State authority initiates public commenting phase following positive human health assessment, marking key step toward potential state registration
Ghent, BELGIUM, July 01, 2026 (GLOBE NEWSWIRE) -- Press Release
Biotalys (Euronext Brussels: BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for sustainable crop protection, today announces further progress in the regulatory review process of its first biofungicide, EVOCA, in the United States.
The California Department of Pesticide Regulation (CDPR), Pesticide Registration Branch, has now initiated the public consultation phase of the EVOCA dossier, marking an important step forward in the evaluation process. This milestone follows the recommendation by CDPR's Human Health Assessment Branch, which concluded that the data and information submitted by Biotalys support the registration of EVOCA in California.
California represents the largest agricultural state in the U.S., including the production of fruit and vegetables such as strawberries, tomatoes and grapes, making it a strategic market for Biotalys' biocontrol pipeline. Earlier this year, the company already received regulatory approval for EVOCA in Florida - its first U.S. state approval for a biofungicide developed by Biotalys.
The public consultation phase consists of a 30-day comment period, during which stakeholders and the public can provide feedback on the proposed decision. Upon closure of the consultation scheduled for 26 July, CDPR is expected to review the submitted comments and progress toward a final regulatory decision in the second half of 2026.
Carlo Boutton, Chief Executive Officer of Biotalys, commented: "The start of the public consultation by the CDPR marks an important and encouraging milestone in the regulatory review of EVOCA in California, as the CDPR is known to perform an extensive review of scientific data, including efficacy and field validation, under some of the most stringent safety and environmental standards globally. In addition, the positive assessment by the Human Health Assessment Branch reinforces our confidence in the strength of our data package and in the potential of our AGROBODY technology platform to deliver a new generation of effective, protein-based crop protection solutions.
California is one of the world's most important agricultural markets, and progress in this process brings us one step closer to offering growers innovative tools that can help make food production more sustainable. While there are still steps ahead, this milestone further strengthens our ambition to bring transformative biological solutions to farmers in key markets around the world."
About EVOCA
EVOCA is a protein-based AGROBODY biocontrol that helps safely control the fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers. An approval of EVOCA paves the way for the regulatory submission of EVOCA NG, the product's next generation version containing the same active ingredient. EVOCA NG is expected to be Biotalys' first commercial biofungicide, with a planned launch in the U.S. in 2029 and in Europe in 2030, targeting a combined market of around USD 1.1 billion1.
About Biotalys
Biotalys is an Agricultural Technology (AgTech) company developing precision biocontrol solutions based on proteins for the protection of crops in both the pre- and post-harvest markets. The company provides novel solutions that bridge the efficacy and scale of chemistry with the environmental advantages of biological solutions. Based on its novel AGROBODY technology platform, Biotalys is developing a strong and diverse pipeline of effective product candidates with a favorable safety profile that aim to address key crop pests and diseases across the whole value chain, from soil to plate. Biotalys was founded in 2013 as a spin-off from the VIB (Flanders Institute for Biotechnology) and is listed on Euronext Brussels. The company is based in the biotech cluster in Ghent, Belgium. More information can be found on www.biotalys.com.
For further information, please contact:
Toon Musschoot, Head of IR & Communication
T: +32 (0)9 274 54 00
E: IR@biotalys.com
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 report on 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', "have the potential", '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.
1 Source: Kynetec 2020; Biotalys
Attachments
- Press Release_Biotalys_Public Review in California initiated_v1 July 2026
- Persbericht Biotalys_Start van publieke consultatiefase in Californië_1 juli 2026
