Dernièrement…

🍇 Après un épisode de gel inédit la semaine dernière, #Amoéba est soulagée d’annoncer le maintien de son programme d’essais sur #vigne. Toutes les équipes d’#Amoéba souhaitent également exprimer leur soutien aux #viticulteurs.
#gelvigne #viticulture

$ALMIB #Amoéba vient de mettre à disposition sur son site internet le Document d’Enregistrement Universel 2020 incluant le rapport financier annuel.
Communiqué de presse : https://bit.ly/2Qcpj5L
Site internet : https://www.amoeba-nature.com

💧$ALMIB #Amoéba vient de soumettre la demande d’autorisation de son dossier #biocide aux États-Unis. Pour en savoir plus : https://bit.ly/3rUshZR

🌱 $ALMIB #Amoéba et ses partenaires lancent en 2021 une nouvelle campagne massive d’essais au champ pour tester son produit de #biocontrôle sur un large spectre de cultures. Pour en savoir plus : https://bit.ly/3fK8w4J

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Market focus

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  • The global plant protection market was worth USD 60 billion in 2019, of which approximately USD 13 billion were fungicides.
  • Biocontrol represents in 2020 about 3.5 to 4 billion USD according to studies and is growing at about 15% per year. Some projections therefore exceed 10 billion USD in 2025.
  • Bioinsecticides are the main segment (60 to 70%).
  • In France (2019) – Sales of biocontrol products increased by 8.5% to €217 million. It represents 11% of the plant protection market. The share of biofungicides is 37% or €80 million.
  • Europe wants to halve the use of pesticides and develop organic agriculture to the tune of 25% of cultivated land by 2030.

Biocontrol

Towards an efficient and sustainable agriculture

Protecting plants in a sustainable and eco-responsible manner

To ensure yield and quality of the crops, it is imperative to protect the cultivated plants against diseases.

 

Reduce the use of chemical fungicides

For decades, conventional fungicides have been used intensively and almost exclusively. Although their effectiveness is undeniable, their over-consumption can lead to associated risks (emergence of resistant strains, environmental impact, residues in agricultural produce …).

 

Responding to a societal and governmental need for ecological solutions in agriculture

France is increasingly investing in a sustainable approach to phytosanitary management. In January 2020, it updated its Ecophyto plan for the third time and announced the application of Ecophyto II+ to reduce dependence on phytosanitary products. The signature of the European Green Deal in December 2019, makes the European countries follow this same objective.

A Promising Technology: Biocontrol

To reduce the use of conventional products while guaranteeing yield and quality, biocontrol is one of the best solutions.

 

What is biocontrol?

The French « Code Rural et de la Pêche Maritime » defines biocontrol products as « agents and products using natural mechanisms within the framework of integrated pest management ».

 

They include in particular :

« Macroorganisms and plant protection products comprising micro-organisms, chemical mediators such as pheromones and kairomones and natural substances of plant, animal or mineral origin.» (Article L.253-6).

 

Most of countries have a similar vision of what biocontrol is, without giving it a legal definition. It could be summarized as “ the use of natural products in pest management”.

 

France sees this technology as the future of agriculture 

In November 2020, the French Ministry of Agriculture published its Biocontrol Deployment Strategy with the aim of accompanying and supporting the development of biocontrol on the territory.

Our innovative active substance

 

An innovative active substance: Amoeba lysate (see photo on the left)

We discovered that the lysed (i.e. killed, burst) cells of the amoeba Willaertia magna C2c Maky, had strong fungicidal properties.

 

Several plant diseases concerned

First of all on oomycetes (microorganisms close to fungi and responsible for downy mildews and late blight) and then on phytopathogenic fungi such as rusts, powdery mildews, etc..

 

This was highlighted in laboratory tests and then, since 2019, has been verified in field trials.

Our differentiation

Dual mode of action

This active substance has a dual mode of action : it stimulates plant defences (an indirect effect on diseases), and also inhibits germination of pathogen spores (a direct effect on the pathogen)

 

Remarkable field efficacy

The very numerous trials have shown that the field efficacy was remarkable, often far superior to that of biocontrol products on the market.

 

Broad spectrum of activity

Broad spectrum against multiple pathogens of major economic importance (mildews, rusts …) on many crops (grapes, potatoes, vegetables, cereals, soybeans …)

Field trials

It is necessary and even mandatory to conduct field trials for the following reasons:

  • To measure the technical value of the product and to know the application rates:

These trials make it possible to determine the effective rate (which can vary according to the target pathogen) and to select the best formulations, to find the best conditions of use, to compare the experimental product with conventional or biocontrol reference products already on the market. The objective is to measure the technical value of the product and to approach the interest it may bring to farmers, even if these trials are not “practical value” trials.

  • To obtain the MA (Marketing Authorization):

It is mandatory in most countries of the world to prove efficacy in the field to obtain a MA. This is the case in Europe, Brazil, but not in the USA except in California.

 

These tests must follow strict procedures

Trials must follow official protocols (which specify, for example, the number of replicates, the number of treatments to be performed and their frequency, the scoring to be done, etc.) and must be performed by GEP (Good Experimental Practices) approved CROs (Contract Research Organizations). At least two years of experimentation are required in Europe. The results are then analyzed and are the subject of a dossier presented to the authorities along with the toxicological and ecotoxicological dossier.

Unprecedented results in biocontrol

Tests conducted since 2019 have measured efficiencies in the order of :

  • 50 to 80% against downy mildew on grapes even in situations of high disease pressure (and with a particularly remarkable efficiency on bunches), potato and tomato late blight, downy mildews of vegetable crops like lettuce or cucurbits.
  • Yellow and brown rust of wheat, Septoria leaf blotch of wheat

 

Adaptable to the sector’s needs

This level of efficiency, unprecedented for a natural biocontrol product, already allows us to envisage that the product could, for example, be used alone at certain periods of time and on certain crops, or combined (mixed or alternating) with conventional fungicides used at very low rates in other cases.

 

This type of product is highly anticipated on row crops, for which the offer of biofungicIdes is for the time being extremely limited.

Amoéba and its partners have conducted more than 150 trials in 11 countries and more than 200 additional trials are scheduled for 2021.

Regulatory calendars

BIOCONTROL – USA

Summary : The marketing of a plant protection product in the United States is subject to obtaining prior market authorization. Amoéba submitted the application for approval of the active substance “Lysate of Willaertia magna C2c Maky” and the plant protection products containing it in September 2020, and believes that marketing in the United States could take place as early as 2022, subject to approval by the competent authorities.

1. Pre-submission

November 2019

Pre-submission meeting with US EPA.

2. Submission

September 2020

Submission of the Active Substance (A.S.) and Formulated Products (F.P.) file containing the A.S..

3. Federal Decision

Mid 2022

Decision to authorize A.S. and F.P. containing A.S. (US EPA). Authorizations at the local level (States).


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The marketing of a plant protection product in the United States is subject to obtaining prior marketing authorization issued by the Environmental Protection Agency (EPA).

For a new plant protection substance of natural origin with food contact, which is the case for Amoeba’s active substance, the application for approval is evaluated by the Biopesticides and Pollution Prevention Division (BPPD) and the legal deadline for the EPA to carry out its evaluation and issue a decision is approximately 18 months, excluding any possible clock suspension in the event of an additional application.

Amoéba submitted the application for approval of the active substance and the plant protection products containing it in September 2020.

Once registration is obtained at the federal level, registration (notification and payment of fees) is required by local regulations in most states and takes approximately one to two months (with the exception of three states, California, New York and Florida, which require further evaluation of the complete dossier).

BIOCONTROL - EU

Summary : The marketing of a plant protection product on the European territory is subject to obtaining a prior marketing authorization. The evaluation is divided into two stages: evaluation of the active substance at the European level, then evaluation of the commercial preparations (products) carried out by the Member States. Amoéba submitted the application for approval of the active substance “Willaertia magna C2c Maky Lysate” to the Austrian competent authority at the end of May 2020 and believes that products containing this active substance could be placed on the market in 2024, subject to approval by the competent authorities.

1. Pre-submission

April 2019

Pre-submission meeting with the evaluating authority (Austria).

2. Submission

May 2020

Submission of the Active Substance file to the evaluating authority (Austria).

3. Evaluating authority Report

Early 2022

Draft Evaluation Report (Austria).

4. EFSA Report

Late 2022

The European Food Safety Authority’s evaluation report.

5. Active substance Approval

Mid 2023

Decision to approve the Active Substance (European Commission).

6. Formulated products Approval

Early 2024

Authorization decisions for plant protection products containing the Active Substance (Member States).


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The marketing of a plant protection product on the territory of the European Economic Area is subject to obtaining prior marketing authorization in accordance with Regulation (EC) No. 1107/2009. The evaluation is divided into two stages:

  • evaluation of the active substance at the European level
  • evaluation of the commercial preparations (products) carried out by the Member States.

 

Approval of the active substance

A product generally contains more than one component. The component that is active against pests/plant diseases is called the “active ingredient”. The European Commission assesses the safety of each active substance before a product is placed on the market. It must be proven that the substance is safe for human health, including its residues in food, and for animal health and the environment.

The evaluation will be carried out on the basis of an application for approval, which contains in particular physico-chemical data on the substance, its toxicity, ecotoxicity, behaviour and environmental fate. The dossier also contains efficacy data for a representative use (one pest, one crop) with a representative product containing the active substance. Once the dossier has been compiled, the applicant submits its application to an EU country called the Rapporteur Member State, which will have previously agreed to evaluate the application.

Amoéba submitted the application dossier for approval at the end of May 2020 to the Austrian Agency for Health and Food Safety (AGES, Agentur für Gesundheit und Ernährungssicherheit).

The procedure for the approval of an active substance, once the dossier has been submitted and the evaluation initiated by the Rapporteur Member State is as follows :

  • Evaluation phase by the Rapporteur Member State: This phase lasts approximately 14 months, excluding a possible 6-month clock suspension in case of a request for further information.
  • Risk assessment phase: The rapporteur Member State sends the draft assessment report to the European Food Safety Authority (EFSA). The EFSA carries out an expert consultation (peer-review) during 3 months, including the Member States and the EFSA, and then publishes within 4 to 8 months (excluding a possible clock suspension in case of a request for additional information) a scientific report (peer-review report) containing its conclusions.
  • Risk management phase : Within 6 months following the EFSA conclusions, the European Commission presents a report and a draft regulation to the Standing Committee on the Food Chain and Animal Health which votes on the approval or non-approval of the active substance. The approval of an active substance implies that this substance is eligible for use in a plant protection product on the territory of the EU.

Under EU rules, there is a 2.5 to 3.5 year delay between the date of admissibility of the application and the publication of a regulation approving a new active substance.

 

Approval of the plant protection product (end-use product)

The plant protection product is the form in which the preparation is supplied to the user and contains at least one approved active substance (see above) and co-formulants. Before a product can be placed on the market or used, it must be authorised in the EU country(ies) concerned according to the same Regulation (EC) No 1107/2009.

The uses requested for a PPP are not restricted to the representative use included in the authorisation of the active substance. Other uses (crop/pest pair) may indeed be requested: the efficacy data and the risk assessment of the new product are evaluated at this stage of the registration of this PPP.

A zonal climate (North, Central and South) authorization system operates in the EU to allow a harmonized and efficient system. The basic procedure for the authorization of a new product and subsequent mutual recognition in other EU Member States is as follows:

  • An application is submitted to the EU country(ies) where the product is intended to be placed on the market.
  • A zonal Rapporteur Member State (zRMS) is selected for each zone where the product is to be authorized. The zRMS carries out an evaluation of the application and other Member States in the same zone comment on the evaluation of the zRMS, which then makes the decision to grant or refuse authorization.
  • ther Member States grant an authorisation unless specific national conditions justify alternative conditions of use (limitation measure) or refuse authorisation.

Under EU rules, the assessment period is 12 months, with a possible additional period of 6 months in case of additional applications per zone rapporteur Member State.