Exposure to biological agents

Exposure to biological agents

Outline of the Community (European Union) legislation about 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

Exposure to biological agents

1) Objective

To establish specific minimum requirements designed to guarantee a better standard of safety and health for workers exposed to biological agents at work.

2) Document or Iniciative

Council Directive 90/679/EEC of 26 November 1990 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) [Official Journal L 374 of 31.12.1990].

Amended by the following acts:

Council Directive 93/88/EEC of 12 October 1993 [Official Journal L 268 of 29.10.1993];
Commission Directive 95/30/EC of 30 June 1995 [Official Journal L 155 of 06.07.1995];
Commission Directive 97/59/EC of 7 October 1997 [Official Journal L 282 of 15.10.1997];
Commission Directive 97/65/EC of 26 November 1997 [Official Journal L 335 of 06.12.1997].

Directive 2000/54/EC [Official Journal L 262 of 17.10.2000] codifies Directive 90/679 as well as its successive amendments. It therefore repeals these different Directives and replaces them.

3) Summary

1.Definition of 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. They are classified into four groups according to their level of risk of infection. “Micro-organism”: a microbiological entity capable of replication or of transferring genetic material. “Cell culture”: the in-vitro growth of cells derived from multicellular organisms.

2. Determination and assessment of risks:

  • the nature, degree and duration of workers’ exposure must be determined for any activity likely to involve a risk;
  • the risk is assessed on the basis of the danger presented by all hazardous biological agents present and on the basis of all available information on all activities involving exposure to several groups of agents. The assessment is renewed regularly;

3. Employers’ obligations

3.1 Replacement

Replacement of a dangerous biological agent by one which is not dangerous or less dangerous, if the nature of the activity so permits.

3.2 Reduction of risks

Exposure to risks must be prevented. Where this is not technically practicable, the exposure risk must be reduced to as low a level as necessary. Nine ways of doing this are listed, e.g. limiting the number of workers exposed, collective and/or individual protection measures, means for safe collection, storage and disposal of waste by workers.

3.3. Information for the competent authority:

  • Where there is a risk, information to be supplied on:
    • the results of the assessment,
    • the activities in which workers may have been exposed,
    • the number of workers exposed,
    • the name and powers of the person responsible for safety and health,
    • the protective and preventive measures taken,
    • an emergency plan in the event of exposure to a group 3 or 4 agent;
  • Immediate information on any accident or incident which may have resulted in the release of an agent and which could cause severe human infection and/or illness;
  • Where the undertaking ceases activity, a list of workers exposed and their medical records to be made available to the competent authority.

3.4 Hygiene and individual protection

Five types of measure to be applied without cost to workers:

  • Workers not to eat or drink in working areas subject to risk;
  • Protective clothing to be supplied;
  • Adequate washing and toilet facilities to be provided, possibly with skin antiseptics and eye washes;
  • All protective equipment to be properly stored, checked and cleaned, and repaired or replaced;
  • Procedures for taking, handling and processing samples.

3.5 Information and training of workers on the potential risks to health, precautions to be taken, hygiene requirements, the use of protective equipment and clothing, and the steps to be taken by workers in the case of incidents and to prevent them.

3.6 Worker information in particular cases

  • Written instructions containing at least the procedure to be followed in the event of a serious accident or incident or for handling a group 4 agent;
  • Immediate information in the event of any accident or incident which may have resulted in the release of a group 3 or 4 biological agent, including the cause and the measures taken or to be taken;
  • Workers must immediately report any accident or incident involving the handling of a biological agent. They must have access to the information contained in the list of workers exposed, i.e. information which relates to them personally and anonymous collective information.

3.7 List of workers exposed to group 3 and/or 4 agents:

The employer indicates the type of work and the agent concerned. The list is kept for at least 10 years after the end of exposure and, in some cases, for up to 40 years after the last known exposure.

3.8 Consultation and participation of workers in connection with matters covered by the Directive.

3.9 Notification to the competent authority prior to the first use of group 2, 3 and 4 biological agents and whenever there are substantial changes of importance to safety or health.

4. Miscellaneous provisions

Health surveillance of workers subjected to risks prior to exposure and at regular intervals thereafter. Practical recommendations are given in Annex IV. If necessary, effective vaccines should be made available. Individual medical records are kept for at least 10 years after the end of exposure and in some cases for up to 40 years. The doctor responsible proposes any protective or preventive measures to be taken in respect of any worker. Workers have access to the results of the health surveillance which concern them and may request a review. All cases of diseases or death must be notified to the competent authority.

Health and veterinary care facilities other than diagnostic laboratories. These must specify appropriate decontamination and disinfection procedures and implement procedures enabling contaminated waste to be handled and disposed of without risk. Containment measures must be selected (Annex V, column A) to minimise the risk of infection in isolation facilities where there are human patients or animals infected with group 3 or 4 agents.

Special containment measures are applicable to industrial processes, laboratories and laboratory animal rooms.

Use of data. The Commission has access to the processing operations carried out by the competent national authorities based on cases of disease or death.

The Directive is without prejudice to the Directives on the confined use (90/219/EEC) and voluntary release (90/220/EEC) of genetically modified organisms.

Technical amendments to the Annexes are adopted by the Commission assisted by a committee.

4) Deadline For Implementation Of Legislation By The Member States

  • Directive 90/679/EEC:
    28.11.1995: Portugal
  • Directive 93/88/EEC:
    31.12.1995: Portugal
  • Directive 95/30/EC: 30.11.1996
  • Directive 97/59/EC: 31.03.1998
  • Directive 97/65/EC: 30.06.1998

5) Date Of Entry Into Force (If Different From The Above)

6) References

Official Journal L 374, 31.12.1990
Official Journal L 268, 29.10.1993
Official Journal L 155, 06.07.1995
Official Journal L 282, 15.10.1997
Official Journal L 335, 06.12.1997

7) Follow-Up Work

On 14 September 1999 the Commission presented a proposal for a European Parliament and Council directive relating to protection of workers against risks linked to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (codified version) [COM(99) 432 final COD990188 not yet published in the Official Journal].

Co-decision procedure
The proposal is currently at first reading before the Parliament.

Opinion of the Economic and Social Committee
Official Journal C 75, 15.03.2000

8)Commission Implementing Measures

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