legislation-profile

CMD - Carcinogens and Mutagens Directive

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) (Text with EEA relevance)

Scope

This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens, mutagens or reprotoxic substances at work. It lays down minimum requirements in this area, including limit values (Art. 1 (1)). This Directive shall apply to activities in which workers are, or are likely to be, exposed to carcinogens, mutagens or reprotoxic substances as a result of their work (Art. 3(1)). Art. 2(a), Art. 2(b), and Art. 2(ba) provide definitions respectively for ‘carcinogen’, ‘mutagen’, and ‘reprotoxic substance’, which define the scope of the CMRD.

Exemptions

The Directive shall not apply to workers exposed only to radiation covered by the Treaty establishing the European Atomic Energy Community (Art.1 (2)). As regards asbestos, which is dealt with by Directive 2009/148/EC, the provisions of this Directive shall apply whenever they are more favourable to health and safety at work (Art. 1(4)).

Regulatory activities

1. Risk assessment by employer In the case of any activity likely to involve a risk of exposure to carcinogens, mutagens or reprotoxic substances, the nature, degree and duration of workers’ exposure shall be determined in order to make it possible to assess any risk to the workers’ health or safety and to lay down the measures to be taken. The assessment shall be renewed regularly and, in any event, when any change occurs in the conditions which may affect workers’ exposure to carcinogens, mutagens or reprotoxic substances (Art. 3(2)). 2. Prevention and reduction of exposure Where the results of the assessment referred to in Art. 3(2) reveal a risk to workers’ health or safety, workers’ exposure must be prevented (Art. 5(1)). Where it is not technically possible to replace the carcinogen, mutagen or reprotoxic substance by a substance, mixture or process which, under its condition of use, is not dangerous or is less dangerous to health or safety, the employer shall ensure that the carcinogen, mutagen or reprotoxic substance is, in so far as is technically possible, manufactured and used in a closed system (Art. 5(2)). Where a closed system is not technically possible, the employer shall ensure that the level of exposure of workers is reduced as low a level as is technically possible (Art 5(3)). Exposure shall not exceed the limit value of a carcinogen as set out in Annex III (Art. 5(4)). 3. Submission of information for the competent authorities by employer Where the results of the assessment referred to in Article 3(2) reveal a risk to workers' health or safety, employers shall, when requested, make them available to the competent authority (Art. 6). 4. Information and training of workers Appropriate measures shall be taken by the employer to ensure that workers and/or workers' representatives in the undertaking or establishment receive sufficient and appropriate training (Art. 11 (1)). 5. Member State Health surveillance The MS shall establish, in accordance with their national laws and/or practice, arrangements for carrying out relevant health surveillance of workers (Art. 14).

Relevant product types

No reference data required

Reference documents

Yes Directive 2009/148/EC Regulation (EC) No 1272/2008

Obligations based on CLP hazard class

Yes Definitions of ‘carcinogen’, ‘mutagen’, ‘reprotoxic substance’, ‘threshold reprotoxic substance’ and ‘non-threshold reprotoxic substance’ Reference is made to Regulation (EC) No 1272/2008

Obligations based on properties of concerns

Yes Article 3- Determination and assessment of risks

EU-level occupational exposure limits

Yes Annex III of the Directive

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

Not in place

Industry submission system in place

Not in place

Format for industry submission

Not specified

Owner

Directorate-General for Employment, Social Affairs and Inclusion (DG EMPL)

Update process

According to Article 16 of the Directive, the European Parliament and the Council shall, in accordance with the procedure laid down in Article 153(2), point (b), of the TFEU set out limit values in Directives on the basis of the available information, including scientific and technical data, in respect of all those carcinogens, mutagens or reprotoxic substances for which this is possible, and, where necessary, other directly related provisions. The Commission is empowered to adopt delegated acts in accordance with Article 17a to make strictly technical amendments to Annex II, in order to take account of technical progress, changes in international regulations or specifications and new findings with regard to carcinogens, mutagens or reprotoxic substances (Art. 17(1).

Amendments

Corrigendum to 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) Directive 2014/27/EU of the European Parliament and of the Council of 26 February 2014 Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017 Directive (EU) 2019/130 of the European Parliament and of the Council of 16 January 2019 Directive (EU) 2019/983 of the European Parliament and of the Council of 5 June 2019 Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 Directive (EU) 2024/869 of the European Parliament and of the Council of 13 March 2024