Biotalys announced progress in regulatory approval processes for EVOCA
, its protein-based biocontrol product, in the US and Europe.
In the United States, the EPA has responded to Biotalys’ information requests. The EPA expects to complete its scientific review by September 30, 2025.
In Europe, Dutch authorities have positively evaluated EVOCA’s regulatory dossier. The Dutch Board for Authorisation of Plant Protection Products (CTGB) and RIVM have classified EVOCA’s active ingredient as low risk.
Both agencies’ assessments recognize the safety profile of EVOCA’s active ingredient. No critical concerns were identified during review. The Netherlands, as rapporteur Member State, proposes approval, pending additional data during peer review.
Biotalys anticipates a European Union decision in the second half of 2026. The approval process is a key milestone for the company’s innovative platform.
Kevin Helash, CEO of Biotalys, expressed satisfaction with the progress. He highlighted the significance of regulatory approval as validation for the AGROBODY platform. He emphasized that EVOCA is the first product developed using this platform. It targets key fungal pests like Botrytis (grey mold) and powdery mildew.
EVOCA offers a biodegradable solution for fruit and vegetable growers. It supports integrated pest management (IPM) strategies, reducing reliance on chemical pesticides. He noted that the platform could develop many more protein-based biocontrols for agriculture. The company aims to provide sustainable, effective crop protection solutions.
EVOCA is currently pending registration and is not yet available for sale in the EU, US, or elsewhere. The product’s approval would represent a significant achievement for Biotalys and its innovative technology.
The company continues to work closely with regulatory agencies to bring EVOCA to market and expand its biocontrol portfolio.
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