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Belgian classifications for micro-organisms based on their biological risks
(Last revision:
March 8, 2010 )
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In Belgium, all installations performing contained use activities involving human, animal or plant pathogens and their genetically engineered derivatives are subjected to regulatory provisions aiming at avoiding adverse effects on human health and the environment which might arise from the contained use of these micro-organisms.

To this end any user shall carry out an assessment of each contained use as regards the risks to human health and the environment that these contained uses may incur. The first stage in this assessment process is the identification of inherent harmful properties of the natural micro-organism.

In order to obtain the necessary information to implement this process the user may refer to classification lists (see table below).

 

Legal basis

Belgian level
- Decree of the Flemish Region (6 February 2004) (PDF File in Dutch)
- Decree of the Walloon Region (4 July 2002) (in French)
- Decree of the Brussels-Capital Region (8 November 2001) (PDF File in French and Dutch)

EU level
- Directive 2009/41/EC on the contained use of genetically modified micro-organisms (and subsidiary decisions)(PDF File)
- Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work (PDF File)

These lists concern natural micro-organisms. They give the inherent risk of a pathogen and are based on the ability of the micro-organism to cause disease to humans, animals or plants on the basis of such factors as the severity of the disease it causes, the routes of infection, its virulence and infectivity. Other aspects such as the existence of effective therapies, possible effects on other species or possible environmental effects can also be taken into account.

Criteria for the classifications

The Regional decrees classify human and animal pathogens into three classes of risk and plant pathogens into two classes of risk.

Definitions of classes of biological risk

The classification lists published in the Regional decrees were established in 1998 taking into account relevant Community legislation, international or national classification schemes as well as relevant scientific publications (see international classifications).

As a consequence of the evolution of scientific knowledge these lists were recently revised for taxonomy and biological risk class. The nomenclature of classified micro-organisms used to establish these lists reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of micro-organisms.
The revised lists, established end 2008, are representative of pathogenic organisms that are prevalent or used for contained use activities in Belgium. Quarantine pests are no more part of the revised lists. A recent list is available in annex of the Royal Decree of 25 august 2005 (BS 31.08.2005).
It should be noticed that micro-organisms which have not been classified for inclusion in classes of risk 2 to 4 of the lists are not implicitly classified in class 1.

As these revised classification lists provide updated information on pathogenic organisms, the user is advised to consult these revised lists for performing a risk assessment in the frame of the contained use legislation.

The revised classification lists are accompanied by an introductive note, explaining more in detail the methodology that has been used to establish the revised lists.

Methodology used for revision of classification lists (in French and Dutch)

 

Revised lists of pathogens and their corresponding class of biological risk

Human and animal pathogens

Bacteria and similar organisms
Fungi
Parasites
Viruses and unconventional agents

Plant pathogens

Bacteria
Fungi
Parasites
Viruses

(lists are in PDF file)
WARNING: The users must contact the Service of Biosafety and Biotechnology for any question relating to the classification and in particular for that of natural micro-organisms which would not appear in the lists.

As mentioned before, classification of a micro-organism on the basis of its biological risk is only a first step in the risk assessment. It gives only a provisional indication of the level of risk of the activity and the corresponding set of containment and other protective measures. It should be followed by a thorough consideration of how the micro-organism is to be manipulated.
Factors to be considered in determining the level of containment include:

  • the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the micro-organism there are known hosts or biota which can be adversely affected by the micro-organism used in the contained use activity);
  • the characteristics of the activity (e.g. its scale, nature, the concentration of the micro-organism);
  • any non-standard operations (e.g. the inoculation of animals with pathogens; equipment likely to generate aerosols);
  • previous cases of laboratory acquired infection;
  • local availability of effective prophylaxis or therapeutic interventions.

A final assessment of risk based on all these considerations is therefore used to set the appropriate containment conditions for the experiment.  The containment level required may be equivalent to the risk classification of the micro-organism or it may be raised or lowered as a result of the above considerations.
Elements to be considered and the procedure to be followed to perform the full risk assessment are referred to in Annex III of the regional Decrees (see above).

Frequently Asked Questions (available soon)

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