Restrictions for PTFE used in Pharmaceutical Plant Engineering?

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17-19 September 2024

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Fluoropolymers have an extreme high chemical stability. However, this stability also means that - once released into the environment - they can remain there for a very long time and cause environmental damage. The EU is planning to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.

Although it has been under discussion for some time, not everyone is aware that the production and thus the availability of PTFE (known to many under the brand name "Teflon"), among other things, is currently being put to the test.

Restrictions and bans on fluorinated hydrocarbons have been in place for some time. In 2006, the EU Directive 2006/122/EC restricted the use of perfluorooctane sulfonic acid (PFOS). This was later followed by the restriction of perfluorooctanoic acid (PFOA) by EU Regulation 2020/784.

European Chemical Agency plans ban or restriction of PFAS substances

However, the current discussion goes considerably further: the European Chemical Agency (ECHA) plans to ban perfluorinated and polyfluorinated alkyl substances (PFAS) - a group designation for currently approx. 4,700 fluoropolymer chemicals produced - in the future or to restrict their use to a few exceptions. The EU "Chemicals Strategy for Sustainability - Towards a Toxin-Free Environment" published in 2020 is the basis for this.

PFAS cause contamination in soils and drinking water, among other things, and there is justified concern that these issues are increasing due to the persistence of these substances. Some PFASs are classified as persistent, bioaccumulative and/or toxic. Even in waste incineration, some of these substances cannot be degraded as they are destroyed only at temperatures above 1,000°C. The use of these substances should therefore be phased out unless it can be proven that they are indispensable for the public good ("unless their use is essential"). Various environmental associations have drafted a manifesto for an urgent ban on the "eternal chemicals" PFAS in October 2022.

The planned bans would predictably lead to cuts in production, supply chains and availability problems. PFAS are also used in large quantities in water-repellent clothing materials or fire-fighting foams. Substitute materials are already being intensively sought for these applications, as the environmental impact is particularly high there.

Switching to alternative materials is usually complicated in the GMP environment. The required EU/FDA material certifications and, in some cases, the approvals of medical devices and/or medicinal products themselves, if PTFE is mentioned there in any form, stand in the way.

In principle, one wants to allow exceptions to the ban for essential applications. It is quite certain that these approvals would be granted for the hundreds of applications in the field of medical technology, pharmaceuticals and biotechnology. However, the manufacturers and/or users would have to apply for and justify such exceptions in each individual case - including evidence that chemically unproblematic alternatives have been sought.

The BDI writes in its assessment of the planned restriction procedure: (only available in German language).

• A lack of viable alternatives to PFAS substances means high costs when trying to replace them.
• Due to the often highly complex international supply chains ...there is a high risk of unforeseen disruptions of the supply chains with all the associated economic impacts. 
• A precise impact analysis per substance therefore requires sufficient time, which unfortunately is not currently granted.
  (translation of the editors)

Users of PTFE and similar fluoropolymers - especially from the pharmaceutical or medical technology sectors - should address this issue and consider becoming actively involved in the ongoing discussion on the regulation of PFAS.

The European Chemicals Agency (ECHA) had started a consultation on possible restrictions or the ban of PFAS under REACH. Here, affected groups or associations can gather arguments for an exemption regulation. ECHA had set July 2022 as the deadline.