USA - Regulatory Services

Toxic Substances Control Act (TSCA) Inventory

The Toxic Substances Control Act of 1976 regulates the introduction of new or already existing chemicals on the US market. It prohibits the manufacture or import of chemicals that are not listed on the TSCA Inventory. A chemical listed on the TSCA Inventory is considered an "existing" chemical substance. Any chemical that is not listed on the inventory is considered a “new chemical substance.” The regulation is administered by the US Environmental Protection Agency (EPA). Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides.

Anyone who intends to manufacture or import a new chemical substance for a non-exempt commercial purpose is required to submit a pre-manufacture notice (PMN) at least 90 days prior to the manufacture or import of the chemical.

For existing substances, the EPA uses Significant New Use Rules (SNURs) to require manufacturers and importer to notify the EPA before chemical substances and mixtures are used in new ways that might create concerns. If the EPA determines that a use of a chemical substance is a “significant new use”, manufacturers and importers need to submit a significant new use notice (SNUN) to the EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Chemical substances on the TSCA Inventory that are subject to SNUR are designated as such by an "S" flag in the Inventory listing.

Our Services for TSCA

In cooperation with our partner GBK GmbH Global Regulatory Compliance, we can help you with your TSCA obligations:

  • Developing a regulatory strategy for the US market
  • Data gap analysis and testing strategies
  • Study planning and monitoring
  • Preparation of pre-manufacture notice (PMN) and significant new use notice (SNUN)
  • Communication, submission and follow-up with the EPA

Contact us to learn how we can help you with your regulatory needs in the US.