XLYNX Materials Secures US EPA Low Volume Exemption for Advanced Reagents

We are pleased to share important progress regarding the commercial availability of a select category of our advanced molecular reagents in the United States. We’ve recently received a Low Volume Exemption (LVE) approval from the U.S. Environmental Protection Agency (EPA), allowing us to import significant quantities of one of our reagents for use by a valued early-adopter customer.

This is a critical step that allows us to further support our customers for commercial applications of these specific reagents in the US. We’re excited about the possibilities this opens up and look forward to continuing to meet the needs of our partners.

 

Understanding the EPA’s Low Volume Exemption (LVE) Program

To provide context on this milestone, it’s helpful to understand the purpose and parameters of the EPA’s Low Volume Exemption program, established under the Toxic Substances Control Act (TSCA).

The LVE program is designed to facilitate the commercial introduction of certain new chemical substances that are produced or imported in moderate quantities (up to 10,000 kg per year), while still ensuring rigorous environmental and public health protection.

Key Features of an LVE:

  • Volume Threshold: The LVE approval enables us to align exactly with our customers’ supply chain requirements. This volume enables the support of initial commercial adoption and integration into high value applications by our partners.
  • Accelerated Market Entry: By meeting the strict LVE criteria, the regulatory review period is significantly streamlined compared to full Pre-Manufacture Notice (PMN) submissions. This accelerates our ability to move advanced materials from successful R&D qualification directly into our customers’ commercial production channels.
  • Excellent Option for Formulation Additives: In many cases, XLYNX’s reagents are used as crosslinking additives in resin formulations. Loading levels typically range from 1–15 weight percent, meaning that 1000 kg of imported crosslinker reagent will enable the production of 10,000 kg or more of product for our customer. The volume threshold in the LVE program provides a great option for importing materials in these types of use-cases. 

 

The Path Forward

This LVE approval is an important commercial green light that enables our partners to transition smoothly from proof-of-concept to product launch using our advanced reagents in the US market.

We remain committed to supporting our partners through every stage of adoption and look forward to strengthening those relationships as we move together toward full market integration for these specialized materials.

For more information on the commercial availability of our advanced products, please contact your XLYNX technical representative.