EPA proposes approval for Biotalys Evoca biofungicide

The U.S. Environmental Protection Agency has issued a proposed registration decision to approve Biotalys’ first biofungicide, Evoca, marking a major regulatory milestone for the Belgium-based agricultural technology company.

The proposed approval opens a 15-day public comment period before the EPA finalizes its decision. In addition, the agency has issued a final rule exempting Evoca’s active ingredient residues from crop tolerance requirements, meaning no maximum residue limits will apply.

Evoca is a protein-based biocontrol product that targets botrytis (gray mold) and powdery mildew in high-value fruit and vegetable crops. The biofungicide is designed to provide growers with a new mode of action for managing resistance to existing fungicides, as recognized by the Fungicide Resistance Action Committee.

“The EPA’s recommendation to approve Evoca marks a pivotal moment for Biotalys, and the advancement of the first protein-based biofungicide of its kind for approval in the United States,” said Kevin Helash, CEO of Biotalys.

If granted final approval, Evoca will be the first product from Biotalys’ protein-based platform to reach the market, with the company expecting it to lead to additional biological products in the coming years. The company also plans to submit Evoca NG, a next-generation version of the biofungicide that uses the same active ingredient but includes improved formulation and production processes.

To read the full EPA documents, please visit: regulations.gov/docket/EPA-HQ-OPP-2021-0165 and federalregister.gov/public-inspection/2025-19712/pesticide-tolerance-exemptions-petitions-revocations-etc-asfbiof01-02-polypeptide.