Ghent, Belgium – October 31, 2025 — Biotalys (Euronext: BTLS) announced today that the U.S. Environmental Protection Agency (EPA) has issued a proposed registration decision recommending approval of its first protein-based biofungicide, EVOCA™, marking a major milestone for the company and for sustainable agriculture globally.
With this move, the EPA has opened a 15-day public comment period before finalising the registration, setting the stage for what could become the first ever approval of a protein-based biofungicide in the United States. Alongside the proposed registration, the EPA has published a final rule exempting EVOCA’s active ingredient residues on treated crops from tolerance requirements — meaning no maximum residue limits (MRLs) will apply. This reflects confidence in EVOCA’s safety profile and underlines its potential as an environmentally friendly crop protection solution. GlobeNewswire
A Historic Moment for Biotalys and Crop Protection
Biotalys has long positioned itself as a pioneer in protein-based biocontrols — aiming to deliver effective, biologically derived alternatives to conventional chemical pesticides. EVOCA, developed on Biotalys’ proprietary AGROBODY™ platform, is designed to combat major fungal diseases such as botrytis (grey mold) and powdery mildew affecting high-value fruits and vegetables. biotalys.com
The EPA’s proposal signals that EVOCA meets stringent safety and efficacy standards while offering growers a new mode of action — and crucially, a more sustainable option. According to Kevin Helash, CEO of Biotalys:
“The EPA’s recommendation to approve EVOCA marks a pivotal moment for Biotalys, and the advancement of the first protein-based biofungicide of its kind for approval in the United States.”
He added that this milestone provides Biotalys with a significant first-mover advantage and validates the company’s vision of delivering biological solutions that combine the safety of biologicals with the performance growers expect.
Why This Matters — Benefits of EVOCA and Biotalys’ Vision
Sustainable Crop Protection & Safety
Unlike traditional chemical fungicides, EVOCA’s protein-based mode of action and exemption from residue tolerance requirements minimize environmental impact and offer a cleaner alternative for growers concerned about chemical residues and ecological balance. Clean residue profiles are increasingly important for producers targeting organic markets or export to regions with strict residue regulations.
Resistance Management Through Novel Mechanism
EVOCA brings a new mode of action, which helps combat the growing issue of resistance to conventional fungicides. The biofungicide has been assigned FRAC code F10 by the Fungicide Resistance Action Committee (FRAC), indicating its distinct mechanism — a valuable addition for integrated pest management (IPM) programs seeking to sustainably manage pathogen resistance.
First-Mover Advantage & Competitive Edge
If approved, EVOCA would become the first protein-based biofungicide authorised in the U.S., giving Biotalys a pioneering position in the biofungicide market. This not only strengthens its brand reputation but may also open doors to rapid market adoption, with growers looking for effective, low-residue, environmentally conscious solutions.
Broad Appeal Across Markets
EVOCA is targeted toward high-value fruits and vegetables — segments where fungal diseases such as botrytis and powdery mildew cause significant losses. The biofungicide’s broad-spectrum efficacy, safety, and residue exemption make it attractive for growers aiming to balance yield, quality, and sustainability.
Leverage for Future Portfolio Expansion
With EVOCA, Biotalys has successfully demonstrated the viability of its AGROBODY™ platform in real-world regulatory environments. This approval paves the way for future candidates in its pipeline — including biofungicides and bio-insecticides — potentially transforming how crop protection is approached globally. Biotalys has already signalled that its next generation formulation, EVOCA NG, is in development and could benefit from accelerated registration given the shared active ingredient.
Timeline & Regulatory Context
- Early in 2025, Biotalys received a favourable assessment from the Dutch regulatory authority (CTGB), which recommended approval of EVOCA’s active ingredient across the European Union, marking progress in its EU registration dossier.
- The U.S. EPA’s proposed registration decision and associated final rule (exempting residue tolerance) were issued on October 31, 2025.
- The 15-day public comment period has opened, after which EPA will make the final decision on registration. Subject to no adverse comments or unresolved issues, EVOCA could be formally approved for use in the U.S. in the coming months — a landmark moment for biotech-driven crop protection.
Biotalys: Leading the Biocontrol Revolution
Biotalys is an international AgTech company founded in 2013 and headquartered in Ghent, Belgium. The firm develops protein-based crop protection agents that aim to provide growers with sustainable, effective, and low-residue alternatives to conventional chemical pesticides. Its AGROBODY™ platform forms the backbone of its innovation pipeline, enabling the development of biocontrol solutions for fungal diseases, pests, and post-harvest challenges.
Since its founding, Biotalys has committed to environmental sustainability, crop safety, and regulatory compliance. EVOCA represents the company’s first biofungicide nearing global registration — a key milestone in realizing its mission to transform crop protection globally.
What This Means for Growers, Retailers & Agriculture Stakeholders
- Growers and Farmers: EVOCA offers an effective, low-residue tool to manage fungal threats, reduce reliance on chemical fungicides, and meet stringent safety and export standards.
- Food Retailers and Exporters: Biofungicide-treated produce could appeal to health-, sustainability- and export-oriented markets due to reduced residues and environmental impact.
- Regulators and Policy Makers: The approval demonstrates that biological solutions can meet rigorous safety and efficacy standards — potentially accelerating regulatory acceptance of future biocontrol agents.
- Investors and AgTech Industry: Biotalys’ regulatory success may enhance investor confidence in protein-based biocontrol and boost investment in sustainable agriculture innovation.
- Environment & Public Health Advocates: Reduced chemical inputs and residue levels align with sustainable agriculture goals, improved soil health, and safer food systems.
What to Watch Next
- Final EPA decision — completion of public comment period and issuance of registration.
- Launch of EVOCA and rollout plans, especially in U.S. regions with high-value horticulture.
- Market uptake and acceptance among growers, supply-chain partners, and exporters.
- Progress in EU registration — as EU authorities continue peer review procedures for EVOCA’s active ingredient.
- Development and regulatory submission of EVOCA NG and other pipeline candidates from Biotalys leveraging AGROBODY™ technology.
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