Amoéba has received marketing authorization in France for its biofungicide AXPERA

European Regulatory Breakthrough

Amoéba has received marketing authorization in France for its biofungicide AXPERA

ANSES Grabs Zonal Rapporteur Lead to Unlock 15-Year Renewable Registration Across EU Crop Protection Networks

In a major step forward for residue-free crop protection, Amoéba has received marketing authorization in France for its biofungicide AXPERA. Announced on June 30, 2026, the marketing approval granted by ANSES follows France’s review as the zonal rapporteur Member State for the European Union. This regulatory milestone permits neighboring EU nations to finalize their respective national approvals. Powered by the proprietary lysate of the amoeba Willaertia magna C2c Maky, AXPERA is classified as a low-risk, preventive treatment exempt from maximum residue limits (MRLs). The approval triggers the commercial phase with distribution leader Koppert, who will market the formulation across European viticulture and vegetable segments to target downy mildew, powdery mildew, and late blight.

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CHASSIEU, FRANCE — June 30, 2026 — Amoéba (FR0011051598 – ALMIB), an industrial greentech company specialized in the development of natural microbiological solutions, announces that it has obtained marketing authorization for its biofungicide AXPERA in France. This first authorization, granted by ANSES following the evaluation conducted by France in its capacity as rapporteur Member State for the European Union, now allows the other concerned Member States to proceed with and finalize their national authorization procedures in the coming weeks and months, according to each country’s specific timelines.

This authorization, which is crucial for Amoéba, marks the launch of the commercialization phase for AXPERA in partnership with Koppert, initially in France and then in the other European countries covered by the agreement once approvals have been granted by the relevant national authorities.

Broad Range of Uses in Vineyards and Vegetable Crops

AXPERA is approved by ANSES as a fungicide that acts by inhibiting the germination of fungal spores. The product is intended for preventive use and can be used alone, as part of a treatment program, or in combination with other fungicides approved for use against specific diseases. It is now approved for the following crops and diseases:

  • Grapes (Wine & Table): Downy Mildew and Powdery Mildew under open field conditions.
  • Tomatoes & Eggplants: Late Blight and Powdery Mildew under open field and protected conditions.
  • Cucurbits: Downy Mildew and Powdery Mildew across open field and greenhouse assets.
  • Basil, Lettuce (Baby Leafs), & Artichokes: Downy Mildew under open field conditions.

Very Favorable Conditions of Use

AXPERA is approved as a low-risk product and can be used in both conventional and organic agriculture. The authorized application conditions yield the shortest re-entry period, pre-harvest interval, and safety buffer distances granted by ANSES for a plant protection product. Furthermore, its active ingredient, the “Lysate of Willaertia magna C2c Maky,” is exempt from maximum residue limits (MRLs), eliminating testing requirements on treated foodstuffs.

The product is also intended to be included on the French list of biocontrol products, aligning it with the French National Biocontrol Strategy and enabling standard commercial advertising while facilitating certifications like “High Environmental Value” (Haute Valeur Environnementale) or “Zero Pesticide Residue” labels.

“The approval of AXPERA in France marks the very first long-term authorization of our biocontrol product in Europe. This success confirms the strength of our regulatory dossier and paves the way for approvals in other European countries,” said Jean-Baptiste Eberst, Amoéba Regulatory Affairs Director.

“This 15-year authorization marks a significant milestone in the rollout of AXPERA technology. It will enable us to accelerate our commercial plan with our partner Koppert, which will commercialize the product as TIAGAN for use in vineyards and YAZU for vegetable crops. The product’s optimal conditions for use, its authorized application on numerous crops, and the exemption from maximum residue limits enhance the appeal of this solution for farmers,” added Jean-Marc Petat, Managing Director of Green for Agro, Amoéba’s subsidiary specializing in biosolutions.

Key Lever for Commercial Expansion

Applications for open-field use have already been submitted in Portugal, Spain, Italy, and Greece. Applications for protected uses have also been submitted across Portugal, Spain, Italy, Greece, Belgium, Poland, and Germany, alongside a mutual recognition application in 12 additional Member States to target broad market access starting in 2027.

Founded in 2010 and listed on Euronext Growth (ALMIB), Amoéba is currently the only company authorized and capable of producing the Willaertia amoeba on an industrial scale. Following product registration in the United States in 2025, this European registration establishes a valid 15-year baseline to expand alternative crop solutions globally.

Strategic Market Context

Amoéba’s 15-year European registration represents an accelerating trend where next-generation biologicals are shifting from niche field testing into mainstream regulatory frameworks. As severe downy and powdery mildew strains develop chemical resistance, food producers are fast-tracking alternative modes of action to maintain crop performance. This regulatory clearance runs parallel to key commercial movements across the global agtech landscape, such as Micropep filing initial regulatory dossiers for Promisin™ to clear an affordable, AI-designed peptide fungicide in South America, and Certis Belchim and Greenhas Group forming a joint venture to co-develop biostimulants, cementing the strategic integration of biorational assets within traditional crop portfolios.

“Securing long-term regulatory clearances to transform unique amoeba-based lysates into standard, scalable crop protection tools.”

Amoéba S.A. — Regulatory & Corporate Communications

Chassieu, Lyon, France | National Marketing Authorization Proceedings | June 2026 | amoeba-nature.com

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