EPA finalized Significant New Use Rules under section 5(a)(2) of the Toxic Substances Control Act for specified chemical substances previously subject to premanufacture notices and EPA orders.

Any person intending to manufacture, including import, or process a subject substance for a designated significant new use must submit a Significant New Use Notice at least 90 days before starting the activity.

The activity may not commence until EPA has reviewed the notice, made the required determination and completed any resulting action. The rule also interacts with existing TSCA import-certification and export-notification duties. It becomes effective on December 14, 2026.

Impact

Impact assessment: High. Key reasons: The final rule creates binding premanufacture and processing notification controls, including for imports, with a prohibition on starting designated uses until EPA completes its review.

Who is affected?

Chemical manufacturers, importers, processors, formulators, distributors, research and development teams, customs and trade-compliance teams, environmental health and safety personnel, and downstream customers handling the subject substances.

Conclusion:

Treat this as a high-impact binding change. Before December 14, 2026, screen chemical inventories and intended uses against the rule, update supplier declarations and TSCA import controls, and build a Significant New Use Notice escalation process. Do not begin a designated use based solely on the passage of 90 days.