Biotalys, an AgTech company focused on protein-based biocontrol solutions, announced a positive regulatory update for its biofungicide, EVOCA. The Dutch regulatory authority, CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden), has recommended the approval of EVOCA's active ingredient across the European Union.
EU Regulatory Progress
The CTGB's initial Draft Assessment Report marks the closure of the first phase of the regulatory review in Europe. "This is a significant milestone in the regulatory journey for our first biocontrol, and we see this as a major win for our team," said Biotalys CEO Kevin Helash. "The CTGB has extensive expertise in the evaluation of biocontrols, and we are very pleased with their recommendation for approval as we believe this validates the potential of our innovative AGROBODY™ technology platform for the development of novel biocontrol solutions for growers."
The next phase involves in-depth reviews by the European Food Safety Authority (EFSA) and EU member states, with Biotalys providing requested data. This process is anticipated to take 12 to 18 months and includes a public consultation, culminating in a vote by European member states on the active ingredient's approval at the EU level.
The CTGB's draft assessment follows its approval of large-scale EVOCA demonstration trials in greenhouses, allowing the sale of harvested fruits and vegetables for consumption.
U.S. Regulatory Status
In the United States, the Environmental Protection Agency (EPA) is currently reviewing EVOCA's regulatory dossier. Biotalys is collaborating with the EPA to facilitate a successful outcome. An update on the EPA review is expected in conjunction with the company's year-end results press release and investor webcast scheduled on 19 March 2025.
About EVOCA
EVOCA is a protein-based biofungicide designed to control fungal diseases such as botrytis (grey mold) and powdery mildew in fruits and vegetables. Trials have demonstrated strong performance across various regions, climates, soil types, production methods, and crops. EVOCA NG is expected to be the first commercial product out of the Biotalys' pipeline.
