Protection of workers from exposure to biological agents

Protection of workers from exposure to biological agents

Outline of the Community (European Union) legislation about Protection of workers from exposure to biological agents


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Employment and social policy > Health hygiene and safety at work

Protection of workers from exposure to biological agents

Document or Iniciative

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).


This Directive protects the health and safety of workers exposed to biological agents * whilst undertaking their work.

Biological agents are classified into four 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 shall 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 shall 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 shall inform the competent national authority when group 2, group 3 or group 4 biological agents are used for the first time.

Lastly, the employer shall 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 shall inform workers and/or their representatives as soon as possible of the causes, risks and measures to be taken.

Health surveillance

The Member States shall establish arrangements to carry out the health surveillance of workers, prior to and following exposure to biological agents.


Directive 90/679/EEC on the risks related to exposure of workers to biological agents is repealed.

Key terms
  • 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.


Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2000/54/EC



OJ L 262 of 17.10.2000

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