Why are fluoropolymers safe?

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