Microbial plant biostimulants are valuable tools for a sustainable agriculture. The EU definition of plant biostimulants defines these substances as: “Product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
- nutrient use efficiency;
- tolerance to abiotic stress;
- quality traits;
- availability of confined nutrients in soil or rhizosphere.”
Microbial plant biostimulants can be registered and marketed in the EU according to Regulation EU no. 2019/1009, under the PFC 6.A, by following the Module B+C which implies the evaluation of the technical documentation by a notified body. However, only 4 types of microbial plant biostimulants are currently covered by the EU Regulation:
- Azobacter spp.
- Mycorrhizal fungi
- Rhizobium spp.
- Azospirillum spp.
These microorganisms have been included in the regulation and do not require any further assessment of their safety. Only their efficacy will be tested as part of the application of Module B.
Following a survey to include other types of microorganisms, the AIT (Austrian Institute of Technology) has been selected to evaluate the safety of the proposed microorganisms. The different steps required before amending the EU Regulation may take a couple of years which may be an obstacle for manufacturers to access the EU market.
In addition, it is planned that new microorganisms introduced into the regulation will be at strain level. This will be highly restrictive compared to the 4 types of microorganisms currently authorized under this regulation. A quicker access may be granted by following the national regulations to register and market microbial biostimulants. Staphyt has gained experience in the preparation and submission of registration applications in the whole EU for different types of microbial biostimulants.
Each country has its own specific marketing procedure, but also different microorganism specific requirements. We have identified these particular requirements and the necessary tools to respond to them.
Staphyt dedicated team is at your service to help you in all aspects leading to microbial biostimulants marketing:
- Registrability assessment and strategic approach
- Data gap analysis and generation of missing data
- Literature search
- Dossier preparation including label and SDS preparation
- Submission to authorities and post-submission follow up
- Regulatory watch
For more information, please contact us: contact@staphyt.com
