Amoéba receives EU approval for biocontrol active substance

Amoéba has gained final approval of its biocontrol active substance by the European Commission as a low-risk substance.

This approval is the result of a five-year European validation process, the final administrative stages of which took place in the first half of 2025.

In January 2025, EFSA published on its website the final report of the scientific evaluation of Amoéba's active substance at European level, concluding on its fungicidal efficacy and on its low risk profile for human health and the environment.

In May 2025, based on this report, the European Commission prepared a draft implementing regulation approving the active substance, which was submitted to a vote by the 27 Member States of the European Union. They voted unanimously in favour of approving the active substance as a low-risk substance.

Today, the implementing regulation is officially published and confirms the entry into force of the approval.

The regulation is available at the link here.

As a reminder, in Europe, Amoéba has initiated the application for marketing authorisation for its biocontrol product, under the brandname 'AXPERA'. The application has been submitted to the nine European Member States targeted as a priority, with a decision expected in late 2025 or early 2026, which will then pave the way for commercialisation.

In the United States, where the active substance has been approved since 2022, the AXPERA biocontrol product is in the final stages of scientific evaluation, with a decision from the US Environmental Protection Agency (US EPA) expected in the coming weeks.

"This European approval is a source of immense pride for Amoeba teams. It rewards more than five years of investment, perseverance and innovation to develop an effective, sustainable and environmentally friendly biocontrol solution. " says Jean-François Doucet, CEO of Amoéba. "This major regulatory recognition validates our scientific approach and our commitment to more sustainable agriculture. It is a milestone that paves the way for the commercialisation of AXPERA in Europe, to meet the specific needs of farmers."