TSCA Section 5 Premanufacture Notice Readiness
Decide who files, record any exclusion, wait for EPA's determination and file the notice of commencement on time.
In Short
- Name who files, in writing.
- EPA decides; not the calendar.
- Commencement: 30 days.
The Chemical Manufacturing Guide
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- Which rules reach your plant
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The Chemical Manufacturing Guide
Approved formulas. Tested batches. Correct labels out the door.
Under TSCA section 5 and EPA's rules in 40 CFR Part 720, a person who intends to manufacture or import a new chemical substance for commercial purposes submits a premanufacture notice (PMN) unless an exclusion applies. EPA reviews it and makes a determination. This guide covers who files, what the review involves and the records to keep. It is orientation, not regulatory advice. Sources checked 4 Oct 2026.
Who must submit
Section 720.22 places the duty on any person intending to manufacture a new chemical substance in the United States for commercial purposes, and on importers unless the substance arrives as part of an article. Where a company contracts with a toll manufacturer that makes the substance only for it, and the company specifies the identity and controls the amount and basic technology, the company files.
More on who must submit
For imports the principal importer files. If it is unclear who should report, the rule says to contact EPA.
What is excluded
Section 720.30 lists substances not subject to notification, including mixtures as a whole (but not new substances within them), small quantities solely for research and development under 720.36, substances for test marketing under an exemption, certain export-only substances, and some byproducts and impurities. Each exclusion has conditions and its own records, so write down which one you rely on and why for every substance.
The Review and EPA's Determination
Under 720.75 the review period runs 90 days from EPA's receipt of a complete notice, unless suspended at the submitter's request with EPA agreement, or extended by EPA for good cause. Within the review period EPA makes one of the determinations set out in section 5(a)(3) of the Act, which can lead to an order or rule restricting the substance.
From notice to Inventory
- Day 0EPA receives a complete noticeSubmitter
- Up to day 90EPA review; may be suspended or extendedEPA
- DeterminationEPA decides under section 5(a)(3)EPA
- Within 30 days of first manufactureNotice of commencement filedAuthorised official
More on the Review and EPA's Determination
Plan launch dates around the determination, not around the calendar alone.
Notice of Commencement
Section 720.102 requires a notice of commencement within 30 calendar days after the first day of manufacture for a non-exempt commercial purpose, on EPA Form 7710-56 through e-PMN, signed by an authorised official. For importers, commencement is when the substance clears customs.
More on notice of Commencement
The notice puts the substance on the TSCA Inventory. Link the first production batch or customs entry to the notice so the date can be shown.
Records to Keep
Section 720.78 asks submitters to keep documentation of information in the notice, other data in their possession or control, production volume records for the first three years, and the date of commencement, for five years from commencement. Research and development and test-marketing exemptions carry their own records.
Worked Example: Substance File NCS-118
More on records to Keep
Keep the PMN, any EPA correspondence, the commencement evidence and the volumes together under one substance record.
Questions
Can we start making the substance on day 91?
Not simply by waiting. EPA must make a determination within the review period, and that determination can restrict manufacture. Follow EPA's outcome.
Who files for a toll-manufactured substance?
The company that specifies the identity and controls the amount and process, under 720.22(a)(2).
How long do we keep PMN records?
Five years from commencement of manufacture or import, under 720.78(a).
Where does V5 fit?
V5 keeps formulations, raw material and batch records, SDS and shipments linked, which helps show first production dates and volumes. Your regulatory team decides and files with EPA.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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