Microbial Risk Assessment and Agronomic Efficiency Criteria for New CMC 7 Microorganisms for Use as Biostimulants
Microbial Risk Assessment and Agronomic Efficiency Criteria for New CMC 7 Microorganisms for Use as Biostimulants
On the 7th of June of 2024, Kerona Scientific attended the stakeholder workshop regarding the study to support the inclusion of new microorganisms and processes under CMC 7 of the Fertilising Products Regulation (EU) 2019/2009 (the FPR) presented by the Austrian Institute of Technology (AIT).
To start, a quick view was given on the study to support the inclusion of new microorganism under CMC 7. The study is being carried out by the AIT under the guidance of the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship, and SMEs (DG GROW). This research focuses on assessing the safety, environmental impact, and agricultural effectiveness of microorganisms used as biostimulants. The goal is to support the inclusion of more microorganisms in Component Material Category (CMC) 7, according to Annex II of the FPR.
The workshop consisted of a discussion between the invited delegates about the inclusion of new microorganisms and it was structured into two main topics: The CMC 7 assessment regarding risks to human, animal and plant health, to safety and to the environment on one hand and the Agronomic efficiency criteria relating to CMC 7 candidates on the other.
For the first topic, panelists stressed the importance of creating a regulatory framework that ensures human, animal, and environmental safety without being overly burdensome. They highlighted the need for methodologies that fosters innovation, expedites market access, and addresses the dual roles of microorganisms as both biostimulants and biocontrol agents.
To meet these needs, they suggested developing methodologies that ensure acceptable timelines, avoid redundant efforts through coordination with EU-level Notified Bodies, consider risk-to-benefit ratios, and are tailored to the biology and ecology of microorganisms using a systems approach. Additionally, they emphasized the necessity of strong data protection and confidentiality measures.
Opinions varied on whether risk assessments should be harmonized for all agricultural microorganisms or differentiated between those with biocontrol and biostimulant functions. A key concern was that the methodology should allow for ongoing updates to the CMC 7 list without needing new Commission-funded studies for each amendment.
To finalise, the panelists discussed about the second topic being the efficiency criteria relating to CMC 7 candidates. During the discussion, panelists emphasized the need to avoid redundant agronomic efficiency testing for CMC 7 amendments, since microbial plant biostimulants are already tested at the product level by EU-Notified Bodies. They suggested focusing on risk assessment instead. Efficiency evaluations for CMC 7 candidates should occur at the genus or species level, reserving strain-level testing for final products. While using species-level data from peer-reviewed literature was supported, concerns were raised about stifling innovation. Thus, methodologies should accommodate novel CMC 7 candidates, even if they lack extensive publications. Strain-level testing may still be necessary for highly innovative candidates.
If you require assistance with assessing fertilisers and biostimulants in the EU, please do not hesitate to contact the fertiliser experts at Kerona Scientific info@kerona.ie