What are PFAS, and when are they used?

Per- and polyfluoroalkyl substances (PFAS), often referred to as “forever chemicals,” are characterized by long carbon chains fully bonded to fluorine atoms. These chemicals are widely utilized due to their unique properties, such as resistance to heat, water, and oils. In the pharmaceutical industry, PFAS are employed in various applications, including:

• APIs: Some fluorinated small-molecule drugs meet the OECD’s definition of PFAS.
• Manufacturing processes: PFAS-based reagents and intermediates are critical for synthesizing complex pharmaceuticals.
• Packaging materials: Fluoropolymers are used in coatings and containers to ensure drug stability and safety during storage and transportation.

Despite their efficacy, PFAS are persistent in the environment and have been linked to adverse health effects, necessitating increased regulatory scrutiny.

Regulatory updates

In 2021, the Organisation for Economic Co-operation and Development (OECD) expanded the PFAS definition to include any fluorinated substance containing at least one fully fluorinated methyl or methylene carbon atom. This broadened scope means more pharmaceutical compounds now fall under PFAS regulation.

European Union Restrictions. In 2023, the European Chemicals Agency (ECHA) proposed a Europe-wide restriction on PFAS. If implemented, this regulation could take effect by 2027, potentially hindering drug development and manufacturing processes. While existing approved drugs and agrochemicals are exempt, clinical candidates in development may not receive this derogation, creating concerns for pharmaceutical innovation and patient care continuity.

Key challenges include:

• Impact on essential medicines. Over 600 medicines on the WHO Essential Medicines List and 78% of Norway’s critical medicines could be affected.
• Competitive disadvantages. EU-based pharmaceutical companies may face higher production costs than those in other jurisdictions.
• Transition timeframes. Insufficient time to identify PFAS alternatives and develop waste treatment technologies.

Mérieux NutriSciences | Pharma & Healthcare Capabilities

At Mérieux NutriSciences | Pharma & Healthcare, we support pharmaceutical companies in managing PFAS-related risks with a comprehensive approach:

1. Product assessment
   • Identifying PFAS in raw materials, finished products, manufacturing processes, and packaging.
   • Analytical Support/Service for evaluating alternatives to PFAS to mitigate long-term risks and costs associated with reformulation.
2. Risk mitigation planning
   • Developing contingency plans to respond to PFAS restrictions.
   • Analytical support for ensuring supply chain resilience by identifying alternative suppliers and materials.
3. Advanced testing solutions
   • Performing PFAS quantification using cutting-edge technologies like LC-MS/MS and HRMS.
   • Confirmatory testing frameworks (similar, for instance, to those used in nitrosamine assessments) to ensure compliance and guarantee product safety.

Regulatory services

• Risk assessment and management—thorough analysis and mitigation of PFAS-related risks in products and processes.
• Alternative solutions evaluation. Identification of viable alternatives to PFAS that meet efficacy, safety, and regulatory standards.