Amoéba: final phase for marketing authorisation of AXPERA

Core Viewpoint - Amoéba is in the final phase of obtaining marketing authorization for its biocontrol product AXPERA in France, with the assessment process led by ANSES, the French Agency for Food, Environmental and Occupational Health & Safety [1][9]. Group 1: Marketing Authorization Process - The marketing authorization application for AXPERA was submitted in March 2025, and France is acting as the rapporteur Member State for the assessment [2]. - The final stage of the assessment includes a comment phase on the draft Registration Report, which is open until March 6, 2026, after which the official marketing authorization will be published [3]. - Amoéba believes there are no obstacles to the marketing authorization, as all requested uses have been deemed acceptable and the product's safety profile confirmed [4]. Group 2: Derogatory Authorizations - Agricultural sectors in France and Italy are seeking exceptional marketing authorizations for AXPERA to address phytosanitary emergencies, similar to the authorization granted in 2025 for use against downy mildew in vineyards [5]. - A new application for exceptional authorization for large-scale trials in the Netherlands has been submitted, allowing AXPERA to be used on multiple crops [6]. - If granted, these derogatory authorizations would enable AXPERA to be marketed for specific uses regardless of the final timetable for standard marketing authorization [7]. Group 3: Company Overview - Founded in 2010, Amoéba specializes in microbiological risk treatment using patented amoebae technology for plant protection and cosmetics [8]. - The company is the only one authorized to use Willaertia amoeba industrially for biocontrol and cosmetic applications, with a focus on the global biocontrol market [10]. - The active substance of AXPERA has been approved in the United States since 2022, and product registration is expected in France in 2026 [11].