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Exposure to carcinogens and mutagens

Exposure to carcinogens and mutagens

Outline of the Community (European Union) legislation about Exposure to carcinogens and mutagens


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 carcinogens and mutagens

Document or Iniciative

Directive 2004/37/EC of the European Parliament and the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC).


This Directive does not apply to workers exposed only to the forms of radiation covered by the Treaty establishing the European Atomic Energy Community (Euratom Treaty). It applies to workers exposed to asbestos when its provisions are more favourable than those of Directive 83/477/EEC (as last amended by Directive 2003/18/EC).
Directive 89/391/EEC applies in full, without prejudice to more binding and/or more specific provisions contained in this Directive.

In the case of any activity likely to carry the risk of exposure to carcinogens or mutagens, the nature, degree and duration of workers’ exposure must be determined on a regular basis in order to assess any risk to workers’ health or safety and decide the steps to be taken. All routes of exposure must be taken into account, including absorption into and/or through the skin. Particular attention must be paid to workers who are especially at risk.


Reduction and replacement

Employers must reduce the use of a carcinogen or mutagen, particularly by replacing it, as far as is technically possible, with a substance, preparation or process that is not dangerous or is less dangerous.

Prevention and reduction of exposure

Employers must ensure that the carcinogen or mutagen is manufactured and used in a closed system. If this is not technically possible, employers must ensure that the level of exposure is as low as is technically possible.
Exposure must not exceed the limits set out in Annex III.

Information for the competent authority

Employers must provide the competent authority, on request, with information relating to such matters as the reasons for using carcinogens or mutagens, the preventive measures taken and the number of workers exposed.

Unforeseeable exposure

In the event of unforeseeable incidents or accidents likely to lead to workers being abnormally exposed, employers must inform their workers. Protective clothing and respiratory personal protective equipment must be worn, and exposure must be kept to the strict minimum necessary.

Foreseeable exposure

For certain activities, such as maintenance work, for which the likelihood of a significant increase in exposure is foreseeable and against which all preventive measures have been taken, employers must decide the measures necessary to reduce as far as possible the amount of time workers are exposed and to ensure that they are protected during these activities. Protective clothing and respiratory personal protective equipment must be worn, and exposure must be kept to the strict minimum necessary. Moreover, the areas used for such activities must be clearly demarked and indicated.

Access to risk areas

Employers must restrict access to risk areas to workers who, by virtue of their work or duties, are required to enter such areas.

Measures regarding hygiene and personal protection

Employers are required to take the following measures regarding hygiene and personal protection for all activities that carry a risk of contamination:

  • ensure that workers do no eat, drink or smoke in work areas where there is a risk of contamination;
  • supply workers with the appropriate clothes and provide separate storage places for work clothes and street clothes;
  • provide washing and toilet facilities;
  • properly store, check and clean protective equipment before and after every use.

Workers must not bear the cost of these measures.

Informing, training and consulting workers

Employers must take appropriate steps to ensure that workers and/or their representatives receive sufficient and suitable training about:

  • potential and additional health risks (smoking);
  • precautions for preventing exposure;
  • hygiene requirements;
  • protective clothing;
  • measures to be taken in the event of an incident.

Employers must ensure that containers, packages and installations containing carcinogens or mutagens are clearly and legibly labelled, and that warning signs are clearly displayed.

Appropriate measures must be taken to ensure that workers are able to assess whether the Directive is being applied correctly. They must be informed as quickly as possible in the event of abnormal exposure.

Employers must have an updated list of workers undertaking activities that carry a risk to their health and safety in terms of exposure to carcinogens and mutagens.

Workers and/or their representatives must be consulted about and involved in all matters related to exposure to carcinogens and mutagens.


Health monitoring

Member States must take steps to ensure that the health of every exposed worker can be adequately monitored. These must be such that it is possible to apply individual and work-related health measures. When a worker’s health is monitored, an individual medical file is to be created.
Practical recommendations relating to the monitoring of workers’ health can be found in Annex II.
All cases of cancer identified as resulting from exposure at work must be notified to the competent authority.


The up-to-date list of workers who have been exposed, which the employer is required to keep, and individual medical files are to be kept for at least 40 years after the end of exposure.

Limit values

The Council sets out in directives, where possible, limit values for all carcinogens or mutagens and, where necessary, other directly related provisions. Annex III contains the limit values for benzene, vinyl chloride monomer and hardwood dusts.

Annexes I (list of substances, preparations and processes) and III (limit values) can be amended only by the Council (Article 137 of the EC Treaty).
Technical amendments to Annex II (practical recommendations relating to the monitoring of workers’ health) are adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.


This Directive is a consolidation Directive that replaces Directive 90/394/EEC and its subsequent amendments (Directive 90/394/EEC, Directive 97/42/EC and Directive 1999/38/EC). It makes no substantive changes and merely consolidates the body of texts which it replaces. The deadlines for the transposition of Directives 90/394/EEC, 97/42/EC and 1999/38/EC into national law continue to apply.



Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2004/37/EC


Directive 90/394/EEC: 31.12.92
Directive 97/42/EC: 27.06.00
Directive 1999/38/EC:

OJ L 158 of 30.04.2004

Related Acts

Council Directive 1967/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [Official Journal L 196 of 16.08.1967]

Directive of the European Parliament and the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [Official Journal L 200 of 30.07.1999]