Document wLer0mjozNV8jamBmd38N2wB
Comments for Annex XV restriction report on Per- and polyfluoroalkyl substances (PFAS)
Preliminary comments
Fiberflon welcomes the opportunity to contribute to the public consultation issued by the European Chemicals Agency (ECHA) regarding the restriction proposal of Per- and polyfluoroalkyl substances (PFAS) under Regulation (EC) No. 1907/2006 (REACH).
Fiberflon is a manufacturer of fluoropolymer coated fabrics, tapes, films and conveyor belts. Since 1988, Fiberflon has been manufacturing temperature and chemical resistant non-stick composite materials that are used in diverse manufacturing applications. We use PTFE, FEP and PFA fluoropolymers for the manufacturing of our materials.
Our Company is part of an informal group of six companies1 that have in common a number of fluoropolymer use applications. However, there is diversity across the companies according to the type of industries each serves; and as such we do not have an industry association to represent us for regulatory matters. Relating to the proposed ECHA (universal) PFAS Restriction, the group shares the view that fluoropolymers should be exempted. The next section of this statement provides the justification for our position. For the purpose of working together on this matter, the group of six companies has engaged an independent third party trustee for handling and aggregating confidential business information for each company.
The following table provides an aggregated overview of the volumes in metric tonnes of fluoropolymers used within the EEA by the six companies over the last five years. The majority of the fluoropolymer volume relates to the use of PTFE, with additional fluoropolymers such as FEP, PFA, ETFE, FKM and others contributing to the total volume used.
2018
Vol. used in EEA
1564
2019
Vol. used in EEA
1433
2020
Vol. used in EEA
1224
2021
Vol. used in EEA
1508
2022
Vol. used in EEA
1525
Across the six companies, the number of workers potentially impacted by the proposed restriction is as follows:
1 The six companies are: Fothergill Group, Fiberflon, Taconic International, Textiles Coated International, VerseidagIndutex GmbH and AFC Materials, located in multiple jurisdictions globally, notably the European Union, U.K., U.S.A., Turkey and Australia, with each company serving EU/EEA markets.
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Location of sites
EEA Rest of the World
Total
Number of workers
261 661 922
This submission is made on an individual company basis to allow provision of confidential data in greater detail.
Fiberflon appreciates the work performed by the five submitters of the restriction proposal and the efforts of the European authorities on the protection of human health and the environment in front of the effects of the PFAS substances that are of concern.
1. Request for exemption of fluoropolymers
The proposed restriction does not differentiate between fluoropolymers (covering fluoroplastics such as PVDF, ECTFE, FEP, PFA, PTFE, etc., as well as fluoroelastomers such as FKM, FFKM, etc.) and other families of PFAS. Fluoropolymers have unique properties that distinguish them from other PFAS and they do not have the environmental and toxicological profiles associated with some substances in this class of chemicals that are of concern. For this reason, we strongly believe that the restriction proposal should differentiate between the different families of PFAS based on their chemical composition, their toxicological profile, and the production method (e.g., the production of fluoropolymers without fluorinated polymerisation aids).
Fluoropolymers are durable, stable, and mechanically strong in harsh conditions in a variety of sectors including but not limited to automotive, aerospace, environmental controls, energy production and storage, and electronics, as well as in technical apparel. They are also stable in air, water, sunlight, chemicals, and microbes, and chemically inert, meeting the requirements for low levels of contaminants and particulates in manufacturing environments critical for the food and beverage, pharmaceutical, medical, and semiconductor industries. Finally, fluoropolymers are biocompatible; non-wetting, nonstick, and highly resistant to temperature, fire, and weather. These unique characteristics make them a critical material for a broad range of industries and sectors, playing a diverse and crucial role for society, with few, if any, viable alternatives, and making them essential in numerous technologies, industrial processes, and everyday products. Furthermore, the restriction of fluoropolymers will make it impossible to achieve key goals set by the European Union, such as the Green Deal, the transition to a circular economy, and the autonomy of Europe in critical technological sectors.
Beyond their socio-economic value for European industry, their unique stability means that they are lowrisk polymers for human health and their environment. Trying to replace them in their many applications would lead to substitution with alternatives (when available) that do not provide the same advanced performance and safety as fluoropolymers. Furthermore, any alternative that may be suggested to replace fluoropolymers will need to perform at least at some degree (even if at lower levels) of chemical and temperature resistance, which means that such alternatives will likely be persistent materials like fluoropolymers.
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Since fluoropolymers are different from the other families of PFAS, there is no scientific, economic, or social basis to justify regulating them in the same way as all of the PFAS. For this reason, we request that fluoropolymers should be fully exempted from this restriction proposal under the REACH regulation.
2. Missing uses
Following the review of the current version of the Annex XV restriction report, we have identified the absence of specific uses of fluoropolymers that have not been evaluated, either because they have not been researched, or that have been searched in general by the dossier submitters (according to Table A.1 of Annex A of the Annex XV restriction report). These uses are as follows:
Sector
Industries Filtration
Uses
Component used in filter elements as the catching media for high-tech
filtration of liquids & gases
Chemical Processing & Energy
Expansion joint fabrics, Gaskets, floating roof seals and insulation
jacket materials
Fluoropolymer Coated Fabrics
Abrasives Packaging
Release fabric between abrasive discs & grinding wheels during
curing
Shrink-wrap tunnel curtains
Aerospace
Release sheets used in the manufacturing of composite parts
of aircrafts
Renewable Energy
Carrier for the production of PEM (polymer electrolyte membraneproton exchange membrane) in the hydrogen fuel cell manufacturing
Fluoropolymer Coated Conveyor Belts
Renewable Energy Automotive
Conveyor belts for manufacturing of module lamination for solar panels
Conveyor belts for vulcanizing ovens for the manufacturing of
rubber extrusion & curing, production of trailer side skirts, for
lamination of head liners, trunk liners and door panels.
Pressing and processing aids for Noise, Vibration and Harshness
(NVH) products
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Sector
Fluoropolymer Coated Pressure Sensitive Tapes
Fluoropolymer Films
Industries Screen Printing
Textiles
3D Printing Packaging Polymer Processing Renewable Energy Composites Packaging Medical Air Filtration
Uses
Conveyor belts for drying printed ink on card, paper, board, metals
and textiles
Conveyor belts for drying natural, synthetic, woven, non-woven and knitted fabrics, thermal bonding of non-woven fabrics, production of non-woven waddings, fusing press
machines, double belt press machines
Conveyor belts used in 3D printers
Conveyor belts for side and base sealing on automatic packaging machinery, for shrink wrap tunnels
Curing of paint chips, P.U., P.E., PVC products
Production of pre-preg and recycled sheets
Release tapes to cover wind turbine blade moulds
Mould Release tapes
Covering heat-sealing bars in bag making, covers for heated platens
on film sealing and wrapping machinery
Covering of the heat sealers in the manufacturing of ostomy bags, heat sealing blister packs
Seam seal tapes used in the production of low emission filter
bags used in dust collectors of cement factories
Furthermore, we have identified some uses that have been evaluated in detail by the dossier submitters (according to Table A.1 of Annex A of the Annex XV restriction report) but for which no derogation has been defined. These uses are the following:
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Sector Fluoropolymer Coated Fabrics
Fluoropolymer Coated Conveyor Belts
Fluoropolymer Coated Fabrics
Industries Construction
Construction
Consumer/professional Cookware
Uses
Architectural Membranes
Conveyor belts for curing crumb rubber mats, PVC & PU backed
flooring, walk-off mats, LVT laminates
Non-stick oven liners, baking sheets
Clamshell grill sheets, vertical & horizontal bun toaster sheets, trays
for high-speed microwave ovens
We are aware that fluoropolymers play a key role in the uses detailed above. Therefore, we can provide enough scientific, technical, and economic information about them to be evaluated by RAC and SEAC and included in the review of the restriction proposal. We will provide this information through different statements that will be submitted separately during the public consultation period (see section 5 of this document).
In all cases, and in our opinion, these uses could be included in the general exemption of fluoropolymers requested in section 1 of this document. Alternatively, we are confident that they could merit derogations.
3. Potential derogations marked for reconsideration
Although we believe that fluoropolymers should be fully exempted from this regulatory action, alternatively, we want to support some of the derogations marked for reconsideration that are defined in the current version of the Annex XV restriction report.
For this reason, we would like to express our appreciation for the consideration of the following potential derogation:
Sector
Industries
Uses
Fluoropolymer Coated Fabrics
Automotive
Self-lubricating bearing materials
We are aware that fluoropolymers play a key role in the uses related to this potential derogation. Therefore, we can provide enough scientific, technical, and economic information about them to be evaluated by RAC and SEAC in order to move these derogations marked for reconsideration into proposed derogations. We will provide this information through different statements that will be submitted separately during the public consultation period (see section 5 of this document).
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4. Proposed derogations
Although we believe that fluoropolymers should be fully exempted from this regulatory action, alternatively, we want to support some of the proposed derogations that are defined in the current version of the Annex XV restriction report.
For this reason, we would like to express our appreciation for the consideration of the following proposed derogations:
Sector
Fluoropolymer Coated Conveyor Belts
Industries Food Processing
Uses
Conveyor belts for: mass cooking of meat, poultry, tortilla belts, contact grilling, steam cooking of pet foods,
dryers for grains, vegetables and fruits
We are aware that fluoropolymers play a key role in the uses related to these proposed derogations. Therefore, we can provide additional scientific, technical, and economic information about them to be evaluated by RAC and SEAC in order to support these proposed derogations. We will provide this information through different statements that will be submitted separately during the public consultation period (see section 5 of this document).
5. Further submissions
We appreciate the proposed derogations and those marked for reconsideration in the current restriction proposal; however, we believe they are neither clear enough nor broad enough to cover all the applications where fluoropolymers are essential. Additionally, due to the vast amount of socially important uses of fluoropolymers and their distinct safety profiles compared to other PFAS, we believe that a broad exemption of fluoropolymers from the proposed PFAS restriction is appropriate.
The above statements and observations will be further substantiated in the course of the consultation process. In particular, we will provide further comments on the proposal and the effects of the contemplated restriction as well as the requested exemptions and/or derogations. We will also provide further justifications as regards the details to be considered for exemptions and/or derogations. For the time being, we kindly request ECHA, including RAC and SEAC, as well as Member States to consider this initial submission as a preliminary statement.
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