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Presentation Outline
- About Gore - Gore's Product Portfolio - EU PFAS Restriction Proposal - EU PFAS Restriction Proposal and Fluoropolymers
2023 W. L. Gore & Associates
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About Gore | Global Facts & Figures
Founded in 1958
One of the 200 largest privately held US companies
12,000+ Associates (2,500+ in Europe)
1969: Discovery of ePTFE
2023 W. L. Gore & Associates
3,500+ unique inventions
12% of revenue dedicated to R&D
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Proposed EU PFAS Restriction
Dossier submitters` concerns from Annex B
- The main concern for all PFAS and/or their degradation products is their very high persistence (vP).
- Supporting concerns are their bioaccumulation, mobility, long range transport potential (LRTP), accumulation in plants, global warming potential and (eco)toxicological effects.
- High persistence in the environment will lead to distribution of PFAS from one environmental compartment to another (e.g. from soil to freshwater to marine environment).
- Continued PFAS emissions will lead to an increased environmental stock leading to increased exposures. Increased exposures will exceed known/unknown PFAS thresholds to cause adverse effects at some point in time.
- Therefore, PFAS should be treated as non-threshold substances like PBT/vPvB substances and PFAS
2023 W. L. Gore & Associates
releases should be used as a proxy for risk. - Fluoropolymers are indirectly of concern because
during their production and use, monomers, oligomers and by-products of processing "are emitted into the environment" and during waste incineration at end of life, other PFAS "may be formed and emitted". Grouping all PFAS together is based on structural similarity (common perfluoroalkyl moieties) that is considered to trigger equivalent hazards and risk, primarily related to the vP property.
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Proposed EU PFAS Restriction EU industries have already voiced constructive suggestions on how to improve the restriction proposal
~ Call for exemption of PFAS that verifiably
do not pose an ,unacceptable risk", e.g.
fluoropolymers.
~ 3 Strong supSuppport for:
~ Derogations for industries until
socioeconomically sensible
alternatives are available
~ Realistic transition timeline for those
applications where socioeconomically
satenlseiabsltefaolrteesreneaatbilvees are available or
~ Correction of technical
misconceptions in the proposal
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Proposed EU PFAS Restriction | Fluoropolymers
Persistency and Related Concerns | Rebuttal based on scientific evidence
Key Takeaway
Fluoropolymers are persistent, but not mobile, bioaccumulative, or bioavailable. They do not concentrate in environmental compartments.
The restriction proposal lacks a sufficient scientific basis with regard to risk assessment of fluoropolymers. It is not even
clear from the proposal whether the dossier submitters associate
any direct hazards with fluoropolymers.
2023 W. L. Gore & Associates
A body of data demonstrates that regulators concerns about
persistency of fluoropolymers, like PTFE, are absent.
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Proposed EU PFAS Restriction | Fluoropolymers
Persistency and Related Concerns | Rebuttal based on scientific evidence
Stated Concern
Rebuttal
Evidence
High persistence will lead to distribution of PFAS from one environmental compartment to another
PTFE is not volatile, is insoluble in water, does not adsorb to soil and does not partition to or concentrate in environmental compartments. It is not mobile and is not subject to long range transport.
Charles River Laboratories data
Increased environmental stock... Resulting increase in exposure
Exceeding thresholds that cause adverse effects PTFE releases can be a proxy for risk Grouping all PFAS together is expedient because common moiety means shared hazard profile
PTFE is not bioavailable. The blanket assertion that long persistence leads to high-risk disregards risk being dependent on the quantity released, uptake in biota and toxicity. Assuming the total concentration is bioavailable overestimates risk. Need to quantify the bioavailable fraction and use it to get a more representative picture of the actual human and environmental risk. Only the bioavailable fraction of a chemical in the environment is available for uptake. Risk requires hazard and bioavailable exposure.
PTFE does not have hazards (persistence alone is not a hazard), therefore PTFE has no threshold for adverse effects to exceed
Risk assumes hazard and bioavailable exposure, neither of which is present for PTFE.
The presence of a single fully fluorinated carbon is insufficient to describe all PFAS and their chemical, physical and biological properties. For example, the hazards of a perfluoroalkyl acid are not shared by a polymeric perfluoropolyether.
Beyer EC, 1993; DeMello WC, 1987; Alberts B, Bray D, Lewis J et al., 1994; Leeson, 2012.; ECETOC Special Report No.18. Brussels, July 2014; Ming-Qiang Zhang and Barrie Wilkinson, 2007.; Mackay D et. al., 2014;Ehlers and Loibner, 2006; Akkanen et al., 2012; Semple et al.,2004; Nat'l Research Council 2003
Henry et al., 2018 and Supplement; published literature; clinical trials;
Supplement to Henry et al., 2018,
CEFIC fact sheet on grouping, May 2021; Anderson et al., 2022. Reg Tox and Pharm, Volume 134, October 2022.
Possible degradation products and/or leachables are otherwise a source of concern
2023 W. L. Gore & Associates
The tested PTFE (fine powder PTFE meeting ASTM D4895) showed a lack of degradation and leachables; therefore, not a source of concern.
Charles River Laboratories data
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Proposed EU PFAS Restriction | Fluoropolymers
Emissions and Related Concerns | Rebuttal based on scientific evidence
Key Takeaway
The main concern is around environmental emissions from manufacturing and end-of-life. The right instrument to regulate emissions from manufacturing is emission control law, not a restriction.
Fluoropolymer manufacturing and processing emissions can be tightly controlled with BAT environmental control technologies. This applies to both exhaust air and the wastewater stream. Fluoropolymers manufactured under BAT have low to undetectable
residual levels.
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Residuals and contaminants impact PTFE performance and are undesirable from a quality perspective.
Note: To produce highly technical products, such as those Gore products enable, PTFE (made with no fluorinated PPAs) cannot achieve high enough molecular weight (MW) and processability as fine powder PTFE (which needs fluorinated PPAs to achieve high MW)
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Proposed EU PFAS Restriction | Fluoropolymers Proposed EU PFAS Restriction | Fluoropolymers
Emissions and Related Concerns | Rebuttal based on scientific evidence
Stated Concern Environmental release of PFAS (processing aids, monomers, oligomers, etc.) used or formed in the production of fluoropolymers...
...during product manufacturing and intended use... ...during product disposal/end-of-life
Rebuttal
The CAS# System is inadequate to differentiate between processing methods and key attributes that influence degradation products.
Fluoropolymer manufacturing and processing emissions can be tightly controlled with BAT environmental control technologies. This applies to both exhaust air and the wastewater stream.
Residual processing aids and other residuals are undesirable because contaminants impact or impair processing of fluoropolymer resins into final products, influence the attributes of the polymer, and impair polymer performance. Post polymerization finishing steps (e.g., washing, drying) reduce residuals.
Processing steps to reduce residuals and volatiles in fluoropolymers, including PFAS-based processing aids and monomers, are undertaken as part of quality control.
Poor quality materials may contain higher levels of impurities, residuals, and other contaminants. These materials would not be suitable for highly technical applications.
When applying high manufacturing standards, residuals are reduced to trace levels in post-polymerization processing steps. For example, PTFE (fine powder PTFE meeting ASTM D4895-16) contains very low to undetectable (<1ppm) levels of processing aid residuals, as published data demonstrates.
Gore commissioned an incineration study to determine if any of 31 studied PFAS were released under typical municipal incineration conditions. PFAS compounds were chosen to represent a broad range of PFAS and were selected due to their occurrence in the environment, literature citations and availability of validated methods from commercial laboratories. Municipal incineration of PTFE showed no significant generation of the studied PFAS.
Evidence ECETOC-133, 2019; Korzeniowski, 2022; Henry et al.,, 2018 and Supplemental; Ebnesajjad, 2000; ASTM4895-16
Charles River Laboratories; Henry et al., 2018 Supplemental. Alexandrov et al., 2019. Chemosphere Volume 226, July 2019, Pages 898906.
2023 W. L. Gore & Associates
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