5 January, 2023
Dear Competent Authorities of Denmark, Germany, Netherlands, Norway, Sweden,
Cc: Commissioner Breton, Commissioner
Sinkevičius
We, the undersigned manufacturers and users of fluoropolymers encourage you to put forward a proposal
for a per- and polyfluorinated alkyl substances REACH restriction in a way that differentiates between
fluoropolymers and other PFAS groups, taking into account the different risk profiles and uses of each group
separately. Recognition of the safe uses of fluoropolymers, as determined by prior rigorous evaluation and
of their importance for many applications, should result in an exemption for fluoropolymers from any
regulatory action under the REACH restriction.
Fluoropolymers have been categorized as PFAS
1
when based solely on their molecular structure. However,
their environmental and toxicological profiles are distinctly different to the majority of other lower
molecular weight PFAS:
•
In general, the properties of many fluoropolymers (fluoroplastics and fluoroelastomers) are such
that they do not display the environmental and toxicological profiles associated with some PFAS that
could be considered of concern;
Specifically, recent
studies
23
have shown that 16 unique families of commercially popular
fluoropolymers meet the OECD Polymer of Low Concern criteria.
4
They are chemically stable, non-
toxic, non-bioavailable non-water soluble and non-mobile materials and they are deemed to have no
significant environmental and human health impacts.
•
Significant benefits are generated along the value chain via the use of fluoropolymers. They have unmatched
chemical and temperature resistance and unique electrical performance. Their stability in combination with
these properties, translates to unique, durable, lasting performance in applications and contributes to
extension of product life. Additionally, the durability of fluoropolymers makes them ideal materials that
enable the development of innovative technologies.
Assessments of alternative materials have shown that, when available, they frequently cannot meet the
critical performance characteristics of fluoropolymer-based materials and lack the combinations and ranges
of properties required for applications that sets the fluoropolymer-based materials apart.
A broad PFAS restriction which includes fluoropolymers could result in:
•
Environmental, health and safety implications such as higher safety risks to employees, medical
patients and consumers; and increased emissions from modes of transport due to technical
regression;
1
Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical
Guidance Series on Risk Management No.61, 9 July 2021.
https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2021)25&docLanguage=E
n
2
A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics
and Fluoroelastomers, Stephen H. Korzeniowski et al, 2022.
https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4646?af=R
3
A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers, Barbara Henry
et al, 2018.
https://setac.onlinelibrary.wiley.com/doi/full/10.1002/ieam.4035
4
Data Analysis of the identification of correlations between polymer characteristics and potential for health or
ecotoxicological concern, OECD 2009.
https://www.oecd.org/env/ehs/risk-assessment/42081261.pdf