Chemical shipments entering the United States must be accompanied by a certification under the Toxic Substances Control Act (TSCA), the federal law administered by the Environmental Protection Agency (EPA) that governs industrial chemicals. The certification is made by the importer to US Customs and Border Protection (CBP), not by the foreign supplier, but suppliers are regularly asked to support it. This article explains how TSCA import certification works. It is general information. For specific cases, consult the EPA's regulations and guidance or a US regulatory adviser.
Why certification is required
Section 13 of TSCA directs CBP to refuse entry to chemical substances, mixtures or articles containing them that do not comply with TSCA rules and orders. To implement this, EPA and CBP regulations require the importer, or its authorised agent, to certify at entry that the shipment either complies with TSCA or is not subject to TSCA. The relevant rules are found in 19 CFR 12.118 to 12.127 for customs and 40 CFR Part 707 Subpart B for EPA.
Positive and negative certification
| Type | When it is used | What it states, in substance |
|---|---|---|
| Positive certification | The shipment contains chemical substances or mixtures subject to TSCA | All chemical substances in the shipment comply with applicable TSCA rules and orders |
| Negative certification | The shipment contains only substances not subject to TSCA | None of the chemicals in the shipment are subject to TSCA |
The exact wording is prescribed in the regulations. Certification may be made electronically through CBP's systems or on the entry documents.
What is subject to TSCA
TSCA covers chemical substances and mixtures in general, but TSCA's definition of chemical substance excludes several categories regulated under other laws. Substances imported solely for these uses are not subject to TSCA and generally take a negative certification:
- Drugs, including APIs, and cosmetics regulated under the Federal Food, Drug, and Cosmetic Act
- Food, food additives and medical devices under the same Act
- Pesticides regulated under FIFRA
- Tobacco and tobacco products
- Certain nuclear materials
- Firearms and ammunition subject to specified taxes
The key is intended use. The same substance may be subject to TSCA when imported as an industrial chemical and not subject when imported as an API for drug manufacture. Importers must be able to justify the position they certify.
The TSCA Inventory
For substances subject to TSCA, the central question is whether the substance is on the TSCA Chemical Substance Inventory. Substances on the Inventory are existing chemicals. A substance not on the Inventory is a new chemical, and generally cannot be manufactured, including imported, for commercial purposes without a premanufacture notice (PMN) to EPA or a valid exemption.
Following the 2016 Lautenberg amendments, the Inventory distinguishes active and inactive substances. An inactive substance must be notified to EPA before it is manufactured or imported again for non-exempt commercial purposes, which moves it back to active status. Importers should check both listing and active status, and whether the listing carries any flags indicating restrictions such as significant new use rules (SNURs) or consent orders.
Exemptions from Inventory listing
Research and development exemption
Chemicals imported in small quantities solely for research and development may be exempt from the requirement to be on the Inventory, provided conditions are met. These include use by, or under the supervision of, a technically qualified individual, and notification of risks to persons handling the substance. The meaning of small quantities is tied to what is reasonably necessary for the R&D purpose. Many laboratory reagents and custom-synthesised research compounds rely on this exemption. Note that R&D-exempt substances still require a positive certification, because they remain subject to TSCA.
Other exemptions
Other routes include the low volume exemption, the low release and exposure exemption, and the test marketing exemption, each of which requires an application or notice to EPA. Certain polymers may also qualify for exemption.
Articles
Chemicals contained in articles, meaning manufactured items with a specific shape or design whose function depends on that shape, generally do not need import certification unless EPA specifically requires it by rule. Importers of articles may still be subject to other TSCA rules, such as restrictions on certain persistent chemicals in articles.
What importers typically ask suppliers for
- The CAS number and exact chemical identity of each substance in the product
- Composition of mixtures, including impurities and additives above relevant thresholds
- Confirmation of intended use where a use-based exclusion is relied on
- A supplier statement on TSCA Inventory status, recognising that the importer remains responsible for the certification
- For R&D shipments, labelling and documentation that support the R&D exemption
Record-keeping and enforcement
Importers should keep records supporting each certification, including the basis for concluding that substances are listed, exempt or excluded. EPA can audit these records, and CBP may detain shipments where certification is missing or doubtful. Incorrect certifications can lead to penalties. EPA has also introduced reporting obligations that can apply to importers, such as data reporting rules for certain per- and polyfluoroalkyl substances, which are separate from import certification.
How we help US buyers
When you request a quotation for delivery to the United States, tell us the intended use and whether you expect to certify positively or negatively. We provide CAS numbers, composition information and SDSs, and can supply a TSCA statement where we have the information to support it. The certification itself remains the importer's legal responsibility.
FAQs
Who makes the TSCA import certification?
The US importer of record, or its authorised customs broker. Foreign suppliers can provide supporting information, but the legal responsibility rests with the importer.
Do APIs need a TSCA certification?
APIs imported for drug use are excluded from TSCA and generally take a negative certification. The same substance imported for an industrial use would be subject to TSCA.
Is a research chemical not on the TSCA Inventory allowed?
It may be imported under the R&D exemption if used in small quantities for research under a technically qualified individual, with a positive certification.