AMOEBA (EPA:AMEBA) - AMOEBA announces that Austria has agreed to be the Rapporteur Member State to start the evaluation of its biocontrol active substance in Europe in the first quarter of 2020 with a view to a potential commercialisation in 2025
Transparency directive : regulatory news
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AMOEBA announces that Austria has agreed to be the Rapporteur Member State to
start the evaluation of its biocontrol active substance in Europe in the first
quarter of 2020 with a view to a potential commercialisation in 2025.
Lyon (France), February 12th, 2019 - AMOEBA (FR0011051598 - AMEBA), producer of
a biological biocide capable of eliminating bacterial risk in water and human
wounds, and a biocontrol product for plant protection, announces that Austria
has agreed to be the Rapporteur Member State for the evaluation of its active
biocontrol substance and specifies the regulatory timetable for Europe.
In Europe, the marketing of a plant protection product is subject to the prior
granting of a marketing authorisation in accordance with Regulation (EC) No
1107/2009 concerning the placing of plant protection products on the market.
The evaluation is divided into two major steps:
1) Evaluation of the active substance at European level followed by
2) Evaluation of the commercial preparations (products) carried out by the
Before submitting an application for approval of an active substance, the
applicant must first obtain the acceptance of one of the Member States to be
the rapporteur of the application.
The Company has therefore requested three Member States - among the most
experienced in the evaluation of plant protection active substances - to
evaluate its application for approval of the active substance, the powdered
lysate of Willaertia magna C2c Maky amoebae.
Austria has agreed to be the Rapporteur Member State, with a submission of the
application expected during the first quarter of 2020 to the Austrian Agency
for Health and Food Safety (AGES, Agentur für Gesundheit und
Before the application is submitted, a pre-submission meeting will be held with
AGES in the 2nd quarter of 2019 to answer any outstanding questions and receive
an estimate of the quality of the application.
In 2019, the Company will also generate the required regulatory data, including
physicochemical data on the substance, its toxicity, ecotoxicity, behaviour and
fate in the environment, as well as field test results.
The Company below recalls the main regulatory steps for the approval of a plant
protection active substance in Europe, once the dossier has been submitted and
the evaluation initiated by the Rapporteur Member State:
1) Assessment phase by the rapporteur Member State: This phase lasts
approximately 14 months, with a possible 6-month clock-stop if additional
information is requested. The rapporteur Member State shall forward the draft
assessment report to the European Food Safety Authority (EFSA), the applicant
and the other Member States. The Company expects that the draft assessment
report will be available in the first quarter of 2022.
2) Risk assessment phase: EFSA carries out the risk assessment and sets-up a
3-month peer review consultation involving the Member States. Following the
expert consultation, EFSA publishes a peer-review report containing its
conclusions within 4 to 8 months, with a possible clock-stop in the event of a
request for additional information.
3) Risk management phase: Within 6 months after EFSA conclusions, the European
Commission shall submit a review report and a draft regulation to the Standing
Committee on the Food Chain and Animal Health, which shall vote on the approval
or non-approval of the active substance. The approval of an active substance
implies that it is eligible for use in a plant protection product on EU
territory. The decision is ultimately adopted by the European Commission.
Under the EU rules, it takes 2.5 to 3.5 years from the date of admissibility of
the application to the publication of a Regulation approving a new active
substance. The regulatory deadlines for the evaluation of applications for
approval of active substances vary according to the novelty, complexity,
completeness and type of application, but also according to the workload of the
competent authorities: these deadlines are not systematically respected as
indicated in the research article A comparison of the EU and US regulatory
frameworks for the active substance registration of microbial biological
control agents(a). Thus, the company estimates that the active substance could
be approved in the 2nd quarter of 2024, provided that approval criteria are
Once the active substance has been approved by the European Commission, EU
Member States have a legal period of 6 months to determine whether the plant
protection products (commercial products) containing this active substance meet
the approval criteria and to issue their marketing authorisation decision. The
Company estimates that the marketing authorisation for the plant protection
product(s) containing the active substance could be granted in 2025, provided
that approval criteria are met.
As a reminder, to date, the Company is in the trial phase for biocidal and
plant protection applications and does not market any products.
Amoéba's ambition is to become a major player 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
EUR1.7Bn (1) on a global chemical biocide market for water treatment, evaluated
at EUR21Bn (2) and on the biocontrol market for plant protection estimated
globally at EUR1.6Bn (4). In the future, the Company is looking at developing
new applications such as chronic wound care, estimated at EUR 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. The Company is currently in a trial phase for biocidal and
plant protection applications and does not market any products. 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
(1) : Amoéba data combined from sources: DRIRE 2013, Eurostat, ARHIA 2013
(2) : Sources combined by Amoéba from water treaters, Freedonia, Eurostat et
(3): BCC Research, "Markets for Advanced Wound Management Technologies,
" Wellesley, MA, 2017
(4): Biopesticides Worldwide Market 2013, CPL, Wallingford, UK
Directeur administratif et Financier
04 26 69 16 00
01 56 88 11 11
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, 2018 (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.