(Boursier.com) — Amoeba confirms that the regulatory timetable for applying for approval of the biocontrol active substance is in line with the Company’s forecasts.
EFSA, the European Food Safety Agency, mentions on its website a deadline for the risk assessment (Risk Assessment Deadline) of July 19, 2023. This date having been assigned by default when starting the review of the file in December 2022, it does not take into account any delay taken by the authorities.
The Company has anticipated this possible shift in its forecasts: the regulatory timetable for biocontrol application in Europe, as published in the 2022 Universal Registration Document filed on April 18, 2023 under number D23-0296 with the AMF and available on the Company’s website, is still valid and recalled below:
-The risk assessment phase ending with the EFSA peer-review report containing its conclusions should be finalized in the second half of 2023.
-The risk management phase ending with the publication of the implementing regulation on the decision of the European Commission in the Official Journal of the EU should be finalized in the first half of 2024.
As applications for approvals for formulated products may be submitted before the final approval of the active substance, the provisional timetable for formulated products is also in line with forecasts.
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