Postponement of the biocide active substance dossier
Amoeba announces a postponement of the conclusion of the evaluation by Malta of the biocide active substance dossier
Chassieu (France), July 5th, 2021 – 5:45 p.m. – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product for plant protection, still in the development phase, announces that it has received, on June 24th, 2021, a final set of questions from the Maltese Authority which is evaluating the biocidal active substance dossier.
As a reminder, in its press release dated April 6th, 2021, specifying the timetable for the biocidal and phytosanitary regulatory dossiers, the Company estimated that the evaluation report of its “Biocide” dossier by the Maltese Authority could be available by mid-2021.
Considering the time needed to submit the response file, as well as the time needed for the assessment of the response file, the Maltese Authority has committed to finalise the assessment report in the 4th quarter of 2021.
The Company has decided to take advantage of this new series of questions to enrich its dossier by also submitting the results of a laboratory study currently under finalization, based on the European standard EN 136231, which demonstrates an abatement of more than 99% of the legionella level over 96 hours. This efficacy study complements the efficacy data already submitted, strengthening the demonstration of the efficacy of the active substance in continuous injection.