United States

US EPA Finalises New-Use Rules For 19 Chemicals With December Start

EPA has finalised substance-specific TSCA significant-new-use rules effective on 14 December 2026. Designated activities require at least 90 days’ advance notice and completion of the EPA review process.

Dr Steven Brennan

2 min readAI-drafted, expert reviewed

Specialty chemical samples beside stainless-steel mixing equipment

Final Rule Takes Effect On 14 December

The US Environmental Protection Agency has finalised significant-new-use rules for 19 chemical substances under the Toxic Substances Control Act. Published on 15 October 2026, the package adds sections 721.12260 to 721.12278 to 40 CFR Part 721 and takes effect on 14 December.

The chemicals were the subject of premanufacture notices and EPA orders. The new rules extend notification requirements to activities designated as significant new uses, according to the conditions in each substance's entry.

Advance Notice Does Not Automatically Permit A New Use

Manufacturers, including importers, and processors must notify EPA at least 90 days before beginning a designated significant new use. The activity cannot begin until EPA has reviewed the notification, made the required determination and taken any action required by that determination.

The rule's 29 October promulgation date is for judicial-review purposes. It does not replace the December effective date.

Conditions Differ Between Substances

The entries specify substance-dependent conditions covering uses, worker protection and environmental releases. EPA also states that issuing a significant-new-use rule does not establish that a chemical is on the TSCA Inventory. The notification requirement applies to the designated new activities, rather than prohibiting every use of the listed substances.

Process Changes Need An Entry-Level Review

Foresight analysis. The substance-specific conditions mean that checking a chemical name alone is insufficient to decide whether notification is required. Regulatory teams should compare the intended activity with the relevant entry and allow for EPA review before committing to the start of a designated new use.

Questions about this change

Can a designated new use begin after simply waiting 90 days?

No. The rule requires advance notification and completion of EPA review, the appropriate determination and any required action before the significant new use begins.

Does the rule prohibit all uses of the 19 substances?

No. The significant-new-use conditions differ by substance. Businesses need to compare their activity with the relevant entry in 40 CFR Part 721.

Dr Steven Brennan

CEO and co-founder of Foresight, and a co-opted member of ECHA's Committee for Socio-economic Analysis. He holds a PhD in chemical engineering.

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