PHARMACEUTICALS both the UK and the US proposing similar regulations. 3
Whilst legislation leading to environmental and health protections are clearly positive steps, grouping all PFAS materials under the assumed properties of environmental persistence and toxicity and not distinguishing between risk or( potential) hazards, may lead to unintended consequences and negate any positive benefits PFAS afford to human health, society and the environment.
Although the EU has given some consideration to the impact of a PFAS ban on 14 sectors, such as cosmetics, textiles, food and transport, the impact on the pharmaceuticals and agrochemicals industries does not seem to have been fully considered( Table 1). 4
While UK legislation is being agreed, and the Environmental Audit Committee( a Commons select committee) is undertaking an inquiry into the risk of PFAS substances, 5 businesses across the UK will undoubtedly be impacted by the proposed EU changes to REACH, as these will apply to businesses in
Northern Ireland and also to any UK equipment and chemical suppliers exporting to the EU.
At the time of writing, the EU was expected to draft its first opinion on PFAS in March, with a consultation period open for 60 days afterward, until about mid-May. This consultation is probably the final opportunity for stakeholders to submit comments before the ECHA forwards its restriction proposal to the EC, currently planned for late 2026.
Impact on pharma
Within the pharmaceutical and agrochemical industries there is set to be significant impact, not least because many APIs may be classified as PFAS under the OECD definition. However, according to the Swedish Chemicals Agency, while these materials are currently derogated from restriction, any intermediates or reagents needed to prepare them may not be. 6
The practical implication of this is that PTFE stirrer bars, fittings, diaphragm valves, membranes and coil reactors are all in scope for restriction, as well as reagents, solvents and protecting groups that are not present in the final material. Excipients are also out of scope for exemption, potentially leading to the re-design of pharmaceutical products and additional lengthy and expensive clinical trials.
The European Federation of Pharmaceutical Industries & Associations( EFPIA) has suggested that if PFAS policies were introduced as they stand within the biopharmaceutical sector, up to 600 medicines on the WHO Essential Medicines List would be at risk, equating to over 70 % of the critical medicines listed in many European countries, and manufacturing in Europe could“ grind to a halt”. 7 Figure 1 shows examples of approved drugs containing a – CF 2
– or CF 3 group and therefore potentially classified as PFAS.
PFAS in pharma
The following section will outline some of the uses of PFAS materials within pharmaceutical development that may fall outside the permitted uses. This is not intended to be
Figure 1- Examples of approved drugs potentially classified as PFAS
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