[{"data":1,"prerenderedAt":20},["ShallowReactive",2],{"blog:tsca-compliance-guide-chemical-imports-non-fda":3},{"slug":4,"category":5,"locale":6,"localeCodes":7,"metaTitle":8,"metaDescription":9,"ogImage":10,"title":11,"subtitle":12,"contentHtml":13,"takeaways":14},"tsca-compliance-guide-chemical-imports-non-fda","food_compliance","en",[6],"TSCA Compliance Guide: Importing Chemicals Not Regulated by FDA","Learn about TSCA Section 13 import certifications and the FDA exclusion. Ensure your chemical imports meet EPA standards when they fall outside FDA oversight.",null,"TSCA Compliance for Importers: Navigating Chemicals Outside FDA Jurisdiction","Understanding the EPA’s Toxic Substances Control Act and the \"FDA Exclusion\" Rule.","\u003Cp>For companies involved in international trade, the regulatory landscape is often divided between two major federal agencies: the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). While the FDA oversees food, cosmetics, and medical products, the EPA manages the \u003Cstrong>Toxic Substances Control Act (TSCA)\u003C/strong>, which regulates chemical substances and mixtures imported into or manufactured in the United States.\u003C/p>\u003Ch2>What is TSCA and Who Does it Affect?\u003C/h2>\u003Cp>Enacted in 1976 and significantly updated by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016, TSCA gives the EPA authority to require reporting, record-keeping, and testing requirements relating to chemical substances. For importers, the most critical aspect is \u003Cstrong>TSCA Section 13\u003C/strong>, which requires that any chemical substance, mixture, or article containing a chemical substance be in compliance with TSCA before it can enter the U.S. customs territory.\u003C/p>\u003Ch3>The \"FDA Exclusion\" Rule\u003C/h3>\u003Cp>One of the most important nuances for importers to understand is the statutory exclusion found in TSCA Section 3(2)(B). By law, the term \"chemical substance\" under TSCA does \u003Cem>not\u003C/em> include:\u003C/p>\u003Cul>\u003Cli>Food and food additives\u003C/li>\u003Cli>Drugs and medical devices\u003C/li>\u003Cli>Cosmetics\u003C/li>\u003C/ul>\u003Cp>Because these categories are already regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA), they are generally exempt from TSCA requirements. However, this exclusion is strictly based on the \u003Cstrong>intended use\u003C/strong> of the product. If a chemical is imported for a purpose other than those listed above—such as an industrial solvent, a lubricant, or a cleaning agent—it falls squarely under TSCA jurisdiction.\u003C/p>\u003Ch2>The TSCA Import Certification Process\u003C/h2>\u003Cp>When a shipment of chemicals arrives at a U.S. port, the importer of record must provide a certification statement to U.S. Customs and Border Protection (CBP). This is typically handled through the Automated Commercial Environment (ACE) portal. There are two types of certifications:\u003C/p>\u003Ch3>1. Positive Certification\u003C/h3>\u003Cp>A statement certifying that all chemical substances in the shipment comply with all applicable rules and orders under TSCA. This is used for industrial chemicals that are not excluded from the Act.\u003C/p>\u003Ch3>2. Negative Certification\u003C/h3>\u003Cp>A statement certifying that all chemical substances in the shipment are \u003Cstrong>not subject to TSCA\u003C/strong>. This is the certification used for products that fall under the FDA exclusion (like food or cosmetics) or other excluded categories like pesticides (regulated by FIFRA) and tobacco.\u003C/p>\u003Cp>Even if your product is an FDA-regulated item, you may still be required to file a Negative Certification to inform Customs why the TSCA rules do not apply to that specific entry.\u003C/p>\u003Ch2>The Challenge of Dual-Use Chemicals\u003C/h2>\u003Cp>Complexity arises when a company imports \"dual-use\" chemicals. For example, a specific chemical might be used as a preservative in a cosmetic product (FDA regulated) but also as a preservative in industrial paint (EPA regulated). \u003C/p>\u003Cp>In these scenarios, the importer must be diligent. If the chemical is being imported for the industrial paint application, it must be listed on the \u003Cstrong>TSCA Inventory\u003C/strong> and comply with any Significant New Use Rules (SNURs). If it is being imported solely for use in a cosmetic, it is exempt from TSCA but must meet all \u003Ca href=\"https://fdaexpress.us/blog/mocra-compliance-checklist-2026\" rel=\"noopener noreferrer\">MoCRA cosmetics compliance standards\u003C/a>, including product listing and safety substantiation.\u003C/p>\u003Ch2>Common Pitfalls for Chemical Importers\u003C/h2>\u003Cul>\u003Cli>\u003Cstrong>Assuming FDA Registration is Enough:\u003C/strong> Just because a facility is registered with the FDA does not mean its industrial-grade cleaning supplies or machinery lubricants are exempt from TSCA.\u003C/li>\u003Cli>\u003Cstrong>Inaccurate Inventory Checks:\u003C/strong> Before importing a non-FDA chemical, you must verify if it is on the TSCA Inventory. If it is a \"new\" chemical substance, a Pre-Manufacture Notice (PMN) may be required 90 days before import.\u003C/li>\u003Cli>\u003Cstrong>Missing Section 13 Deadlines:\u003C/strong> Failure to provide the required certification at the time of entry can lead to the shipment being detained or refused entry by CBP.\u003C/li>\u003C/ul>\u003Ch2>How to Ensure Compliance\u003C/h2>\u003Cp>Navigating the intersection of EPA and FDA regulations requires a clear understanding of your product's end-use. For products that fall under the FDA's umbrella—such as food ingredients or beauty products—ensuring your \u003Ca href=\"https://fdaexpress.us\" rel=\"noopener noreferrer\">FDA facility registration\u003C/a> and US Agent representation are current is the first priority. For everything else, a robust TSCA compliance program is essential.\u003C/p>\u003Cp>At \u003Cstrong>FDA Express\u003C/strong>, we specialize in helping companies manage the FDA side of this regulatory coin. Whether you are navigating MoCRA for cosmetics or FURLS for food facilities, our portal provides a secure way to track your registrations and ensure you are ready for U.S. market entry. While we focus on FDA pathways, understanding the broader chemical regulatory environment like TSCA is vital for any successful importer.\u003C/p>",[15,16,17,18,19],"TSCA regulates chemical substances in the U.S. but excludes items already regulated by the FDA, such as food, drugs, and cosmetics.","Importers must provide a TSCA Section 13 certification (Positive or Negative) to U.S. Customs for every chemical shipment.","A Positive Certification confirms the shipment complies with all TSCA rules, while a Negative Certification is used for substances specifically excluded from TSCA.","Dual-use chemicals require careful documentation to determine whether EPA or FDA regulations apply based on the intended end-use.","Failure to comply with TSCA import requirements can lead to shipment detentions, fines, and mandatory exportation of the goods.",1780076543970]