EPA Approves EVOCA, a New Class of Biofungicide

Biotalys has received a significant regulatory milestone with the U.S. Environmental Protection Agency’s approval of EVOCA—a first-in-class protein-based biofungicide designed to combat botrytis and powdery mildew in high-value fruit and vegetable crops. The decision marks the first time the EPA has cleared a fungicide using a novel protein mode of action, now officially listed under FRAC code F10. Only eight new codes have been added by the Fungicide Resistance Action Committee in the past ten years, underlining the significance of this development.

This regulatory nod not only validates Biotalys’ AGROBODY platform but also sets a new bar for biological crop protection products. EVOCA stands out for its unique ability to offer consistent performance while enabling more robust resistance management strategies. With mounting pressure from fungicide resistance, and rising scrutiny around chemical residues, the product arrives at a crucial time for global agriculture.

The EPA’s decision also includes an exemption from tolerance requirements, confirming that no maximum residue limits will be enforced on treated crops. That’s a clear advantage for growers operating in fresh produce markets and export-oriented supply chains where residue standards are tightening.

Market Expansion and Next Steps for the EVOCA Platform

With federal approval secured, Biotalys is now focused on completing regulatory pathways in key markets. California—one of the most important agricultural states—has already initiated its independent review process. Florida is expected to follow as a priority. Meanwhile, peer review in the EU is underway, led by the Netherlands, which has recommended approval pending further data.

At the same time, Biotalys is preparing regulatory submissions for EVOCA NG, a next-generation version of the product that maintains the same active ingredient but features updates to formulation and production. U.S. clearance for EVOCA NG is anticipated between 2028 and 2029, with EU and Brazilian approvals projected by 2030. Combined, these markets represent a commercial opportunity valued at over $1.2 billion.

What sets EVOCA apart is its compatibility with standard agricultural practices. It can be applied pre- or post-harvest, in both greenhouse and open-field settings, and doesn’t require major operational changes for growers. Field trials have shown strong results across different environments and crops, further supporting the product’s case as a scalable, commercial-grade tool—not just a niche biological alternative.

By offering an option that performs on par with synthetic fungicides but without residue concerns, EVOCA is positioned to play a central role in integrated disease management strategies. Biotalys’ long-term vision is to leverage the AGROBODY platform to unlock more protein-based solutions that can diversify the crop protection toolbox at a time when regulatory and market pressures are reshaping the industry.