Intertek has solutions for all your chemical regulatory needs under the Toxic Substances Control Act (TSCA), and the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) amendment to TSCA.
TSCA, administered by the United States Environmental Protection Agency (USEPA or EPA), regulates the introduction of new chemicals and existing chemicals. All chemicals manufactured or imported and intended for commerce within the U.S. are required to be listed on the Toxic Substances Control Act (TSCA) inventory. It is critically important to understand TSCA nomenclature when reviewing the Inventory. If a company intends to manufacture or import a new chemical substance for a commercial purpose, a Premanufacture Notice (PMN) must be submitted to the Environmental Protection Agency (EPA). PMNs for imported new chemical substances should be submitted by the principal importer as defined at 40 CFR §720.3(z).
Through the LCSA, the general approach to chemical safety has been strengthened by explicitly requiring that the EPA make an affirmative determination on all Premanufacture Notices (PMNs) and significant new use notices (SNUNs) that the relevant chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
This new requirement for affirmation before a company can proceed to the marketplace is seemingly increasing the scrutiny of the assessments and challenging industry with additional data and extended timeframes. The LCSA is also impacting existing markets with a more defined approach to the risk assessment and risk management of chemicals already listed on the TSCA inventory. Finally, companies with a critical interest in CBI will need to pay greater attention as the new Act changes the type of information that can be protected as confidential and defines substantiation requirements for these claims.
To support companies in addressing these challenges, Intertek offers the following services:
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