What Is a TSCA Certification: Definition and Importance
The answer to what a TSCA certification is starts with the law itself. TSCA (Toxic Substances Control Act) took effect in 1976 and was updated in 2016 by the Lautenberg Chemical Safety Act. Administered by the U.S. Environmental Protection Agency (EPA), the law oversees the safety of all chemical substances manufactured in or imported into the United States. Our article What Is Export? A Roadmap takes this topic one step further.
Purpose:
- Protecting human health
- Reducing chemical risks to the environment
- Ensuring transparency for all chemical products imported into or sold in the U.S.
TSCA is one of the most important regulations for manufacturers shipping chemical products to the U.S.
Products Covered by TSCA
TSCA covers a very broad range of products. Among chemical-based products commonly exported to the U.S., the following stand out:
- Adhesives: PVA, hotmelt, solvent-based or polyurethane adhesives
- Solvents: industrial solvents
- Paints and coatings: packaging and industrial coatings
- Polymers and plastic raw materials
- Filler and coating additives
A TSCA Inventory check is required for each of these products.
The TSCA Compliance Process, Step by Step
1. TSCA Inventory Check
The EPA's official list is checked to see whether your product's substances are included.
- If they are listed → certification can proceed directly.
- If they are not → the “Premanufacture Notice (PMN)” process is started.
2. TSCA Certification
With each import, one of the following certifications is made to U.S. Customs:
- Positive Certification: the product complies with TSCA.
- Negative Certification: the product is outside the scope of TSCA.
3. MSDS/SDS Documents
Detailed safety information on the chemical content (Safety Data Sheet) should be prepared and provided in a TSCA-compliant format.
4. EPA Notifications
If the product contains a new or unlisted chemical, a pre-notification is filed with the EPA through a “Premanufacture Notice.” This process can take 90-180 days.
Risks of TSCA Non-Compliance
If TSCA compliance is not in place when exporting to the U.S.:
- Customs holds: the product may be held at the port or returned.
- Penalties: non-compliance may result in penalties of up to 37,500 USD per day.
- Loss of business reputation: distributors and buyers may decline to work with non-compliant products.
- Amazon and e-commerce risks: platforms such as Amazon may not allow the sale of chemical products without TSCA compliance.
Practical Tips for Exporters
- Prepare early: a TSCA Inventory check should be completed before shipping to the U.S.
- Labels and documents: SDS documents should be complete and up to date.
- Working with a U.S.-based representative can make U.S. customs filings go more smoothly.
- TSCA applies to your chemical products, while for food and cosmetic products an FDA registration service helps you avoid problems at U.S. entry
- Amazon sales: if the product will be listed on Amazon, TSCA compliance should be supported with documents that can be verified in Seller Central.
Frequently Asked Questions (FAQ)
Is there a TSCA certificate?
TSCA does not issue a certificate on its own. The exporter or importer submits a TSCA Certification (positive/negative) to CBP.
What is the TSCA Inventory?
It is the EPA's list of registered chemicals. If the substance is on this list, it can be imported. If not, a new notification to the EPA is required.
Who must comply with TSCA?
All exporters and importers shipping chemical products to the U.S.
How long does the TSCA compliance process take?
It depends on the product; it can be quick for existing chemicals, while new products may take around 3 to 6 months on average.
What happens if TSCA compliance is not met?
The shipment may be held at customs or refused entry, and significant penalties may apply.
How does it differ from FDA
FDA regulates food, cosmetic and drug products; EPA and TSCA cover industrial and chemical products. We cover this topic in more detail in our Selling Cosmetics in Europe article.
