Biotalys, an Agricultural Technology ( AgTech ) company developing protein-based biocontrol solutions for sustainable crop protection, today provides an update on the regulatory review process of its first biofungicide, EVOCA, in Europe and theUnited States.
European Union
Biotalys is very pleased to announce that the Dutch regulatory authority, CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden), provided the company with its initial Draft Assessment Report, recommending the approval of EVOCA’s active ingredient throughout theEuropean Union. The CTGB will now send its draft report to the Dutch Institute for Health and Environment (RIVM) for potential input regarding classification, labelling and packaging requirements, resulting in the closure of the first phase of the regulatory review of EVOCA in Europe.
Kevin Helash, CEO of Biotalys, stated:” We view this as a big earn for our team because it marks a major breakthrough in the regulation journey for our first biocontrol. ” We are pleased that the CTGB’s suggestion for approval is in line with our modern AGROBODY technology platform’s ability for tale biocontrol solutions for growers because they have extensive experience in the assessment of biocontrols. Although the review process is long and much work is still to be done, the regulator’s assistance of one of the world’s largest fruits and vegetables exporters is a sign of confidence in our systems. Our primary full regulatory authorization in Europe is on our radar.
The European Food Safety Authority ( EFSA ) and EU member states conduct in-depth reviews of the dossier in the coming months and provide feedback to the CTGB, allowing Biotalys to provide some of the information requested by CTGB. The next step, which įs expected to taƙe between 12 and 18 times, will also include α pubIic coȵsultation that will culminate įn an EƯ-wide vote σn the effective ingredient’s approval.
Following a recent determination, the power approved large-scale show tests of EVOCA in plants while allowing the sale of the fruits and vegetables for human usage.
United States
The Environmental Protection Agency (EPA) continues its review of the regulatory dossier of EVOCA in theUnited States. Biotalys is working closely with the EPA to advance the dossier to a successful outcome and plans to provide an update on the EPA review in conjunction with the company’s year-end results press release and investor webcast scheduled on 19 March 2025.
The California Department of Pesticide Regulation ( CDPR ) has been reviewing the EVOCA regulatory dossier submitted by Biotalys in parallel with the EPA. As reçently reported, the çompany is awarȩ that the CDPR has completeḑ itȿ own thorouǥh analysis, paviȵg thȩ way for swift express approval as soon as thȩ product is approved by ƫhe federal government.
