U.S. TSCA (Toxic Substances Control Act): Key Compliance Requirements for Chemical Market Entry
Overview
Toxic Substances Control Act (TSCA) was firstly enacted in 1976. It is the Nation’s primary chemical management law and provides the U.S. Environmental Protection Agency (EPA) with the authority to require reporting, record-keeping, and testing requirements and restrictions relating to chemical substances and mixtures. In June 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) to amend the TSCA of 1976. The new law will strengthen the EPA’s authority to manage existing and new chemical substances in commerce.
U.S. TSCA Requirements
Toxic Substances Control Act (TSCA) classifies chemical substances into existing substances and new substances by the U.S. TSCA Inventory (the Inventory). For purposes of regulation under U.S. TSCA, if a chemical is on the Inventory, the substance is considered an existing chemical substance in U.S. commerce. Any chemical that is not on the Inventory is considered a new chemical substance. A new substance will become an existing substance after EPA’s review, so the U.S. TSCA Inventory continues to grow, and now lists about 86,847 chemicals. The Lautenberg Act will significantly change the abilities of the EPA to evaluate both existing chemicals and new chemicals.
Obligations of Existing Chemical Substances
For the existing chemical substances listed on the U.S. TSCA Inventory, the manufacturers/ importers are requested to check if there is any Import Certification Requirement (Certification), Chemical Data Reporting Rule (CDR) for their product and if meet the Active-Inactive rule.
| Import
Certification Requirement (Certification) |
Imports of chemical substances, mixtures or articles that contain a chemical substance or mixture must comply with the Toxic Substances Control Act in order to enter the U.S. market. Importers must certify that imported chemical substances either comply with U.S. TSCA (positive certification) or are not subject to U.S. TSCA (negative certification). Certain chemicals require no certification. |
| Significant
New Use Rule (SNUR) |
Once EPA determines that a use of a chemical substance is a significant new use, the manufacturers/ importers should submit a Significant New Use Notice (SNUN) to EPA at least 90 days before they manufacture (including import), or process the chemical substance for that use. |
| Chemical Data
Reporting Rule (CDR) |
Manufacturers (including importers) are required to report if they meet certain production volume thresholds, generally 25,000 lbs or more of a chemical substance at any single site. However, a reduced reporting threshold (2,500 lb) now applies to chemical substances subject to certain U.S. TSCA actions. The next reporting period will be in 2028. |
| Notice of Activity Form B |
Any person who intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. |
Obligations of New Chemical Substances
For new chemical substances not listed on the U.S. TSCA Inventory, a Pre-manufacture Notice (PMN) should be submitted to EPA at least 90 days before manufacturing (including importing) the substance for a non-exempt commercial purpose.
TSCA Compliance Recommendations for the U.S. Market
The U.S. TSCA applies not only to subsidiaries of Chinese companies operating in the United States but also to U.S. companies importing chemicals from China. For businesses whose products fall under the scope of TSCA, compliance is a prerequisite for lawful trade. Key compliance points include:
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Determine whether the product is subject to TSCA and whether any component substance qualifies as a new substance under TSCA.
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If the substance is new and meets specific exemption criteria, it may be eligible for direct exemption or Pre-Manufacture Notice (PMN) exemption. If not exempt, a PMN submission is required before manufacture or import.
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If the substance is listed in the existing TSCA Inventory and the annual export volume exceeds 25,000 pounds (~11.3 tons) or 2,500 pounds(~1.13 tons), the importer must submit Chemical Data Reporting (CDR) in due course.
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For general existing chemical substances, companies must ensure TSCA Form B notice and (or) TSCA import certification.
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If the product involves TSCA high-priority or risk-evaluated substances, further compliance actions may be required.
Self-Service TSCA Inventory Search
REACH24H has developed a global chemical inventory search platform—CHEMCHECK—that allows users to freely search the U.S. TSCA Inventory using a substance name or CAS number. The system helps determine whether a substance is listed in the latest TSCA Existing Chemical Substances Inventory and provides further compliance guidance as needed.
Our Services
• U.S. TSCA Compliance Analysis Report
• Positive/ Negative Certification Statement
• Bona Fide Intent Notice
• Pre-manufacture Exemption (LVE, TME, LoREX, Polymer Exemption, etc.)
• Chemical Data Reporting (CDR)
• Significant New Use Notification (SNUN)
• Pre-manufacture Notification (PMN)
• Notice of Commencement (NOC)
• Notice of Activity (NOA Form B)
Our Advantages
1. Localized Presence
We operate a subsidiary in the United States, maintaining close communication with the U.S. EPA and other regulatory authorities, ensuring timely and accurate updates on regulatory policies and compliance requirements.
2. Official Recognition
As a designated regulatory service provider by the U.S. Department of Commerce for the China region, we are trusted by clients for our high standards and professional expertise in delivering TSCA compliance services.
3. Extensive Regulatory Expertise
Backed by a highly skilled technical team and years of hands-on regulatory experience, we provide accurate, efficient, and customized TSCA compliance solutions for businesses of all sizes.
4. Multilingual Service Capabilities
Our team offers support in English, Japanese, Korean, and other major languages, enabling seamless global communication and enhancing service efficiency for international clients.
5. Responsive and Confidential
We are committed to rapidly addressing client needs and strictly adhering to confidentiality agreements to safeguard your data and privacy throughout the compliance process.
