PFAS, which stands for per- and polyfluoroalkyl substances, are a diverse group of chemicals that include PFCAs, PFOA, PFSAs, PFHxS, and thousands of others. These chemicals have been in commercial production since the 1950s and are now widely used in consumer and industrial applications. One characteristic of PFAS is their persistence in the environment, as they are extremely resistant to degradation. PFAS have emerged as contaminants of global concern because of their potential to accumulate in the human body and food chains. On 12-13 February 2024, a wide range of stakeholders, including governments, industry, non-governmental organisations (NGOs), and academics came together to discuss various topics related to PFAS. These topics covered areas such as country risk management approaches, innovation challenges for finding safer alternatives, effective risk communication strategies, monitoring techniques, waste management, and approaches to managing contamination.

1. 1
OECD Global Forum on PFAS – 12 - 13 February 2024 – Auditorium, OECD Boulogne, France
Franz-Manfred Schüngel (Merck Healthcare KGaA)
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Moving to Safer Alternatives

2. 2
PFAS
Who we are
• The European Federation of Pharmaceutical Industries and Associations (EFPIA)
represents the innovative pharmaceutical and biopharmaceutical industry in Europe.
• Through its direct membership of 37 national associations and 40 leading pharmaceutical
companies, EFPIA is the voice on the EU scene of 1,900 companies committed to
researching and improving health and the quality of life around the world.
• Bringing innovative medicines to patients requires research, manufacturing and supply:
• Kirsty Reid, kirsty.reid@efpia.eu
• Franz-Manfred Schüngel, franz-manfred.schuengel@merckgroup.com
Research & Development Manufacturing Distribution and Use
Production Equipment
Consumables
Chemicals
Packaging Materials
Plastics
Refrigerants

3. 3
Alternative Substances:
Limits to Substitution in Pharma
• Function embedded in the structure: if the chemistry matters, substitution is impossible …
• … and challenging when key properties are both desired and problematic: fluoropolymers
are resistant to various physical and chemical conditions, which is linked to persistence
Example: active
ingredients (API)
Example: seals or
reactor lining

4. 4
„Regrettable“ Substitution:
Aspects of Environmental Impact or Benefit
Every substance life cycle has complex environmental impact:
• Energy / carbon footprint, global warming potential
• Land use, deforestation, biodiversity
• Fossil, natural, mineral and capital, human resource consumption
• Inherent toxicological or ecological properties
• Substance emissions during manufacture, use or end of life
• Longevity of the product or shelf life of the consumable
• Energy efficiency during storage, transport and distribution (cool chain)
• Recyclability, reuse, circularity
Changes in substance or sourcing may influence multiple aspects
?

5. 5
Rethinking „Safe Alternatives“:
Sustainability is more process than substance dependent
Safe alternative PFAS management would minimize harmful emissions by
• Sustainable sourcing and manufacturing emission reduction
• Reuse, recycling and disposal schemes or quotas
• Supply chain information on materials and sustainability data
• Mitigate unavoidable emissions by air or wastewater treatment
• Substance management through taxation, quotas or certificates
• Substance ban as ultima ratio, where alternatives are available and beneficial
Alternative processes may be safer and less impactful than alternative substances, and
have less potential to be regrettable

6. 6
Support by OECD and Regulators
• Standardize evaluation and quantification of environmental risks and benefits of
substance use over the full lifecycle
• Define non-polymeric PFAS as a group of substances with common properties,
applicable to regulatory purposes
• Complement Substances of Concern with desirable sustainable alternatives
Thank you for your kind attention!