Microbial biostimulants have become a key component of sustainable agriculture in Europe. These products are included in the new Regulation (EU) 2019/1009, as long as they meet the requirements of Component Material Category (CMC) 7, which is reserved for microorganisms.
At present, European legislation allows the use of only four groups of microorganisms in biostimulants registered as CE-marked products:
- Azotobacter spp.
- Azospirillum spp.
- Rhizobium spp.
- Mycorrhizal fungi
These microorganisms must be used without any modifications other than drying or freeze-drying, ensuring their biological integrity and safety for plants, animals, humans, and the environment.
Expanding the CMC 7 category
The Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) of the European Commission has commissioned a technical study from the Austrian Institute of Technology (AIT) to update and expand the list of authorized microorganisms.
The main objective of the study is to define a scientific and regulatory evaluation methodology that will make it possible to add new microorganisms to Annex II of Regulation (EU) 2019/1009, while ensuring their safety and agronomic effectiveness.
Development of the evaluation methodology
The AIT's work is structured into four main tasks:
- TASK 1 - Design of an evaluation methodology adapted to existing European criteria for micro-organisms already in use.
- TASK 2 - Selection of candidate micro-organisms previously proposed by European companies through the EU Survey.
- TASK 3 - Evaluation of the micro-organisms selected in Task 2, applying the methodology developed in Task 1.
- TASK 4 - Elaboration of concrete proposals for amendments to Annex II of Regulation (EU) 2019/1009, which will include the new validated micro-organisms.
Assessing market potential
One of the first steps in the process is determining whether the candidate microorganisms have commercial relevance within the EU internal market. This involves assessing their current use in authorized products in one or more Member States.
It must also be evaluated whether the microorganism poses any risk to human, animal, or plant health, or to the environment. Finally, the biostimulant product containing it will be assessed to determine whether it can be agronomically effective. This process does not exclude lesser-known micro-organisms, rather it prioritizes those with the greatest impact potential.
Prospects for the study
During 2024 and 2025, the AIT held several workshops with experts, companies and representatives of the European Commission. These sessions highlighted the importance of developing methodologies that foster innovation, accelerate market access and reduce overlaps between micro-organisms.
The research team plans to finalize the methodology in 2026, with the expectation that the first new microorganisms will be officially incorporated into CMC 7 in 2027. This will be a key regulatory step for the biostimulant industry in Europe, as it will expand opportunities for product development and commercialisation.
DG GROW and AIT's initiative represents a decisive step towards a more inclusive regulatory framework, based on science and open to innovation. The extension of CMC 7 will not only benefit biostimulant manufacturers, but will also boost European agricultural sustainability by promoting the use of safe and effective microorganisms that improve productivity and reduce reliance on chemical inputs.
Source: sunchemicals.eu
