By Janet Kanters

Biotalys, an agricultural technology company, has confirmed the U.S. Environmental Protection Agency (EPA) regulatory approval for its first biofungicide, EVOCA.

This marks the first time a protein-based biofungicide of its kind has been approved by the EPA, positioning EVOCA as a groundbreaking solution in the fight against fungal diseases in high-value fruits and vegetables.

EVOCA offers a novel approach to crop protection, targeting fungal pathogens such as Botrytis (grey mold) and powdery mildew. Its precision biocontrol mechanism minimizes risks to beneficial organisms and the environment, making it a sustainable alternative to traditional chemical fungicides.

With the EPA’s green light, Biotalys is now preparing to secure state-level registrations in key agricultural regions, including California and Florida. These states are critical hubs for fruit and vegetable production in the U.S. Meanwhile, in Europe, EVOCA is progressing through the peer review phase, with the Netherlands recommending approval, pending additional data requested during the review process.

The EPA’s decision also clears the path for Biotalys to advance its next-generation product, EVOCA NG, which is currently in the final stages of development. EVOCA NG features the same active ingredient as EVOCA but benefits from enhanced formulation and production methods. Biotalys anticipates a shorter regulatory review process for EVOCA NG, with U.S. registration expected by 2028-29, followed by launches in the EU and Brazil by 2029-30.

“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,” said Kevin Helash, CEO of Biotalys. “The product has an entirely new mode of action to target fungal diseases, highlighting the uniqueness of Biotalys’ technology platform as a pathway to discovering many new modes of action in the coming years.”

In a further boost to EVOCA’s market potential, the EPA recently issued a final rule exempting the product’s active ingredient residues from tolerance requirements on treated crops. This exemption reflects EVOCA’s strong safety profile, eliminating the need for maximum residue limits.

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