Key Takeaways
- Biotalys (Euronext: BTLS) announced that the U.S. Environmental Protection Agency (EPA) has issued a proposed registration decision recommending approval of its first biofungicide, EVOCA.
- The EPA also confirmed a tolerance exemption for EVOCA’s active ingredient, meaning no maximum residue limits will apply on treated crops.
- EVOCA targets botrytis (grey mold) and powdery mildew in fruits and vegetables, offering a new mode of action recognized by the Fungicide Resistance Action Committee (FRAC).
- The product represents the first protein-based biofungicide of its kind to reach this stage in the U.S. regulatory process.
Biotalys Moves Closer to U.S. Approval for EVOCA
Biotalys announced that the EPA has proposed to approve EVOCA, its pioneering biofungicide, marking a major step toward market authorization in the United States. The proposed registration decision opens a 15-day public comment period, during which growers, industry associations, and other stakeholders can provide feedback before the agency finalizes its decision.
Alongside the proposed registration, the EPA has issued a final rule exempting EVOCA’s active ingredient residues from tolerance requirements, signifying that treated crops will not require maximum residue limits. The ruling highlights EVOCA’s favorable safety profile and potential as a sustainable crop protection tool.
A New Mode of Action in Biofungicides
EVOCA is designed to control botrytis and powdery mildew, two common fungal pathogens affecting high-value crops such as grapes, berries, and vegetables. The biocontrol product operates through a novel protein-based mechanism, providing an alternative mode of action that helps growers manage resistance to existing chemical fungicides.
The Fungicide Resistance Action Committee (FRAC) has recognized EVOCA’s mode of action as distinct, underscoring its role in integrated pest management programs. Unlike traditional fungicides, EVOCA aims to protect crops without disrupting beneficial organisms or causing environmental harm.
Biotalys Highlights Regulatory Milestone
“The EPA’s recommendation to approve EVOCA marks a pivotal moment for Biotalys and for the advancement of the first protein-based biofungicide of its kind in the U.S.,” said Kevin Helash, CEO of Biotalys. “It underscores our team’s innovation in developing biological solutions that are both effective and safe for growers and the environment.”
Helash added that the company’s protein-based technology platform supports the creation of targeted, consistent, and scalable biocontrol products for modern agriculture. “EVOCA is just the beginning,” he said. “We look forward to expanding our portfolio of fungicides and insecticides in the years ahead.”
Next Steps For Biotalys: EVOCA NG and Future Commercial Launch
Following the anticipated EPA approval, Biotalys plans to move forward with EVOCA NG, the next-generation formulation of its biofungicide. The company expects the regulatory process for EVOCA NG to be shorter, as it uses the same active ingredient but with enhanced production and formulation improvements.
4 Comments