A New Era of PFAS Regulation – The Gradual Phase-Out Begins

Per- and poly-fluoroalkyl substances (PFAS) are human-made chemicals that have become widespread environmental hazards. These substances do not biodegrade naturally and are found in various products, including household items, clothing, cleaning agents, and medical devices. Increasing evidence shows their adverse impacts on human health and the environment, prompting global regulatory actions.

Growing Concerns and Regulatory Responses

Researchers have raised alarms about the potential impacts of rising PFAS levels on the environment and human health. Since the 1940s, around 14,000 PFAS chemicals have been used in different industrial and consumer products. Governments and regulatory bodies worldwide are intensifying efforts to mitigate damage and restrict PFAS use.

The Stockholm Convention on Persistent Organic Pollutants

The Stockholm Convention aims to restrict or prohibit toxic, persistent chemicals. Several PFAS compounds are listed under this convention due to their persistence and widespread presence:

• Perfluorooctanoic acid (PFOA) and related substances have been targeted for global elimination since 2019.
• Perfluorooctanesulfonic acid (PFOS) and related substances have been under global restriction since 2009.
• Perfluorohexanesulfonic acid (PFHxS) and related substances were added for global elimination in 2022.

Tightened Restrictions in the US and Europe in 2024

Significant regulatory actions are being taken in both the US and Europe:

• The European Chemicals Agency (ECHA) is evaluating a proposal to restrict over 10,000 PFAS chemicals across various sectors. The outcome, expected by early 2025, could significantly influence global PFAS policies.
• The EU/EEA has restricted Perfluorinated carboxylic acids (C9-14 PFCAs) since February 2023. Germany's proposal to restrict undecafluorohexanoic acid (PFHxA) received approval in 2024.

EPA's New PFAS Manufacturing Rule

In January 2024, the US Environmental Protection Agency (EPA) finalized a rule restricting the manufacture and use of 329 specific PFAS chemicals. This rule requires a comprehensive EPA review and risk assessment before any new manufacturing or processing can commence.

In February 2024, the EPA proposed changes to classify PFAS as hazardous waste and amend the Resources Conservation and Recovery Act (RCRA) to include multiple PFAS compounds. By April 2024, PFOA and PFOS were designated as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), allowing federal and state agencies to pursue fines against responsible parties.

Staying Ahead of Emerging Regulations

To navigate the rapidly evolving regulatory landscape, companies must:

1. Understand PFAS in the Supply Chain:
   • Evaluate and audit product chains to identify and address PFAS presence.
   • Conduct laboratory testing to confirm chemical contamination levels.
   • Request a demo: Schedule a personalized demo to see how our compliance software can help your business.
     
      
2. Develop a PFAS Risk Assessment Strategy:
   • Monitor ongoing regulatory developments.
   • Develop corporate strategies to mitigate potential supply chain disruptions.
   • Identify and evaluate viable substitutes for PFAS components.

How iLenSys Can Help

iLenSys offers comprehensive support to help companies maintain compliance with evolving regulations. Our compliance software solution helps manage product lifecycles and stay updated with regulatory requirements:

• Reviews product and BOM files to identify risk components
• Conducts supplier surveys to understand PFAS compliance and documentation
• Works with suppliers and labs to get testing as required
• Provides documentation to demonstrate product/part compliance
• Prepares reporting documentation
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Contact Us

For more information on how iLenSys can help your company stay compliant with PFAS regulations, get in touch with our team. Stay ahead of the curve and focus on innovation while we handle your compliance needs.

• Contact Our Experts: Reach out to our team for a consultation on your specific compliance needs and challenges.