Protection of workers from exposure to biological agents

KEY POINTS

This directive protects the health and safety of workers exposed to biological agents¹ (e.g. micro-organisms² or cell cultures³) 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.

Amendments

Annexes to Directive 2000/54/EC were substantially updated by amending Directive (EU) 2019/1833 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments.

Amending Directive (EU) 2020/739 adds SARS-CoV-2 to the list of biological agents known to infect humans and therefore amends Annex III to Directive 2000/54/EC accordingly.