Biotalys has received regulatory approval from the U.S. Environmental Protection Agency (EPA) for its first biofungicide, EVOCA
. Developed using Biotalys’ AGROBODY technology platform, EVOCA is the first protein-based biofungicide of its kind to gain EPA approval.
With this approval, Biotalys can now proceed with registration dossiers for key U.S. regions, including California and Florida, two of the country’s most important fruit and vegetable growing areas. In Europe, EVOCA is currently under peer review, and the Netherlands has proposed approval, pending the submission of additional data.
The company is also advancing its next-generation product, EVOCA NG. This version, still in final development stages, shares the same active ingredient as EVOCA but features an improved formulation and production process. The regulatory review for EVOCA NG is expected to be shorter, with plans to obtain registration in the U.S. by 2028-29 and in Europe and Brazil by 2029-30. Biotalys aims to launch EVOCA NG in these markets, which together represent around USD 1.2 billion in potential annual sales.
“This approval is a major milestone for EVOCA and brings us closer to offering farmers a sustainable crop protection tool,” said Kevin Helash, CEO of Biotalys. “The product’s new mode of action highlights the strength of our technology platform and its potential to discover many new modes of action in the future. The EPA’s decision validates our efforts and our team’s dedication.”
EVOCA is designed to combine the efficacy and scalability of conventional fungicides with the environmental benefits of biological solutions. It provides growers with flexible options for pre- and post-harvest applications across a wide range of crops, both indoors and outdoors.
By the end of October 2025, the EPA also issued a final rule exempting EVOCA’s active ingredient residues from maximum residue limits, thanks to its outstanding safety profile.
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