Belgian agri-tech firm Biotalys has won a major regulatory victory with the US Environmental Protection Agency (EPA) granting approval for its first biofungicide, Evoca.

Developed using Biotalys’ proprietary Agrobody technology, Evoca is the first protein-based biofungicide of its kind to receive EPA approval.

Evoca is a precision biocontrol solution with a new mode of action that targets fungal pathogens such as botrytis (grey mold) and powdery mildew in high-value fruits and vegetables—while minimizing risk to beneficial organisms and the environment.

“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. 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.”

With federal approval secured, Biotalys can now advance state registrations in California and Florida—two of the U.S.’s most important fruit and vegetable growing regions. In Europe, Evoca has entered the peer review phase, with the Netherlands proposing approval pending additional data requirements.

The company also plans to advance regulatory submissions for Evoca NG, its next-generation biofungicide currently in the final stages of development.

Evoca NG contains the same active ingredient as Evoca but features enhanced formulation and production methods, promising a shorter review process. Biotalys expects U.S. registration for Evoca NG in 2028–29, followed by approval in the EU and Brazil in 2029–30, targeting commercial launches in markets valued at roughly US$ 1.2 billion combined.

Evoca offers growers a solution that combines the efficacy and scale of conventional chemistries with the environmental benefits of biological products.

Key advantages include use in both pre- and post-harvest applications across a broad range of crops, in greenhouse and outdoor settings, compatibility with various application methods and seamless integration into existing farm management practices.

The EPA also recently issued a final rule exempting EVOCA’s active ingredient residues on treated crops from tolerance requirements, reflecting its exemplary safety profile.