EU PFAS Ban Threatens Pharmaceutical Packaging Industry: Challenges and Implications

The European Union is poised to ban perfluoroalkyl and polyfluoroalkyl substances (PFAS) in 2025, affecting pharmaceutical excipients, raw materials, and packaging materials1.

PFAS are widely used in drug production and packaging, particularly in blister packaging for solid-dose drugs and elastomeric packaging for injectable drugs1.

The ban could potentially cause significant disruption across the pharmaceutical industry, as companies scramble to find viable replacements for PFAS1.

Changing packaging materials for marketed drugs will trigger the need for reauthorization by regulators, adding complexity and potential delays17.

The pharmaceutical industry relies heavily on fluoropolymers, a subset of PFAS, for safe manufacturing, distribution, and use of medicinal products7.

Industry concerns include potential supply chain disruptions and the difficulty in finding suitable alternatives for PFAS in pharmaceutical applications7.

There are debates about whether a blanket ban is warranted, as some argue that polymeric PFAS used in pharma packaging may not pose the same environmental or health risks as monomeric PFAS7.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) warns that the ban could affect supplies of more than 600 essential medicines and potentially halt manufacturing in Europe within three years9.

The industry is calling for a more nuanced approach to PFAS regulation, considering the critical nature of medical applications and the limited availability of environmentally friendly alternatives7.

Companies are preparing for potential derogations and extended transition periods for medical applications of PFAS, though these are not guaranteed7.

Sources:

1. https://www.pharmaceutical-technology.com/analyst-comment/european-pfas-ban-burden-packagers/

7. https://www.pharmaceutical-technology.com/sponsored/will-european-pfas-ban-disrupt-pharma-supply-chains/

9. https://www.fiercepharma.com/pharma/sweeping-chemical-ban-could-cause-european-drug-manufacturing-grind-halt-and-put-critical