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COMMUNITY CLASSIFICATION Article 2, second paragraph, and Article 18 INTRODUCTORY NOTES 1. In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list. Where appropriate, indicators are given of the toxic and allergic potential of these agents. Animal and plant pathogens which are known not to affect man are excluded. In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms.

2. The list of classified agents is based on the effect of those agents on healthy workers. No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding. Additional risk to such workers should be considered as part of the risk assessment required by the Directive. In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.

3. Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified in group 1. For genera where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health. When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.

4. Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace. This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.

5. The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.

6. The list of classified biological agents reflects the state of knowledge at the time that it was devised. It will be updated as soon as it no longer reflects the latest state of knowledge.

7. Member States are to ensure that all viruses which have already been isolated in humans and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.

8. Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may present a limited risk of infection for workers because they are not normally infectious by the airborne route. Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with.

9. The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace.

10. This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or where it is advisable to keep a list of exposed workers for more than 10 years. These indications are shown by the following letters: A: Possible allergic effects D: List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposure T: Toxin production V: Effective vaccine available and registered within the EU The application of preventive vaccination should take account of the code of practice given in Annex VII. BACTERIA and similar organisms NB: For biological agents appearing on this list, the entry of the whole genus with the addition of ‘spp.’ refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details. VIRUSES (*)

(*) See paragraph 7 of the introductory notes. NB: Viruses have been listed according to their order (O), family (F) and genus (G). PRION DISEASE AGENTS PARASITES NB: For biological agents appearing on this list, the entry of the whole genus with the addition of ‘spp.’ refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details. FUNGI NB: For biological agents appearing on this list, the entry of the whole genus with the addition of ‘spp.’ refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.