This document is an excerpt from the EUR-Lex website
Exposure to carcinogens and mutagens
Exposure to carcinogens and mutagens
WHAT IS THE AIM OF THE DIRECTIVE?
It sets out the minimum requirements for protecting workers against risks to their health and safety arising, or likely to arise, from exposure to carcinogens* and mutagens* at work. To reduce the risks associated with such exposure to workers’ health and safety, it lays down preventive and protective measures, as well as exposure limits.
The directive applies to a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen or category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008 (Classification, packaging and labelling of chemicals and their mixtures). In addition, it applies to a carcinogenic substance, mixture or process referred to in Annex I to the directive, as well as a substance or mixture released by a process referred to in that annex. Following the amendment of the directive in 2017, this annex contains 6 entries:
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 which generates respirable crystalline silica dust.
The directive does not apply to workers exposed only to radiation covered by the Treaty establishing the European Atomic Energy Community.
It applies to workers exposed to asbestos when its rules are more favourable to health and safety at work than those of Directive 2009/148/EC (Workers' protection from exposure to asbestos).
Directive 89/391/EEC (Health and safety at work — general rules) applies in full, without prejudice to more binding and/or more specific rules contained in this directive.
Determining exposure and assessing risks
In the case of any activity likely to involve a 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.
Directive 2014/27/EU aligns Directive 2004/37/EC to Regulation (EC) No 1272/2008 which established a new system for the classification, labelling and packaging of substances and mixtures in the EU, based on the Globally Harmonised System of Classification and Labelling of Chemicals at international level.
Directive (EU) 2017/2398 updates Directive 2004/37/EC by:
Reduction and replacement
Employers must reduce the use of a carcinogen or mutagen, particularly by replacing it, in so far as is technically possible, by a substance, mixture or process that is not dangerous or is less dangerous.
Prevention and reduction of exposure
When it is not possible to replace the carcinogen or mutagen, the employer 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.
Several measures must be applied by the employer whenever a carcinogen or mutagen is used.
Information for the competent authority
Employers must provide the competent authority, on request, with information relating to such matters as, for instance, the reasons for using carcinogens or mutagens, the preventive measures taken or the number of workers exposed.
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 and only workers who are essential for the work shall be permitted to work in the concerned area.
Where there is a foreseeable risk of increased exposure, for example, during maintenance work, and after all other preventive measures have been taken, employers must decide the measures necessary to reduce the duration of workers’ exposure to the minimum possible and to ensure that they are protected during these activities. Protective clothing and individual 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 demarcated and indicated.
Access to risk areas
Employers must restrict access to risk areas to those 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:
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:
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 check 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.
EU countries must establish arrangements for monitoring workers’ health so that, if appropriate, their health is adequately monitored prior to exposure and at regular intervals afterwards. These arrangements 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.
Following the amendment of Directive 2004/37/EC by Directive (EU) 2017/2398, health monitoring can, at the advice of a doctor or authority responsible for the health monitoring of workers, continue after the end of exposure for as long as considered to be necessary to safeguard the health of the worker concerned.
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. EU countries must take this information into account in their reports submitted to the European Commission under Directive 89/391/EEC.
Directive (EU) 2017/2398 requires the Commission to evaluate, as part of the next evaluation of the implementation of Directive 2004/37/EC, the need to modify the limit value for respirable crystalline silica dust.
In addition, by the first quarter of 2019, the Commission must, taking into account the latest developments in scientific knowledge, assess the option of amending the scope of this directive to include reprotoxic substances*.
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.
Following the amendment of the Directive in 2017, Annex III contains the limit values for the following substances:
For vinyl chloride monomer and hardwood dusts, Directive (EU) 2017/2398 revises the limit values in the light of more recent scientific data. For 11 new carcinogens, occupational exposure limit values were introduced.
FROM WHEN DOES THE DIRECTIVE APPLY?
It has applied since 20 May 2004. Directive 2004/37/EC codifies and replaces Directive 90/394/EEC and its successive amendments, Directives 97/42/EC and 1999/38/EC. The deadlines for those directives to become national law (29 April 2003 at the latest) continued to apply.
EU countries have to incorporate the measures introduced by Directive (EU) 2017/2398 into national law by 17 January 2020.
For more information, see:
Directive 2004/37/EC of the European Parliament and of 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) (codified version) (OJ L 158, 30.4.2004, pp. 50-76). Text published in corrigendum (OJ L 229, 29.6.2004, pp. 23-34)
Successive amendments to Directive 2004/37/EC have been incorporated in the original text. This consolidated version is of documentary value only.
Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (OJ L 345, 27.12.2017, pp. 87-95)
Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, pp. 28-36)
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1-1355)
See consolidated version.
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, pp. 1-8)
See consolidated version.
last update 20.04.2018