Plant Science

Biotalys Secures EPA Approval for EVOCA Biofungicide

The Dutch regulatory authority issued a Draft Assessment Report recommending approval of Biotalys EVOCA’s active ingredient in the EU.

Key Takeaways

  • The EPA has approved EVOCA™, the first protein-based biofungicide developed using Biotalys’ AGROBODY™ platform.
  • EVOCA targets botrytis and powdery mildew in high-value fruit and vegetable crops with a novel mode of action.
  • Biotalys will now pursue state registration in California and Florida and continue regulatory progress in Europe.
  • The company is preparing U.S. submissions for its next-generation product, EVOCA NG, with anticipated registrations from 2028 onward.
  • Leadership highlighted the approval as a milestone validating Biotalys’ technology and its potential in sustainable agriculture.

Biotalys Gains EPA Approval for First-of-Its-Kind Biofungicide

Biotalys announced that the U.S. Environmental Protection Agency has approved EVOCA™, marking the agency’s first approval of a protein-based biofungicide developed through the company’s AGROBODY™ technology platform. EVOCA introduces a new mode of action recognized by the Fungicide Resistance Action Committee (FRAC) under code F10.

Designed for high-value fruits and vegetables, EVOCA targets botrytis (grey mold) and powdery mildew, enabling growers to manage fungal pressure while minimizing environmental and non-target impacts. The product can be used in both pre- and post-harvest applications and integrates with conventional farm practices.


Biotalys Advances Regulatory Pathway in U.S. and Europe

Following federal approval, Biotalys will proceed with state-level registrations in California and Florida. In Europe, EVOCA is undergoing peer review, with the Netherlands recommending approval subject to additional requested data. Meanwhile, EVOCA NG—Biotalys’ next-generation formulation—remains in late-stage development. The company anticipates U.S. registration for EVOCA NG in 2028–29, followed by EU and Brazil registrations in 2029–30.

Kevin Helash, CEO of Biotalys, stated: “This approval marks a major regulatory milestone for EVOCA and moves us closer to delivering a new, sustainable tool for farmers to protect their crops. The EPA’s decision reinforces the potential of our technology to help shape the future of agriculture and is a testament to the dedication of our entire team.”


EPA Confirms Tolerance Exemption for EVOCA’s Active Ingredient

The EPA has also issued a final rule exempting EVOCA’s active ingredient residues from tolerance requirements. No maximum residue limits will apply, reflecting the product’s safety profile.

Growers adopting EVOCA are expected to benefit from a new resistance-management tool, broad application flexibility, and compatibility with diverse production systems.

EVOCA remains unregistered outside the United States and is not offered for sale in other jurisdictions.

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