Biotalys provides update on regulatory review for Evoca

European Union
Biotalys has announced 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 the European Union. The CTGB will now send its draft report to the Dutch Institute for Health and Environment (RIVM) for potential input regarding classification, labeling, and packaging requirements, resulting in the closure of the first phase of the regulatory review of Evoca in Europe.

Biotalys CEO Kevin Helash said: "This is a significant milestone in the regulatory journey for our first biocontrol, and we see this as a major win for our team. The CTGB has extensive expertise in the evaluation of biocontrols, and we are very pleased with their recommendation for approval as we believe this validates the potential of our Agrobody technology platform for the development of novel biocontrol solutions for growers. While the review process is lengthy and there's a lot of work still to be done, earning the support of the regulator in one of the largest exporting countries of fruits and vegetables worldwide is a sign of confidence in our technology. We look forward to receiving our first full regulatory approval in Europe."

In the next phase, the European Food Safety Authority (EFSA) and EU member states perform in-depth reviews of the dossier and provide feedback to the CTGB, while allowing Biotalys to deliver certain data requested by CTGB. This next phase is expected to take in total between 12 and 18 months and also includes a public consultation, ending with a vote by the European member states on the approval of the active ingredient at EU level.

United States
The Environmental Protection Agency (EPA) continues its review of the regulatory dossier of Evoca in the United 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.

In parallel with the EPA, the California Department of Pesticide Regulation (CDPR) has been reviewing the regulatory dossier for Evoca submitted by Biotalys. As announced previously, the company understands that the CDPR has finalized its own in-depth review, opening a path to a swift approval at the state level pending EPA approval of the product at the federal level