EPA Issues Pro­posed Regis­tra­tion Decision for Biota­lys’ EVOCA™ Biofungicide

Ghent, BEL­GI­UM – Octo­ber 31, 2025, 7.00 CET – Biota­lys (Euronext: BTLS) is pleased to announce that the United States Envir­on­ment­al Pro­tec­tion Agency (EPA) has issued its pro­posed regis­tra­tion decision to approve the company’s first bio­fun­gi­cide, EVOCA*. The agency will now ini­ti­ate the final phase in its reg­u­lat­ory review, allow­ing stake­hold­ers such as grow­ers and industry asso­ci­ations 15 days to provide feed­back before final­iz­ing its reg­u­lat­ory decision.

The EPA has also pos­ted a final rule exempt­ing EVOCA’s act­ive ingredi­ent residues on treated crops from tol­er­ance require­ments, indic­at­ing that no max­im­um residue lim­its will apply and high­light­ing the product candidate’s exem­plary safety profile.

EVOCA is a pre­ci­sion biocon­trol solu­tion that tar­gets the fungal patho­gens botryt­is (grey mold) and powdery mil­dew in high-value fruits and veget­ables without harm­ing bene­fi­cial organ­isms or the envir­on­ment. The product can­did­ate offers grow­ers a new mode of action to man­age res­ist­ance to exist­ing fun­gi­cides as was recog­nised by the Fun­gi­cide Res­ist­ance Action Com­mit­tee (FRAC)**, a pan­el of renown industry experts.

“The EPA’s recom­mend­a­tion to approve EVOCA marks a pivotal moment for Biota­lys, and the advance­ment of the first pro­tein-based bio­fun­gi­cide of its kind for approv­al in the United States. This achieve­ment under­scores Biota­lys’ pion­eer­ing lead­er­ship in agri­cul­tur­al innov­a­tion and provides the com­pany with a sig­ni­fic­ant first-mover advant­age in trans­form­ing how grow­ers pro­tect their crops safely and sus­tain­ably.” said Kev­in Helash, CEO of Biotalys.

“Our pro­tein-based plat­form has the poten­tial to trans­form crop pro­tec­tion by deliv­er­ing next gen­er­a­tion bio­lo­gic­al solu­tions with new modes of action, developed to cre­ate tar­geted, con­sist­ent and scal­able products to meet farm­ers’ needs, as demon­strated today by the EPA’s pub­lic­a­tion,” he added.

“This sig­ni­fic­ant mile­stone reflects the ded­ic­a­tion and expert­ise of the entire Biota­lys team,” Helash con­cluded. ​“EVOCA is just the begin­ning for Biota­lys, and we look for­ward to bring­ing our pipeline of fun­gi­cides and insect­icides to the mar­ket in the com­ing years.”

An approv­al of EVOCA paves the way for the reg­u­lat­ory sub­mis­sion of EVOCA NG, the next-gen­er­a­tion ver­sion of the product can­did­ate, and Biota­lys’ anti­cip­ated first com­mer­cial launch. The com­pany expects the review pro­cess for EVOCA NG to be sig­ni­fic­antly short­er as the product con­tains the same act­ive ingredi­ent as EVOCA and fea­tures enhanced for­mu­la­tion and pro­duc­tion methods.