THE Challenge
Importing to a new product to address a Technical Service Bulletin.
A prestigious automaker, known for high-performance and quality, had to distribute a windshield repair kit with a stronger adhesive to its US dealerships. While approved in Europe, the adhesive was not approved to import and distribute in the US. The adhesive contained an ingredient not tested and approved by the EPA; therefore, it was not listed in the US Toxic Substances Control Act’s (TSCA) Chemical Substance Inventory. To avoid a potential buy-back of high-value vehicles, they reached out to Kem Krest’s regulatory and compliance team for help.
OUR APPROACH
Applying deep regulatory and compliance knowledge to accelerate product acceptance.
Our regulatory and compliance team knew exactly what to do. We applied for a Low-Volume Exemption (LVE) and followed its strict requirements. Our team worked closely with the adhesive’s manufacturer, gathering information and providing it directly to the EPA. To follow handling requirements, we trained dealers on how to apply the adhesive. As a result, we obtained authorization to import, label, and distribute the product to US dealerships. We also secured an extra supply to have on-hand for future needs.
THE RESULT
Overcoming import restrictions and preventing buybacks!
The Kem Krest team quickly jumped into action and successfully navigated complex regulatory and compliance challenges. We obtained the LVE in only 8 months, a process that can take up to 26 months. As a result, the automaker avoided buying back thousands of vehicles, saving well over $1.0 billion.