Per- and polyfluoroalkyl substances (PFAS) have garnered significant global attention due to their widespread use, persistence in the environment and potential health risks. These synthetic chemicals, sometimes called 'forever chemicals' due to their resistance to degradation, are increasingly coming under scrutiny from regulators across various sectors, including the pharmaceutical industry. With PFAS regulations constantly evolving, pharmaceutical companies must understand their impact and adapt to the changing regulatory landscape.
What are PFAS?
PFAS are a large group of man-made chemicals that include perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Known for their water- and grease-repellent properties, these chemicals have been used for decades in various industries, including manufacturing, firefighting and consumer products like non-stick cookware, water-resistant fabrics and food packaging.
In the pharmaceutical sector, PFAS are sometimes used in the manufacturing process in the form of coatings for equipment or in specialized packaging. They help ensure drug stability and prevent contamination.
However, PFAS have been linked to environmental contamination and human health risks, including potential effects on the immune system, liver damage and an increased risk of cancer. These concerns have prompted regulatory agencies worldwide to address PFAS in various products and industrial processes.
PFAS regulations
Regulatory bodies across the globe are tightening control over PFAS use, emissions and contamination. These regulations vary by region, but the overall trend is toward limiting PFAS in products and ensuring proper substance management.
The European Union (EU) has been proactive in addressing the issue, with the Registration, Evaluation, Authorisation[BC1] and Restriction of Chemicals (REACH) regulation identifying certain PFAS for restriction. In addition, the EU is considering a broad ban on non-essential PFAS uses across industries by 2030.
While the pharmaceutical industry is classified as essential, stricter controls on PFAS emissions during production and more stringent monitoring of environmental contamination will still impact operations. From 2027, the European Chemicals Agency (ECHA) is expected to introduce far-reaching restrictions on PFAS. This will affect companies such as pharmaceutical and medical device manufacturers.
Compared with the healthcare sector, the food and consumer goods industries have responded more rapidly to PFAS-related regulatory changes, offering valuable lessons for pharmaceutical organizations.
The proposed bans on PFAS present significant challenges for the pharmaceutical industry, as PFAS are used at different stages of the production process. There is a particular focus on PFAS used in pumps and seals, although packaging, substrates and raw materials may also be affected.
Possible consequences of the PFAS ban, such as the temporary unavailability of certain intermediate products or the risk of quality degradation in the final product, require a proactive and forward-looking approach. The substitution of PFAS may involve high development costs and require long-term research processes. Therefore, pharmaceutical manufacturers and their suppliers need to act now, testing products and production processes in time to meet future requirements.
Impact of PFAS regulations on the pharmaceutical industry
The pharmaceutical industry, though not a major source of PFAS emissions compared to other sectors, must still navigate the evolving regulatory landscape. Areas to consider include:
- Drug formulation: some excipients used in drug formulations may contain PFAS
- Manufacturing processes: PFAS may be used in equipment coatings, gaskets or as processing aids in pharmaceutical manufacturing
- Packaging: certain types of drug packaging may use PFAS to provide a barrier to moisture, oxygen or other contaminants
Conclusion
As global PFAS regulations tighten, the pharmaceutical industry must remain vigilant in addressing the use of these chemicals in products and processes. By proactively assessing and managing PFAS risks, pharmaceutical companies can ensure regulatory compliance while continuing to produce safe and effective medicines. Successfully navigating these challenges will be critical to maintaining regulatory approval and public trust in the years ahead.
Why SGS?
As new PFAS regulations continue to emerge, we draw on decades of cross-industry expertise to deliver forward‑looking, tailored studies aligned with pharmaceutical needs. Supported by extensive experience in regulatory compliance and environmental testing, we provide comprehensive assistance to companies navigating the complexities of PFAS oversight. From auditing supply chains to testing products and wastewater for PFAS content, we act as a trusted partner, combining robust analytical capabilities today while helping the industry meet regulatory challenges and remain prepared should future requirements tighten.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
