The Growing PFAS Focus in Europe and the UK – Strategies for Life Sciences Companies

PFAS, or per- and polyfluoroalkyl substances – which are widely used across industries and in life sciences applications, from cosmetics and food-contact-material to medical devices and pharmaceuticals – have become an increasing focus of regulatory scrutiny across Europe.  In the EU, broad legislative measures aim at restricting the manufacture, placing on the market, and use of PFAS across a wide range of industries, resulting in industry and policy consequences.  In contrast, the United Kingdom is considering more targeted regulatory approaches, signaling a potential divergence from the EU framework.  The life sciences sector is particularly affected by these developments, given its historic reliance on PFAS in discovery, development, manufacturing, packaging, delivery, and safe use of medicines and healthcare products.  These substances are often used for safety and performance reasons, e.g., in diagnostic assays and implantable medical devices, and play a key role in many pharmaceutical manufacturing processes.  While carve-outs are likely to apply for certain uses, a broad legislative measure will undoubtfully have sweeping consequences for the life sciences industry. This blog post examines the evolving European regulatory landscape and considers the implications of forthcoming PFAS restrictions for businesses operating in the life sciences sector in Europe.

Regulators face a significant challenge in addressing PFAS, including their chemical versatility because their molecular structures can be modified in many ways while retaining – or even losing – the characteristics that define them as PFAS.

European Union approach

In response to these challenges, EU regulators have increasingly concluded that the traditional substance-by-substance approach is too slow and ineffective to manage the risks associated with PFAS.  Recent EU legislative initiatives, for example the Packaging and Packaging Waste Regulation (“PPWR”), adopt broad definitions of PFAS, typically by reference to substances containing at least one fully fluorinated methyl or methylene carbon atom.  These definitions capture more than 10,000 substances, including many materials currently used throughout life sciences supply chains.

New legislation relevant to the food sector will soon apply.  From August 2026, the PPWR will impose PFAS concentration restrictions for food contact packaging.  These restrictions supplement existing food contact material legislation and will be particularly relevant to life sciences businesses exporting packaged food products to the EU.

With potentially fundamental implications for the life sciences industry, the EU is also progressing its proposed restriction on PFAS under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (“REACH”).  The proposal seeks to introduce a broad restriction on the manufacture, placing on the market, and use of PFAS within the EU.  Recognizing the pivotal functions of PFAS and the lack of alternatives (or that alternatives may have similar characteristics), the regulators are currently considering a range of risk management options intended to mitigate the impact of a full ban, including (time limited) carve-outs for medical device and pharmaceutical uses.  For many uses in the life sciences sector, however, options such as derogations may not be sufficient.  The recent consultation period launched by the European Chemicals Agency has now closed; the Agency’s advisory committee on socioeconomic analysis will assess stakeholder feedback before issuing an opinion, bringing together input from the Agency’s risk assessment committee, expected by the end of 2026.

Great Britain approach

The UK has not proposed a universal PFAS restriction equivalent to the EU’s proposal.  Instead, the UK government’s February 2026 PFAS plan sets out its proposal for understanding PFAS sources, tackling PFAS pathways, reducing ongoing exposure to the extent possible, and supporting the aspirational transition to alternatives, if and when available.  The plan expressly recognizes that some PFAS perform critical functions, including in medical goods, and that non-PFAS alternatives may not yet be viable for all applications.  However, the plan has since been criticized by the House of Commons Environmental Audit Committee, which called for a more precautionary and preventative approach, faster UK REACH reform, and restrictions on PFAS in non-essential consumer products starting in 2027.  Although part of the UK, EU REACH continues to apply in Northern Ireland under post-Brexit arrangements.

In relation to packaging, there is currently no equivalent Great Britain-wide statutory PFAS concentration limit for food contact packaging matching the PPWR.  However, the UK PFAS plan records that the Food Standards Agency and National Reference Laboratory are undertaking work on PFAS testing in food and food contact materials.

Where do these trends leave industry?

In view of these upcoming restrictions, life sciences companies should consider how PFAS-related changes interact with sector-specific regulatory requirements and potential liability exposures.  Substituting PFAS-containing materials may require technical, quality, and regulatory assessment, including validation, stability work, biocompatibility assessment, change control, supplier qualification, or updates or variations to technical documentation and product dossiers.

Although some of the key legislative measures remain in draft form, and there is divergence between the EU and UK approach, the legislative direction is increasingly clear: broader PFAS restrictions are likely to continue across Europe, accompanied by heightened regulatory scrutiny and litigation risk.  Life sciences companies would be well advised to begin assessing exposure now.

Key considerations include:

• Product stewardship and portfolio assessment: Identify where PFAS may be present across products, packaging, manufacturing processes, or supply chains, including where PFAS may be unintentionally introduced through raw materials or components. Mapping exercises are likely to become increasingly important as reporting and compliance obligations expand.  Companies should distinguish among products placed on the EU, Northern Ireland, and Great Britain markets, because the applicable PFAS obligations may differ.
• Next-generation products: Consider replacing PFAS with potentially appropriate alternatives for pipeline and next-generation products, if available and viable. Reworking existing products, if even possible, is often considerably more costly and time-consuming, and often less effective, than developing new products which rely on alternative options, that, to date, have not been available.
• Supply chain visibility and contractual management: PFAS-related compliance will depend heavily on access to reliable supply chain information. Proactive engagement with suppliers and customers will help ensure appropriate information flows, contractual protections, audit rights, and allocation of compliance responsibilities.  For many companies, upstream visibility remains limited, particularly in complex or global supply chains.  Contractual controls should include PFAS-specific information covenants, change notification obligations, audit rights, testing or certification requirements, cooperation obligations for regulatory enquiries, and appropriate risk allocation where suppliers cannot confirm PFAS status.  “PFAS-free” statements should be read with understanding for the definition, test method, detection limits, and jurisdictional thresholds used.
• Quality, regulatory, and recall risks: The identification of PFAS in marketed products may already raise regulatory compliance and product quality concerns, particularly where product specifications, regulatory filings, or safety assessments do not contemplate PFAS content or they exceed notified or regulated thresholds. In some circumstances, this could trigger corrective action or recall considerations.
• Litigation and enforcement exposure: Increased regulation is likely to be accompanied by increased litigation risk. For example, companies may face claims relating to product liability, environmental contamination, alleged failures to warn, or misleading sustainability statements.  For products placed on the EU market, the revised Product Liability Directive, together with the continued growth of collective redress mechanisms in the EU, is likely to further increase exposure.  Environmental NGOs and claimant groups are also becoming increasingly active in challenging both regulators and industry participants.
• Environmental and site liability: Historic manufacturing activities and waste management practices may create long-tail liabilities, including remediation obligations, permitting issues, and disputes relating to impacted land or water. Companies involved in transactions or site closures should carefully assess potential PFAS-related legacy risks.
• Transactional and diligence considerations: PFAS should increasingly form part of M&A, financing, and commercial diligence exercises. Acquirers and investors may wish to assess whether target companies use PFAS, depend on PFAS-containing inputs, or face potential exposure from manufacturing sites, historic operations, or future regulatory restrictions.

The legal and commercial landscape surrounding PFAS is evolving rapidly.  Businesses that map their PFAS use and exposure now, build supply chain visibility, assess substitution options, and integrate PFAS considerations into quality, compliance, product stewardship, and transactional strategies, will likely be better positioned to respond to future regulatory developments in the EU and UK.

Sidley advises clients across the life sciences sector on navigating the evolving PFAS regulatory and litigation landscape, including compliance strategy, supply chain risk management, product stewardship, investigations, and disputes.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.