Formaldehyde Evaluation Published by EPA

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8 January 2025

Navigating EPA’s Formaldehyde Risk Evaluation

In December 2024, the U.S. Environmental Protection Agency (EPA) finalized its TSCA Risk Evaluation for Formaldehyde, marking a major regulatory milestone. This evaluation, conducted under the Toxic Substances Control Act (TSCA), highlights significant risks the substance poses to human health and sets the foundation for forthcoming regulatory actions. Here’s what you need to know and how businesses can prepare.

What is Formaldehyde?

Formaldehyde is a colorless, flammable gas at room temperature, widely used in industrial and consumer products. It occurs naturally in the environment and is also produced as a result of combustion processes, such as vehicle exhaust or cigarette smoke.

Key applications:

  • Building materials: Plywood, particleboard, and insulation.
  • Preservatives: Found in cosmetics, medicines, and household products.
  • Industrial processes: Used in resins, adhesives, and coatings.

Despite its widespread applications, formaldehyde is a known carcinogen with well-documented health and environmental risks.

Key Findings from the EPA Risk Evaluation on Formaldehyde

EPA’s report provides a comprehensive analysis of formaldehyde’s risks throughout its lifecycle—from manufacturing to disposal:

  • Human Health Risks: Formaldehyde exposure is linked to respiratory issues, skin and eye irritation, and cancers such as leukemia and nasopharyngeal cancer.
  • Exposure Concerns: High-risk groups include workers handling formaldehyde-based products and consumers exposed during product use.
  • Environmental Impact: Releases into air and water during the lifecycle of formaldehyde present long-term environmental challenges.

What Does This Mean for Businesses?

The finalized evaluation paves the way for risk management measures expected in the coming months. Companies involved in manufacturing, distributing, or using formaldehyde-containing products should act now to mitigate risks and prepare for compliance.

Practical Steps for Businesses:

  • Review Product Portfolios: Identify items containing formaldehyde and assess exposure risks.
  • Update Safety Data Sheets (SDS): Reflect the latest regulatory findings and include enhanced safety precautions.
  • Implement Risk Mitigation Strategies: Where possible, substitute formaldehyde with safer alternatives.
  • Stay Informed: Monitor EPA updates and prepare for new risk management rules impacting formaldehyde use.

Formaldehyde Evaluation in the European Union

In the European Union (EU), formaldehyde is also under strict regulatory scrutiny. It is classified as a carcinogen and mutagen under the REACH Regulation, triggering requirements for labeling, safe handling, and restricted use.

Additionally, the European Chemicals Agency (ECHA) has listed formaldehyde-related substances in its Candidate List of Substances of Very High Concern (SVHCs). This classification imposes mandatory communication along the supply chain and may lead to further restrictions.

Businesses operating globally must align with both U.S. and EU frameworks to ensure compliance and mitigate risks.

How Lisam Can Help

Navigating formaldehyde regulations across regions requires efficient tools and expertise. Lisam’s ExESS software is specifically designed to simplify compliance and chemical management:

  • SDS Authoring and Updates: Maintain up-to-date and compliant safety documentation.
  • Chemical Inventory Management: Gain visibility into chemicals across your supply chain.
  • Regulatory Monitoring: Stay ahead of global regulatory changes with real-time updates integrated into our software.

Request a demo of ExESS today and discover how Lisam can help you stay ahead of regulatory requirements.

Request a Demo

Conclusion

EPA’s risk evaluation for formaldehyde underscores the growing importance of chemical compliance. Proactive preparation not only ensures adherence to regulations but also reinforces a company’s commitment to safety, transparency, and environmental responsibility.

Sources:
EPA Launches New Initiatives to Enhance New Chemical Reviews Under TSCA

Author

Lisam

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