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RNS - A new milestone towards the market launch of AXPERA: EU Member States unanimously vote in favour of the approval of Amoéba's biocontrol active substance

Company: Amoéba Date: 2025-05-21 Language: English Register to download

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**Press release**

# **A new milestone towards the market launch of AXPERA:**

# **EU Member States unanimously vote in favour of the approval of Amoéba's biocontrol active substance**

**Chassieu (France), 21 May 2025 - 6.00 p.m. - Amoéba (FR0011051598 - ALMIB)**, an industrial greentech specialized in the development of natural microbiological solutions based on the patented use of amoebae*,* announces that **the 27 Member States of the European Union have voted unanimously in favour of approving as a low-risk substance the lysate of** *Willaertia magna* **C2c Maky, the biocontrol active ingredient in the AXPERA solution.** As a reminder, AXPERA has recently obtained temporary exceptional authorisations for use against grapevine downy mildew in France and on several crops in the Netherlands.

In January 2025<sup>1</sup> [,](#page-0-0) the EFSA (European Food Safety Authority) published on its website the final and positive report of the scientific evaluation at European level of Amoeba's active substance, the lysate of *Willaertia magna* C2c Maky.

On the basis of this scientific report, the European Commission has prepared a draft implementing regulation for the approval of Amoéba's biocontrol active substance as **a low-risk substance**.

In accordance with European procedures, this draft was put to the vote of **the 27 Member States of the European Union. They voted unanimously in favour of approving the active substance as a lowrisk substance**.

The European Commission will now be able to formalise this vote by publishing the implementing regulation, **the final step officially marking the approval of Amoeba as a biocontrol active substance**.

The draft regulation and the voting form are published on the European Commission's website: <https://ec.europa.eu/transparency/comitology-register/screen/documents/107227/2/consult?lang=en>

"*Although we were expecting it with confidence, we are proud to have reached this new milestone, which is essential for the market launch of our biocontrol solution in Europe from 2026. This unanimous vote by the 27 Member States paves the way for final approval of our biocontrol active substance* 

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<span id="page-0-0"></span><sup>1</sup> [See the press release dated 15 January 2025.](https://amoeba-nature.com/en/investor/press-releases/?CLIENT=ACTUS-0-502&ID=ACTUS-0-89558)

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*and is a very positive sign for obtaining marketing authorisations for the AXPERA product, which is currently under review in several European countries.*" says Jean-François Doucet, CEO of Amoéba.

## **About Amoéba:**

Founded in 2010, Amoéba is a greentech company based in Chassieu (Lyon, France) whose ambition is to become a major player in the treatment of microbiological risk based on the patented use of amoebae in the plant protection and cosmetics sectors.

With know-how that is unique in the world and protected by numerous patents, Amoéba is currently the only company capable of exploiting the full potential of the *Willaertia* amoeba on an industrial scale and cultivating it in sufficient volumes to offer biological solutions that constitute a viable alternative to the chemical products widely used today. Amoéba is currently focusing on the global biocontrol market for plant protection and on the cosmetics market. As the marketing of plant protection products is subject to obtaining local regulatory authorisations, the Company has carried out the necessary regulatory procedures and filed registration dossiers in Europe and the United States. With regard to the active substance, it has already obtained approval in 2022 in the USA and a positive and definitive report from EFSA in Europe. Product approvals are expected in the coming months.

The cosmetic application does not require prior approval from a competent authority in Europe or the United States. The cosmetic ingredient is already registered on the INCI (International Nomenclature of Cosmetic Ingredients) list, paving the way for it to be marketed worldwide except in China, where local approval is required.

Amoéba is listed on Euronext Growth (ALMIB). The company is a member of the Bpifrance Excellence network and is eligible for the PEA-PME scheme. For more information, visit [www.amoeba-nature.com.](http://www.amoeba-nature.com/)

### **Contacts:**

| Amoéba                                                                                                    |                                                                                                | ACTUS finance & communication                                                            | Droit Devant Agency                                                                                                    |
|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Chief Executive Officer<br>Jean-François DOUCET<br>+33 (0)4 26 69 16 00<br>jf.doucet@amoeba<br>nature.com | Investor relations<br>Pierre JACQUEMIN<br>GUILLAUME<br>+33 (0)1 53 67 36 79<br>amoeba@actus.fr | Financial<br>press<br>relations<br>Serena BONI<br>+33 (0)4 72 18 04 92<br>sboni@actus.fr | Business<br>and<br>general<br>public press relations<br>Laëtitia PINTO<br>+33 (0)7 64 83 39 85<br>pinto@droitdevant.fr |

### *Disclaimer*

*This press release contains certain forward-looking statements concerning Amoéba which are based on its own assumptions and estimates and on information that is currently available to us. However, Amoéba gives no assurance that the estimates contained in such forward-looking statements will be verified, with these estimates subject to numerous risks, including the risks set forth in Amoéba's universal registration document filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 17, 2025 under number D.25-0281 and available on the Amoéba website [\(www.amoeba](http://www.amoeba-nature.com/)[nature.com\)](http://www.amoeba-nature.com/). The forward-looking statements contained in this press release are also subject to risks not yet known to Amoéba or not currently considered material by Amoéba. The occurrence of all or part of such risks could cause Amoéba's actual results, financial conditions, performance, or achievements to be materially different from such forward-looking statements.*

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