CHAPTER I

GENERAL PROVISIONS

Objective
Article 1
1
This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work.
It lays down particular minimum provisions in this area.
2
Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive.
3
This Directive shall apply without prejudice to the provisions of Council Directive 90/219/EEC and of Council Directive 90/220/EEC .

Definitions
Article 2
For the purpose of this Directive:
1. 'biological agents' shall mean micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity;
2. 'micro-organism' shall mean a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material;
3. 'cell culture' shall mean the in-vitro growth of cells derived from multicellular organisms.
'Biological agents' shall be classified into four risk groups, according to their level of risk of infection:
1. group 1 biological agent means one that is unlikely to cause human disease:
2. group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available;
3. group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available;
4. group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

Scope — Determination and assessment of risks
Article 3
1
This Directive shall apply to activities in which workers are or are potentially exposed to biological agents as a result of their work.
2
In the case of any activity likely to involve a risk of exposure to biological agents, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.
In the case of activities involving exposure to several groups of biological agents, the risk shall be assessed on the basis of the danger presented by all hazardous biological agents present.
The assessment must be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to biological agents.
The employer must supply the competent authorities, at their request, with the information used for making the assessment.
3
The assessment referred to in paragraph 2 shall be conducted on the basis of all available information including:
a
classification of biological agents which are or may be a hazard to human health, as referred to in Article 18;
b
recommendations from a competent authority which indicate that the biological agent should be controlled in order to protect workers' health when workers are or may be exposed to such a biological agent as a result of their work;
c
information on diseases which may be contracted as a result of the work of the workers;
d
potential allergenic or toxigenic effects as a result of the work of the workers;
e
knowledge of a disease from which a worker is found to be suffering and which has a direct connection with his work.

Application of the various Articles in relation to assessment of risks
Article 4
1
If the results of the assessment referred to in Article 3 show that the exposure and/or potential exposure is to a group 1 biological agent, with no identifiable health risk to workers, Articles 5 to 17 and Article 19 shall not apply.
However, point 1 of Annex VI should be observed.
2
If the results of the assessment referred to in Article 3 show that the activity does not involve a deliberate intention to work with or use a biological agent but may result in the workers' being exposed to a biological agent, as in the course of the activities for which an indicative list is given in Annex I, Articles 5, 7, 8, 10, 11, 12, 13 and 14 shall apply unless the results of the assessment referred to in Article 3 show them to be unnecessary.
Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, p. 1). Directive as last amended by Directive 98/81/EC (OJ L 330, 5.12.1998, p. 13).
Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ L 117, 8.5.1990, p. 15). Directive as last amended by Directive 97/ 35/EC (OJ L 169, 27.6.1997, p. 72).