Key Takeaways
- The European Commission has granted final approval for Amoéba's biocontrol substance, Lysate of Willaertia magna, as a low-risk active substance.
- The approval follows a five-year EU evaluation process, with unanimous support from all 27 Member States.
- Amoéba has submitted market authorization requests for its biocontrol product AXPERA in nine EU countries.
- A U.S. EPA decision on AXPERA is also expected in the coming weeks, where the substance has been approved since 2022.
- This regulatory milestone follows a major distribution agreement with Koppert.
EU Commission Approves Amoéba's Low-Risk Biocontrol Substance
Amoéba (FR0011051598 – ALMIB), a French industrial greentech company specializing in microbiological solutions, has received final approval from the European Commission for its biocontrol active substance, Lysate of Willaertia magna. The substance has been officially recognized as a low-risk solution under the EU regulatory framework, enabling further commercialization steps for the company’s biocontrol product, AXPERA.
The regulatory process, which began five years ago, reached its conclusion in the first half of 2025. In January 2025, the European Food Safety Authority (EFSA) published its final scientific evaluation, confirming the fungicidal efficacy and low-risk profile of the substance. In May 2025, EU Member States voted unanimously in favor of its approval, and the final implementation regulation has now been officially published.
AXPERA Moves Closer to Market Entry
With the approval in place, Amoéba is moving forward with its plan to commercialize AXPERA in Europe. The company has already submitted market authorization requests to nine priority EU countries, with regulatory decisions expected by late 2025 or early 2026.
In the United States, the active substance has been approved since 2022, and the product is currently undergoing final evaluation by the U.S. Environmental Protection Agency (EPA). A decision is anticipated in the coming weeks.
Substance Characteristics and Agronomic Relevance
The biocontrol substance is noted for its:
- Low-risk profile, based on extensive environmental and human health testing;
- Proven efficacy against a broad range of crop pathogens;
- Contribution to sustainability goals, as it offers a chemical-free alternative to conventional pesticides.
It is designed to support more sustainable farming practices by enhancing crop protection without relying on synthetic inputs. The product is seen as addressing both agronomic performance and regulatory trends encouraging reduced chemical use in agriculture.
Strategic Partnerships and Industry Impact
This regulatory milestone follows Amoéba's distribution agreement with Koppert, a global provider of biological crop protection solutions. The partnership is expected to accelerate AXPERA’s entry into European markets upon national authorizations.
In a statement, Jean-François Doucet, CEO of Amoéba, described the approval as “a major regulatory recognition that validates our scientific approach and commitment to sustainable agriculture.”
Amoéba continues to position itself within the biocontrol sector, aiming to offer alternatives to traditional agrochemicals in response to changing regulatory and market demands.
Next Steps For Amoéba
With the EU approval finalized, the next phases for Amoéba include:
- Advancing through national market authorization processes in the targeted nine EU countries;
- Awaiting the EPA's decision in the U.S.;
- Preparing for the broader commercialization of AXPERA through its existing and potential new partnerships.
The company’s focus remains on enabling sustainable crop protection while expanding its presence across key agricultural markets.
