(Boursier.com) — Amoeba announces that the MCCAA (Malta Competition and Consumer Affairs Authority), the competent authority of the rapporteur Member State (Malta) evaluating the application for approval of the biocidal active substance “Willaertia magna C2c Maky”, recommends its non-approval for biocidal use in cooling towers in Europe.
Based on the application dossier for approval of the biocidal active substance “Willaertia magna C2c Maky”, the Maltese authority concluded in its draft report that the active substance is not likely to meet the approval criteria, considering that “innate efficacy has not been sufficiently demonstrated and that a Trojan horse effect cannot be excluded under realistic conditions of use”.
Malta therefore recommends to the other Member States of the European Union and to the European Chemicals Agency (ECHA) that the substance not be approved, and therefore not included on the list of authorized biocidal active substances.
Malta’s draft assessment report will now be discussed at European level between Member States under the auspices of ECHA, before a decision by the European Commission in mid-2023.
“The Trojan horse effect is purely hypothetical and has never been characterized as a danger. Concerning efficacy, European regulations require demonstration of the ability of the substance to produce a sufficient effect on a relevant target organism: the studies carried out by Amoéba have amply demonstrated this activity of Willaertia magna C2c Maky against legionella.Again, the evaluators question the methodology of our studies while the biocide standards are exclusively developed for chemical products and non-existent for microorganisms, creating a barrier to access to the biocidal market for this type of natural substance. The recommendation of non-approval by Malta is therefore a result tinged with incomprehension”, declares Jean-Baptiste EBERST, Regulatory Director at Amoéba.
Amoéba specifies that the application for approval of the biocidal active substance, the live amoeba Willaertia magna C2c Maky, and biocidal products containing it, filed in April 2021 with the United States Environmental Protection Agency, the US EPA (US Environmental Protection Agency), is still under investigation. The conclusions are expected by mid-2022.
In Canada, the registration application dossier for the active substance and the biocidal products containing it, submitted in 2019, is currently being assessed. The decision of the Canadian agency could be communicated during the year 2022.
At the same time, Amoéba is continuing to develop its biocontrol application, in particular thanks to collaborations with its partners and other major players in the plant protection sector through new field trial campaigns.
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