PFAS in Medical Devices and Pharmaceuticals: What manufacturers need to know

Per- and polyfluoroalkyl substances (PFAS) represent a vast group of chemical compounds, comprising at least 10,000 synthetic substances that have been used in various applications since the 1950s. PFAS possess unique properties, including high resistance to degradation and heat, anti-adhesive, and water-repellent characteristics. They are widely used in pesticides, textiles, cosmetics, food packaging, coatings, and medical devices.

Due to their extensive use and chemical properties, PFAS accumulate in the environment. They also pose risks to human health. For this reason, on 27 February 2025, France passed Law No. 2025-188, aiming to protect the population from PFAS-related risks. Starting January 2026, this law will prohibit the manufacture, import, export, and marketing of any cosmetic, clothing, textile, or ski wax product containing PFAS.

1. PFAS: The “Forever Chemicals“

PFAS are classified as persistent organic pollutants (POPs), meaning these substances are persistent, mobile, bio-accumulative, and toxic. Due to the strength of their carbon-fluorine bond, PFAS exhibit significant resistance to metabolic and environmental degradation, making them prone to accumulating in the environment over long periods. This has earned them the nickname “forever chemicals“. Humans can be indirectly exposed to PFAS through food, the environment, or the use of products containing PFAS. Associated risks include adverse effects on the reproductive system, foetal development, neurological disorders, immunotoxicity, endocrine disruption, and carcinogenic effects.

2. Different Regulations Worldwide

Stockholm Convention and Its Implementation via the POP Regulation in Europe

The Stockholm Convention is an international treaty aimed at banning or restricting the production, use, and commercialization of POPs. To date, 152 countries have signed this convention. Within the European Union (EU), the convention is implemented through the POP Regulation (Regulation (EU) No. 2019/1021), which applies to all Member States and allows specific exemptions, such as the use of perfluorooctanoic acid (PFOA), its salts, and related compounds in invasive and implantable medical devices, which may be used until 4 July 2025.

Among the PFAS family, perfluorooctane sulfonate (PFOS) and its derivatives, widely used in industrial applications, have been listed under the Stockholm Convention since 2009, with their use restricted in the EU under the POP Regulation. Similarly, PFOA, its salts and related compounds have been banned in the EU since 4 July 2020, in accordance with the POP Regulation. More recently, in June 2022, perfluorohexane sulfonate (PFHxS), its salts, and related compounds were added to the Stockholm Convention. In response, the European Commission incorporated these substances into the POP Regulation in May 2023, with enforcement starting on 28 August 2023. Currently, 32 substances, including certain PFAS, are listed in the POP Regulation.

REACH Regulation and CLP Classification

In Europe, the restrictions outlined in Annex XVII of the REACH Regulation aim to ban or limit the production, commercialization, import, or use of a chemical substance or group of substances for specific or all applications.

Some PFAS are included on the candidate list of Substances of Very High Concern (SVHC) under the REACH Regulation, including PFOA, perfluorobutanesulfonic acid (PFBS) and its salts, hexafluoropropylene oxide dimer acid (HFPO-DA or GenX) and its salts, perfluoroheptanoic acid (PFHpA) and its salts, among others. Their use requires notification and authorization, particularly if the product or article in question is marketed in quantities exceeding one ton per producer/importer per year and contains more than 0.1% (mass/mass) of PFAS classified as SVHC.

Additionally, several PFAS have harmonized classifications under the Classification, labelling and packaging of substances and mixtures (CLP) Regulation. For example, PFOS and PFOA are classified as Category 2 carcinogens (H351: suspected of causing cancer) and Category 1B reproductive toxins (H360: may damage fertility or the fetus; H360D: may damage the fetus).

PFAS Regulations Worldwide

Regulations governing the use of PFAS vary widely around the world.

In the U.S., several laws have been adopted or proposed by individual states. For instance, Maine has banned numerous products, including cosmetics, containing intentionally added PFAS. Although this law will only take effect in 2030, manufacturers have been required to report their use of PFAS since 1 January 2023. California, on the other hand, passed a law on 30 September 2022, prohibiting the sale of textiles containing more than 50 ppm of PFAS starting 1 January 2027.

At the federal level, in early 2024, the U.S. Environmental Protection Agency (EPA) proposed adding nine PFAS and their salts and structural isomers to the list of hazardous substances under 40 CFR Part 261 Appendix VIII. These include PFOA, PFOS, PFBS, HFPO-DA (GenX), perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), perfluorodecanoic acid (PFDA), perfluorohexanoic acid (PFHxA), and perfluorobutanoic acid (PFBA). If these substances are released into the environment, responsible parties will need to report the incident and conduct cleanup efforts under CERCLA (Comprehensive Environmental Response, Compensation & Liability Act). Additionally, in 2024, thresholds for six PFAS in drinking water were approved in the U.S., with limits ranging from 4 to 10 ng/L depending on the substance.

Japan’s PFAS regulations are relatively advanced compared to other Asian countries. In 2009, PFOS and its salts were classified as Class I Specified Chemical Substances under the Chemical Substances Control Law (CSCL) in response to their inclusion in the Stockholm Convention. This classification imposes strict restrictions on the manufacture, use, and import of these substances. PFOS is also subject to export restrictions under Japan’s Foreign Trade Law. Furthermore, Japan established a temporary target value of 50 ng/L for PFOS and PFOA in drinking water in 2020.

China, South Korea, India, Singapore, and other Asian nations are signatories to the Stockholm Convention, but no national standards for PFAS have yet been established in these countries. Similarly, countries with significant industrial PFAS usage, such as Brazil and Russia, lack specific regulations.

Toward New European Restrictions

In January 2023, national authorities from Germany, Denmark, the Netherlands, Norway and Sweden submitted a REACH restriction proposal for PFAS to the European Chemicals Agency (ECHA). Unlike the French law of February 2025, this European proposal encompasses numerous applications, including the medical devices industries. Covering over 10,000 substances, the proposal was made public in February 2023 and is currently under review by ECHA’s expert committees, including the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC). Their opinions will be forwarded to the European Commission, which will propose amendments to REACH Annex XVII. This proposal will then be reviewed by EU Member States and the European Parliament before adoption.

3. Significant Impact on Medical Devices

Many medical devices, packaging, and manufacturing additives contain PFAS (e.g., tubes and catheters, surgical meshes for hernia treatment, inhalers). Their physical properties (chemical and thermal resistance, anti-adhesive qualities for bodily fluids and contaminants, reduced risk of inflammatory reactions, etc.) make them ideal materials.

However, due health and environmental risks, the proposed PFAS restriction, outlined in the previous section, suggests a ban on the manufacture, use, and marketing of PFAS within the European market as a substance itself, as a constituent in another substance, in a mixture, or in an article, depending on the concentration:

The proposed PFAS restriction could lead to a gradual replacement of additives, equipment, materials, and packaging containing PFAS in medical devices currently on the European market. Manufacturers can already begin exploring alternatives to PFAS, such as biodegradable polymers, ceramic-based composites, non-fluorinated polymers, metallic coatings, or silicones. These substitutes may not always offer the same performance, durability, or cost-efficiency as PFAS-based materials.

4. Transition Periods and Exemptions

The REACH PFAS restriction proposal includes an 18-month transition period after its enforcement. Two restriction options are outlined: total restriction after the transition period (Restriction Option 1, RO1) or restriction with specific time-limited exemptions (Restriction Option 2, RO2). The second option, supported by the proposal’s authors, includes limited-time exemptions for medical devices. For example, a ban on PFAS following a 12-year exemption period (after the 18-month transition) is proposed for fluoropolymers and perfluoropolyethers used in tubes and catheters, as well as implantable medical devices (excluding meshes, wound treatment products, and tubes and catheters). Generally, exemption periods range from 5 to 12 years, depending on the availability of alternatives and associated justification.

5. How to prepare for these regulatory changes?

The ban on PFAS could have a significant impact on industries that use these components in their products.

To prepare for PFAS usage restrictions, medical device manufacturers should start with mapping and conducting an internal audit to identify PFAS in their products and processes. This analysis helps assess regulatory and operational risks and prioritize necessary actions. It is crucial to examine products, manufacturing processes, and supply chains to pinpoint critical stages where PFAS are used. An evaluation of the impacts on product availability, performance, and compliance should also be carried out.

At the same time, the ban on PFAS presents an opportunity to invest in innovation by collaborating with partners to develop alternative materials or processes. Research and development projects should explore substitutes that offer similar properties to PFAS, such as chemical and thermal resistance or anti-adhesive qualities. These materials must be tested to ensure their effectiveness and biocompatibility. Close collaboration with suppliers and research institutes can accelerate the development of suitable solutions.

Finally, compliance and transparency are essential to ensure a smooth transition. Continuous monitoring of legislative developments, such as the POP and REACH regulations, is necessary to maintain product compliance. Implementing a compliance management system and participating in industry working groups can help share best practices and anticipate challenges.

In summary, a proactive approach based on identifying uses, fostering innovation, and ensuring compliance will help minimize the impacts of the PFAS ban while positioning the manufacturer as a responsible and innovative player.

Need Help?

Anticipating stricter PFAS regulations in the coming years, Efor offers support for medical device manufacturers and pharmaceutical industries during this transition. Our expertise includes:

• Identifying PFAS in manufacturing processes and raw materials,
• Exploring potential alternatives to PFAS,
• Reevaluating biocompatibility and revalidating processes following implemented changes,
• Regulatory monitoring.

Our technical teams are available for your projects and can be reached directly at TechnicalDivision@efor-group.com.