A sector in need of innovation
Water treatment has not seen any innovation in terms of biocidal substances for half a century
Chlorine, bromine and isothiazolone are the 3 most widely used conventional products on the European market. However, the effectiveness of these products is reputed to be insufficient: many publications report that legionellae (plankton in water and sessile in biofilm) can be resistant to chemical biocides.
An economic and environmental impact
In addition to their economic impact linked to side effects (environmental taxes, water consumption, corrosion of installations, etc.), chemical biocides are also dangerous for humans and the environment.
Products that are not sustainable in the long term
Finally, it has been shown that the use of chemical biocides can select bacterial populations and promote bacterial resistance to antibiotics, one of the greatest health challenges of the 21st century according to the WHO.
Nevertheless, the lack of an alternative has forced manufacturers and water treatment professionals to adopt this chemical solution.
Our disruptive solution
Our breakthrough biocide controls the legionella level, both those present in the water and those colonizing the biofilm.
The effectiveness of the biocide is due to the natural properties of the amoeba Willaertia magna C2c Maky, a predator of pathogenic bacteria and other free amoebae.
For the first time in 50 years of industrial water treatment, Amoéba gives industry the opportunity to choose a responsible alternative.
Our added value
It would be the only biocide used in cooling towers that would be without hazard class for human health and the environment
The absence of toxicity, pathogenicity and ecotoxicity of the active substance Willaertia magna C2c Maky allows our product to be classified without hazard class (neither physical risks, nor risks to human and animal health, nor environmental risks) according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). The biocide is biodegradable and non-persistent in the environment.
The control of legionella and biofilm has been proven in numerous field tests on industrial air cooling towers.
The use of our biocide reduces water consumption as well as the quantities of anti-corrosion products.
Compatibility with products used in water treatment
Amoeba’s biocide is compatible with the most commonly used anti-scale, anti-corrosion and anti-algae products.
In line with the Water Framework Directive and the European Green Pact
The Water Framework Directive (Directive 2000/60/EC and its amendments) and the Green Pact aim in particular to strengthen environmental protection by progressively reducing the discharge of substances hazardous to the environment. Amoéba’s biological disruption technology, by eliminating the use of bromine, chlorine or isothiazolone chemicals, is in line with these policies.
A large panel of tests over 5 years, in France and abroad
More than twenty field trials have been carried out to evaluate the efficacy of the biological biocide BIOMEBA, whose active principle is the microorganism Willaertia magna C2c Maky.
This work, which ran from 2013 to 2018, was carried out in France, Germany, the Netherlands, Canada, Italy and the United States, in collaboration with water treatment specialists and industrial companies.
A multitude of variables tested
The cooling systems tested ranged from 1m3 to 800 m3 , covering nearly 3 orders of magnitude of cooling tower sizes. Their characteristics were very different and covered a wide range of situations: new or old towers, different climates and seasons. The state of corrosion and scaling, as well as the quality of the make-up water were also varied: from very aggressive make-up water (TH=0°f) to scaled make-up water (50°f) were tested.
The experiments were carried out according to a protocol that made it possible to evaluate the efficiency compared to the usual chemical treatment: a chemical phase was generally carried out before the “biological treatment” using the BIOMEBA. The levels of legionella and biofilm were controlled according to the methods of the art.
The results of the various tests demonstrate the effectiveness of BIOMEBA in preventing the growth of legionella and controlling biofilm in cooling towers.
BIOCIDE - USA
Summary: The marketing of a biocidal product in the United States is subject to prior market authorization. The evaluation of a biocidal product containing a new active substance is carried out by the Environmental Protection Agency and takes approximately 18 months.
1. Pre-submissionNovember 2019
Pre-submission meeting with the US EPA (Environmental Protection Agency).
2. SubmissionEarly 2021
Submission of a request for approval of the Active Substance (A.S.) and Formulated Products (F.P.) containing the A.S..
3. Federal decisionLate 2022
Authorization decision for the Active Substance and Formulated Products containing the A.S. (US EPA). Local (State) authorizations.
The marketing of a biocidal product in the United States is subject to prior marketing authorization from the Environmental Protection Agency (EPA).
Being a naturally occurring substance, products containing Amoeba’s biocidal active substance, the amoeba Willaertia magna C2c Maky, are biopesticides. The application for approval is therefore evaluated by the Biopesticides and Pollution Prevention Division (BPPD).
The evaluation of a biocidal product containing a new active substance takes approximately 18 months. Ultimately, if the EPA considers that the biocidal product can be used without posing unreasonable risks to human health and the environment, then it issues a federal marketing authorization.
Once registration of the product is obtained at the federal level, registration (notification and payment of fees) is required by local regulations in most states and takes approximately one to two months (except in California, New York and Florida, which require further evaluation of the file).
BIOCIDE - EU
Summary : The marketing of a biocidal product on the European territory is subject to obtaining a prior marketing authorization. The authorization procedure is divided into two stages: evaluation of the active substance at the European level and then evaluation of the commercial preparations. Amoéba submitted the application for approval of the active substance Willaertia magna C2c Maky in August 2019 to the Maltese authority and believes that the active substance could be approved in 2022 for use in cooling towers. A provisional authorization could thus allow the placing on the market of biocidal products containing this substance as early as 2022, subject to approval by the competent authorities.
1. Pre-submissionMay 2019
Pre-submission meeting with the evaluating authority (Malta).
2. SubmissionAugust 2019
Submission of a new application for the Biocidal Active Substance approval.
3. Evaluation authority reportLate 2021
Draft Assessment Report (Malta) / Submission request for provisional authorizations.
4. Products Provisional AuthorizationMid 2022
Provisional Marketing Authorization Decisions (Member States or EU Commission).
5. Active Substance ApprovalLate 2022
Decision to approve the Active Substance (EU Commission).
6. Products Final AuthorizationMid 2023
Final Marketing Authorization Decisions (Member States).
The marketing of a biocidal product on the territory of the European Economic Area is subject to obtaining a prior marketing authorization according to Regulation (EU) No. 528/2012. The authorization procedure consists of two steps: evaluation of the active substance at the European level and then evaluation of the commercial preparations (products) carried out either at the European level or at the level of the Member States, depending on the procedure chosen by the applicant.
Approval of the active substance
A biocidal product usually contains more than one component. The component that is active against harmful organisms is called the “active substance”. The European Commission assesses the safety of each active substance before a product is placed on the market. It must be proven that the substance is safe for human health, animal health and the environment.
The evaluation is done on the basis of an application dossier, which contains in particular physico-chemical data on the substance, its toxicity, ecotoxicity, behavior and environmental fate. The dossier also contains efficacy data carried out with a representative product containing the active substance.
The procedure for the approval of an active substance is as follows:
- Evaluation phase by the evaluating authority: which lasts approximately 12 months, after verification of the completeness of the dossier, excluding a possible 6-month clock suspension in case of a request for additional information. Amoéba submitted the application dossier for approval of the active substance in August 2019 to the Maltese authority, which confirmed the completeness of the dossier in January 2020.
- Peer-review phase: The evaluating authority submits its draft assessment report to the European Chemicals Agency (ECHA), which organizes a peer-review for a period of at least 9 months. At the end of the peer-review, ECHA’s Biocidal Products Committee (BPC) publishes its opinion, which is used by the European Commission to present a draft regulation to the Standing Committee on Biocidal Products, which votes on the approval or non-approval of the active substance. The approval of an active substance implies that the substance is eligible for use in a biocidal product in the EU territory.
Biocidal product approval (commercial preparation)
Biocidal product is the form in which the preparation is supplied to the user and which contains at least one approved biocidal active substance (see above) and co-formulants. Before a biocidal product can be placed on the market or used, it must be authorised in the EU country(ies) concerned according to the same EU Regulation (EU) No 528/2012.
The basic procedure for the authorisation of a biocidal product containing a new approved active substance is as follows, at the choice of the applicant :
- either by national mutual recognition procedure: The application for authorization of the biocidal product is submitted to a reference Member State, which carries out the evaluation. Once the product is approved in this Member State, the other designated (concerned) Member States recognize the assessment of the reference Member State and approve the placing of the product on the market in their territory.
- or by Union authorization procedure: The application for authorization 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 the European Commission on the recommendation of the ECHA and the authorization is valid for all EEA member states.
Without waiting for the official approval of the new biocidal active substance, the applicant can nevertheless apply for a provisional authorization to market the biocidal product containing the new active substance:
- if, as part of the approval procedure for a new active substance, the evaluating authority presents in its evaluation report (preceding the collective review at European level, see previous chapter) a recommendation for the approval of the new active substance,
- and if 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 an immediate or delayed unacceptable effect on human health, animal health or the environment.
The evaluation period for the application for provisional authorisation is estimated at 12 months. This provisional authorization is valid for 3 years, extendable for 1 year, and can be converted into a so-called definitive authorization once the new active substance has been approved by the European Commission.