Biotalys Advances Toward Regulatory Milestones for EVOCA™ in the United States and Europe

Biotalys, a next-generation Agricultural Technology (AgTech) company based in Belgium, has announced key progress in the regulatory approval process for its groundbreaking protein-based biocontrol product, EVOCA™. This marks a major step forward in the company’s mission to revolutionize crop protection through sustainable, science-driven innovations that meet the demands of modern agriculture.

In the United States, the company received a formal update from the Environmental Protection Agency (EPA), confirming that Biotalys has successfully responded to all outstanding information requests related to the EVOCA regulatory dossier. According to the latest communication, the EPA now anticipates completing its comprehensive scientific review of the product over the coming months, with a final regulatory decision expected by September 30, 2025. This milestone highlights the robust nature of the data submitted and reflects Biotalys’ proactive approach in addressing the agency’s queries, particularly around safety, environmental impact, and efficacy.

Meanwhile, in Europe, EVOCA™ is also making substantial headway. The Dutch Board for Authorisation of Plant Protection Products and Biocides (CTGB) and the National Institute for Public Health and the Environment (RIVM)—both integral parts of the European regulatory framework—have issued positive evaluations of EVOCA’s regulatory dossier. These evaluations affirm the scientific integrity of the product and its alignment with European standards for efficacy and safety. With these approvals in place, EVOCA™ will now move into the peer review phase at the European Union level, paving the way for eventual EU-wide authorization.

This dual advancement in both major markets underscores the strength of Biotalys’ R&D capabilities and its unwavering commitment to sustainable agriculture. Unlike conventional chemical pesticides, EVOCA™ leverages Biotalys’ proprietary AGROBODY™ technology platform, offering a novel mode of action that harnesses the power of proteins to protect crops effectively while minimizing residues, resistance risks, and environmental impact. This innovation is part of a broader shift within the agri-inputs industry toward safer, nature-inspired solutions that meet both farmer needs and evolving regulatory expectations.

“The progress we are seeing with regulatory authorities in both the U.S. and Europe reflects the quality of our science and the urgent need for sustainable alternatives in crop protection,” said a Biotalys spokesperson. “These milestones bring us closer to offering farmers a solution that delivers strong performance while supporting the global transition to safe and resilient food systems.”

As the company advances toward commercialization, Biotalys continues to engage with growers, industry partners, and regulators to ensure EVOCA™ is ready to support agricultural productivity across diverse geographies and crops. With regulatory reviews tracking positively and pilot-scale testing demonstrating promising results, EVOCA™ is poised to become a flagship biocontrol product with global relevance.

*EVOCA™ is a trademark of Biotalys NV.

Source – Biotalys