US EPA projects taking a regulatory decision by end of September 2025; Dutch authorities finalise first phase of regulatory dossier for EVOCA in Europe
Ghent, BELGIUM, June 11, 2025 (GLOBE NEWSWIRE) -- Press release
Biotalys), an Agricultural Technology (AgTech) company developing protein-based biocontrols for sustainable crop protection, is pleased to announce progress in the regulatory approval procedures in both the United States and Europe of its first protein-based biocontrol product, EVOCA*.
In the US, Biotalys received a communication from the Environmental Protection Agency (EPA) that the company has provided responses to all the agency's requests for additional information. The EPA currently projects it will complete the scientific review of the EVOCA dossier later this summer and make a regulatory decision by September 30th, 2025.
In Europe, Biotalys is pleased to confirm that both the Dutch Board for Authorisation of Plant Protection Products (CTGB) and the Dutch Institute for Health and Environment (RIVM) have now provided positive evaluations of EVOCA's regulatory dossier, paving the way for the peer review phase at the European level.
In their review, both Dutch authorities have classified EVOCA's active ingredient as low risk based on the current data. This classification is important as it recognizes the active ingredient's safety profile and aligns with Biotalys' commitment to delivering sustainable, effective solutions for crop protection. No critical areas of concern were identified and therefore the Netherlands, as rapporteur Member State, proposes that the active ingredient of EVOCA can be approved in Europe, subject to the provision of certain additional data during the peer review phase. Biotalys' current assessment is that a regulatory decision in the European Union can be expected in the second half of 2026.
Kevin Helash, Chief Executive Officer of Biotalys,said: "We are pleased with the regulatory progress in both the US and EU, and look forward to a favorable outcome. An approval decision would be a major milestone for our company and a validation for our unique AGROBODY technology platform. This platform has the potential to develop many more protein-based biocontrol solutions for growers to fight key pests and diseases in agriculture. I am very grateful for the thorough review and guidance by the regulatory agencies, and for the hard work by our team to generate and provide the required scientific data on our innovative product."
The first biocontrol developed on Biotalys' AGROBODY technology platform, EVOCA helps safely control fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers looking to add effective, biodegradable solutions to their integrated pest management (IPM) initiatives to reduce chemical applications.
* EVOCA: Pending Registration. This product is not currently registered for sale or use in the European Union, the United States or elsewhere and is not being offered for sale.
About Biotalys
Biotalys is an Agricultural Technology.
For further information, please contact:
Toon Musschoot, Head of IR & Communication
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Important Notice
Biotalys, its business, prospects and financial position remain exposed and subject to risks and uncertainties. A description of and reference to these risks and uncertainties can be found in the annual reporton the consolidated annual accounts published on the company's website.
This announcement contains statements which are "forward-looking statements" or could be considered as such. These forward-looking statements can be identified by the use of forward-looking terminology, including the words 'aim', 'believe', 'estimate', 'anticipate', 'expect', 'intend', 'may', 'will', 'plan', 'continue', 'ongoing', 'possible', 'predict', 'plans', 'target', 'seek', 'would' or 'should', and contain statements made by the company regarding the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are warned that none of these forward-looking statements offers any guarantee of future performance. Biotalys' actual results may differ materially from those predicted by the forward-looking statements. Biotalys makes no undertaking whatsoever to publish updates or adjustments to these forward-looking statements, unless required to do so by law.
Attachments
- Biotalys press release_Regulatory Progress in US and EU_11 June 2025 (https://ml.globenewswire.com/Resource/Download/b41b7531-f360-4795-b5e3-579b24d8dfbe)
- Biotalys persbericht_regelgevende vooruitgang in de VS en EU_11 juni 2025 (https://ml.globenewswire.com/Resource/Download/9769fc13-800c-400b-9adf-05b3510a1f44)
