The Environmental Protection Agency (EPA) has recently published the Final Risk Evaluation for Formaldehyde under the Toxic Substances Control Act (TSCA), confirming that this chemical poses an “unreasonable risk” to human health.
To understand the potential regulatory implications for the healthcare and industrial sectors, it is essential to review the key milestones that led to this decision.
March 2024: the Draft Risk Evaluation
In March 2024, the EPA released a preliminary draft of the Risk Evaluation for Formaldehyde, initiating a public consultation process. The document highlighted the harmful effects of formaldehyde exposure, particularly in the healthcare, manufacturing, and furniture industries.
Formaldehyde, widely used as a fixative in laboratories and hospitals, has already been classified as carcinogenic by the International Agency for Research on Cancer (IARC) and other international health agencies. Through this evaluation, the EPA aimed to assess the actual risk of workplace and everyday exposure.
May 2024: public consultation and Scientific Review
Following the release of the draft, a 60-day public comment period was opened to gather input from stakeholders. During this time, the EPA organized virtual meetings with the Science Advisory Committee on Chemicals (SACC) from May 20 to 23, 2024, where experts, businesses, and healthcare organizations discussed the data and potential regulatory implications.
This stage was crucial to ensure transparency and stakeholder involvement in the decision-making process, providing valuable insights for the final evaluation.
January 2025: EPA Publishes the Final Risk Evaluation
After reviewing public comments and refining its assessment, on January 2, 2025, the EPA published the Final Risk Evaluation for Formaldehyde. The findings are clear:
Formaldehyde presents an “unreasonable risk” to human health, particularly for workers exposed to prolonged inhalation and frequent skin contact.
The EPA identified critical concerns in multiple sectors, including laboratories, hospitals, and industries that use formaldehyde in production processes.
Formaldehyde is now subject to risk management measures, which may restrict or ban its use in certain contexts.
Next Steps: toward new Formaldehyde regulations
Now that the Final Risk Evaluation has been completed, the EPA will move forward with concrete actions to mitigate the identified risks.
The EPA will propose a Risk Management Rule to reduce formaldehyde exposure under Section 6 of the TSCA, aiming to protect workers and consumers from its associated risks.
Public Involvement → Throughout the regulatory process, companies, healthcare institutions, and stakeholders will have the opportunity to comment and influence the proposed measures.
What Are the Implications for Healthcare and Research?
The introduction of stricter formaldehyde regulations could significantly impact hospitals and laboratories, where it is currently used as a fixative for biological samples. The urgent need for safer and compliant alternatives is now more evident than ever.
In this context, innovative solutions such as GAF®—the fixative developed by Addax Biosciences—offer a sustainable and safe alternative. Free from formaldehyde and carcinogenic compounds, GAF® ensures the same level of fixation efficacy while safeguarding worker health and regulatory compliance.