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Directive 2004/37/EC - carcinogens or mutagens at work

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) Directive 89/391/EEC) as last amended by Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017.

Note: This Directive replaces Directive 90/394/EEC and its subsequent amendments (Directive 97/42/EC and Directive 1999/38/EC).


This Directive covers the protection of workers from health and safety risks from exposure to carcinogens or mutagens at work. This Directive does not apply to workers exposed to radiation for cases covered by the Euratom Treaty.


Definition of ”limit value”, ”carcinogen” and ”mutagen”. Reference is made to Regulation (EC) No 1272/2008.


The employer shall assess and manage the risk of exposure to carcinogens or mutagens. This process shall be renewed regularly and data shall be supplied to the authorities upon request. Special attention should be paid to investigate and take account of all possible ways of exposure (including all skin-related possibilities), and to persons at particular risk.

Workers' exposure must be prevented. If replacement is not possible, the employer shall use a closed technological system. The employer shall reduce the use of carcinogens or mutagens by replacing them with a substance that is not dangerous or less dangerous.

Where a closed system is not technically possible, the employer shall reduce exposure to the minimum.

Exposure shall not exceed the limit value of a carcinogen, as set out in Annex III.

Wherever a carcinogen or mutagen is used, the employer shall:

  • Limit the quantities of these carcinogens or mutagens at the place of work;
  • Keep the number of workers exposed as low as possible;
  • Design the work processes so as to minimise the substance release;
  • Evacuate carcinogens or mutagens at source, also respecting the environment;
  • Use appropriate measurement procedures (especially for early detection of abnormal exposures in the event of unforeseeable events or accidents);
  • Apply suitable working procedures and methods;
  • Use individual protection measures if collective protection measures are not enough;
  • Provide the necessary hygiene measures (regular cleaning);
  • Keep workers informed about related issues;
  • Demarcate risk areas and use adequate warning and safety signs (including ”No smoking” signs);
  • Draw up emergency plans;
  • Use sealed and clearly/visibly labelled containers for storage, handling, transportation and waste disposal.

Employers shall make certain information available to the competent authority upon request (activities, quantities, exposures, number of exposed workers, preventive measures) and inform workers if abnormal exposure has happened.

In cases of abnormal exposure or incident, only workers essential for repairs shall be permitted to work in the affected area, and only with appropriate protection. The exposure should not be permanent and shall be minimised.

If a temporary, planned, higher exposure is unavoidable (e.g. as part of maintenance), the employer/management shall consult workers/representatives on the measures which will be taken to minimise exposure, and provide appropriate prevention, together with access control.

If there is a risk to workers, specified areas shall be made accessible solely to workers who, by reason of their work or duties, are required to enter them.

The employer shall take adequate measures to ensure proper hygiene (minimising the risk of contamination with carcinogens/mutagens). Provisions and conditions must be free of charge for the workers, and will include:

  • The prohibition of eating/drinking/smoking in contamination risk areas
  • Provision of appropriate protective clothing
  • Provision of separate storage places for working/protective clothing and for street clothes
  • Acces to appropriate and adequate washing and toilet facilities
  • Availability of cleaned, checked and maintained protective equipment, stored in a well-defined place.

The employer shall also provide appropriate training on potential risks to health, precautions to prevent exposure, hygiene requirements, protective equipment, clothing and incidents handlings.

Employers shall inform workers about objects on site containing carcinogens or mutagens, and label them clearly and legibly, together with warning and hazard signs. Employers shall inform workers and/or representatives about abnormal exposure incidents as quickly as possible.

Workers and/or any workers' representatives shall control and be involved in the application of this Directive.

Employer will keep an up-to-date list of workers exposed, and will give specified access to data to authorized persons (doctor, authorities, workers and representatives).

Consultation and participation of workers shall take place in accordance with Directive 89/391/EEC.

The Member States shall establish arrangements for health surveillance of workers if there is a risk to their health and safety (prior to exposure, at regular intervals thereafter; and even after the end of exposure - if this is requested by the responsible doctor/authority). If a worker is suspected of suffering ill-health due to exposure, then the subsequent health surveillance of other exposed workers may be required, and the risk shall be reassessed. Individual medical records of health surveillance shall be kept.

Information and advice must be given to workers regarding any health surveillance that they may undergo following the end of exposure. Workers shall have access to the results of the health surveillance that concern them. Workers concerned, or the employer, may request a review of the results of the health surveillance. All cases of occupational cancers shall be notified to the competent authority. Records shall be kept for at least 40 years following the end of exposure, and transferred to the authority concerned if the firm ceases to exist.

Member States have to comply with the 2017 amendments in scope by 17 January 2020. Transitional measures (graded lowering of the limit values) apply to hardwood dusts and Chromium (VI).


ANNEX I: List of substances, mixtures and processes

  1. Manufacture of auramine.
  2. Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch.
  3. Work involving exposure to dusts, fumes and sprays produced during the roasting and electro-refining of cupro-nickel mattes.
  4. Strong acid process in the manufacture of isopropyl alcohol.
  5. Work involving exposure to hardwood dusts.
  6. Work involving exposure to respirable silica dust generated by a work process

ANNEX II: Practical recommendations for the health surveillance of workers

ANNEX III:  Limit values and other directly related provisions (in 2017 binding limit values and skin notations were reviewed/set for the following agents)

  • Hardwood dusts
  • Chromium (VI) compounds
  • Refractory ceramic fibres
  • Respirable crystalline silica dust
  • Benzene
  • Vinyl chloride monomer
  • Ethylene oxide
  • 1,2-Epoxypropane
  • Acrylamide
  • 2-Nitropropane
  • o-Toluidine
  • 1,3-Butadiene
  • Hydrazine
  • Bromoethylene

ANNEX IV: Repealed Directive and its successive amendments

ANNEX V: Correlation table

Read the full text of the last consolidated version of the Directive (including later amendments)

Read the full text of the original Directive (without amendments)

National laws implementing this Directive

Further information on this topic

See also further documents on that topic:

Health, socio-economic and environmental aspects of possible amendments to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at work (2011) Executive summary reports: German, English, French

Guidance for National Labour Inspectors on the interaction of the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH) (Regulation (EC) No. 1907/2006), the Chemical Agents Directive (CAD) and the Carcinogens and Mutagens Directive (CMD)

Evaluation of the Practical Implementation of the EU Occupational Safety and Health (OSH) Directives in EU Member States - Directive on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (2017)