AMOEBA (EPA:ALMIB) - AMOÉBA announces the submission in Europe of a new application for approval of its biocidal active substance
Transparency directive : regulatory news
12/08/2019 17:45
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PRESS RELEASE
AMOEBA announces the submission in Europe of a new application for approval of
its biocidal active substance
Lyon (France), August 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, still in trial phase,
announces that a new application for approval of its biocidal active substance
Willaertia magna C2c Maky has been submitted to the European Chemical Agency
(ECHA). The first phase of the evaluation will be carried out by the Malta
Competition and Consumer Affairs Authority (MCCAA).
As a reminder (see Press Release dated 25 February 2019), the Maltese authority
has agreed to act as evaluating competent authority for this new application
for approval. The active substance that has now entered the evaluation process
is Willaertia magna C2c Maky amoeba in its living form, intended for use in
cooling towers for the prevention of legionella growth (Product Type 11 -
Preservatives for liquid-cooling and processing systems) and the control of the
(Product Type 12 - Slimicides).
A pre-submission meeting was held in April 2019 between the MCCAA, its
non-governmental experts based in the Netherlands and Amoéba. The purpose of
this pre-submission meeting prior to the submission of the application was to
discuss the technology and intended use of the biocide, validate the data
required for this new submission and agree on the submission date and the
various stages of the evaluation.
The MCCAA confirmed to be in favour of consulting the European Chemicals Agency
(ECHA) to ensure a harmonised view at European level on the type and level of
data required, and in particular concerning the non sufficiently demonstrated
efficacy and the hypothetical risk associated with a 'Trojan horse' effect that
justified the non-approval at the time of the initial application (see Press
Release dated 5 June 2018). This consultation should take place in the coming
months.
Considering the 18-month evaluation period set by Regulation (EU) 528/2012,
Amoéba considers that the Maltese authority's evaluation report could be
available in the second quarter of 2021.
Provided that the competent authority of Malta submits in its assessment report
a recommendation for the approval of the new active substance, Amoéba may
submit an application for provisional authorisations for biocidal products
containing the active substance Willaertia magna C2c Maky, either to the
competent authority of Malta and other targeted Member States (national
procedure and mutual recognition) or to ECHA (Union authorisation procedure).
Provided that these authorities, on the basis of the Maltese authority's
assessment report, expect the biocidal product to be sufficiently effective and
not to have an immediate or delayed unacceptable effect on human health, animal
health or the environment, Amoéba could then consider a provisional marketing
authorisation in the designated territories in the first half of 2022.
Reminder of the procedure for registering a biocidal product in Europe:
The marketing of a biocidal product on the territory of the European Economic
Area is subject to prior marketing authorisation.
The pre-market assessment of biocidal products and their active substances is
regulated and harmonised at European level by Regulation (EU) No 528/2012
concerning the making available on the market and use of biocidal products. The
evaluation in Europe is divided into two stages: evaluation of the active
substance at European level and evaluation of the end-use products (products)
carried out either at European or Member State level, depending on the
procedure chosen by the applicant.
* Approval of the active substance
A biocidal product generally contains more than one component. The ingredient
active against harmful organisms is called an "active substance". The European
Commission assesses the safety of each active substance before it is placed on
the market. It must be proven that the substance is safe for human health,
animal health and the environment.
The assessment is based on an application dossier, which includes
physico-chemical data on the substance, its toxicity, ecotoxicity, behaviour
and fate in the environment. The dossier shall also contain efficacy data using
a representative product containing the active substance. Once the file has
been compiled, the applicant submits his application to an EU country called
the evaluating competent authority, which will have previously agreed to assess
the application.
The procedure for the approval of an active substance is as follows:
1) Evaluation phase by the evaluating authority: The authority verifies the
completeness of the file, carries out the evaluation and prepares a first
draft competent authority report. This step lasts about 14 months, except
for a possible clock suspension of 6 months if additional information is
requested. The evaluating authority shall forward its draft assessment
report to the European Chemicals Agency (ECHA), the applicant and the other
Member States.
2) Peer review phase : ECHA organises an expert consultation (peer review) for
a period of at least 9 months, including Member States and ECHA. This
collective review includes a review of the dossier and discussions in ECHA
Working Groups, bringing together experts from different Member States and
ECHA. At the end of the collective review, ECHA's Biocidal Products
Committee (BPC) publishes its opinion on the approval of the biocidal
active substance. On the basis of this opinion of the BPC, the European
Commission submits a draft regulation to the Standing Committee on Biocidal
Products, which votes on the approval (subject, if necessary, to conditions
and restrictions) or non-approval of the active substance by a qualified
majority (55% of the Member States, representing at least 65% of the
population). The approval of an active substance implies that it is
eligible for use in a biocidal product on EU territory. The decision is
ultimately adopted by the European Commission, which
publishes the implementing decision in the Official Journal of the EU. If
the active substance is authorised, it is included in the Annex to
Regulation (EU) 540/2011, the European list of approved active substances.
An active substance is initially approved for a maximum period of 10 years.
Under EU rules, there is a timeline of 2 to 2.5 years between the date of
admissibility of the application and the publication of a regulation approving
a new active substance. This time frame varies greatly depending on the
complexity of the case.
* Approval of the biocidal product (commercial preparation)
The biocidal product is the form in which the preparation is provided to the
user and which contains at least one approved biocidal active substance (see
previous chapter) and co-formulants. Before a biocidal product can be placed on
the market or used, it must be authorised in the concerned EU country(ies). The
same Regulation (EU) No 528/2012 lays down the rules and procedures for the
authorisation of biocidal products.
The basic procedure for the authorisation of a biocidal product containing an
approved new active substance is as follows, at the choice of the applicant:
- either by national mutual recognition procedure: the application for
authorisation of the biocidal product shall be submitted to a reference
Member State, which shall carry out the evaluation. Once the product has
been approved in that Member State, the other designated Member States
(concerned) shall recognise the assessment of the reference Member State and
approve the placing on the market of the product in their territory.
- or by Union authorisation procedure: the application for authorisation of the
biocidal product is submitted to the European Chemicals Agency (ECHA). The
evaluation is delegated to one of the Member States. The approval is made by
ECHA and the authorisation is valid for all EEA Member States.
Without waiting for official approval of the new biocidal active substance, the
applicant may nevertheless apply for a provisional authorisation to place the
biocidal product containing the new active substance on the market:
- if, as part of the approval procedure for a new active substance, the
evaluating authority submits in its assessment report (prior to the peer-
review at European level, see previous chapter) a recommendation for the
approval of the new active substance,
- and whether the competent authorities (in the case of a national procedure)
or ECHA (in the case of a Union authorisation procedure) expect the biocidal
product to be sufficiently effective and not to have immediate or delayed
unacceptable effects on human health, animal health or the environment.
The evaluation period for the provisional authorisation application file is
estimated at 12 months. This provisional authorisation is valid for 3 years,
renewable for 1 year, and can be converted into a so- called definitive
authorisation once the new active substance has been approved by the European
Commission.
About AMOEBA:
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
www.amoeba-biocide.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
Valérie FILIATRE
General Manager
+33 (0)4 26 69 16 00
valerie.filiatre@amoeba-biocide.com
Investors Relations
Grégory BOSSON Agence Calyptus
+33(0)1 53 65 37 90
gregory.bosson@calyptus.net
Medias relations
Constance LOZET Agence Ekno
+33(0)7 78 41 19 70
constance.lozet@ekno.fr
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 25, 2019 under number D19-0383 (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.