2025-21674Notice

EPA Updates Status on New Chemicals Under Review

Published Date: 12/1/2025

Notice

Summary

The EPA just shared updates on new chemicals submitted for review between July and August 2025. If you make, use, or sell chemicals, this affects you because the EPA is checking safety and asking for comments by December 31, 2025. Staying in the loop helps businesses avoid surprises and keep things running smoothly without extra costs or delays.

Analyzed Economic Effects

5 provisions identified: 3 benefits, 2 costs, 0 mixed.

Manufacturers/importers must file PMNs before manufacture

Under TSCA section 5, anyone who intends to manufacture (including import) a new chemical for a non-exempt commercial purpose or to manufacture/process a chemical for a significant new use must submit a PMN, MCAN, or SNUN to EPA before starting that activity. The notice reiterates that these submission requirements apply to manufacturers and importers.

EPA can grant Test Marketing Exemptions (TMEs)

TSCA section 5(h)(1) authorizes EPA to allow persons to manufacture or process a new chemical for 'test marketing' under restrictions if they show the activity will not present an unreasonable risk. The notice states TMEs are an available pathway under that section.

EPA requests public comments by Dec 31, 2025

The EPA is asking the public to comment on new-chemical submissions covered from 08/01/2025 through 08/31/2025. Comments must be submitted by December 31, 2025 using docket EPA-HQ-OPPT-2025-0067 at https://www.regulations.gov.

EPA posts new-chemical status and details online

EPA makes information about PMNs, SNUNs, MCANs, exemption applications, and final determinations available online at its new-chemicals pages and ChemView (https://www.epa.gov/new-chemicals-under-toxic-substances-control-act-tsca/pre-manufacture-notices and https://chemview.epa.gov/). You can look up receipt dates, uses, and EPA status for submissions.

Do not submit CBI via regulations.gov; follow CBI rules

The notice instructs commenters not to submit Confidential Business Information (CBI) through https://www.regulations.gov and explains that if you include CBI you must follow EPA's CBI submission procedures and also submit a non-CBI version for the public docket. These instructions apply to comments on docket EPA-HQ-OPPT-2025-0067.

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Key Dates

Published Date
Comments Due
12/1/2025
12/31/2025

Department and Agencies

Department
Independent Agency
Agency
Environmental Protection Agency
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