Opinion from German Social Insurance
issued 17 October 2025
Amendment of Directive 2004/37/EC concerning the inclusion of substances and the establishment of limit values in Annexes I, III and IIIa.
Preliminary remark
On 18 July 2025, the European Commission presented a proposal to amend the Directive on Carcinogens, Mutagens and Reprotoxic Substances (CMRD)1 as regards the addition of substances and setting limit values in its Annexes I, III and IIIa. With this 6th amendment to the CMRD, limit values are to be introduced for cobalt and inorganic cobalt compounds, polycyclic aromatic hydrocarbons (PAHs), and 1,4-dioxane. In addition, work involving exposure to fumes from welding processes is to be included in Annex I, and the existing entry for mercury and divalent inorganic mercury compounds in Annex III is to be corrected.
The German Social Insurance (DSV) welcomes the European Commission’s aim of continuously improving occupational safety and health. Protecting workers from carcinogenic, mutagenic, or reprotoxic substances (CMR substances) is a key contribution to preventing work-related illnesses. Uniform limit values across Europe not only protect employees’ health but also ensure reliable framework conditions and a level playing field for companies in Europe. The expansion of the scope to include cobalt, PAHs, 1,4-dioxane, and activities involving welding fumes therefore represents an important step forward. Nevertheless, from the DSV’s perspective, several points must be taken into account in the further legislative process. These include the effective use of transitional periods to promote innovation and substitution, strengthening occupational safety expertise within the European Chemicals Agency (ECHA), and addressing the specific requirements of activities involving exposure to welding fumes.
Opinion
Work involving welding fumes
The European Commission proposes to include work involving exposure to welding fumes containing CMR substances in Annex I of the CMRD. The DSV supports this proposal and advocates that these provisions remain unchanged in the further legislative process. The DSV also welcomes the Commission’s decision not to introduce a general occupational exposure limit value for welding fumes.
Depending on the welding process used, as well as on the base materials (for example, the metals or alloys being welded) and filler materials (for example, electrodes, welding wires, or rods), the composition of welding fumes is highly heterogeneous. Therefore, Germany has no uniform limit value for “welding fumes” as such. Instead, the general dust limit value (for respirable dust) applies. The toxicologically relevant components of welding fumes are assessed individually, and concrete protective measures to minimise exposure are derived on this basis.
To improve health protection across Europe and to optimise welding processes, the DSV suggests further promoting the exchange of best practice examples. In Germany, for instance, the statutory accident insurance, together with partners,2 is engaged in the “SAFE WELDING” (“SICHER SCHWEISSEN”) initiative.3 Its goal is to actively bring the topic into workplaces, raise employee awareness, reduce welding fume emissions and exposure, and thereby effectively minimise health risks. A key element of this initiative is the Welding Fume Reduction Programme, which follows a holistic approach that considers all relevant factors from emission reduction and the design of working conditions to the use of appropriate protective measures and workplace cleanliness. Even easily implementable measures – such as avoiding stirred-up dust, optimising workflows, or adjusting positions during welding—can significantly reduce exposure.
Limit values
The DSV explicitly supports the European Commission’s proposal to introduce new occupational exposure limit values for cobalt and inorganic cobalt compounds,4 PAHs,5 and 1,4-dioxane.6 This is particularly relevant for cobalt and its inorganic compounds, as demand for cobalt will rise significantly during the green transition – driven especially by the increasing need for batteries, the shift from fossil fuels to alternative technologies, and the growing importance of recycling and recovery of critical raw materials. The proposed limit values will substantially increase the level of protection for many workers across Europe – for example, for employees in pharmaceutical production, laboratories, and the chemical industry in the case of 1,4-dioxane, and for fire brigades, automotive maintenance and repair work, and road construction in the case of PAHs. In Germany, biological and occupational exposure limit values already exist for the substances addressed in the proposed 6th amendment to the CMRD, and in many cases these regulations are among the strictest in the EU.
The DSV emphasises that the planned transitional provisions must be actively used to advance substitution processes and promote innovations that will enable safer alternatives in the long term. The objective should be to ensure consistent implementation of the limit values in all affected sectors. To achieve this, accompanying measures – such as advisory services provided by the German statutory accident insurance – are indispensable. In addition, EU funding programmes can specifically help support investments in occupational safety.
Occupational safety expertise within ECHA
The DSV is committed to ensuring that the ECHA possesses the necessary expertise in all relevant areas to carry out substance assessments on a sound and comprehensive basis. For the work of the Committee for Risk Assessment (RAC), it is crucial that, alongside hazard identification of a substance, extensive knowledge about workplace exposure to hazardous substances, as well as occupational medical and epidemiological expertise, is included in the evaluation. Since 2019, the RAC has supported the Directorate-General for Employment, Social Affairs and Inclusion (DG EMPL) of the European Commission and has made a significant contribution to the scientific assessment of the potential health effects of occupational exposure to chemicals.
About us
The German Federal Pension Insurance (DRV Bund), the German Social Accident Insurance (DGUV), the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the national associations for statutory health and long-term care insurance funds at the federal level and the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) have joined forces to form the "German Social Insurance - Working Group Europe" (Deutsche Sozialversicherung Arbeitsgemeinschaft Europa e. V.) with a view to their common European policy interests. The association represents the interests of its members vis-à-vis the bodies of the European Union (EU) as well as other European institutions and advises the relevant stakeholders in the context of current legislative projects and initiatives. As part of the statutory insurance system in Germany, health and long-term care insurance with 75 million insured persons, pension insurance with 57 million insured persons and accident insurance with more than 70 million insured persons in 5.2 million member companies offer effective protection against the consequences of major risks of life.