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2016/0130(COD) - 13/05/2016 Legislative proposal

PURPOSE: to improve workers’ health protection by reducing occupational exposure to carcinogenic chemical agents.

PROPOSED ACT: Directive of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Directive 2004/37/EC aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace and lays down minimum requirements to that effect including limit values, on the basis of the available scientific and technical data.

The provisions of the Directive apply to any chemical agent that meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 (CLP).

Estimates of the recent and future  burden  of occupational  diseases indicate that work-related cancer  is a problem and will remain so in the future as a result of exposure of workers to carcinogens. Cancer is the first cause of work-related deaths in the EU. Annually, 53 % of occupational deaths are attributed to cancer, compared with 28% for circulatory diseases and 6% for respiratory diseases.

Ensuring a safe and healthy work environment for over 217 million workers in the EU is a strategic goal for the Commission according to its recent Communication on the EU Strategic Framework on Health and Safety at Work 2014 – 2020 (setting out an occupational health and safety strategy).

Occupational exposure limit values set under the Directive 2004/37/EC should when appropriate be revised to take into account new scientific data, improvements in measurement techniques, risk management measures and other relevant factors.

IMPACT ASSESSMENT: as regards respirable crystalline silica dust, the option maintained is the one which includes the possibility of inclusion in Annex I to the Directive together with the establishment of a limit value for respirable crystalline silica dust (respirable fraction) in Annex III.

The limit values to be introduced in Annex III proposed in this initiative and agreed by the Advisory Committee on Safety and Health at work (ACSH).

According to the impact assessment, this is estimated to save around 100 000 lives by 2069. As regards the impact on workers, this proposal should result in benefits in terms of preventing workers from getting avoidable work-related cancer, and thus preventing unnecessary suffering and illness. In addition, this proposal would also prevent unnecessary health costs, as follows: 

  • respirable crystalline silica dust: the proposed limit value at 0.1 mg/m3 will provide for 99,000 avoided cancer cases by 2069 for a total monetized health benefit quantified between EUR 34 and 89 billion;
  • hardwood dust: a limit value of 3 mg/m3 will provide for a total monetized health benefit between EUR 12 and 54 million; benefits are also expected in relation to introducing an exposure limit value at 0.025 mg/m3 for all chromium (VI) compounds.

CONTENT: the proposal seeks to revise the limit values in Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work and to revise or to introduce exposure limit values for 13 chemical agents. More specifically, it aims to:

  • include in Annex I to the Directive work involving exposure to respirable crystalline silica dust generated by a work process and establish a corresponding limit value in Annex III. The words ‘respirable crystalline silica dust’ used in Article 1 refer to the dust particles that reach the alveoli;
  • establish in Annex III limit values for further 10 additional carcinogens: certain chromium compounds (VI); some refractory ceramic fibers; 1,2-epoxypropane, 1,3-butadiene, 2 nitropropane; Acrylamide; Bromoethylene; Chromium VI; Ethylene oxide; Hydrazine; o-toluidine. It is appropriate to establish a limit value for hydrazine and to assign to it a notation indicating the possibility of significant dermal uptake. A skin notation assigned to a limit value identifies the possibility of significant uptake through the skin;
  • revise the existing limit values for hardwood dusts and vinyl chloride monomer in the light of available scientific data.

This proposal leaves Member States the possibility to keep or set more favourable standards for workers and the flexibility to take into account specific features in their national situation.

The limit values set in this Directive will be kept under review in the light of the implementation of Regulation (EC) No 1907/2006, in particular to take account of the interaction between limit values set out under Directive 2004/37/EC and DNELs (Derived No Effect Levels) derived for hazardous chemicals under that Regulation.