Due to great differences in respect of pathogenicity, microorganisms have been classified on the basis of hazard by international and national authorities. The World Health Organization (WHO) groups microorganisms according to their hazard in 4 groups. Whereas the definitions of the different risk groups (or classes) are generally agreed, the classification of species to one of the (Risk) Groups 1, 2, 3 or 4 (or Class 1 - 4) may vary in different countries.

A permit from health authorities may be required for the export, import of and/or work with organisms of (Risk) Group/Class 3 and 4. In some countries a working permit is also required to handle group 2 organisms.

Risk Group 1: low or very low individual and community risk

A microorganism that is unlikely to cause human or animal disease.

Risk Group 2: moderate individual risk, low community risk

A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposure may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.

Risk Group 3: high individual risk, low community risk

A pathogen that usually causes severe human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.

Risk Group 4: high individual and community risk

A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

The classification of plant pathogens varies for different countries, as the citeria are not only the pathogenicity or virulence of a species or strain, but also its occurrence in a particular country and the availability of possible hosts. Many countries require import permits for certain species.

For the use of or for transport restrictions of plant pathogenic microorganisms national or European directives should be consulted (see PP/1998/01/04).

Datasheets on "Quarantine Pests for Europe" have been published by CAB International in association with the European and Mediterranean Plant Protection Organization (EPPO) in 1997 (Smith et al. 1997).

Certain toxin producing bacteria and fungi are considered as a potential danger for public health. In different countries import and/or export restrictions may exist. The export of certain toxin producing microorganisms is controlled by national and European regulations.

4. PREVENTION OF BIOLOGICAL WARFARE PROLIFERATION: EXPORT CONTROL OF DUAL-USE GOODS BY THE EUROPEAN UNION

The "Council Regulation (EC) No. 3381/94 of 19 December 1994 on the control of exports of dual-use goods" is effective from 1 July 1995 and controls the export of biological materials pathogenic to human, animal or plants, of toxins and of genetically modified microorganisms.

These biological materials are listed in Annex I of the Council Decision of 19 December 1994 on the joint action adopted by the Council on the basis of Article J.3 of the Treaty on European Union concerning the control of exports of dual-use goods (94/942/CFSP) (Publication L367/8/CEC of 31.12.1994).

Council Regulation 3381/94 is amended by Council Regulation (EC) No. 837/95 of 10 April 1995 (Publication L90/1 of 21.04.1995).

Council Decision 94/942/CFSP is amended by Council Decision 95/127/CFSP of 10 April 1995 (Publication L90/2 of 21.04.1995).

Group 1: unlikely to cause disease

Corresponds to (Risk) Group or Class 1

Group 2: may cause disease

Corresponds to (Risk) Group or Class 2

Restricted to laboratories.

In some countries a working permit is required.

Group 3: causing severe disease

Corresponds to (Risk) Group or Class 3

Restricted to laboratories.

"Acceptance of Responsibility" form required (seeM/1998/1.05 Appendix 1for an example).

In some countries a working permit is required.

Group 4: causing severe disease

Corresponds to (Risk) Group or Class 4 (see page 13).

Contains no bacteria, fungi or yeasts.

Next to the publication of lists of species classified in one of the abovementioned groups in several European directives (see PP/1998/01/04), more detailed lists are available:

A classification of fungi into biosafety categories is also proposed by de Hoog, 1996. The list includes all species accepted in the recent medical literature.

For plant pathogenic microorganisms no classification system exists. In Europe, restrictions for certain species have been published (see PP/1998/01/04). The import of plant pathogenic microorganisms may be prohibited by some countries.

The export of (myco)toxin producing microorganisms may be controlled by national regulations or regulations of the European Union (control of export of dual-use goods, see PP/1998/01/04). The following classification is proposed:

T1: not toxic Restricted to laboratories.

T2: hallucinogenic "Acceptance of Responsibility" form required (see M/1998/1.05 Appendix 2 for an example).

T3: severe toxins Legal restrictions (dual-use goods, country-dependent). "Acceptance of Responsibility" form required (see M/1998/1.05 Appendix 3 for an example). 

 A coding system for plasmids is not proposed. The collections have to maintain and distribute plasmids that are qualitatively verified (see PP/1998/03/01, PP/1998/03/02 and PP/1998/03/03) upon arrival and at regular intervals. In case the quality control tests fail, the proper plasmid has to be removed from the physical stock..

 Some resources can only be distributed after written consent of the requester not to use the material for commercial purposes and not to distribute it to third parties without prior agreement from the depositor.

de Hoog. 1996. Risk assessment of fungi reported from humans and animals. Mycoses 39, 407-417

Smith et al. (Editorial Committee): "Quarantine Pests for Europe. Data sheets on quarantine pests for the European and Mediterranean Plant Protection Organization", 2^nd edition, CAB International, Wallingford, 1997. ISBN 0-85199-154-8.