Update of the European regulatory application calendar
Amoéba announces the update of the European regulatory application calendar.
Chassieu (France), March 25th , 2022 – 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, is updating the calendar for the regulatory applications currently under evaluation in Europe.
Biocide application (active substance: viable Willaertia magna C2c Maky) in Europe:
The application for approval of the active substance submitted in 2019 is currently being evaluated by the Maltese authority (MCCAA). In November 2021, the Maltese authority committed to submit the active substance assessment report to the company by March 31st, 2022 (see Press Release of November 15th, 2021). In March 2022, MCCAA has informed Amoéba that it would take a few more weeks to fully finalize the assessment report.
Biocontrol application (active substance: lysate of Willaertia magna C2c Maky) in Europe:
The application for approval of the active substance, submitted in 2020, is currently being evaluated by the Austrian authority (AGES). In December 2021, AGES informed the Company that the assessment report should be finalized by the end of March 2022 (see Press Release of December 14th, 2021). In March 2022, AGES informed Amoéba that, due to the exceptional pandemic situation in Austria, many expert evaluators were incapacitated or quarantined, leading to an extension of the evaluation for a few weeks.
Applications in other geographic areas:
For the other applications under evaluation (biocide in the USA and Canada ; biocontrol in the USA and Brazil), the information provided in the Press Release of December 14th, 2021 are still valid.