Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

By Courtney Soulsby | European Pharmaceutical Review | April 10, 2025

Read the full article by Tom Perkins (European Pharmaceutical Review)

"There is worldwide concern around the use of PFAS. In the EU, a joint PFAS Restriction Proposal under REACH was submitted, aiming for a full ban by 2028/2030. This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. PFAS are one of several materials that could be reclassified as emerging contaminants that must be designed out of future products because of their harmful health impacts. PFAS are synthetic chemicals, known as ‘forever chemicals’ found in everyday products across the world, including pharmaceutical products.

These chemicals are everywhere and have been used in many ways over the decades, bringing a range of benefits – from water- and stain-resistant coatings and firefighting foams to nail polish and food packaging. However, the world is now learning they are also persistent pollutants that contaminate our soil, water and air. In Europe, this has resulted in the contamination of drinking water supplies in several countries. Human biomonitoring has also detected a range of PFAS in people’s blood. Annual health-related costs related to PFAS across Europe are estimated at up to €4.6 billion."