Executive Summary Sheet

Impact assessment on further Proposal to amend the annexes to the Carcinogens and Mutagens Directive 2004/37/EC.

A. Need for action

Why? What is the problem being addressed?

Exposure to carcinogens and mutagens at the workplace can cause cancer, which is the main work-related health problem in the EU-28, as well as other significant non-cancer health problems. To contribute to the protection of workers from such risks, the EU has adopted the Carcinogens and Mutagens Directive 2004/37/EC (CMD). It lays down requirements in this area to eliminate or reduce exposure, including occupational exposure limit values (OELs). However, CMD needs to be regularly updated based on available information, including scientific and technical data. Two legislative proposals updating the CMD - COM(2016)248 and COM(2017)11, addressing together 20 carcinogens, have been proposed. The first amendment has already been adopted by the co-legislators – Directive (EU)2017/2398. This impact assessment accompanying the third proposal covers further five chemical agents to which around 1 000 000 workers are exposed at their workplaces.

What is this initiative expected to achieve?

The initiative pursues three specific objectives: ·To reduce occupational exposure to carcinogens and mutagens in the European Union; ·To increase the effectiveness of the EU framework by updating it on the basis of scientific expertise; ·To achieve a more balanced protection of workers across the EU against carcinogens while ensuring more clarity and level playing field for economic operators.

What is the value added of action at the EU level?

Establishing new or revising the existing OELs in Annex III to the Directive will provide more clarity for employers and enforcers, thus facilitating and improving compliance and enforcement of the provisions of the CMD, and thereby workers protection. By lowering existing and closing gaps of non-existing national OELs, EU action can contribute to further enhancing the minimum basis of protection for all EU workers in this area and to level the playing field among EU businesses. Action taken by Member States alone cannot address these concerns, and consequently EU level action to achieve this objective appears necessary and in line with Article 5(3) of the TEU.

B. Solutions

What legislative and non-legislative policy options have been considered? Is there a preferred choice or not? Why?

A number of options were identified and discarded for the covered carcinogens. For example, banning them from the workplace was considered disproportionate and reliance on non-legislative guidance or on self-regulation would not be able to substantially contribute to the solving of the identified problems. Proposals for legislative options with regard to five carcinogens (OELs in Annex III) were based on the outcomes of discussions by scientists, employers, workers and Member States' representatives. For most of the carcinogens more stringent and less stringent options were also analysed. The retained options are considered complementary and to add value to existing REACH measures in the relevant cases. Legal certainty for stakeholders is best achieved through clear listing of chemical agents under the CMD together with OELs allowing management of the risk of occupational exposure to chemical carcinogens.

Who supports which option?