Overview

Toxic Substances Control Act (TSCA) was first 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 86,000 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.

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.

How to Comply with U.S. TSCA?

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:

• Determine whether the product is subject to TSCA and whether any component substance qualifies as a new substance under TSCA.

• 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.

• 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.

• For general existing chemical substances, companies must ensure TSCA Form B notice and/or TSCA import certification.

• If the product involves TSCA high-priority or risk-evaluated substances, further compliance actions may be required.

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

• 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.

• 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.

• 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.

• 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.

• 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.

For more information and inquiries on U.S. TSCA , please feel free to contact us at customer@reach24h.com.