Key Takeaways
- Amoéba has received French market authorization for its AXPERA biofungicide from ANSES, the first permanent approval of the product in Europe, with France acting as the EU's reporting member state.
- The authorization covers multiple uses across grapevines, cucurbits, tomatoes, eggplant, basil, lettuce, and artichoke, targeting downy mildew and powdery mildew, both outdoor and under cover.
- AXPERA is classified as a low-risk product approved for both conventional and organic farming, with exemption from maximum residue limits (MRLs) and some of the shortest re-entry and pre-harvest intervals granted by ANSES.
- The approval triggers commercial launch in partnership with Koppert, which will distribute the product under the brand names TIAGAN for vineyards and YAZU for vegetable crops.
- The French authorization, valid for 15 years and renewable, opens the path for national approvals already requested in Portugal, Spain, Italy, Greece, Belgium, Poland, and Germany, with mutual recognition sought in 12 additional EU member states targeting market access from 2027.
Amoéba Secures First Permanent European Authorization for AXPERA
French industrial greentech company Amoéba, which develops natural microbiological solutions based on patented amoeba technology, has obtained market authorization in France for its biofungicide AXPERA. The approval, granted by ANSES following an evaluation in which France served as the EU's rapporteur member state, is the product's first permanent authorization in Europe and enables other member states to proceed with and finalize their own national approval processes in the coming weeks and months, according to each country's individual timeline.
The authorization marks the launch of AXPERA's commercialization phase, beginning in France, in partnership with Koppert. The product will subsequently roll out across other European countries covered by the partnership agreement as national authorizations are granted.
AXPERA Broad Authorization Across Vineyards and Vegetable Crops
AXPERA is authorized by ANSES as a fungicide that works by inhibiting fungal spore germination. Approved uses include downy mildew and powdery mildew control on wine and table grapes grown outdoors, downy mildew and powdery mildew on cucurbits both outdoors and under cover, downy mildew on tomatoes and eggplant outdoors and under cover with powdery mildew control under cover, and downy mildew control on basil, lettuce (including young shoots), and artichoke grown outdoors. The product is designed for preventive use and can be applied alone, integrated into a treatment program, or combined with other fungicides registered against the targeted disease.
Favorable Usage Conditions and Regulatory Advantages
AXPERA is authorized as a low-risk product suitable for both conventional and organic farming under current regulations. Its approved usage conditions include some of the shortest re-entry intervals, pre-harvest intervals, and safety distances granted by ANSES for a plant protection product, contributing to its appeal for growers balancing crop protection, efficacy, and ease of use.
The product's active substance, Willaertia magna C2c Maky lysate, is listed among active substances exempt from maximum residue limits — a significant regulatory advantage that simplifies the commercialization of treated crops by removing residue analysis requirements. AXPERA is also intended for inclusion on the French biocontrol product list, which would support certifications such as “Haute Valeur Environnementale” and “Zéro Résidu de Pesticide,” strengthen the product's positioning within France's national biocontrol strategy, and permit commercial advertising of the product.
A Springboard for European Commercial Expansion
With French authorization secured, applications for outdoor uses have already been submitted in Portugal, Spain, Italy, and Greece, while applications for under-cover uses have been filed in those same countries plus Belgium, Poland, and Germany. Under-cover uses will also be the subject of mutual recognition requests in 12 additional EU member states, targeting market access from 2027. The French authorization is valid for 15 years and renewable, providing a foundation for future geographic expansion and broader use across additional crops and diseases.
“The approval of AXPERA in France is our biocontrol product's very first permanent authorization in Europe. This success confirms the strength of our regulatory file and paves the way for authorizations in other European countries,” said Jean-Baptiste Eberst, Director of Regulatory Affairs at Amoéba.
“This authorization, granted for 15 years, marks a decisive moment in the deployment of AXPERA technology. It will allow us to accelerate our commercial plan with our partner Koppert, who will distribute our biofungicide under the brand names TIAGAN for vineyards and YAZU for vegetable crops. The product's optimal usage conditions, its authorized use on numerous crops, and its exemption from maximum residue limits strengthen the appeal of this solution for farmers and supply chains engaged in the agroecological transition. We welcome this achievement with great pride,” said Jean-Marc Petat, Managing Director of Green for Agro, Amoéba's biosolutions subsidiary.
