US registration of Evoca marks a significant milestone, according to Biotalys, as it is the first protein-based biofungicide of its kind to be approved by the EPA
Belgium-based Biotalys has announced that it has received regulatory approval from the US Environmental Protection Agency (EPA) for its first biofungicide Evoca. Developed using the company’s Agrobody technology platform, Evoca is the first protein-based biofungicide of its kind to be approved by the EPA, according to Biotalys.
“Evoca is a precision biocontrol solution with a new mode of action that targets the fungal pathogens botrytis (grey mould) and powdery mildew in high-value fruits and vegetables while minimising the risk to beneficial organisms or the environment,” Biotalys said.
Following regulatory approval, Biotalys can now move forward with the dossiers for state registrations in California and Florida, two of the most important growing regions for fruit and vegetables in the US.
“In Europe, Evoca has entered the peer review phase, and the Netherlands – as the rapporteur member state – has proposed approval in Europe, subject to the provision for certain additional data as requested during the peer review phase,” the company revealed.
The company can also proceed with building up the US regulatory submission for Evoca NG – its next-generation product – currently in the final phases of development.
“The regulatory review process for Evoca NG is expected to be significantly shorter, as the product contains the same active ingredient as Evoca and features enhanced formulation and production methods,” the company said. “Biotalys envisages obtaining registration of Evoca NG in the US in 2028/29 and in the EU and Brazil in 2029/30, and subsequently launching it commercially in these markets worth around US$1.2bn combined.”
Kevin Helash, CEO of Biotalys, commented: “This approval marks a major regulatory milestone for Evoca and moves us closer to delivering a new, sustainable tool for farmers to protect their crops. The product has an entirely new mode of action to target fungal diseases, highlighting the uniqueness of Biotalys’ technology platform as a pathway to discovering many new modes of action in the coming years. The EPA’s decision reinforces the potential of our technology to help shape the future of agriculture and is a testament to the dedication of our entire team.”
Biotalys said the benefits of Evoca to growers include flexibility for use in both pre- and post-harvest applications across a wide range of food and non-food crops in both greenhouse and outdoor growing conditions; compatibility with an array of application methods and easy integration into existing farm management practices; and a new mode of action to manage resistance build-up, when compared with existing fungicides.
At the end of October, the EPA also posted a final rule exempting Evoca’s active ingredient residues from tolerance requirements, meaning that no maximum residue limits will apply.
