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Amoéba

Legal Proceedings Report Jun 5, 2018

1107_rns_2018-06-05_8601dc13-e4f3-45bd-9e5f-6a0557861f7a.pdf

Legal Proceedings Report

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AMOEBA informs of the release of the Biocidal Products Committee opinion

Lyon, 5 th June 2018 - AMOEBA (FR0011051598 - AMEBA), producer of a biological biocide capable of eliminating the risk of waterborne bacteria, announces that the Biocidal Products Committee (BPC) opinion related to the application for the active substance Willaertia magna C2c Maky approval for use in product-type 11 (PT 11 - Preservatives for liquid-cooling and processing systems) has been published on the European Chemicals Agency website.

The document, referenced ECHA/BPC/206/2018, can be viewed at: https://echa.europa.eu/documents/10162/6cfedc78-5965-6c25-160f-99c335e4e4bd

In accordance with our April, 26th 2018 press release, the opinion adopted by the Biocidal Products Committee is the non-approval of the active substance Willaertia magna C2c Maky for the use in PT 11.

This recommendation for non-approval, which has to be confirmed by the European Commission, is based on two elements:

    1. The Committee considers that « it cannot be excluded that there are unacceptable effects on human health due to a so-called 'Trojan horse' effect, with the amoeba acting as a reservoir for possible pathogenic bacteria.».
    1. The Biocidal Products Committee also felt that « the efficacy to prevent the growth of legionella [was] not sufficiently demonstrated ».

If the European Commission follows the Biocidal Products Committee's recommendation, the Company will file an application for decision annulment to the European competent authorities, in conjunction with a demand for decision suspension. Indeed, the Company considers that:

    1. The « Trojan Horse » effect is a laboratory concept which has led to assumptions of harmful effects for human health, whose risk has not been scientifically proven. However, the risk assessment on a biocidal active substance cannot be based on hypothesis. The European jurisprudence has actually ruled that a preventive measure cannot be taken on a purely hypothetical approach to the risk, based on a mere conjecture which has not been scientifically validated.
    1. A chemical substance (isothiazolone C(M)IT/MIT) used for water treatment in cooling towers has been evaluated by the French ANSES in 2015 and approved despite the lack of proven efficacy in the field. This substance was granted the right to submit confirmatory data at the product market authorization phase. The same substance, for a similar use (slimicide) was also evaluated by the French ANSES in 2015 and approved while its efficacy in both laboratory and field were not demonstrated. On this point, the Company considers that it did not benefit from an equal treatment with chemical products, though being a fundamental right to which the Company was legitimately and statutory entitled.

« The release of the BPC opinion confirmed with no surprise the conclusion of the April, 26th 2018 meeting. For me, I still cannot understand this decision, particularly in view of the chemical products currently authorized for the same use, and that we undoubtedly know they are harmful for human health and the environment. We will do our utmost to assert our rights if the European Commission confirms the Opinion of the BPC that I consider against the basic principles of French and European law. », says Fabrice PLASSON, Managing Director of AMOEBA.

About AMOEBA:

Amoéba's ambition is to become the world leader in the treatment of bacterial risk in the fields of water, healthcare and plant protection. Our biological solution is an alternative to chemical products widely used today. Amoéba is currently focusing on the market of industrial cooling towers estimated at €1.7Bn (1) on a global chemical biocide market for water treatment, evaluated at €21Bn (2) and on the biocontrol market for plant protection estimated globally at €1.6Bn (4) . In the future, the Company is looking at developing new applications such as chronic wound care, estimated at € 751 million (3) in the USA. Sales of associated products with healthcare, biocides and crop protection are subject to the Company being granted local regulatory market authorizations.

Created in 2010, based in Chassieu (Lyon, France) with a subsidiary in Canada and in the United States, Amoéba is quoted on the compartment C of Euronext Paris. The Company is a member of the BPIfrance Excellence network and is eligible for the PEA-PME SME equity savings plan setup. More information on www.amoebabiocide.com.

(1): Amoéba data combined from sources: DRIRE 2013, Eurostat, ARHIA 2013

(2): Sources combined by Amoéba from water treaters, Freedonia, Eurostat et MarketsandMarkets

(3): BCC Research, "Markets for Advanced Wound Management Technologies," Wellesley, MA, 2017

(4): Biopesticides Worldwide Market 2013, CPL, Wallingford, UK

Contacts :

Amoéba Nathalie COMBROUSSE Marketing Communication Manager Tel : (+33)4 81 09 18 15 [email protected] Actifin Ghislaine GASPARETTO Investors communication Tel. : (+33)1 56 88 11 11

[email protected]

Disclaimer

This press release contains certain forward-looking statements concerning AMOEBA which are based on its own assumptions and hypothesis and on information that are available to us. However, AMOEBA gives no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of AMOEBA filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 27, 2017 (a copy of which is available on www.amoeba-biocide.com). The forward-looking statements contained in this press release are also subject to risks not yet known to AMOEBA or not currently considered material by AMOEBA. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of AMOEBA to be materially different from such forward-looking statements.

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