Amoéba: AXPERA in Final Authorization Phase in France
Amoéba announces that ANSES has initiated the final phase of the evaluation of its biocontrol product AXPERA, submitted in March 2025. Concurrently, French and Italian agricultural sectors are seeking derogatory authorizations to use the product at the start of their production season.
Final Evaluation Phase by ANSES
The evaluation process of the AXPERA market authorization application by ANSES is currently in its final phase. This stage includes a comment period on the draft evaluation report, which began in February and will conclude on March 6, 2026. It will be followed by the signing and official publication of the authorization in France, an administrative phase that may span several weeks. Amoéba indicates that at this stage of the draft report, there are no elements opposing the issuance of the market authorization. All requested uses have been deemed acceptable, and the product's safety profile has been confirmed. Once the French authorization is obtained, other concerned member states will then initiate the national procedure for authorizing the product on their territories.
Derogatory Market Authorizations Sought by French and Italian Agricultural Sectors
Agricultural sectors in France and Italy have initiated steps to obtain derogatory market authorizations to address emergency phytosanitary situations, similar to the one granted in 2025 in France for the use of AXPERA against vine mildew. The goal is for the sectors to be able to use AXPERA from the start of the production season. Additionally, Amoéba has submitted a new request for an exceptional experimental authorization to Dutch authorities to use AXPERA on multiple crops, including the possibility of consuming the harvests.
