Updates for the draft Registration Report (dRR) for biopesticides based on microorganisms

The Explanatory Notes for the implementation of the data requirements on microorganisms and plant protection products containing them in the framework of Reg. (EC) No 1107/2009 were issued last November 2023.

Several points stand out in the notes:

Clear explanation of which study must be performed under GLP: GLP are not required for studies considered as part of the characterisation process of the microorganisms.
Microorganisms must be identified as unambiguously belonging to as specific species (DNA sequence or WGS data or phylogenomic analysis). Appropriate method must be used for addressing the identification and EFSA Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA Journal 2018 ; 16(3) : 5206 should be used. Also, if WGS data are provided, applicant must describe the output as proposed by EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021; 19(7):6506).
Phylogenetic tree must be presented to support the risk assessment.
Growth requirements: Minimum, optimum and maximum temperature for growth must be reported and can be used as justification in other sections to rule out growth at body temperature.
Genetic stability data requirement: only applicable for non-virulent variants of plant pathogenic viruses.
Presence of transferable antimicrobial resistance genes: only applicable for bacteria.
Minimum Effective Dose may not be necessary to address but the proposed rate still must be justified.

Full details are provided on the technical guidelines and template, please click here to consult.

Staphyt team has already followed these requirements after discussions with zRMS during pre-submission meetings. For more than 5 years now, part of them have been, case by case, requested. This document presents the advantage to make these rules official and harmonized.

In addition to these explanatory notes, a new revision (rev3) of SANCO/6895/2009 is available now, which includes the updated draft Registration report templates for microorganisms and plant protection products. The main take-home messages on this revision are as it follows:

Templates have been adapted and conformed with other Regulations (e.g. data requirements in accordance with Reg. (EU) No 284/2013, study lists in accordance with SANCO 12580/2012).
Part B 10 it is not applicable for microorganisms.
GAPs present tables with each line numbered for allowing within sections easy cross-reference.

Staphyt has already started to product registration dossier on their basis. Not all elements are fit for the purpose of a microbial registration (see the environmental fate section), but it is at least an improvement we must recognize.

The path is still long for a streamlined development of microbials in Europe, but we must keep working, step by step, for improvements that combine accurate science and relevant needs.