TSCA certification: an importer's guide
Documents & Records
Key takeaways
TSCA certification is an importer's declaration, not a general EPA product approval certificate.
Positive certification confirms applicable TSCA compliance. Negative certification addresses goods outside TSCA's scope.
Research quantities are not automatically exempt from import certification.
Inventory status, exemptions and substance-specific restrictions require review before signing.
TSCA certification is a declaration made for a chemical import into the United States under the Toxic Substances Control Act framework. It confirms either that the substances comply with applicable TSCA rules and orders or that the shipment is not subject to TSCA.
The term TSCA certificate can suggest that EPA issues an approval for each product. In the ordinary import process, the importer or an authorized agent makes the certification. The declaration must be supported by the actual substances, intended uses and applicable regulatory status.
First establish TSCA applicability
EPA's chemical import guidance covers chemical substances, mixtures and the circumstances in which certification is required. Research and development shipments are included in the certification framework. A small quantity or a laboratory destination does not automatically remove the requirement.
Some products or uses are outside TSCA's chemical-substance definition, including qualifying drugs, devices, foods and pesticides regulated through other frameworks. Chemicals in articles generally do not require import certification unless a specific TSCA rule requires it. Determine the actual product category and use before choosing a statement.
A chemical sold as a research reagent may require a different assessment from the same substance imported for a qualifying drug use. Do not infer scope from the tariff code, the supplier's industry or a generic statement on its catalog.
TSCA positive certification vs negative certification
The two statements express different legal conclusions. A TSCA negative certification is not an alternative for a shipment whose compliance has not been established.
Outcome | What it means | Required supporting decision |
|---|---|---|
TSCA positive certification | The chemical shipment is subject to TSCA and meets the applicable rules and orders | Review identity, Inventory or exemption status, and relevant restrictions |
TSCA negative certification | The chemicals in the shipment are not subject to TSCA | Establish the excluded product or use and check whether it is already clearly identified |
No certification required under the relevant provision | A defined certification exclusion applies | Document the actual exclusion, including any rule-specific exception |
EPA notes that a negative statement is required for certain excluded categories when they are not otherwise clearly identified. Relevant agency entry documentation may already establish that identity. Avoid treating every excluded product as requiring the same additional form.
Who signs and files the certification?
The importer or its authorized agent signs and files the statement electronically or in writing with CBP. EPA's guidance identifies the certifier's name, e-mail address and telephone number as required contact information. Electronic certification is filed through the Automated Commercial Environment, while paper statements must be included in the entry documentation before release.
The CBP regulation at 19 CFR 12.121 provides the certification requirements and prescribed statements. A supplier's declaration can support the importer's review, but it does not remove the need for a valid certification for the entry.
Mercury's customs brokerage services can support entry coordination. The importer should still retain the technical basis for the decision, especially when substance identity or an exemption is complex.
A TSCA certification example and supporting record
A useful certification record connects the entry to the decision being made. As an illustrative example, an importer receiving a laboratory solvent would record the shipment reference, chemical identity, applicable Inventory or exemption assessment, restriction review, selected positive statement and authorized certifier.
The positive statement confirms compliance with applicable TSCA rules and orders and that the importer is not offering a substance in violation of TSCA. Use the complete prescribed wording from the regulation or EPA guidance in the actual filing. This explanatory summary is not substitute certification text.
EPA gives the negative statement as: “I certify that all chemicals in this shipment are not subject to TSCA.” Select that wording only after establishing that the actual shipment falls outside TSCA's scope. Do not select it merely because a substance is nonhazardous or intended for research.
Keep product identity, shipment reference and certifier details with either statement. A statement copied from an earlier import may be wrong if the composition, use or legal status has changed.
TSCA compliance checklist before import
Before signing a Toxic Substances Control Act certification, work through the substance-specific review:
Identify every relevant chemical substance, including mixture constituents and available identifiers.
Determine whether each substance and intended use is within TSCA's scope.
Review Inventory status or the actual basis for an applicable exemption.
Check significant new use rules, relevant orders, restrictions and other applicable requirements.
Select the appropriate certification treatment and verify the prescribed wording.
Provide the broker with consistent entry information and retain the supporting record.
Inventory listing alone does not establish compliance with every requirement. Conversely, an exemption from a particular notification provision does not automatically eliminate import certification or all other TSCA obligations. Research exemptions have conditions and should be evaluated on their own terms.
How to get TSCA certification ready for clearance
The practical task is to complete and support the declaration, rather than apply for a generic EPA certificate. Resolve uncertain identity or regulatory status with the supplier and qualified chemical-compliance personnel before shipping. If necessary, delay dispatch until the basis for certification is established.
Keep this process separate from the agency authorizations described in Mercury's US import permit guide. Prepare the supporting product description through the commercial invoice workflow. A consistent product record lets the broker file the correct statement without treating customs release as proof of broader chemical compliance.
