Key Takeaways
- The Dutch regulatory authority (CTGB) has issued a Draft Assessment Report recommending approval of Biotalys’ EVOCA’s active ingredient in the European Union.
- The next phase of the European process includes evaluations by the European Food Safety Authority (EFSA) and EU member states.
- The U.S. Environmental Protection Agency (EPA) continues its review of EVOCA’s dossier, with updates expected in March 2025.
- The California Department of Pesticide Regulation (CDPR) has completed its review, pending federal EPA approval.
What progress has been made in Europe?
Biotalys (Profile) announced that the Dutch regulatory authority, CTGB, has provided an initial Draft Assessment Report recommending approval of the active ingredient in EVOCA™, the company’s first biofungicide. This development marks the conclusion of the first phase of the European regulatory review. The report has been forwarded to the Dutch Institute for Health and Environment (RIVM) for further input on classification, labeling, and packaging requirements.
The next phase of the process will involve in-depth evaluations by the European Food Safety Authority (EFSA) and EU member states. This phase, expected to take 12 to 18 months, will include public consultation and culminate in a vote by EU member states on approval of the active ingredient.
Biotalys CEO Kevin Helash expressed optimism about the milestone: “This is a significant milestone in the regulatory journey for our first biocontrol, and we see this as a major win for our team. Earning the support of the regulator in one of the largest exporting countries of fruits and vegetables worldwide is a sign of confidence in our technology.”
The CTGB’s recommendation follows its decision to approve large-scale demonstration trials of EVOCA in greenhouses, allowing harvested fruits and vegetables to be sold for human consumption.
What is the status of EVOCA in the U.S.?
In the U.S., the Environmental Protection Agency (EPA) is reviewing EVOCA’s regulatory dossier. Biotalys is working closely with the EPA to advance the process and plans to share an update in March 2025 during its year-end results announcement.
Separately, the California Department of Pesticide Regulation (CDPR) has completed its in-depth review of EVOCA, opening the door for state-level approval once the EPA grants federal approval.
What is EVOCA™?
EVOCA™ is a biofungicide developed by Biotalys using its AGROBODY™ technology platform. It is designed to offer sustainable crop protection by reducing reliance on chemical fungicides. The product has undergone extensive development and testing, with the goal of providing growers with an innovative tool to safeguard crops while addressing environmental considerations.
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