TSCA: US Toxic Substances Control Act

Author Hugues Orgitello Last updated 30 May 2026 ~9 min read

Guide, TSCA chemicals

The Toxic Substances Control Act is the United States federal law that governs chemical substances in commerce, from raw materials to the chemicals embedded in finished electronics. Enacted in 1976 and overhauled by the 2016 Lautenberg Act, TSCA is administered by the Environmental Protection Agency. For hardware makers, three parts matter most: Section 6 restrictions on existing chemicals such as PIP (3:1), Section 5 review of new chemicals through PMN and SNUR, and the import certification that every chemical shipment must carry at the border. This guide maps those mechanisms, the TSCA Inventory that underpins them, the 2023 PFAS reporting rule, and how the regime compares with EU REACH for a product sold on both markets.

TSCA in one page

TSCA is codified at 15 U.S.C. Chapter 53 and implemented through Title 40 of the Code of Federal Regulations, principally Parts 700 to 799. It is one of the few US environmental statutes that reaches substances inside articles, which is why a circuit board, a cable harness or an enclosure can fall within its scope even though no chemical is sold loose.

The original 1976 act grandfathered the roughly 62,000 substances already in commerce onto an Inventory and presumed them acceptable, leaving EPA to prove unreasonable risk before acting. The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act reset that balance: EPA must now systematically prioritise and evaluate existing chemicals, make a risk determination without considering cost at the evaluation stage, and impose restrictions where it finds unreasonable risk.

Section	Subject	What it requires
Section 4	Testing	EPA can order data generation on a substance
Section 5	New chemicals and new uses	PMN before manufacture or import; SNUR triggers a SNUN
Section 6	Existing chemicals	Risk evaluation and restrictions, including article bans
Section 8	Reporting and records	CDR every four years, plus targeted rules such as PFAS
Section 13	Imports	Certification at customs entry
Section 14	Confidential business information	Protection and substantiation of CBI claims

There is no TSCA mark. Compliance is evidenced by records, filings and import certifications, not by a label affixed to the product.

Section 6: restrictions that reach electronics

Section 6 is the operative restriction power. The most consequential recent action for electronics came under Section 6(h), the expedited track the Lautenberg Act created for persistent, bioaccumulative and toxic (PBT) substances.

The 2021 PBT rules and PIP (3:1)

In January 2021 EPA finalised rules for five PBT chemicals. Four of them (decaBDE, PCTP, 2,4,6-TTBP and HCBD) appear narrowly in electronics, but the fifth, phenol isopropylated phosphate (3:1), known as PIP (3:1), is widespread. It is used as a plasticiser and flame retardant in:

• wire and cable insulation and jacketing
• adhesives, sealants and coatings
• hydraulic fluids and lubricants
• some plastics and rubber components found in assemblies

The rule restricts processing and distribution in commerce of PIP (3:1) and of articles containing it. Because PIP (3:1) sits deep in global supply chains, EPA issued enforcement discretion and then several extensions to the compliance date for articles and their replacement parts. Manufacturers should treat the compliance date as a moving target and confirm the current deadline directly against the EPA PBT page rather than relying on the original 2021 text.

How a Section 6 article restriction works

A Section 6 rule can prohibit manufacture, processing, distribution, use or disposal, and can apply to the chemical alone or to articles that contain it. When articles are covered, downstream commercial actors inherit obligations: they may need to stop distributing affected stock, notify their own customers, and keep records demonstrating that products placed after the compliance date are free of the restricted substance or fall within an exemption.

Other Section 6 evaluations to watch

EPA runs a continuous pipeline of risk evaluations on existing chemicals such as solvents and flame retardants. Several substances common in electronics manufacturing (certain chlorinated solvents used in cleaning, and brominated flame retardants) are in evaluation or have draft risk determinations, any of which can lead to a future Section 6 rule. TSCA evaluations are published on the EPA docket, so a watch on the priority list is part of due diligence.

Section 5: new chemicals, PMN and SNUR

Section 5 is the gate for anything not already on the Inventory.

Premanufacture Notice (PMN)

Before manufacturing or importing a new chemical substance for a non-exempt commercial purpose, a company must submit a PMN to EPA at least 90 days in advance. EPA reviews health and environmental data, intended uses and exposure, and must reach an affirmative determination before commerce can begin. If EPA finds potential risk, it can issue a consent order or a SNUR to control the conditions of use.

Exemptions exist: the Low Volume Exemption (LVE, up to 10,000 kg per year), the Low Release and Low Exposure exemption (LoREX), the test marketing exemption (TME) and the polymer exemption each have their own eligibility and notification rules.

Significant New Use Rule (SNUR)

A SNUR is a regulation, not a one-off review. Once EPA designates a use as significant and new, any person intending that use must file a Significant New Use Notice (SNUN) 90 days beforehand. SNURs are frequently paired with PMN outcomes to lock in the limited conditions EPA reviewed, and they also apply to existing chemicals where EPA wants to capture future uses that were not previously assessed. For importers, a SNUR on an existing substance can convert a routine import into a notification-triggering event.

Instrument	Applies to	Lead time	Outcome
PMN	New substance not on Inventory	90 days	EPA determination before commerce
SNUN	Designated significant new use	90 days	EPA review of the specific use
LVE	New substance, low volume	30 days	Exemption if granted
TME	New substance, test marketing	45 days	Time-limited exemption

The TSCA Inventory and import certification

Reading the Inventory

The TSCA Inventory lists every substance in or formerly in US commerce. Since the 2017 Inventory Notification (Active/Inactive) rule, substances are flagged active or inactive: manufacturing or importing an inactive substance requires a Notice of Activity before resuming. A substance absent from the Inventory is, by definition, a new chemical and triggers Section 5.

Identifying substances by their correct CAS number and confirming Inventory status is the foundational step. Confidential substances appear on the confidential portion of the Inventory and may require a bona fide intent submission to confirm a match.

Import certification at the border

TSCA Section 13, implemented at 19 CFR 12.118 to 12.127, requires a certification at the time of entry for chemical substances, mixtures and (where applicable) articles containing them. Two statements are possible:

1. Positive certification: "I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA."
2. Negative certification: "I certify that all chemicals in this shipment are not subject to TSCA."

Certifications are filed electronically through the Automated Commercial Environment (ACE). A false certification exposes the importer to penalties under Section 16. For finished electronics, the practical question is whether any embedded chemical is subject to a TSCA rule (for example a Section 6 restriction such as PIP (3:1)); if so, the positive certification and supporting records are essential.

Section 8 reporting, including PFAS

Section 8 underpins EPA's data collection.

Chemical Data Reporting (CDR)

The CDR rule requires manufacturers and importers above volume thresholds to report production, import, processing and use information every four years. Articles are generally outside CDR, but importers of bulk substances and mixtures are squarely within it.

The 2023 PFAS reporting rule

In October 2023 EPA finalised a rule under Section 8(a)(7), codified at 40 CFR 705, requiring retrospective reporting of PFAS. Key features:

• It covers anyone who manufactured or imported PFAS, including PFAS in articles, for a commercial purpose for any year from 2011 to 2022.
• The PFAS definition is structural and broad, capturing many fluoropolymers and side-chain fluorinated substances used in electronics (coatings, lubricants, separators, dielectric films).
• There is no de minimis concentration threshold and no general article exemption, which makes this rule unusually demanding for importers of finished hardware.
• Reporters must submit available information on identity, categories of use, production volume, byproducts, disposal and exposure.

The submission window was originally scheduled for 2025; EPA has adjusted the timing, so confirm the current opening and closing dates against the EPA Section 8(a)(7) page before building an internal deadline.

TSCA versus EU REACH for electronics makers

A device sold on both sides of the Atlantic faces two chemical regimes with different logic.

Dimension	TSCA (United States)	REACH (European Union)
Administering body	EPA	ECHA
Burden of proof	EPA-led, shifted partly to industry since 2016	Industry: no data, no market
Substances in articles	Reached via Section 6 rules and Section 8 reporting	SVHC candidate list, Article 33, SCIP
Concentration trigger	Use and substance specific (no single threshold)	0.1 percent w/w of an article for SVHC
Pre-market gate	PMN for new chemicals (Section 5)	Registration above 1 tonne per year
PFAS	Section 8(a)(7) reporting, no article de minimis	Annex XVII restrictions plus proposed universal restriction
Marking	None	No CE mark, but compliance is a market condition

Practically, treat the two as parallel tracks. The same bill of materials feeds a REACH and SCIP analysis for the EU (see the REACH guide) and a TSCA Inventory, Section 6 and PFAS analysis for the US. RoHS sits alongside both and restricts a fixed list of substances in electrical and electronic equipment (see the RoHS guide).

Where the regimes diverge in practice

REACH gives you a published SVHC list and a clear 0.1 percent threshold per article, which makes screening tractable. TSCA gives no such universal list for articles: you must check each candidate substance against the specific Section 6 rules and reporting requirements that apply to it. The PFAS rule is the sharpest divergence, because its breadth and absence of a de minimis make it harder to scope than the EU restriction approach.

Step by step: a TSCA screen for a hardware product

1. Build a full-depth bill of materials with CAS numbers for substances in each component, gathered through supplier declarations.
2. Confirm Inventory status for each substance: active, inactive or absent (new chemical, Section 5 applies).
3. Screen against Section 6 rules, in particular PIP (3:1) and the other 2021 PBT chemicals; flag any article containing a restricted substance.
4. Check current compliance dates on the EPA PBT page, since article deadlines have shifted several times.
5. Run a PFAS analysis under Section 8(a)(7), tracing fluorinated materials back to 1 January 2011 import or manufacture.
6. Determine the import certification statement (positive or negative) and prepare supporting records for ACE entry.
7. Assess Section 5 triggers if any substance is new to the Inventory or subject to a SNUR.
8. Document and retain records under Section 8 and the relevant CFR parts, ready for an EPA request.

Common pitfalls

Pitfall	Consequence	Mitigation
Assuming articles are out of TSCA scope	Missed PIP (3:1) restriction or PFAS reporting on imported hardware	Screen the bill of materials, not just bulk chemicals
Treating the 2021 PIP (3:1) deadline as fixed	Distributing non-compliant stock after a date that has actually changed	Re-check the current compliance date on the EPA PBT page
Applying a REACH-style 0.1 percent threshold to TSCA	Wrong scoping, missed obligations with no de minimis (PFAS)	Use TSCA's substance- and use-specific rules, not a single threshold
Filing the wrong import certification	Section 16 penalties for a false statement at entry	Decide positive versus negative per shipment with documented basis
Importing a substance absent from the Inventory	Unlawful manufacture or import of a new chemical	Confirm active Inventory status before entry; file a PMN if new
Ignoring inactive-Inventory substances	Resuming an inactive substance without a Notice of Activity	Check active versus inactive flag and file before reactivating
Tracing PFAS only from a recent date	Under-reporting under the 2011 retrospective window	Investigate fluorinated materials back to 1 January 2011

Further reading

• REACH 1907/2006: chemical substances and SVHC
• RoHS: restriction of hazardous substances in EEE
• California Proposition 65 warnings
• WEEE 2012/19/EU: EU e-waste framework
• Conflict minerals: CMRT and Dodd-Frank
• spilma glossary

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Sources and references

Sources & references

1. Toxic Substances Control Act, 15 U.S.C. Chapter 53 , EPA www.epa.gov/laws-regulations/summary-toxic-substances-control-act
2. Frank R. Lautenberg Chemical Safety for the 21st Century Act , EPA www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act
3. PBT chemicals under TSCA Section 6(h), final rules including PIP (3:1) , EPA www.epa.gov/assessing-and-managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-chemicals
4. Reviewing new chemicals under TSCA (PMN and SNUR), Section 5 , EPA www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca
5. TSCA Chemical Substance Inventory , EPA www.epa.gov/tsca-inventory
6. TSCA import and export requirements (Section 13 / 19 CFR 12.118) , EPA www.epa.gov/tsca-import-export-requirements
7. PFAS reporting rule under TSCA Section 8(a)(7), 40 CFR 705 , EPA www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-8a7-reporting-and-recordkeeping
8. Chemical Data Reporting (CDR) under TSCA , EPA www.epa.gov/chemical-data-reporting