Directive 2004/37/EC - carcinogens or mutagens at work
Note: This Directive replaces Directive 90/394/EEC and its subsequent amendments (Directive 97/42/EC and Directive 1999/38/EC).
Protection of workers against health and safety risks from exposure to carcinogens or mutagens at work. This Directive does not apply to workers exposed to radiation 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, data shall be supplied to authorities at request. Special attention is made to take account of all possible ways of exposure routes (including the skin), 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 a carcinogen or mutagen by replacing it with a substance that is not or less dangerous.
Where a closed system is not technically possible, the employer shall reduce exposure to minimum.
Exposure shall not exceed the limit value of a carcinogen set out in Annex III.
Wherever a carcinogen or mutagen is used, the employer shall:
- limit the quantities of a carcinogen or mutagen at the place of work;
- keep as low as possible the number of workers exposed;
- design the work processes so as to minimise the substance release;
- evacuate carcinogens or mutagens at source, but respect the environment;
- use appropriate measurement procedures (especially for early detection of abnormal exposures from unforeseeable event or accident);
- apply suitable working procedures and methods;
- use individual protection measures if collective protection measures are not enough;
- provide for hygiene measures (regular cleaning);
- inform workers;
- demarcate risk areas and use adequate warning and safety signs (including ”no smoking”);
- draw up emergency plans;
- use sealed and clearly and visibly labelled containers for storage, handling, transportation and waste disposal.
Employers shall make certain information available to the competent authority if requested (activities, quantities, exposures, number of exposed workers, preventive measures) and inform the workers if abnormal exposure happened.
In such cases only workers essential for repairs shall be permitted to work in the affected area, and only with appropriate protection. The exposure may not be permanent and shall be minimised.
If a temporary, planned higher exposure is unavoidable (e.g. maintenance), the employer shall consult workers/representatives on the measures to minimise exposure, and provide appropriate prevention, together with access control.
If there is a risk for workers 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 must be free of charge for the workers:
- prohibition of eating/drinking/smoking in contamination risk areas
- appropriate protective clothing
- separate storage places for working/protective clothing and for street clothes
- appropriate and adequate washing and toilet facilities
- cleaned, checked and maintained protective equipments, 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 equipments, clothing and incidents.
Employers shall inform workers on objects containing carcinogens or mutagens, and label them clearly and legibly, together with warning and hazard signs. Employer shall inform workers and/or representatives on abnormal exposures as quickly as possible.
Workers and/or any workers' representatives shall control and be involved in the application of this Directive.
Employer keeps an up-to-date list of workers exposed, and gives specified access to data for authorized persons (doctor, authority, worker 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 for health and safety (prior to exposure, at regular intervals thereafter; and even after the end of exposure - if indicated by the responsible doctor/authority). If a worker is suspected to suffer ill-health due to exposure, 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 ceased to exist.
Member States have to comply with the 2017 amendments 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
- Manufacture of auramine.
- Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch.
- Work involving exposure to dusts, fumes and sprays produced during the roasting and electro-refining of cupro-nickel mattes.
- Strong acid process in the manufacture of isopropyl alcohol.
- Work involving exposure to hardwood dusts.
- 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
- Vinyl chloride monomer
- Ethylene oxide
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 until 2014)
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)