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EPA TSCA Chemical Import Compliance Guide for Taiwan Exporters

Understand the Toxic Substances Control Act (TSCA) compliance requirements when importing chemicals, chemical-containing products and articles into the United States.

TSCA compliance USAEPA chemical import certificationTSCA Section 13 importPFAS TSCA restrictionschemical substance inventory USA
EPA TSCA Chemical Import Compliance Guide for Taiwan Exporters

What Is TSCA and Who It Affects

The Toxic Substances Control Act (TSCA), administered by EPA, regulates the manufacturing, processing, distribution in commerce and disposal of chemical substances in the United States. Importers of chemical substances — whether as standalone chemicals or as part of mixtures and some articles — are treated as manufacturers under TSCA and bear full compliance obligations.

Taiwan exporters affected include: chemical manufacturers, paint and coatings companies, electronics manufacturers (for chemicals in production), plastics processors, textile finishers and any exporter whose product releases a chemical substance under normal use conditions. Articles that contain a restricted substance in a concentration above the threshold are also subject to TSCA.

The TSCA Chemical Substance Inventory

EPA maintains the TSCA Chemical Substance Inventory — a list of chemicals that are legally allowed in US commerce. Before importing any chemical substance, confirm it is on the inventory. New chemicals not on the inventory require a Pre-Manufacture Notice (PMN) submitted to EPA at least 90 days before import.

The inventory includes an active/inactive designation. Importing an inactive chemical requires notification to EPA. Use EPA's ChemView database to search inventory status before commissioning a shipment.

TSCA Section 13 Import Certification

Under TSCA Section 13 and 19 CFR Part 12, importers of chemical substances must certify at the port of entry that the shipment either: (A) complies with all applicable TSCA rules and orders, or (B) is not subject to TSCA.

The certification is a positive or negative certification attached to or included on the entry documentation. CBP enforces this requirement. Failure to provide the correct certification can result in the shipment being denied entry or held for examination. Work with your US customs broker to ensure TSCA certifications are included in entry paperwork for every relevant shipment.

PFAS Restrictions Under TSCA

EPA has issued or is developing TSCA Section 6 rules restricting or prohibiting per- and polyfluoroalkyl substances (PFAS) in various applications. Current restrictions cover uses of specific PFAS in surface coatings, textiles and industrial processes. The PFAS landscape is rapidly evolving — new rules are being finalized regularly as of 2025.

Taiwan exporters of outdoor gear, cookware, food packaging, textiles and industrial chemicals must conduct PFAS substance reviews against the current restricted list. Many retailers and brands have also imposed contractual PFAS-free requirements on their supply chains ahead of regulation.

Significant New Use Rules (SNURs)

EPA issues Significant New Use Rules (SNURs) for chemicals that require pre-notification to EPA before they are used in new applications. If your product introduces a regulated chemical into a use that is designated as a significant new use under a SNUR, you must file a Significant New Use Notice (SNUN) at least 90 days before manufacture or import for that new use.

Check the SNUR database on EPA's website for any chemicals in your product formulation that may be SNUR-regulated.

Penalties and Enforcement

TSCA violations carry civil penalties up to $46,989 per violation per day. EPA may also issue administrative orders, seek injunctive relief and refer cases to the Department of Justice for criminal prosecution. CBP and EPA coordinate enforcement at the border.

EPA also has authority under TSCA Section 6(a) to prohibit or restrict the manufacture, import, distribution or use of a chemical. Compliance with these rules requires ongoing regulatory monitoring — subscribe to EPA's TSCA update service and work with a US regulatory counsel who specialises in chemical import compliance.

Frequently Asked Questions

Does TSCA apply to articles (finished products) like electronics?

TSCA applies to articles if they contain a regulated chemical substance that is intended to be released or is expected to be released during normal conditions of use. Some TSCA rules specifically apply to articles (e.g., the rule on PCBs in articles). Review the specific TSCA rule for your chemical.

What is the difference between TSCA and REACH?

Both regulate chemicals but differ in scope and approach. EU REACH uses a registration-based system where manufacturers and importers register chemicals with ECHA. TSCA uses EPA administrative rules and risk evaluations. Compliance with REACH does not ensure TSCA compliance.

Does a small business exemption exist under TSCA?

Some TSCA reporting and record-keeping requirements have small business exemptions, but core TSCA Section 13 import certification and substance inventory obligations apply regardless of business size.

Sources & References

  • EPA -- TSCA Chemical Substance Inventory
  • EPA -- Importing Chemicals Under TSCA: Section 13 Compliance
  • CBP -- TSCA Import Certification Requirements

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