Why are fluoropolymers safe?

Are fluoropolymers safe during their intended use phase?

In short, the answer is yes, fluoropolymers have been proven safe during their intended use phase. Let’s find out more about the safety of fluoropolymers and the PLC criteria.

Fluoropolymers are a distinct class of per‐and polyfluoroalkyl substances (PFAS), high molecular weight polymers with fluorine attached to their carbon‐only backbone. They possess a unique combination of properties and unmatched functional performance, which are critical to the products and manufacturing processes they enable. For this reason, fluoropolymers are irreplaceable in several uses and applications.

Although fluoropolymers fit the PFAS structural definition, as described by the OECD11, they have very different physical, chemical, environmental, and toxicological properties when compared with other PFAS. Fluoropolymers have documented safety profiles and are thermally, biologically, and chemically stable, negligibly soluble in water, nonmobile, nonbioavailable, nonbioaccumulative, and nontoxic.12, 13

An in depth-assessment of eighteen different fluoropolymers accounting for approximately 96% of the global commercial fluoropolymer market against thirteen widely accepted polymer hazard assessment criteria, showed that these polymers are of low concern (PLC) and pose no significant risk to human health and the environment. 

The PLC criteria were developed over time within regulatory frameworks around the world to facilitate polymer hazard assessment that identifies low-risk polymers and to assist the prioritization of regulatory activity on high-risk substances. ​Fulfilling these criteria, as 96% of fluoropolymers do, means these materials are considered to be a low hazard to human health and the environment.14

The in-depth assessment found that fluoropolymers are solid, inert, and stable materials and none of the eighteen tested fluoropolymers are soluble in water or octanol. Moreover, they are biologically inert, and not expected to move in or between environmental media. These properties and water insolubility mean fluoropolymers are not mobile in the environment. In addition, as fluoropolymers are high molecular weight materials, they cannot be absorbed through a cell membrane – they are neither bioavailable nor bioaccumulative, and they also have low extractables and leachables. Fluoropolymers resist degradation by acids, bases, oxidants, reductants, photolytic processes, microbes, and metabolic processes and for this reason, they are thermally, chemically, and biologically highly inert.

In conclusion, 96% of the commercially available fluoropolymers meet the PLC criteria and are deemed to be of low hazard to human health and the environment. Given their intrinsically distinct characteristics, fluoropolymers should not be grouped with other PFAS for hazard assessment or regulatory purposes.15

Annex I: Fluoropolymers including fluoroplastics and fluoroelastomers who meet the Polymer of Low Concern (PLC) criteria.2,3

FluoroplasticsFluoroplastics
PTFE (polytetrafluoroethylene)EFEP (ethylene‐ tetrafluoroethylene‐hexafluoropropylene)
ETFE (ethylene tetrafluoroethylene)CPT (terpolymer, chlorotrifluoroethylene‐tetrafluoroethylene (CPT) terpolymer)
FEP (fluorinated ethylene propylene)THV (d tetrafluoroethylene, hexafluoropropylene, vinylidene fluoride (TFE‐HFP‐VF2 [THV])
PFA (perfluoroalkoxy polymer)
  1. Organisation for Economic Co‐operation and Development (OECD). (2021). Reconciling terminology of the universe of per‐and polyfluoroalkyl substances: recommendations and practical guidance. Series on Risk Management No.  61. one.oecd.org/document/ENV/CBC/MONO(2021)25/en/pdf
  2. Henry B. J., Carlin P. J., Hammerschmidt J. A., Buck, R. C., Buxton W., Fiedler H., Seed J., Hernandez O. (2018). A Critical Review of the Application of Polymer of Low Concernand Regulatory Criteria to Fluoropolymers, Integr Environ Assess Manag2018:316–334 setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4035
  3. Korzeniowski S.H., Buck, R. C., Newkold R. M., El kassmi A., Laganis E., Matsuoka Y., Dinelli B.,  Beauchet S., Adamsky F., Weilandt K. ,Soni V., Kapoor D., Gunasekar P., Malvasi M., Brinati G., Musio S. (2022). A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integr Environ Assess Manag2022:1–30 https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4646
  4. OECD (2009). Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. Organisation for Economic Co-operation and Development, ENV/JM/MONO(2009)1, 27th January 2009.  www.oecd.org/env/ehs/risk-assessment/42081261.pdf
  5. Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts, J.K. Anderson, Regulatory Toxicology and Pharmacology 134 (2022) 105226. https://pubmed.ncbi.nlm.nih.gov/35817206
  6. Organisation for Economic Co‐operation and Development (OECD). (2021). Reconciling terminology of the universe of per‐and polyfluoroalkyl substances: recommendations and practical guidance. Series on Risk Management No.  61. one.oecd.org/document/ENV/CBC/MONO(2021)25/en/pdf
  7. Henry B. J., Carlin P. J., Hammerschmidt J. A., Buck, R. C., Buxton W., Fiedler H., Seed J., Hernandez O. (2018). A Critical Review of the Application of Polymer of Low Concernand Regulatory Criteria to Fluoropolymers, Integr Environ Assess Manag2018:316–334 setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4035
  8. Korzeniowski S.H., Buck, R. C., Newkold R. M., El kassmi A., Laganis E., Matsuoka Y., Dinelli B.,  Beauchet S., Adamsky F., Weilandt K. ,Soni V., Kapoor D., Gunasekar P., Malvasi M., Brinati G., Musio S. (2022). A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integr Environ Assess Manag2022:1–30 https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4646
  9. OECD (2009). Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. Organisation for Economic Co-operation and Development, ENV/JM/MONO(2009)1, 27th January 2009.  www.oecd.org/env/ehs/risk-assessment/42081261.pdf
  10. Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts, J.K. Anderson, Regulatory Toxicology and Pharmacology 134 (2022) 105226. https://pubmed.ncbi.nlm.nih.gov/35817206
  11. Organisation for Economic Co‐operation and Development (OECD). (2021). Reconciling terminology of the universe of per‐and polyfluoroalkyl substances: recommendations and practical guidance. Series on Risk Management No.  61. one.oecd.org/document/ENV/CBC/MONO(2021)25/en/pdf
  12. Henry B. J., Carlin P. J., Hammerschmidt J. A., Buck, R. C., Buxton W., Fiedler H., Seed J., Hernandez O. (2018). A Critical Review of the Application of Polymer of Low Concernand Regulatory Criteria to Fluoropolymers, Integr Environ Assess Manag2018:316–334 setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4035
  13. Korzeniowski S.H., Buck, R. C., Newkold R. M., El kassmi A., Laganis E., Matsuoka Y., Dinelli B.,  Beauchet S., Adamsky F., Weilandt K. ,Soni V., Kapoor D., Gunasekar P., Malvasi M., Brinati G., Musio S. (2022). A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers, Integr Environ Assess Manag2022:1–30 https://setac.onlinelibrary.wiley.com/doi/epdf/10.1002/ieam.4646
  14. OECD (2009). Data analysis of the identification of correlations between polymer characteristics and potential for health or ecotoxicological concern. Organisation for Economic Co-operation and Development, ENV/JM/MONO(2009)1, 27th January 2009.  www.oecd.org/env/ehs/risk-assessment/42081261.pdf
  15. Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts, J.K. Anderson, Regulatory Toxicology and Pharmacology 134 (2022) 105226. https://pubmed.ncbi.nlm.nih.gov/35817206