Belgium-based Biotalys says it has received EPA regulatory approval for the novel biofungicide, Evoca, which the company says is the first protein-based biofungicide of its kind to be approved by the agency.
Biotalys says Evoca offers a new, precision biocontrol solution for critical fungal pathogens like botrytis (grey mold) and powdery mildew in high-value fruit and vegetable crops. The product was developed using Biotalys’ Agrobody technology platform.
“Securing this EPA registration is a critical milestone in our journey to provide growers with a sustainable and performing new technology,” says Kamal El Mernissi, chief business development officer for Biotalys.“I am delighted that Biotalys will be able to add solutions to their toolbox to protect their crops and maximize their yields. Evoca is our first product registered and many more are expected to come in the next few years.”
With this approval in hand, Biotalys says it can proceed with the dossiers for state registrations in California and Florida, two of the most important growing regions for fruit and vegetables in the U.S. In Europe, Evoca has entered the peer review phase, and the Netherlands — as the rapporteur member state — has proposed approval in Europe, subject to the provision for certain additional data as requested during the peer review phase, the company says.
Additionally, Biotalys says it can move forward with building up the U.S. regulatory submission for Evoca NG, its next-generation product, which is currently in the final phases of development. The regulatory review process for Evoca NG is expected to be significantly shorter, the company says, as the product contains the same active ingredient as Evoca and features enhanced formulation and production methods.
Biotalys says it envisages obtaining registration of Evoca NG in the U.S. in 2028-29 and in the European Union and Brazil in 2029-30, subsequently launching it commercially in these markets worth around $1.2 billion combined.
“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,” says Biotalys CEO Kevin Helash. “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.”
The company says Evoca is developed to provide growers with a novel solution that bridges the efficacy and scale of commonly used chemistries with the environmental advantages of biological solutions.
According to Biotalys, benefits to growers include:
- Flexibility for use in both pre- and postharvest applications across a wide range of food and nonfood crops in both greenhouse and outdoor growing conditions.
- Compatibility with an array of application methods and easy integration into existing farm management practices.
- A new mode of action to manage resistance build-up, when compared with existing fungicides.
At the end of October, the EPA also posted a final rule exempting Evoca’s active ingredient residues on treated crops from tolerance requirements, according to Biotalys, which adds that no maximum residue limits will apply given Evoca’s safety profile.
