Latest update: 08/04/2021

Directive 2000/54/EC - biological agents at work

of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)


This Directive lays down minimum requirements for the health and safety of workers exposed to biological agents at work.


Definitions of the terms biological agents, micro-organisms and cell culture.


Biological agents are classified into four risk groups according to their level of risk of infection. 

In the case of activities involving exposure to several groups of biological agents, the risk must 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 shall avoid the use of a harmful biological agent if the nature of the activity so permits, by replacing it with a biological agent which is not dangerous or is less dangerous to workers' health.

Employers’ obligations

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.

Member States shall comply with the 2019 amendments of the Annexes by 20 November 2021.

The most recent amendment addresses SARS-CoV-2 and Member States shall comply with this by 24 November 2020.


Annex I: Indicative list of activities that may result in workers being exposed to a biological agent

Annex II: The biohazard sign

Annex III: Community classification - biological agents known to infect humans

Annex IV: Practical recommendations for the health surveillance of workers

Annex V: Indications concerning containment measures for work which involves the handling of group 2, 3 and 4 biological agents

Annex VI: Containment principles for industrial processes involving group 2, 3 or 4 biological agents

Annex VII: Recommended code of practice on vaccination

Annex VIII: Directive 90/679/EEC and its successive amendments were repealed by the present directive

Annex IX: Correlation table for articles of the repealed directive 90/679/EEC and the present directive

Read the full text of the consolidated version of the Directive (including later amendments)

Read the full text of the original Directive (without amendments)

National laws implementing this Directive

Further information on this topic

See also further document of the European Commission on that topic:

Evaluation of the Practical Implementation of the EU Occupational Safety and Health (OSH) Directives in EU Member States - Directive on the protection of workers from risks related to exposure to biological agents at work (2017)

Commission Statement following the presentation of Commission Directive (EU) 2020/739 to the European Parliament and the Council in respect of the prevention and protection of the health and safety of workers that are or can be occupationally exposed to SARS-CoV-2 2020/C 212/03 (2020)