead lines
on locomotives) coatings are also used. The pantographs are exposed to high electric fields,
rain, contaminants, electric arcs and mechanical constraints, temperature changes and sun
radiation. They must be self-cleaning to avoid getting electrically conductive. For heavy
machinery, PTFE wax is used to coat parts which need a high abrasion resistance (e.g.
containers, excavators).

In the interior of transportation vehicles, polymeric PFASs are used for the coating of trim
materials to achieve stain protection and give surfaces an expensive feel and look. PFASs are
used to provide water and dirt repellence to textiles used in the interiors of transportation
vehicles e.g. seats, carpets and roof linings. Generally, side-chain fluorinated polymers are
applied. Apart from water and dirt repellence, PFASs also improve safety because of their fire-
protective properties of fluoropolymers.

Anti-fouling coatings on ship hull can contain PFASs to increase their stability and to give
them more hydrophobic properties (Glüge et al., 2020).

PFASs are used in reflective and protective coatings for traffic signs and roads. Examples
include surface-treated pavement marking tapes and beaded retroreflective sheets which are
applied for driver and pedestrian safety. ETFE films are used as an anti-graffiti overlay for
traffic signage. Machinery, that is used in the production of tyres, is partly coated with
polymeric PFASs (e.g. the curing mould) because of non-stick properties.

The PFAS content which is needed to achieve the desired function depends on the material to
which the coating is applied. Stakeholders estimate a range from 1% (PTFE waxes), <5%
(windshield coatings to achieve water repellence) - 100%.

A.3.11.1.8. HVACR-systems in transportation vehicles

HVACR-systems are used to control the ambient conditions of various compartments of


transport vehicles. Examples are the air-conditioning (AC) system to cool/heat the passenger
cabin of a car for personal comfort and to minimise accidents due to heat -fatigue.
Furthermore, filters of the AC-system ensure that the air which arrives in the passenger cabin
is free from particulate matter. Larger refrigeration systems are necessary to transport cooled
and frozen produce. Furthermore, fluorinated gases are used as heat -exchange media in
systems to cool down or heat batteries in electric vehicles because of their dielectric
properties. This may also be applicable to electric vehicle charging stations and charging
cables.

The use of PFASs in HVACR is included in section A.3.9.

High Efficiency Particulate Air (HEPA) filters for AC-systems are produced using PTFE.
According to stakeholder information, PTFE is needed to manufacture filters with
microstructures which are necessary for the filter to meet the set requirements. HEPA filters
are commonly used for aeroplane AC-systems but are also increasingly used in road transport
vehicles.

A.3.11.1.9. Lifesaving and fire protection

PFASs provide important functions to lifesaving and fire protection systems in all kinds of
transportation vehicles due to their specific properties which are outlined in the chapters
above.

Most of the applications of PFASs in lifesaving and fire protection systems are covered under
the respective chapters for coatings and finishes and sealing applications. PFASs are used in:

 Life jackets.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

 Life rafts.
 Airbag systems (likely the housing, airbag material).
 Seatbelts (retractor mechanism only).
 Fluoropolymer insulation on the cables of brake wear sensors, in collision prevention
or adaptive cruise control systems.
 Fluoropolymer tubing in ABS.
 Emergency ventilation blowers in tunnels.

The products mentioned are often made of durable age-resistant polyamid fabrics 34. By
incorporation of trifluoromethyl groups into the backbone or as side-chain of polyamides, an

increased thermal and mechanical stability as well as a low friction coefficient of the polymers
are achieved (Zhou et al., 2019). The low friction coefficient and the age-resistance are
required for save operations in case of accidents. Additionally, a high temperature resistance
is needed in some cases as the systems are required to work reliably also in case of fires.

PFASs are used as flame retardants and anti-dripping additives in polymers e.g. in interiors
of transportation vehicles.

2-Bromo-3,3,3-trifluoro-1-propene (2-BTP) is used in hand-held fire extinguishers in aircrafts


or in fire extinguishers for protection of critical infrastructure such as national defence systems
or power grid and power generation (see also A.3.9). The fire primarily is extinguished by
increasing the heat capacity of the atmosphere, extracting heat from the flame, thus lowering
the flame temperature to the point of extinction. The fluorinated gas is non-conductive and
chemically inert and thus suitable to extinguish fires of electronic components.

A.3.11.1.10. Other uses related to transportation

Adhesive PTFE based tape serves as a substitute for paints e.g. for marking of aircrafts. The
products provide a chemically resistant surface for the aircraft and reduce the aircraft’s
surface energy.

PFASs are also used in flotation fluids in gyroscopes. These are mainly used in aircrafts to
provide a “artificial horizon” but also in trains (inclination sensors), and road vehicles
(navigation system and control systems). The function of PFASs in these flotation fluids is
unclear.

In wheel weights, which are used to balance wheels of transportation vehicles, a (acrylic foam
tape layer is used to affix the weight to the wheel surface. Furthermore, a fluoropolymer
incorporated into in the weight provides weatherability and reduces the potential of the weight
to corrode.

Sealing and lubrication applications play an important role in the transportation of fuel rods
for nuclear power plants, according to stakeholder information. But no specific information
was provided.

PFASs are also used in cover sheets for new vehicles. No stakeholder information for this
specific use was provided but considering the large numbers (>15 000 000) of yearly
manufactured road vehicles (ACEA, 2020).

34
https://www.hella.com/techworld/de/Technik/Elektrik -Elektronik/Airbag-System-3083/, date of
access: 2021-11-24.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.11.2. Volumes

Table A.42 provides an overview of the different PFASs used in the transportation sector, their
applications and (where available) the volumes used. All numbers presented refer to the EEA,
unless stated otherwise. A detailed explanation of the origin of the volumes presented is
provided after Table A.42.

Table A.42. PFASs used in the transportation sector . All numbers presented refer to the EEA,
unless stated otherwise.
PFASs Volumes used in transportation Source
sector (t/y)a
Polymeric PFASs Stock volume: in EEA registered road Stakeholder
e.g. PTFE, ETFE, PFPE, PFA, FEVE, vehicles: information +
FKM 97 216 and 222 208a t calculation by the
Yearly volume: used in newly Dossier Submitters
manufactured road vehicles:
6 410 - 14 653 t
Side-chain fluorinated Volume unknown. Used for impregnating Stakeholder
polymers textiles and to equip non-woven textiles information
e.g. C 6-SC FP for different applications like wheel arch
liners and sound and dash insulators to
reduce noise, vibration and harshness.

Ionomers Volume unknown. Used in electronics Stakeholder


e.g. perfluoropolymeric sulfonyl (e.g. LED or in fuel cells) information
fluoride
Fluoroalkylsilanes Yearly volume: Stakeholder
<1 information
PFASs in HVACR applications b Yearly volume: Stakeholder
e.g. R1234yf ca. 12 222 in EEA in newly manufactured information, publicly
(tetrafluoropropene), R134a road vehicles for passenger comfort available information
(1,1,1,2-tetrafluoroethane), R- and calculations by
407C [blend of R-32 Yearly volume: the Dossier
(difluoromethane), R-125 ca. 1 010 filled into newly manufactured Submitters based on
(pentafluoroethane), and R134a products for transport refrigeration this information
(1,1,1,2-tetrafluoroethane)], 1-
methoxyheptafluoropropane
Stakeholder
 2-BTP Yearly volume: information
10 – 100 in handheld fire extinguishers in
aircrafts
Low molecular C6 telomer Yearly volume: Stakeholder
substances 100 – 1 000 t/y for initial technical textile information
finishing (unclear if this figure only
relates to textiles used in transportation
applications)
a
Note that PlasticsEurope mentions 15 500 – 18 500 t for the transport sector (not only cars; 2020 and
2015 figures resp.). Fluoropolymer Market update (Wood, 2022).
b Volumes in the transport sector are not used for environmental or socio-economic impact assessment.

A general impact assessment for all PFAS in HVAC R applications in all sectors has been made.

A.3.11.2.1. Low molecular C6 telomer substances

Low molecular C6 telomer substances are used for a for initial technical t extile finishing in an
amount of 100 – 1 000 t/y. It remains unclear if this figure only relates to textiles used in
transportation applications or if it is a general figure for the treatment of textiles.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.11.2.2. Side-chain fluorinated polymers

According to stakeholder information side-chain fluorinated polymers are used for


impregnating textiles and to equip non-woven textiles for different applications like in wheel
arch linters and sound and dash insulators to reduce noise, vibration and harshness. A
different stakeholder provided input that 10 – 100 t/y of C6-SCFP are used for this application
in the EEA.

A.3.11.2.3. PFAS in HVACR systems

HVACR-systems

According to stakeholder information the following amounts of PFAS containing heat exchange
media are used in the HVACR-systems of road vehicles to cool/heat the passenger cabins:

 Ca. 0.6 kg/personal vehicle;


 Ca 1 kg/unit per truck;
 Ca 6 kg/unit per bus.

In 2019, 15 769 041 passenger vehicles were manufactured and registered in the EU (ACEA,
2020). For trucks and busses, the number of newly registered vehicles was used as proxy for
newly manufactured vehicles. In 2019, 2 503 992 new trucks (sum of light and heavy
commercial vehicles) and 42 838 new busses were registered in the EU (ACEA, 2020). This
amounts to a total number of newly registered vehicles of 18 315 844. Using the information
on the amount of PFASs per vehicle, the total annual volume of PFASs in HVACR-systems of
road vehicles amount to 12 222 t.

Approximately 1 010 t/y is filled into newly manufactured HVACR-systems for transport
refrigeration (stakeholder information), see also A.3.9.2.

PFASs in life saving and fire protection systems

One stakeholder provided information on the use of 2-BTP in hand-held fire-extinguishers in


aircrafts. According to this information 10 – 100 t/y are sold for this application in the EEA.

A.3.11.2.4. Polymeric PFASs

According to stakeholders, in 2018, 65 000 t of polymeric PFASs were sold worldwide in the
automotive sector. Using the number of vehicles produced worldwide in 2019 (79 095 104 35),
this results in approximately 800 g of polymeric PFASs per vehicle. This number is in line with
“350 g of fluoropolymer per car” as was estimated by Améduri (2020). With a total amount
of 277 759 682 registered vehicles in the EEA, this amounts to a stock of polymeric PFASs of
between 97216 and 222 208 t in all road vehicles (cars, vans, trucks, busses) registered in
2020 (ACEA, 2020).

Using the number of newly registered vehicles in 2019 that was used to calculate the
fluorinated gases use, a total volume of polymeric PFASs of between 6 410 and 14 653 t is
estimated (A.3.11.2).

Regarding other sectors of transportation (aerospace, marine, railway) only limited


information was provided. One stakeholder provided input from market research reports. One
of these reports estimated that market size for fluoropolymers (without PVDF) was 12 800 t
for 2020 for the EMEA (Europe, Middle East and Africa) region. However, it is unclear if this
figure relates to the transportation sector. Another report estimated the market size of

35
https://www.vda.de/de/aktuelles/zahlen-und-daten/jahreszahlen/automobilproduktion, date of
access: 2021-11-22.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

fluoroelastomers in the automotive and aerospace sector to be 5 355 t for 2020.

Body-, hull-, and fuselage construction

For fuselage construction in the aerospace sector information was provided that 100 –
1 000 t/y are used by one stakeholder in the form of PTFE strips or miscellaneous fixation
parts for internal hull.

Sealing applications

Stakeholders provided different estimations on the used volume in sealing applications. The
total European demand for fluoroelastomers for sealing applications is in the range of 1000 –
10 000 t/y, and for PTFE it is in the range of 100 – 1 000 t/y. Another stakeholder uses 100
– 1 000 t/y of PTFE for sealing applications in cars. A different stakeholder uses of 10 – 100 t/y
of polymeric PFASs to produce seals for marine vessels.

Lubricants

One stakeholder mentioned an annual use of PTFE of 1 000 – 10 000 t to produce lubricants
for maintenance free bearings and sliding elements. Another stakeholder used 0.1 – 0.2 g of
fluorinated lubricants “per component” in automotive applications. However, no details were
provided on the number of parts of automotive vehicles that need lubrication. Another
stakeholder mentioned a European demand of 100 – 1 000 t/y of fluoropolymers for
lubrication.

Electrical engineering and information technology

Various stakeholders provided input on the volumes of polymeric PFASs used in electric
engineering and information technology in the transport sector. The information is
summarised in Table A.43.

Table A.43. Stakeholder information on the volumes of polymeric PFASs used in electric
engineering and information technology applications.
Polymeric PFASs Range Specific application
(if specified) (t/y) (if provided)
PTFE 100 – 1 000
FEP 100 – 1 000
PVDF 1 000 – 10 000 Energy storage in electric cars: used as binder and for the
ion-permeable separator in batteries and membranes
Porous PTFE 100 – 1 000 For the ventilation of electronic components in road
vehicles (e.g. housings of electronic equipment such as
lamps)
PTFE 100 – 1 000 PTFE tape for cable electrical insulation in aircrafts
PTFE 10 – 100 C able conduit in aircrafts
100 – 1 000 For the ventilation of electronic components in road
vehicles (e.g. housings of electronic equipment such as
lamps, control units) and for tank ventilation (e.g. fuel and
urea tanks) in road vehicles
Ionomers e.g. Used in ion exchange membranes (IEMs) that provide
perfluoropolymeric mechanical and chemical stability while delivering high
sulfonyl fluoride proton conductivity. It separates anode and cathode, but
facilitates the transport of hydrogen-ions from the anode
to the cathode side

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Coatings and finishes

Various stakeholders provided input on the volumes of polymeric PFASs used for coatings and
finishes. The information is summarised in Table A.44.

Table A.44. Polymeric PFASs volumes used in coatings and finishes according to stakeholder
information.
Polymeric Range Specific application
PFASs (t/y) (if provided)
(if specified)
PTFE 100 – 1 000 Interior coating systems for public transportation vehicles
PTFE 100 – 1 000 production of PTFE lined hoses
PTFE 100 – 1 000 Production of braking hoses
PTFE 10 - 100 Production of hoses for hydraulic fluids and fuel for aircrafts

A.3.11.3. Summary

Because of the vast range of properties, PFASs are widely used in the transport sector. PFASs
are used in body-, hull and fuselage construction; sealing applications and lubricants; fuel
engine systems; hydraulic fluids; electrical engineering and information technology; coatings
and finishes; HVACR-systems and lifesaving and fire protection. Stakeholders estimate a stock
of polymeric PFASs in the automotive subsector of 100 000 t (rounded number) and an annual
volume of between 6 000 and 14 500 t (rounded numbers). The main fluoropolymers used
are PTFE, PVDF, FEP and fluoroelastomers. For the other subsectors (besides automotive),
nor for PFAA, PFAA precursors and side-chain polymers estimates could be made. Volumes of
PFASs in HVACR systems amount to 12 000 t/y (rounded number) in newly manufactured
vehicles and 1 000 t/y (rounded number) filled into newly manufactured products for
transport refrigeration.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.12. Electronics and semiconductors

A.3.12.1. Uses

Glüge et al. (2020) identified uses of PFASs in the electronics industry and listed the main
properties of PFAS. Uses and properties were confirmed by a stakeholder and additions were
made by this stakeholder. Also, literature and publicly available sources were consulted.
roperties of PFASs relevant to the electronics industry and those that are relevant specifically
to the semiconductor industry are included in Table A.45, whereas an overview of uses in
products and components, is provided in Table A.46.

Table A.45. PFAS properties relevant to the electronics and semiconductor industry –
Literature and publicly available sources, complemented by a stakeholder.
Industry Identified properties
Non-reactive, stable, low surface tension, non-sticking, high purity, low
dielectric constant, low off-gassing, ensuring vacuum environment, low
dissipation factor, ultra- thin, resistant to oil, resistant to water, resistant to
sulphur, high volume/surface resistivity, high dielectric breakdown strength,
Electronics
piezoelectric and pyroelectric properties, dipoles, hydrophobic, good solubility
in polymers, optically clear, low loss insulation, flame resistance, thermal
stability, low refractive indices, good heat conductivity, good evaporative
cooling, acidic, insulation.
Heat resistance, low dielectric constant, clearness, plasma resistance, high
photosensitivity, ability to generate acids, low surface tension, Marangoni
effect, low refractive index, acidic, non-reactive, stable, non-corrosive,
Semiconductor
temperature uniformity, generation for reactive oxygen/fluoride species,
chemical resistance, high purity, anti-adhesion, insulation, barrier properties,
thermal stability.

Table A.46. Uses in electronic products and components (including semiconductors) –


Literature and publicly available sources, complemented by a stakeholder.
Product / component Used as/for
Wires and cables Insulator
Printed C ircuit Boards Fibre reinforced layer, coating
Flat panel displays Reduce static electricity build-up, reduce dust
attraction
Multilayer circuit board Bonding ply composition
C apacitators Separation of high voltage components
Polymer optical fibres Transparency, flexibility, low refractive index
LC D Provide liquid crystal with dipole moment, moisture
sensitive coating
Tactile sensor
Gauge wire
Audio transducers
Piezoelectric panels
Electroluminescent lamps C oating
Razors Friction reduction
Acoustical equipment Provide electrical signal
5 G communication equipment
Semiconductor, photoresist matrix C hange solubility when exposed to light
Semiconductor, wafers Wafer thinning, non-stick coating on carrier wafer
Semiconductor Antireflective coating

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

PFASs are not only used in electronic products and components to enhance their functionality,
but also in the production process of those products or components. Here, the latter is divided
into two use categories: process chemicals (e.g. solvent, grease, deposition fluid) and
production tools/equipment that are used in the process (e.g. valves, containers, tubes).
Table A.47 provides an overview of the uses in the production process that were identified by
Glüge et al. (2020). The information was checked and complemented by a stakeholder.

Table A.47. Uses of PFASs in the production process of electronics and semiconductor
products and components. Complemented by a stakeholder.
Used as / for Specification Industry
Electronics Semiconductor
Testing fluid Wafer testing, electronics testing X X
Heat transfer fluid Submersion cooling, chemical vapour X X
deposition
Solvent C leaning, deposition of lubricants, ultra X X
clean seals and damping material
Additive Additive to lubricants X
C leaning Drying, etch cleaning, remove cured X X
epoxy resins, remove dielectric film build
up
Sealing Technical equipment in contact with X
chemicals or reactive plasma
C arrier fluid Dissolve lubricants. See also A.3.15 X
Fluid for lubricant See also A.3.15 X
deposition
Etching Etching of piezoelectric ceramic filters, X
wetting agent, reduce reflection of
etching solution, dry etching
Quenching C ontrolling diffusion of acid X
Rinsing Removing developer X
Developing C ontrol of development process X
Working fluid X
Photosensitizer Increase Photosensitivity X
Photo acid generator Generate strong acids X

Ultra-pure chemical Ultra-pure environment, submersion in X


process chemicals
Technical equipment Ultra-pure environment X
for handling, storage
and transport

In Table A.48, an overview of the identified uses and properties of PFASs in the electronics
industry (excluding semiconductors) is provided based on input from stakeholders. In general,
the information received varied in level of detail pertaining to substance, sub -uses,
application(s) and sectors. For instance, not all substances were associated with a use or
function, stakeholders sometimes listed properties of each PFAS without specifying details in
application etc. Due to limited information, use categories are roughly split between electronic
products and components and uses in the production process of those products or
components.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.48. Uses and properties of PFASs in the electronics industry identified by stakeholders.
Use category Sub-use Properties Area of use/application(s) Examples of PFASs
 Precise and constant transmission Insulated wires and cables in electrical, PTFE, PFA, ETFE, FEP, FEPM,
 Stable insulation under high energy and semiconductor applications PFPE
temperature conditions (this includes data cable/5G, LAN cables,
 Moldability automotive parts, medical, sub-sea,
 Low particulation aerospace, clean room production etc).
 UV-resistance
 C hemical/radiative resistance at
elevated temperatures
Heating
Wires and  Dielectric and thermal properties
cables,
cables  Resistance to corrosion
coaxial cable
 Water and oil resistant
 Stress crack resistance
longevity/durability
 Flex life
 Light weight
 Low density
 Fire retardancy
Low mechanical friction
 Hydrophobic/oleophobic coating, can Printed circuit boards, switches, PTFE, FEP and PFA, 2-
also act as gas barrier so some connectors, relays, resistors, capacitors, (perfluorohexyl)ethyl acrylate,
electronic components can be in transformers, inductors, integrated 2-(Difluoromethoxymethyl)-
proximity to corrosive gases, circuits, display device, small motors and 1,1,1,2,3,3,3-heptafluoro-
 Adhesion to copper bearings present in electronic devices like propane, 1,1,1,2,2,3,3,4,4-
 Anti-adhesive PC s, automobile, game machine, various Nonafluoro-4-methoxy-butane,
 Excellent dielectric performance for home applications, mechanical equipment. PFHxA
Coating of
low signal loss Touch screen coating and various
electronic Membranes
 High water- and oil- repellence to electronics also in smart phones.
components
provide protective coating Feedstock for plasma polymerization
 Antireflective coatings of electronic components and
 Low surface tension devices to provide a protective nanolayer.
Micro Electro-Mechanical Systems,
C onformal and anti-solder coating, copper
clad laminates, hard disk.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Area of use/application(s) Examples of PFASs


 Air permeability Vent filter for automobile electrical PTFE, Fluoropolymers
 Water pressure resistance components such as Electronic C ontrol
 Liquid repellent Unit, battery box, motor control substrate
Electronic  Heat-resistant case, lamps and power windows modules
Vent filters
components  Durability etc. Vent filters for home appliances such
 C hemical resistance as electric toothbrushes and washable
 Weatherability shavers
 Dustproof characteristic
 Air permeability Sound-permeable membrane for mobile PTFE
Sound-
 Water pressure resistance phones and digital cameras
permeable
 Liquid repellent
membrane
 Acoustic characteristics
 Particle collection efficiency Air filter for vacuum cleaner/air purifier PTFE
 Pressure loss
 Durability
 Repeated dust release characteristics
Air filter  Filtration
 C hemical resistance
 Water resistant
 Dustproof
 Tensile strength
 Heat-resistant PTFE
Tactile
 Tensile strength
switch
 Durability
components

 Dielectric performance, Blended into the matrix to reduce signal PFA


 Low signal loss, losses in new 5G and higher speeds,
 Adhesion to copper and laminate
 Thermal resistance
Printed
 Heat conductivity
circuit
 Electrical insulation
boards
 Oil/water repellent
 Low refractive index
 C hemical resistance
 Mold release

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Area of use/application(s) Examples of PFASs


 Reduction of dielectric loses Mobile phones PTFE, PFA
Antennas  Prevention of signal losses
and  Water repellent
membranes  Surface tension
 C ontact angle
 Strong dipole Displays for computer monitors, TV’s, Non polymeric PFASs,
Liquid crystal
 No surface activity control units (medical device, cars), PFHxA.
displays
 Antistatic laptops, smart phones and tablets.
(LC D)
 C onductivity Surface protection.
Organic - Displays and lights for consumers (smart Non-polymeric PFASs , PFHxA.
light- phones, tablet, TV, monitor)
emitting
diode
(OLED)
 Low signal loss, C ore and cladding. Transmission media in- F-PMMA
Optical fibres  Integration friendly vehicle data communication systems, to
(Polymer  Transmittance/low signal loss property achieve safe driving or auto-pilot system
optical fibre) (Advanced Driver Assistance Systems,
ADAS, and self-driving cars)
- Small portable scanning printing F-PMMA
Rod lenses
equipment, including barcode readers
 Flame retardant Displays, touch screen, sensors, foldable PTFE
 Anti-fouling smartphone, scintillator panels, high
Others  Smoothness temperature film capacitors,
 Hydrophobic/oleophobic potentiometers, copy machine, cable and
fault locator.
 Heat-resistant Unspecified PFHxA, Fluoropolymers
 Realisability
 Dimensional stability
 Tensile strength
Unspecified  C ontrol and Influence of
 Tribological properties
 Flame retardancy
 Wear protection
 Melt behaviour

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Area of use/application(s) Examples of PFASs


 Antistatic/Antidust agent
 Visual effect
 Low Surface tension

- In electrical enclosures, connectors, PTFE, 1-Propene, 1,1,2,3,3,3-


appliances, consumer electronics hexafluoro-, polymer with 1,1-
Anti-drip (mobiles, TV, laptops, computer hardware, difluoroethene and
agent building and construction parts/articles, tetrafluoroethene
automotive batteries, equipment housing,
lighting etc.
- In electrical substation or electrical control 1,1,1,2,2,4,5,5,5-nonafluoro-
rooms, data centres, telecommunications 4-(trifluoromethyl)-3-
Fire
switch rooms, computer control rooms, pentanone a
protection
airport control towers, clean rooms, and
fluid
computer-controlled manufacturing
operations.
Heat transfer fluids for liquid immersion (Z)-1,1,1,4,4,4-Hexafluoro-2-
cooling butena, Butane, 1-ethoxy-
1,1,2,2,3,3,4,4,4-nonafluoro-,
2,3,3,4,4-pentafluoro-5-
methoxy-2,5-bis[1,2,2,2-
tetrafluoro-1-
(trifluoromethyl)ethyl]tetrahyd
rofuran, Perfluamine,
Heat 1,1,1,2,2,4,5,5,5-nonafluoro-
transfer 4-(trifluoromethyl)-3-
fluids pentanone,
2-(Trifluoromethyl)-3-
ethoxydodecafluorohexane,
Reaction mass of
1,1,2,2,3,3,4,4,4-nonafluoro-
N,N-bis(nonafluorobutyl)butan-
1-amine and 1,1,2,2,3,3,4,4,4-
nonafluoro-N-[1,1,2,3,3-
hexafluoro-2-

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Area of use/application(s) Examples of PFASs


(trifluoromethyl)propyl]-N-
(1,1,2,2,3,3,4,4,4-
nonafluorobutyl)butan-1-
amine.
 Temperature and chemical resistance Sealing for LC D, home appliance Fluorinated gases
Sealing for
 Abrasion resistance production equipment. Sealing for reducer
electronic
 Oil resistance of industrial robot for automation. Sealing
components
for hard disk of servers
- For a variety of materials, including
lubricants, coatings, silicones, and in
Solvent
industrial cleaning formulations. Solvent
to post process 3D printed articles
 Drying/rinsing agent Fluorinated gases a
Aerosol/  Optics cleaning 2-(Difluoromethoxymethyl)-
Solvent  Particulate/ionic removal 1,1,1,2,3,3,3-heptafluoro-
cleaning of  Precision cleaning propane,
electronics 1,1,1,2,2,3,4,5,5,5-decafluoro-
components 3-methoxy-4-
(trifluoromethyl)pentane
Hard disk drives PTFE, PFA, ETFE, PFPE,
Lubricant Tetrabutylphosphonium
Perfluorobutylsulfonate
 C hemical resistance - PFPEs and PC TFE base oils
Lubricating  Heat resistance
oilb  C leanliness

Various electronic applications (Z)-1,1,1,4,4,4-Hexafluoro-2-


buten, Butane,
Lubricant
1,1,1,2,2,3,3,4,4-nonafluoro-
deposition b
4-methoxy-, Butane, 1-ethoxy-
1,1,2,2,3,3,4,4,4-nonafluoro-
a
C overed in section A.3.9 on fluorinated gases
b C overed in section A.3.15 on lubricants

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

In Table A.49, an overview of the identified uses of PFASs in the semiconductor industry is provided based on input from stakeholders. Uses
identified in the semiconductor industry were primarily focused on semiconductor manufacturing and related equipment that is used to produc e
semiconductors. PFAS offer several essential functionalities including coating ability for making uniform and thin films on wafers, photo-imaging
ability for printing electronic circuits, and durability to etchant for making electronic circuits.

Table A.49. Uses and properties of PFASs in the semiconductor industry identified by stakeholders.
Use category Sub-use Properties Examples of PFAS

Semiconductor manufacturing

Photolithography Photoacid generators  Strong electronegativity of F atom Fluorinated salts


in the complex resist/chemical
matrix allows for controlled
generation of strong acid upon
exposure to UV light

Photolithography Antireflection coatings  Low dielectric constant Acrylate and methacrylate-based copolymers
 Low refractive index
 Good thermal stability
 Good barrier properties

Photolithography Topcoats and Embedded  Hydrophobicity Fluoropolymers


Barrier Layers
Photolithography Surfactants  Uniformity in coating with minimal Non-polymeric PFASs (non-ionic)
effect on properties provided by
other critical resist/chemical
ingredients (i.e., without impact
to refractive indexes)

Photolithography Filters  C hemical resistance Fluoropolymers


Nanoimprint Lithography  Low surface adherence Fluoropolymers
Plasma Etch and Wafer  Anisotropic etching capabilities PFC , HFC and HFO gases
C leaning
Wafer Wet etch  Wetting agents Fluorinated organic acids
 Selective metal oxide removal

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Examples of PFAS


Vapour deposition C leaning  Provision of reactive fluoride to PFC , HFC and HFO gases
chamber enable cleaning of surfaces

Heat Transfer Fluids  High precision temperature Hydrofluoroethers, perfluoropolyethers (including


control imparted by thermal PFPMIE), and other fully fluorinated liquids
stability (perfluorinated amines and perfluoroalkylmorpholines,
 Viscosity vs temperature PFPE, Butane, 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluoro-,
characteristics 2,3,3,4,4-pentafluoro-5-methoxy-2,5-bis[1,2,2,2-
 Specific heat tetrafluoro-1-(trifluoromethyl)ethyl]tetrahydrofuran,
 Electrical conductivity Perfluamine, 1,1,1,2,2,4,5,5,5-nonafluoro-4-
characteristics (trifluoromethyl )-3-pentanone

Vacuum pump Vacuum fluid  Thermally stable Fluorocarbon ether polymers of


 Non-flammable and insoluble in polyhexafluoropropylene oxide,
water, acids, bases and most
organic solvents

Thermal Testing of  High precision temperature Hydrofluoroethers, perfluoropolyethers (including


Semiconductor Devices control imparted by thermal PFPMIE), and other fully fluorinated liquids
(in-line and end of line) stability (perfluorinated amines and perfluoroalkylmorpholines,
 Viscosity vs temperature Reaction mass of 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-
characteristics, bis(nonafluorobutyl)butan-1-amine and
 Specific heat and electrical 1,1,2,2,3,3,4,4,4-nonafluoro-N-[1,1,2,3,3-hexafluoro-2-
conductivity characteristics (trifluoromethyl)propyl]-N-(1,1,2,2,3,3,4,4,4-
nonafluorobutyl)butan-1-amine
Advanced Semiconductor Encapsulants and Temperature resistance Fluoropolymers
Packaging Thermal Interface Beneficial material flow
Materials Wetting, degassing and composite
homogeneity

Advanced Semiconductor Flux  High-temperature thermal Surfactants


Packaging stability (>160 C )
Advanced Semiconductor Temporary Adhesives  Solubility in organic solvents, low Fluorinated Tetracarboxylic acid anhydride derivatives,
Packaging dielectric constants, and high aromatic diamines, acrylate and methacrylate-based
copolymers

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Examples of PFAS


thermal and thermo-oxidative
stability

Advanced Semiconductor Hydrophobic  Unique hydrophobicity Fluoropolymers


Packaging: coating/hermetic seal
packages
Semiconductor  C hemical resistance Fluoropolymers (i.e., teflon, viton, PTFE, PFA, FEP,
Manufacturing Equipment  Low volatility/high stability ETFE, PVDF, FFKM, etc)
& Infrastructure - Enabling  Thermal resistance
Uses of Fluoropolymer  C leanliness
Articles (polymer parts  UV resistance
embedded within  Flame resistance
manufacturing equipment,
spare parts and
infrastructure, piping,
tubing, gaskets, etc.)
Release sheet for  Heat-resistant PTFE
thermocompression  Releasability
bonding process of  Flexibility
semiconductor chips  Tensile strength
Data C entres - Immersion  High precision temperature Perfluoroalkanes, Hydrofluoroethers,
C ooling of Semiconductor control imparted by thermal perfluoropolyethers (including PFPMIE), fluoroketones
Devices/Servers stability and other fully fluorinated liquids (perfluorinated amines
 Viscosity vs temperature and perfluoroalkylmorpholines, 2,2,3,3,5,5,6,6-
characteristics octafluoro-4-(trifluoromethyl)morpholine, Perfluamine,
 Specific heat and electrical Reaction mass of 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-
conductivity characteristics bis(nonafluorobutyl)butan-1-amine and
 Non flammable 1,1,2,2,3,3,4,4,4-nonafluoro-N-[1,1,2,3,3-hexafluoro-2-
 Material compatibility (trifluoromethyl)propyl]-N-(1,1,2,2,3,3,4,4,4-
 Ease of IT hardware maintenance nonafluorobutyl)butan-1-amine,
2,2,3,3,5,5,6,6-octafluoro-4-
(trifluoromethyl)morpholine,
Methyl Perfluoropropyl Ether,
2-(Difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoro-
propane,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use Properties Examples of PFAS


1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl)-3-
pentanone.
Production, storage, usage  C hemical transportation PVDF
of high-purity chemicals

Semiconductor Products and components

Photoresist Epoxy, case masking  Resistance to fire, grease, stain, Fluorotelomer-related compounds
etc.

Plastics such as PC /ABS  Flame retardancy Perfluoroalkane sulfonic acids (PFSA), their salts and
esters

Fluoroelastomers,  C ross linking agent for Bisphenol AF and its salts


polymers including fluoroelastomers, monomer, high
polyimides, polyamides, temperature composites and
polyesters, polycarbonate electronic materials
Adhesive, coating,  Solvability Perfluoroalkylethers
lubricanta
a C overed in section A.3.15 on lubricants.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Based on input from stakeholders and information from literature (Glüge et al., 2020), 163
PFASs were identified at being in use or used at some point in the electronics and
semiconductor industry combined. Glüge et al., 2020 further identified 93 PFASs as being
patented for use in the electronics and semiconductor industry and two PFASs as analytically
detected.

Of the 163 PFASs identified at being in use or used at some point in the electronics and
semiconductor industry, 48 are polymeric PFASs (18 fluoropolymers, 11 side-chain fluorinated
polymers, 16 PFPE and three unknown), 114 are non-polymeric PFASs (42 ionic and 72 non-
ionic of which 17 are fluorinated gases) and one is unknown.

A.3.12.2. Volumes

In Table A.50 and Table A.51, a summary is provided of the yearly use volumes in the
electronics and semiconductor industries in the EEA in 2020, as provided by stakeholders.

The estimates are based on responses of 27 out of the 30 companies’ active in the
electronics/semiconductor industry; three companies did not provided quantities.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.50. Estimated yearly PFASs use in the electronics and semiconductor industry in the EEA.
C2- C3 PFAAs ≥C4 Side-chain Total PFAAs Total Fluoro PFPE Total Total PFASs
(non-ionic) (t/y) fluorinated and PFAA fluorinated polymers (t/y) polymeric (t/y)
PFAS polymers precursors gases (t/y) PFASs
substances (t/y) (t/y) (t/y) (t/y)
(t/y)

low high low high low high low high low high low high low high low high low high

Total
electronics and 159 221 671 1 315 11 13 841 1 549 140 140 1 551 4 063 9 552 1 560 4 615 2 541 6 304
semiconductors

Table A.51. Estimated yearly PFASs use in the electronics and semiconductor industry in the EEA. (Midpoint used in impact assessment)
C2- C3 PFAAs ≥C4 Side-chain Total Total Fluoro PFPE Total Total PFASs
(non-ionic) (t/y) fluorinated PFAAs and fluorinated polymers (t/y) polymeric (t/y)
PFAS polymers PFAA gases (t/y) PFASs
substances (t/y) precursors (t/y) (t/y)
(t/y) (t/y)

midpoint midpoint midpoint midpoint midpoint midpoint midpoint midpoint midpoint


Total
electronics
190 993 12 1 195 140 2 807 281 3 088 4 423
and semi-
conductors

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

According to stakeholders, approximately 65% of the PFASs used are polymeric PFASs. The
semiconductors industry accounts for approximately 45% of the polymeric PFASs use and
approximately 7% of the non-polymeric PFAS use.

Stakeholders indicate the use of an amount of 140 t of 12 different fluorinated gases. The
Fluorinated gases are mostly used as a solvent cleaner. Between 400 and 840 t/y were
reported to be used as intermediate.

The main polymeric PFASs used in the electronics and semiconductor industry are PTFE, PFA,
PVDF, ETFE and FEP. FEP is highly used for Local Area network (LAN) cabling (fire resistance).

The main non-polymer ionic PFAS used in the electronics and semiconductor industry is
perfluorobutanesulfonate (PFBS), a surfactant. The non-polymer non-ionic PFASs are mainly
solvent cleaners and heat transfer fluids.

A.3.12.3. Summary

Because of the vast range of properties, PFASs are widely used in the electronics and
semic onductors industry. PFASs are used in products and components to enhance their
functionality and in the process to make those products and components. Stakeholders report
an estimated annual use of between 2 500 and 6 300 t (rounded numbers). Approximately
65% of the PFASs used are fluoropolymers. The main fluoropolymers used are PTFE, PFA,
PVDF, ETFE and FEP. The main non-polymeric ionic PFAS is perfluorobutanesulfonate (PFBS),
a surfactant. Non-polymeric non-ionic PFASs are mainly used as solvent cleaners and heat
transfer fluids. The semiconductor industry accounts for approximately 45% of the polymeric
PFASs and approximately 7% of the non-polymeric PFASs.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.13. Energy sector

A.3.13.1. Uses

Glüge et al. (2020) identified uses of PFAS in the energy industry and listed the main
properties of PFASs. For this study, both the uses and properties were confirmed by a
stakeholder and additional uses and properties were added. Also, literature and publicly
available sources were consulted (JRC, 2018)36. PFASs properties are included in Table A.52.

Table A.52. PFAS properties relevant to the energy industry - literature and publicly available
sources, complemented by a stakeholder.
Industry Identified properties
Energy C hemical/thermal resistance, ion transportation, high weatherability,
high transparency, corrosion resistance, oleophobic, hydrophobic, low
surface tension, stable, non-reactive, acid gas scrubber, heat
absorption, conductivity, capacity to dissolve gases, bipolar,
resistance to acids, and highly oxidizing species, wettability, heat
conductivity, high dielectric strength, low global warming p otential,
forms no residue, dirt repellence, high vapour barrier, high
transparency, particular and chemical filtration.

An overview of PFAS uses in the energy industry is provided in Table A.53.

Table A.53. PFASs uses in the energy industry – literature and publicly available sources,
complemented by a stakeholder.
Energy facility/unit Use as/for
Solar collector Front and back sheet, adhesive
Photovoltaic cells Adhesive to hold mesh cathode in place
Heat exchanger C oating
C oal based power plant Acid gas scrubber, separation of gases, filter
Nuclear power plant Sealing for aggressive chemicals
Lithium batteries Binder for electrodes, prevent thermal runaway reaction, oxygen
transport, electrolyte, sealing
Vanadium redox batteries Ion exchange membrane
Zinc batteries Prevent formation of dendrites, hydrogen evolution and electrode
corrosion due to adsorption to electrode
Alkaline batteries Surfactant
Flow batteries Membranes
Battery systems C ooling
Fuel cells Membranes, sealing, binding
Power transformers C ooling liquid
Gas insulated equipment Insulation
Electrical components Testing Fluid
Electrical substations Fire protection fluid
Unknown Heat transfer fluid

In Table A.54, an overview of the identified uses and properties of PFASs in the energy
industry is provided, based on input from stakeholders. In general, the information received
varied in the level of detail pertaining to substance, sub-uses application(s) and sectors. For
instance, not all substances were associated with a use or funct ion, stakeholders sometimes

36
https://www.engineeredfluids.com/post/are-pfas-the-next-pcbs, date of access: 2022-12-16.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

listed properties of each PFAS without specifying details in application etc.

Table A.54. Identified uses and application of PFASs in the energy industry identified by
stakeholders.
Area of Examples of
Use category Sub-use Properties
use/application(s) PFAS
Solar collector Solar array bearings PTFE
(for tracking
systems)
Photovoltaic Film/coating Water repellency Front and back PVDF, ETFE,
cells Tape  Soil sheets of PV FEVE, PFPE
repellency modules (The PV
 Thermal back sheet is
stability designed to protect
 Electric the inner
stability components of the
 Weather module, specifically
resistance the photovoltaic
(UV, cells and electrical
humidity, components from
temperature external stresses as
s) well as act as an
 Sand electric insulator)
abrasion
 Antifouling
 Barrier
properties
 Light weight
 Low
flammability
Extreme
durability
Wind energy Film/coating  Durability Wind Blade FEVE, ETFE,
and cables as Weatherability Protection C oating Perfluorobutane
well (prevent moisture in sulphonamide
the air from
affecting curing
process), Windmill
towersa,b. Release
film for wind
turbines.

Lubricant Used as PTFE


lubricants/oils/greas
es for wind
turbines a,b

Coal based Heat exchanger  High Power plants PTFE,


power plant tubing temperature Fluoropolymers
Filters resistance
 Steam
resistant
 UV and
chemical
inert

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Area of Examples of
Use category Sub-use Properties
use/application(s) PFAS
 Durability
 High
flexibility
Particulate
filtration
Nuclear power Infrastructure: C ontaining C losed vessels PTFE
plant Gasket material aggressive acid
and alkaline
media
PEM fuel cells Membrane  Hydrophobic Transportation PTFE
electrode agent (avoid (automotive,
assemblies flooding of aviation etc.), zero-
(MEA); Gas the cell) emission
Diffusion Layer  Binder powertrains for cars
(GDL)/Microporo  Electrical and buses c, backup
us layer, insulator power for critical
Gaskets, sealant.  C onductor systems and remote
 C hemical locations, portable
resistant generators and
 Thermal compact charging
resistant devices, C ombined
heat and power
 Mechanical systems for homes
resistant and commercial
Durability buildings, mobile
power systems for
material handling
equipment such as
forklifts
Membrane  Best Separates protones Perfluoroalkane
electrode association and electrons and sulfonic acids
assemblies of provides the proton (PFSA) or
(MEA); conductivity, conductivity perfluoroalkyleth
membrane chemical (thereby producing er sulfonic acids
stability and electric current) (PFAE) ionomers,
mechanical while separating the PTFE
strength reactants: hydrogen
Hydrophobic and air (oxygen), in
(PTFE backbone) the case of a fuel
cell
Membrane Hydrophobic MPL are placed PTFE
electrode inside an MEA to
assemblies prevent water
(MEA); leakage, ensure
Microporous insulation, and
layers (MPL) improve contact
between GDL and
the electrode
Sealant Seal on MEA b Fluoropolymers,
fluoroelastomers
b
PEM Sealing  Inert Fluoropolymers,
electrolyser/PE materials; C hemical fluoroelastomers
M fuel cells gaskets resistant

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Area of Examples of
Use category Sub-use Properties
use/application(s) PFAS
PEM PFSA ionomer,
electrolyser PTFE
Lithium-ion Seals,  C ooling Use to contain Fluoroelastomer,
batteries electrode Electric stability aggressive PVDF
binders, electrolytes
separator
films/coatings,
electrolyte
additives,
thermal
management
pack/module
Batteries Battery fluid, Rechargeable
C ompounds for batteries
separator films,
Binder
Flow batteries Ionomer  Ionic Rechargeable Fluoropolymers
membranes resistance batteries
Ion exchange  Mechanical Sealing for
membrane properties aggressive
 Durability chemicals b
 C hemical
stability
 C orrosion
resistance
Thermal
resistance
Electro-lysis Equipment:  Stability Alkaline water Polymeric PFASs:
technologies gaskets, tubes,  Durability electrolysis PTFE, FKM,
(not PEM) inline of  Mechanical (technology for large PVDF, TFM
pipes/tanks compression scale hydrogen (chemically
C reep production) modified PTFE),
characteristics FEP, EC TFE, PFA,
and chemical PFPE
resistance
d
Oil and gas Equipment:  Inert,
appli-cation gaskets, tubes,  Hydrophobic
inline of  C hemical
pipes/tanks. and
Wires and temperature
capacitors. resistant
 C orrosion
protection
barrier
 High
mechanical
strength and
resistance
 Air
permeability
Flexibility/
ductility

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Area of Examples of
Use category Sub-use Properties
use/application(s) PFAS
Others Switchgears  C hemical Used as insulation Fluoropolymers;
High Voltage DC and gas in Medium & PTFE, PVDF.
C onverter Valves temperature High Voltage Non-polymeric
resistant Switchgear Power PFASs; PFBS,
 Dielectric Transmission C 4-FN and C 5-FK
properties Technologies
Flame Used in conversion
retardancy of electric power (AC
to DC ) due to their
chemical and
thermal properties.
Used in
polycarbonates.
a
C overed in section A.3.14 on construction products
b
C overed in section A.3.15 on lubricants
c
C overed in section A.3.11 on transport
d
C overed in section A.3.16 on petroleum and mining

Based on input from stakeholders and information from literature (Glüge et al., 2020), 40
PFASs were identified at being in use or used at some point in the energy industry. Glüge et
al. (2020), further identified 13 PFASs as being patented for use in the energy industry and
four PFASs as analytically detected.

Of the 40 PFASs identified as being in use or used at some point in the energy industry, 23
are polymeric PFASs (15 fluoropolymers, two side-chain polymers, five PFPE and one
unknown) and 17 are non-polymeric PFASs (six ionic and 11 non-ionic of which one is a
fluorinated gas).

A.3.13.2. Volumes

A summary of the use volumes in the energy industry in the EEA is presente d in Table A.55
and Table A.56. The estimates are based on responses of 30 companies active in the energy
industry. Based on data from the Urban mine platform on the volume of lithium-ion batteries
(157 000 t/y) and estimations from stakeholders that the PFASs content (PTFE and PVDF) in
batteries is around 1%, the volume of polymeric PFASs in batteries was estimated at
1 600 t/y. It should be noted that the lithium-ion battery data from the Urban Mine platform
also contains data on batteries used in electric vehicles. No PFAS volume data is available f or
other types of batteries (e.g. flow batteries)37.

37
http://www.urbanmineplatform.eu/homepage , date of access: 2022-12-16.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.55. Estimated yearly PFASs use in the energy sector in the EEA.
C2- C3 PFAAs ≥C4 Side-chain Total PFAAs Fluoropolyme PFPE Total Total PFASs
(non-ionic) (t/y) fluorinated and PFAA rs (t/y) polymeric (t/y)
PFAS polymers precursors (t/y) PFASs
substances (t/y) (t/y) (t/y)
(t/y)

low high low high low high low high low high low high low high low high

Total 233 233 20 20 40 41 293 294 2 590 2 917 2 3 2 592 2920 2 884 3 214

Table A.56. Estimated yearly PFASs use in the energy sector in the EEA. (Midpoint used in impact assessment)
C2- C3 PFAAs ≥C4 Side-chain Total PFAAs Fluoropoly PFPE Total Total PFASs
(non-ionic) (t/y) fluorinated and PFAA mers (t/y) polymeric (t/y)
PFAS polymers precursors (t/y) PFASs
substances (t/y) (t/y) (t/y)
(t/y)

Midpoint Midpoint Midpoint Midpoint Midpoint Midpoint Midpoint Midpoint

Total 233 20 41 294 2 754 3 2 756 3 049

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

According to stakeholders, the main polymeric PFASs used in the energy industry are PTFE,
PFA and a PFSA-ionomer, which account for 65%, 14% and 5% of the total fluorinated
polymer use, respectively.

A.3.13.3. Summary

Because of the vast range of properties, PFASs are widely used in the energy industry.
Stakeholders report an estimated annual use of between 2 900 and 3 200 t (rounded
numbers). Approximately 84% of the PFASs used are polymeric PFASs. The main
fluoropolymers used are PTFE, PFA and a PFSA-ionomer, which account for 65%, 14% and
5% of the total fluoropolymer use respectively. Literature sources indicate an annual volume
of PFASs (mainly PVDF and PTFE) in batteries of 1 600 t.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.14. Construction products

A.3.14.1. Uses

PFASs have many uses in construction products and the building industry, including in
architectural membranes and other roofing materials, wires and cables, paints and
coatings/impregnations, sealants, adhesives, and more. They are applied because they have
desirable technical functions such as wetting, weatherproofing, UV resistance, corrosion
prevention, chemical and thermal resistance, friction reduction, durable, soil and water
resistance.

Table A.57 provides identified use categories, sub-uses, technical function and examples of
PFASs in building materials/construction products based on Glüge et al. (2020), Fernández et
al. (2021), OECD (2022) and stakeholder input.

It should be noted that there are some overlaps between the use categories in Table A.57 –
e.g. between the broad category coatings and paints and some more sector specific uses like
the metal sector. It should also be noted that there are some overlaps between some use
categories in the table and uses described in other sections of Annex A. The use category
wires and cables are included in the table for the sake of completeness, as this category is in
general handled in section A.3.12 (Electronics and semiconductors). The same goes for the
foam blowing agents that is included in section A.3.9 (Applications of fluorinated gases).

Table A.57. Identified PFAS uses, technical function and examples of PFAS in building
material/construction products based on literature and stakeholder input.
Use category Sub-use(s) Technical functions Examples of PFASs
Architectural Durability, chemical and Fluorinated polymers e.g.
membranes including UV resistance, light PTFE, ETFE, FEP, PVDF
fluoropolymer films weight, low maintenance, Non-polymeric PFASs
(ETFE) and fabrics or wetting during e.g. PBSF, HC FO-
fiber glass application of film 1233zd1
coated/laminated with
fluoropolymers in e.g.
stadium roofs,
greenhouses, flexible
solar panels
Weatherproofing Durability and stain Fluoropolymers
Roofing
Membranes made of resistance, moisture
materials such as control and solar
synthetic rubber, reflectivity
polyvinyl chloride (PVC ),
polyolefin, or other
heavy-duty
thermoplastics, and
coated with a
fluoropolymer layer.
Used for e.g. flat-type
roofs
Electrical cable and wire Flexible, durable, PTFE, PC TFE, ETFE, FEP,
insulation (in e.g. air temperature resistance PVDF
conditioner units,
Wires and computers, light fixtures
cables and heated flooring),
PTFE-impregnated
plastic or a fiberglass-
based tapes for electrical

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use(s) Technical functions Examples of PFASs


applications (e.g. to
wrap bundles of wires),
gasket hoses

Skidways for Low moisture absorption, PTFE


constructions strong weather
Skidways resistance, chemical
inertness, electrical and
thermal insulation
Bridge bearings Water repellence and low Polymeric PFASs e.g.
Construction
friction PTFE, PC TFE, ETFE,
bearings
PVDF, FKM
Sealing of porous C reate a smooth, water- Polymeric PFASs e.g.
materials such as stone, resistant protective PTFE and acrylate- and
grout, unglazed tile, and barrier that increases urethane -based side-
concrete in e.g. kitchen resistance to oil, water, chain fluorinated
and bathroom tilework, stains, snow, ice, and polymers
and stone, tile or graffiti Non-polymeric PFASs:
concrete flooring. Also e.g. fluorosurfactant
used in exterior
applications such as
patios, staircases,
foundations, and parking
garages. PTFE tape (and
liquid/paste pipe thread
Sealings and sealant) is also a type of
adhesives sealing used to seal e.g.
pipe connections
Adhesives for e.g. tiles, Increase the strength of Polymeric PFASs e.g.
flooring, drywall, ceiling, the bond adhering fluoroelastomers
wood-related materials materials together by Non-polymeric PFASs:
and molded increasing wettability fluorosurfactants
structures. Tapes for and/or enhance the
structural glazing are penetration into
also included as well as substrates
caulks to fill gaps and
crevices, creating a
water-proof seal in
building facings,
elevators and furniture
PTFE tape (also PTFE PTFE
tape for professional
applications like for
drinking water,
compressed air systems
and installation of
Household
windows and doors)
application
DIY sealant and For DIY sealant and Polymeric PFASs e.g.
adhesive products as adhesive, see sealants PTFE and acrylate-,
e.g. foam mounting and adhesives above urethane- and siloxane-
tapes and squares, and based side-chain
damage-free hanging fluorinated polymers
solutions for e.g. Non-polymeric PFASs:

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use(s) Technical functions Examples of PFASs


pictures e.g. fluorosurfactant

For production of certain Specific uses confidential Non-polymeric PFASs


types of construction (surfactant or solvent)
Processing
products (articles) The
aids (PA)
PAs is not part of the
final product.
Used as internal Eliminate of melt fracture Micro-powder PTFE, high-
lubricant/additive/ (shark-skin effect), MW PTFE, PVDF, PFPE
polymeric processing aid improve wear and
in thermoplastics (e.g. abrasion resistance,
PE and PP) thermo reduce coefficients of
setting plastics and friction (C OF), make
elastomers surfaces easier to clean,
increase melt tension and
Polymer strength, and improve
processing processability and mould
additives release, reduce of die
(PPA) build-up, improve of the
surface finish with high
gloss levels, increase
production start-up,
reduce pressure, increase
output at constant die
pressure and
temperature, lower
energy consumption
Flame retardants (e.g. Flame retardant. Antidrip Polymeric PFASs e.g.
PFBS as additive to additive. Antistatic agent PTFE, High-MW PTFE,
polycarbonate resins). to prevent the buildup of PVDF
High-MW PTFE additive static electricity and Non-polymeric PFASs:
Other polymer as drip suppression of dissipate the electric PFBS, PFHxS-Li+ ,
additives burning plastics. PFHxS- charge formed on the pigments
Li+ as antistatic. C oating substrate
of plastics with
fluoropolymers.
Pigments
Foam blowing Foam insulation for e.g. Reduce thermal Fluorinated gases 1
agents/additiv polyurethane and other conductivity
es foam formulations
Wetting agent and Improve levelling and Polymeric PFASs e.g.
sealers in spreading and increase acrylate-, urethane- and
coatings/paints/ resistance to oil, water siloxane-based side-
varnishes/lacquers for and stains chain fluorinated
wood substrate polymers
Non-polymeric PFAS:
Wood sector
e.g. fluorosurfactants
Resin/adhesive for Urea–formaldehyde Non-polymeric PFASs:
particleboard/chipboard/ adhesive resins: fluorosurfactants
low-density fiberboard Improved cold-water
swelling and internal
bond strength

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use(s) Technical functions Examples of PFASs


Surface Increase the durability of Polymeric PFASs e.g.
treatment/coating of glass and limit the PTFE, PC TFE
glass buildup of dust and Non-polymeric PFASs
Glass sector building/construction debris on glass surfaces. e.g. PBSF
materials such as Wetting agent during
windows, doors, and coating step
mirrors
C oating/painting of Protects metal building Polymeric PFASs e.g.
metal (including coil products against PTFE, FEP, PVDF, FEVE
coating). Exterior weathering and staining and silane/siloxane-
finishes for large and increases corrosion based side-chain
buildings, bridges, and resistance. C oatings also fluorinated polymers
industrial structures, in used to increase the
addition to high touch energy efficiency of
Metal industry
metal surfaces such as metal roofs and exterior
/sector
elevators and sanitary walls (by increasing
fixtures. Metal reflectivity), to keep
entrances, doors, and snow and ice from
door components sticking to roofs and
(hinges, frames, latches, gutters and to aid in the
handles, locks, etc) may penetration of coated
be coated with PFAS roofing nails
Surface-protective Resistance to rain Polymeric PFAS: FEVE,
films/coatings for wind erosion of the blades. ETFE
turbine blades Weathering (UV and Non-polymeric PFASs:
oxidation attacking resin Perfluorobutane
in composite), abrasion sulphonamides
and light impacts.
Outdoor Prevention of moisture in
electrical the air from affecting
energy curing process.
components Surface coatings for Resistance to weathering Polymeric PFASs e.g. FEP
solar panels of glass or and rain, and also fluoropolymer and
ETFE maintain a clean surface silane/siloxane-based
and reduce dirt build-up, side-chain fluorinated
which can block light and polymers
reduce conversion
efficiency
Surface treatments of Make surfaces durable, Polymeric PFASs e.g.
both absorbing and non- soil and water resistant acrylate-, urethane- and
absorbing surfaces (e.g. silane/siloxane-based
glass, enamel, ceramics, side-chain fluorinated
metal, stone, concrete polymers
Surface
and linoleum, laminated
protection
plastic floor). Often sol-
gel method is used for
creating (polymerisation
of) a nanometer thin
film on the surface.
C oating of surfaces of C orrosion resistance, Polymeric PFAS: PTFE,
Architectural bridges and buildings, thermal stability, flame PVDF, EC TFE, FEVE, FEP,
coatings and including anti-graffiti resistance, weather PFPE & acrylate- and
paints coating resistance, UV durability silane/siloxane-based
side-chain fluorinated

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use category Sub-use(s) Technical functions Examples of PFASs


polymers

Fluorinated additives in Wetting and levelling Polymeric PFASs e.g.


paints to achieve specificagents that lower surface PVDF, FEVE, EC TFE,
finishes and durability tension for even flow and PTFE, FEP, PFPEs
requirements on spread. Provide non- Non-polymeric PFASs:
buildings and stick, dirt and stain surfactants, pigments
constructions resistant, oil- and water-
repellent, and anti-
corrosive properties.
Binders that join
ingredients together
and/or help impregnate
the substrate to decrease
bubbling and peeling.
De-aerator to decrease
bubbling.
1 HC FO-1233zd(E) is used as foam blowing agent in e.g. roofing. Fluorinated gases/foam blowing agents
are covered in section A.3.9.

In Glüge et al. (2020), the following industries and use categories are considered to be
relevant for the use of construction products within the building industry: building and
construction, coatings, paints, and varnishes, production of plastic and rubber, plastic, rubber
and resins, wood processing, treatment and coating of metals, pipes, pumps, fittings and
liners, sealants and adhesives, stone, concrete and tile (treatment), wire and cable insulation,
gaskets and hoses. Based on this, 76 PFASs were identified as (potentially) being in use or
used at some point in construction products. Glüge et al. (2020) further identified 67 PFASs
as being patented for use in construction products. Sub-uses that were clearly out of scope
of being considered construction products (e.g. mold release agents in production of plastic
and rubber that is covered in section A.3.15) was removed from the count.

Of the 76 PFASs identified at being in use or used at some point in construction products, 28
are polymeric PFASs (15 fluoropolymers, nine side-chain fluorinated polymers, three PFPEs,
and one ‘unknown’). 47 are non-polymeric (30 ionic and 15 non-ionic) and one substance is
considered as ‘unknown’, as no information was available on its chemical identity.

Several substances are used across different use categories of building materials/construction
products. This is also reflected in Table A.57, where e.g. PTFE is mentioned in almost all use
categories.

A.3.14.2. Volumes

In Table A.58 the estimated annual volumes of PFASs in building materials/construction


produc ts uses in the EEA are given. The estimate for polymeric PFASs is based on input from
stakeholders whereas the estimate for non-polymeric PFASs is based on the split between
polymeric PFASs and non-polymeric PFASs in the categories ‘building and construction’ and
coatings and paints’ in Glüge et al. (2020). The reason for using this approach is that the
input from stakeholders on the annual volume of non-polymeric PFASs is considered to be too
low.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

The total annual volumes of PFASs for the construction sector in table Table A.58 has the
following caveats:

i) The data on polymeric PFASs provided by stakeholders likely does not cover all
relevant users.
ii) The data provided on polymeric PFASs was, in some cases, not clearly split by
uses, and it can’t be excluded that it may include some double counting (when
different supply chain stages report volumes for the same products).
iii) Where data has been provided as ranges, the upper bounds have been used to
quantify a ‘worst-case’ scenario.
iv) Estimations of annual volumes of non-polymeric PFASs is partly based on Glüge et
al. (2020). This approach has uncertainties but is used in lieu of better data. The
volumes can’t be split by uses.

Table A.58. Estimated PFASs volumes in building materials/construction products used in the
EEA.
Volume (t/y)
Range Midpoint
PFAAs and PFAA Side-chain fluorinated
13 40 27
precursors polymers
Non-polymeric PFASs 974 2 365 1 670
Polymeric PFASs* 4 254 10 320 7 287
Total PFASs 5 241 12 725 8 983
*Polymeric PFASs here only refers to fluoropolymers as no information on PFPEs was received

PTFE, ETFE and PVDF make-up 97% of the reported total usage of fluoropolymers in building
materials/construction products. The remaining 3% covers a range of fluoropolymers
including fluoroelastomers such as FKM, FFKM and THV.

Wood (2022) estimated the total quantity of fluoropolymers sold in the construction sector in
the EEA in 2020 to be 4 500 t, which is similar to the lower end for fluoropolymers in Table
A.58. It is, however, not clear if Wood (2022) included the same uses as is included Table
A.57.

Stakeholders only provided input on acrylate-based side-chain fluorinated polymers which is


different to Glüge et al. (2020), who also identified the use of urethane- and silane/siloxane-
based side-chain fluorinated polymers. The volumes in Table A.58 for side-chain fluorinated
polymers might therefore be an underestimation.

A.3.14.3. Summary

Because of the wide range of properties, PFASs are widely used in construction products. An
annual PFASs use of between 5 000 and 13 000 t (rounded numbers) is estimated based on
literature and numbers reported by stakeholders. Approximately 81% of the PFASs used are
polymeric PFASs. The main fluoropolymers used are PTFE, ETFE and PVDF which account for
97% of the total fluoropolymer use.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.15. Lubricants

A.3.15.1. Uses

Uses and properties of PFAS-based and PFAS containing lubricants were identified by
stakeholders and in literature (Ebnesajjad S. & Morgan R (Eds.), 2019; Glüge et al., 2020;
Rudnick, 2020).

Ebnesajjad S. & Morgan R (Eds.) (2019) separates lubricants into five categories, low viscosity
lubricants, engine oils, greases, solid/dry-films, and release-agents. It should, however, be
noted that the same commercial products are sometimes used as low viscosity, dry film, or
release-agent lubricants.

An overview of PFAS seen in lubricants is given in Table A.103.

A.3.15.1.1. Low viscosity lubricants

According to Ebnesajjad S. & Morgan R (Eds.) (2019) the fluid phase for low viscosity
lubricants is typically either mineral oil or synthetic oil. Low viscosity lubricants can be 100%
base oil, but they often contain solid additives, such as e.g. micro-powder PTFE, graphite,
molybdenum disulphide (MoS2), tungsten disulphide (WS2) or boron nitride (BN). Dispersants
or wetting agents can be used to assure particle suspension. Besides this, other additives like
rust inhibitors can be added. Fluorosilicone oils can also be used as base oils (Ebnesajjad S.
& Morgan R (Eds.), 2019).

A.3.15.1.2. Engine oil

Engine oil is a low viscosity lubricant. The most common base oil in engine oil is mineral oil.
However, synthetic base oil is occasionally also used (Somayaji, 2008). Micro-powder PTFE
can/may be added as an anti-wear additive. However, the use of PTFE in engine oils is rather
limited due to its inherent instability in oil, the risk of oil filter clogging, as well as difficulties
with recycling (JRC, 2016). Engine oil is only mentioned here for the sake of completeness
and will not be discussed further in this section on lubricants.

A.3.15.1.3. Grease

Grease is basically a base oil that contains a thickening agent to increase its viscosity. Greases
are typically produced using mineral, synthetic or plant-derived oils. Thickening agents may
be soaps or it can be a solid with a high surface area. According to Ebnesajjad S. & Morgan R
(Eds.) (2019) micro-powder PTFE can be used as thickener/solid additive/fortifier alone or in
combination with other thickeners, however, most greases based on mineral oils do not use
fluoropolymers as thickeners. The use of PFASs as thickeners is more common for some
synthetic oils (PFPEs, oligomer PCTFE, polyalphaolefin oils, fluorosililicone oils). When used
alone, the PTFE level ranges from 20-40% and when used together with other thickeners the
range is from 3-40% (Ebnesajjad S. & Morgan R (Eds.), 2019). Micro-powder PTFE is often
used as thickener in PFPE-based greases. Silica, micro-powder PTFE and/or high-MW PCTFE
is commonly used as thickener in PCTFE-based greases (base oil of oligomer/low-MW PCTFE)
(Rudnick, 2020).

A.3.15.1.4. Solid/Dry films

Easy volatilisation of the liquid is usually important for these applications, therefore, the fluid
phase for dry films can be oil but is more likely to be water, a very low-MW hydrocarbon, or
a polar organic compound such as isopropanol or acetone, as these will evaporate before end
use. After evaporation of the solvent, the solid additive (e.g. graphite or micro-powder PTFE)
will be left as a dry film. Dry film lubricants may be applied multiple times (Ebnesajjad S. &
Morgan R (Eds.), 2019).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.15.1.5. Release-agents

Release-agents can be considered as a special case of dry film use. Release -agents are also
known as anti-blocking agents, surface lubricants, parting agents, or slip-aids. They are used
particularly in the manufacture or modification of (thermo)plastic and elastomer shapes,
preventing sticking and build-up of resin on process equipment. External lubricants are
typically coated from liquid suspension or solution on a mould or contact surface by
(aerosol)spraying or brushing. Most external release-agents must be applied multiple times
as resin is processed. Internal lubricants/release-agents are incorporated into the resin before
the forming or processing of the plastic or elastomeric part . Internal lubricants (release-
agents/slip-agents) is therefore a type of processing aid (PA) (Ebnesajjad S. & Morgan R
(Eds.), 2019). Internal lubricants are not considered a lubricant as such and is mentioned
here for the sake of completeness.

As described above the most common PFASs in lubricants are polymeric PFASs like micro -
powder PTFE (solid additive), PFPE (base oil) and PCTFE (base oil). According to Ebnesajjad
S. & Morgan R (Eds.) (2019) other polymeric PFASs such as polyfluorosiloxane/fluorosilicone
oils (base oils or additives), FEP and PAVE (additive) are occasionally also present in
lubricants.

Non-polymeric PFASs such as dispersants/wetting agents in lubricants and solvents in


lubricants and lubricant applications (e.g. cleaning before adding a lubricant ) are sometimes
also used.

A.3.15.1.6. PFPE, PCTFE and fluorosilicone base oils

PFPE, PCTFE and fluorosilicone oils can be used directly as lubricants, or they can be used as
base oil for greases (Rudnick, 2020). PFPE are fluids known to be chemically inert, have low
outgassing, are thermally stabile (service temperature range from approx. -80 ºC to approx.
350 ºC (depending on the type of PFPE)), are non-flammable and radiation resistant. The
vapour pressure and volatility of the PFPE oils vary with average MW so that higher-viscosity
(higher MW) oils generally have lower volatility losses (Rudnick, 2020). Commonly used
thickening agents for PFPE-greases are finely divided silica, ‘attapulgus clay’, montmorillonite,
ammeline, boron nitride, talc, calcium carbonate, zinc oxides, micro-powder PTFE and FEP
(Rudnick, 2020). PFPE greases are especially used for applications that require perf ormance
over a significant temperature range and wherein oxygen-resistance is needed. For PFPE
greases thickened with micro-powder PTFE, DuPont (Chemours) and Solvay make a point of
saying that special grades of PTFE are used for the thickening (Ebnesajjad S. & Morgan R
(Eds.), 2019).

PCTFE lubricants are known to have good lubricity, to be chemically inert to a high number of
aggressive chemicals, be non-flammable, have low outgassing, be thermally stabile, radiation
resistant, have high dielectric strength, high density and low compressibility (Rudnick, 2020).
PCTFE-based greases (base oil of oligomer/low-MW PCTFE) thickened with silica, micro-
powder PTFE and/or high-MW PCTFE is commercially available (Rudnick, 2020).

Fluorosilicone oils (polyfluorosiloxane oils) can resists oxidation, harsh chemicals, fuels, has
a low evaporation and a wide service temperature range (-40 to 204 °C). Greases based on
fluorosilicone oils can be thickened with amorphous fumed silica, PTFE and organics (Dow
Corning, 2005).

A.3.15.1.7. Micro-powder PTFE as additive in lubricants

The extremely low coefficient of friction of (micro-powder) PTFE in combination with its good
thermal stability makes it attractive as a solid lubricant additive. Micro -powder PTFE is
compatible with PFPE and PCTFE. It is therefore used as additive in low viscosity lubricants
based on PFPE and PCTFE and is also used as thickener and additive in PFPE, PCTFE and
fluorosilicone greases. Micro-powder PTFE is also used as a solid additive in non-PFAS based

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

low viscosity lubricants and greases as well in dry-film lubrication/external release-agents


where the solvent can be PFASs or a non-PFASs.

Examples of uses of dry-film lubrication ((Ebnesajjad S. & Morgan R (Eds.), 2019) and input
from stakeholders) include glass cloth for automotive (bushings for car door hinges, trunk
lids, seats and wipers), electronics (bushings for office machines), hydraulics (cylindrical
bushings for hydraulic machinery), industrial machinery (thrust washers for conveyor belts),
food processing (industrial, retail or Quick Service Restaurants) and consumer use (bike
chains and waterproof zippers).

A.3.15.1.8. Lubricant additives other than micro-powder PTFE

According to Ebnesajjad S. & Morgan R (Eds.) (2019) there are many types of low-MW PFASs
(besides micro-powder PTFE) that may be used as additives for lubricants including
fluorosurfactants and fluorinated or partially fluorinated alkanes, ethers, amines, esters, and
metal salts of alkyl phosphates. The low-MW PFASs are typically used in specialised
applications such as for recording media, hydraulic fluids, firearms, and conveyor chains but
recent patents have also described their use in internal combustion engines.
Perfluoropolyether and perfluoroalkyl phosphates, phosphonates, and salts thereof have been
disclosed as lubricants for magnetic media lubrication. They were applied from solution in a
hydrofluoroether solvent. Essentially the same compounds have been disclosed as corrosion
inhibitors for perfluoropolyethers oils and grease (Rudnick, 2020).

A.3.15.1.9. PFAS-based solvents used in lubricants and lubricant applications

Various PFAS-based solvents (functional fluids) are applied in relation to lubrication. Based
on input from stakeholders generally, these uses can be divided in:

 PFAS-based carrier and deposition solvent as part of a lubricant dispersion. According


to industry, these processes take place in closed system where the evaporated solvent
is captured, and VOC regulations complied with.
 Cleaning agents:
o This can be for cleaning parts/articles to be lubricated (to avoid contamination
of the lubricant), or

It can be for maintenance. Specific examples have been provided by an industry stakeholder
referring to PFAS-based solvents: "PFAS are essential for cleaners, which are used to clean
switch cabinets or fuse boxes as well as transformers in power plants and wind power under
voltage/high voltage. For equipment that cannot be shut down, there is no alternative. For
large production facilities (e.g. automotive plants), cleaning can be performed with these
products in full operation. The alternative is usually to stop the entire production line to
perform the cleaning. The financial cost is very high."

Please note that these solvents used for cleaning are NOT part of the lubricants.

A.3.15.1.10. Properties of PFAS-based lubricants and specific properties

According to industry stakeholders, PFAS-based lubricants are used in situations where they
are superior in terms of technical performance compared to other lubricants and/or where
other types of lubricants would not be technically feasible. Temperature resilience, chemical
inertness and a very low friction coefficient are often referred to as key aspects, but also other
properties are illuded to. Below, the main properties referred to – alone or in combination are
listed:

Temperature resilience. Use in outdoor environments (incl. aerospace, airplanes, offshore)


and/or in equipment which can become very hot (e.g. ovens, heaters, corrugated paper
machinery, steel mills and printers). The temperature resilience of fluorinated lubricants is a

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

key property. E.g. lubricated bearings can be used in almost any application subject to high
and/or low temperatures.

Use when chemical inertness is crucial, including production of oxidising/reactive chemicals


(including acids and alkalis, aggressive gases such as ammonia or chlorine) and to prevent
reaction with oxygen in other applications (preventing fire, self -ignition, and explosion). The
latter includes e.g. breathing equipment in hospitals (e.g. moving parts in respirators,
lubrication of cannulas, lubrication of artificial joints) and diving equipment. This property
combined with pressure shock resistance is also import ant for some applications. Quote from
an industry stakeholder: "Only PFPE can achieve oxygen pressure shock resistance for
greases/pastes beyond 30 bar. This is essential for valve manufacturers and oxygen
processing industries, such as the steel industry or the medical sector." The 'slide-ability' is
associated with the fact that PFPE lubricants have the highest film thickness of all base oils.

Related to the above, these lubricants are also resistant to radiation which is important in
aerospace and nuclear power plant applications, and resistant to electric current, which is
important in many electrical applications.

Further related to the above, the non-solubility in water is also of importance for avoiding the
lubricant in interacting and possibly degrading following contact with water and moist.

Low vapour pressure preventing outgassing (e.g. one benefit is lifetime lubrication of some
parts, rather than frequent re-lubrication of e.g. bearings or in fine instruments where
maintenance is difficult). Low outgassing is also important for many vacuum pumps and
combined with the inertness preventing degradation products, this is also key in clean-room
production such as for wafers, semiconductors, and other high-tech equipment and for some
aerospace applications. This is also considered vital for electrical contacts in many
applications, optical instruments (e.g. cameras) and light housings where lubricant
condensate needs to be minimized.

A very low friction coefficient which is in particular important in applications were rotating or
sliding movements need lubrication. For micro-powder PTFE a stakeholder states: "They also
possess very low coefficients of friction, typically 0.01 for PTFE lubricant powders, allowing
for excellent non-stick properties…" NB! It shall be noted that PFASs are not applicable for
'high load'. Quote from an industry stakeholder: "PTFE doesn’t carry load very well (here
molybdenum disulphide is the best - PTFE films rupture at 5 000 psi, whereas molybdenum
disulphide films rupture at 500 000 psi), but PTFE is beneficial as a friction modifier in finished
grease formulations." The very low friction coefficient combined with inertness and low
outgassing is also crucial for many applications within electronics.

Noise and vibration reduction. The low friction coefficient will in turn reduce noise and
vibrations and is e.g. in relation to the automotive industry pointed at as an additional benefit
from the use of fluorinated lubricants.

Good chemical compatibility with metals, elastomers, and plastics/polymers of PFPEs.


Combined with some of the above properties, PFAS-based lubricants are often applied to
reduce friction between plastic parts e.g. in electronics, electromechanical applications, and
in plastic gears.

"Less need for lubrication". In combination, the above properties are often referred to by
industry when arguing that the need for maintenance and re-lubrication is low or not needed.
This ageing stability in turn might lead to less environmental impact in terms of lower amount/
less resources needed and longer lifetime of equipment. This in turn also reduces the lifetime
costs for maintenance. This aspect is also elaborated by Grechin et al. (2018), who
furthermore elaborated how PFAS-based lubricants, even though more expensive than PFASs-
free lubricants can lead to a lower total cost of ownership due to decreased
operating/maintenance costs.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Olfactorily hardly noticeable. Combined with low vapour pressure/low outgassing this
prevents odour in e.g. car applications where smell is no longer allowed. Alternatives to PFAS-
based lubricants might result in emission of VOC, which is no longer allowed within the car
industry. In combination with the above properties many industrial stakeholders refer to the
low toxicity of PTFE and PFPEs as key issue in relation their approval for use in medica l
technology, food processing and drinking water applications. Many stakeholders highlight that
in many applications it is the combination of specific tribological properties that make PFASs-
based lubricants the preferred choice in high-performance applications.

Many stakeholders highlight that in many applications it is the combination of specific


tribological properties that make PFASs-based lubricants the preferred choice in high-
performance applications. Table A.59 below gives a non-exhaustive list of PFAS uses in
lubricants, based on literature and information from stakeholders. The properties that are
listed, are identified as most important by the stakeholders or presented in literature
(Ebnesajjad S. & Morgan R (Eds.), 2019; Glüge et al., 2020; Rudnick, 2020).

Table A.59. Non-exhaustive list of PFASs uses in lubricants based on literature and
information from stakeholders.
Branch / Application Properties PFASs (and
sector concentration
examples provided by
stakeholders)
C hains and bearings (e.g. in High temperature PFTE (90-99%; 30-70%)
ovens) applications (e.g. ovens) PFPE (60-75%; 30-70%)
Lifetime lubrication in micro- "Unique tribological PTFE (1-10%)
amounts in closed parts. function", chemical PFPE (80-90%)
Moving mechanical parts, stability, temperature
semi-closed. Lubricants and resilience
lubricant sprays for incidental
Food sector
food contact (NSF-H1[1]a).
As a lubrication additive on 'Slide-ability' PTFE (2.5–100%)
the inside coating of metal
food and beverages
containers - it enables filling
without damaging the
coating.
C ombustion engines High temperature PTFE (5-50%)
Hydraulic systems incl. Anti-erosion, Potassium
control valves. temperature resilience, decafluoro(pentafluoroet
chemical stability hyl)cyclohexanesulphona
te ('low concentration' in
ppm range)
'PFAS' (another
stakeholder refers to 'a
Civil/
PFAS' without further
military
specification (50 ppm)
aircrafts
Bearings Thermo-oxidative PTFE (30-70%)
and
stability, low vapour PFPE (30–70%)
aerospace
pressure, low
flammability, chemically
inert
Actuators of jet engines, and Temperature, wear PTFE (10-30%)
landing gears resistance, chemically
inert, high-pressure
stability, minimal oil
bleed

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Engine starter spline shafts, High/low temperature, PFPE (grease)
hydraulic pumps splines and low volatility
fuel pump splines in aircraft
engines.
Brake and hydraulic fluids High temperature PFPE
Bearings, gears and ball High/low temperature PFPE (grease)
screws in electro-mechanical
actuator. PFPE greases used
due to wide operating window
(-70 to 180 °C ), low starting
torque and anti-fretting
properties.
C ouplings, valves, regulators C ontact with reactive, PFPE
and seals (PFPE greases) in corrosive or explosive
oxygen systems in space and liquids and gases
aviation applications. (oxygen compatibility
and long-time stability)
Moving parts of astronauts' Non-flammability PFPE (oil)
pressure suits.
Bearings of antenna arrays on Minimise wear and does PFPE (oil)
spacecraft's not migrate to other
parts of the system.
Bearings that permit Minimise ware and does PFPE (oil)
extension of the paddle arms not migrate to other
supporting solar cells on parts of the system.
spacecraft's
Slide wire of potentiometers Minimise wear and does PFPE (oil)
in spacecraft's not migrate to other
parts of the system.
O-ring lubrication in C ontact with reactive, PFPE (oil & grease)
spacecraft's corrosive or explosive
liquids and gases
(inertness to fuels and
oxidants)
Flotation fluids in gyroscopes Damping/reducing PC TFE (oil)
in aircrafts and missiles frictional loss
Hydraulic oil and heat transfer Non-flammable, high PC TFE (oil)
fluids for aircrafts temperature
Oxygen delivery system to C ontact with reactive, PC TFE (oil)
spacecraft oxidizer tanks corrosive or explosive
liquids and gases
Breathing systems in Low outgassing, PC TFE
airplanes and submarines C hemical inertness in
contact with reactive,
corrosive or explosive
liquids and gases
Military – Various military lubrication Not specified PTFE
defence functions (e.g. aircraft and
application electronics)
s
Automotive C ombustion engines High temperature PTFE (5-50%)

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Friction reduction in various Low friction, chemical PFPE (base oils)
mechanical devices including stability, compatibility PFTE (lubricating aid and
automotive brake system with seals, noise thickener)
components. reduction
Bearings and throttle sensors Temperature resistance, PTFE
non-stick properties, PFPE
good slide-ability
ESP systems in cars to Viscosity regulation, PTFE
measure turning speed of the temperature resilience,
wheels and many other water repellence,
applications. chemically resistant
Automotive Electrical Temperature resilience, PTFE
C omponents and Auxiliary chemical stability, arc- PFPE
C omponents resistant, low vapour
pressure/little outgassing
Mechanisms of the sliding of Temperature resilience PTFE (10-30%)
doors and windows
Mould release agents, Non-stick, chemical PTFE (1-100%)
assembly aids, grease for e.g. stability, slide-ability,
throttle sensors, bearings, temperature, water
moveable parts, seat rail, repellence
door hinge, switch actuation.
NB! Unclear whether 'mould
release' shall be seen a
'lubricant use'.
Automotive interior. PFPE Various PFPE
lubricants used to reduce
noises, itch or judder where
different materials come into
contact. Lifetime lubrication.
Window wiper motors, High temperature PFPE
electronic waste gate
actuators, O-rings in fuel
connectors (combustion
engines), intake manifolds
shaft and seals, Exhaust gas
recirculation (EGR) valves,
overrun clutches, alternator
bearings and water pumps.
PFPE lubricants used for these
applications due to high-
temperature stability,
chemical resistance and
material compatibility.
Several stakeholders
refer to "Lifetime
lubrication" of 'various
car parts', which would
otherwise need to be re-
lubricated every year if
more mainstream

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
lubricants were used

Valves in powertrains High temperature PTFE


resilience; chemical PFPE
Trains
resistance
Train door lubrication Temperature resilience PTFE (10-30%)
Bearings in pumps Resistance to PFPE
degradation caused by
radiation, no-sludge and
gum formation
Laboratory glassware to Temperature reliance and PTFE
prevent locking chemical inertness
Bearings and other moving Low friction PTFE
parts
C ritical bearings, manipulator C hemically inert, Fluoropolymer (not
greases for nuclear waste temperature resilience, further specified)
handling, fuel manufacturer low friction
Nuclear equipment lubrication,
compaction equipment
lubrication for example.
Anti-galling thread lubricant C ontact with reactive, PC TFE
for stainless steel assemblies corrosive or explosive
liquids and gases
Lubricant for processing Resistance to PC TFE
uranium hexafluoride degradation caused by
radiation
Oil for use in nuclear service Hydrogen-free oil PC TFE (oil)
Lubrication of controls for PC TFE (grease)
nuclear applications
Lubricants and greases Very high stability, Polymeric PFASs + From
extremely low pour C 3 to C 6 fluorinated
Watch- point, anti-wear chains (not further
making additives, excellent water specified)
demixion, extremely low
surface tension, etc.
Vacuum pumps and bearings Temperature resilience PFPE
Hearing
during production. Note that and low PTFE
loss
it is not clear whether the degradation/chemical
application
PFASs as lubricant also plays stability, UV-resistance
s
a role in the final products.
Electric circuit breakers Temperature resilience, PTFE
chemical stability, arc-
Electronics
resistant, low vapour
(including
pressure/little outgassing
semi-
Semi-conductors Low friction PFPE
conductor;
manufacturing: Multiple uses, PTFE
see A.3.12)
such as wafer handling
mechanisms, vacuum grease,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
linear guides of multibeam
inspection stage, source
mirror actuators, and several
other bearing applications.
Working fluid and seals in C ontact with reactive, PFPE (oil)
vacuum pumps exposed to corrosive or explosive
aggressive environment liquids and gases
Emergency smoke ventilation Temperature resilience PFPE (grease)
fans in e.g. tunnels. (the fans need to
function at 400 °C for
2h)
Grease for sliding contacts in Non-oxidizable, non- PFPE
electric switch and for flammable, lifetime
pushbuttons lubrication
Rack and pinion disk drive Temperature resilience PFPE
lubricant
Spindle and actuator bearings Temperature resilience PFPE
in disk drives
Top coating lubricant on Low outgassing PFPE
computer disc drives
Vacuum pump oil for semi- Temperature resilience, PC TFE (oil)
conductor manufacturing low outgassing
equipment
Vacuum pump oil for Temperature resilience, PC TFE (oil)
equipment used to plasma- low outgassing
desmear multilayer printed
circuit boards
Inert grease for semi- C hemically inert PC TFE (grease)
conductor processing
equipment
Vacuum pump oil for Temperature resilience, PC TFE (oil)
equipment used to plasma low outgassing
clean electronics and medical
devices
Instrument fill fluids where C hemical stability in PC TFE (oil)
strong oxidizing agents contact with reactive,
prelude the use of glycerine corrosive or explosive
or silicon oil fill fluids e.g. liquids and gases
Diaphragm seals, pressure
gauges, manometers, dead
weigh testers and sensors.
Diagnostically and optical Low outgassing PTFE
Laboratory equipment: Lubrication of PFPE
supplies, moveable parts, for instance
equipment, ball-bearings in various
and applications where parts need
instrument to be moved without friction
ation Bearings, jewels, and pivots Not specified PFPE
in many kinds of instruments

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Optical instruments and light Low outgassing PFPE
housings where lubricant
condensate needs to be
minimised.
Wax coating to protect glass C hemical stability in PC TFE (grease/wax)
from attack by aggressive contact with reactive,
compounds corrosive or explosive
liquids and gases
Vacuum pump oil for mass PC TFE (oil)
spectrometers
Valves, fittings, O-rings, Very low vapour PFPE/PFTE
pressure gauges in oxygen pressure. Long-term
enriched environments stability and
(ventilators) functionality.
Hospital
Medical injection device Low friction Fluorocarbon gel (not
equipment
(Syringe, pumps, pens) further specified)
(see
Hospital (and home oxygen Life-supporting systems PC TFE (oils and greases)
A.3.10)
systems/units). Hyperbaric where an oxygen-
oxygen chambers. enriched atmosphere
Anaesthesia machines. (>23% O2) or high-
Nitrous oxide systems. pressure air is required
Wind power – lubrication of Low friction; very good PTFE (0.25–25%)
screws, nuts, magnetic wear-resistant and
anchors, bolts etc. tribologically
irreplaceable properties
Wind power (bearings) High temperature PTFE
resilience; chemical PFPE
Renewable resistance
energy Fuel cell technology – Excellent tribological PTFE
(see assembly aid e.g. grease for properties, very good PFPE
A.3.13) O-rings friction properties,
eliminate noise, easy
assembly
Energy storage and energy Temperature, low Fluoropolymer (not
conversion via hydrogen such outgassing (vacuum, further specified)
as PEM – bearings and as applications)
lubricant additive in plastics
Lubrications of screws, nuts, Low friction; very good PTFE (0.25–25%)
magnetic anchors, bolts etc. wear-resistant and
tribological properties
C asing/tubing sealants for Not specified PTFE
high-definition threads in high
Off-shore/ chrome steel
Oil & gas Bearings Thermo-oxidative PTFE (30-70%)
(see stability, low vapour PFPE (30–70%)
A.3.16) pressure, low
flammability, chemically
inert
Sealing systems for C hemically stable in PC TFE (oils)
centrifugal and rotary pumps contact with reactive,
corrosive or explosive

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
liquids and gases

Anti-seize lubricant for drilling PC TFE


tools in hydrogen sulphide
environments
Alkylation lubricant PC TFE
(compatible with HF and
sulphuric acids)
Instrument fill fluid for oil PC TFE
exploration equipment
Machinery for production of PFASs-based lubricants PTFE
oxidising chemicals do not react with oxygen
and thereby
lower/prevent the risk of
fire, auto ignition and
explosion compared to
other types of lubricants
Bursting discs and gaskets for C hemical inertness PTFE
heat exchangers, synthesis
units and reactors
Valves, fittings, couplings, O- C hemical inertness in PFPE
rings and seals exposed to contact with reactive,
reactive and corrosive corrosive or explosive
chemicals. liquids and gases
C hlorine (and bromine) C hemical resistance in PC TFE (oils and greases)
industry: Vacuum pump oils, aggressive environment
compressor oil, valve and
plug cock grease, lubrication
Chemical for chlorine vaporiser, valve
industry stem lubricant, assembly and
repair of chlorine cylinder
valves, tank car maintenance
(valves), thread lubricant
Sealing systems for C hemical inertness in PC TFE (oils)
centrifugal and rotary pumps. contact with reactive,
Sealing systems for rotary corrosive or explosive
agitators and mixers in liquids and gases
reactive chemical processes.
Sealants for flange faces.
Lubricants for equipment C hemical inertness in PC TFE
used in the fluorination contact with reactive,
process for blow-moulding corrosive or explosive
polyethylene bottles and liquids and gases
gasoline tanks
Sulphur trioxide spill control C hemical inertness in PC TFE (oil slurried with
mixture contact with reactive, hollow glass beads)
corrosive or explosive
liquids and gases

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Oxygen service - lubricants C hemical inertness in PC TFE (oils and greases)
for remote control solenoid contact with reactive,
valves, thread lubricant, corrosive or explosive
instrument fill fluid, rotary liquids and gases
meter lubricant, diaphragm
compressor oil, vacuum pump
oils for evacuating oxygen
cylinders and bulk (cryogenic)
storage tanks, vacuum pump
oils for oxygen plasma
cleaning, bearing grease for
liquid oxygen (LOX) pumps
Bulk gas
and lubricant for compressors
industry
in portable oxygen plants
Welding gases - lubricants for Low outgassing, PC TFE (oils)
bearings in LOX pumps and C hemical inertness in
vacuum pump oils for contact with reactive,
evacuating oxygen cylinders corrosive or explosive
liquids and gases
Helium service - oil for helium Low outgassing, PC TFE (Oils)
compressors and lubricants C hemical inertness in
for helium regulators contact with reactive,
corrosive or explosive
liquids and gases
C arbon dioxide pump oil Low outgassing PC TFE (Oils)
C utting/drawing/forming oil PC TFE
for processing refractory
metals such as tantalum,
molybdenum, tungsten,
Metal- rhenium, titanium and
working niobium
industry Manufacture of woven wire C hemical inertness in PC TFE
(see A.3.5) and cable for safe use in contact with reactive,
aggressive applications corrosive or explosive
liquids and gases
Additive to other cutting oils PC TFE
for enhanced tool life
Machining of high nickel alloys PC TFE
Grease for swivel joints in C hemical inertness in PC TFE (grease)
Steel
oxygen delivery systems and contact with reactive,
industry
oxygen heating systems corrosive or explosive
(see A.3.5)
liquids and gases
Wastewater chemicals - PC TFE lubricants are PC TFE
lubricants that are compatible compatible with e.g.:
Water and with water treatment oxygen, ozone, hydrogen
wastewater chemicals that are used in peroxide, chlorine,
treatment chlorinators, pumps valves calcium hypochlorite,
etc. sodium hypochlorite and
chlorinated cyanurates

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Swimming pool chemicals - PC TFE lubricants are PC TFE
lubricants compatible with compatible with e.g.:
compacting equipment for calcium hypochlorite and
tableting swimming pool chlorinated cyanurates
chemicals
Lubricant encased within C hemical inertness Not specified
peristaltic pumps which are
used in applications of the
potable water industry for
chemical dosing
Diving Equipment with O 2 PFAS-based lubricants do PTFE
contact not react with oxygen
and thereby
lower/prevent the risk of
fire, autoignition and
explosion compared to
other types of lubricants
Diving
Valves, fittings, O-rings, Long-term stability and PFPE
equipment
pressure gauges in oxygen functionality are crucial
enriched environments
Diving gear Life-supporting systems PC TFE (oil and grease)
where an oxygen-
enriched atmosphere
(>23% O2) or high-
pressure air is required
Handicap Prosthesis, orthosis, Temperature resilience, PTFE
assistant wheelchair, exoskeleton etc.; chemically resistant,
equipment piston and gear wheel non-stick, not flammable,
(medical applications; Lubricant noise reduction
devices, additive in plastic components
see A.3.10)
Roller bearings of corrugated High temperature PTFE (3-100%)
paper machinery resilience PFPE (3-100%)

Lubrication processes in C hemical compatible with PC TFE


Paper
relation to pulp-bleaching chlorine, sodium
chlorine, sodium chlorate, chlorate, chlorine
chlorine dioxide, oxygen and dioxide, oxygen and
hydrogen peroxide. hydrogen peroxide
Polymer processing industry Temperature resilience, PTFE (5-30%)
(injection mould lubrication). low friction PFPE (5-30%)
Often micro-powder PTFE is
added as lubrication/polymer
processing additive to the
polymer before processing
Plastics
(internal lubrication).
Lubrication of ejector pins,
sliders, folding units and
sliding surfaces in plastic
injection moulding tools
(external lubrication).

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Lubrication on silicone cable PFPE is compatible with PFPE
accessories silicone
Bearings that support chains High temperature PFPE
that runs through an oven. resilience
Plastic films are generally
heat-treated in continuous
ovens at high temperatures
(>200 °C )
Rubber/ Lubrication of tire moulds to High temperature PFPE (grease)
tire reduce galling, roughing or resilience
industry warping at movable joints.
Bearings that support chains High temperature PFPE
that runs through an oven. resilience
Textile (see Textiles are generally heat-
A.3.3) treated in continuous ovens
at high temperatures
(>200 °C ).
Pharma- C lean room applications Low outgassing PFPE
ceutical (including robots in clean
industry room)
Dry-film lubrication of bike PTFE
Consumer chains
(see A.3.6) Dry-film lubrication of PTFE
Waterproof zippers
C hains, bearings/ball- Various PFTE
bearings/sliding bearings, PFPE
pivots, valves, and self- Various PTFE and PFPE
operated regulators combinations
Plain bearings for e.g. hinges,
seat recliners, vibration
dampers, chain tensioners,
shock absorbers, pumps,
ropeway suspensions, etc.
Other All kinds of industrial
sectors and machines with moving parts
industrial Valves
application Dry lubrication for assembly
s not of bolts, screws nuts and
specifically joints in general
mentioned Various 'oxygen service'
above b applications, i.e., lubrication
in systems with a high risk of
contact with high oxygen
concentration (e.g. when
applying some types of
pumps).
Mechanisms and devices
under high vacuum
Offices machines, including
heaters and printers

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Branch / Application Properties PFASs (and


sector concentration
examples provided by
stakeholders)
Power tools
Lifts and escalators
a
"NSF-H1" is an approval system for food-grade lubricants.
b
Agriculture, construction, fluid power, process industries, robots and robotics, 3D printing at industrial
scale, power and energy distribution, district energy and building automation, metallurgy and mining,
marine equipment, pulp and paper, machinery sector (e.g. snow blowers, lawn movers, gears and belts
of conveyers)

A.3.15.1.11. Name and other identifiers of PFASs used in lubricants

Based on input from stakeholders and information from literature (Glüge et al., 2020) 38
PFASs was identified at being in use or used at some point in lubricant applications. Glüge et
al. (2020) further identified three PFASs as being patented for use in lubricant applications.

Of the 38 PFASs identified at being in use or used at some point in lubricant applications 19
are polymeric PFASs (15 PFPEs, four fluoropolymers and one other), 18 are non-polymeric
PFASs (15 non-ionic and three ionic) and one substance is considered as unknown, as no
information was available on its chemical identity.

Six of the 15 identified PFPE are used as base oils in lubricants and two are used as additives.
For the last seven identified PFPE, the properties in lubricants is not available.

Most of non-polymeric PFAS-based solvents identified are fluorinated liquids often called
functional or engineered fluids. These substances are also mentioned in section A.3.9 and
A.3.10.

In Table A.107 of the appendix examples of PFASs used in lubricant applications are provided.

A.3.15.2. Volumes

In Table A.60 the estimated annual volumes of PFASs in lubricant uses in the EEA is given.
The estimates are primarily based on input from stakeholders.

Table A.60. Estimated PFASs volumes in lubricants used in the EEA in 2020.
PFAS use Volume (t/y) Comments
Range Midpoint
This covers only PFPE base oils as no
information on the volume of other
Base oil 300 - 800 550
PFASs-based base oils like PC TFE
and fluorosilicon oils was received.

Micro-powder PTFE
800 – 1 200 1 000
additive

Other additives than


1 - 10 6
PTFE
PFAS-based carrier
and deposition 35 - 75 55
solvents
PFAS-based cleaning
35 - 75 55
solvents

Total PFASs 1 171 – 2 160 1 666

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Wood (2022) estimated the total quantity sold in the EEA of fluoropolymers used in lubricants
to be 1 500 t in 2020 which is higher than for fluoropolymers (PTFE) in Table A.60.

According to information received from an industry stakeholder, between 1 000 and 5 000 t
fluorinated lubricants are produces in the EU per year. Note that this volume includes other
components than PFASs.

No data has been identified to quantify in any detail the share between formulation, import
and export of lubricants containing PFASs, although one estimate is that about 90% of
lubricants used in the EU are manufactured in the EU. This estimate has been challenged by
stakeholders in the second stakeholder consultation based on the high PFPE manufacturing
capacity in EU (Solvay Solexis (Italy)). A stakeholder also states that: “In recent years, there
has also been an uptick in the EU import ation of PFPE base oils from emerging Chinese
producers”.

Further it shall be noted that there is international trade in articles containing PFASs-based
lubricants (in cars, pumps, bearings, etc.). No quantitative data on these trade aspects have
identified or received.

A.3.15.3. Summary

Because of the wide range of properties, PFASs are widely used in lubricants, either as (part
of) base oils (PFPEs and PCTFE), as micro-powder additive (PTFE), or in very low volumes as
other additive (wide range of PFASs) or as a solvent. Stakeholders report an estimated annual
PFASs use of between 1 200 and 2 200 t (rounded numbers). Approximately one third of the
PFASs used are (part of) base oils and two thirds are micro-powder additives.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.16. Petroleum and mining

A.3.16.1. Uses

Because of the vast range of properties PFASs are also used in the petroleum and mining
industries. A summary for the general public was made available (NEA, 2021a).

First the uses of non-polymeric PFASs are described for both the petroleum and mining
industry followed by the uses of polymeric PFASs.

A.3.16.1.1. Use of non-polymeric PFASs in petroleum industry

The uses of PFASs in the oil and gas industry, as discussed by Glüge et al. (2020), and defined
according to the OSPAR0F 38 categorisation of chemicals used in the oil and gas sector, are
the following:

 Drilling fluids: Fluorinated surfactants act as a foaming agent that initiates and extends
the fractures in the formation. Stimulation chemicals: fluorinated surfactants have
become more commonly used in enhanced oil and gas recovery (EOR) to support the
displacement of the oil/gas from the underground sand and rock formations.
 Production chemicals: PFAS-based products are commonly used as anti-foaming
agents.
 Water and gas tracers: PFAS-based tracers are used as water and gas tracers to map
oil and gas reservoirs. They are considered low risk and can be detected at extremely
low concentrations.
 Other uses: Evaporation of liquid fuels (e.g. gasoline) can be prevented by an aqueous
surface film containing anionic surfactants, including PFAS-based chemic als (Glüge et
al., 2020). The same properties may be exploited in the containment of gas and oil
within transport of petroleum produc ts. However, this has so far not been confirmed
in active use in Europe. Oil spills on water can be contained and prevented from
spreading by a chemical barrier consisting of a fluorinated surfactant (Glüge et al.,
2020). Further minor use of PFAS as extraction solvents in analytical equipment for oil
content analysis has been identified.
 EOR may be performed after production in a well has already been conducted for a
while in order to support the displacement of the oil or making it easier to flow by
altering its properties and thereby increase the production. Data collected during the
consultation indicated minimal use of PFASs for enhanced oil/gas recovery stimulation
products in Europe. There are no identified products currently on the market for this
application.

A.3.16.1.2. Use of non-polymeric PFASs in mining industry

In the mining sector, PFASs (including both PFCA salts and PASF compounds) a re reported to
have been used, for example to increase the extraction efficiency in copper and gold mining.
Based on the Glüge et al. (2020) review, the specific functions provided by PFAS in the mining
sector include the following:

 Use as an acid mist suppressing agent in mineral recovery.


 Agents to increase wetting of the sulfuric acid or cyanide used to leach ore, enha ncing
the amount of metal recovery.
 Use as hydrocarbon foaming agent .
 Fluorinated surfactants used in ore floating to create stable aqueous foams to separate
the metal salts from soil.
 Use in the recovery of metal salts from aqueous solutions.

38
The Oslo and Paris convention for the Protection of the Marine Environment of the North -East
Atlantic.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

It is unclear to what extent these practices are currently required/utilised in Europe and hence
if/which PFAS compounds are currently being used for these applications. It has been
indicated, based on input by industry, that non-polymeric PFASs are not being used widely in
the mining sector in Europe. However, no further input has been received to definitively
confirm the level of ongoing use, and the specific application of PFASs in this sector.

A.3.16.1.3. Uses of fluoropolymers in the petroleum industry

A wide range of fluoropolymers such as fluoroplastics and fluoroelastomers are identified as


being used in the oil and gas industry. The most common use for these materials in this sector
is in the components of the equipment and piping used in extraction, transport and storage
of petroleum resources.

Oil and gas transport and storage equipment

Pipes and tubes used in the production and transportation of oil are generally large and for
economic reasons are typically manufactured from carbon steel rather than more expensive
corrosion resistant alloy (Glüge et al., 2020). Lining the interior surface of oil well pipes with
fluorocarbons, such as PTFE, can help to prevent or reduce oil-induced corrosion, caused by
its acidic nature. Lining the exterior of offshore pipes also protects them from corrosion
through sea water. Furthermore, fluoropolymers are used in leak proofness layers for flexible
pipes conveying oil or gas and for elastic tubes for submersible pumps.

Fluoropolymers are widely used in the equipment and piping used in extraction machinery or
infrastructure. Based on the input from industry (manufacturers, suppliers, and downstream
users, through CfE responses and further consultation), the main uses for fluoropolymers
include the production of the following components used in oil and gas extraction equipment.
In Table A.61 a summary of uses in the petroleum industry is given.

Table A.61. Main PFASs uses in petroleum industry.


Examples of sub-uses of fluoropolymers in the petroleum industry

 Lining of piping, flowmeters and fittings,  Filtration equipment (e.g. HEPA filters - a
compensator joints, fluid-handling synthetic composite with ‘expanded’ PTFE
components, process vessels, tanks, storage membrane)
and transport containers
 Flexible risers and flowlines  Vibration dampers
 Liners in the high-pressure lines used in  Packer elements
offshore choke and kill systems
 Seals used in downhole drilling operations  Pneumatic actuators, pneumatic regulating
(e.g. flange sealing applications, wellhead devices
and C hristmas tree equipment)
 Valve bodies  Blow-out preventors
 Valve packing  Stators and “mud motors”
 Valve seals, elastic tubes  Submersible pumps
 O-rings  Pump liners
 Pipe gaskets  Packaging vents – leaking and rupturing
 C apacitive sensors and their connecting  Dispensers, nozzles, compressors
cables
 Ball valves,  Subsea hydraulic couplers
 Fluid transfer equipment  Heat exchangers
 Flexible pipes

The key functional property that makes fluoropolymers important in this sector is the extreme
durability and capability of maintaining their form and mechanical strength and corrosion

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

resistance under the extreme environments found in down hole drilling (e.g. high
temperature, high pressure, presence of steam and harsh chemicals).

Fluoroelastomers have elastomeric properties resulting from crosslinking at molecular level.


Fluoroelastomers are widely used to produce components (e.g. seals, liners, valves, O-rings,
gaskets and packer elements). Other properties include e.g. rapid gas decompression
resistance, extrusion resistance and resistance to compression fluids.

Cables

Polymeric PFASs are used in the cable insulation for communication cables in oil and gas
drilling. For example, the resistance of several fluoropolymers to harsh chemicals and heat
have allowed them to be used and marketed in numerous wire and cable applications in the
onshore and offshore oil and gas sector, including electrical downhole cables, fibre optic
downhole cables and hybrid electric/fibre cables. Cable insulation made from PFA, PVDF, FEP
or ETFE can withstand extremely high temperatures near the bottom of the well.

A.3.16.1.4. Use of fluoropolymers in mining

There are indications of fluoropolymer use (fluoroplastics and fluoroelastomers) in the mining
sector in Europe. However, very limited input from the mining industry was provided.

The key applications for which PFAS-based chemicals are used in the petroleum and mining
industries are summarised in Table A.62. While it is expected that PFASs will be used in
refineries of petroleum products, no data was available on current products, or their volumes
of use in Europe in the CfE. It is not clear if refineries are covered by the use category of
chemical processing where the use of PTFE gaskets for petroleum refineries ( e.g. Philips
alkylation process) has been noted.

Table A.62. Summary of polymeric PFASs used in the petrole um and mining industries.

Use Sub-use a Property

Drilling Fluorosurfactants and anti-foaming agents


fluid/production
chemicals b
Stimulation Enhanced oil/gas recovery stimulation products
chemicals
Petroleum exploration Water and gas Tracers used to map oilfields
and production tracers
Other C hemicals used in the storage or containment
of oil and gas
Fluoropolymer used in pipeline, valves,
gaskets, O-rings, seals, cable and wiring
insulation, flexible pipes
Extraction of ores Acid mist suppressing agent
and minerals Wetting agents
Hydrocarbon foaming agent (Flotation)
Mining applications c Fluorinated surfactants used in ore floating
(Flotation)
Equipment Fluoropolymer used in pipes, cables, hoses,
conveyor belts, gaskets, bearings, membranes
a For petroleum extraction, as defined under the Harmonised Mandatory C ontrol System under OSPAR

Decision 2000/2. This does not apply to mining.


b Referred to as ‘C hemicals used in the actual production and processing of hydrocarbons’ under OSPAR
c Uses not covered under OSPAR Decision 2000/2.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A variety of PFASs (non-polymer PFASs, fluoropolymers) are used in petroleum and mining.
Around 100 substances (with and without CAS numbers) are identified in this sector. The list
of PFASs used in this sector is not provided here as it is partly reported in the Glüge et al.
(2020) recent publication and partly due to Confidential Business Information.

A.3.16.2. Volumes

For the forward-looking trends (2020-2050), it is noted that petroleum production is expected
to decline significantly in Europe over this period (Table A.63). It is, however, noted that the
demand for PFAS-based tracer and anti-foaming agents and fluoropolymers is expected to
increase in future years due to harsher conditions for future oil and gas exploration and
production applications.

Table A.63. Baseline projections (including UK) for volumes of PFASs and fluoropolymers
used (t/y) in the petroleum and mining sector.
Compound Estimated volume of PFASs (t/y)
1990 2000 2010 2020 2020
range midpoint
Water and PFAS-based 0.0 0.3 0.6 1.0 1.0
gas tracers
tracers
Production Fluorosiloxane- 0.0 1.1 - 2.8 2.3 - 5.6 3.4 - 8.5 6
chemicals based
antifoaming
agents
Fluoro- - 2 000 - 2 500 - 3 000 - 3 500 – 5 500
polymers 4 300 5 400 6 400 7 500
(all)

A.3.16.2.1. Water and gas tracers

According to stakeholder information fluorinated alkanes are used as tracers in certain cases,
depending on reservoir characteristics and the range of other tracers used. Industry input
notes that such tracers are used sporadically in small (10-15 kg) quantities39. Additional data,
provided by national authorities on the basis that the chemical identity of the tracers is
confidential, demonstrates that other PFAS-based compounds are also used as tracers in the
oil and gas sector in quantities at about 1.0 t/y. Hence, the volumes of PFAS-based tracers of
confidential identity represent the main bulk (ca. 99%) of PFAS used for this application, and
a total volume of use is estimated at 1.0 t/y.

A.3.16.2.2. Production chemicals

Information on the volumes of production and sales of fluorinated polysiloxane-based anti-


foaming agent products in Europe has been provided by a small number of suppliers (two) as
part of the CfE. In the absence of information of the current market share of hese suppliers,
it has not been possible t o produce an estimate for total levels of production and sales of
these products on the European market. However, data has been provided from national
authorities to allow an estimate of current total volumes of use in Europe is ~170 t/y.

39
https://www.bp.com/en/global/corporate/energy -economics/statistical-review-of-world-
energy.html, date of access: 2022-12-16.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.16.2.3. Stimulation chemicals

Very little information on specific oil/gas well stimulation products currently being marketed
and sold in the EU has been obtained. Information on current production or use of these
products in Europe was not divulged in any responses to the CfE. When manufacturers or
suppliers were contacted in direct consultation they did not know if these products were
currently being marketed or used. Therefore, t o the best of knowledge of the Dossier
Submitters the use of PFAS-based products for well stimulation is likely to be minimal in
Europe.

A.3.16.2.4. Fluoropolymer applications

Based on stakeholder input from one supplier a very approximate estimate has been derived
for the use of fluoropolymers in the sector at 3 500 to 7 500 t/y in 2020. Estimates for historic
use volumes of fluoropolymers were developed with basis in the assumption that
fluoropolymer use in 1950 was 0 and that the trend in levels of sale have grown with linear
progression from 0 kg in 1950 up to present volumes in the 2020 baseline. Very little
information on volumes of fluoropolymer products specific for petroleum and mining are
available. However, in the consultation one stakeholder commented that the estimated
volumes might be underestimated.

A.3.16.3. Summary

Because of the vast range of properties PFASs are widely used in the petroleum and mining
industries. In petroleum exploration and production PFASs are used as e.g. drilling/fluid
production chemicals, stimulation chemicals and water and gas tracers. A wide range of
fluoropolymers are identified as being used in the oil and gas industry. The most common use
is in the components of the equipment and piping used in extraction, transport and storage
of petroleum resources. In mining, PFASs are applied for e.g. extraction of ores and minerals
and in several equipment (e.g. in pipes, cables, hoses and membranes). A very approximate
estimate has been derived from this assessment, suggesting the estimated total sales of
fluoropolymers in Europe in 2020 for use in the pet roleum and mining sector is 3 500 to
7 500 t/y.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.17. Active substances in Plant Protection Products (PPP), Biocidal


Products (BP) and Medicinal Products (MP)

A.3.17.1. Uses

Active substances in Plant Protection Products (PPP), Biocidal Products (BP), and Medicinal
Products (MP) are considered being somewhat different chemically from other PFAS
subgroups. Generally, these active substances are substances that are characterized by the
presence of one or more CF 3-group(s) in their molecular structure 40, mostly aromatics.
Introducing this group in the molecular structure of biologically active substances could alter
specific properties, such as stability and lipophilicity.

A side effect of the introduction of the CF 3-groups in the molecular structure, is that
metabolites and/or degradation products can be formed that are extremely stable and
potentially hazardous. Trifluoroacetic acid (TFA) is one of the possible major
metabolites/degradation products for these types of substances. TFA is extremely persistent
in the environment.

In this chapter an overview is given of active substances in PPP, BP and active pharmaceutical
ingredients (API) in MP, regulated in the EU by their respective regulations (Table A.64).

Table A.64. Active substances in PPP, BP and MP and their respective regulations.
Uses Legislation

Active substances in plant protection products Regulation (EC ) No 1107/2009 (PPPR)

Active substances in biocidal products Regulation (EU) No 528/2012 (BPR)

Active pharmaceutical ingredients (API) in Directive 2001/83/EC (human); Regulation


human and veterinary medicinal products (EC ) 726/2004 (human and veterinary)

To provide an impression of the amount of PFAS used as active substances in MP, PPP or BP,
a non-exhaustive overview of these substances is given in Table A.108 to Table A.110 in the
Appendix:

 A search for PFAS within the scope of the current chemical definition yielded 48 hits
for active substances in PPP (see Table A.108). Some of them are listed being active
substances in PPP as well as in BP.
 A search on ECHA’s webpage for EU biocidal active substances containing fluorine
yielded nine biocidal active substances that fulfil the current PFAS definition. These
substances are currently approved as biocidal active substances and include the
product types PT18 (insecticides), PT08 (wood preservatives), PT14 (rodenticides),
PT07 (film preservatives), PT09 (fibre, leather, rubber, polymer preservatives), PT10
(building material preservatives), and/or PT 21 (antifouling agents) (see Table A.109).
 A search for substances following current PFAS definition, yielded 65 medicinal
products authorised in the EU. It is also indicated whether the medicinal product
appears on the WHO essential medicines list. The anatomical/therapeutical group
(assigned by WHO) and CAS no are added. The ATC is a drug classification system
that classifies the active substances of medicinal products according to the organ or
system on which they act and their therapeutic, pharmacological, and chemical
properties (see Table A.110).

40
C o-formulants present in PPP, BP, and MP may also be defined as PFAS. These substances are not
covered here.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

A.3.17.2. Volumes

These substances will be shortly mentioned, but no detailed information on volumes,


emissions and alternatives will be collected and assessed since in Annex E the proposal is
outlined to exempt these regulated substances from the restriction.

As indicated in Table A.65, a rough estimation of less than 5% of total PFASs is the already
regulated PPP, BP and MP: 0.2% for active pharmaceutical ingredients in medicinal products
and 2% for the active substances in plant protection products. No data was available on active
substances in biocidal products.

Table A.65. PFAS numbers, used as active substances in PPP, BP, and MP.
Use Amount EU Details and assumptions
Human use numbers, prescribed medicines, numbers are
extrapolated to EU based on number of inhabitants.

PFAS Active
At human use, the non-prescribed medicines (also known as
Pharmaceutical >500 t/y
over the counter (OTC ) sold medicines) are not considered.
Ingredients
This estimation is on human use only.
(API) in >0.2% compared to
human total PFAS
Per- and polyfluorinated gases used in propellants are not
medicines
included. When a substance is used as propellant it is not
considered an API. Whereas when the same substance is used
as an anaesthetic, it is considered an API.
PFAS Active No information on volumes is available.
Pharmaceutical
Ingredients
(API) in
veterinary
medicines
 Rough estimation based on ratio of PFAS PPP/total PPP in
NL times total PPP in EU.
PFAS active
o Total PPP in NL (2019) is 9 294 t/y (according to
substances in 5 479 t/y
The Netherlands Food and C onsumer Product
Plant 2% compared to total
Safety Authority (NVWA))
Protection PFAS
o PFAS PPP in NL (2019) is 152 t/y (1.6% of total
Products
PPP in NL) (NVWA)
o Total PPP in EU is 335 000 t/y (Eurostat)
PFAS active No information on volumes is available.
substances in
Biocidal
Products

A.3.17.3. Summary

PFASs used as active substances in PPP, BP and MP are generally characterized by the
presence of one or more CF3-group(s) that have been introduced in their molecular structure
to alter properties such as stability and lipophilicity. At least 48 active substances in PPP were
identified as PFASs, 9 active substances in biocidal products in various PT groups and 65
active substances in medicinal products. However, these active substances were exempted
from this assessment. Based on extrapolated data from the NL on use and prescribed
medicines, volumes are estimated to be >500 t/y for API in human medicines and for active
substances in PPP the volume was estimated to be 5 479 t/y. No data was available for BP
and veterinary medicines.

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A.3.18. Waste

A.3.18.1. Introduction

REACH does not cover substances, mixtures and articles when they enter the end-of-life stage
and become waste. However, the methodology for the REACH identification of risks of a
substance for the environment and human health should take the waste stage into
consideration (ECHA, 2010).

Waste stage is the end-of-life stage. There will be delay between production and waste stage:
Products put on the market will, depending on the substance/mixture/article lifetime, enter
the waste stage (far) later. Applications with longer lifetimes i.e., passenger cars or
construction material might have highly deviating waste quantities compared to production
volumes in the same year. Also, EEA import/export disbalances might lead to deviating waste
tonnages compared to production tonnages.

For destruction or recovery of fluorinated gases (partly) specific regulations exists and it must
be reported to EU as part of the F-gas regulation (UBA, 2021). When pric es rise, recovery
and reclamation become more important. Generally, waste streams for small residential
appliances such as small air conditioning units, differs from the end‐of life treatment for large
commercial and industrial systems: For the smaller appliances collection, storage and
treatment is organized under WEEE regulation. For the larger systems certified technical
personnel is needed for the mandatory recovery of the Fluorinated gases according to the F‐
gas Regulation.

Specific regulation does not exist for PFASs other than F-gases/fluorinated gases.

In this section an overview of waste collection and waste treatment is provided. Objects or
substances that have become waste are not within the scope of REACH. However, PFASs in
waste are important for the identification of risks of a substance for human health and the
environment. The information in this section is based on information from the individual
studies (volumes) in A.3.3 to A.3.17.

To identify waste streams that contribute most to human and environmental exposure the
following factors are of relevance:

 Waste streams with high volumes in the EU/EEA


 Waste streams with high average PFAS concentration or freight.
 Waste streams with high recycling rates.
 Waste streams with high releases into the environment (landfilling, land application,
recycling).

A.3.18.2. Fate of waste from use sectors

The following four use sectors of PFASs were therefore studied in more detail:

1. TULAC (textiles solely)


2. Food contact material and packaging (paper & board solely)
3. Electrical and electronic equipment (WEEE)
4. Transport: End-of-life-vehicles (ELV)

Other uses also reach the end-of-life stage. For some uses the solid waste stage is less
relevant i.e. because of most emissions are expected during use. See Table A.66 and Table
A.67 below. This applies for ski wax, consumer mixture, metal plating and cosmetics for
instance. The latter two will have emissions but mostly directly via water to WWTP. Uses,
other than the 4 mentioned above, are not elaborated on in detail, but waste stage emissions
in Annex B.9. will calculated using ERCs.

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Table A.66. PFAS entering the solid waste stage. In light green the uses for which the waste
stage is described in more detail because it is considered of higher relevance.
PFAS use Polymeri Fluorinat PFAAs Open Articles
c PFASs ed gases application (high relevance for
(low PFAS load waste stage &
entering waste recycling if ticked)
stage)
Lubricants x x x
TULAC x x x
Food contact x x x
materials and
packaging
C onsumer x x
mixtures
C onstruction x x x
products
C osmetics x
Metal plating x x
Ski wax x
Transportation x x
Petroleum & x
Mining
Medical x x x x x
applications
HVAC R x x x
Electronics, x x x x
semiconductor
Energy x x x

Table A.67. PFAS tonnages entering the solid waste stage (t/y in EEA).
Use Tonnages enter solid
waste stage (t/y)

TULAC 50 853

FC M & packaging 24.565

Manufacturing of metal 984


products and metal
plating

C onsumer mixtures **

C osmetics **

Ski wax 1

HVAC R decommissioning 19 724

Medical devices 8 500

Transport 6 410

Electronics and semiconductors 3 752

Energy* 2 995
C onstruction products 6 495

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Use Tonnages enter solid


waste stage (t/y)

Lubricants 1 447

Petroleum and mining 1

PPP, BP and MP **

*: Waste from the energy sector is expected to sharply increase as many of the first windmills from 20-
25 years ago are currently replaced. A mount of accruing blade material from stripping down wind
turbines in Germany alone: 20 000 t/y. (Windmill blades are often coated with fluoropolymers ). For
solar panels the same is applicable: Sharply increasing waste volumes. (And solar panels front - and
back sheet are often coated with fluoropolymers).
**: Waste stage emissions of lesser importance (use phase emissions of most importance) .

Additionally, PFASs in sewage sludge were investigated as this is a potentially important


indirect source for PFAS emission in the waste stage.

Finally common waste treatment methods, which are applicable for almost all PFAS uses,
haven been studied: landfilling and incineration. Next to that also land application/composting
and recycling have been studied. Emissions from waste treatment (waste collection emissions
exempted because of lacking data) are mentioned in Annex B.9.

A.3.18.2.1. Waste collection

Waste is collected by private or municipal waste collection services. Via bins and containers
waste is loaded on/into trucks and lorries and transported to pre -sorting/waste transfer
stations or directly to final treatment such as landfilling or waste incinerators.

For PFAAs the production waste of PFAS manufacturers is of importance as was seen in the
Netherlands where PFAA/PFASs polymerization aids were spread broadly via waste collection
companies. For fluorinated gas appliances collection specific regulations exist as mentioned
above.

For end-of-life fluoropolymer applications, commercial and industrial waste streams are the
most relevant. A smaller proportion of fluoropolymers ends up in municipal waste. In Figure
A.21 an overview of fluoropolymer waste is plotted based on data of PlasticsEurope
(Conversio, 2022). The chemical industry, automotive, electronics & semiconductor and
Medical & Pharma are the largest contributors to fluoropolymer waste in Europe (Table A.68).

Statistical gaps exist between officially collected waste and waste generated.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Figure A.21. Fluoropolymer waste collection in Europe (2020) and main sectors based on
stakeholder information.

Table A.68. Collected fluoropolymer waste in Europe in 2020 per industry segment.
Industry segment Collected fluoropolymer waste in 2020 (in kt)

Transport (automotive only) 3.5

Aerospace 0.3

Electronics & semiconductor 2.7

Medical & Parma 2.3

C hemical industry 9.4

Other 5.3

TOTAL 23.5

A.3.18.2.2. Textile waste

Watson et al. (2018) estimated that an average of 36% of textile is collected separately, in
seven EU countries (DE, DK, FR, IT, NL, SE and UK, years assessed 2010-2016).

The overall amount of textile entering a specific waste treatment option cannot be determined
precisely e.g. because of a lack of data on the share of textile waste in “Health care and
biological wastes”. A high share of textiles enters “Household and similar waste” (64% are
not collected separately). Most of this waste category is incinerated (with or without energy
recovery) or is disposed of in landfills. It is therefore assumed that the largest proportion of
textile waste is treated accordingly. In line with this, it was stated by Boiten (2021) that 87%
of the total fibre input in Europe is ultimately destined for landfill or incineration, with
significant leakages into natural environments.

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Generally, it must be noted, that apparel and other textiles which are reused can contribute
to the global distribution of PFASs. Considering the average lifetime of textiles and apparel,
it can be estimated that if a full ban of PFASs was to take place in 2025, PFAS concentration
will still be present in waste streams until 2037 and beyond, dependent on the increase of
recycling.

Export of second-hand textile outside EEA is likely also of relevance.

A.3.18.2.3. Waste from FCM – paper and board packaging

The yearly EEA quantity of PFAS used in paper and board packaging was estimated between
827 and 4 962 t, based on intentionally added PFASs (Hollins, N/A).

According to a stakeholder “PTFE coated/printed materials need to be correctly collected,


sorted and recycled. In recycling processes PTFE waxes should be removed before releasing
washing water into the environment “. As PTFE is persistent, it likely stays either in the
recycled paper or aluminium and/or is released to water. Non polymeric PFASs are also likely
to be present in lacquers and ink applied to (food contact) paper.

The average lifetime of food packaging can be assumed to be around one year based on
information on plastic packaging (Conversio, 2018), but could be higher for other applications
such as cupcake forms.

Depending on the food collection system in place within the country and sometimes the
municipality, the collection of these items can differ. Food-contact articles and thermal paper,
wet-proof and/or greaseproof impregnated and/or glued paper and cardboard 41 shall be
disposed of in the residual waste in Germany (UBA, 2020c). Similar approaches are assumed
for other European countries as paper for recycling must be kept separate from other waste
as contaminated papers are not acceptable for recycling (EPRC, 2021).

The reality, however, can differ, and items can be and are partly disposed of via the separately
collected paper waste.

Within Eurostat “Paper and cardboard waste” encompasses waste from paper and cardboard
packaging (15 01 01) as well as paper and cardboard waste from mechanical treatment (19
12 01) and separately collected fractions (20 01 01) (EC, 2010). Considering the findings on
the littering of plastic waste from UBA (2020b) it is not unlikely, that part of PFAS-containing
paper and cardboard waste fractions are not accounted for in Eurostat waste data as they
enter into the environment directly via littering.

Within Eurostat, the waste fraction “Household and similar waste” contains bulky waste (20
03 07) as well as street-cleaning residues (street-cleaning residues). Based on Eurostat data
from 1990-2001 bulky waste presents a share of on average 8% of household and similar
waste. This is based on data reported for 2000 and 2001 for several European countries
(European Communities, 2003).

In the “Paper and Cardboard” waste stream all of the waste amount in EEA is treated by
recovery through recycling (see Appendix), except a minor amount in Western Europe that is
recorded under energy recovery (R1). Considering that FCM packaging end up in the paper
and cardboard waste stream to a limited extent, it is likely, that a large share of FCM is either
landfilled, incinerated or composted if it is disposed of as residual waste.

With regards to the fraction of paper in household waste (see Appendix), the Netherlands

41such as posters, coffee-to-go cups, fast food wrappers, baking paper, muffin forms as well as solid,
empty paper packaging such as pizza cardboard packaging, varnished, glazed or chromo papers, and
boards produce with plastic varnishes or films as well as papers with adhesives applications which
cannot be easily separated such as sticky notes, self-adhesive seals for envelopes.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

report around 20% of the paper in the household residual waste based on samples taken
(Rijkswaterstaat, 2017). Germany states that around 5.2% of the residual household waste
corresponds to waste paper, other European countries indicated shares of around 21 to 30%
of the paper in residual waste (BMUV, 2020; Zero Waste Europe, 2020). Based on the
calculated average, as no information on all EEA countries is available, an average share of
paper and cardboard in the household/residual waste of 19% can be assume d.

Considering the average lifetime of FCM and especially paper and board packaging, it can be
estimated that if a full ban of PFASs was to take place in 2025, PFAS concentrations will likely
decrease within a few years depending however on paper recycling.

A.3.18.2.4. WEEE

The quantity of PFAS used in WEEE including the semiconductor and the energy industry is
estimated with a midpoint of around 5 800 t/y. Substances regulated under the F-gas
Regulation were not considered within this estimation.

With regards to exports, a study conducted by the Basel Coordination Centre for Africa (BCCC)
and the United Nations University (UNU) found many incorrectly or completely undeclared
WEEE exported to Nigeria during the research period (2015 to 2016). Appropriate disposal or
recycling leading to the destruction of the PFAS content is not necessarily ensured in the
importing countries. Thus, the disposal of WEEE in recipient countries may contribute to the
global distribution of PFASs and thus to possible risks to human health and the environment.

The WEEE Directive currently does not contain any explicit provisions or requirements
concerning PFASs. Furthermore, despite the applicable regulatory framework of the WEEE
Directive, illegal or unsound treatment may take place, creating a risk of emissions of PFAS
contained in WEEE into the environment.

Finally, while Regulation (EC) No 1013/2006 on shipments of waste prohibits the export of
WEEE to non-OECD countries for recovery, recycling and disposal, illegal export can occur
(Odeyingbo et al., 2018). WEEE which is illegally transported to non-OECD countries could in
turn undergo unsound treatment methods leading to emissions of PFASs and risks to the
environment in these countries.

In some cases, batteries will be treated together with the WEEE categories as batteries and
accumulators are installed permanently. However, batteries must be removed under Article
12 (3) of the Batteries Directive (Directive 2006/66/EC) 42 which in practice applies to some
applications (batteries in TV remotes). Data on the battery waste stream (alkaline, lead, Ni-
Cd and other batteries) has been considered. No assumptions were made on the possible
quantities of batteries within WEEE as information is lacking and batteries should be removed
prior to treatment.

Especially lithium-ion batteries are used heavily and the growth due to electrification of
transport is extreme. These batteries contain PVDF (a binder) in about 1-1.4%. In the end-
of-life stage risks related to toxicity and toxic emissions of lithium-ion batteries become
apparent and amplified. These emissions, inc luding PFAS emissions, are of high risks since
chemical transformation processes are not well understood. Incomplete combustion
(temperatures <850 °C) of fluoropolymer cathode materials but also fluorinated ingredients
in the electrolyte can lead to the formation of various persistent PFASs. Potential products of
the thermolysis of fluoropolymer binder (often PVDF or FEP) are: Short and long chain
perfluoroalkyl acids (PFAAs); and CF4 (Zackrisson and Schellenberger, 2020).

In the end-of-life stage the risks related to toxicity, fire and high voltage in the lithium-ion

42It is understood, that batteries and accumulators according to Article 12 should be removed but in
some applications, removal is not practically possible (permanently installed batteries) as such these
are assumed to be treated within the WEEE.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

life cycle become apparent and amplified. Lithium-ion batteries are a green technology but
contain different hazardous substances, that can be emitted especially during e.g. fire events.
These emissions are of high risks since chemical transformation proce sses are not well
understood so far.

Generally, the recycling and re-use of WEEE can contribute to the global distribution of PFASs,
especially if they are sold as used equipment to developing countries without appropriate
treatment capacities. The mechanism of extended producer responsibility (EPR) as laid down
in the WEEE Directive additionally enables Member States to lay financial and/or
organisational responsibility on producers of EEE concerning proper collection and treatment
of WEEE. A recent report by the ECA (2021)indicated that currently only two Member States
are on track to achieve the collection targets set for 2019 thereby putting the EU in danger
of not meeting its ambitious targets for the collection of WEEE. It should also be noted that
the WEEE Directive currently does not contain any explicit provisions or requirements
concerning PFASs.

A.3.18.2.5. End-of-Life-Vehicles (ELV)

As cars have a long average lifespan, cars sold many years ago may enter the end -of-life
stage today. Cars have an average lifetime of 17 up to 20 years (EC, 2019). As lower number
of cars were sold 20 years ago, the PFAS load entering waste stage from end-of-life vehicles
is lower than the PFAS tonnage (about 6 400 t) put on the market today. The PFAS load,
especially the fluoropolymer share in ELVs (usually around 12 years old), is significantly lower
compared to modern cars put on the market.

In 2019, almost 16 million cars were put on the market according to ACEA. The Heinrich Böll
Foundation’s European Mobility Atlas 2021 mentions that every y ear, around 12 million cars
leave European roads. Using Eurostat data for 2019, around 6.9 million ELVs were statistically
covered for EU27 + 1.6 million from the UK. This means that there are still large statistical
gaps between the total number of ELV leaving the European roads and the number of ELVs
officially collected.

The quantity of PFASs used in vehicles in the EU corresponds to between 6 000 and
14 500 t/y (see also A.3.11.3). This tonnage will grow strongly as in modern (electric) cars
more PFASs are used. Plastics Europe mentioned in their report on fluoropolymer industry in
Europe, that transport, as one of their key sectors, has the highest shares of fluoropolymer
sales in 2015 with 15 500 t (Wood, 2022). Within the U.S. transport is ranked as the second
most important sector in terms of production value following electronics (Fluoropolymer
Industry, 2018).

As most PFAS-applications in vehicles are textiles and polymer applications, the relevant
fraction in which PFASs from ELV end up are non-ferrous materials from shredding also
referred to as shredder heavy fraction (SHF) and the shredder light fraction (SLF). The SLF is
a mixed fraction and includes, for example, textiles, foams, plastics and plastic films as well
as broken glass, paint residues and wood (BDSV, 2012). Median values calculated based on
several literature sources indicate that a share of about 74% of plastics ends in the SLF.
Median values calculated for the SHF indicate a share of 4% of plastics (BKV, 2020; Martens,
2011; UBA, 2016; UBA, 2020a).

In the future, it is expected that the quantities of vehicles placed on the market will increase
(Kuhnert et al., 2018). Next to that a shift to electric cars or hybrid electric cars is expected.
In Germany, around 14% of all newly regist ered passenger cars in 2020 had an electrically
powered engine (battery-electric, plug-in, fuel cell) (KBA, 2021). On the European market,
the average share of new passenger plug-in electric cars lies at 11.4% in 2020 (Kane, 2021).
For relevant waste streams, this means increasing quantities of SLF and SHF.

Améduri (2020) estimated an increase to 1 – 2 kg PFASs/car in the future. With regards to


disposal, data do not indicate if this refers to incineration without energy recovery or simply

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

landfilling. In several Member States, it is still allowed to dispose of SLF in landfills other
countries require a pre-treatment of the SLF before landfilling (Mehlhart et al., 2018).
Generally, neither the recycling process nor landfilling destroys the PFAS content within the
relevant fractions. Both paths can contribute to the distribution of PFASs in the environment.

The Heinrich Böll Foundation’s European Mobility Atlas 2021 mentions that every year, around
12 million cars leave European roads due to total loss after an accident, economic write-off,
non-compliance or a change in design preferences. Up to two thirds of vehicles leaving the
European roads are handled in authorised recycling facilities. About one million cars are
exported as used vehicles to non-EU countries. It is unclear how the other ca. 3 million cars
are handled (Heinrich-Böll-Stiftung, 2021).

Figure A.22. A car's last journey. Source: European Mobility Atlas 2021.

A.3.18.2.6. Landfilling

A considerable part of the European waste is still being landfilled, but percentages vary a lot
among the European member states (more landfilling in Central and Eastern Europe) as well
as in time (declining landfilling share) (CMS, 2013). The percentages also vary among the
different waste types.

Many modern landfills are equipped with a plastic liner capturing the leachate. However, this
is not always the case for older landfills (Lang et al., 2017). In Europe the landfill directive
(1999/31/EC) stipulates, that all newly constructed landfills need to be equipped with “a
geological barrier and a bottom liner during the operational/active phase”, however it is
unclear how many landfills in Europe are currently equipped with liners.

According to Eurostat 96% of the landfilled waste was non-hazardous waste with only 4%
being hazardous, which is then deposited on the respective landfill. The exact number of
landfills and landfill types is unknown, however according to Eurelco there are an estimated
500 000 (former) landfills in Europe with 90% preceding the EU-landfill directive 1999/31/EC.
ECHA (2012) on the other hand provides default values for a landfill scenario stating that
there are approximately (active) 8 400 landfills in Europe from which ~400 are for hazardous,

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

~5 000 for non-hazardous and ~3 000 for inert waste. The data is however from 2006 and
should be used with caution. According to Eurelco is can be stated with reasonable safety tha
Europe host more than 500 000 (f) landfills 43.

Landfills have more or less a symbiotic relationship with Waste Water Treatment Plants
(WWTP) as landfills send leachate to WWTP and WWTP send sludge to landfills.

A.3.18.2.7. Incineration

According to the Fluorpolymer Group (a subgroup of Plastics Europe) more than 50% of the
fluoropolymers in the market stays in use for many years. Overall ~23 kt of fluoropolymer
waste was disposed of in 2017 according to the Fluoropolymer Group of PlasticsEurope

Incineration of PFAS containing waste is currently seen as the most effective treatment option
for (party) destroying PFASs. The fluorine in the PFASs will end up in either the botto m/fly
ash or the flue gas. Incineration has been used as a method of destroying other halogenated
organic chemicals such as polychlorinated biphenyls (PCBs) and ozone -depleting substances
(ODSs). High temperatures and long residence times break the carbon-halogen bond, after
which the halogen can be scrubbed from the flue gas. PFAS compounds are however more
difficult to break down due to fluorine’s electronegativity.

The Confederation of European Waste-to-Energy Plants (CEWEP) reported 4 992 waste-to-


energy (WtE) plants which treated a total of 96 million tonnes of waste thermally in 201944.
According to the waste incineration (WI) BREF there were 470 municipal solid waste
incinerators in Europe in 2019 with a total capacity of 87.44 million t/y (JRC, 2019). The WI
BREF reported 121 hazardous waste incinerators in Europe in 2019 with a total capacity of
6.75 million tonnes of waste per year, however the exact incineration conditions are unknown.
Table A.69 summarises this information.

Table A.69. Summary of numbers and capacity of European waste incinerators .


Source Number of non- Number of hazardous Capacity/incinerated
hazardous incinerators waste incinerators waste [million t]
PRTR 472
C EWEP 492 96
WI-BREF 470 87.44
WI-BREF 121 6.75

A.3.18.2.8. Recycling

Europe is striving to achieve a circular economy and to increase its circular material use rate.
Products from recycled materials are only possible if substances of concern, such as PFASs,
are avoided in products as much as possible. This is usually not the case in the typical
recycling processes of the considered waste streams. Hence, PFASs are often maintained in
the economic cycle and may pose an obstacle to produce safe products from recycled
materials. Especially paper & board, plastic packaging and WEEE waste streams are relevant
from a recycling perspective.

A.3.18.2.9. Sewage sludge from urban wastewater treatment

Sewage sludge is generated in WWTP by separating undissolved particles from water, which
is done in lagoons or basins. As WWTP receives waters from urban and industrial sources

43 https://eurelco.org/2018/09/30/data-launched-on-the-landfill-situation-in-the-eu-
28/#:~:text=With%20a%20reasonable%20safety%20level,the%20Landfill%20Directive%20(1999),
date of access: 2022-12-16.
44 https://www.cewep.eu/waste-to-energy-plants-in-europe-in-2019/, date of access: 2022-12-20.

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

sludge can contain PFASs originating from the production and use phase of PFAS products
(e.g. cosmetics).

The most recent data was used to calculate the amount of sewage sludge for the EEA.
Moreover, it must be noted, that the data reported within Eurostat on production does not
align with the volumes treated as waste, which was also found by Bianchini et al. (2016) who
highlighted the structural lack of homogeneity and reliability on the Eurostat data on sewage
sludge.

Generally, the total quantities fluctuate slightly but remain between 5.78 and 6.53 million
tonnes per year since 2011. Within the EEA sewage sludge from urban wastewater treatment
is disposed of or recovered (land application) in roughly equal proportions.

Bianchini et al. (2016) reported, that due to the Landfill Directive (1999/31/EC) amounts of
sewage sludge disposed of in landfills will rapidly decrease in upcoming years as Member
States reduce the amount of biodegradable waste sent to landfills by 2016.

In Eastern Europe, an increasingly larger percentage of households connected to treatment


plants can be expected. Here, agricultural use of the sludge is still considered as the preferred
disposal method. The reuse of biosolids as soil improver/fertilizer in arable crops represented
the most used disposal/recovery option in some European countries. This has led to
restrictions in the use of biosolids with Directive 86/278/EEC. However, an evaluation of the
directive in 2014 has found shortcomings also with regards to contaminations such as PFASs.
These are currently not regulated. Most countries in the EU have prohibit ed the use of
untreated sludge on land, while some Member States (France, Ireland, and the UK) permit
the use of untreated sludge (Collivignarelli et al., 2019). Currently, among the EU-27
countries France, Finland, Germany, Ireland, Italy and Spain have the highest share of
biosolids recycled to land.

The sewage sludge mass flow (Appendix) indicates that a possible yearly total of 0.27 t of
PFASs are not destroyed within the EEA. Especially the application on farm land poses a risk,
as PFASs can enter directly into the environment. T his has been seen to cause massive
problems in Raststatt Germany as wel as in Wisconsin, USA 45.

Literature and measurement campaigns clearly show that precursors make a significant
contribution to the total load of PFASs in WWTPs. WWTPs usually receive wastewater from
both industry and households. PFAS concentrations are higher in wastewater with a high
proportion of industrial wastewater. PFASs concentrations in industrial wastewater can be up
to a factor of 1 000 higher. Literature also shows that the quantities and type of PFASs depend

very much on the type of industry. Due to the large number of PFAS compounds and the
many use categories of these substances, tracing the origin of specific PFASs in wastewater
is difficult (STOWA, 2021). STOWA measurements showed that PFAS concentrations in the
outgoing wastewater were often found to be higher than in the incoming wastewater.
According to the researchers there are both known and unknown PFAS compounds present in
the incoming wastewater. Currently, unknown PFAS compounds cannot be detected and
measured due to their instability. According to the researchers, these unstable, undetected
PFAS precursors are partly converted into stable PFAS (where all available sites are occupied
by fluorine atoms), which can be measured. This leads to the higher concentrations found in
the treated wastewater. These findings confirm existing foreign research.

Several of the analysed PFAS use waste streams have a high likelihood of adding PFASs into
the waste streams and in cases where the PFASs are not destroyed, these waste streams can
contribute to the global distribution of PFASs via recycling or other treatment options.
Especially textile waste presents a high PFAS load in waste and a high share of PFASs not

45
https://www.theguardian.com/environment/2022/sep/19/us -states-toxic-sewage-sludge-pfas-
farmers, date of access: 2022-12-16.

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destroyed during its treatment. Similarly, the paper packaging applications of FCM can be
seen as a possible source of PFASs into the environment due to the high share of recycling of
paper. Further waste streams considered in the present investigation such as ELV and WEEE
could grow strongly in the coming years. (Especially the market for electric vehicles, which
contain more PFASs, likely will grow strongly). This will further contribute to the issue of the
ubiquitous occurrence of PFASs.

It is hard to estimate the effects of a total PFAS ban on the future PFAS concentration in
sludges. As the sludge is generated in the WTTP, which receive waters from many different
sources including landfills, it can be estimated, that PFASs will be present in sludge for many
years following a PFAS ban. Additionally, sludge from urban WWTP presents a high risk as
around half of the waste sludge is directly spread on arable land.

A.3.18.2.10. Land application/composting

Organic waste c an be further reused via composting or through the application on land. In
the case of sewage sludge, 50% is reused through these two methods, however these
methods are not suitable for the destruction of PFASs. As such it is assumed, that through
the use as compost and other land applications of organic waste, PFASs are not significantly
destroyed in reasonable time frames, in contrast they can be considered as directly released
to the environment.

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A.4. Uses advised against by the registrants


The analysis in this Annex XV dossier is based on substances that have been identified as
being used in various applications.

No review of registration dossiers for all the potentially relevant PFAS has been undertaken
in terms of identifying any specific uses that are advised against by the registrants.

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Appendices to Annex A

Appendix A.2. Manufacture, import and uses


Table A.70. PFAS from the OECD and REACH registry database combined. Substances
identified as fluorinated gases are indicated in bold.
CAS No [1][2] PFAS Chemical Name REACH Midpoint
category registered
(OECD) volume band
(t/y)

19430-93-4. n:2 1-hexene, 3,3,4,4 5 5,6,6,6-


This is a fluorotelo nonfluoro-
100 – 1 000
monomer for a mer
fluoropolymer olefins
80793-17-5 Hydroflu Octane, 1,1,1,2,2,3,3,4,4 5 5
orocarbo 5,6,6-tridecafluoro- 0 – 10
ns (HFC)
355-04-4 perfluor Pentane, 1,1,1,2,2,3,3,4 5 5 5- 550
oalkanes undecafluoro-4- 100 – 1 000
(trifluoromethyl)-
2043-57-4 n:2 Octane, 1,1,1,2,2,3,3,4,4 5
fluorotelo 5,6,6-tridecafluoro-8-iodo- Intermediate
mer use only
iodides
80806-68-4 other 1-nonanol, 4,4 5
fluorotelo 5,6,6,7,7,8,8,9,9,9-tridecafluoro-
mer- Intermediate
based use only
non-
polymers
647-42-7 n:2 1-octanol, 3,3,4,4 5
fluorotelo 5,6,6,7,7,8,8,8-tridecafluoro-
Intermediate
mer
use only
alcohol

34451-26-8 n:2 1-octanethiol, 3,3,4,4 5


fluorotelo 5,6,6,7,7,8,8,8-tridecafluoro-
mer-thiol 0 – 10
derivative
s
73609-36-6 #N/A Silane, dichloromethyl(3,3,4,4 5
5,6,6,7,7,8,8,8- 10 – 100
tridecafluorooctyl)-
85857-16-5 n:2 Silane, trimethoxy(3,3,4,4 5
fluorotelo 5,6,6,7,7,8,8,8-
10 – 100
mer tridecafluorooctyl)-
silanes
375-72-4 perfluoroa 1-butanesulfonyl fluoride,
lkanesulfo 1,1,2,2,3,3,4,4,4-nonafluoro- Intermediate
nyl use only
halides
101947-16-4, a n:2 Silane, triethoxy(3,3,4,4 5
PFOA precursor fluorotelo 5,6,6,7,7,8,8,9,9,10,10,10- C onfidential
mer heptadecafluorodecyl)-

166
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

silanes

144317-44-2 Perfluoroa Sulfonium, triphenyl-,


lkane 1,1,2,2,3,3,4,4,4-nonafluoro-1-
sulfonic butanesulfonate (1:1)
C onfidential
acids
(PFSAs) +
salts
52299-25-9 perfluoroa Phosphinic acid, P,P-
lkyl bis(1,1,2,2,3,3,4,4,4-
0 – 10
phosphini nonfluorobutyl)-
c acids
38565-52-5 fluorotelo Oxirane, 2-(2,2,3,3,4,4 5
Intermediate
mer 5,6,6,7,7,7-tridecafluoroheptyl)-
use only
epoxides
297730-93-9 hydrofluo Hexane, 3-ethoxy-1,1,1,2,3,4,4 5
10–100 /
roethers 5,6,6,6-dodecafluoro-2-
confidential
(trifluoromethyl)-
26650-09-9 n:2 Thiocyanic acid, 3,3,4,4 5
fluorotelo 5,6,6,7,7,8,8,8-tridecafluorooctyl
Intermediate
mer-thiol ester
use only
derivative
s
27619-89-2 n:2 1-octanesulfonyl chloride, 3,3,4,4
fluorotelo 5 5,6,6,7,7,8,8,8-tridecafluoro-
mer
Intermediate
sulfonyl
use only
based
compoun
ds
17527-29-6 n:2 2-propenoic acid, 3,3,4,4 5
fluorotelo 5,6,6,7,7,8,8,8-tridecafluorooctyl
100–1 000
mer ester
acrylates
1228350-17-1 fluorotelo 2-propenoic acid, 2-methyl-, 4,4
mer 5 5,6,6,7,7,8,8,9,9,9-
methacryl tridecafluorononyl ester 0 – 10
ates
(other)
307-35-7 perfluoroa 1-octanesulfonyl fluoride,
lkane 1,1,2,2,3,3,4,4 5 5,6,6,7,7,8,8,8- Intermediate
sulfonyl heptadecafluoro- use only
halides
2144-53-8 n:2 2-propenoic acid, 2-methyl-,
fluorotelo 3,3,4,4 5 5,6,6,7,7,8,8,8-
mer tridecafluorooctyl ester 100 – 1 000
methacryl
ates
56773-42-3 Perfluoroa Ethanaminium, N,N,N-triethyl-,
0 – 10
lkane 1,1,2,2,3,3,4,4 5 5,6,6,7,7,8,8,8-

167
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

sulfonic heptadecafluoro-1-
acids octanesulfonate (1:1)
(PFSAs) +
salts
34454-97-2 Perfluoroa 1-butanesulfonamid,
lkanesulfo 1,1,2,2,3,3,4,4,4-nonafluoro-N-
100 – 1 000
namidoet (2-hydroxyethyl)-N-methyl-
hanols
67584-55-8 perfluoroa 2-propenoic acid, 2-
lkane [methyl[(1,1,2,2,3,3,4,4,4-
sulfonyl nonfluorobutyl)sulfonyl]amino]eth 100 – 1 000
(meth)acr yl ester
ylates
34455-29-3 n:2 1-propanaminium, N-
fluorotelo (carboxymethyl)-N,N-dimethyl-3-
mer [[3,3,4,4 5 5,6,6,7,7,8,8,8-
sulfonyl tridecafluorooctyl)sulfonyl]amino] 100 – 1 000
based -, inner salt
compoun
ds
42532-60-5 perfluoroa Propanenitrile, 2,3,3,3-
lkyl tetrafluoro-2-(trifluoromethyl)- ≥1 to <10
cyanide
756-12-7 perfluoroa 2-butanone, 1,1,1,3,4,4,4-
lkyl heptafluoro-3-(trifluoromethyl)- 1 – 10
ketones
756-13-8 perfluoroa 3-pentanone, 1,1,1,2,2,4 5 5
lkyl 5-nonafluoro-4- 100 – 1 000 + 550
ketone (trifluoromethyl)-
132182-92-4 hydrofluo Pentane, 1,1,1,2,2,3,4 5 5 5-
roethers decafluoro-3-methoxy-4- 10 – 100
(trifluoromethyl)-
1187-93-5 perfluoroa Ethene, 1,1,2-trifluoro-2-
lkyl (trifluoromethoxy)-
100 – 1 000
ethers/
alkenes
62037-80-3 Per- and Propanoic acid, 2,3,3,3-
polyfluoro tetrafluoro-2-(1,1,2,2,3,3,3-
ether heptafluoropropoxy)-, ammonium
10 – 100
carboxylic salt (1:1)
acids
(PFEC As)
90622-71-2 perfluoroa Alkyl iodides, C 6-18, perfluoro
Intermediate
lkyl
use only
iodides
68391-08-2 n:2 Alcohols, C 8-14, γ-ω-perfluoro
fluorotelo Intermediate
mer use only
alcohols
85631-54-5 n:2 2-Propenoic acid, γ-ω-perfluoro- 10 – 100

168
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

fluorotelo C 8-14-alkyl esters


mer
acrylates
375-50-8 perfluoroa Butane, 1,1,2,2,3,3,4,4-
Intermediate
lkyl octafluoro-1 4-diiodo-
use only
iodides
375-80-4 perfluoroa Hexane, 1,1,2,2,3,3,4,4 5 5,6,6-
Intermediate
lkyl dodecafluoro-1,6-diiodo-
use only
iodides
85995-91-1 n:2 Alkyl iodides, C 8-14, γ-ω-
fluorotelo perfluoro Intermediate
mer use only
iodides
306-94-5 perfluoroa Naphthalene, 1,1,2,2,3,3,4,4,4a 5
lkanes 5,6,6,7,7,8,8,8a- 0 – 10
octadecafluorodecahydro-
335-27-3 perfluor Cyclohexane, 1,1,2,2,3,3,4 5 5
oalkanes 5,6-decafluoro-4,6- 0 – 10
bis(trifluoromethyl)-
338-83-0 perfluoroa 1-Propanamine, 1,1,2,2,3,3,3-
lkyl heptafluoro-N,N- ≥1 000 to
amines bis(1,1,2,2,3,3,3- <10 000
heptafluoropropyl)-
382-26-3 Hydrofluo Propane, 1,1,1,3,3-pentafluoro-3- Intermediate
roethers methoxy-2-(trifluoromethyl)- use only
382-28-5 other per Morpholine, 2,2,3,3 5 5,6,6-
- and octafluoro-4-(trifluoromethyl)-
polyfluoro
alkyl
100 – 1 000
ether
based
substance
s
1800-91-5 n:2 1,9-Decadiene, 3,3,4,4 5 5
fluorotel 5,6,6,7,7,8,8-dodecafluoro-
0 – 10
omer
olefins
15290-77-4 Hydroflu Cyclopentane, 1,1,2,2,3,3,4- 5
orocarbo heptafluoro- 0 – 10
ns (HFC)
19190-61-5 Per- and Butanoic acid, 2,2,3,3,4,4-
polyfluoro hexafluoro-4-[(1,2,2-
ether trifluoroethenyl)oxy]-, methyl
carboxylic ester 0 – 10
acids
(PFEC As)
esters
25628-08-4 Perfluoroa Ethanaminium, N,N,N-triethyl-,
lkanesulfo 1,1,2,2,3,3,4,4,4-nonafluoro-1- 0 – 10
nic acids butanesulfonate (1:1)

169
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

(PFSAs) +
salts
34455-22-6 n:2 1-Octanesulfonamide, N-[3-
fluorotelo (dimethylamino)propyl]-3,3,4,4 5
mer 5,6,6,7,7,8,8,8-tridecafluoro-
Intermediate
sulfonyl
use only
based
compoun
ds
59493-72-0 other per 1-Propanaminium, 3-[[4-
- and [(heptadecafluorononen-1-
polyfluoro yl)oxy]benzoyl]amino]-N,N,N-
alkyl trimethyl-, iodide (1:1)
C onfidential
ether
based
substance
s
96383-55-0 n:2 2-Propenoic acid, 2-chloro-,
fluorotelo 3,3,4,4 5 5,6,6,7,7,8,8,8-
mer- tridecafluorooctyl ester
10 – 100
based
non-
polymers
102061-82-5 Perfluoroa 1-Butanesulfinic acid,
lkane 1,1,2,2,3,3,4,4,4-nonafluoro-,
sulfinic sodium salt (1:1)
C onfidential
acids
(PFSAs) +
salts
103055-07-8 Benzamide, N-[[[2 5-dichloro-4-
(1,1,2,3,3,3-
C onfidential
hexafluoropropoxy)phenyl]amino]
carbonyl]-2,6-difluoro-
130841-23-5 Benzene, 1 4-dichloro-2-
(1,1,2,3,3,3-hexafluoropropoxy)- C onfidential
5-nitro-
161075-00-9 1-Propene, 1,1,2,3,3,3-
hexafluoro-, oxidized, polymd., 100 – 1 000
reduced, fluorinated
220133-51-7 Perfluoroa Sulfonium, dimethylphenyl-,
lkane 1,1,2,2,3,3,4,4,4-nonafluoro-1-
sulfonic butanesulfonate (1:1)
C onfidential
acids
(PFSAs) +
salts
220689-12-3 Perfluoroa Phosphonium, tetrabutyl-,
lkane 1,1,2,2,3,3,4,4,4-nonafluoro-1-
1 +/
sulfonic butanesulfonate (1:1)
confidential
acids
(PFSAs) +

170
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

salts
332350-93-3 other Phosphonium,
sulfonyl- triphenyl(phenylmethyl)-, salt
based with 1,1,2,2,3,3,4,4,4- C onfidential
non- nonafluoro-N-methyl-1-
polymers butanesulfonamide (1:1)
371771-07-2 Side- 1,2-Benzenedicarboxamide, N1-
chain [1,1-dimethyl-2-
Intermediate
fluorinate (methylsulfinyl)ethyl]-N2-[2-
use only
d methyl-4-[1,2,2,2-tetrafluoro-1-
aromatics (trifluoromethyl)ethyl]phenyl]-
874288-98-9 perfluoroa Ethane, 1,2-dichloro-1-
Intermediate
lkyl ether [difluoro(trifluoromethoxy)metho
use only
halides xy]-1,2,2-trifluoro-
908020-52-0 Per- and Acetic acid, 2,2-difluoro-2-
polyfluoro [1,1,2,2-tetrafluoro-2-(1,1,2,2,2-
ether pentafluoroethoxy)ethoxy]-,
10 – 100
carboxylic ammonium salt (1:1)
acids
(PFEC As)
919005-14-4 Per- and Propanoic acid, 2,2,3-trifluoro-3-
polyfluoro [1,1,2,2,3,3-hexafluoro-3-
ether (trifluoromethoxy)propoxy]- Intermediate
carboxylic use only
acids
(PFEC As)
958445-54-0 Per- and Propanoic acid, 2,2,3-trifluoro-3-
polyfluoro [1,1,2,2,3,3-hexafluoro-3-
ether (trifluoromethoxy)propoxy]-,
Intermediate
carboxylic methyl ester
use only
acids
(PFEC As)
esters
1189052-95-6 n:2 Phosphonic acid, P-(3,3,4,4 5
fluorotelo 5,6,6,7,7,8,8,8-
mer tridecafluorooctyl)-, sodium salt 0 – 10
phosphon (1:1)
ic acids
1190931-27-1 Per- and Acetic acid, 2,2-difluoro-2-[[2,2,4
polyfluoro 5-tetrafluoro-5-
ether (trifluoromethoxy)-1,3-dioxolan-
10 – 100
carboxylic 4-yl]oxy]-, ammonium salt (1:1)
acids
(PFEC As)
1190931-39-5 Per- and Acetic acid, 2,2-difluoro-2-[[2,2,4
polyfluoro 5-tetrafluoro-5-
ether (trifluoromethoxy)-1,3-dioxolan- Intermediate
carboxylic 4-yl]oxy]-, potassium salt (1:1) use only
acids
(PFEC As)

171
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

1190931-41-9 Per- and Acetic acid, 2,2-difluoro-2-[[2,2,4


polyfluoro 5-tetrafluoro-5-
ether (trifluoromethoxy)-1,3-dioxolan- Intermediate
carboxylic 4-yl]oxy]- use only
acids
(PFEC As)
13846-22-5 perfluoroa Propane, 1,1,2,2,3,3-hexafluoro-
lkyl 1,3-bis[(1,2,2- Intermediate
ethers/ trifluoroethenyl)oxy]- use only
alkenes
203929-12-8 n:2 1-Hexene, 3,3,4,4 5 5,6,6-
fluorotelo octafluoro-6-iodo- Intermediate
mer use only
olefins
36097-07-1 n:2 1-Butanethiol, 4-[(3,3,4,4 5
fluorotelo 5,6,6,7,7,8,8,8-
mer-thiol tridecafluorooctyl)thio]- 0 – 10
derivative
s
428-59-1 perfluoroa Oxirane, 2,2,3-trifluoro-3-
lkyl (trifluoromethyl)- 100 – 1 000
epoxides
88992-45-4 n:2 1-Propanaminium, 2-hydroxy-
fluorotelo N,N,N-trimethyl-3-[(3,3,4,4 5
mer-thiol 5,6,6,7,7,8,8,8- 10 – 100
derivative tridecafluorooctyl)thio]-, chloride
s (1:1)
62880-93-7 n:2 1-Propanesulfonic acid, 2-methyl-
fluorotelo 2-[[1-oxo-3-[(3,3,4,4 5
mer-thiol 5,6,6,7,7,8,8,8- 10 – 100
derivative tridecafluorooctyl)thio]propyl]ami
s no]-, sodium salt (1:1)
76-19-7 Perfluor Propane, 1,1,1,2,2,3,3,3- 450
100 – 1 000
oalkane octafluoro-
754-12-1 Perfluor 2,3,3,3-tetrafluoroprop-1-ene ≥1 000 to 4 500
oalkane <10 000
29118-24-9 Hydrochl (E)-1,3,3,3-tetrafluoroprop-1- 4 500
≥1 000 to
orofluor ene
<10 000
oolefins
102687-65-0 N/A (1E)-1-chloro-3,3,3- ≥1 000 to 4 500
trifluoroprop-1-ene <10 000
357409-09-7 Hydroflu 1,1,1,2- unknown
orocarbo tetrafluoroethane;hydrobromi Not registered
ns de
406-58-6 Hydroflu 1,1,1,3,3-pentafluorobutane unknown
orocarbo Confidential
ns
460-73-1 Hydroflu 1,1,1,3,3-Pentafluoropropane 1 000
orocarbo 1 000+
ns

172
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

374-27-6 Hydroflu 3,3,4,4,4-pentafluorobut-1- 5


oroolefin ene 1 – 10
s
811-97-2 Hydroflu Norflurane (HFC-134a) 55 000
≥10 000 to
orocarbo
<100 000
ns
354-33-6 Hydroflu Pentafluoroethane (HFC-125) 55 000
≥10 000 to
orocarbo
<100 000
ns
138495-42-8 Hydroflu (S,S)-1,1,1,2,2,3,4 5 5 5- 55
orocarb decafluoropentane; reaction ≥10 to <100/
ons mass of: (R,R)-1,1,1,2,2,3,4 5 confidential
5 5-decafluoropentane
677-56-5 Hydroflu 1,1,1,2,2,3- unknown
orocarbo Hexafluoropropane (HFC- Not registered
ns 236cb)
420-46-2 Hydroflu 1,1,1-trifluoroethane 4 500
≥1 000 to
orocarbo
<10 000
ns
690-39-1 Hydroflu 1,1,1,3,3,3-hexafluoropropane 450
orocarbo 100 – 1 000
ns
SUBTOTAL OECD list F luorinated gases 131 080
Source: OECD, ECHA 2020

Only the first 72 substances in the table (up to C AS no 76-19-7) appear in the
OEC D database of PFAS.

There are also fluorinated gases not in the OEC D list. Some important substances,
including volume range, are presented below
116-15-4 Perfluori Hexafluoropropene, HFC 1216 55 000
≥10 000 to
nated Not in the main OEC D list - only
<100 000
olefins appears as a “related chemical”
79-38-9 N/A C hlorotrifluoroethylene 5 500
1 000 to
Not in the main OEC D list - only
<10 000
appears as a “related chemical”
406-58-6 Hydroflu 1,1,1,3,3-pentafluorobutane, No info. 15 000
orocarbo HFC-365 mfc Production
ns capacity
Solvay
Taveaux:
15 000 t:
Booten et al.
(2020)
306-83 Hydrochl 2,2-dichloro-1,1,1- Intermediate 2 000
orofluor trifluoroethane, use only
ocarbons HCFC-123
204-075-2 Perfluor Octafluorocyclobutane ≥10 000 to 55 000
oalkanes <100 000
(import only)

173
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

Fluorinated gases not included in OECD fluorinated gas list 127 000
SUBTOTAL Fluorinated gases both included or excluded from OECD 258 530
fluorinated gas list
Stakeholders input from the second stakeholder consultation
(Manufactured in/sold in EEA (and UK))
1064698-37-8 N/A 3M Fluorinert Liquid Fluid FC -40 ≥100 to <1 000 550
1093615-61- N/A 3M Fluorinert Liquid Fluid FC -770 ≥10 to <100 55
2
Reaction mass of 2,2,3,3 5 5,6,6-
octafluoro-4-(1,1,1,2,3,3,3-
heptafluoropropan-2-
yl)morpholine and 2,2,3,3 5
5,6,6-octafluoro-4-
(heptafluoropropyl)morpholine
2187449-42-7 N/A 3M Performance Fluid PF 5056 ≥10 to <100 55

Reaction mass of
perfluoro(dimethyl - N -
Butylamine ) and perfluoro
(methyl - di - N - propylamine)
and perfluoro (dimethyl - N -
propylamine and 2,2,3,3 5 5,6,6,
octafluoro-4-
(trifluoromethyl)morpholine and
perfluoro-N-pentane
2176446-38-9 Perfluoroa 3M Performance Fluid PF 5058 55
lkanes
Reaction mass of
perfluoro(dimethyl - N -
Butylamine ) and perfluoro
(methyl - di - N - propylamine) ≥10 to <100
and perfluoro (dimethyl - N -
propylamine and 2,2,3,3 5 5,6,6,
octafluoro-4-
(trifluoromethyl)morpholine and
perfluoro-N-pentane
3709-71-5 Perfluoror 3M FA-188 Foam Blowing Additive 550
inated (2E)-1,1,1,2,3,4,5,5,5- ≥ 100 to <1 000
olefins Nonafluoro-4-(trifluoromethyl)-2- Additive
pentene
375-03-1 Hydrofluo 1-methoxyheptafluoropropane
No info
roether
163702-08-7 Hydrofluo 2-(Difluoromethoxymethyl)- 10
>10 t for
roether 1,1,1,2,3,3,3-heptafluoro-
reaction mass
propane
163702-07-6 Hydrofluo 1,1,1,2,2,3,3,4,4-nonafluoro-4- >10 t for 10
roether methoxy-butane reaction mass
163702-06-5 Hydrofluo 2-(difluoromethylethoxy)-
No info
roether 1,1,1,2,3,3,3-heptafluorpropane
163702-05-4 Hydrofluo 1-Ethoxy-1,1,2,2,3,3,4,4,4- No info

174
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

CAS No [1][2] PFAS Chemical Name REACH Midpoint


category registered
(OECD) volume band
(t/y)

roether nonafluorbutane
Total fluorinated gases (based on stakeholder consultation) >1 285
TOTAL Fluorinated gases manufactured/processed in EEA 259 815

[1] The first 72 substances (up to C AS no. 76-19-7) were identified by filtering the OEC D database for
“REAC H Registered” substances and obtaining the registered volume data from the EC HA database.
[2] The bold substances in this table have been identified as fluorinated gases in PFAS scope however
they are not included in the OEC D database of PFAS. As discussed, the numbers for total fluorinated
gas volumes in this study were obtained from the stakeholder consultation and the total volume data
provided in the EEA report.

It has been noted that there can be some ambiguity in the definition of “F-gas” (in or outside PFAS
scope). From a purely chemical and physical perspective, an F-gas could be considered as any substance
that contains at least one fluorine atom and is a gas at standard temperature and pressure. This is a
very wide definition and is likely the reason why some F-gas substances that meet this description (and
do or do not meet the PFAS definition as well) do not appear in the OEC D database.

Table A.71. Volume bands of PFASs non-polymers with unsaturated bonds.


CAS No Name Volume band/
(t/y)
1187-93-5 Trifluoro(trifluoromethoxy)ethylene 100-1 000
1623-05-8 1,1,1,2,2,3,3-heptafluoro-3-[(trifluorovinyl)oxy]propane 100-1 000
1644-11-7 1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-
1-10
[(trifluorovinyl)oxy]propane
10493-43-3 Trifluoro(pentafluoroethoxy)ethylene 1-10
13846-22-5 1,1,2,2,3,3-hexafluoro-1,3-bis[(trifluorovinyl)oxy]propane Not available –
intermediate use
only
19190-61-5 Methyl 2,2,3,3,4,4-hexafluoro-4-[(1,2,2-
0
trifluoroethenyl)oxy]butanoate
29514-94-1 1,1,2,2-tetrafluoro-2-[(trifluorovinyl)oxy]ethanesulfonyl
1-10
fluoride
442-390-9 1,1,2,2,3,3-hexafluoro-1-trifluoromethoxy-3-
10-100
trifluorovinyloxypropane
700874-87-9 1-[Difluoro(trifluoromethoxy)methoxy]-1,2,2-
10-100
trifluoroethylene
TOTAL
220-2 200
(rounded)
Source: Wang et al. (2020), OECD database and the ECHA dissemination sites.

175
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.72. Volume bands of perfluoroethers non-polymers with saturated bonds.


CAS No Name Volume band/
(t/y)

382-28-5 2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine 100-1 000

62037-80-3 Ammonium 2,3,3,3-tetrafluoro-2-


10-100
(heptafluoropropoxy)propanoate

144728-59-6 2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-
N/A
tetrafluoroethanesulfonyl fluoride

874288-98-9 1,2-dichloro-1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-
N/A
trifluoroethane

919005-14-4 2,2,3-trifluoro-3-[1,1,2,2,3,3-hexafluoro-3-
N/A
(trifluoromethoxy)propoxy]propanoic acid

957209-18-6 2,3,3,4,4-pentafluoro-2,5-bis(1,1,1,2,3,3,3-
1-10
heptafluoropropan-2-yl)-5-methoxytetrahydrofuran

161075-00-9 Hexafluoropropene, oxidized,


100-1 000
oligomers, reduced, fluorinated

Total (rounded) 210-2 100

Source: Wang et al. (2020), OECD database and the ECHA dissemination sites.

Table A.73. A summary of annual imports of PFAS chemicals from third countries into EU-27.
Year
2010

2011

2012

2013

2014

2015

2016

2017

2018

2019
PFA S group

Fluoropolymers
22 194 31 122 29 644 29 070 32 004 29 706 33 072 38 202 46 008 36 149
(t)
Fluoropolymer –
40 -5 -2 10 -7 11 16 20 -21
YoY Growth (%)
Fluorinated gas
7 005 9 722 12 249 14 106 16 773 13 970 18 781 23 631 27 456 19 191
– Volumes (t)
Fluorinated gas –
39 26 15 19 -17 34 26 16 -30
YoY Growth (%)
PFA A
(precursors)
and others 87 644 79 881 85 354 75 540 77 157 77 881 83 267 105 334 110 281 103 583
PFA S
Volumes (t)
O the r PFAS – YoY
-9 7 -11 2 1 7 27 5 -6
Growth (%)
Source : https://ec.europa.eu/eurostat/we b/international-trade-in-goods/data/database, date of acce ss:
2022-12-20.

176
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.74. A summary of annual exports of PFAS chemicals from EU-27 into third countries (t).
Year

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019
PFAS group

Fluoropolymer –
29 535 28 469 26 595 23 323 27 360 26 546 26 107 27 068 30 167 28 718
Volumes (t)
Fluoropolymer – YoY
-4 -7 -12 17 -3 -2 4 11 -5
Growth (%)
Fluorinated gas –
9 559 7 459 7 116 7 415 8 507 12 360 18 242 16 443 13 660 10 371*
Volumes (t)
Fluorinated gas – YoY
-22 -5 4 15 45 48 -10 -17 -24
Growth (%)
PFAA (precursors)
and other PFAS - 90 728 98 378 128 659 133 519 131 424 115 358 99 810 122 130 127 711 131 866
Volumes (t)
Other PFAS – YoY
8 31 4 -2 -12 -13 22 5 3
Growth (%)
Source: https://ec.europa.eu/eurostat/web/international-trade-in-goods/data/database, date of access: 2022-12-20.
*Remark from stakeholder: The export figures shown above (Eurostat extract) are far too low as only export of bulk gases is p resented. According to EEA
the bulk export of F-gases was about 26 000 t in 2019. An unknown number of F-gas volume in exported equipment must be added to this volume.

177
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.2. Fluoropolymer applications, including fluoroelastomers


Table A.75. Non-exhaustive overview of common commercial FPs and their applications – part 1 of 2.

construction
Lubricants,

Cosmetics
packaging

Consumer

Ski waxes
products
mixtures
contact,
Fluoropolymers

plating
TULAC

Metal
Food
C ross reference dossier Table A.16 A.3.4 Table A.84 Table A.57 Table A.29 Table A.27 A.3.8
and and Table
A.3.15 A.83
Fluropolymers High: High: Range: High: N/A High: 960 N/A
estimated use volumes 109 544 20 430* 800 to 1 200* 10 320 Low: 960
(t/y) Low: Low: Low:
33 091 15 330* *Micropowder 4 254
PTFE
*Addressed as There is only
“polymeric PFAS, total PFAS
but main use are (polymeric and
fluoropolymers. non-polymeric)
volumes of
Table A.18 Table A.60 Table A.31 and Table A.28 1.6 t presented
Table A.32 in the dossier
Table A .26 Table A.58 in the summary
of A.3.8.
Key applications For PPE and For processing As there are For industrial As there are For As there are
felt fabrics equipment already non- or already non- processing already non-
for filtration PFAS professional PFAS under PFAS
alternatives on settings under alternatives/ harsh alternatives on
the market with harsh non-PFAS conditions the market with
satisfactory conditions coatings on the satisfactory
functionality market with functionality
satisfactory
functionality

178
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

construction
Lubricants,

Cosmetics
packaging

Consumer

Ski waxes
products
mixtures
contact,
Fluoropolymers

plating
TULAC

Metal
Food
Thermoplastics
Polytetrafluoroethylene Linings Laminates Lubricants e.g Lubricants: Micro beads or C hemical Ski wax
(PTFE) Tapes Seals C ook Ware, lubricants for Micro-powder micropowder processing components
Filters Beverage cans, string PTFE as solid used in e.g
Laminates Piping, gaskets, instruments as additives leave-on
Waterproof & equipment, etc. in PTFE products such
stain industrial micropowder C onstruction as mascara and
repellent production of food products: rinse-off
clothing and food Resistant products such
Architectural ingredients are components as hair
& carpet also lined/coated and coatings bleaches.
coatings with PTFE. such as Bulking
Fabrics Seals for food glassfiber
process coatings
applications Pipes
(C offee machines, Fittings
valves etc.)
Scrappers
Sulfonated
tetrafluoroethylene
(PSEPVE)
Perfluoro methyl alkoxy Non stick
copolymer (MFA)
Polychlorotrifluoroethylene Packaging and Lubricants:
(PC TFE) barrier films Base oil
Fluorinated ethylene Felt fabrics Food processing
propylene for filtration and packaging
(FEP) equipment

179
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

construction
Lubricants,

Cosmetics
packaging

Consumer

Ski waxes
products
mixtures
contact,
Fluoropolymers

plating
TULAC

Metal
Food
Polyvinyldifluoride (PVDF) Beverage tubings Guitar strings Fluid handling
and hoses and piano keys systems,
C onveyor beltings valves,
pumps and
water piping.
Resistant
paints
Architectural
coatings.
Fluoroethylene vinyl ether Architectural
(FEVE) coatings
Ethylene (E) copolymer of High strength Pipes and
C TFE (EC TFE) films components
Food processing
and packaging
equipment
Perfluoroalkoxy alkane Food processing Industrial and
(PFA) and packaging architectural
equipment coatings
Ethylene copolymer of TFE Food processing Building
(ETFE) and packaging textiles
equipment
THV (a semicrystalline Bag liners Flexible and
three resistant
component terpolymer of coatings
the given monomers) Multilayer
barrier
coatings
Elastomers

180
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

construction
Lubricants,

Cosmetics
packaging

Consumer

Ski waxes
products
mixtures
contact,
Fluoropolymers

plating
TULAC

Metal
Food
High fluorine terpolymers Table A.81
of VDF/HFP/TFE and
VDF/PMVE/TFE
VDF/PMVE/TFE Table A.81
perfluoro elastomers
Ethylene/TFE/PMVE Table A.81
elastomers
Vinylidene fluoride- Food packaging
hexafluoropropylene materials
copolymer (FKM) Food processing
equipment
NOTE: PFAS production and waste are not included in this table, since they are out of scope concerning fluoropolymer uses and applications

181
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.76. Non exhaustive overview of common commercial FPs and their applications – part 2 of 2.
Fluoropolymers

that are not or


“This column
Electroncics

sectors/use

mentioned in
semiconduc

include uses
Fluorinated

applications

the dossier.
Petroleum
Transport

Medical
devices

mining
Energy

vaguely
gases

Other
tors
and

and
s
C ross reference dossier A.3.11, Table Table A.37, Not Table A.48 and Table A.54 A.3.16 and Some “other
A.41, Table Table A.99 and relevant Table A.49 Table A.62 uses” are
A.42 Table A.105 mentioned in
Table A.83

Fluropolymers Range: High: 12 032 Not High:4 615 High: 2 920 Range: N/A
estimated use volumes 6 000 to Low: 3 233 relevant Low: 1 560 Low: 2 592 3 500 to
(t/y) 14 500 7 500

“Stakeholders Table A.40 Table A.50 Table A.55 Table A.63


estimate of
polymeric
PFAS where
the major
volumes are
fluoropolymers
according to
stakeholders
(rounded
numbers)”
Key applications For For sensing Not Electronic Energy storage For For processing
equipment, and biomedical relevant equipment and systems and processing under harsh
installations devices and components for components for under conditions.
and implants their their harsh
components maintained maintained conditions

182
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

that are not or


Fluoropolymers

“This column
Electroncics

sectors/use

mentioned in
semiconduc

include uses
Fluorinated

applications

the dossier.
Petroleum
Transport

Medical
devices

mining
Energy

vaguely
gases

Other
tors
and

and
s
that operate functionality functionality
under harsh
conditions
Thermoplastics
Polytetrafluoroethylene C hemical Biomedical Wire and cable Li ion batteries C hemical C hemical
(PTFE) processing devices insulation Membranes for processing processing
equipment such as hydrogen industry industry
breathing air Semiconductor production and Production of
devices, manufacturing electrochemical filter systems
medical processes for industrial
ventilators and Systems for plants.
oxygen supply storage, 3D-printing
systems. transport, and Printing inks
production of Processing aid
hydrogen in
thermoplastics,
thermos-
setting plastics
and elastomers
Antidrip
additive in
plastics
Sealing
components
for radioactive
waste
processing
systems

183
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

that are not or


Fluoropolymers

“This column
Electroncics

sectors/use

mentioned in
semiconduc

include uses
Fluorinated

applications

the dossier.
Petroleum
Transport

Medical
devices

mining
Energy

vaguely
gases

Other
tors
and

and
s
Sulfonated Membranes for
tetrafluoroethylene hydrogen
(PSEPVE) production and
for
electrochemical
processes
Perfluoro methyl alkoxy Biologic Semiconductor
copolymer (MFA) applications electronics
Optoelectronic
devices
Polychlorotrifluoroethylene C ryogenic Pharmaceutical Electrical
(PC TFE) seals packaging packaging
Lighting
Semiconductor
processing
Fluorinated ethylene Medical C able and wire Systems for C hemical Fluid handling
propylene components Insulation storage, processing C hemical
(FEP) Semiconductor transport, and equipment processing
wet bench production of equipment
equipment hydrogen

Polyvinylfluoride (PVF) Flammability Wire and cable Solar panels


a partial fluorinated lowering insulation.
fluoropolymer and coatings of Electronic
therefore not a PFAS airplane component
interiors such as
photovoltaic
module back
sheets

184
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

that are not or


Fluoropolymers

“This column
Electroncics

sectors/use

mentioned in
semiconduc

include uses
Fluorinated

applications

the dossier.
Petroleum
Transport

Medical
devices

mining
Energy

vaguely
gases

Other
tors
and

and
s
Adhesive for
coating and
lamination

Polyvinyldifluoride (PVDF) Flammability Sensing and High purity Solar panels Filaments for
lowering biomedical semiconductors Energy storage additive
coatings of devices Wire and cable devices such as manufacturing
airplane Membranes in isolators Li ion batteries for e.g
interiors cochlear Sensors Separator in 3D printing
implants and Electric Vehicle General
C atheters (EV) batteries chemical
Food and processing
pharmaceutical Production of
processing filter systems
for industrial
plants.
Pipe and
pumping
applications
Fluoroethylene vinyl ether C oating and
(FEVE) finishes

Ethylene (E) copolymer of Membranes Medical Flame resistant Industrial acids


C TFE (EC TFE) for fuel cells devices wire and cable and corrosives
insulation storage

Perfluoroalkoxy alkane Resistant C hemical Fluid handling

185
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

that are not or


Fluoropolymers

“This column
Electroncics

sectors/use

mentioned in
semiconduc

include uses
Fluorinated

applications

the dossier.
Petroleum
Transport

Medical
devices

mining
Energy

vaguely
gases

Other
tors
and

and
s
(PFA) components processing C hemical
and fittings equipment processing
Electrical equipment
insulation. Production of
Semiconductor filter systems
manufacturing for industrial
plants.
Ethylene copolymer of TFE Automotive Oxygen Wire and cable C hemical C hemical
(ETFE) and mass respirator insulation processing processing
transit cabling components Wet bench equipment equipment
Fuel tubing equipment Military and
and fittings. Radomes defence
Seals equipment (for
instance
munition,
bullet proof
vests)
Greenhouse
glass coatings
Sealing
components
for radioactive
waste
processing
systems
THV (a semicrystalline Fuel hoses Wire and cable Solar panels Safety glass
three insulation Lighting
component terpolymer of Optical fibres
the given monomers)

186
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

that are not or


Fluoropolymers

“This column
Electroncics

sectors/use

mentioned in
semiconduc

include uses
Fluorinated

applications

the dossier.
Petroleum
Transport

Medical
devices

mining
Energy

vaguely
gases

Other
tors
and

and
s
Elastomers
High fluorine terpolymers Table A.13 Table A.13 Table A.13 Table A.13
of VDF/HFP/TFE and industrial industrial
VDF/PMVE/TFE
VDF/PMVE/TFE Table A.13 Table A.13 Table A.13 Table A.13
perfluoro elastomers Industrial industrial
Ethylene/TFE/PMVE Table A.13 Table A.13 Table A.13 Table A.13
elastomers industrial industrial
Vinylidene fluoride- Li ion batteries Table A.13 Table A.13
hexafluoropropylene industrial Sealing
copolymer (FKM) components
Table A.102 for radioactive
waste
processing
systems

NOTE: PFAS production and waste are not included in this table, since they are out of scope concerning fluoropolymer uses and application.

187
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

There is a column "other sectors/uses" in Table A.75 and Table A.76, where certain uses of
fluoropolymers could not be allocated to any of the sectors specified in the dossier. These
uses and applications may though be relevant to other sectors and applications not mentioned
in the dossier. Some of these uses such as "Fluid handling and Chemical processing
equipment" appear to be horizontal and can refer to any type of process industry that handles
chemical processes and fluids in some form.

There are a number of uses and applications for unspecified fluoropolymers for which limited
information was available as shown below in Table A.77.

Table A.77. Uses and applications for unspecified fluoropolymers for which limited
information was available .
Uses and applications for Use description Remarks
unspecified fluoropolymers
for which limited
information was available
Extrusion and moulding (non- Extrusion and moulding Use of FP for plastics and
stick) processes for technical rubber rubbers processing is not
parts and fittings covered in the dossier
Professional cleaning and Fluoropolymer coatings and Use of FP in professional
polishing components enable preventing cleaning and polishing is not
corrosion and facilitating covered in the dossier
cleaning
Pyrotechnics Fluorine containing oxidizers, Use of FP in pyrotechnics is not
primarily polymers, are covered in the dossier
extensively used in pyrotechnic
compositions
Artificial turfs (AT) Unclear if and how FP would be Laura et al test results of total
used in AT fluorine, suggest that the
fluorine in synthetic AT
materials (i.e., not including
organic fill) consists mostly of
non-extractable, non-PFAA
precursors, such as
fluoropolymers. It cannot be
ruled out that contributions
from inorganic fluorine species
may occur in the turf that could
not be extracted in water.

Some thermoplastic fluoropolymers such as sulfonated tetrafluoroethylene (PSEPVE),


perfluoro methyl alkoxy copolymer (MFA) and a range of fluoroelastomers are not described
in terms of uses but only mentioned in the dossier.

Sectors mentioned in the dossier are named slightly differently in the literature sources found
in the reference list. Examples are automotive and aerospace, that can be include d in the
transportation sector, that also covers other means of transportation than automotive and
aerospace such as marine vessels.

Polyvinylfluoride (PVF) is a partial fluorinated fluoropolymer and therefore not a PFAS, which
could be an alternative fluoropolymer to polymeric PFAS such as PVDF and PTFE for certain
applications in transport, electronics, and the energy sector.

188
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.3. Textiles, upholstery, leather, apparel and carpets


Table A.78. Requirements/Standards relating to PPE (specific technical standards) – Industry Data commissioned by the EC (Wood, 2020).
Product Applicable Standard Function tested Scope Further details
TULAC category
Surgical drapes and Medical EN 13795 Mechanical resistance, microbiological Surgical drapes, As a medical device,
gowns Medical applications purity and a barrier effect against liquids: gowns and clean textiles used in
applications Resistance to microbial penetration air suits, used as operating rooms
Resistance to liquid penetration in reference medical devices for have to be conform
to achieve a reasonable physiological patients, clinical to the requirements
comfort staff and of the European
equipment Medical Devices
Directive 2007/47/EC
(modified
93/42/EEC )
Protective textiles against Medical EN 14216 Maximum protection against infection over Medical infection
infection applications blood and secretions rejection. High prevention surgery
hydrolyses stability (repeated 130 °C hot blankets, surgery
steam disinfection, often repeated laundry) protection aprons
etc.

Protective clothing against Medical EN 14126 Performance requirements and test PPE for workers in
infective agent applications methods for maximum protection against hospital laundries,
infections like Ebola Ebola -emergency

Awnings (Strong dynamic Outdoor technical EN 20811 Determination of resistance to water All Textiles
water-repellence) textiles penetration. Hydrostatic pressure test min.
200 cm ; 10 mbar/min

EN ISO Determination of resistance to surface Textile fabrics


4920 wetting (spray test)

189
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
AATC C 22 Water Repellency: Spray Test Not specified

EN 29 865 Determination of water-repellency of fabrics Textiles


by the Bundesmann rainshower test

EN ISO105- C olour fastness - Part B04: C olour fastness Textiles


B04 to artificial weathering: Xenon arc fading
lamp test
DIN 53931 Determination Of The Resistance Of Textiles Textiles Other Standards that
To Mildew; Growth Test are indirectly related
to the use of FC
EN ISO Determination of the abrasion resistance of Textiles
12947 (1-4) fabrics by the Martindale method

ASTM Test Method for stiffness of fabric by Not specified


D4032 circular bend procedure

190
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
Hand and arm protection PPE for industrial EN Specifies the requirements applicable to all Protective gloves The standard deals
and professional 420:2010- protective gloves relevant test methods and with particular
use (other than 03 the general requirements such as aspects of quality,
sportswear) resistance of the glove material against health and safety.
water penetration. It shall be used in The standard is used
conjunction with specific product standards. in conjunction with
specific product
standards as a basis
for the placing on the
market of protective
gloves under the
Directive 89/686/EEC
for personal
protective
equipment. The use
of protective gloves
is not limited to
individual sectors,
but affects many
areas of life and
work in different
branches.
EN Protective gloves against mechanical risks Protective gloves The standard is to
388:2003 apply in combination
with DIN EN
420:2003-12
EN Specifies the requirements for gloves to Protective gloves
374:2003 protect the user against chemicals and/or
micro-organisms and defines terms to be
used

191
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
EN This standard specifies thermal Protective gloves
407:2004 performance for protective gloves against
heat and/or fire: a) Resistance to
flammability b) C ontact heat resistance c)
C onvective heat resistance d) Radiant heat
resistance e) Resistance to small splashes
of molten metal f) Resistance to large
splashes of molten metal

EN This standard applies to any gloves to Protective gloves a. Resistance to


511:2006 protect the hands against convective and against cold convective cold b.
contact cold down to –50 °C . Resistance to contact
cold c. Penetration
by water (0 or 1) 0 =
water penetration 1
= no water
penetration.
EN This standard applies to gloves to protect Protective gloves To protect from
421:2010 from ionising radiation and radioactive radioactive
contamination. contamination it is
important that, the
glove has to be liquid
proof and it needs to
pass penetration test
EN 374
EN 659 Not specified Protective gloves
for firefighters

EN 12477 Requirements such as burning behavior, Gloves giving


contact heat and convective heat, small protection from
splashes manual metal
welding

192
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
EN 50237 This standard applies to insulating gloves Gloves for
and mitts made of plastic or elastomer for Electricians
use without over-gloves for mechanical
protection. Gloves for working at nominal
voltages up to 7500 V.

Protective C lothing PPE for industrial EN 340 Requirements and test methods for Protective clothing The European
and professional protective clothing for fire-fighting The outer fabric is Standard specifies:
use (other than woven from 75% Protective clothing,
sportswear) meta-aramid, 23% C lothing,
para-aramid and Performance, Grades
2% antistatic (quality),
fibres. The fabric is Ergonomics,
laminated with Anthropometric
water vapour characteristics,
permeable Fitness for purpose,
membrane made C lassification
of bi-component systems, C lothing
expanded PTFE- sizes, Ageing
film. (materials),
C ompatibility,
Marking, Instructions
for use

EN 943 Part 1: Performance requirements for Protective clothing


ventilated and non-ventilated 'gas-tight' against liquid and
(Type 1) and 'non-gas-tight' (Type 2) gaseous chemicals,
chemical protective suits Part 2: Protective including liquid
clothing against liquid and gaseous aerosols and solid
chemicals, including liquid aerosols and particles
solid particles. Part 2: Performance
requirements for “gas-tight” (Type 1)
chemical protective suits for emergency

193
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
teams (ET)

EN ISO Determination of resistance of protective Protective clothing e.g. PPE for police
6529 clothing materials to permeation by liquids - Protection uniform, workers in
and gases against chemicals chemistry parks, oil
platforms, mineral-oil
industry etc.
EN 14325 Test methods and performance Protective clothing
classification of chemical protective clothing - Protection
materials, seams, joins and assemblage against chemicals

EN 368 Resistance of materials to penetration by Protective clothing C onfirmed by ocular


liquids No degradation, >80% run off and - Protection inspection after use
no penetration to the innermost surface against liquids of: – petroleum
products – inorganic
acids 36% –
inorganic bases 40%
– alcohols – sodium
hypochlorite 10%
EN 31092 Water-vaping resistance (Ret) Max 11 m 2 Polyamide fabric
Pa/W
EN14605 Performance requirements for clothing with Protective clothing
liquid-tight (Type 3) or spray-tight (Type 4) against liquid
connections, including items providing chemicals (acids)
protection to parts of the body only e.g.
maximum gasoline/chemical repellency for
worker in the chemical industry, high
durability professional washing and dry

194
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
cleaning.

EN 13982 Part 1: Performance requirements for Protective clothing


chemical protective clothing providing for use against
protection to the full body against airborne solid particulates
solid particulates (type 5 clothing)

EN 13034 Performance requirements for chemical Protective clothing


protective suits offering limited protective against liquid
performance against liquid chemicals (Type chemicals
6 equipment)
EN ISO Protection against heat and flame - C lothing to protect
11612 Minimum performance requirements: A: against heat and
Minimum protective performance with flame e.g. oil-
respect to flame spread (test method EN drilling protective
ISO 15052) B: Performance with respect to wear with
insulation against convective heat (test maximum high oil-
method EN ISO 9151) C : Performance with and chemical
respect to insulation against heat radiated (fracking)
(test method EN ISO 6942) D: Performance repellency, high
with respect to insulation against aluminum durability against
spraying ( test method EN ISO 9185) E: repeated laundry/
Performance with respect to insulation dry cleaning etc.
against cast iron spraying (test method EN
ISO 9185) F: Performance with respect to
insulation against heat through contact
(test method EN ISO 12127)

195
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
EN ISO This standard specifies minimum basic Protective clothing This PPE protects
11611 safety requirements and test methods for for use in welding against spatter, short
protective clothing including hoods (head), and allied contact time with
aprons, sleeves and gaiters (feet). processes flame, radiant heat
from the arc, and
minimizes the
possibility of
electrical shock by
short-term,
accidental contact
with electrical
conductors in normal
conditions of
welding. Test
methods: EN ISO
15025, EN ISO 6942,
EN ISO 9150
EN ISO 343 Specifies the requirements and test Protective clothing Value X stands for
methods for materials and the seams of - Protection the waterproofing of
clothing designed to give protection against against rain the article. There are
precipitation (rain, snow), mist and ground 3 classes derived
moisture from the amount of
pressure the fabric
can withstand: 3 is
the highest (i.e. the
most waterproof)
and 1 is the lowest.
Value Y stands for
the breathability of
the fabrics (plus all
the layers used in
the article). There
are 3 classes for
breathability. C lass 1
= the lowest and

196
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
C lass 3 = the highest

EN 14058 Articles are divided in three classes Protective clothing C lothing certified
depending on their thermal resistance - Garments for with this standard
(insulation). With the test method two protection against includes: Thermal
optional features can be tested: the water cool environments resistance Air
vapour resistance and thermal insulation. permeability
Penetration of water.
Water vapour
resistance Thermal
insulation

197
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
Other Protective clothing PPE for industrial EN 1073 This standard is for requirements and test Protective clothing Protective clothing,
and professional methods for ventilated protective clothing against radioactive Radiation protection,
use (other than against particulate radioactive contamination Radioactive
sportswear) contamination materials,
C ontamination,
C lothing, Particulate
air pollutants,
Industrial overalls,
Protective suits,
Performance testing,
Splitting tests, Leak
tests, Gas resistance
tests, Water
tightness tests, Dust-
tightness tests,
Perforating tests,
Tear tests, C hemical-
resistance tests,
Abrasion resistant
materials, Protective
coatings, Breathing
apparatus, Visors,
Air, Gas flow, Flow
measurement,
Seams, Design,
Occupational safety,
Performance, Wear
resistance, Strength
of materials,
C lassification
systems, Marking,
Instructions for use,
Testing conditions.

198
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
EN 50286 Not specified Electrical insulating
protective clothing
for work on low-
voltage
installations
EN 61482 Determination of the arc rating of flame Live working -
resistant materials for clothing Protective clothing
against the
thermal hazards of
an electric arc
EN 1149-5 This European Standard specifies material Protective clothing These anti-static
and design requirements for electrostatic - Electrostatic clothing are
dissipative clothing, used as part of a total properties compliant and
earthed system, to avoid incendiary designed for use in
discharges an ATEX (EXplosive
ATmosphere)
working environment
where a risk of
explosion is possible,
e.g. tank truck
driver.
Protective clothing for PPE for industrial EN 469 Requirements: • Flame spread (test PPE worn during
firefighters and professional (mentioned method ISO 15025) • C onvective heat (test structural
use (other than standards method EN 367) • Radiant heat (test firefighting to
sportswear) therein: EN method ISO 6942) • Heat resistance (test protect mainly
ISO 24920, method ISO 17493) •Water repellence, against heat and
EN ISO dimensional stability, resistance to flame.
6530 chemicals

199
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
Protective clothing for PPE for industrial EN ISO The C -combat suit shall be water and oil Protective
military and professional 14419 repellent, Oil repellence, min 5 and C (hemical)-combat
use (other than resistance to surface wetting, min 5 suit, Viscose FR
sportswear) according to EN 24920 (spray test). Both
new and washed/dried materials shall be
tested. Wash/dry procedure (three
wash/dry cycles): The C -combat suit shall
be possible to be washed in 60 °C and then
tumble dried of a maximum of 80 °C for at
least 3 times according to ISO 6330 with
maintained protective ability. The C -combat
suit shall be water and oil repellent and be
tested according to ISO 2811
(Determination of resistance to water
penetration –hydrostatic pressure test.)
The C -combat suit shall be able to be
washed in 60 ºC for at least 3 times with no
loss in protective ability. The C -combat suit
shall be able to be dried in a tumble dryer
in a temperature of a maximum of 80 ºC
with no loss in protective ability The
permeability of the C -combat suit shall not
be lower than 40 mm/s when using a
pressure drop of 100Pa according to SS-EN
ISO 9237:1995 (Textiles - Determination of
the permeability of fabrics to air)
EN 29865 Water repellency, water absorption, after 3 PES Fabric
washes (25%) Water repellency after 3
washes (min. 4)
EN ISO W Spray test-before wash/after 3 washes PES Fabric
4920 EN (min. 5/min) 60 °C 8.5 tumble dry
ISO 6330

200
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
EN ISO Penetration and Repellency to Liquid Fabric Viscose FR
6350 chemicals

Protective clothing for PPE for industrial TLP 9004 Oil- and water-repellency, fuel repellency PPE clothing for
police and professional (mentioned police
use (other than standards
sportswear) therein: EN
ISO 24920,
EN ISO
14419, EN
228, EN ISO
6530
Protective clothing for fire PPE for industrial TL 8305- Maximum oil- and water-repellency, Technical delivery
fighters, police, military and professional 0020 fastness to repeated washing cycles condition uniform
and chemical protection use (other than (mentioned standards therein: EN 29865, twill
sportswear) EN ISO 14419

TL 8305- Maximum water-, oil-repellency after Technical delivery


0023, TL repeated washing. condition for
8305-0302, uniform double-
TL 8305- twill, medium-fine
0335, TL twill and woven
8305-0336 fabric
(mentioned
standards
therein: EN
29865, EN
ISO 14419)
Protective/Safety PPE for industrial EN ISO Maximum repellence concerning dangerous PPE shoes
footwear and professional 20345 liquids, chemicals, blood etc.
use (other than
sportswear)

201
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
EN ISO
20346

EN ISO
20344 test
methods,
DIN EN
12568 test
methods
Medical EN 455 Disposable medical protective footwear
applications
Ready made garments - PPE for industrial EN 14360 Maximum water repellency because of high Protective off
Impact from above with and professional dynamic energy at 150-200 km speed of shore jackets and
high energy droplets use (other than water droplets trousers on boats
sportswear) and ships,
protective motor
cycle wear
Protective clothing for PPE for industrial ISO 27065 Performance requirements for protective e.g. protective
agricultural workers and professional clothing worn by operators applying liquid suits in agriculture
use (other than pesticide application of
sportswear) pesticides

Protective clothing for Professional FIA- Maximum protection against fuel, heat and e.g. outer
automobile (racing) Sports clothing Standard flame garments, socks,
drivers 885 shoes, balaclava
hoods and gloves
Fuel cells Outdoor technical Safety Maximum resistance to hydrolysis und acid C ertified carbon
textiles Standards of conditions e.g. treated non-woven carbon fibre nonwoven for
Internationa fibre separator in phosphoric acid fuel cell
l Electro- conditions
technical
C ommission
(IEC )

202
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
Filters Outdoor technical VDI 3677 Long-term temperature resistance, stability Filters for wasted
textiles Blatt air/incineration
3:2012-11 plants

Roofing textiles Outdoor technical DIBT- Maximum dynamic water repellency, Protective
textiles C ertified maximum dirt repellency, UV-stability long architecture
lifecycle textiles (Energy
saving, UV-
protection), e.g.
lightweight textile
roofing systems
Textile components of Outdoor technical Airbus- Maximum release properties, air Membrane textiles
aircraft parts textiles C ertified permeability for in mould
injection processes
of carbon fibre
composite parts
Textile components of Outdoor technical Audi- Maximum repellency against dry soil and e.g. convertible
automobile parts textiles Standard white spirit, heavy dynamic rain repellency, tops
LAH 893-80 maximum performance because of high
impact (>200 km/h) of raindrops

Textile components of Outdoor technical AATC C TM 96 hours fuel rejection ; maximum fuel non woven engine
automobile parts textiles 118-oil rejection of e.g. non-woven engine compartment
repellency: compartment interior/cushion (safety interior/cushion
hydrocarbon feature in case of fire), strong oil/fuel- (safety feature in
resistance repellency of flame-retardant case of fire),
test nonwoven/PU-foam motor compartment nonwoven/PU-
sound cushions. foam motor
compartment
sound cushions

203
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Product Applicable Standard Function tested Scope Further details


TULAC category
Textile components of Outdoor technical Other- Repellency- resistance to wetting by oily e.g. fuel, oil,
automobile parts textiles Automotive liquids, hydrophobicity coolant-repellent,
Standards inflammable
for Oil nonwoven for
repellency safety
cushion/sound
absorbing
automotive parts

204
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.4. Food contact materials and packaging


Table A.79. Summary of data used for estimating PFAS (surfactants) volume in Paper and
Board Food Packaging.
Geographical Data Source
coverage
t
Total Paper and EU-27 & United C arton Board 6 169 000 (C epi, 2020)
Board (P&B) Kingdom (UK) Data from 2019
Packaging & Norway (NO) Wrapping 2 647 000
C onsumption
(That may be Sum of 8 816 000
used in food & above
feed contact i.e.
closest C ase 28 369 000
disaggregated materials
categories to food Other P&B 4 166 000
packaging) packaging
Total 41 351 000**
Total organic UK 95% of the Range of fluorine Dinsmore (2020)
fluorine packaging had content (mg/kg
content of fluorine or g/t):
supermarket food content Average = 537
packaging e.g. Maximum =
popcorn bags, 1200
cookie bags, pizza
boxes,
greaseproof
paper.
Paper and US 46% food contact papers and Schaider et al.
paperboard food 20% paperboard samples have (2017)
wrappers from detectable fluorine
fast food
restaurants
Permitted EU and US EU(BfR): Range is: (BfR, 2020; FDA-
concentrations of 0.5 – 1.2% 0.4 – 1.2% US, 2021)
PFAS in paper and US FDA (dry weight)
board food typically 0.5%
packaging C fE
0.4 – 1.0%
Estimate of the Not specified Up to 1% (assume 0.5 – 1.0%) Estimate (see
proportion of (assumed EU) Table A.22)
total* paper
packaging that
contains PFAS
Total organic EU Oil-beading compostable: Straková et al.
fluorine content of 680 mg/kg TOF (2021)
throwaway Oil-beading takeaway paper:
packaging 480 mg/kg TOF
Oil-spreading or soaking
paper/board:
14.5 mg/kg TOF
Notes: *Presumed to be packaging that may come into contact with food, rather than generic (packaging
for non-food items) packaging; **Assumed to include feed and food contact P&B.

205
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.80. Substances (indicative list with some examples) used in FCM and packaging.
Substance Abbrev CAS number Chemical Use Function/
iation formula regulatory
listing

2,3,3,3-tetrafluoro-2- GenX, 13252-13-6 C 6HF11O 3 C onsumer PPA in Reg.


heptafluoropropoxy)- HFPO- and industrial 10/2011.
propinoic acid; or DA, cookware Substitute
perfluoro[2(n- FRD- for PFOA
propoxy)propanoic acid] 903

Polytetrafluoroethylene; PTFE 9002-84-0 (C 2F4)n C ooking and Monomer


a polymer of: baking listed in Reg
tetrafluoroethylene (TFE) equipment, 10/2011
coated
rubber Polymer for
coating
cookware,
such as
coatings on
frying pans
and articles
for oven
baking, and
moulded
articles for
industrial
use.
Silicone Rubber, 64706-30-5 Liquid No data
fluorinated processing
FKM, fluoroelastomers 64706-30-65 equipment

Rubber
PTFE: 9002-84- components
(1,1- Difluoroethylen - 0;
hexafluoropropenpolymer VDF-co-
) HFP/FKM#1:
Ethene, 1,1,2,2- 9011-17-0;
tetrafluoro-, -
homopolymer (PTFE) -
Ethylene- FEP: 25067-11-
tetrafluoroethylene 2
copolymer (ETFE) -
FKM
Perfluoroelastomer
(FFKM)
Tetrafluoroethylene-
perfluoropropylene
copolymer (FEP)
Perfluoroalkyl(C 6-C16) No data 65530-64-5 NH2+(C H2C Food, non- Additive
phosphates of bis(2- H2OH) food and feed
hydroxyethyl)amine (O)P(O-) packaging
or (OC H2C H2
Diethanolamine salts of C nF2n+1)2
mono- and
bis(1H,1H,2H,2H-

206
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Abbrev CAS number Chemical Use Function/


iation formula regulatory
listing

perfluoroalkyl(C 8-C18)
phosphates
[mono- and di-PAP, FT]

Table A.81. PFAS that have been identified for all food contact and packaging use. Entries
have been organised according to chemical groupings in this table. Source: see note at the
end of the table.
Substance Name* Abbre- CAS Chemical Use Function and
viation Number** Formula Regulatory
Listing†

Perfluorooctanoic acid, PFOA 3825-26-1 C 8H4F15NO 2 C onsumer PPA listed in Reg.


ammonium salt cookware 10/2011.
No longer used.
Industrial
food
processing
and food
transport
equipment
Food & feed
packaging
Perfluorooctane sulfonic PFOS 1763-23-1 No data Food & feed No longer used.
acid packaging
Perfluoroheptanoic acid No data 375-85-9 C 7HF13 O 2 Food & feed No data
packaging
Perfluorohexanoic acid (PFHxA) 307-24-4 C 6HF11O 2 Food & feed No data
packaging
2,3,3,3-tetrafluoro-2- GenX, 13252-13-6 C 6HF11O 3 C onsumer PPA in Reg.
heptafluoropropoxy)- HFPO-DA, cookware 10/2011.
propinoic acid; or FRD-903 Industrial Substitute for
perfluoro[2(n- food PFOA
propoxy)propanoic acid] processing
and food
transport
equipment
Food & feed
packaging
Hexafluoropropylene No data 116-15-4 C 3F6 C onsumer Monomer in Reg.
cookware 10/2011.

Perfluoroalkyl vinyl ethers: e.g. e.g. C 3F6O C onsumer Monomers listed


Perfluoromethyl vinyl ether PFMVE 1187-93-5 (PFMVE) cookware in Reg. 10/2011.
Perfluoroethyl vinyl ether PFEVE 10493-43-3 C 4F8O
Perfluoropropyl vinyl ether PFPVE 1623-05-8 (PFEVE)
C 5F10O
(PFPVE) Industrial
food
processing
and food

207
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

transport
equipment

Perfluoroalkyl phosphonic (PFPAs) 40143-76- No data Non-food C oating for


acids 8, 40143- packaging polyethylene film
78-0, used e.g. for
52299-26- packaging toys
0, 63225- and foodstuff.
55-8
Perfluoroalkyl phosphinic (PFPiAs) 40143-77- No data Non-food
acids 9, 40143- packaging
79-1,
52299-27-
1, 63225-
54-7
Ammonium perfluoroalkyl No data 6130-43-4, NH4+ Non-food C oating for
carboxylate 4149-60-4, C nF2n+1C O P&B polyethylene film
4234-23-5, O‒ (4149- packaging used e.g. for
4288-72-6 60-4) packaging toys
and foodstuff.
PFAS that have
been patented for
use in paper
packaging for
non-food articles
1-Alkanol, 1H,1H,2H,2H- No data 63225-56- No data Non-food C oating for
perfluoro-, 1-(hydrogen 9, 63225- packaging polyethylene film
sulfate), ammonium salt 57-0, used e.g. for
(1:1) 63225-58- packaging toys
1, 63225- and foodstuff
59-2

C hlorotrifluoroethylene No data 79-38-9 C lC F=C F2 C onsumer Monomer


cookware Listed in 10/2011.
(The monomer is
not a PFAS, the
polymer is a
PFAS).
Vinylidene fluoride No data 75-38-7 C H2C F2 C onsumer Monomer
cookware Listed in 10/2011.
(The monomer is
not a PFAS, the
polymer is a
PFAS).
(Perfluorobutyl)ethylene No data 19430-93-4 C 6H3F9 C onsumer Monomers listed
cookware in Reg. 10/2011.
Potassiumperfluorobutanes No data 29420-49-3 C 4F9KO 3S Food & feed No data
ulfonate packaging
Perfluoropolyether (PFPE) No data 76415-97- No data Food & feed No data
or Perfluoropolyether 9, 69991- packaging
dicarboxylic acid, 62-4

208
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

ammonium salt
Perfluoro-1,2- No data 306-98-9 C 8F16 Food & feed No data
dimethylcycloalkane packaging
6:2-8:2 or 8:2-8:2-di No data No data No data Food & feed No data
polyfluoroalkyl phosphate packaging
ester (PAP)
8:2, 10:2, 12:2, 14:2 or No data No data No data Food & feed No data
16:2 fluorotelomer alcohol packaging
(FTOH) and mono-
phosphate or di-phosphate
Phosphoric acid, mono- No data No data No data Food & feed No data
and bis(gamma, omega- packaging
perfluoroalkyl) esters,
compounds with
diethanolamine
Pentanoic acid, 4,4-bis No data 71608-61-2 No data Food & feed No data
[(gamma-omega- packaging
perfluoro-C 8-20-alkyl)thio]
derivatives, compounds
with diethanolamine
3,3,4,4,5,5,6,6,7,7,8,8,8- No data 17527-29-6 No data Food & feed No data
tridecafluorooctyl acrylate, packaging
or methacrylate acetate
3,3,4,4,5,5,6,6,7,7,8,8,8- No data 2144-53-8 C 12H9F13O 2 Food & feed No data
tridecafluorooctyl packaging
methacrylate, acetate
and/or malate
1-Octanesulfonamide, N- No data No data No data Food & feed No data
ethyl- packaging
1,1,2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-heptadecafluoro
Acrylic acid, ester with N- No data No data No data Food & feed No data
ethyl- packaging
1,1,2,2,3,3,4,4,5,5,6,6,7,7
, 8,8,8-heptadecafluoro-N-
(2-hydroxyethyl)-1-octane-
sulfonamide
N-(2-Hydroxyethyl) No data 1691-99-2 No data Food & feed No data
perfluorooctyl packaging
sulphonamide
Acrylic acid, N- No data 25268-77-3 No data Food & feed No data
methylperfluorooctanesulfo packaging
namido-ethyl ester
(Perfluorooctylsulfonylamin No data 68310-75-8 No data Food & feed No data
opropyl)trimethylammoniu packaging
m iodide
2-Propenoic acid, 2- No data 1893-52-3 No data Food & feed No data
amino]ethylester[ethyl[(tri packaging
decafluorohexyl)sulfonyl]-
2-Propanoic acid, 2- No data No data No data Food & feed No data
((ethyl(pentadecafluorohep packaging

209
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

tyl)-sulfonyl) amino)ethyl
ester
Acrylic acid, 2- No data No data No data Food & feed No data
[methyl[(nonafluorobutyl) packaging
sulfonyl]ethylester amino]
Ethanaminium, N,N,N- No data No data No data Food & feed No data
triethyl-, salt with packaging
1,1,2,2,3,3,4,4,
5,5,6,6,7,7,8,8,8-
heptadecafluoro-1-
octanesulfonicacid (1:1)
2,3,3,4,4,5,5-Heptafluoro- No data 1547-26-8 C 5H3F7 C onsumer Monomer
1- pentene cookware Listed in 10/2011.
Food & feed C omonomer, in
packaging combination with
the comonomers
Non-food ethylene and
packaging tetrafluoroethylen
e, in the
manufacture of
fluoropolymers.
Perfluoro[(2-ethyloxy- No data No data C 6HF11O 4 Industrial Temperature
ethoxy)acetic acid] food resistant polymer
processing coating systems
and food for frying, cooking
transport and baking
equipment utensils
Perfluoro[(2-ethyloxy- No data 908020-52- C 6HF11O 4 C onsumer Monomer and
ethoxy)acetic acid]], 0 (+ NH3) cookware emulsifier (PPA)
ammonium salt Listed in 10/2011.

Sodium 4- No data e.g. C 15H4F19 C onsumer Monomer and


perfluorononyloxy- 59536-17-3 NaO 4S cookware emulsifier (PPA)
benzenesulphonate

Perfluoro[2-(poly(n- No data 51798-33-5 (C 3F6O)n C onsumer Monomer and


propoxy))propanoic acid] C 6HF11O 3 cookware emulsifier (PPA)
or perfluoropolyether Listed in
carboxylic acid 10/2011.

Perfluoro acetic acid, α- No data 329238-24- C 3F6C lO- C onsumer PPA Listed in
substituted with the 6 [C F2- cookware 10/2011.
copolymer of perfluoro- C F(C F3)-O]n-
1,2-propylene glycol and [C F(C F3)- Industrial PPA in Reg.
perfluoro-1,1-ethylene O]m- food 10/2011 –
glycol, terminated with C F2C OOH processing specification:
chlorohexa-fluoropropyloxy and food Up to 0.5% w/w
groups transport in the
equipment polymerisation of
fluoropolymers
that are
processed at

210
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

temperatures at
or above 340 °C
and are intended
for use in
repeated use
articles
2H-perfluoro-[(5,8,11,14- No data 37486-69-4 No data C onsumer PPA Listed in
tetramethyl)- cookware 10/2011.
tetraethyleneglycol ethyl
propyl ether]

perfluoro{acetic acid, 2- No data 1190931- No data C onsumer PPA Listed in


[(5- methoxy-1,3- 27-1 cookware 10/2011.
dioxolan-4-yl)oxy]},
ammonium salt
3H-perfluoro-3-[(3- ADONA 958445-44- No data C onsumer PPA Listed in
methoxy- 8 cookware 10/2011.
propoxy)propanoic acid],
ammonium salt

Polytetrafluoroethylene; PTFE 9002-84-0 (C 2F4)n C onsumer Monomer and


a polymer of: cookware PPA
tetrafluoroethylene 116-14-3 Industrial Listed in 10/2011.
food
processing
and food
transport
equipment
Food & feed Additive (in
packaging micropowder
form) for other
Non-food
plastics to get
packaging
better non-
sticking
properties for
these plastics.
Polytrifluoroethylene No data No data No data Non-food Food packaging
packaging foils.

Polychlorotrifluorethyene (PC TFE) 9002-83-9 No data Non-food Food packaging


packaging films,
pharmaceutical
blister packaging.
High barrier film.
Polyvinylidene fluoride PVDF 24937-79-9 (C 2H2F2)n Industrial Used for solid and
food lined pipes,
processing fittings, valves,
and food pumps, tower
transport packing, and tank
equipment and trailer linings
for fluid-handling
applications.

211
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Vinylidene fluoride- No data 9011-17-0 (C H2C F2)x- Food & feed No data
hexafluoropropene (C F2C FC F3)y packaging
copolymer
A dipolymer made from No data 9011-17-0 No data Industrial A fluoroelastomer
HFP and vinylidene fluoride 1478-61-1 food designed for
(VF). processing finished parts,
and food which are
transport compliant with
equipment the regulations of
the U.S. Food and
Drug
Administration
(FDA) 21 C FR
177.
2600(c)(4)(i).
VF and HFP copolymers No data 9011-17-0 No data Industrial Monomers in Reg.
food 10/2011
processing
and food
transport
equipment
VF, HFP and No data 25190-89-0 (C F2C F2)x- Industrial Monomers in Reg.
tetrafluoroethylene (TFE) (C F2C FC F3)y- food 10/2011
copolymers (C F2C H2) processing
and food
transport
equipment
Food & feed
packaging
Poly No data No data No data Food & feed No data
(hexafluoropropyleneoxide) packaging
, polymer with 3-N-
methylaminopropylamine,
N,
N,dimethyldipropylenetria
mine and poly
(hexamethylenediisocyanat
e) with a fluorine content
of 59,1%

Reaction product of No data No data No data Food & feed No data


hexamethylene-1,6- packaging
diisocyanate
(homopolymer),
transformed with
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluoro-1-octanol
with a fluorine content of
48%

212
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Reaction product of No data 647-42-7 No data Food & feed No data


hexamethylene-1,6- packaging
diisocyanate
(homopolymer), converted
with
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluoro-1-octanol
with a fluorine content of
48%
Hexane, 1,6-diisocyanato-, No data 357624-15- No data Food & feed No data
homopolymer, 8 packaging
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluoro-1-octanol-
blocked
C opolymer of 1,1- No data No data No data Food & feed No data
difluoroethylene, packaging
tetrafluoroethylene,
trifluoro methyl
trifluorovinyl ether and a
halogenated alkene,
optionally cured with
triallyl isocyanurate and
2,5-dimethyl-2,5-di(tert-
butylperoxy)hexane
Hexane, 1,6-diisocyanato-, No data 1279108- No data Food & feed No data
homopolymer, α-[1-[[[3- 20-1 packaging
[[3
(dimethylamino)propyl]ami
no]propyl]amino]carbonyl]
-1,2,2,2-tetrafluoroethyl]-
ω-(1,1,2,2,3,3,3-
heptafluoropropoxy)
poly[oxy[trifluoro(trifluoro
methyl)-1,2-ethanediyl]]-
blocked

Hexane, 1,6-diisocyanato-, No data No data No data Food & feed No data


homopolymer, α-[1-[[[3- packaging
[[3
(dimethylamino)propyl]ami
no]propyl]amino]carbonyl]
-1,2,2,2-tetrafluoroethyl]-
ω-(1,1,2,2,3,3,3-
heptafluoropropoxy)poly[o
xy[trifluoro(trifluoromethyl
)-1,2-ethanediyl]]
Other HFP copolymers HFP 116-15-4 C 3F6 Industrial Monomer in Reg.
e.g. with TFE food 10/2011
processing
and food
transport
equipment

213
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

C opolymer of No data 116-15-4 No data Food & feed No data


hexafluoropropylene, TFE, (hexafluoro packaging
and perfluoroethyl vinyl propylene)
ether 116-14-3
10493-43-3
(vinyl
ether)
A copolymer of propylene, No data 115-07-1 No data Food & feed No data
TFE, and 3,3,3- 116-14-3 packaging
trifluoropropene cured 677-21-4
with a salt of a quarternary (trifluoropr
ammonium compound and opene)
phenol, 4,4'-(2,2,2-
trifluoro-1-
(trifluoromethyl)ethylidene
)bis-
A copolymer of TFE and No data 116-14-3 No data Food & feed No data
trifluoromethyl 1187-93-5 packaging
trifluorovinyl ether, and (ether)
optionally employing a
halogenated alkene.
2-Propen-1-ol, reaction No data 464178-90- No data Food & feed No data
products with 3 packaging
pentafluoroiodoethane-TFE
telomer, dehydroiodinated,
reaction products with
epichlorohydrin and
triethylenetetramine
1-Hexene, No data 82606-24-4 (C 6H3F9.C 2F4) Food & feed No data
3,3,4,4,5,5,6,6,6- x packaging
nonafluoro-, polymer with
1,1,2,2-tetrafluoroethene
2,3,3,4,4,5,5-Heptafluoro- No data 94228-79-2 (C 5H3F7.C 2H4. Food & feed No data
1-pentene polymer with C 2F4)x packaging
ethene and TFE
Perfluoroalkoxy alkanes PFA e.g. C 7F14O C onsumer Polymer.
(PFA); 26655-00- cookware Non-stick coating
a copolymer of: 5, for pans and
Perfluoroalkyl vinyl ether, facilitates
and tetrafluoroethene 1623-05-8 cleaning of the
116-14-3 cookware.
Industrial Monomer in Reg.
food 10/2011.
processing
and food
transport
equipment
Perfluoroethylene FEP 25067-11-2 (C 3F6.C 2F4)n C onsumer Polymer for
propylene, or Fluorinated cookware coating cookware,
Ethylene Propylene (FEP); 116-15-4 such as frying
is a copolymer of: 116-14-3 pans and articles
Hexafluoropropene (see for oven baking,

214
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

above), and- moulded articles


tetrafluoroethylene for industrial use,
and for use in
non-porous (very
good chemical
resistance) films
with excellent
abrasion
resistance.
Industrial Monomers in Reg.
food 10/2011
processing
and food
transport
equipment
Silicone Rubber, No data 64706-30- No data Industrial A silicone-based
fluorinated 65 food fluoroelastomer.
processing
and food
transport
equipment
Siloxanes and silicones, No data 1643944- No data Industrial Used as a
methyl-phenyl, methyl- 25-5 food lubricant, or a
3,3,3-trifluoropropyl processing component of,
and food bearing grease to
transport lubricate facer roll
equipment bearings in paper
and paperboard
manufacturing.
Food & feed No data
packaging

Glycine, N,N-bis[2- No data 220459-70- No data Food & feed No data


hydroxy-3-(2- 12 packaging
propenyloxy)propyl]-,
monosodium salt, reaction
products with ammonium
hydroxide and
pentafluoroiodoethane-
tetrafluoroethylene telomer
Glycine, N-ethyl-N- No data 2991-51-7 No data Food & feed No data
[(heptadecafluorooctyl)sulf 67584-51-4 packaging
onyl]-, potassium salt, or 67584-53-6
nonafluorobutyl or 67584-62-7
tridecafluorohexyl or
pentadecafluoroheptyl
Diphosphoric acid, No data 162492-15- No data Food & feed No data
polymers with ethoxylated 1 with packaging
reduced Me esters of phosphorou
reduced polymerized s pentoxide
oxidized TFE. This 1314-56-3
substance is also known or

215
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

as: phosphate esters of pyrophosph


ethoxylated perfluoroether, oric acid
prepared by reaction of 2466-09-3.
ethoxylated perfluoroether
diol.
Diphosphoric acid, No data 200013-65- No data Food & feed No data
polymers with ethoxylated 6 packaging
reduced methyl esters of
reduced polymerized
oxidized TFE
Diphosphoric acid, No data 200013-65- No data Food & feed No data
polymers with ethoxylated 6 (reduced packaging
reduced methyl esters of methyl
reduced polymerized esters)
oxidized TFE. Fomblin 162492-15-
HC /P2-1000. This 1
substance is also known as (perfluoroet
phosphate esters of her diol)
ethoxylated perfluoroether, 1314-56-3
prepared by reaction of (pentoxide)
ethoxylated perfluoroether
diol with phosphorous 2466-09-3
pentoxide or (acid)
pyrophosphoric acid

Diphosphoric acid, No data No data No data Food & feed No data


polymers with methyl packaging
esters reduced ethoxylates
oxidized reduced
polymerized tetrafluoro
ethylene
2-propenoic acid, 2- No data 1012783- (C 11H7F13O 2. Food & feed No data
hydroxyethyl ester, 70-8 C 5H8O 3. packaging
polymer with α-(1-oxo-2- (C 2H4O)nC 6H
propen-1-yl)-ω- 6O 3.(C 2H4O)n

hydroxypoly(oxy-1,2- C 3H4O 2)x


ethanediyl), α-(1-oxo-2-
propen-1-yl)-ω-[(1-oxo-2-
propen-1-yl)oxy]poly(oxy-
1,2-ethanediyl) and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-
propenoate
2-propenoic acid, 2- No data 1158951- (C 11H7F13O 2. Food & feed No data
methyl-, polymer with 2- 86-0 C 6H10O 3. packaging
hydroxyethyl 2-methyl-2- C 4H6O 2.(C 2H4
propenoate, α-(1-oxo-2- O)n
propen-1-yl)-ω- C 3H4O 2)x.xN
hydroxypoly(oxy-1,2- a
ethanediyl) and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-

216
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

propenoate, sodium salt

2-propenoic acid, 2- No data 1878204- (C 12H9F13O 2. Food & feed No data


methyl-, 2-hydroxyethyl 24-0 C 6H10O 3. packaging
ester, polymer with 2- C 3H4O 2)xxNa
propenoic acid and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-
methyl-2-propenoate,
sodium salt
2-propenoic acid, 2- No data 1206450- (C 11H7F13O 2. Food & feed No data
methyl-, 2-hydroxyethyl 10-3 C 6H10O 3. packaging
ester polymer with 1- C 6H9NO.C 3H4
ethyenyl-2-pyrrolidinone, O 2)xxNa
2-propenoic acid and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-
propenoate sodium salt

Phosphoric acid ester of No data 200013-65- No data Food & feed No data
ethoxylated perfluoropoly- 6 packaging
etherdiol 162492-15-
1
1314-56-3
2466-09-3
Diphosphate ester of N- No data No data No data Food & feed No data
ethyl perfluorooctane packaging
sulfonamido ethanol (N-
EtFOSE)

 N,N',N''- No data 2250-98-8 No data Food & feed No data


[phosphinylidynetris(oxyet packaging
hane-2,1-diyl)]tris[N-
ethylheptadecafluorooctane
-1-sulphonamide]
1-Butanaminium, N,N,N- No data 3109-63-5 No data Food & feed No data
tributyl-, packaging
hexafluorophosphate(1-)

N-Ethyl-N-(2- No data 67969-69-1 No data Food & feed No data


hydroxyethyl)perfluoroocta packaging
nesulfonamide phosphate,
diammonium salt
[SN-mono-PAP/PFPA]
1-Octanesulfonamide, N, No data 30381-98-7 No data Food & feed No data
N’-(phosphinicobis(oxy-2, packaging
1-ethanediyl))bis(N, ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7
,8,8,8-heptadecafluoro-,
ammonium salt)

217
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Perfluoroalkyl(C 6-C16) No data 65530-64-5 No data Food & feed No data


phosphates of bis(2- packaging
hydroxyethyl)amine
or
Diethanolamine salts of
mono- and
bis(1H,1H,2H,2H-
perfluoroalkyl(C 8-C18)
phosphates
[mono- and di-PAP, FT]
Ethanol, 2,2′-iminobis-, No data 65530-64-5 NH2+(C H2C Non-food PFAS that have
compd. with α,α′- H2OH) P&B been patented for
[phosphinicobis (oxy-2,1- (O)P(O– packaging use in paper
ethanediyl)]bis[ω- )(OC H2C H2C packaging for
fluoropoly(difluoromethyle nF2n+1)2 non-food articles
ne)] (1:1)
Perfluoroalkyl substituted No data No data No data Food & feed No data
phosphate ester acids, packaging
ammonium salts formed by
the reaction of 2,2-bis[
([gamma], [omega]-
perfluoro C 4-20 alkylthio)
methyl]-1,3-propanediol,
polyphosphoric acid and
ammonium hydroxide
Ammonium bis(N-ethyl-2- No data No data No data Food & feed No data
perfluoroalkylsulfonamido packaging
ethyl) phosphates,
containing not more than
15% ammonium mono (N-
ethyl-2-
perfluoroalkylsulfonamido
ethyl) phosphates, where
the alkyl group is more
than 95% C 8 and the salts
have a fluorine content of
50.2% to 52.8% as
determined on a solids
basis
Ammonium salts of esters No data No data No data Food & feed No data
from reaction with 2,2’-bis packaging
perfluoralkyl substituted
phosphoric acid formates
[(alfa, omega-perfluoro
C 4-C 20 alkylthio) methyl] -
1,3-propanediol,
polyphosphoric acid and
ammonium hydroxide

218
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Ammonium-bis- (N-ethyl- No data No data No data Food & feed No data


2- packaging
perfluoralkylsulfonamidoet
hyl) phosphate cannot
contain more than 15%
ammonium mono(N-ethyl-
2-
perfluoralkylsulfonamidoet
hyl) phosphate
Ammonium bis (N-ethyl-2- No data No data No data Food & feed No data
perfluorooctansulfonamidet packaging
hyl) phosphate with
maximum content of 15%
ammonium mono (N-ethyl-
2-
perfluorctansulfonamidethy
l) phosphate
Ammonium-bis- (N-ethyl- No data 1071022- (C 12H9F13O 2. Food & feed No data
2- 26-8 C 10H19NO 2. packaging
perfluorooktansulfonamidet C 4H6O 2.C 3H4
hyl) phosphate with O 2)x.xC 2H4O2
maximum content of 15%
ammonium mono (N-ethyl-
2-
perfluoroktansulfonamideth
yl) phosphate
Diethanolamine salts of No data No data No data Food & feed No data
mono- and bis packaging
(1H,1H,2H,2H
perfluoroalkyl)
phosphates where the alkyl
group is even-numbered in
the range C 8-C 18 and the
salts have a fluorine
content of 52.4% to 54.4%
as determined on a solids
basis.
Diethanolamine single No data No data No data Food & feed No data
(1H,1H,2H,2H -perfluoro- packaging
alkyl) phosphate and dual-
(1H,1H,2H,2H-perfluoro-
alkyl) phosphate.
Diethanol amino salts of No data No data No data Food & feed No data
mono- and bis (1H, 1H, packaging
2H, 2H-perfluoroalkyl)
phosphates
2-Propenoic acid, 2- No data 1334473- (C 11H7F13O 2. Food & feed No data
methyl-, 2- 84-5 C 8H15NO 2. packaging
(dimethylamino)ethyl C 6H9NO)x.xC
ester, polymer with 1- 2H4O 2
ethenyl-2-pyrrolidinone
and

219
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-
propenoate, acetate

2-Propenoic acid, No data 68228-00-2 No data Food & feed No data


3,3,4,4,5,5,6,6,7,7,8,8,8- packaging
tridecafluorooctyl ester,
polymer with α-(1-oxo-2-
propen-1-yl)-ω-
hydroxypoly(oxy-1,2-
ethanediyl)
Butanedioic acid, 2- No data 1345817- No data Food & feed No data
methylene-, polymer with 52-8 packaging
2-hydroxyethyl, 2-methyl-
2-propenoate, 2-methyl-2-
propenoic acid and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-
methyl-2-propenoate,
sodium salt

2Butanedioic acid, 2- No data 1345817- (C 12H9F13O 2. Food & feed No data


methylene-, polymer with 52-8 C 6H10O 3. packaging
2-hydroxyethyl 2-methyl- C 5H6O 4.C 4H6
2-propenoate, 2-methyl-2- O 2)x.xNa
propenoic acid and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl 2-
methyl-2-propenoate,
sodium salt
Perfluoropentanoic acid PFPeA 2706-90-3 No data Industrial Perfluoropenta
Perfluoropentadecanoic PFPeDA and food acids (PFPEs) are
acid 141074-63- processing used as lubricants
7 and food during
transport production,
equipment processing, and
packaging of
food.
C opolymer of TFE, PFMVE No data 105656-63- (C 4H3BrF4.C 3 Industrial Monomers in Reg.
and 1 F6O.C 2H4. food 10/2011
1-Butene, 4-bromo- C 2F4)x processing
3,3,4,4-tetrafluoro-, and food
polymer with ethene, transport
1,1,2,2-tetrafluoroethene equipment
and 1,1,2-trifluoro-2- Food & feed No data
(trifluoromethoxy)ethene. packaging
intended to be cross-linked
with triallylisocyanurate
A copolymer of TFE and No data 26425-79-6 No data Industrial Monomers in Reg.
PFMVE modified with 1,3,5- (TFE and food 10/2011
triallyl isocyanurate or PFMVE) processing
1,3,5-triallyl cyanurate and and food

220
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

3,3,4,4,5,5,6,6,7,7,8,8- transport
dodecafluoro-1,9-diene, equipment
manufactured and
characterised as further
described in the
notification
A copolymer of TFE and No data 26425-79-6 No data Food & feed No data
perfluoromethylvinyl ether packaging
(PFMVE) modified with
1,3,5-triallyl isocyanurate
(TAIC ) and
3,3,4,4,5,5,6,6,7,7,8,8-
dodecafluoro-1,9-diene,
manufactured and
characterized as further
described in the
notification
A copolymer of TFE and No data 26425-79-6 No data Food & feed No data
PFMVE \ modified with packaging
3,3,4,4,5,5,6,6,7,7,8,8-
dodecafluoro-1,9-diene
and 1,3,5-triallyl cyanurate
or 1,3,5-triallyl
isocyanurate
A perfluorocarbon cured No data 116-14-3 No data Industrial Monomers in Reg.
elastomer (PC E) produced (TFE) C 4F8O food 10/2011
by terpolymerizing TFE, 1187-93-5 No data processing
PFMVE and perfluoro-6,6- (PFMVE) and food
dihydro-6-iodo-3-oxa-1- 106108-22- No data transport
hexane, and subsequent 9 equipment
curing of the terpolymer (perfluoro- No data Food & feed
with triallylisocyanurate alkane) No data packaging
and 2,5-dimethyl-2,5-di(t- 193018-53-
butylperoxy)hexane 0
(terpolymer
)
1025-15-6
(triallylisoc
yanurate)
78-63-7
(hexane)
A perfluorocarbon cured No data 116-14-3 No data Food & feed No data
elastomer (PC E) produced 2599-84-0 packaging
by terpolymerizing TFE, , (vinyl
perfluoro-2,5-dimethyl- ether)
3,6-dioxanonane vinyl 106108-22-
ether, and perfluoro-6,6- 9 (hexene)
dihydro-6-iodo-3-oxa-1- 106108-23-
hexene, and subsequent 0
curing of the terpolymer (terpolymer
with triallylisocyanurate )
and 2,5-dimethyl-2,5-di(t- 1025-15-6

221
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

butylperoxy)hexane 78-63-7

Perfluorocarbon cured No data 1187-93-5 No data Food & feed No data


elastomers produced by (methyl packaging
polymerizing perfluoro vinyl
(methyl vinyl ether) with ether)
TFE and perfluoro(8-cyano 116-14-3
-5-methyl -3,6-dioxa -1- 69804-19-9
octene, followed by curing (per fluoro
with trimethylallyl octene)
isocyanurate and/or triallyl 6291-95-8
isocyanurate, and with 2,5 1025-15-6
-dimethyl -2,5-di (t- 78-63-7
butylperoxy) hexane and
as further described in this
notification
A perfluorocarbon-cured No data 116-14-3 No data Industrial Monomers in Reg.
elastomer (PC E) produced (TFE) food 10/2011
by terpolymerizing TFE 2599-84-0 processing
perfluoro (2,5-dimethyl- (vinyl and food
3,6-dioxanone vinyl ether) ether) transport
and perfluoro (6,6-dihydro- 106108-22- equipment
6-iodo- 3-oxa- 1-hexene) 9 (perfluoro Food & feed
and subsequent curing of alkene) packaging
the terpolymer by 106108-23-
crosslinking with 0
triallylcyanurate and (terpolymer
vulcanizing with 2,5- )
dimethyl- 2,5-di (t- 101-37-1
butylperoxy) hexane, as a (triallycyan
68% dispersion on finely urate)
divided silica 78-63-7
(hexane)
1,9- No data 190062-24- No data Industrial Monomers in Reg.
Decadiene,3,3,4,4,5,5,6,6- 9 (trifluoro food 10/2011
,7,7,8,8-dodecafluoro-, ethene) processing
polymer with TFE and and food
trifluoro transport
(trifluoromethoxy)ethene equipment
manufactured and Food & feed
characterized as further packaging
described in the
notification.
3-cyclohexane-1-carboxylic No data No data No data Food & feed No data
acid, 6-((di-2- packaging
propenylamino)carbonyl)-
,(1R,6R), reaction products
with
pentafluoroiodoethane-

222
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

tetrafluoroethylene
telomer, ammonium salts

C opolymer of 1,1- No data No data No data Food & feed No data


difluoroethylene, packaging
hexafluoropropene, TFE,
and a halogenated alkene,
optionally cured with
triallyl isocyanurate and
2,5-dimethyl-2,5-di(tert-
butylperoxy)hexane
1-Propene,1,1,2,3,3,3- No data 25190-89-0 No data Industrial Monomers in Reg.
hexafluoro-polymer with (polymer food 10/2011
1,1-difluoroethene and TFE with ethene processing
modified with triallyl and TFE) and food
isocyanurate and transport
3,3,4,4,5,5,6,6,7,7,8,8- equipment
dodecafluoro-1,9-diene, Food & feed
manufactured and packaging
characterised as further
described in the
notification.
Tetrafluoroethylene- No data 25190-89-0 (C F2C F2)x- Food & feed No data
hexafluoropropylene- (C F2C FC F3)y- packaging
vinylidene fluoride (C F2C H2)
copolymers
Tetrafluoroethylene- No data 68258-85-5 No data Food & feed No data
ethylene-3,3,4,4,5,5,6,6,6- packaging
nonafluoro-1-hexene
terpolymer
Ethene, 1,1,2,2- No data 31784-04-0 (C F2C F2)x- Food & feed No data
tetrafluoro-, polymer with (C F2C FOC 2F5) packaging
1,1,2-trifluoro-2- y
(1,1,2,2,2-
pentafluoroethoxy)ethene
Ethene, tetrafluoro-, No data 56357-87-0 No data Food & feed No data
polymer with 1,1- packaging
difluoroethene and
trifluoro(trifluoromethoxy)e
thene modified with 1,3,5-
triallyl isocyanurate (TAIC )
and
3,3,4,4,5,5,6,6,7,7,8,8-
dodecafluoro-1,9-diene,
manufactured and
characterized as further
described in the
notification
Poly(hexafluoro-propylene No data 25038-02-2 No data Food & feed No data
oxide) packaging

223
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

A polymer produced from No data 116-14-3 No data Industrial Monomers in Reg.


TFE and 1,1,2,2- (TFE) food 10/2011
tetrafluoro-2-((1,2,2- 29514-94-1 processing
trifluoroethenyl)oxy) (fluoride) and food
ethane sulfonyl fluoride. transport
The polymer is hydrolysed equipment
and may optionally be Food & feed
further neutralized to its packaging
ammonium salt.
Ethene, tetrafluoro-, No data 56357-87-0 No data Industrial Monomers in Reg.
polymer with 1,1- (ethene, food 10/2011
difluoroethene and fluoro, processing
trifluoro(trifluoromethoxy)e polymer and food
thene modified with 1,3,5- mixture) transport
triallyl isocyanurate (TAIC ) equipment
and
3,3,4,4,5,5,6,6,7,7,8,8-
dodecafluoro-1,9-diene,
manufactured and
characterized as further
described in the
notification
Fluorocarbon cured No data 116-14-3 No data Industrial Monomers in Reg.
elastomer produced by (TFE) food 10/2011
copolymerizing TFE and 115-07-1 processing
propylene and subsequent (propylene) and food
curing of the copolymer 27029-05-6 transport
with triallylisocyanurate (copolymer equipment
and 2,2’bis-(t-butylperoxy) ) Food & feed
diisopropylbenzene. 1025-15-6 packaging
(triallylisoc
yanurate)
25155-25-3
(2,2’bis-(t-
butylperoxy
)
diisopropyl
benzen)
Fluorocarbon cured No data 116-14-3 No data Food & feed No data
elastomer produced by (TFE) packaging
copolymerizing 115-07-1
tetrafluoroethylene and (propylene)
propylene and subsequent
curing of the copolymer 1025-15-6
with triallylisocyanurate (triallylisoc
and 2,2'-bis(tert- yanurate)
butylperoxy) 25155-25-3
diisopropylbenzene (benzene)

224
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Fluorocarbon cured No data 116-14-3 (C 6H3F9.C 2H4. Food & feed No data
elastomer produced by 115-07-1 C 2F4)x packaging
copolymerizing TFE and 1025-15-6
propylene and subsequent 101-37-1
curing with (triallylcyan
triallylisocyanurate or urate)
triallylcyanurate and 2,2’- 25155-25-3
bis(tert-butylperoxy)
diisopropylbenzene
Ethylene ETFE 25038-71-5 No data Industrial Monomer in Reg.
tetrafluoroethylene food 10/2011
copolymer processing
and food
transport
equipment
C hlorotrifluoroethylene EC TFE 79-38-9 No data Industrial Monomer in Reg.
food 10/2011
processing
and food
transport
equipment
C opolymer of TFE, PFMVE No data No data No data Food & feed No data
and 1-iodo-2-bromotetra- packaging
fluoroethane intended to
be cross-linked with
triallylisocyanurate

C opolymer No data No data No data Food & feed No data


perfluoroalkylacrylate packaging

C opolymers of 2- No data No data No data Food & feed No data


(perfluoroctylsulfonylamino packaging
methyl) ethylmethacrylate,
2,3-
epoxypropylmethacrylate,
ethoxyethylacrylate and
methacryloylmethyl-
trimethylammoniumchlorid
e
C opolymers of 2- No data No data No data Food & feed No data
perfluoroalkylethyl packaging
acrylate, 2-N,N-
diethylaminoethyl
methacrylate, glycidyl
methacrylate, acrylic acid,
and methacrylic acid2
C opolymer of No data No data No data Food & feed No data
3,3,4,4,5,5,6,6,7,7,8,8,8- packaging
tridecafluorooctylacrylate,
2-hydroxyethylacrylate,
polyethylenglycolmonacryla

225
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

te and
polyethylenglycoldiacrylate
with a fluorine content of
35.4 – 45.1%
C opolymer of 2- No data 1440528- No data Food & feed No data
(dimethylamino) ethyl 04-0 packaging
methacrylate with
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl
methacrylate, N-oxide,
acetate
C opolymer of 2- No data No data No data Food & feed No data
dimethylaminoethylmethac packaging
rylate and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctylmethacryl
ate, N-oxide, acetate, with
a fluorine content of 45%

C opolymer with 2,2’- No data No data No data Food & feed No data
ethylendioxydiethyldimetha packaging
crylat, 2-hydroxyethyl-
methacrylate and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctylmethacryl
ate, acetate and/or malate
C opolymer with 2- No data No data No data Food & feed No data
hydroxyethylmethacrylate, packaging
methacrylic acid, itaconic
acid and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctylmethacryl
ate, sodium salt
C opolymer with 2- No data No data No data Food & feed No data
hydroxyethylmethacrylate, packaging
vinylpyrrolidon, acrylic acid
and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctylacrylate,
sodium salt, with a fluorine
content of 41.9%

C opolymer with No data No data No data Food & feed No data


methacrylic acid, 2- packaging
hydroxyethylmethacrylate,
polyethylenglycolmonacryla
te and
3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctylacrylate,

226
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

sodium salt with a fluorine


content of 45.1%

Perfluoroalkyl acrylate No data 92265-81-1 No data Food & feed No data


copolymer (C AS Reg. No. packaging
92265-81-1) containing 35
to
40 weight percent fluorine,
produced by the
copolymerization of
ethanaminium,N,N,Ntrimet
hyl-2-[(2-methyl-1-oxo-2-
propenyl)-oxy]-,
chloride; 2-propenoic acid,
2-methyl-, oxiranylmethyl
ester; 2-propenoic acid,
2-ethoxyethyl ester; and
2-propenoic acid, 2-
(heptadecafluoro-
octyl)sulfonyl]
methyl amino]ethyl ester
C opolymers of 2- No data 247047-61- No data Food & feed No data
perfluoroalkylethyl 6 packaging
acrylate, 2-N,N-
diethylaminoethyl
methacrylate, and glycidyl
methacrylate.
C opolymer of 2- No data 479029-28- No data Food & feed No data
perfluoroalkylethyl 2 (2- packaging
acrylate, 2- (dimethyla
(dimethylamino)ethyl mino)ethyl
methacrylate, and oxidized methacrylat
2-(dimethylamino)ethyl e
methacrylate
C opolymer of No data 1225273- (C 14H22O 6.C 12 Food & feed No data
perfluorohexylethyl 44-8 H9F13O 2. packaging
methacrylate, 2-N,N- C 10H19NO 2.C
diethylaminoethyl 6H10O 3)x.

methacrylate, 2- xC 4H6O 5
hydroxyethyl methacrylate,
and 2,2'-
ethylenedioxydiethyl
dimethacrylate, malic acid
salt
C opolymer of No data 863408-20- (C 14H22O 6.C 12 Food & feed No data
perfluorohexylethyl 2 H9F13O 2. packaging
methacrylate, 2-N,N- C 10H19NO 2.C
diethylaminoethyl 6H10O 3)x.

methacrylate, 2- xC 2H4O 2

227
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

hydroxyethyl methacrylate,
and 2,2'-
ethylenedioxydiethyl
dimethacrylate, acetic acid
salt
C opolymer of No data 863408-20- No data Food & feed No data
perfluorohexylethyl 2 or packaging
methacrylate, 2-N,N- malic acid
diethylaminoethyl salt
methacrylate, 2- 1225273-
hydroxyethyl methacrylate, 44-8
and 2,2'-
ethylenedioxydiethyl
dimethacrylate, acetic acid
salt or malic acid salt.
2,3-Epoxypropyl No data 92265-81-1 No data Food & feed No data
methacrylate - 2- packaging
ethoxyethyl acrylate - N-
methylperfluorooctane-
sulfonamidoethyl acrylate -
trimethylethanolammoniu
m chloride methacrylate,
copolymer
2-(Perfluorooctyl sulfonyl No data No data No data Food & feed No data
aminomethyl) ethyl packaging
methacrylate, copolymer
[copolymer of fluorinated
(meth)acrylate polymers]
Methacrylic acid, 2- No data 479029-28- No data Food & feed No data
(dimethylamino)ethyl 2 packaging
ester, polymers with
gamma-omega-per- fluoro-
C 8-14-alkyl acrylate,
acetates, N-oxides
Methacrylic acid, 2- No data 783306-31- No data Food & feed No data
(dimethylamino)ethyl 0 packaging
ester, polymers with
gamma-omega-per- fluoro-
C 8-14-alkyl acrylate, N-
oxides
Perfluoroalkyl acrylate No data 152521-13- No data Food & feed No data
copolymers including: 6, 90451- packaging
Perfluoroalkyl acrylate 86-8
copolymer (Foraperle 321)
2-Propenoic acid,2-methyl- 196316-34-
, 2-(dimethylamino) ethyl 4
ester, polymers with g-w-
perfluoro-C 10-16-alkyl
acrylate and vinyl acetate,
acetates

228
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Acetic salts of the No data No data No data Food & feed No data
copolymer of packaging
perfluoroalkylethylacrylate,
vinyl acetate and dimethyl
aminoethylmetacrylate
2-(Diethylamino)ethyl No data No data No data Food & feed No data
methacrylate – 2,3- packaging
epoxypropyl methacrylate
– perfluoroalkyl(C 4-
C 18)ethyl acryl
2-(Dimethylamino)ethyl No data No data No data Food & feed No data
methacrylate – packaging
perfluoroalkylethyl acrylate
– vinyl acetate, copolymer
Fluorinated polyurethane No data 328389-91- No data Food & feed No data
anionic resin prepared by 9 packaging
reacting perfluoropolyether (polyuretha
diol, isophorone ne)
diisocyanate, 2,2- 88645-29-8
dimethylolpropionic acid (diol)
and triethylamine 4098-71-9
(diisocyana
te)
4767-03-7
(acid)
121-44-8
(triethylami
ne)
2-Propen-1-ol, reaction No data * 355-43-1 No data Food & feed No data
products with packaging
1,1,1,2,2,3,3,4,4,5,5,6,6-
tridecafluoro-6-
iodohexane*,
de-hydroiodinated,
reaction products with
epichlorohydrin and
triethylenetetraamine with
a fluorine content of 54%
2-propen-1-ol, reaction No data 464178-94- No data Food & feed No data
products with 7 packaging
1,l,1,2,2,3,3,4,4,5,5,6,6-
tridecafluoro-6-
iodohexane,
dehydroiodinated, reaction
products with
epichlorohydrin and
triethylenetetramine
Piperazinium, 1- (2- No data 103555-98- C l‒ Non-food PFAS that have
hydroxyethyl) -1-methyl-4- 2 C nF2n+1C (O P&B been patented for
(perfluoro-1-oxoalkyl) -, )NC 4H8N+(C packaging use in paper
chloride (1:1) H3) packaging for
C H2C H2OH non-food articles

229
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Poly(oxy-1,2-ethanediyl), No data 138226-34- NH4+ Non-food


α-sulfo-ω- 3 C nF2n+1OC 6 P&B
[(perfluoroalkyl)oxy]-, H4SO3‒ packaging
sodium salt
Poly(oxy-1,2-ethanediyl), No data 138226-35- C nF2n+1SO2 Non-food
α-[2- 4 N(C 3H7)C H2 P&B
[[(pentadecafluoroheptyl) C H2 packaging
sulfonyl]propylamino]ethyl (OC H2C H2)x
]-ω-hydroxy OH
Poly(oxy-1,2-ethanediyl), No data 138226-36- C nF2n+1OC 6 Non-food
α-[[4-[(perfluoroalkyl)oxy] 5 H4C H2(OC H P&B
phenyl]methyl]-ω-[[4- 2C H2)x packaging
[(nonadecafluorononyl)oxy OC H2C 6H4O
] phenyl]methoxy] C nF2n+1
Ethanol, 2-[2- No data 138473-75- 2 Na+ Non-food
[(perfluoroalkyl)oxy]ethoxy 3 C nF2n+1C H2 P&B
]-, dihydrogen phosphate, OC H2C H2O packaging
disodium salt C H2C H2OPO
32‒
Ethanol, 2- No data 138473-76- NH4+ PO2‒ Non-food
[methyl(perfluoroalkyl)ami 4 (OC H2C H2N P&B
no]-, hydrogen phosphate (C H3)C H2C H packaging
(ester), ammonium salt 2C nF2n+1)2
Benzenesulfonic acid, 4- No data 138473-77- NH4+ Non-food
[(perfluoroalkyl)oxy]-, 5 C nF2n+1OC 6 P&B
ammonium salt (1:1) H4SO3‒ packaging

C arbamic acid, No data 138473-78- Na+ Non-food


[(perfluoroalkyl)sulfonyl]pr 6 C nF2n+1SO2 P&B
opyl-, sodium salt N(C 3H7)C OO packaging

Glycine, N-ethyl-N- No data 138473-79- NH4+ Non-food
(perfluoro-1-oxoalkyl)-, 7 C nF2n+1C (O P&B
ammonium salt )N(C 2H5)C H packaging
2 C OO‒
1-Propanaminium, N- No data 138473-80- C nF2n+1SO2 Non-food
(carboxymethyl)-N,N- 0 N(C 3H7)C H2 P&B
diethyl-3- C H2 packaging
[propyl[(perfluoroalkyl)sulf C H2N+(C 2H
onyl]amino]-, inner salt 5)2C H2C OO‒
Poly(oxy-1,2-ethanediyl), No data 138570-74- C nF2n+1SO2 Non-food
α-[2-[[(perfluoroalkyl) 8 N(C 3H7)O(C P&B
sulfonyl]propylamino]ethyl H2C H2 packaging
]-ω-[2-[[(perfluoroalkyl) O)xC H2C H2N
sulfonyl]propylamino]ethox (C 3H7)SO2C
y]- n F2n+1
Potassium perfluoroalkane No data 2795-39-3 K+ Non-food
sulfonate C nF2n+1SO3 P&B
‒ packaging

230
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

1-Propanaminium, 3- No data 38006-74-5 C l‒ Non-food


[[(perfluoroalkyl)sulfonyl]a C nF2n+1SO2 P&B
mino]-N,N,N-trimethyl-, NHC H2C H2 packaging
chloride (1:1) C H2N+(C H3)
3
1-Alkanesulfonamide, No data 64264-44-4 C nF2n+1SO2 Non-food
perfluoro-N-[2- N(C 3H7)C H2 P&B
(phosphonooxy) ethyl]-N- C H2OP packaging
propyl (=O)(OH)2
Ethanol, 2,2′-iminobis-, No data 65530-63-4 NH2+ Non-food
compd. with α-fluoro-ω-[2- (C H2C H2OH) P&B
(phosphonooxy)ethyl]poly( C nF2n+1C H2 packaging
difluoromethylene) C H2OPO3H‒
(2:1)4a
NH2+ (C H2C H2OH)
C nF2n+1C H2 C H2OPO3H‒
not specified
65530-63-4
1-Propanaminium, N- No data 90179-39-8 C nF2n+1OC 6 Non-food
(carboxymethyl)-N,N- H4C H2(OC H P&B
dimethyl-3-[(perfluoro-1- 2C H2)x packaging
oxoalkyl)amino]-, inner OC H2C 6H4O
salt C nF2n+1
Piperazinium, 1-(2- No data 103555-98- C l‒ Non-food
hydroxyethyl)-1-methyl-4- 2 C nF2n+1C (O P&B
(perfluoro-1-oxoalkyl)-, )NC 4H8N+(C packaging
chloride (1:1) H3)
C H2C H2OH
Oxirane, 2- No data 122193-68- C nF2n+1C H2 Non-food
[[(perfluoroalkyl)oxy]meth 4 C H2OC H2C 2 P&B
yl]- OH3 (n packaging
=6)
Poly(oxy-1,2-ethanediyl), No data 138226-34- NH4+ Non-food
α-sulfo-ω- 3 C nF2n+1OC 6 P&B
[(perfluoroalkyl)oxy]-, H4SO3‒ packaging
sodium salt
Poly(oxy-1,2-ethanediyl), No data 138226-35- C nF2n+1SO2 Non-food
α-[2- 4 N(C 3H7)C H2 P&B
[[(pentadecafluoroheptyl) C H2 packaging
sulfonyl]propylamino]ethyl (OC H2C H2)x
]-ω-hydroxy OH
Poly(oxy-1,2-ethanediyl), No data 138226-36- C nF2n+1OC 6 Non-food
α-[[4-[(perfluoroalkyl)oxy] 5 H4C H2(OC H P&B
phenyl]methyl]-ω-[[4- 2C H2)x packaging
[(nonadecafluorononyl)oxy OC H2C 6H4O
] phenyl]methoxy] C nF2n+1
Ethanol, 2-[2- No data 138473-75- 2 Na+ Non-food
[(perfluoroalkyl)oxy]ethoxy 3 C nF2n+1C H2 P&B
]-, dihydrogen phosphate, OC H2C H2O packaging
disodium salt C H2C H2OPO
32‒

231
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name* Abbre- CAS Chemical Use Function and


viation Number** Formula Regulatory
Listing†

Ethanol, 2- No data 138473-76- NH4+ PO2‒ Non-food


[methyl(perfluoroalkyl)ami 4 (OC H2C H2N P&B
no]-, hydrogen phosphate (C H3)C H2C H packaging
(ester), ammonium salt 2C nF2n+1)2
Benzenesulfonic acid, 4- No data 138473-77- NH4+ Non-food
[(perfluoroalkyl)oxy]-, 5 C nF2n+1OC 6 P&B
ammonium salt (1:1) H4SO3‒ packaging

C arbamic acid, No data 138473-78- Na+ Non-food


[(perfluoroalkyl)sulfonyl]pr 6 C nF2n+1SO2 P&B
opyl-, sodium salt N(C 3H7)C OO packaging

Glycine, N-ethyl-N- No data 138473-79- NH4+ Non-food
(perfluoro-1-oxoalkyl)-, 7 C nF2n+1C (O P&B
ammonium salt )N(C 2H5)C H packaging
2 C OO‒
1-Propanaminium, N- No data 138473-80- C nF2n+1SO2 Non-food
(carboxymethyl)-N,N- 0 N(C 3H7)C H2 P&B
diethyl-3- C H2 packaging
[propyl[(perfluoroalkyl)sulf C H2N+(C 2H
onyl]amino]-, inner salt 5)2C H2C OO‒
PPA = polymer processing additive

*PFAS identified as being used in packaging from Glüge et al. (2020), PFAS in Paper and Board for Food
C ontact (Trier et al., 2018), Per and polyfluoroalkyl substances (PFAS in food contact material (RIVM,
2019), Product – C hemical Profile for Food Packaging C ontaining Perfluoroalkyl or Polyfluoroalkyl
Substances (DTSC , 2020), BfR recommendations (BfR, 2020), US EPA food contact database (FDA-US,
2021), some patents and individual EFSA opinion substance reports.

**C AS number where data available.

†Regulatory listing mainly refers to C ommission Regulation (EU) No. 10/2011 of 14 January 2011 on
plastic materials and articles intended to come into contact with food, but in some cases US EPA and
other listing is specified.
Table A.82. PFAS Positively Identified as Used/Were Used in Consumer Cookware. Source:
see note below table.
Substance Name Abbreviation CAS Chemical Function and Listing in
Number** Formula EU Regulation
10/2011

Perfluorooctanoic PFOA 3825-26-1 C 8HF15O 2 Listed in Reg. 10/2011.


acid, ammonium salt
Short-C hain PFAS.
Emulsifier (PPA), but no
current use. Previously
used in manufacture of
PTFE as a PPA. Listed in
10/2011 as only to be
used in repeated-use
articles, sintered at high
temperatures.

232
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name Abbreviation CAS Chemical Function and Listing in


Number** Formula EU Regulation
10/2011

2,3,3,3-tetrafluoro-2- GenX, 13252-13-6 C 6HF11O 3 PPA in Reg. 10/2011.


heptafluoropropoxy)- HFPO-DA,
propinoic acid; or FRD-903 Emulsifier. Replacement
perfluoro[2-(n- for PFOA in production of
propoxy)propanoic PTFE. For use as top
acid] layer for cooking, baking
and roasting utensils,
used at max temperature
of
230 °C .
Hexafluoropropylene No data 116-15-4 C 3F6 Monomer in Reg.
10/2011.
For use in temperature
resistant polymer coating
systems for frying,
cooking and baking
utensils.
Perfluoroalkyl vinyl e.g. e.g. C 3F6O Monomers listed in Reg.
ethers: PFMVE 1187-93-5 (PFMVE) 10/2011.
Perfluoromethyl vinyl PFEVE 10493-43-3 C 4F8O
ether PFPVE 1623-05-8 (PFEVE) For use in temperature
Perfluoroethyl vinyl C 5F10O resistant polymer coating
ether (PFPVE) systems for frying,
Perfluoropropyl vinyl cooking and baking
ether utensils and moulded
articles for industrial use.

Anti-stick coatings.
For manufacturing of
PTFE for use as top layer
for cooking, baking and
roasting utensils, used at
max temperature of
230 °C .
C hlorotrifluoroethylen No data 79-38-9 C lC F=C F2 Monomer
e Listed in 10/2011 (The
monomer is not a PFAS,
the polymer is a PFAS).
Vinylidene fluoride No data 75-38-7 C H2C F2 Monomer
Listed in 10/2011. (The
monomer is not a PFAS,
the polymer is a PFAS).
(Perfluorobutyl)ethyle No data 19430-93-4 C 6H3F9 Monomers listed in Reg.
ne 10/2011.

C o-monomer.
For use in polymers,
sintered at high
temperatures.

233
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name Abbreviation CAS Chemical Function and Listing in


Number** Formula EU Regulation
10/2011

2,3,3,4,4,5,5- No data 1547-26-8 C 5H3F7 Monomer


Heptafluoro-1- Listed in 10/2011.
pentene
For fluoro-copolymers for
their application as a
PPA.
Perfluoro[(2-ethyloxy- No data 908020-52-0 C 6HF11O 4 Monomer and emulsifier
ethoxy)acetic acid]], (+ NH3) (PPA) Listed in 10/2011.
ammonium salt
For use in temperature
resistant polymer coating
systems for frying,
cooking and baking
utensils.
as FC M.
Sodium 4- No data e.g. C 15H4F19 Monomer and emulsifier
perfluorononyloxy- 59536-17-3 NaO 4S (PPA)
benzenesulphonate Only for use in coatings
on kitchen utensils for
cooking, baking, roasting
etc.
Perfluoro[2-(poly(n- No data 51798-33-5 (C 3F6O)n Monomer and emulsifier
propoxy))propanoic C 6HF11O 3 (PPA) Listed in 10/2011.
acid] or
perfluoropolyether For the emulsion
carboxylic acid polymerisation of FPs.
Perfluoro acetic acid, No data 329238-24-6 C 3F6C lO- PPA Listed in 10/2011.
α-substituted with the [C F2-
copolymer of C F(C F3)- For FPs that are
perfluoro-1,2- O]n- processed at
propylene glycol and [C F(C F3)- temperatures at or above
perfluoro-1,1- O]m- 340 °C and are intended
ethylene glycol, C F2C OOH for use in repeated use
terminated with articles.
chlorohexa- Listed in 10/2011 as
fluoropropyloxy FC M.
groups
2H-perfluoro- No data 37486-69-4 No data PPA Listed in 10/2011.
[(5,8,11,14-
tetramethyl)- For use in FPs that are
tetraethyleneglycol processed at
ethyl propyl ether] temperatures at or above
300 °C (in repeated use)
or 360 °C (in single use)
articles.
perfluoro{acetic acid, No data 1190931-27-1 No data PPA Listed in 10/2011.
2-[(5- methoxy-1,3-
dioxolan-4-yl)oxy]}, Emulsifier/
ammonium salt dispersing agent (PPA).
For FPs processed at
temperatures at or above

234
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Name Abbreviation CAS Chemical Function and Listing in


Number** Formula EU Regulation
10/2011

370 °C .

3H-perfluoro-3-[(3- ADONA 958445-44-8 No data PPA Listed in 10/2011.


methoxy- Emulsifier for use in the
propoxy)propanoic polymerisation of FPs
acid], ammonium salt that are processed at
temperatures at or above
190 °C .

Polytetrafluoroethylen PTFE 9002-84-0 (C 2F4)n Monomer


e; 116-14-3 Listed in 10/2011.
a polymer of:
tetrafluoroethylene Polymer for coating
cookware, such as
coatings on frying pans
and articles for oven
baking, and moulded
articles for industrial use.
Temperature resistant
polymer coating systems
for frying, cooking and
baking utensils.
Non-stick baking paper,
films, foil and cooking
bags.
Perfluoroalkoxy PFA e.g. C 7F14O Polymer.
alkanes (PFA); 26655-00-5, Non-stick coating for
a copolymer of: 1623-05-8 pans and facilitates
Perfluoroalkyl vinyl 116-14-3 cleaning of the cookware.
ether, and
tetrafluoroethene
Perfluoroethylene FEP 25067-11-2 (C 3F6.C 2F4 Polymer for coating
propylene, or 116-15-4 )n cookware, such as frying
Fluorinated Ethylene 116-14-3 pans and articles for
Propylene (FEP); is a oven baking, moulded
copolymer of: articles for industrial use,
Hexafluoropropene and for use in non-
(see above), and- porous (very good
tetrafluoroethylene chemical resistance)
films with excellent
abrasion resistance.
Lower melting
temperature than PTFE.
Note : PFAS positively ide ntified as used in packaging from Glüge e t al. (2020), PFAS in Paper and Board for Food
C ontact (Trier e t al., 2018), Per and polyfluoroalkyl substances (PFAS in food contact material (RIVM, 2019), Product
– C he mical Profile for Food Packaging C ontaining Pe rfluoroalkyl or Polyfluoroalkyl Substances (DTSC, 2020), BfR
re com mendations (BfR, 2020), US EPA food contact database (FDA-US, 2021) and individual EFSA opinion substance
re ports. **CAS number whe re available. PPA = polymer processing additive, 10/2011 is a reference to Commission
R e gulation (EU) No. 10/2011 of 14 January 2011 on plastic m aterials and articles intended to come into contact with
food.

235
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.5. Metal plating and manufacture of metal


products
Table A.83. PFAS used (or patented) in metal plating processes and in the manufacture of
metal products.
Group/substance EU market (t/y) Source
Metal plating
3,3,4,4 5 5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic 10-100 (registration (UBA, 2022)
acid dossier, volume not
(6:2 FTS) limited to the use of
metal plating)
N,N,N,-triethylethanaminium 1,1,2,2,3,3,4,4,4- 1-10 (registration (NEA, 2017)
nonafluorobutane-1-sulfonate (derivate of PFBS) dossier, volume not
limited to the use of
metal plating)
Potassium 1,1,2,2-tetrafluoro-2- Unknown – not (KEMI, 2015;
(perfluorohexyloxo)ethane sulfonate (F-53) registered. Wang et al.,
Potassium 2-(6-chloro-1,1,2,2,3,3,4,4 5 5,6,6- 2020)
dodecafluorohexyloxy)-1,1,2,2-tetrafluoroethane
sulfonate
(F-53B)
Perfluoroalkyl phosphinic acids 1-10 (registration Glüge et al.
dossier, volume not (2020)
limited to the use of
metal plating)
Perfluorohexanesulfonamides Unknown
1-Alkanesulfonamide, N,N'-bis(2,3-dihydroxy propyl)- Unknown
perfluoro-
Tridecafluoroheptanamide Unknown
Alkanamide, N,N-bis(2,3-dihydroxy propyl)-perfluoro Unknown
N-Alkyl perfluoroalkane sulfonamides Unknown
1-Alkanesulfonamide, N,N'-[phosphonicobis(oxy- Unknown
2,1,ethanediyl)]bis[perfluoro-N-methyl)
Fluorinated (meth)acrylate polymers Unknown

Manufacture of metal products


Potassium perfluorohexane-1-sulphonate Unknown Glüge et al.
Potassium undecafluorocyclohexanesulphonate Unknown (2020)
1-Propanaminium, 3-[[(perfluoroalkyl)sulfonyl]amino]- Unknown
N,N,N-trimethyl-, chloride (1:1)
1-Propanaminium, N-ethyl-3- Unknown
[[(perfluoroalkyl)sulfonyl]amino]-N,N-dimethyl-, ethyl
sulfate (1:1)
N-[3-(Dimethylamino)propyl]-N- Unknown
[(perfluoroalkyl)sulfonyl]-β-alanine
C yclohexanecarboxamide, N-[3-(dimethyl Unknown
amino)propyl]-1,2,2,3,3,4,4 5 5,6,6-undecafluoro-
1-Propanaminium, N-(2-carboxyethyl)-N,N-dimethyl- Unknown
3-[[(1,2,2,3,3,4,4 5 5,6,6-
undecafluorocyclohexyl)carbonyl]amino]-, inner salt
1-Propanaminium, N-(2-carboxyethyl)-3-[[[1,2,2,3,3,4 Unknown
5 5,6, 6-decafluoro-4-
(trifluoromethyl)cyclohexyl]carbonyl] amino]-N,N-
dimethyl-, inner salt

236
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Group/substance EU market (t/y) Source


Poly(oxy-1,2-ethanediyl), α-[2-[ethyl[(perfluoroalkyl) Unknown
sulfonyl]amino]ethyl]-ω-hydroxy
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2- 100-1 000
[[2-(trifluoromethyl)phenyl]azo] butyramide (registration dossier,
volume not limited
to the use of
manufacture of
metal products)
6:2 FTS 10-100 (registration
dossier, volume not
limited to the use of
manufacture of
metal products)
3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1- 10-100 (registration
acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4- dossier, volume not
chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide] limited to the use of
manufacture of
metal products)
Reaction mass of ammonium(3,3,4,4 5 1-10 (registration
5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen dossier, volume not
phosphate and ammonium bis(3,3,4,4 5 limited to the use of
5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate manufacture of
metal products)
Polytetrafluoroethylene (PTFE) Unknown
Polyvinylidene fluoride (PVDF) Unknown
Siloxanes and silicones, di-Me, Me 3,3,4,4 5 Unknown
5,6,6,7,7,8,8,8-tridecafluorooctyl
Siloxanes and silicones, di-Me, Me 3-(1,1,2,2-tetra fluoro Unknown
ethoxy)propyl, Me 3,3,4,4 5 5,6,6,7,7,8,8,8-
tridecafluorooctyl
Hexafluoropropylene polymer (HFP) Unknown
Polychlorotrifluoroethylene (PC TFE) Unknown
Ethylene tetrafluoroethylene copolymer (ETFE) Unknown
Fluorinated ethylene propylene (FEP) Unknown
Ethylene-chlorotrifluoroethylene copolymer (EC TFE) Unknown
Perfluoralkoxy polymer (PFA) Unknown
Ethylene-tetrafluoroethylene-hexafluoro propylene Unknown
copolymer
Hexafluoropropylene-tetrafluoroethylene-vinylidene Unknown
fluoride copolymer (THV)
Ethylene-hexafluoropropylene-perfluoropropyl vinyl Unknown
ether-tetrafluoroethylene copolymer
Hexafluoropropylene-perfluoropropyl vinyl ether-tetra Unknown
fluoroethylene-vinylidene fluoride copolymer
Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoro ethoxy-) Unknown
Pentane, 1,1,1,2,2,3,4 5 5 5-decafluoro- Unknown
C yclopentane, 1,1,2,2,3,3,4-heptafluoro- 1-10 (registration
dossier, volume not
limited to the use of
manufacture of
metal products)
Fluororubber (FKM, FFKM, FPM) Unknown
Fluorosilicone (FVMQ) Unknown

237
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.6. Consumer mixtures


Table A.84. Examples for specific PFAs used for certain applications (Glüge et al., 2020).
Use Name CAS number
General cleaning agents Potassium N-ethylperfluoroalkane- 67584-51-4
sulfonamido acetate 67584-52-5
67584-53-6
67584-62-7
2991-51-7
Ammonium (n:2) fluorotelomer 65530-71-4
phosphate monoester
3,3-Dichloro-1,1,1,2,2- 422-56-0
pentafluoropropane
Methyl perfluoroalkyl ether 22410-44-2
375-03-1
163702-07-6
C leaning agents for Perfluoroalkylcarboxylic acids (PFC As) 375-22-4
dishes and glasses 335-67-1
Glass cleaners Potassium N-ethyl perfluoroalkane- 67584-53-6
sulfonamide acetate 2991-51-7
C arpet and upholstery Perfluoroalkylphosphonic acids (PFPAs) 40143-76-8
cleaners 40143-78-0
Perfluoroalkylphosphinic acids (PFPiAs) 52299-26-0
40143-77-9
610800-34-5
1240600-40-1
1240600-41-2
40143-79-1
500776-81-8
Dry cleaning of metals, Ethyl perfluoroalkyl ether 163702-05-4
glass, ceramics, etc.
Guitar strings and piano Polyvinylidene fluoride, PVDF 24937-79-9
keys
Lubricants for string PTFE micropowder 9002-84-0
instruments
Anti-fog agents Fluorotelomer alcohols (FTOHs) and 647-42-7
fluorotelomer ethoxylates (FTEOs): 678-39-7
6:2FTOH; 8:2 FTOH; 10:2FTOH; 865-86-1
6:2FTEOs 52440-44-4
C oating for Guitar strings PTFE (polytetrafluoroethylene)/FEP 9002-84-0
(fluorinated ethylene propylene)/ETFE 25067-11-2
(ethylene tetrafluoroethylene) 25038-71-5
C leaning for optical 1,1,1,2,2,3,4,5,5,5-Decafluoropentane 138495-42-8
devices
Floor polish Potassium N-ethylperfluoroalkane- 67584-51-4
sulfonamidoacetate 67584-52-5
67584-53-6
67584-62-7
2991-51-7

238
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Products sampled in 2016 were analysed for PFBA, PFBS, PFHxA, PFHxS, PFOA, PFNA, PFDA,
PFOS, 4:2 FTOH, 6:2 FTOH, 8:2 FTOH, 10:2 FTOH, 6:2 FTA, 8:2 FTA, 10:2 F TA, MeFOSA,
EtFOSA, MeFOSE, EtFOSE; products sampled in 2014 were analysed for PFBA, PFBS, PFHxA,
PFHxS, PFHpA, PFOA, PFNA, PFDA, PFOS, 4:2 FTOH, 6:2 FTOH, 8:2 FTOH, 4:2 FTS, 6:2 FTS,
PFUnDa, PFDoDA, PFTriA, PFTeA, 6:2 diPAP, 6:2 mono-PAP, 8:2 diPAP, 8:2 mono-PAP. Errors
in dealing with the units were corrected using Blom and Hanssen (2015). Blank cells symbolise
that no PFAS could be detected (see Table A.85).

Table A.85. Sum of PFAS and TOF content for several consumer mixtures (Borg and Ivarsson,
2017).
Product Year of product Sum (PFAS) [µg/L] Total organic
sampling fluorine [µg/L]

Rinse aid 1 2016 0.75 <1 000


Rinse aid 2 2016 1.2 2 000
Floor polish 2016 1 840 18 500
Furniture polish 2016 <1 000
C ar polish 1 2014 3 370 3 000
C ar polish 2 2014 3 130 8 000
Dishwasher 1 2014 9 680 14 500
Dishwasher 2 2014 2.6 <1 000
Waterproofing textiles
2014 660 <1 000
– Wash in

Table A.86. Measured PFAS content for several consumer mixtures(Blom and Hanssen, 2015;
Borg and Ivarsson, 2017). Blank cells indicate that the PFAS in question could not be
detected.
Product Year of PFBA PFHxA PFOA PFDA 6:2 8:2
product [µg/L] [µg/L] [µg/L] [µg/L] FTOH FTOH
sampling [µg/L] [µg/L]

Rinse aid 1 2016 0.75


Rinse aid 2 2016 0.75 0.47
Shoe wax 2016 0.53
Floor polish 2016 0.47 0.59 1834
Furniture polish 2016
C ar wax 1 2016 1.4
C ar wax 2 2016 2.8
C ar polish 1 2014 0.47 263 3 110
C ar polish 2 2014 0.509 31 130
Dishwasher 1 2014 1.12 0.555 391 9 290
Dishwasher 2 2014 2.62
Waterproofing
textiles – Wash 2014 630
in 1
Waterproofing
textiles – Wash 2014 680
in 2

239
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.87. Quantified PFAs content for a group of polishes and cleaners (Favreau et al.,
2017). Samples were collected in 2012/2013 in Switzerland. In total , the product content
was analysed regarding 41 different PFAS.
Product 6:2 FTS N-EtFOSE 6:2 FTOH
group

Occurrence Content Occurrence Content Occurrence Content


[mg/kg] [mg/kg] above LOQ [mg/kg]
C leanser 0 out of 24 - 1 out of 24 1.2 1 out of 24 4
Polish 1 out of 18 0.1 0 out of 18 - 1 out of 18 26.0

Table A.88. Determined Fluorotelomers for cleaning products, waxes and sealants. The
products were sampled in 2011 and 2013 in the USA (Liu et al., 2015).
Product group Product 6:2 FTOH 8:2 FTOH 10:2 FTOH
number [mg/kg] [mg/kg] [mg/kg]
C ommercial
A1 3.28 2.95 1.46
carpet care liquid
A2 105
A3 0.194
Household
carpet/fabric-
B1
care liquids and
foams
B2 0.372
Floor waxes and
wood/stone C1 1.59 1.4
sealants
C2 4.01 0.442
C3 24.2 6.91
C4 331 92.4
C5 13.9 0.477

Table A.89. Quantified PFAS in cleaners (Kotthoff et al., 2015). Six products were used for
measuring PFAS except FTOHs and three products for FTOHs. The samples were collected in
2010 in Germany.
PFOA PFOS PFTeA 6:2 FTOH 8:2 FTOH 10:2
[mg/kg] [mg/kg] [mg/kg] [mg/kg] [mg/kg] FTOH
[mg/kg]
Maximum
0.0011 0.0016 0.0008 38.7 547.1 81.9
concentration
Median
0.0007 0.0012 0 38 63 22.6
concentration

240
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.90. Sum of 45 analysed PFAS and extractable organic fluorine (EOF) for several
cleaning products sampled in 2021 in the Netherlands (Pancras, 2021).
Product Sum (PFAS) [µg/kg] Extractable organic fluorine
[µg/kg]
Dishwash 1 0 590
Dishwash 2 6 10 000
Dishwash 3 4 1 200
Dishwash 4 7 630
C leaning agent 1 5 4 600
C leaning agent 2 5 470
C leaning agent 3 6 250
C leaning agent 4 8 460
C leaning agent 5 16 150

Table A.91. Sum of 16 analysed PFAS and TOF for four different anti-fog sprays purchased
online (Herkert et al., 2022).
Product Sum (PFAS) [µg/kg] Total organic fluorine
[µg/kg]
Spray A 25 000 20 700
Spray B 327 221
Spray C 529 202
Spray D 566 190

241
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.7. Cosmetics

Figure A.23. Functions of INCI names in cosmetics. Searched for 169 INCI names in total in the CosIng database, for 9 INCI names the function
section was empty or “not reported” was given as information. Total function count surpasses 160, as several INCI names have several listed
functions.

242
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.92. PFAS INCI names found in cosmetic products in the different databases . Shown are only the most frequent found PFAS among all
databases and the top ten ranked PFAS within each database (CosmEthics, Kemiluppen and ToxFox), rank within database (the number of
products in which the according PFAS was found). Note that a hyphen ( -) equals not found in this database, grey cells represent the top 10
ranked substances of all databases and/or within a database ).
PFAS INCI names CAS No EC/List no Fluorinat Covered by any Rank Rank Rank
ed existing or pending CosmEthics Kemiluppen ToxFox
carbons PFAS restriction (number of (number of (number of
products) products) products)
PTFE 9002-84-0 618-337-2 fluoropoly No 1 (541) 1 (64) 1 (321)
mer
C 9-15 fluoroalcohol 223239-92-7 - C 9-C 15 Existing, included in 3 (208) 3 (27) 3 (76)
phosphate the PFOA restriction
in POPs and the C 9-
C 14 PFC As restriction
in REAC H
Perfluorodecalin 306-94-5 206-192-4 C 10/fully No 6 (64) 5 (13) 4 (70)
F
Perfluorooctyl triethoxysilane 51851-37-7 257-473-3 C6 Existing, included in 2 (232) 4 (14) -
the
(3,3,4,4,5,5,6,6,7,7,
8,8,8-
tridecafluorooctyl)
silanetriol and TDFAs
restriction in REAC H
Perfluorononyl dimethicone - - C9 Existing, included in 4 (111) 11.5 (5) 5 (60)
the PFOA restriction
in POPs and the C 9-
C 14 PFC As restriction
in REAC H
Polyperfluoromethylisopropyl 69991-67-9 615-044-1 C4 No 8 (55) 7 (9) 6 (55)
ether
Octafluoropentyl methacrylate 355-93-1 206-596-0 C4 No 12 (31) 2 (31) -
Acetyl trifluoromethylphenyl 379685-96-8 609-497-4 C1 No 7 (63) 7 (9) -
valylglycine
Methyl perfluorobutyl ether 163702-07-6 - C4 No 11 (34) 7 (9) -
Polyperfluoroethoxymethoxy - - C 1+C 2 No 9 (47) 11.5 (5) -

243
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

PFAS INCI names CAS No EC/List no Fluorinat Covered by any Rank Rank Rank
ed existing or pending CosmEthics Kemiluppen ToxFox
carbons PFAS restriction (number of (number of (number of
products) products) products)
difluoroethyl PEG phosphate
Ammonium C 6-16 65530-72-5/ 685-094-7/ C 6-C 16 Existing, included in 14 (25) 10 (6) -
perfluoroalkylethyl phosphate 65530-71-4/ 809-881-3/ the PFOA restriction
65530-70-3 809-882-9 in POPs and the C 9-
C 14 PFC As restriction
in REAC H
Methyl perfluoroisobutyl ether 163702-08-7 605-340-9 C4 No 16 (23) 9 (7) -
Trifluoropropyldimethyl/trimet - - C1 No 10 (42) 23.5 (1) -
hylsiloxysilicate
Polyperfluoroisopropyl ether 25038-02-2 626-882-2 C3 No 21.5 (7) 19 (2) 11 (1)
Trifluoromethyl C 1-4 alkyl - - C1 No 25 (6) - 8 (7)
dimethicone
PEG-8 trifluoropropyl - - C1 No 30 (3) - 9 (2)
dimethicone copolymer
HC yellow no. 13 10442-83-8 443-760-2 C1 No* - - 7 (16)
Polysilicone-7 146632-08-8 - C8 Existing, included in - - 11 (1)
the PFOS restriction
in POPs
Polysilicone-10 - - unclear unclear - - 11 (1)

* Included in the C osmetics Regulation provisions: Annex III/26 (EC , 2022).

244
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.8. Ski wax


Table A.93. Examples of PFAS-based ski waxes, applications and normalised prices from
a review in 2020.
Trade name Supplier Specific application Normalised price
(e.g ski, snowboard, (€/g, from supplier
glide wax, grip wax) websites)
Glider for skis 1,Swix HF7 Swix Ski, glide 1.006
Violet
Swix vr 55 krystal line grip Swix Ski, glide, grip 0.38
wax silber-violet
Glider 1, Swix LF6 Blue Swix Ski, glide 0.23

Vauhti Quick HF Skin C are Vauhti Ski, snowboard, glide 0.34


80mL Red
SWIX FC 10X C ERA F/ Swix Ski 4
7045951824131
SWIX FC 7X C ERA F/ Swix Ski 4.5
7045951824117

5SKIGO C 22 GUL/ Skigo Ski 2.33


7393753630048
TOKO JETSTREAM POWDER TOKO Ski 3.8
BLUE/7613186169350 JETSTREAM
BRIKO MAPLUS FP4/ BRIKO Ski 1.8
8028383990079 MAPLUS
REX RAC ING SERVIC E 63 rex Ski 4.3

VAUHTI FC LDR/ VAUHTI Ski 5.4


6419696087204
GALLIUM GIGA SPEED GALLIUM Ski 6.33
MAXFLUOR/ 4948575107853
SWIX HF MARATHON/ Swix Ski 1.93
7045951580778
SKIGO HF UNIVERSAL/ SKIGO Ski 1.22
7393753630208
TOKO HF HOTWAX/ TOKO Ski 0.68
4250423601612

Table A.94. Examples of fluorine-free waxes, applications and normalized prices from a
review in 2020.
Trade Name Supplier Specific application Normalised price
(e.g ski, snowboard, (€/g, from supplier
glide wax, grip wax) websites)
BP77 Base prep Hard 900 g Swix Ski, snowboard, glide 0.09
BP77 Base prep Hard 100 g wax 0.08
BP88 Base Prep Swix Ski, snowboard, glide 0.11
Medium,900 g wax 0.11
BP88 Base Prep Medium,
180 g
BP99 Base Prep Soft, 180 g Swix Ski, snowboard, glide 0.09
wax
C H10X Yellow, 0 °C /10 °C , Swix Ski, snowboard, glide 0.18
180 g, wax 0.14
C H10X Yellow, 0 °C /10 °C , 0.09
60 g
C H10X Yellow, 0 °C /10 °C ,

245
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Trade Name Supplier Specific application Normalised price


(e.g ski, snowboard, (€/g, from supplier
glide wax, grip wax) websites)
900 g
C H12X C ombi, 54 g Swix Ski, snowboard, glide 0.17
C H12X C ombi, 900 g wax 0.08
C H3X C old Powder, 30 g Swix Ski, snowboard, glide 0.91
wax
C H5X Turquoise, -8 °C / Swix Ski, snowboard, glide 0.15
-14 °C , 180 g wax
C H5X Turquoise, -8 °C / 0.17
-14 °C , 60 g
C H5X Turquoise, -8 °C / n.a.
-14 °C , 900 g
C H7X Violet, -2 °C /-8 °C , Swix Ski, snowboard, glide 0.09
180 g wax 0.20
C H7X Violet, -2 °C /-8 °C , 0.09
60 g
C H7X Violet, -2 °C /-8 °C ,
900 g
C H8X Red, -4 °C /4 °C , 180 g Swix Ski, snowboard, glide 0.09
C H8X Red, -4 °C /4 °C , 60 g wax 0.20
C H8X Red, -4 °C /4 °C , 900 g 0.09
F4-100C Glidewax Liquid Swix Ski, snowboard, glide 0.14
100 mL wax 0.15
F4-80NC liquid 80 mL 0.09
F4-150C spray 150 mL 0.14
F4-180 solid 180 g 0.20
F4-60 solid 60 g
F4-900 solid 900 g 0.15
F4-75C paste 75 mL
F6LNC Blue liquid glide, Swix Ski, snowboard, glide 0.21
-6 °C /-15 °C ,80 mL wax
F7LNC Violet liquid glide Swix Ski, snowboard, glide 0.18
1 °C /-6 °C ,80 mL wax
F8LNC Red liquid glide Swix Ski, snowboard, glide 0.18
0 °C /+10 °C , 80 mL wax
HS10 Yellow, 0 °C /+10 °C , Swix Ski, snowboard, glide 0.19
180 g wax 0.28
HS10 Yellow, 0 °C /+10 °C ,
60 g
HS5 Turquoise, -10 °C / Swix Ski, snowboard, glide 0.19
-18 °C , 180 g wax
HS5 Turquoise, -10 °C /
-18 °C , 60 g
HS5 Turquoise, -10 °C /
-18 °C , 900 g
HS6 Blue, -6° C /-12 °C , Swix Ski, snowboard, glide 0.20
180 g wax 0.30
HS6 Blue, -6 °C /-12 °C , 60 g 0.12
HS6 Blue, -6 °C /-12 °C , 0.12
900 g
HS6 Blue liquid 125 mL
Marathon White Fluor Free, Swix Ski, snowboard, glide 0.93
40 g wax
Marathon Black Fluor Free, Swix Ski, snowboard, glide 0.99
180 g wax 1.13
Marathon Black Fluor Free,
40 g
N15 Swix Skin C are Swix Ski, snowboard, glide
N15 Swix Skin C are Spray wax
150 mL

246
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Trade Name Supplier Specific application Normalised price


(e.g ski, snowboard, (€/g, from supplier
glide wax, grip wax) websites)
0.17

N19 Glide Wax For Skin Skis Swix Ski, snowboard, glide n.a.
wax
Phantom DPS Ski, snowboard, glide n.a.
wax
Quick Wax mountainFl Ski, snowboard n.a.
ow
Fast Wax Nordic Ski n.a.
waxes
Natural Skiwax bar Holmenkol Ski n.a.
Natural Skiwax spray
Natural Skiwax paste
Natural Skiwax stick
Natural Skiwax fluid
Green Ice Wax Green Ice Ski, snowboard n.a.
Wax
Purl Wax Purl Ski, snowboard n.a.
Wend Mf non-fluoro race bar Wend Ski, glide 0.34
with meadowfoam 300 g 0.39
Wend Mf non-fluoro race bar
with meadowfoam 100 g
Fluoro-Free C ompetition Dominator Ski, snowboard, glide n.a.
(FFC ) Series wax
ELITE Dominator Ski, snowboard, glide n.a.
wax
Start RG Race Glider Red Start Ski, snowboard, glide n.a.
wax
Start RG Race Glider purple Start Ski, snowboard, glide n.a.
wax
Start RG Race Glider blue Start Ski, snowboard, glide n.a.
wax
Start RG Race Glider green Start Ski, snowboard, glide n.a.
wax
Start RG Race Glider base Start Ski, snowboard, glide n.a.
wax
Universal yellow Solid Fluor MAPLUS Ski, snowboard n.a.
Free
Universal Red Solid Fluor Free MAPLUS Ski, snowboard n.a.

247
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.9. Applications of fluorinated gases


Table A.95. Fluorinated gases currently in commercial use for Heating, Ventilation, Air Conditioning and Refrigeration (HVACR) and other
uses – Organised by HFC Code (Source : Stakeholder consultation and literature review carried out during the development of the re striction
proposal).
Substance Code CAS number General use Sub-use Specific use
Fluoroform HFC -23 75-46-7 Refrigeration (in
(trifluoromethane) blend, see R-
(Not in scope) 473A)
Difluoromethane HFC -32 75-10-5 Refrigeration Domestic and commercial air Split non-ducted units
(Not in scope) and heat pumps conditioning
Domestic refrigeration
Industrial refrigeration
Transport refrigeration
Electronics cooling
Water and space heating heat
pumps
1,1,1,2,2,3,4,5,5,5- HFC -43-10mee 138495-42-8 Solvents Precision & electronics
Decafluoropentane cleaning, commercial &
industrial cleaning and carrier
solvent & lubricants
Other Immersion cooling of
electronics
Pentafluoroethane HFC -125 354-33-6 Fire suppressant Total flooding agent Protection of high value
assets and electrical
equipment. Military
aircraft engine nacelles.
1,1,1,2-Tetrafluoroethane HFC -134a 811-97-2 Foam-blowing Rigid polyurethane foam C ommercial refrigeration
agents (commercial refrigeration and
domestic appliances)
Rigid polyurethane boardstock C ontinuous panel
and panels production
Rigid polyurethane spray foam Open-cell spray foam
Propellants C onsumer propellants C onsumer products

248
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


C ommercial and industrial Technical uses where non-
flammability and
inhalation safety required
– air dusters and lubricant
aerosols
Refrigeration C ommercial refrigeration C ondensing unit systems,
and heat pumps bottler coolers, ice cream
cabinets, standalone plug-
in displays.
Industrial refrigeration Data centre cooling
Transport refrigeration Refrigerated shipping
containers
Domestic and commercial air Split non-ducted units – in
conditioning areas with high ambient
temperature, chillers
Mobile air conditioning New cars, air conditioning
in trains
Electronics cooling
Water and space heating heat
pumps
Heat pump clothes dryers
Other Plasma coating of HDPE
1,1,1-Trifluoroethane HFC-143a 420-46-2
Used in blends (see below)

1,1-Difluoroethane HFC-152a 75-37-6 Foam-blowing Rigid polyurethane spray foam Open cell spray foam
(Not in scope) agents Extruded polystyrene foam XPS
(XPS)
Propellants Consumer propellants Consumer aerosols
Cover gases Magnesium casting
1,1,1,2,3,3,3- HFC-227ea 431-89-0 Foam-blowing Rigid polyurethane boardstock Rigid boardstock,
Heptafluoropropane agents and panels continuous panel
production
Rigid polyurethane spray foam
Rigid polyurethane pipe-in-pipe Block foam

249
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


and block foam manufacture/pipe
insulation
Polyurethane integral skin
Phenolic foam
Fire suppressant Total flooding agent & Protection of high value
streaming agent assets and electrical
equipment.
1,1,1,3,3,3- HFC-236fa 690-39-1 Fire suppressant Streaming agent Protection of high value
Hexafluoropropane assets and electrical
equipment. Onboard
aircraft.

1,1,1,3,3- HFC -245fa 460-73-1 Foam-blowing Rigid polyurethane foam Domestic appliances,
Pentafluoropropane agents (commercial refrigeration and commercial refrigeration
domestic appliances)
Rigid polyurethane boardstock Rigid boardstock,
and panels continuous panel
production
Rigid polyurethane spray Foam C losed-cell spray foam
Rigid Polyurethane pipe-in-pipe Block foam
and block foam manufacture/pipe
insulation
Refrigeration Domestic and commercial air C hillers
and heat pumps conditioning

Solvents Solvent in aerosols; precision &


electronics cleaning and
commercial & industrial
cleaning
1,1,1,3,3-Pentafluorobutane HFC -365mfc 406-58-6 Foam-blowing Rigid polyurethane foam C ommercial refrigeration
Agents (commercial refrigeration and
domestic appliances)
Rigid Polyurethane (PU) Rigid boardstock,
Boardstock and Panels continuous panel

250
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


production
Rigid polyurethane spray Foam C losed-cell spray foam
Rigid polyurethane pipe-in-pipe Block foam
and block foam manufacture/pipe
insulation
Polyurethane integral skin Skin foams
Phenolic foam Phenolic boardstock
production/phenolic block
foams
Solvents Solvent in aerosols; precision &
electronics cleaning and
commercial & industrial
cleaning
2-Bromo-3,3,3- BTP, 2-BTP, 1514-82-5 Fire suppressant Streaming agent Niche applications
trifluoroprop-1-ene Halotron BrX aviation/military to replace
halon 1211
1-C hloro-1,2,2,2- HC FC -124 2837-89-0 Fire suppressant Total flooding agent Support existing/legacy
tetrafluoroethane systems.
1,1-Dichloro-1-fluoroethane HC FC -141b 1717-00-6 Foam-blowing Rigid polyurethane (PU) Rigid boardstock (believed
(Not in scope) agents Boardstock and Panels to be largely phased out)
Solvents Solvent in aerosols; precision & Largely phased out.
electronics cleaning and
commercial & industrial
cleaning
3,3-Dichloro-1,1,1,2,2- HC FC -225ca/cb 422-56-0 Solvents Solvent in aerosols; precision & Largely phased out.
pentafluoropropane electronics cleaning and
commercial & industrial
cleaning
1,1,-Difluoroethylene HFO-1132a 75-38-7 Refrigeration (in
(Not in scope) blend, see R-
473A)
2,3,3,3-Tetrafluoropropene HFO-1234yf 754-12-1 Refrigeration Domestic refrigeration Domestic fridge/freezer
and heat pumps C ommercial refrigeration Bottler coolers

251
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


Industrial refrigeration
Mobile air conditioning New cars
Domestic and commercial air Stationary air conditioning
conditioning and chillers
Other Plasma coating of HDPE
Trans-1,3,3,3- HFO-1234ze(E) 1645-83-6 Refrigeration Domestic and commercial air Stationary air conditioning
Tetrafluoroprop-1-ene and heat pumps conditioning and chillers
1,3,3,3-Tetrafluoropropene HFO-1234ze(E) 29118-24-9 Foam-blowing Rigid polyurethane foam C ommercial refrigeration
agents (commercial refrigeration and
domestic appliances)
Rigid polyurethane spray foam Open-cell spray foam
Extruded polystyrene foam Emerging use as XPS
(XPS)
Propellants C onsumer propellants Non-flammable propellant
and novelty aerosols
Refrigeration Domestic refrigeration Domestic fried/freezer
and heat pumps C ommercial refrigeration Bottler coolers
Industrial refrigeration Data centre cooling
Heat pumps Steam production
Trans-1,1,1,4,4,4- HFO-1336mzz(E) 66711-86-2 Refrigeration Domestic and commercial air C hillers
hexafluorobut-2-ene and heat pumps conditioning
Water and space heating heat
pumps
C is-1,1,1,4,4,4-Hexafluoro- HFO-1336mzz(Z) 692-49-9 Foam-blowing Rigid polyurethane foam Domestic appliances,
2-butene agents (C ommercial Refrigeration and commercial refrigeration
Domestic Appliances)
Rigid polyurethane (PU) Emerging use as rigid
Boardstock and Panels boardstock
Phenolic foam Emerging use as phenolic
boardstock
production/phenolic block
foams
Propellants C onsumer propellants
Solvents Solvent in aerosols; Precision &

252
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


electronics cleaning,
commercial & industrial
cleaning and carrier solvent &
lubricants
1-C hloro-2,3,3,3- HC FO-1224yd 3110-38-1 Refrigeration Domestic and commercial air C hillers
tetrafluoropropene and heat pumps conditioning
Heat pumps Steam production
(Z)-1-C hloro-2,3,3,3- HC FO-1224yd(Z) 111512-60-8 Foam-blowing Rigid polyurethane foam
tetrafluoropropene agents (commercial refrigeration and
domestic appliances)
Refrigeration Water and space heating heat
and heat pumps pumps
Solvents Solvent in aerosols; Precision &
electronics cleaning,
commercial & industrial
cleaning and carrier solvent &
lubricants

Trans-1-chloro-3,3,3- HC FO-1233zd(E) 102687-65-0; Foam-blowing Rigid polyurethane foam Domestic appliances,


trifluoropropene agents (commercial refrigeration and commercial refrigeration
domestic appliances)
Rigid Polyurethane (PU Emerging use as rigid
Boardstock and Panels boardstock
Phenolic foam Emerging use as phenolic
boardstock production/
phenolic block foams
Refrigeration Domestic and commercial air C hillers
and heat pumps conditioning
Heat pumps Steam production
Solvents Solvent in aerosols; precision &
electronics cleaning,
commercial & industrial
cleaning and carrier solvent &
lubricants

253
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


Methoxytridecafluoro- MPHE, SionTM No data Solvents Precision & electronics Methoxytridecafluoro-
heptene isomers cleaning, commercial & heptene isomers
industrial cleaning and carrier
solvent & lubricants
Other Debinding agent, 3D printing
Dodecafluoro-2-methyl-3- FK-5-1-12 756-13-8 C over gases Magnesium casting
pentanone Fire Suppressant Local streaming agent

1,1,2,2-Tetrafluoro-1- HFE-347pc-f2 406-78-0 Solvents Precision & electronics


(2,2,2-trifluoroethoxy) cleaning, commercial &
ethane industrial cleaning
Methyl perfluoropropyl ether HFE-7000 375-03-1 Solvents C arrier solvent & lubricants
Methyl nonafluorobutyl HFE-449mccc/ 163702-08-7 Solvents Precision & electronics
ether + Methyl HFE-449s1 163702-07-6 cleaning, commercial &
nonafluoroisobutyl ether (HFE-7100) industrial cleaning and carrier
solvent & lubricants
Other Immersion cooling of
electronics
C over gas Magnesium casting
Solvents C ultural heritage paper
preservation
1-Ethoxy-nonafluorobutane HFE-569mccc/ 163702-05-4 Solvents Precision & electronics
HFE-569sf2 cleaning, commercial &
(HFE-7200) industrial cleaning and carrier
solvent & lubricants
C over gas Magnesium casting
3-Methoxyperfluoro(2- HFE-7300 132182-92-4 Solvents
methylpentane)
3-Ethoxyperfluoro(2- HFE-7500 297730-93-9 Solvents C ommercial & industrial
methylhexane) cleaning
Refrigerant Electronics cooling, military
applications
Hexafluoroisopropanol HFIP 920-66-1 Solvents 3D printing processing liquid

254
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


2,3,3,3-tetrafluoro-2- C 4-FN 42532-60-5 Insulating gas Electrical switchgear (high
(trifluoromethyl)- voltage)
propanenitrile
1,1,1,3,4,4,4-heptafluoro-3- C 5-FK 756-12-7 Insulating gas Electrical switchgear (medium
(trifluoromethyl)-2- voltage)
butanone
(E)-1,1,1,2,3,4,5,5,5- FA-188 3709-71-5 Foam-blowing Polyurethane foam, closed cell
nonafluoro-4- agents
(trifluoromethyl)- 2-pentene
Perfluorohexane (n- and FC -72/PF-5060 1064697-81-9 Solvents Heat transfer agent
iso-) C ultural heritage paper
preservation
Perfluorotripropylamine FC -3283 338-83-0 Solvents Heat transfer agent
(perfluamine)
Perfluorotributylamine FC -40/FC -3284 311-89-7 Solvents Heat transfer agent
(1064698-37-8) Other Immersion cooling of
electronics
Perfluoro-N-propyl- FC -770 1093615-61-2 Solvents Heat transfer agent
morpholine (mixture of
isomers)
Perfluoro-2-methylpentane Flutec RC 1 355-04-4 Foam-blowing Rigid closed-cell PU/PIR
agents insulation foam
1,1,2,3,3,3- Galden HT-55 69991-67-9 Other Immersion cooling of
Hexafluoropropene, /HT-70 electronics
oxidized, polymd.
(Perfluoropolyether, PFPE)
HFC Blend R-404A N/A Refrigeration C ommercial refrigeration C entralised supermarket
(HFC -125/143a/134a) and heat pumps systems, C ondensing unit
systems. Ice cream
cabinets/ice machines,
standalone plug-in
displays
Transport refrigeration Refrigerated shipping
containers, reefer ships

255
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


Industrial refrigeration Large-scale food storage
and processing

HFC Blend R-407A N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -32/125/134a) and heat pumps
HFC Blend R-407C N/A Refrigeration Transport refrigeration Reefer ships
(HFC -32/125/134a) and heat pumps Domestic and commercial air Self-contained units, Split
conditioning non-ducted units, Multi-
split units, Split ducted
units, chillers
Industrial refrigeration Data centre cooling
Mobile air conditioning Trains
Water and space heating heat
pumps
Heat pump clothes dryers
HFC Blend R-407E N/A Refrigeration Domestic and commercial air
(HFC -32/125/134a) and heat pumps conditioning
HFC Blend R-407F N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -32/125/134a) and heat pumps
HFC Blend R-407H N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -32/125/134a) and heat pumps
HFC Blend R-410A N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -32/HFC -125) and heat pumps Domestic and commercial air Self-contained units, Split
conditioning non-ducted units, Multi-
split units, Split ducted
units, chillers
Variable Refrigerant Flow
(VRF) air conditioning
system
Domestic refrigeration
Industrial refrigeration Data centre cooling
Transport refrigeration

256
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


Water and space heating heat
pumps
HFC Blend R-422A N/A Refrigeration Industrial refrigeration Large-scale food storage
(HFC -125/134a/isobutane) and heat pumps and processing
HFC Blend R-422D N/A Refrigeration Industrial refrigeration Large-scale food storage
(HFC -125/134a/isobutane) and heat pumps and processing
HFC Blend R-428A N/A Refrigeration Industrial refrigeration Large-scale food storage
(HFC -125/143a/propane/ and heat pumps and processing
isobutane)
HFC Blend R-434A N/A Refrigeration Industrial refrigeration Large-scale food storage
(HFC -125/143a/134a/ and heat pumps and processing
isobutane)
HFC /HFO Blend R-444B N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32/152a/HFO- conditioning units
1234ze(E))
HFC /HFO Blend R-446A N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32/HFO- conditioning units
1234ze(E)/600))
HFC /HFO Blend R-447A N/A Air conditioning C ommercial and industrial air Ducted self-contained
HFC -32/125/HFO-1234ze conditioning units
HFC /HFO Blend R-447B N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32/125/HFO-1234ze conditioning units
(E))
HFC /HFO Blend R-448A N/A Refrigeration C ommercial refrigeration C ondensing unit systems,
(HFC -32/125/134a HFO- and heat pumps standalone display cases
1234yf/1234ze(E))
HFC /HFO Blend R-449A (XP40) N/A Refrigeration C ommercial refrigeration C ondensing unit systems,
(HFC -32 /125 /134a/HFO- and heat pumps standalone display cases
1234yf) Heat pumps
HFC /HFO Blend R-449B N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -32/125/134a HFO- and heat pumps
1234yf)
HFC /HFO Blend R-450A N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -134a/HFO-1234ze(E)) and heat pumps

257
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


HFC /HFO Blend R-452A N/A Refrigeration C ommercial refrigeration C ondensing unit systems
(HFC -32/125/HFO-1234yf) and heat pumps Transport refrigeration New and retrofitted
vehicles, low GWP
replacement in
refrigerated shipping
containers
HFC /HFO Blend R-452B N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32/125/HFO-1234yf) conditioning units
HFC /HFO Blend R-454A N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32/HFO-1234yf) conditioning units
HFC /HFO Blend R-454B N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32/HFO-1234yf), conditioning units
HFC /HFO Blend R-455A N/A Air conditioning C ommercial and industrial air Ducted self-contained
(C O2/HFC -32/HFO-1234yf) conditioning units
HFC /HFO Blend R-456A N/A Refrigeration Transport refrigeration Shipping containers
(HFC -32/134a/HFO- and heat pumps
1234ze(E))
HFC /HFO Blend R-459A N/A Air conditioning C ommercial and industrial air Ducted self-contained
(HFC -32 /HFO- conditioning units
1234yf/1234ze(E))
HFC /C O2 blend R-469A N/A Refrigeration Transport and industrial Ultra low-temperature
(C O2/HFC -32/HFC -125) refrigeration applications such as
reefers, chemical
processes and
environmental simulation
HFC /HFO/C O2 Blend R-473A N/A Refrigeration Transport and industrial Ultra low-temperature
(C O2/HFC -23/HFC - refrigeration applications such as
125/HFO-1132a) reefers, chemical
processes and
environmental simulation
HFC Blend R-507A N/A Refrigeration Industrial refrigeration Large-scale food storage
(HFC -125/143a) and heat pumps and processing

258
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance Code CAS number General use Sub-use Specific use


HFC /PFC Blend R-508B N/A Refrigeration Industrial refrigeration Ultra low-temperature
(HFC -23/PFC -116) vaccine preservation
HFC /HFO Blend R-513A N/A Refrigeration Domestic and commercial air C hillers
(HFO-1234yf/HFC -134a) and heat pumps conditioning
Transport refrigeration Refrigerated shipping
containers
C ommercial refrigeration C ondensing units
Industrial refrigeration Ultra low-temperature
vaccine preservation
Heat pumps
HFC /HFO Blend R-513B N/A Refrigeration Transport refrigeration Low GWP replacement in
(HFO-1234yf/HFC -134a) and heat pumps refrigerated shipping
containers
HC O/HFO Blend R-514A N/A Refrigeration Domestic and commercial air C hillers
HFO-1336mzz(Z) / and heat pumps conditioning
trans-1,2 dichloroethene
(1130(E))
HFC /HFO Blend R-515B N/A Refrgeration and Domestic and commercial air C hillers
(HFC -227ea/HFO- heat pumps conditioning
1234ze(E))
Difluorochloromethane HC FC Blend A, 75-45-6 Fire suppressant Total flooding agent Support existing/legacy
(HFC -22) NAF-S-III systems.
1-C hloro-1,2,2,2- 2837-89-0
tetrafluoroethane
(HC FC -124)
2,2-Dichloro-1,1,1- 306-83-2
trifluoroethane
(HC FC -123)
d-limonene 5989-27-5
1,1,1,2-Tetrafluoroethane HFC Blend B 811-97-2 Fire suppressant Total flooding agent Support existing/legacy
(HFC -134a) Halotron II, systems.
Pentafluoroethane 354-33-6
(HFC -125)
C arbon Dioxide 124-38-9

259
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

The R notation used for blends in this table is a globally used commercial shorthand way of naming refrigerants established b y the American Society of
Heating, Refrigerating and Air-C onditioning Engineers (ASHRAE). The R notation is a safety classification based on toxicity and flammability data (ASHRAE,
2021).

260
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.96. List of specific fluorinated gas substances identified in different commercial
applications.
Entry Substance Code Structure

1 Fluoroform (trifluoromethane) HFC -23 (not in scope) C HF3

2 Difluoromethane HFC -32 (not in scope) C H2F2

3 1,1,1,2,2,3,4,5,5,5- HFC -43-10mee C F3-C F2-C HF-C HF-C F3


Decafluoropentane
4 Pentafluoroethane HFC -125 C F3-C HF2

5 1,1,1,2-Tetrafluoroethane HFC -134a C F3-C H2F

6 1,1,1-Trifluoroethane HFC -143a C F3-C H3

7 1,1-Difluoroethane HFC -152a (not in scope) C HF2-C H3

8 1,1,1,2,3,3,3-Heptafluoropropane HFC -227ea C F3-C HF-C F3

9 1,1,1,3,3,3-Hexafluoropropane HFC -236fa C F3-C H2-C F3

10 1,1,1,3,3-Pentafluoropropane HFC -245fa C F3-C H2-C HF2

11 1,1,1,3,3-Pentafluorobutane HFC -365mfc C F3-C H2-C F2-C H3

12 1-C hloro-1,2,2,2-tetrafluoroethane HC FC -124 C HC lF-C F3

13 1,1-Dichloro-1-fluoroethane HC FC -141b (not in scope) C C l2F-C H3

14 3,3-Dichloro-1,1,1,2,2- HC FC -225ca/cb C F3-C F2-C HC l2


pentafluoropropane
15 1,1,-Difluoroethylene HFO-1132a (not in scope) C H2=C F2

16 1-C hloro-2,3,3,3- HFO-1224yd(Z) * C HC l=C F-C F3


tetrafluoropropene
17 1-C hloro-3,3,3-trifluoro-1-propene HFO-1233zd(E) ** C HC l=C H-C F3

18 2,3,3,3-Tetrafluoropropene HFO-1234yf C H2=C F-C F3

19 Trans-1,3,3,3-tetrafluoroprop-1- HFO-1234ze(E) *** C HF=C H-C F3


ene
20 1,3,3,3-Tetrafluoropropene HFO-1234ze(E) *** C HF=C H-C F3

21 Trans-1,1,1,4,4,4-hexafluorobut-2- HFO-1336mzz(E) C F3-C H=C H-C F3


ene
22 C is-1,1,1,4,4,4-Hexafluoro-2- HFO–1336mzz(Z) C F3-C H=C H-C F3
butene
23 (Z)-1-C hloro-2,3,3,3- HC FO-1224yd * C HC l=C F-C F3
tetrafluoropropene
24 Trans-1-chloro-3,3,3- HC FO-1233zd(E) ** C HC l=C H-C F3
trifluoropropene
25 2-Bromo-3,3,3-trifluoroprop-1-ene BTP, 2-BTP, Halotron BrX C H2=C Br-C F3

261
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Entry Substance Code Structure

26 Methoxytridecafluoro-heptene MPHE, SionTM C F3-C F2-C F2-


isomers C F=C (OC H3)-C F2-CF3
27 Dodecafluoro-2-methyl-3- FK-5-1-12 (fluoroketone) C F3-C F(C F3)-C (=O)-C F2-
pentanone C F3
28 1,1,2,2-Tetrafluoro-1-(2,2,2- HFE-347pc-f2 C F3-C H2-O-C F2-C HF2
trifluoroethoxy) ethane
29 Methyl perfluoropropyl ether HFE-7000 C H3-O-C F2-C F2-C F3

30 Methyl nonafluorobutyl ether + HFE-449mccc/HFE-449s1 C H3-O-C F2-C F2-C F2-C F3


Methyl nonafluoroisobutyl ether (HFE-7100)
31 1-Ethoxy-nonafluorobutane HFE-569mccc/HFE-569sf2 C H3-C H2-O-C F2-C F2-C F2-
(HFE-7200) C F3
32 3-Methoxyperfluoro(2- HFE-7300 C F3-C F2-C F(OC H3)-C F-
methylpentane) (C F3)2
33 3-Ethoxyperfluoro(2-methylhexane) HFE-7500 C F3-C F(C F3)-C F(OC H2-
C H3)-C F2-C F2-C F3
34 Hexafluoroisopropanol HFIP C F3-C HOH-C F3

35 2,3,3,3-tetrafluoro-2- C 4-FN C F3-C F(C N)-C F3


(trifluoromethyl)- propanenitrile
36 1,1,1,3,4,4,4-heptafluoro-3- C 5-FK (C F3)2-C F-C (=O)-C F3
(trifluoromethyl)-2-butanone
37 (E)-1,1,1,2,3,4,5,5,5-nonafluoro-4- FA-188 C F3-C F=C F-C F-(C F3)2
(trifluoromethyl)- 2-pentene
38 Perfluorohexane (n- and iso-) FC -72/PF-5060 C F3-(C F2)4-C F3

39 Perfluorotripropylamine FC -3283 (C F3-C F2-C F2)3N


(perfluamine)
40 Perfluorotributylamine FC -40 (C F3-C F2-C F2-C F2)3N

41 Perfluoro-N-propylmorpholine FC -770 O-(C F2-C F2)2-N-C F2-C F2-


(mixture of isomers) C F3/O-(C F2-C F2)2-N-C F-
(C F3)2
42 Perfluoro-2-methylpentane Flutec RC 1 C F3-C F2-C F2-C F-(C F3)2

43 1,1,2,3,3,3-Hexafluoropropene, Galden HT-55/HT-70 C F2=C F-C F3, oxidized and


oxidized, polymerized polymerized
(Perfluoropolyether, PFPE)

262
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.97. Intended applications of EU-28 total supply of fluorinated gases. Source data reported in the F -gas Report (EEA, 2020).
Intended Applications of 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Bulk Supply

Refrigeration, air 61 377 58 720 58 678 65 964 61 045 58 574 58 999 95 688 74 023 78 016 78 012 68 676 55 600
conditioning and heating
and heat transfer fluids
Foams, incl pre-blended 14 286 15 284 11 709 11 503 9 234 8 526 8 202 12 967 9 572 10 157 11 521 11 083 11 041
polyols
Aerosols 9 090 11 131 8 425 9 547 7 808 10 950 9 690 8 954 9 421 8 728 10 300 9 109 8 964

Fire protection 649 491 531 1 677 2 508 1 451 1 385 1 858 818 585 502 324 130

Electrical Equipment 1 197 1 422 969 1 290 1 344 1 362 1 419 622 745 813 951 640 534

Semiconductor, 127 301 184 265 243 169 71 1 057 715 755 924 897 769
photovoltaics and other
electronics manufacture
Other or unknown 1 861 2 219 2 185 1 501 1 437 1 684 1 132 6 402 1 485 997 1 266 1 450 1 255
applications

Totals (including SF 6)* 88 586 89 569 82 681 91 749 83 620 82 715 80 898 127 547 96 779 100 050 103 475 92 179 78 293

SF 6 quantities 1 810 1 860 1 435 1 522 1 502 1 490 1 535 716 909 1 004 1 225 843 727

Totals (excluding SF 6) 86 776 87 709 81 246 90 227 82 118 81 225 79 363 126 831 95 870 99 046 102 250 91 336 77 566

Notes: *SF6 included in these figures but not separated out per application. SF 6 is primarily used in electrical equipment because of its excellent electrical
insulation properties and in the manufacture of semiconductors; it also has other medical uses and as a cover gas in magnesiu m casting for installations
using less than 850 kg SF6/y until 2018 (sand casting may still be permitted). It is outside of the scope of this project however and therefore it has been
deducted.

263
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.98. Estimation of quantities of Hydrofluoroolefins Used , as a Proportion of F -gases in Products and Equipment for EU-28. Source: EEA
(2020).
Intended Applications of Bulk Supply 2016 2017 2018 2019
Usage data for F-gases
Refrigeration, air conditioning and
78 016 78 012 68 676 55 600
heating and heat transfer fluids
Foams, incl pre-blended polyols 10 157 11 521 11 083 11 041
Aerosols 8 728 10 300 9 109 8 964
Fire protection 585 502 324 130
Electrical Equipment 813 951 640 534
Semiconductor, photovoltaics and other
electronics manufacture 755 924 897 769

Other or unknown applications 997 1 266 1 450 1 255


         
Totals (including SF6)* 100 050 103 475 92 179 78 293
SF6 quantities 1 004 1 225 843 727
         
Totals
99 046 102 250 91 336 77 566
(excluding SF 6)
         
Usage data for unsaturated HFOs and
6 305 13 400 17 767 18 350
HC FOs
HFO & HCFO Proportion of total
(%)* 6 13 19 24

Notes: *HFOs are mainly used in mobile air conditioning and commercial refrigeration (stakeholder discussions).

264
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.10. Medical devices


Table A.99. Medical implants and materials (Teo et al., 2016). Additions from stakeholder.

Parylene
Silicone

PMMA
PDMS
PTFE

PHA

SU8
PEK
PET

LCP
PA

PP
PE

PI
Anestesiology Epidural catheters ✓ ✓ ✓
C ardiovascular Pacemaker, implantable ✓ ✓ ✓ ✓ ✓ ✓ ✓
defibrillator/cardioverter, left ventricular assist
device, heart valves, artificial blood vessels,
catheters, suture material and pledgets
Dental Dentures, dental implants, orthodontic wires, ✓
dental instrumentation
Ear, nose, throat C ochlear implants, stapes implants, nasal ✓ ✓ ✓ ✓ ✓
implants for nose reconstruction
Gastroenterology Penile implants, neurostimulator in sacral ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
and urology nerve stimulation, foley catheter, artificial
urinary sphincter implant, hernia or vaginal
mesh
General and Synthetic blood vessels, breast implants, ✓ ✓ ✓ ✓ ✓
plastic surgery cheek, jaw and chin implants, lip implant,
titanium surgical implants, hip implant, clamps
for high frequency surgery
Hematology and C entral venous access device, peripherally ✓ ✓ ✓
pathology inserted central catheter
Neurology Implantable pulse generator for deep brain ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
stimulation, neuroprosthetiocs, cognitive
protheses, catheters
Opthalmic dexamethasone intravitreal implant, retinal ✓ ✓ ✓ ✓
prothesis, artificial inocular lens, glaucoma
valve, fluocinolone ophthalmic implant, orbital
implant, catheters
Orthopedic Orthopedic implants, medical splints ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

265
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.100. Main coatings reported during the CfE and additional stakeholder information.
Product name CAS number
SF-coat-AS-20280 2414599-48-9

SF-coat-SFE-X008 441049-46-2

AsahiGuard-AG-E082 746622-86-6

ETFE, PTFE, PC TFE 25038-71-5/9002-84-0/9002-83-9

Table A.101. Main applications of PFAS in technology (analytical, biological and laboratory)
reported by stakeholders (RINA, 2021).
PTFE in wire and heat shrink, sensors, tubing/housing, gaskets, seals, O-rings, connectors,
coatings of device surfaces such as mixing equipment, tip fittings and diaphragm pumps.

F-Gases as a carrier for analytical testing, and the following gases R -134a, R-404A, R-407F, R-
410A, R-449A, R-452A, R-507A, R-508B and R-513A.

FKM (Polymer of 1,1-difluoroethene/1,1,2,3,3,3-hexafluoroprop-1-ene) and FFKM in O-rings,


sealing surfaces, seals, diaphragms, vacuum pumps, gauges and controllers.

FFKO in vacuum pumps, gauges and controllers.

ETFE in diaphragms, hoses, valves, housings, pumps, sealing surface and seals.

EC TFE in vacuum pumps, diaphragm pumps, tubes, seals, bushes, cables and valves.

FEP-encapsulated FFKM O-ring in vacuum pumps, gauges and controllers.

FEP for non-reactive inert tubes/tubing, in liquid handling instruments, seals and bushes.

Fluoromethacrylate within pharmaceutical consumables and equipment as filters, hydrophobic


and oleophobic membranes, connectors, seals and spacer materials.

PVDF for tubes, seals and bushes.

FPM and FFPM in O-rings in pumps.

Polychlorotrifluoroethylene PC TFE in laboratory equipment for liquid handling such as bottle top
dispensers, bottle top burettes, tubes, seals, and bushes.

PFA in non-reactive inert tubes/tubing, in liquid handling instruments and for seals.

Perfluoro(tributylamine) as a reagent standard for mass spectroscopy.

PFPE-oils (perfluoroalkyl ethers/alkanes + aromatics - more than 10 ether linkages) as a


lubricant.

266
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.102. Polymers and elastomers used in medical devices (including medical device
production).
Polymer Abbreviation CAS number
fluoroelastomers FKM Multiple nr’s

perfluoroelastomer FFKM

polychlorotrifluoroethylene PC TFE 9002-83-9a

polyvinylidene fluoride PVDF 9011-17-0

fluorosilicones FVQM 63148-56-1

fluorosilicone rubber FVQM 64706-30-5

polytetrafluorethene PTFE 9002-84-0

poly(tetrafluoroethylene-co- 26655-005
perfluoro(propylvinyl ether))

poly(ethene-co-chlorotrifluoroethene) EC TFE 25101-45-5

tetrafluoroethylene-hexafluoropropene FEP 25067-11-2


copolymer

poly(ethylene-co-tetrafluoroethylene) ETFE 25038-71-5

1-Propene, 1,1,2,3,3,3-hexafluoro-, THV 25190-89-0


polymer with 1,1-difluoroethene and
tetrafluoroethene

1-propene, 1,1,2,3,3,3-hexafluoro-, THVP 68182-34-3


polymer with 1,1-difluoroethene,
1,1,1,2,2,3,3-heptafluoro-3-
[(trifluoroethenyl)oxy]propane and
tetrafluoroethene

a main use as pharmaceutical packaging

Table A.103. List of additional uses of PFASs in medical devices (as mentioned by
stakeholders).
PFAS substance Additional uses
PTFE, PFA, FEP and some Are used to make printed circuit boards and formed or
fluorinated surfactants moulded components. Printed circuit boards are used in many
applications including medical equipment.
Ethyl trifluoroacetate Used in crown structures to label antibodies.
Hexafluoroisopropanol Used for QC for oligonucleotides.
2,2,2-Trifluoroethyl methacrylate Incorporated into intra ocular lenses.
(TFEMA)
Ethyl trifluoroacetate and ethyl Used as raw materials to synthetise 2-NTA and BFPP. (2-NTA
pentafluoropropionate and BFPP are active molecules in are required for medical
signal generation).
PBSF (perfluoro-1-butanesulfonyl Surgical staples use a PBSF surfactant as a coating to
fluoride) approximate skin for surgical or other acute wounds.

267
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

PFAS substance Additional uses


C 6-PFAS Filters used in intensive-care ventilators and breathing
systems.
Packaging of sterilised medical devices; they provide a
permeable bacterium barrier.
Single-use detergent-proof washbowls.
Wound dressing.
Perfluorohexyloctane (F6H8) + Sterile eye drops- non-active invasive medical device- for
C 14F13H17 (C AS nr 133331-77-8) ophthalmic use: for lubrication of dry, irritated eyes -
stabilization of the tear film and relief of symptoms of dry
eyes.
PTFE and PET with fluorinated C 6 Hydrophobic/oleophobic membranes. Are used for (sterile)
based side-chain coatings venting of several medical devices, for example cell culture
devices, analytical devices (e.g. PC R cartridges for C orona
virus and other viruses and bacteria), blood tube systems for
dialyzer systems, tube systems for eye surgery, microfluidic
chips for "organ on a chip" pharmaceutical research systems,
pharmaceutical packaging of liquids going into human body
C 6-Fluoretelomer-acrylate- In Surgical gowns, to create a protective liquid barrier.
copolymer
Surface protection of rubber stoppers for pharmaceutical
syringes and pharmaceutical vials
PFTE Printed circuit boards are envisioned to enable wireless
charging of medical implants. This will allow for fewer large
scale invasive surgeries to the patient, substantially reducing
patient risk.
Heat sealing for intravenous bags.
Filters for medical masks. This includes C OVID -19 mask, which
are used in extreme numbers: 29 – 91 billion per year globally
(Muensterman et al., 2022)
Medical splints coatings to ensure the proper healing of
fractured bones.
PFA or FEP Polymer coating of aluminium MDI
Fluorinated monomers: Are used in the manufacture of plastics used in the production
hexafluoroisopropyl methacrylate of permeable contact lenses. Usually, material content varies
(C AS 3063-94-3) typically between 4% and 60% as a percentage of the finished
Trifluoroethyl methacrylate (C AS polymer.
352-87-4)
Bis (hexafluoroisopropyl) itaconate
(C AS 98452-82-5)
PFPE Medical and silicone tapes, wound dressings are single -use
disposable medical/surgical supplies, some of which rely on
PFPE-enabled release liners for their function.
Fluoropolymer Polyimide films with fluoropolymer resin are used for cryogenic
bags for long term storage of various blood and tissue
components that will not be compromised during the
preservation process.
Orthodontic wires for aligning teeth
Ostomy bags (filters), AED’s, release liners.

268
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.104. Estimated fluorinated gas greenhouse warming potential (GWP) based on reported volumes of medical gases in the EU (responses
to CfE and ECHA database) and assuming a n emission factor of 0.1%.
CAS number Substance GWP production CO2 equivalents
volume (t/y) (t/y)
midpoint
811-97-2 HFC -134a 1 430 25 487 77.7% 36 446 77.1%
431-89-0 HFC -227ea 3 320 3 068 9.4% 10 186 21.6%
163702-08-7
HFE7100 2 597 556 1.7% 165 0.3%
163702-07-6
163702-06-5
HFE7200 59 55 0.2% 3 <0.01%
163702-05-4
375-03-1 HFE7000 575 8 <0.1% 3.2 0.0%
138495-42-8 HFC -43-10mee 1 640 5.5 <0.1% 1.6 0.0%
57041-67-5 desflurane 989 1 <0.1% 0.2 0.0%
26675-46-7 isoflurane 350 0.25 <0.1% 0.1 0.0%
28523-86-6 sevoflurane 216 0.25 <0.1% 0.1 0.0%
13838-16-9 enflurane 583 0.25 <0.1% 0.1 0.0%
151-67-7 halothane 41 0.25 <0.1% 0.0 0.0%
76-19-7 perfluoropropane (PFC -218) 8 830 0.25 <0.1% 1.3 0.0%
76-16-4 perfluoroethane (PFC -116) 12 200 0.15 <0.1% 1.2 0.0%
355-25-9 perfluorobutane (PFC -3-1-10) 8 860 0.1 <0.1% 0.4 0.0%
115-25-3 octafluorocyclobutane 10 300 0.05 <0.1% 0.3 0.0%
75-73-0 tetrafluoromethane 7 390 0.03 <0.1% 0.1 0.0%
HFE7000 32 806 100% 47 252 100%

269
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.105. Other polymeric PFASs (non-PTFE).


Fluoropolymer Main properties which result in the uses Uses
Ethylenechlorotrifluoroethylene (EC TFE) C hemically and biologically inert/unreactive, non Laboratory, analytical and medical equipment,
contaminating, flexible internal connection parts in vacuum pumps,
diaphragm pumps, tubes, seals, bushes, cables
and valves
Ethylenetetrafluoroethylene (ETFE) C hemically and biologically inert/unreactive Laboratory, analytical and medical equipment,
internal connection parts in chemical resistant
vacuum pumps, chemical resistant diaphragm
pumps, housing cover, diaphragms, hoses, valves
Polyvinylidene fluoride (PVDF) Non-reactive inert chemically stable, flexible, Analytical instruments/measurement devices,
thermally resistant tubes, seals, bushes
Fluoromethacrylate C hemically and biologically inert/unreactive, Pharmaceutical consumables and equipment,
durable, non-contaminating, flexible tubes, seals and bushes. Liquid handling
instrument parts in contact with media, water
purification systems in dialysis
Fluorinated ethylene propylene (FEP) C hemically and biologically inert/unreactive, Analytical instruments/measurement devices,
durable, non-contaminating, flexible, suitable for tubes, for sealing applications, for laboratory
tubes liquid handling equipment

Table A.106. Other uses of PFAS.


Uses Main properties for uses
Perfluoropolyether (PFPE) oils Low outgassing behaviour, high vacuum capable, UV-stability,
inert/unreactive, in manufacturing of analytical equipment (and micro
electronics)
Pentadecafuorooctanoic acid (PFOA) Non-implantable medical devices: Flexible medical endoscopes and video
processors for image sensors for the chip lens.
Tris(nonafluorobutyl)amine, Heptacosafluorotributylaminie (PFTBA), Analytical mass spectroscopy standard. Also used as solvent and blood
fluorinert FC -43, Perfluorobutylamine substitute

270
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.15. Lubricants


Table A.107. Examples of PFASs used in lubricant applications .
CAS no Name(s) as specified in the Use in PFAS PFAS
sources consulted lubricant type Sub group
application
69991-67-9 1-Propene, 1,1,2,3,3,3-hexafluoro-, Base oil Polymeric PFPE Y
oxidized, polymd.
69991-61-3 Ethene, 1,1,2,2-tetrafluoro-, oxidized, Base oil Polymeric PFPE Z
polymd.
60164-51-4 Poly[oxy[trifluoro(trifluoromethyl)- Base oil Polymeric PFPE K
1,2-
ethanediyl]], α-(1,1,2,2,2-
pentafluoroethyl)-ω-
113114-19-5 Oxetane, 2,2,3,3-tetrafluoro-, Base oil Polymeric PFPE D
homoPolymer, fluorinated
161075-14-5 1-Propene, 1,1,2,3,3,3-hexafluoro-, Additive Polymeric PFPE
oxidized, Polymerized, reduced
hydrolyzed
370097-12-4 1-Propene, 1,1,2,3,3,3-hexafluoro-, Additive Polymeric PFPE-C O-NH2
oxidized, polymd., reduced,
hydrolysed reaction products with
ammonia
63148-56-1 Siloxanes and Silicones, Me 3,3,3- Base Polymeric Other
trifluoropropyl oil/Additive
9002-83-9 Polychlorotrifluoroethylene Base Polymeric Fluoropolymer
oil/Additive
9002-84-0 Poly(1,1,2,2-tetrafluoroethylene) Additive Polymeric Fluoropolymer
(PTFE)
67584-42-3a C ycloalkanesulfonic acid, Additive Non- Ionic
perfluoro(pentafluoroethyl)-, polymeric
potassium salt (1:1)
51798-33-5 Poly[oxy[trifluoro(trifluoromethyl)- Additive Polymeric PFPE-C OOH
1,2-ethane diyl]], α-(1- carboxy- (surfactant)
1,2,2,2-tetrafluoroethyl)-ω-
[tetrafluoro (trifluoromethyl)ethoxy]-
163702-05-4 Ethyl nonafluorbutyl ether OR Ethyl Solvent Non- Non-ionic
perfluoroalkyl ether polymeric
163702-06-5 Ethyl nonafluorisobutyl ether OR Ethyl Solvent Non- Non-ionic
perfluoroisobutyl ether polymeric
163702-07-6 Methyl nonafluorobutyl ether OR Solvent Non- Non-ionic
Methyl perfluoroalkyl ether polymeric
163702-08-7 Propane, 2-(difluoromethoxymethyl)- Solvent Non- Non-ionic
1,1,1,2,3,3,3-heptafluoro- OR Methyl polymeric
perfluoroisoalkyl ether
aAlso used as anti-erosion/anti-corrosion additive in aviation hydraulic fluids

271
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Appendix A.3.17. Active substances in Plant Production Products (PPP), Biocidal Products
(BP) and Medicinal Products (MP)
Table A.108. Non-exhaustive list of EU approved active substances for PPPs covered by the current PFAS definition.
Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program
List no under REACH or proposed
Triflumoron/tritosulfuron (ISO) 604- 142469- Withdrawn Skin Sens. 1B, H317 Active substance in biocidal and plant
(containing ≤ 0.02% 2-amino- 291-0 14-5 Aquatic Acute 1, H400 protection products
4-methoxy-6-(trifluormethyl)- Aquatic Acute 1, M-
1,3,5-triazine); factor=10
1-[4-methoxy-6- Aquatic C hronic 1, H410
(trifluoromethyl)-1,3,5-triazin- Aquatic C hronic 1, M-
2-yl]-3-[2- factor=10
(trifluoromethyl)benzenesulfony
l]urea (containing ≤ 0.02% 2-
amino-4-methoxy-6-
(trifluoromethyl)-1,3,5-triazine)
Isoxaflutole (ISO); 604- 141112- Adopted Repr. 2, H361d Active substance in plant protection
5-cyclopropyl-1,2-oxazol-4-yl 222-4 29-0 Aquatic Acute 1, H400 products
α,α,α- trifluoro-2-mesyl-p-tolyl Aquatic Acute 1, M-
ketone factor=10
Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=100

Submitted Repr. 2, H361d***


STOT RE 1, H372
Aquatic Acute 1, H400
Aquatic Acute 1, M-
factor=10
Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=100
Triflusulfuron-methyl; 603- 126535- Adopted C arc. 2, H351 Active substance in plant protection
methyl 2-((]([4- 146-9 15-7 Aquatic Acute 1, H400 products

272
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
(dimethylamino)-6-(2,2,2- Aquatic Acute 1, M-
trifluoroethoxy)-1,3,5-triazin-2- factor=100
yl]carbamoyl)[)sulfamoyl)-3- Aquatic C hronic 1, H410
methylbenzoate Aquatic C hronic 1, M-
factor=10
Trifloxystrobin( ISO); 604- 141517- Adopted Lact. Active substance in plant protection
methyl (E)-methoxyimino- 237-6 21-7 Skin Sens. 1 products
(]((E)-α-[1-(α,α,α-trifluoro-m- Aquatic Acute 1
tolyl)ethylideneaminooxy]-o- Aquatic C hronic
tolyl)[)acetate
Tefluthrin (ISO); 616- 79538- Adopted Acute Tox. 2, H300 Active substance in plant protection
2,3,5,6-tetrafluoro-4- 699-6 32-2 Acute Tox. 2, H310 products
methylbenzyl (1RS,3RS)-3- Acute Tox. 1, H330
[(Z)-2-chloro-3,3,3- STOT RE 1, H372
trifluoroprop-1-enyl]-2,2- Aquatic Acute 1, H400
dimethylcyclopropanecarboxylat Aquatic Acute 1, M-
e factor=10 000
Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=10 000
Pyroxsulam (ISO); 610- 422556- Opinion adapted Skin Sens. 1, H317 Active substance in plant protection
N-(5,7- 007-6 08-9 Aquatic Acute 1, H400 products
dimethoxy[1,2,4]triazolo[1,5- Aquatic Acute 1, M-
a]pyrimidin-2-yl)-2-methoxy-4- factor=100
(trifluoromethyl) pyridine-3- Aquatic C hronic 1, H410
sulfonamide Aquatic C hronic 1, M-
factor=100
Pyridalyl (ISO); 605- 179101- Opinion development Skin Sens. 1, H317 Active substance in plant protection
2,6-dichloro-4-(3,3- 845-4 81-6 Repr. 2, H361d products
dichloroallyloxy)phenyl 3-[5- Aquatic Acute 1, H400
(trifluoromethyl)-2- Aquatic Acute 1, M-
pyridyloxy]propyl ether factor=1000
Aquatic C hronic 1, H410
Aquatic C hronic 1, M-

273
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
factor=100

Picolinafen (ISO); 604- 137641- Submitted STOT RE 2, H373 Active substance in plant protection
N-(4-fluorophenyl)-6-[3- 030-0 05-5 Aquatic Acute 1, H400 products
(trifluoromethyl)phenoxy]pyridi Aquatic Acute 1, M-
ne-2-carboxamide; 4′-fluoro-6- factor=1000
[(α,α,α-trifluoro-m- Aquatic C hronic 1, H410
tolyl)oxy]picolinanilide Aquatic C hronic 1, M-
factor=100
Penthiopyrad (ISO); 606- 183675- Adopted Aquatic Acute 1, H400 Active substance in plant protection
(RS)-N-[2-(1,3-dimethylbutyl)- 001-8 82-3 Aquatic Acute 1, M- products
3-thienyl]-1-methyl-3- factor=1
(trifluoromethyl)pyrazole-4- Aquatic C hronic 1, H410
carboxamide Aquatic C hronic 1, M-
factor=1
Fluopyram (ISO); 619- 658066- Adopted Aquatic C hronic 2, H411 Active substance in plant protection
N-(](2-[3-chloro-5- 797-7 35-4 products
(trifluoromethyl)pyridin-2-
yl]ethyl)[)-2-
(trifluoromethyl)benzamide;
Flonicamid (ISO); 605- 158062- Adopted Acute Tox. 4, H302 Active substance in plant protection
N-(cyanomethyl)-4- 127-0 67-0 products
(trifluoromethyl)pyridine-3-
carboxamide;
Flutolanil (ISO); 613- 66332- Intention Aquatic Acute 1, M- Active substance in plant protection
N-[3-(propan-2-yloxy)phenyl]- 921-3 96-5 factor=1 products
2-(trifluoromethyl)benzamide; Aquatic C hronic 1, M-
α,α,α-trifluoro-3′-isopropoxy-o- factor=10
toluanilide

274
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Flutianil (ISO); 812- 958647- Adopted Aquatic C hronic 1, H410 Active substance in plant protection
(2Z)-(]([2-fluoro-5- 888-4 10-4 Aquatic C hronic 1, M- products
(trifluoromethyl)phenyl]thio)[)[ factor=100
3-(2-methoxyphenyl)-1,3-
thiazolidin-2-ylidene]acetonitrile
Flurochloridone (ISO); 262- 61213- Adopted Acute Tox. 4, H302 Active substance in plant protection
3-chloro-4-(chloromethyl)-1-[3- 661-3 25-0 Skin Sens. 1, H317 products
(trifluoromethyl)phenyl]pyrrolidi Repr. 1B, H360Df
n-2-one Aquatic Acute 1, H400
Aquatic C hronic 1, H410
Fluopicolide (ISO); 607- 239110- Adopted Active substance in plant protection
2,6-dichloro-N-[3-chloro-5- 285-6 15-7 products
(trifluoromethyl)-2-
pyridylmethyl]benzamide
Flazasulfuron (ISO); 600- 104040- Intention Aquatic Acute 1, M- Active substance in plant protection
1-(4,6-dimethoxypyrimidin-2- 514-0 78-0 factor=1 000 products
yl)-3-(3-trifluoromethyl-2- Aquatic C hronic 1, M-
pyridylsulfonyl)urea factor=100
Diflufenican (ISO); 617- 83164- Adopted Aquatic Acute 1, H400 Active substance in plant protection
N-(2,4-difluorophenyl)-2-[3- 446-2 33-4 Aquatic Acute 1, M- products
(trifluoromethyl)phenoxy]-3- factor=1000
pyridinecarboxamide Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=100
C yflumetofen (ISO); 642- 400882- Adopted Skin Sens. 1A, H317 Active substance in plant protection
2-methoxyethyl (RS)-2-(4-tert- 974-5 07-7 C arc. 2, H351 products
butylphenyl)-2-cyano-3-oxo-3-
(α,α,α-trifluoro-o-
tolyl)propionate
Benfluralin 217- 1861-40- Opinion development Skin Irrit. 2, H315 Active substance in plant protection
465-2 1 Eye Irrit. 2, H319 products
Skin Sens. 1, H317
C arc. 2, H351
Repr. 2, H361d

275
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Lact., H362
STOT SE 2, H371
Aquatic Acute 1, H400
Aquatic Acute 1, M-
factor=10
Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=10
Sulfoxaflor (ISO); 807- 946578- Adopted Acute Tox. 4, H302 Active substance in plant protection
[methyl(oxo)(](1-[6- 366-8 00-3 Aquatic Acute 1, H400 products
(trifluoromethyl)-3- Aquatic Acute 1, M-
pyridyl]ethyl)[)-λ6- factor=1
sulfanylidene]cyanamide; Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=1
Fluazinam (ISO); 616- 79622- Adopted Acute Tox. 4, H332 Active substance in plant protection
3-chloro-N-[3-chloro-2,6- 712-5 59-6 Skin Irrit. 2, H315 products
dinitro-4- Eye Dam. 1, H318
(trifluoromethyl)phenyl]-5- Skin Sens. 1, H317
(trifluoromethyl)pyridin-2- Repr. 2, H361
amine; STOT SE 3, H335
Aquatic Acute 1, H400
Aquatic Acute 1, M-
factor=10
Aquatic C hronic 1, H410
Tembotrione (ISO); 608- 335104- Adopted Skin Sens. 1B, H317 Active substance in plant protection
2-(](2-chloro-4- 879-8 84-2 STOT RE 2, H373 products
(methylsulfonyl)-3-[(2,2,2- Aquatic Acute 1, H400
trifluoroethoxy)methyl]benzoyl) Aquatic Acute 1, M-
[)cyclohexane-1,3-dione; factor=100
Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=10

276
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Metaflumizone (ISO); 604- 139968- Adopted Repr. 2, H361d Active substance in plant protection
1-[[](Z)-[[]2-(4-cyanophenyl)- 167-6 49-3 Lact., H362 products
1-[[]3- STOT RE 2, H373
(trifluoromethyl)phenyl]ethylide
ne]amino]-1-[[]4-
(trifluoromethoxy)phenyl]urea
Oxathiapiprolin (ISO); 801- 1003318- Adopted Aquatic C hronic 1, H410 Active substance in plant protection
1-(4-(](4-[[]5-(2,6- 263-1 67-9 products
difluorophenyl)-4,5-dihydro-
1,2-oxazol-3-yl]-1,3-thiazol-2-
yl)[)piperidin-1-yl)-2-[[]5-
methyl-3-(trifluoromethyl)-1H-
pyrazol-1-yl]ethan-1-one
Mefentrifluconazole; - 1417782- Adopted Skin Sens. 1, H317 Active substance in plant protection
(2RS)-2-[4-(4-chlorophenoxy)- 03-6 Aquatic Acute 1, H400 products
2-(trifluoromethyl)phenyl]-1- Aquatic Acute 1, M-
(1H-1,2,4-triazol-1-yl)propan- factor=1
2-ol; Aquatic C hronic 1, H410
Aquatic C hronic 1, M-
factor=1
Bifenthrin (ISO); 617- 82657- notified Active substance in biocidal and plant
(2-methylbiphenyl-3-yl)methyl 373-6 04-3 protection products
rel-(1R,3R)-3-[(1Z)-2-chloro-
3,3,3-trifluoroprop-1-en-1-yl]-
2,2-
dimethylcyclopropanecarboxylat
e;
Fipronil (ISO); 424- 120068- registered Active substance in biocidal and plant
(±)-5-amino-1-(2,6-dichloro- 610-5 37-3 protection products
α,α,α-trifluoro-para-tolyl)-4-
trifluoromethylsulfinyl-pyrazole-
3-carbonitrile

277
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Flufenoxuron; 417- 101463- registered Active substance in plant protection
() 1-(4-(2-cloro-α,α,α-p- 680-3 69-8 products
trifluorotolyloxy)-2-
fluorophenyl)-3-(2,6-
difluorobenzolyl)urea
Picoxystrobin (ISO); 601- 117428- registered Active substance in plant protection
methyl (2E)-3-methoxy-2-[2- 478-9 22-5 products
((]([6-(trifluoromethyl)pyridin-
2-
yl]oxy)[)methyl)phenyl]acrylate
Triflumizole (ISO); 614- 68694- notified Active substance in plant protection
(1E)-N-[4-chloro-2- 708-8 11-1 products
(trifluoromethyl)phenyl]-1-(1H-
imidazol-1-yl)-2-
propoxyethanimine; (ISO)

Prosulfuron 94125- no C LH intention Active substance in plant protection


N-[(4-methoxy-6-methyl-1,3,5- 34-5 products
triazin-2-yl)carbamoyl]-2-
(3,3,3-
trifluoropropyl)benzenesulfona
mide
or
1-(4-methoxy-6-methyl-1,3,5-
triazin-2-yl)-3-[2-(3,3,3-
trifluoropropyl)phenylsulfonyl]ur
ea
Haloxyfop-P 95977- no C LH intention Active substance in plant protection
(R)-2-(](4-[3-chloro-5- 29-0 products
(trifluoromethyl)- 2-
pyridyloxy]phenoxy)[)propanoic
acid

278
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Gamma-C yhalothrin; 76703- no C LH intention Active substance in plant protection
(S)-a-cyano-3-phenoxybenzyl 62-3 products
(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoropropenyl)-2,2-
dimethylcyclopropanecarboxylat
e
lambda-C yhalothrin; -; 415- 91465- no C LH intention Active substance in biocidal and plant
[(R)-cyano-(3- 130-7 08-6 protection products
phenoxyphenyl)methyl]
(1S,3S)-3-[(Z)-2-chloro-3,3,3-
trifluoroprop-1-enyl]-2,2-
dimethylcyclopropane-1-
carboxylate
Tau-Fluvalinate; 102851- no C LH intention Active substance in plant protection
[cyano-(3- 06-9 products
phenoxyphenyl)methyl] (2R)-2-
[2-chloro-4-
(trifluoromethyl)anilino]-3-
methylbutanoate
Tetraconazole; 112281- no C LH intention Active substance in plant protection
(+/-)-2-(2,4-Dichlorophenyl)-3- 77-3 products
(1H-1,2,4-triazole-1-ylpropyl)-
1,1,2,2-tetrafluorethyl ether
Flufenacet; 142459- no C LH intention Active substance in plant protection
N-(4-Fluorophenyl)-N-(propan- 58-3 products
2-yl)-2-(]([5-(trifluoromethyl)-
1,3,4-thiadiazol-2-
yl]oxy)[)acetamide
Beflubutamid; 113614- no C LH intention Active substance in plant protection
N-benzyl-2-[4-fluoro-3- 08-7 products
(trifluoromethyl)phenoxy]butan
amide

279
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Penoxsulam; 219714- no C LH intention Active substance in plant protection
2-(2,2-difluoroethoxy)-N-(5,8- 96-2 products
dimethoxy-[1,2,4]triazolo[1,5-
c]pyrimidin-2-yl)-6-
(trifluoromethyl)benzenesulfona
mide
C yflufenamid; 180409- no C LH intention Active substance in plant protection
N-[(Z)-N-(cyclopropylmethoxy)- 60-3 products
C -[2,3-difluoro-6-
(trifluoromethyl)phenyl]carboni
midoyl]-2-phenylacetamide
Acrinathrin; 600- 101007- no C LH intention Active substance in plant protection
(S)-C yano(3- 147-6 06-1 products
phenoxyphenyl)methyl (Z)-
(1R,3S)-2,2-dimethyl[2-(2,2,2-
trifluoro-1-
trifluoromethylethoxycarb
onyl)vinyl]-
cyclopropanecarboxylate
fluazifop-P; 617- 83066- no C LH intention Active substance in plant protection
(2R)-2-(4-([5- 435-2 88-0 products
(trifluoromethyl)pyridin-2-
yl]oxy)phenoxy)propanoic acid

Flubendiamide; 608- 272451- no C LH intention Active substance in plant protection


3-iodo-N'-(2-mesyl-1,1- 064-7 65-7 products
dimethylethyl)-N-(](4-[1,2,2,2-
tetrafluoro-1-
(trifluoromethyl)ethyl]-o-
tolyl)[)phthalamide
Flumetralin; 613- 62924- no C LH intention Active substance in plant protection
N-(2-chloro-6-fluorobenzyl)-N- 108-3 70-3 products
ethyl-α,α,α-trifluoro-2,6-dinitro-
p-toluidine; flumetralin (ISO)

280
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Substance name EC / CAS no CLH status/status Classification adopted Regulatory Program


List no under REACH or proposed
Fluometuron; 218- 2164-17- no C LH intention Active substance in plant protection
1,1-Dimethyl-3-[3- 500-4 2 products
(trifluoromethyl)phenyl]urea

Oxyfluorfen; 255- 42874- no C LH intention Active substance in plant protection


2-chloro-1-(3-ethoxy-4- 983-0 03-3 products
nitrophenoxy)-4-
(trifluoromethyl)benzene
*The approval of these substances is pending.

281
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Table A.109. Non- exhaustive list of EU approved biocidal active substances covered by the
current PFAS definition.
Substance EC/List CAS no. BAS Product-type Approval
name no. number start date
Hexaflumuron; -; 86479- 1314 PT18-Insecticides, 01/04/2017
1-(3,5-dichloro- 401-400-1 06-3 acaricides and products
4-(1,1,2,2- to control other
tetrafluoroethoxy arthropods
)phenyl)-3-(2,6-
difluorobenzoyl)
urea
C hlorfenapyr; 602-782-4 122453- 66 PT08-Wood 01/05/2015
(ISO)4-bromo-2- 73-0 preservatives,
(4-chlorophenyl)- PT18-Insecticides,
1-ethoxy methyl- acaricides and products
5- to control other
trifluoromethylpy arthropods
rrole-3-
carbonitrile
Bifenthrin - 82657- 8 PT08-Wood preservatives 01/02/2013
04-3
Fipronil -; 120068- 33 PT18-Insecticides, 01/10/2013
424-610-5 37-3 acaricides and products
to control other
arthropods
Flocoumafen -; 90035- 34 PT14-Rodenticides 01/10/2011
421-960-0 08-8
lambda- -; 91465- 41 PT18-Insecticides, 01/10/2013
C yhalothrin; 415-130-7 08-6 acaricides and products
[(R)-cyano-(3- to control other
phenoxyphenyl) arthropods
methyl] (1S,3S)-
3-[(Z)-2-chloro-
3,3,3-
trifluoroprop-1-
enyl]-2,2-
dimethylcyclopro
pane-1-
carboxylate
Tralopyril - 122454- 1403 PT21-Antifouling 01/04/2015
29-9 products

Table A.110. Non- exhaustive list of active pharmaceutical ingredients (APIs) following current
PFAS definition, authorised as medicinal products.
Type of registration
API CASNR CH NH CV NV A126a WHO- Orpha ATC
EML n
alpelisib 1217486-61-7 x L01XX
apalutamide 956104-40-8 x L02BB
aprepitant 170729-80-3 x x A04AD
bendroflumethiazide 73-48-3 x C 03AA
C 03AB
C 03EA
benfluorex 23602-78-0 x A10BX
bicalutamide 90357-06-5 x x x L02BB
cangrelor 163706-06-7 x B01AC

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ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Type of registration
API CASNR CH NH CV NV A126a WHO- Orpha ATC
EML n
celecoxib 169590-42-5 x x x C 08C A
L01XX
M01AH
cinacalcet 226256-56-0 x H05BX
desflurane 57041-67-5 x N01AB
dexfenfluramine 3239-44-9 x A08AA
doravirine 1338225-97-0 x J05AG
dutasteride 164656-23-9 x G04C A
G04C B
efavirenz 154598-52-4 x x x J05AG
elexacaftor 2216712-66-0 x R07AX a
enzalutamide 915087-33-1 x L02BB
fenfluramine 458-24-2 x A08AA
flecainide 54143-55-4 x C 01BC
fluoxetine 54910-89-3 x x x x N06AB
flunixin 38677-85-9 x QM01AG
fluphenazine 69-23-8 x x N05AB
fluvoxamine 54739-18-3 x x N06AB
fosaprepitant 172673-20-0 x A04AD b
fosnetupitant 1703748-89-3 x A04AD b
fulvestrant 129453-61-8 x x L02BA
gemcitabine 95058-81-4 x x L01BC
glecaprevir 1365970-03-1 x J05AP
isoflurane 26675-46-7 x x x N01AB
ivosidenib 1448347-49-6 x x x L01XX
lansoprazole 103577-45-3 x x A02BC
A02BD
ledipasvir 1256388-51-8 x J05AP
leflunomide 75706-12-6 x x L04AA
letermovir 917389-32-3 x x J05AX
lomitapide 182431-12-5 x x C 10AX
maraviroc 376348-65-1 x J05AX
mefloquine 53230-10-7 x x P01BC
P01BF
netupitant 290297-26-6 x A04AD b
nilotinib 641571-10-0 x x L01XE
nilutamide 63612-50-0 x L02BB
nitisinone 104206-65-7 x A16AX
penfluridol 26864-56-2 x N05AG

perflutren 76-19-7 x V08DA


ponatinib 943319-70-8 x L01XE
regorafenib 755037-03-7 x L01XE
rolapitant 552292-08-7 x A04AD
sevoflurane 28523-86-6 x x N01AB
silodosin 160970-54-7 x G04C A
siponimod 1230487-00-9 x L04AA
sitagliptin 486460-32-6 x A10BH
sorafenib 284461-73-0 x L01XE
tafluprost 209860-87-7 x S01EE
telotristat 1033805-22-9 x A16AX
teriflunomide 163451-81-8 x L04AA

283
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

Type of registration
API CASNR CH NH CV NV A126a WHO- Orpha ATC
EML n
tezacaftor 1152311-62-0 x R07AX
tipranavir 174484-41-4 x J05AE
travoprost 157283-68-6 x S01EE
trifluoperazine 117-89-5 x N05AB
upadacitinib 1310726-60-3 x L04AA
vinflunine 162652-95-1 x L01C A
voxilaprevir 1535212-07-7 x J05AP
a No ATC code is available, based on similarity with tezacaftor and ivacaftor , the code R07AX was tentatively
assigned.
b No ATC code available, based on similarity with aprepitant and rolapitant the code A04AD was tentatively

assigned.
List of abbreviations:
C H=centralised authorisation for human health,
NH=decentralised registration for human health (mutual recognition),
C V=centralised authorisation for veterinary purposes,
NV=decentralised registration for veterinary purposes (mutual recognition),
A126a=registration in Article 126a.
WHO-EML=list of essential medicines of the World Health Organisation (WHO, 2019), ATC = Anatomical
Therapeutic C hemical (ATC ) C lassification System up to the chemical -therapeutic-pharmacological
subgroup (level 4) 46. Number of potential alternatives is only reported for registered PFAS -medicinal
products.
Orphans are medicinal products that have been developed to treat rare diseases and that have a market
protection for 10 years (+potential 2 years extension) 47.

46
https://www.whocc.no/atc_ddd_index/, date of access: 2022-12-16.
47https://ec.europa.eu/health/documents/community -register/html/index_en.htm, date of access:
2022-12-16.

284
ANNEX XV RESTRICTION REPORT – Per- and polyfluoroalkyl substances (PFASs)

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