Micro-organisms can be used as plant protection products, biocidal products, and plant biostimulants. As described in the Biocidal Products Regulation, a micro-organism is “any microbiological entity cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths”.
By their nature, micro-organisms are very different from conventional chemicals and may present different hazards: they can proliferate and persist under particular environmental conditions, and they may produce various metabolites and toxins of significance.
Increasing interest in more environmentally friendly products for controlling plant diseases and pests has led to a greater use of micro-organisms as biopesticides. Depending on the intended use of the product, a microbial pesticide may be regulated as a plant protection product under Regulation (EC) No. 1107/2009 or as a biocide under Regulation (EU) No. 528/2012. Under both regulations, there are separate data requirements for micro-organisms. The most important information is obtained from the identification and characterisation of the micro-organism, which forms the basis for assessing the product’s effects on human health and the environment. Efficacy trials and risk assessments will need to take the specific properties of the micro-organism into account.
The new Fertilising Products Regulation (FPR) (EU) 2019/1009 extends its scope to other fertilising materials such as plant biostimulants. These products act on plant processes, improving nutrition and plant vigour; they include inoculants of bacterial endosymbionts such as Rhizobium, and mycorrhizal and non-mycorrhizal fungi.
We provide a wide range of services for microbial active substances, including data gap analysis (completeness check), study commissioning, preparation of microbial dossiers and assistance with technical equivalence applications.
If you have any queries relating to microbial products and our services, please send an email to firstname.lastname@example.org or contact our team on +353 1 849 5284.