Solutions
Found in everyday products, chemicals such as perfluorinated and polyfluorinated substances (PFAS), are linked to potential health and environmental safety risks.¹ Evolving global regulation, increased public scrutiny, and product recalls related to these substances are driving the attention of C-suite executives to invest in risk mitigation efforts.
Chemicals of concern (CoC) is the term used to describe a subset of chemicals, substances, or chemical byproducts contained within commodities across the pharmaceutical, medical device, consumer products, and food industries that have been linked to potential increased consumer health risks and negative impacts on the environment.2 PFAS, titanium dioxide (TiO2), benzene, and nitrosamines are just a handful of the emerging compounds that are prompting global regulators—such as the European Medicine Agency (EMA),3 US Food and Drug Administration (FDA),4 European Chemicals Agency (ECHA),5 and Environmental Protection Agency (EPA)6—to evaluate local regulation around the acceptable use of these potentially toxic substances within products. With attention from health and environmental agencies alike, billions of dollars are likely at stake in potential revenue and market access losses, lawsuits, and the potential detriment of removing essential medicines from the hands of patients who need them most.
• Highly regulated products with potential CoC risks, thus greater need for proactive mitigation and remediation
• Potential immediate impacts to current formulations, market products, manufacturing processes and equipment, R&D portfolios, and third-party supplier sources
• Potential downstream implications to patient trust and maintaining market access (especially for medically required products)
• Industry and external advocacy forums being established for companies to engage on future regulation, proactive mitigation strategies, and technical approaches7
| Evolving regulation at-a-glance | |
Nitrosamines:
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Titanium dioxide:
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PFAS:
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Benzene:
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• Consideration for products such as cosmetics, feminine care, oral care, personal care products, textiles, paints, chemical cleaners, batteries and electronics, and firefighting foams
• Potential impacts to many manufacturing operations including equipment and processes, materials/ingredients used in synthesis of major products, and processes for controlling industrial waste and environmental emissions
• The transition away from PFAS may require significant adjustments to production processes; manufacturers may need to evaluate and optimize their manufacturing techniques to accommodate alternatives
| Evolving regulation at-a-glance | |
Titanium dioxide:
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PFAS:
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Benzene:
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• National drinking water standards issued to eliminate PFAS from local water sources requiring novel monitoring and filtering techniques for enforcement starting in 202926
• Community water systems and non-transient, non-community water systems will hold primary responsibility for implementing and enforcing adherence to the regulation27
• Increased reporting requirements for environmental and sustainability objectives28
Deloitte brings a demonstrated methodology, backed by industry-specific experience, to help organizations mitigate potential risks across the ecosystem while managing the end-to-end life cycle of a risk mitigation program. Our team can help you understand and navigate the potential implications of CoC across the product life cycle, from initial identification of risk to downstream patient and consumer impacts.
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Oliver Steck |
Mayura Gill |
Jillian Patane |
Fred Gibbons |
1. EPA, “Our current understanding of the human health and environmental risks of PFAS,” last updated May 16, 2024.
2. Ibid.
3. European Medicines Agency (EMA), “Nitrosamine impurities,” accessed April 2024.
4. EPA, “Our current understanding of the human health and environmental risks of PFAS.”
5. European Chemicals Agency (ECHA), “ECHA publishes PFAS restriction proposal,” press release, February 7, 2023.
6. EPA, “Biden-Harris administration finalizes first-ever national drinking water standard to protect 100M people from PFAS pollution,” press release, April 10, 2024.
7. ReachCentrum, “The Titanium Dioxide Industry Consortium (TDIC),” accessed May 20, 2024; Lhasa Limited, “Complex nitrosamines,” accessed May 20, 2024; OECD, “OECD Global Forum on the Environment dedicated to per- and polyfluoroalkyl substances,” event held February 12–13, 2024.
8. EPA, “Our current understanding of the human health and environmental risks of PFAS.”
9. European Medicines Agency (EMA), “Nitrosamine impurities,” accessed April 2024.
10. Japan Ministry of Health, Labour and Welfare, “Self-inspection on risks of contamination with nitrosamines in drugs,” translated by Pharmaceuticals and Medical Devices Agency (PMDA), October 8, 2021.
11. Korea Ministry of Food and Drug Safety (MFDS), “Compilation of analysis methods on the determination of mutagenic impurities in drug substances or drug products,” August 11, 2023.
12. World Health Organization (WHO), “Draft Working Document for Comments: WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products,” April 2024.
13. EMA, “Final feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the impact of the removal of titanium dioxide from the list of authorized food additives in medicinal products,” September 8, 2021.
14. EPA, “Addition of certain PFAS to the TRI by the National Defense Authorization Act,” last updated May 17, 2024.
15. EPA, “TSCA Section 8(a)(7) reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances,” last updated March 29, 2024.
16. European Chemicals Agency (ECHA), “ECHA publishes PFAS restriction proposal,” press release, February 7, 2023.
17. FDA, “FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs,” December 27, 2023.
18. USP-NF, “Notice of intent to revise: Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342,” November 18, 2022.
19. EUR-Lex, “Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food additive titanium dioxide (E 171),” Official Journal of the European Union, January 18, 2022.
20. FDA, “CAP 3C0325: Request to revoke color additive listing for use of titanium dioxide in food,” April 14, 2023.
21. California Legislature, “AB-418, The California Food Safety Act,” 2023.
22. ECHA, “ECHA publishes PFAS restriction proposal.”
23. Gap Inc., “Chemicals management,” accessed May 20, 2024.
24. Enhesa, “Estée Lauder expands PFAS phase-out, aims for elimination by end of year,” February 20, 2023.
25. Valisure, “Timeline of consumer product recalls due to benzene,” accessed May 20, 2024.
26. EPA, “Per- and polyfluoroalkyl substances (PFAS),” last updated May 17, 2024.
27. EPA, “Safe Drinking Water Act (SDWA) resources and FAQs,” accessed May 20, 2024.
28. European Commission, “Corporate sustainability reporting,” accessed May 20, 2024.
Deloitte offers framework for assessing PFAS risk.
Six steps pharma manufacturers can take to limit nitrosamines and other impurities.
