The Regulation (EC) No 1107/2009 provides rules for placing plant protection products in the market, based on a risk assessment, which encourages the development of less harmful substances. This Regulation includes chemical active substances and microorganisms, where, according to this Regulation, microorganisms are defined as “any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material”.
Microorganisms used as active substances in plant protection or biocidal products have a very different risk profile than chemicals. Many MPCAs have gained favour in recent years due, in part, to the perception that, because they are of natural origin, they are safer and/or more organic than the synthetic pesticides. However, there is no reason to believe that all forms of biocontrol are intrinsically safe. Studies are needed to identify the real risks of MPCAs and MPCPs to human health and to the environment as a basis for appropriate regulation of these beneficial organisms.
In the current EU registration procedure, microorganisms used as active substances and plant protection products containing microorganism are primarily treated as potentially risky organisms that are not only able to produce toxic substances, but are also potentially dangerous because they can multiply, spread and perhaps genetically adapt. It is important to be aware that placing a high inoculum of a microorganism in the environment can be treated as equivalent to a pesticide, as they fall under the same regulations as their chemical counterparts. The risk assessment for a microorganism active substance is different than that for chemicals (for instance their potential pathogenicity for humans and non-target organisms present in the environment, or their contribution to the possible development of resistance to antibiotics), and should be considered in full before allowing the use of the microorganism as an active substance on the EU market.
The objective of the training is to support development of expertise as regards the risk assessment methodologies for microorganisms to be used in biocidal and plant protection products. This shall also enhance competences in evaluating dossier admissibility/validity and risk assessment, and will also aim to promote, as much as possible, harmonisation of the procedures of evaluation, and authorisation of such microorganisms within the EU.