25 April 2023

PFAS ban Impact on Pharmaceuticals

Danish, German, Dutch, Norwegian and Swedish authorities prepared the restriction proposal of around 10 000 per- and polyfluoroalkyl substances (PFASs). The six-month consultation on the restriction proposal, give anyone with information on PFAS the opportunity to have their say. Of particular interest is information relevant to the risks, socio-economic aspects, and alternative substances.


The cornerstone of this initiative is the proposed revision of the REACH Regulation. This revision will involve a complete ban on PFAS and is scheduled to take effect in 2025.


PFAS are a group of more than 4 700 man-made chemicals. PFAS are used in a wide variety of consumer products and industrial applications because of their unique chemical and physical properties, including oil and water repellence, temperature and chemical resistance, and surfactant properties. The long-chain PFAS accumulates in humans, animals and sediment/soil, the short-chain PFAS accumulates in the environment due to their persistency and high mobility in air and water.


PFAS are also used in the pharmaceutical industry as active pharmaceutical ingredients and excipients, as well as in product packaging and manufacturing processes. The ban on PFAS could have significant consequences for drug and API manufacturers. The inability to use PFAS in the manufacturing process may reduce manufacturing capacity in Europe, leading to weakened supply chains and risks of medicine shortages.


An online seminar PFAS ban: Impact on Pharmaceuticals will be held on 25th of April 2023 from 16:00 to 17:00 CEST time. During the seminar Kirsty Reid, the Director of Science Policy at EFPIA, will give a presentation on the ban proposal. Kirsty will share the relevance of the ban to the originator industry. Participants will then be able to ask questions and discuss the impacts jointly.