The UK Health Security Agency (UKHSA) will conduct a UK-wide human biomonitoring study to understand levels of per- and polyfluoroalkyl substances (PFAS) and other potentially harmful chemicals in the population, as the pharmaceutical industry faces increasing scrutiny around its use of the substances.
The study will analyse blood and urine samples collected through the existing Health Survey England to assess population exposure to PFAS, alongside chemicals including lead, arsenic, bisphenols, phthalates and flame retardants.
For pharma manufacturers, the findings could contribute to the growing evidence base surrounding PFAS exposure, including potential occupational risks and the need for tighter controls on their use in industrial applications.
Why PFAS matter to pharmaceutical manufacturing
PFAS comprise more than 10,000 synthetic chemicals, often referred to as 'forever chemicals' due to their strong carbon-fluorine bonds, which make them highly resistant to degradation in the environment.
Their chemical stability and resistance to heat and harsh substances have made them useful across a range of industrial applications, including pharmaceutical manufacturing.
Within the pharma sector, certain fluorinated compounds are intentionally incorporated into drug molecules to influence properties such as chemical stability and bioavailability.
PFAS are also used in manufacturing equipment and processing components, including lined vessels, gaskets, seals and tubing, as well as some high-purity water systems. Their resistance to chemical degradation makes them particularly useful in demanding production environments.
The substances also appear in pharmaceutical packaging, including certain blister pack materials and container-closure components, where they can provide barriers against moisture and oxygen.
However, growing concerns about their persistence, environmental accumulation and potential health effects have placed their continued use under increasing scrutiny.
Proposed restrictions on PFAS, particularly the sweeping restriction under consideration in the EU, could have significant implications for pharmaceutical manufacturers and their supply chains.
The sector faces the challenge of identifying where PFAS are used, assessing the availability of suitable alternatives and understanding how any restrictions could affect manufacturing processes and product supply.
Biomonitoring to inform the evidence base
The UKHSA's study will help establish typical background levels of PFAS exposure across the UK population.
The programme will also investigate exposure to lead, arsenic, bisphenols, phthalates and flame retardants, with initial findings expected in 2027.
The data could help researchers and policymakers better understand patterns of chemical exposure, including whether certain population groups experience higher levels due to factors such as occupation or proximity to contaminated sites.
Dr Edward Wynne-Evans, Director of Radiation, Chemicals, Climate and Environmental Hazards at UKHSA, said: "PFAS are an area of significant public interest and we understand the concerns people may have about these chemicals and what they could mean for their health."
While PFAS can be detected in people, there remain important evidence gaps around what different levels of exposure mean for an individual’s long-term health. Our work is focused on helping to address those questions through research, biomonitoring and evidence reviews.
"The evidence available to date suggests that any health effects are likely to be limited. The strongest evidence from across the globe currently relates to possible associations with raised cholesterol and potentially lower birth weight, but further work is required to better understand these findings and their significance."
Responding to the announcement, Stephanie Metzger, Sustainable Chemicals Policy Advisor at the Royal Society of Chemistry, said: “We are pleased to see that the UKHSA is beginning a programme of human biomonitoring, following the Government's commitments in the PFAS Plan."
"It's really important to establish baseline levels of PFAS in the UK population in order to track trends over time. It will also help health authorities and regulators to know if any specific groups of people have unusually high levels, whether that is due to occupational exposure or living near a PFAS hot spot."
Really understanding this data can help scientists and policymakers to identify priority areas for intervention and remediation. Tracking PFAS blood levels over time can also help to indicate whether control measures, such as the way they are being regulated, are actually working.
She added that it would be "crucial" for the UKHSA to ensure regulators have the guidance needed to set appropriate limits on PFAS use.
