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

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