Key Takeaways
- Biotalys has received state registration for its EVOCA™ biofungicide in Florida, marking the first approval of an AGROBODY™ biocontrol product by any U.S. state.
- Florida accepted the broad label previously approved by the U.S. Environmental Protection Agency (EPA), confirming EVOCA’s regulatory profile for controlling Botrytis and powdery mildew in fruits and vegetables.
- In California, the Department of Pesticide Regulation’s Human Health Assessment Branch has accepted the EPA-approved label, with full approval projected for the second half of 2026.
- European regulatory review is also advancing, with a two-month public consultation phase expected to begin this week, involving the European Food Safety Authority (EFSA) and the Dutch Board for the Authorisation of Plant Protection Products (CTGB).
- EVOCA’s approval paves the way for EVOCA NG, Biotalys’ planned commercial biofungicide, targeting a combined U.S. and European market of approximately USD 1.1 billion, with a U.S. launch planned for 2029 and a European launch for 2030.
Biotalys Reaches First State Milestone with EVOCA Florida Registration
Biotalys (Euronext: BTLS), an agricultural technology company headquartered in Ghent, Belgium, announced on April 27, 2026, that its protein-based biofungicide EVOCA™ has received state registration in Florida. The Florida Department of Agriculture accepted the product using the broad label already approved by the U.S. Environmental Protection Agency, making this the first state-level approval for any Biotalys AGROBODY™ biocontrol product in the United States.
EVOCA is designed to control two major fungal diseases — Botrytis (grey mold) and powdery mildew — in fruit and vegetable crops. Florida is the second largest U.S. state for the production of strawberries, tomatoes, and bell peppers, all crops that face pressure from these pathogens.
“We are proud to see EVOCA obtain state registration in Florida, as it sets the stage for the future of our protein-based biocontrol solutions. Florida is the second largest U.S. state for the production of key fruits and vegetables such as strawberries, tomatoes and bell peppers that face significant challenges from diseases like Botrytis and powdery mildew. The first state-level approval for our novel biocontrol underscores our commitment to providing innovative tools to growers locally and validates our technology for continued product developments. We look forward to advancing sustainable crop protection and supporting growers with science-driven solutions that meet market demands both in terms of efficacy and sustainability,” said Carlo Boutton, interim CEO at Biotalys.
Biotalys Advances EVOCA Regulatory Review in California and Europe
California Progress
In California — the largest agricultural state in the United States — the Department of Pesticide Regulation (DPR) continues its review of EVOCA. The agency’s Human Health Assessment Branch has accepted the EPA-approved label, and the company projects full state approval in the second half of 2026. California represents a significant commercial opportunity given its scale of fruit and vegetable production.
European Union Review
Regulatory review of EVOCA in the European Union is also progressing. Biotalys stated that a two-month public consultation phase is expected to be initiated this week. Following that period, the European Food Safety Authority (EFSA) and the Dutch Board for the Authorisation of Plant Protection Products (CTGB) will review submitted comments before the dossier advances to the decision phase. No approval timeline for the EU was specified in the announcement.
EVOCA and the Path to EVOCA NG Commercialization
EVOCA is a protein-based AGROBODY biocontrol product. Biotalys states that approval of EVOCA allows the company to submit EVOCA NG — the next generation formulation containing the same active ingredient — for regulatory review. EVOCA NG is described as Biotalys’ first planned commercial biofungicide, with a U.S. launch targeted for 2029 and a European launch for 2030. The company estimates the combined addressable market for EVOCA NG at approximately USD 1.1 billion.
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