EUROPE – COM / Guidance: Assessment of metabolites produced by microorganisms

The European Commission has published a new guidance document that aims to provide a practical approach on how the data requirements on metabolites can be applied in the approval of microorganisms as active substances at EU-level and the authorisation of plant protection products at MS level. This guidance document addresses metabolites present in the active substance and the plant protection product and also those produced by the microorganism after application (in situ production).

To determine whether the microorganism is producing a metabolite of concern, the guidance document is organised according to a “step-by-step” procedure. The described approach implies that the assessment of all metabolites produced by a microorganism through an evaluation as performed for chemical active substances is not required, not feasible and unnecessary from a risk perspective, however parts of such assessment are needed under certain circumstances described in this document. The approach ensures that applicants provide all available data on metabolites including any indication of hazardous effects of any of these metabolites. For those metabolites for which a hazard is identified, this identified hazard is followed-up on by generating additional data where needed for a focused risk assessment for those particular metabolites.

This document has been finalised in the Standing Committee on Plants, Animals, Food and Feed on 23/10/2020. It will apply to applications submitted from 01/11/2021 onwards.

To download:

SANCO/2020/12258 of 23/10/2020 – Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances in accordance with Regulation (EC) No 1107/2009

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE – COM / Guidance: Assessment of antimicrobial resistance of microorganisms

Applying microorganisms in the environment by spreading them as plant protection products may potentially contribute to the antimicrobial resistance (AMR) concern, through the spread of resistance genes which can be horizontally transmitted from the microbial pest control agent to pathogenic bacteria.

This new guidance document published by the European Commission explains how to assess antimicrobial resistance of microorganism, as well as the risk of increasing the spread of antimicrobial resistance of human and veterinary concern, in relation to the approval criteria and the low risk criteria set under Regulation (EC) No 1107/2009.

It addresses mainly bacteria via a stepwise approach. The case of viruses and fungi is not addressed extensively since:

– Viruses excluding bacteriophages have not been reported in the scientific literature as contributor to the AMR concern.

– The acquisition of antimicrobial resistance in fungi is multifactorial.

For viruses and fungi there is no need to assess the potential transfer of genes for resistance to antimicrobials. However, some information regarding the antimicrobial susceptibility of fungi still needs to be provided because it has to be demonstrated that there are sufficient treatment options in case infections with the fungal microorganism may occur.

The case of bacteriophages (viruses that infect bacteria) is not currently addressed by this guidance document. The interest in the use of bacteriophages as plant protection products might be reason to develop a specific guidance in the future.

This document, finalised in the Standing Committee on Plants, Animals, Food and Feed on 23/10/2020, will apply to applications submitted from 01/05/2021 onwards.

To download:

SANTE/2020/12260 of 23/10/2020 – Guidance on the approval and low-risk criteria linked to “antimicrobial resistance” applicable to microorganisms used for plant protection in accordance with Regulation (EC) No 1107/2009

 

Lynxee consulting’s team is at your disposal to answer your questions.

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EUROPE: Adoption of a new EPPO Standard PP 1/319 for the efficacy evaluation of plant defence inducers

The EPPO Standard “PP 1/319 (1) General principles for efficacy evaluation of plant protection products with a mode of action as plant defence inducers” describes the conduct of trials for the efficacy evaluation of plant defence inducers (PDIs) products and sets the definition of PDIs.

The efficacy demonstration of a PDI should be based on:

– The preliminary evaluation of the absence of direct effect of the PDI on the target pest (under controlled conditions)

– Efficacy trials to evaluate the level of efficacy of the stand-alone PDI product 

As PDIs are rarely recommended to be used alone, the Standard also precises how to set up trials to evaluate the PDI efficacies in mixture or in an integrated pest management (IPM) program.

To download: 

PP 1/319 (1) General principles for efficacy evaluation of plant protection products with a mode of action as plant defence inducers

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

FRANCE: Implementation of the national biocontrol strategy for 2020-2025

The “EGAlim” law of 30 October 2018 planned the implementation of a national strategy for biocontrol products in order to reduce the risks and the effects of the use of plant protection products on human health and the environment.

On 10 November 2020, the Government published its national strategy with the main priorities in progress or to be developed in order to promote the development and the use of biocontrol products as an alternative to conventional plant protection products.

4 main priorities have been defined:

– Innovation: accelerate research, industrialisation and development of new biocontrol solutions

→ Improve knowledge, foster and support companies in the development and industrialisation of new products…

– Regulation: Simplify the procedures for the authorisation and the use of biocontrol solutions

→ Strengthen the definition of biocontrol, simplify the submission of applications for authorisation/renewal of macro-organisms, reduce delays for decisions, grant the logo “Usable in Organic Farming (UAB)” faster…

– Ensure the implementation of biocontrol in France

→ Develop trial sites, inform the public to promote biocontrol, develop and strengthen the training of professional users, provide appropriate and independent advice, support farmers…

– Promote biocontrol at European level

→ Achieve a target of 50% reduction of the use of plant protection products by 2025 as set by the European Green Pact and the European Commission’s “farm to fork” strategy.

 

To download: 

National implementation strategy for biocontrol (in French)

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

FRANCE: Update of the list of neonicotinoids substances banned

A draft decree is currently under public consultation until 26 November 2020 in order to update the list of active substances of the neonicotinoid family or with the same modes of action and subject to a use ban. This draft decree is being issued under article L.253-8 of the French Rural Code as modified by the draft law on the conditions for marketing some plant protection products in the case of pest threat to sugar beet.

As a reminder, in application to the biodiversity law of 08 August 2016, 5 active substances of the neonicotinoid family (acetamiprid, clothianidin, imidacloprid, thiacloprid and thiamethoxam) are banned from use in plant protection products and seed treatments. The “EGAlim” law of 30 October 2018 extended this ban to active substances with an identical mode of action (flupyradifurone and sulfoxaflor).

Three of these substances are currently banned at European level (clothianidin, thiacloprid and thiamethoxam) and one will be soon (imidacloprid from 01 December 2020). According to the draft decree, the active substances concerned by a National ban will be acetamiprid, flupyradifurone and sulfoxaflor.

 

To download: 

Draft Decree listing the active substances from the neonicotinoïds family or with a neonicotinoid-like modes of action (in French)

 

See also our previous articles: 

FRANCE: List of neonicotinoids substances banned

FRANCE: Confirmation of the ban of two neonicotinoid-like active substances

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

LYNXEE: Appointment of Marie Surget, Efficacy expert

Lynxee consulting’s team is pleased to announce the appointment of Marie Surget.

Graduated with a Master in plant biotechnology, Marie worked during several years as a field trialist and GEP study Director in different contractors and agrochemical companies. Then she participated in the drafting of BADs within a consulting company and then an agrochemical company.

Marie joined Lynxee consulting in November 2020, where she is in charge of BAD writing.

 

Lynxee consulting’s team now counts four Efficacy Experts. Do not hesitate to contact us for quotes! http://lynxee.consulting/en/contact/