Key Takeaways
- Regulatory Progress: Biotalys moves forward in U.S. and EU regulatory pathways for its first biocontrol product.
- Low-Risk Classification: Dutch evaluations support EVOCA’s safety profile, with no major areas of concern identified.
- Projected Timelines: U.S. decision expected by Q3 2025; EU decision projected in H2 2026.
- Platform Potential: EVOCA is the first product from Biotalys’ AGROBODY™ platform targeting fungal pathogens.
- Pending Registration: EVOCA is not yet authorized for sale or use in any market.
Biotalys Reaches Regulatory Milestones for EVOCA™ in the U.S. and Europe
Biotalys, an agricultural technology company specializing in protein-based biocontrols, has announced updates on the regulatory review status of its lead product, EVOCA™, in both the United States and the European Union.
In the U.S., the Environmental Protection Agency (EPA) has confirmed that Biotalys has submitted all requested information related to EVOCA’s regulatory dossier. The EPA currently anticipates completing its scientific review and issuing a regulatory decision by the end of September 2025.
EVOCA™ Dossier Receives Positive Evaluation in the Netherlands
In the European Union, EVOCA’s regulatory dossier has received favorable assessments from both the Dutch Board for Authorisation of Plant Protection Products (CTGB) and the Dutch Institute for Health and Environment (RIVM). These initial evaluations identified no critical areas of concern and classified EVOCA’s active ingredient as low risk based on the data submitted to date.
This classification supports EVOCA’s potential fit within sustainable crop protection frameworks. The dossier will now proceed to peer review at the European level. Biotalys anticipates a decision in the EU by the second half of 2026, pending completion of that review and submission of additional data as required.
Product and Platform Overview: EVOCA™ and AGROBODY™
EVOCA™ is the first biocontrol product developed using Biotalys’ AGROBODY™ technology platform. It is designed to control fungal pathogens such as Botrytis (grey mold) and powdery mildew, common issues in fruit and vegetable production. The product is intended to support growers using integrated pest management (IPM) strategies aimed at reducing synthetic chemical inputs.
As of now, EVOCA™ is not registered for sale or use in the U.S., EU, or any other jurisdiction.
Biotalys Company Perspective and Next Steps
Kevin Helash, CEO of Biotalys, acknowledged the significance of the progress in both jurisdictions. “We are pleased with the regulatory progress in both the U.S. and EU, and look forward to a favorable outcome,” he stated. Helash noted that regulatory approval would mark a milestone for the company and demonstrate the potential of its AGROBODY™ platform to generate additional biocontrol products in the future.
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