Belgian biotech firm Biotalys has received a major boost in the United States, with the Environmental Protection Agency (EPA) recommending approval of its protein-based biofungicide EVOCA. The agency has also issued a final rule exempting EVOCA’s active ingredient from residue tolerance requirements, underscoring its strong safety profile.
EVOCA targets botrytis (grey mold) and powdery mildew in high-value fruit and vegetable crops, offering a new mode of action that helps manage resistance to conventional fungicides. The product has been recognized by the Fungicide Resistance Action Committee (FRAC) for its potential to support sustainable crop protection.
It marks “a pivotal moment for Biotalys, and the advancement of the first protein-based biofungicide of its kind for approval in the US,” said CEO Kevin Helash, calling the milestone a “significant first-mover advantage” in transforming how growers protect crops safely and sustainably.
Europe lags behind on biocontrol innovation
Despite the EPA’s endorsement, EVOCA remains under regulatory review in Europe and is not yet approved for sale or use. This delay is raising questions about whether European regulators are being overly cautious — and whether that caution is stifling innovation.
Helash has previously voiced frustration with the EU’s regulatory pace, telling AgTechNavigator last year: “The thing that worries me about Europe in general is it’s one of the longest timelines for registration in the world.” The region is unlikely to be “the number one” target for new launches, he said.
The slow approval process not only affects market access but also impacts funding and development timelines for biocontrol products –a critical issue for startups and scale-ups in the sector.
A missed opportunity for European growers?
EVOCA’s approval in the US paves the way for the submission of EVOCA NG, a next-generation version with improved formulation and production methods. Biotalys expects a shorter review process for EVOCA NG, given it shares the same active ingredient.
Meanwhile, European growers – many of whom are under pressure to reduce chemical inputs and meet sustainability targets – may be missing out on a tool that offers precision, safety, and environmental compatibility.
Is it time for regulatory reform in Europe?
The contrast between U.S. and EU timelines for biocontrol approvals is becoming increasingly stark. While the EPA moves swiftly to evaluate and greenlight novel solutions, Europe’s multi-year review processes may be discouraging innovation at a time when climate resilience and sustainable farming are more urgent than ever.
As Biotalys prepares to bring its pipeline of protein-based fungicides and insecticides to market, the question remains will Europe catch up or continue to fall behind in the race to modernize crop protection?
