Biotalys has announced that the United States Environmental Protection Agency (EPA) has issued its proposed registration decision to approve the company’s first biofungicide, EVOCA.

This marks a significant step forward in the regulatory process for Biotalys. The EPA will now initiate the final phase of its review, opening a 15-day public participation period during which growers and industry stakeholders can provide feedback before the agency finalizes its decision.

The EPA has also published a final rule exempting EVOCA’s active ingredient residues on treated crops from tolerance requirements. This means no maximum residue limits will apply, underscoring EVOCA’s outstanding safety profile.

EVOCA is an innovative precision biocontrol solution designed to target key fungal pathogens such as botrytis (grey mold) and powdery mildew in high-value fruits and vegetables. The biofungicide effectively manages these diseases without harming beneficial organisms or the environment. Recognized by the Fungicide Resistance Action Committee (FRAC), EVOCA introduces a new mode of action to help growers combat resistance issues associated with conventional fungicides.

“The EPA’s proposed approval of EVOCA marks a pivotal moment for Biotalys and represents the advancement of the first protein-based biofungicide of its kind toward approval in the United States,” said Kevin Helash, CEO of Biotalys. “This achievement underscores Biotalys’ pioneering role in agricultural innovation and provides a significant first-mover advantage in helping growers protect their crops safely and sustainably.”

Helash added, “Our protein-based platform has the potential to transform crop protection by delivering next-generation biological solutions with new modes of action. These solutions are designed to be targeted, consistent, and scalable, addressing the evolving needs of farmers worldwide—as reflected in today’s recognition by the EPA.”

He concluded, “This milestone is a testament to the dedication and expertise of the entire Biotalys team. EVOCA is just the beginning, and we look forward to bringing our broader pipeline of fungicides and insecticides to market in the coming years.”

An approval of EVOCA will also pave the way for the regulatory submission of EVOCA NG, the next-generation version of the product candidate and Biotalys’ anticipated first commercial launch. The company expects the review process for EVOCA NG to be significantly shorter, as it contains the same active ingredient as EVOCA but features enhanced formulation and production methods.