Grove tijdlijnen van vermarkting biologische oplossingen voor de landbouw.
(Vanaf mei 2020)
Amoéba grapevinedowny mildew
(France), August11 2020- the publication of a first scientific article on its biocontrol application(https://www.mdpi.com/2223-7747/9/8/1013/pdf)in the special issue« Natural Products for Plant Pest and Disease Control» ofPlants, journal of theMDPIGroup, peer-reviewed.
As a reminder, the marketing of biocontrol products containing this active substance is envisaged by Amoéba in 2024 in Europe (dossier submitted, cf. Press Release of 29 May 2020) and in the first half of 2022 in the United States (submission envisaged in July 2020, cf. Press Release of 29 April 2020, postponed to September 2020).
The prioritization of Amoéba's Regulatory Affairs Department resources on biocontrol application leads to a delay in the filing of a new application for biocidal application in the United States, which was envisaged in mid 2020 (see Universal Registration Document of April 30, 2020) and will be submitted at the end of 2020, with first marketing in the United States estimated in the first half of 2022.
Amoeba Fungicidal use in agriculture
The biocontrol solution, developed by Amoéba, is intended for a fungicidal use in agriculture.
A possible approval mid-2023 The dossier submission is in line with Amoébatime schedule. The approval procedure that is starting will take between 2.5 and 3.5 years, with an expected decision in 2023.
The main steps are as follows:
•Evaluation phase by the rapporteur Member State (approximately 14 months): at the end of which the draft report is submitted to the European Food Safety Authority (EFSA).
•Risk assessment phase (7 to 11 months): EFSA carries out the risk assessment and risk communication on food safety aspects and then organises an consultation with experts and publishes a scientific report containing its conclusions.
•Risk management phase (9 to 12 months): the European Commission presents a draft regulation to the Standing Committee on the Food Chain and Animal Health, which ultimately votes on the approval or non-approval of the active substance. In general, an active substance is approved for a period of 10 years, or even 15 years if it is classified as "low risk".
These timeframes could be reduced depending on the deployment of the “Farm to Fork Strategy” strategy of the European Commission (published on May 20th, 20202) who “will also facilitate the placing on the market of pesticides containing biological active substancesand[...] will act to reduce the length of the pesticide authorisation process by Member States”