Amoéba announces the publication of the EFSA's final report confirming its positive and definitive conclusions

Amoéba (FR0011051598 - ALMIB), an industrial greentech specialising in the development of natural microbiological solutions based on the patented use of amoebae, announces that the European Food Safety Authority (EFSA) has published the final assessment report on Amoéba's biocontrol active substance[1].

As a reminder, Amoéba received on 13 December 2024[2] the positive and definitive conclusions of the EFSA, which validated the efficacy and low-risk profile of its biocontrol active substance.

The EFSA has just published the final report on its website, and its conclusions remain unchanged:

• A proven fungicidal efficacy;

• A low risk profile for human and animal health, as well as for ecosystems and environmental organisms;

• The criteria for exemption from a maximum residue level[3] have been met.

EFSA's final report can be consulted at the following address: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9194.

The European Commission now has a maximum of 6 months to ratify the approval of the active substance, in accordance with the usual administrative provisions.

Heading for the market

Amoéba will now be able to launch the marketing authorisation application procedure for its biocontrol products in Europe, under the name "AXPERA". The application will be submitted to the eight European Member States targeted as a priority[4]. A decision is expected by the end of 2025, paving the way for commercialisation.

As a reminder, in 2024 Amoéba submitted an application for federal market authorization application for its "AXPERA" range in the United States (with the exception of California, where the procedure is separate). The US EPA's (US Environmental Protection Agency) conclusions are expected in mid-2025.

[1] Scientific name:Willaertia magna C2c Maky lysate.

[2] See the press release dated 16 December 2024.

[3] Highest level of a pesticide residue legally tolerated in or on food.

[4] Belgium, France, Germany, Greece, Italy, Netherlands, Portugal, Spain.