The Toxic Substances Control Act (TSCA) governs the manufacture, importation, and use of chemical substances in the United States (U.S.). For manufacturers, importers, and compliance teams, TSCA compliance is not optional—it directly impacts market access, enforcement risk, and supply chain continuity. Understanding TSCA compliance requirements is increasingly complex as reporting obligations expand, and enforcement intensifies.
TSCA is the primary U.S. law governing the regulation of chemical substances in commerce. Administered by the Environmental Protection Agency (EPA), TSCA gives regulators authority to evaluate, restrict, and require reporting on chemicals that may pose risks to human health or the environment.
TSCA applies to chemical substances manufactured, imported, processed, or distributed in the country. It covers chemicals as standalone substances, as part of mixtures, and within articles. Importantly, TSCA is a regulatory framework, not a certification or one-time approval. However, it does require importers to provide a TSCA certification statement to U.S. customs. This “certification” is essentially a self-declared TSCA compliance statement.
Compliance requirements vary depending on the chemical substance, its use, and a company’s role in the supply chain. Manufacturers and importers typically carry the greatest responsibility, but downstream companies can still be impacted when products contain regulated substances. As EPA scrutiny increases, understanding TSCA regulations is essential for reducing risk and avoiding costly enforcement actions.
TSCA applies broadly across the supply chain, beyond chemical producers.
Impacted groups include:
Companies often underestimate their obligations until enforcement or customer requests expose compliance gaps. Even companies selling finished goods may face TSCA compliance requirements for articles containing substances subject to reporting, restrictions, or Significant New Use Rules (SNURs). Understanding applicability early helps teams avoid last-minute compliance surprises.
TSCA compliance involves several interrelated obligations. While requirements vary by substance and activity, the following areas form the foundation of most TSCA programs.
The TSCA Inventory is the EPA’s list of chemical substances allowed in U.S. commerce. Substances are classified as either existing or new. Existing chemicals appear on the Inventory, while new chemicals require EPA review before they can be manufactured or imported.
Companies must confirm whether substances in their products appear on the TSCA Inventory. This determination directly impacts reporting, notification, and compliance obligations under TSCA regulations.
For substances not listed on the TSCA Inventory, manufacturers and importers must submit a Pre-Manufacture Notification (PMN) to the EPA before commercial activity begins. PMNs give the EPA a chance to evaluate potential risks before commercialization and, if needed, impose restrictions.
This requirement is especially important for companies introducing new formulations or sourcing new materials. Missing a PMN obligation can delay market entry and trigger enforcement action.
TSCA reporting requirements include chemical data submissions, exposure information, and business records demonstrating compliance. The EPA may request documentation during inspections or audits, making accurate recordkeeping critical.
Companies must retain records for specified timeframes and ensure information is complete and traceable. Weak documentation is a common source of TSCA compliance risk, particularly in complex supply chains.
One of the most significant recent developments under TSCA is the Section 8(a)(7) PFAS reporting rule. This rule requires companies to report information on per- and polyfluoroalkyl substances (PFAS) manufactured or imported since 2011.
The requirement applies broadly to PFAS present in chemicals, mixtures, articles, and components. Companies must report data such as chemical identity, uses, volumes, byproducts, and exposure information. The long lookback period creates substantial challenges, particularly for organizations with limited historical supplier data.
Many companies are still determining whether PFAS were used in legacy products or whether they were present in upstream components. That typically requires structured supplier outreach and documentation to support a defensible reporting position.
For a deeper dive, read our guide on the TSCA Section 8(a)(7) PFAS reporting rule or find answers to common questions with our TSCA PFAS reporting rule FAQ.
SNURs restrict specific new uses of certain chemical substances. If a company plans to use a chemical in a way the EPA considers “significant” and new, it must notify the EPA before proceeding.
SNURs require ongoing monitoring because changes in product design, suppliers, or materials can trigger new TSCA obligations, often without an obvious compliance signal.
The EPA may restrict, phase out, or impose controls on chemicals that it determines present an unreasonable risk. These actions can limit permitted uses and drive changes to labeling, workplace protections, and supply availability.
To stay compliant, companies should monitor EPA risk evaluations and risk management rules. As TSCA requirements evolve, teams should assess impacts on products, sourcing, and timelines.
TSCA compliance is easiest to manage when it’s treated as an ongoing program, rather than a one-time exercise. As products change, suppliers shift, and EPA actions evolve, teams need a repeatable process to confirm what’s in scope and document decisions consistently.
Effective TSCA programs start with clear, repeatable steps. This high-level TSCA compliance checklist helps teams assess readiness and identify gaps early.
If any step relies on guesswork or one-off supplier emails, that’s a signal to standardize workflows and strengthen traceability. A structured checklist also makes it easier to respond to customer requests, inspections, and internal audits with confidence.
TSCA compliance challenges usually trace back to limited chemical visibility and manual, disconnected processes. When product and supplier data lives in email threads and spreadsheets, teams struggle to prove what’s in scope, respond quickly, or maintain a defensible record.
Common issues include:
Addressing these challenges requires scalable systems—not spreadsheets—so teams can collect standardized data, maintain traceability, and act on regulatory changes without last-minute scrambles.
Managing TSCA requirements manually increases risk as regulations expand and supply chains grow. Source Intelligence supports TSCA compliance through our broader Product Compliance solutions, which help teams scale data collection, strengthen traceability, and stay ahead of changing rules.
Our TSCA solution helps teams:
With better visibility and less manual work, compliance teams can focus on risk mitigation instead of data chasing.
Explore our TSCA solution to see how Source Intelligence helps organizations stay compliant with greater confidence and control.
TSCA compliance refers to meeting EPA requirements for manufacturing, importing, processing, and reporting chemical substances under the Toxic Substances Control Act (TSCA).
Yes. TSCA applies to chemicals, mixtures, and articles imported into the United States, making importers directly responsible for compliance.
No. TSCA governs chemical compliance in the U.S., while REACH applies to the European Union. Requirements and obligations differ significantly.
Non-compliance can result in fines, shipment delays, product bans, and reputational risk, especially during audits or enforcement actions.
Yes. Certain substances regulated under other U.S. laws (such as food, drugs, medical devices, pesticides, and radioactive materials) are generally exempt from TSCA. Limited exemptions may also apply to research and development activities, depending on use and volume.
The TSCA Chemical Data Reporting rule requires manufacturers and importers to periodically report information on chemical production volumes, uses, and exposure. This data helps the EPA evaluate chemical risks and prioritize regulatory action.
The U.S. Environmental Protection Agency (EPA) enforces TSCA through reporting reviews, inspections, and enforcement actions. Companies must be prepared to demonstrate compliance through accurate data and documentation.