Executive Summary Sheet

Impact assessment on further Proposal to amend the annexes to the Carcinogens and Mutagens Directive

A. Need for action

Why? What is the problem being addressed?

Exposure to some chemical agents in the workplace can cause cancer, which is the first cause of work-related deaths in the EU. Every hour in EU28, 7-12 people die of cancer because of past exposure to carcinogenic substances at work. To protect workers against such risks, the EU has adopted the Carcinogens and Mutagens Directive (CMD), which sets out steps to be taken to eliminate or limit exposure to carcinogenic chemical agents and includes Occupational Exposure Limit (OEL) values. However, the CMD needs to be updated. The Commission has conducted a scientific and economic assessment of 25 priority chemical agents to which around 20 million workers are exposed in the EU. Out of those, 13 agents, were covered in an earlier Commission proposal (COM(2016)248) and accompanying impact assessment (IA) (SWD(2016)152). This supplementary IA applies the same methodology for the remaining substances.

What is this initiative expected to achieve?

The initiative pursues three specific objectives: To further improve protection from occupational exposure to chemical carcinogens in the European Union; To increase the effectiveness of the EU framework by updating it on the basis of scientific expertise; To ensure more clarity, facilitate implementation, and contribute to a level playing field for economic operators by reducing divergences in national protection levels.

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

Compliance and enforcement of the provisions of the CMD, and thereby workers protection, can be facilitated and improved by identifying and listing occupational carcinogens as process-generated substances (PGS) in Annex I to the Directive, and by revising existing or establishing new OELs in Annex III to the Directive. By providing adequate common definitions of PGS and 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 against the risks arising from occupational exposure to carcinogens. Competitive differences between firms located in Member States with different national limit values may be reduced through the establishment of clear specific minimum requirements for worker protection in the form of EU-wide limit values for those agents. 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. 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 seven out of the 12 carcinogens (OELs in Annex III and/or inclusion in Annex I) 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 several 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. With regard to five remaining carcinogens (diesel engine exhaust, rubber process dust and fumes, beryllium and inorganic beryllium compounds, 4,4'-Methylene-bis-(2 chloraniline) (MOCA) and hexachlorobenzene) action through amendment of the CMD is withheld at this stage due to legal considerations or absence of agreed position in the Advisory Committee on Safety and Health at Work.

Who supports which option?