Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000


Employers’ obligations are described with respect to work involving (or likely to involve) exposure to biological agents.

Employers should avoid using a harmful biological agent by replacing it with one which is not dangerous or less dangerous to workers’ health, if possible. Workers’ risk of exposure to biological agents should be reduced where possible to protect their health and safety. Where the results of the risk assessment reveal a risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information.

Employers must ensure hygiene and individual protection by prohibiting eating or drinking in working areas, providing protective clothing, providing appropriate toilet and washing facilities, and maintaining protective equipment properly.

Moreover, workers and their representatives must receive appropriate training involving working with biological agents and be provided with written instructions and display notices of the procedure to be followed in case of a serious accident or the handling of biological agents of group 4.

Employers must keep a list of workers exposed to group 3 and/or 4 biological agents for a minimum of 10 years following exposure (or 40 years following exposure resulting in an infection), indicating the type of  work done and the biological agent to which they have been exposed (if possible).

Prior notification must be given to the competent authority at least 30 days before the commencement of work with group 2, 3 or 4 biological agents.

Member States must establish arrangements for carrying out relevant health surveillance of workers both prior to exposure and at regular intervals thereafter. Effective vaccines must be made available free of charge for workers not already immune to the biological agent to which they are (or are likely to be) exposed. If a worker is found to be suffering from an infection or illness as a result of exposure, surveillance should be offered to other workers.

Particular attention should be paid to uncertainties about:

  • the presence of biological agents in human patients and animals
  • the hazards represented by biological agents present in human patients or animals
  • the risks posed by the nature of the work

Appropriate decontamination and disinfection procedures should be implemented for contaminated waste to be handled and disposed.

Laboratories carrying out work involving group 2, 3 or 4 biological agents for research must determine the relevant containment measures in order to minimise the risk of infection.

Adjustments to biological agent classifications are made in light of technical progress, changes in international regulations and new scientific findings.

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