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Protection of workers from exposure to biological agents

Protection of workers from exposure to biological agents



Directive 2000/54/EC – protection of workers from risks related to exposure to biological agents at work


It sets rules concerning risk assessment and limitation if the exposure of the health and safety of workers to biological agents cannot be avoided.


This directive protects the health and safety of workers exposed to biological agents* (e.g. micro-organisms* or cell cultures*) whilst undertaking their work.

Biological agents are classified into 4 risk groups, according to the risk of infection involved:

  • group 1 includes agents that are unlikely to cause human disease;
  • group 2 concerns agents that can cause human disease but are unlikely to spread to the community, for which effective treatment is available;
  • group 3 includes agents that can cause human disease and may spread to the community, although prevention or treatment is possible;
  • group 4 concerns agents that can cause severe human disease. They present a high risk of spreading to the community, for which there is no effective treatment.

Risk assessment

Risk assessment must be carried out for all professional activities that may expose workers to biological agents. The nature, degree and duration of exposure shall be determined in order to plan preventive measures.

The employer must participate in regular risk assessments.

Employers’ obligations

If the activity so permits, the employer must replace the harmful agents with agents that are not dangerous or are less dangerous, considering their conditions of use and the level of scientific knowledge thereof.

Moreover, if there is a risk to the safety or health of workers, the employer must ensure that such risk is reduced to a sufficiently low level. The employer may:

  • limit the number of workers exposed to a minimum;
  • control the release of agents into the workplace, using technical procedures;
  • organise collective and/or individual protection measures;
  • prevent or reduce accidental release outside the workplace, using hygiene measures;
  • install risk warning signs;
  • draw up plans to deal with accidents;
  • provide for the collection, storage and disposal of waste;
  • arrange for safe handling conditions and transport of biological agents.

The employer is obliged to keep a list of workers exposed to group 3 and/or group 4 agents. This list may be kept for up to 40 years in some cases. Furthermore, the employer must inform the competent national authority when group 2, group 3 or group 4 biological agents are used for the first time.

Lastly, the employer must ensure that workers and/or their representatives are sufficiently informed and trained, concerning:

  • potential risks to health;
  • precautions to be taken to prevent exposure;
  • hygiene rules;
  • use of protective equipment and clothing;
  • measures to be taken in the case of incidents.

If there is an accident or incident, the employer must inform workers and/or their representatives as soon as possible of the causes, risks and measures to be taken.

Health surveillance

EU countries must establish arrangements to carry out the health surveillance of workers, prior to and following exposure to biological agents.


It has applied since 6 November 2000. It is a codification of Directive 90/679/EEC on the risks related to exposure of workers to biological agents which it repealed.


Biological agents: 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.

Micro-organism: a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material.

Cell culture: the in-vitro growth of cells derived from multicellular organisms.


Directive 2000/54/EC of the European Parliament and 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) (OJ L 262, 17.10.2000, pp. 21-45)


Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, pp. 1-8)

Successive amendments to Directive 89/391/EEC have been incorporated in the original text. This consolidated version is of documentary value only.

Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU (OJ L 134, 1.6.2010, pp.66-72)

last update 05.12.2016