Risk Assessment of Microorganisms used as Pesticides or Biocides

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”.

Session Details

Objective

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 Microbial Pest Control Agents (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 Microbial Pest Control Products (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 plant protection products and biocides. 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.

Support provided by the project

The project will support a total of 210 participants through the organisation and implementation of a 6 training sessions of 3 days each, distributed in two full days and two half days.

Participants from MS and Candidate Countries, potential candidate countries and EFTA/EEA countries are expected.

Selection of Participants

The criteria to attend the training session should be the following:

  • Relevance to daily work: be a staff of authorities in Member States involved in risk assessments and decision making of active substances and plant protection and/or biocidal products in the context of the EU regulations mentioned above.
  • Sufficient level of language: in order to ensure the transfer of knowledge and opportunities to exchange views, participants should master the language of the training session for which they applied, if not specified otherwise the official language of the workshops will be English;
  • Ability to share their experience: priority will be given to participants whom the position will allow to share with colleagues the outputs of the training.

The participants should have a computer with a working camera and audio system (speaker and microphone, preferably a headset) as well as a good internet connection. 

The Project Manager will take care to give priority the participants corresponding to these criteria.

Consortium Partner

  • AETS (Project Leader)
  • AINIA (Partner)

Technical Partners

CtGB (Netherlands)

Contact

National Contact Points in charge of identification of participants: https://ec.europa.eu/food/sites/food/files/safety/docs/btsf_national-contact-points.pdf 

Tara ALVAREZ (Project Manager) 

20199604.ramo@aets-consultants.com 

+33 (0)5 59 72 43 23

 

Our EU rules on Risk Assessment of Microorganisms or Biocides Team

Project Manager

Tara Alvarez

Registration Manager

Event Staff

Clara Blanco

Niamh O’Brien

Tara Alvarez

Previous Training Sessions

EU rules on Risk Assessment of Microorganisms or Biocides Session 1 28 June 2021 to 02 July 2021 Online Virtual Course
EU rules on Risk Assessment of Microorganisms or Biocides Session 2 20 Sep 2021 to 24 Sep 2021 Online Virtual Course
EU rules on Risk Assessment of Microorganisms or Biocides Session 3 04 Oct 2021 to 08 Oct 2021 Online Virtual Course