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)

TFE Safety Task Force: Guide for Safe Handling of Tetrafluoroethylene

The industry has been working for several decades to ensure Tetrafluoroethylene (TFE) is handled safely, with PlasticsEurope establishing the TFE Safety Task Force in 2003 to share relevant information and identify gaps in know-how and investigate these gaps. In 2017, the TFE Safety Task Force published its ‘Guide for the Safe Handling of Tetrafluoroethylene’ to help the industry take the necessary measures to ensure TFE is handled safely. The Guide details different approaches to reduce the likelihood and impact of any potential accidents. The TFE Safety Task Force is available to answer any questions and is also open for new members to join. Please reach out to TFE@plasticseurope.org to learn more.

About Tetrafluoroethylene (TFE)

Tetrafluoroethylene (TFE) is a colourless, odourless gas and its main industrial application is the production of fluoropolymer resins, such as polytetrafluoroethylene (PTFE).

Given the wide range of uses of fluoropolymers which their unique combination of properties allows, it is vital to ensure the safe usage of TFE. TFE is an extremely flammable and chemically unstable gas. Even in the absence of oxygen, it can explosively decompose and unfortunately, there have been industrial accidents from the unwanted ignition of TFE.

Resources

Guide for the Safe Handling of Fluoropolymer Resins

Guide for the Safe Handling of Tetrafluoroethylene

TFE Safety publications

Ferrero, F., Beckmann-Kluge, M., Spoormaker, T. and  Schröder, V., “On the Minimum Ignition Temperature for the explosive Decomposition of Tetrafluoroethylene on hot walls: Experiments and calculations,” Journal of Loss Prevention in the Process Industries25, Issue 2, March 2012, Pages 293–301.

Ferrero, F., Zeps, R., Beckmann-Kluge, M., Schröder, V. and Spoormaker, T., “Analysis of the self-heating process of tetrafluoroethylene in a 100-dm3-reactor,” Journal of Loss Prevention in the Process Industries25, Issue 6, November 2012, Pages 1010–1017.

Ferrero, F., Meyer, R., Kluge, M., Schröder, V. and Spoormaker, T., “Self-ignition of Tetrafluoroethylene Induced by Rapid Valve Opening in Small Diameter Pipes,” Journal of Loss Prevention in the Process Industries26, 177-185, 2013.

Ferrero, F., Meyer, R., Kluge, M., Schröder, V. and Spoormaker, T., “Study of the spontaneous ignition of stoichiometric tetrafluoroethylene–air mixtures at elevated pressures,” Journal of Loss Prevention in the Process Industries26, Issue 4, July 2013, Pages 759-765.

Kluge, M., Kreißig, M., Liebner, C. and Spoormaker, T., “Identifying Hazardous Conditions for Rapid Compression Scenarios of Chemically Unstable Gases in Industrial Scaled Pipes,” Chemical Engineering Transactions48, 2016, Pages 607 – 612.

Liebner, C. and Shenton, M.J., “Identifying hazardous conditions for compression heat igniting the chemically unstable gas Tetrafluoroethylene in industrial scale,” Chemical Engineering Transactions77, 2019, Pages 151-156.

Liebner, C., Schröder, V. and Shenton, M.J., “Safety Related Properties of Tetrafluoroethylene Research on the Explosive Decomposition on an Industrial Scale,” Proceedings of 13th ISHPMIE, November 2020, Pages 506-513.

A free electronic copy of the TFE Safety guide is available from PlasticsEurope; PlasticsEurope TFE Safety Task Force can be contacted at TFE@plasticseurope.org.

Contact guy@acumenpa.com for more information.

  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