Feedback from German Social Insurance dated 20 March 2024
European Commission proposal for a Regulation establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals
Preliminary remarks
The German Social Insurance (DSV) welcomes the Commission's initiative to establish a standardised platform for chemicals in order to make data traceable, accessible, interoperable and reusable for interested parties.
To date, the assessment of chemicals has been a largely non-transparent process. This is especially due to the fact that the basis for the assessment is not publicly available. The planned initiative and the resulting access to all available information within the database would not only create more transparency, but also make the assessment of chemicals more comprehensible. This could help to increase the overall acceptance of the assessment process of chemicals.
Opinion
With regard to the management of the data platform, we consider the establishment of a steering committee to be valuable. Nevertheless, the DSV believes that the requirements for the composition of the committee should be scrutinised and reconsidered. The involvement of the Commission is generally to be considered sensible. Nevertheless, the committee that is to advise the European Commission on the governance structure of the data platform in future in accordance with Article 4(3) of the proposed Regulation should be made up predominantly of representatives of the agencies, and therefore stem from the specialist area. In our view, advice, for example on the standard data formats and scientific vocabulary used, can best be provided by those who actually use the information on the data platform in practice.
The DSV expressly supports the request to the European Environment Agency (EEA) to compile and/or collect more data on human bio-monitoring, as provided for in Article 6. The same applies to the request to the European Chemicals Agency (ECHA) for data on air monitoring provided for in Article 7 of the proposal on the Information Platform for Chemicals Monitoring (IPCHEM). Determining the data can help to better verify the state of the art. Comparable data on exposure to hazardous substances also help in intensifying efforts to raise occupational health and safety to a higher and more uniform level across the EU.
The DSV continues to support the planned introduction of a standardised format for chemical data and the use of standardised terms in accordance with Chapter III of the proposed Regulation. This is the only way to ensure the cross-divisional utilisation and correct use of the available data.
However, with regard to the access rights currently provided for in Article 16 of the proposed Regulation, the DSV rejects exclusive access of the public authorities to the complete database. In the same way as authorities, scientific bodies such as the German Research Foundation’s Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) and statutory insurers should be granted full access. In contrast, we believe that limited public access to the data platform is justifiable.
The DSV welcomes the fact that the planned data platform may enable ECHA to establish an early warning system for identifying (new) hazards from chemicals due to the improved availability of data.
In this context, however, we would like to point out that an early warning system can only work if qualitative and usable data are available. However, the data generation mechanism provided for in Article 21(3) of the proposed Regulation restricts the functioning of the early warning system. This needs to be reconsidered. The inclusion of incomplete data should be avoided. ECHA should therefore also be authorised to commission scientific studies if the data available is limited, incomplete or restricted to a specific area.
Furthermore, we consider it essential to ensure that the independence of ECHA and its processes is maintained, and that the necessary expertise is available to assess a substance in relation to all the different areas. One example of this is the task of the former Scientific Committee on Occupational Exposure Limits (SCOEL). In addition to the risk assessment of a substance, its assessments also include comprehensive expertise regarding exposure to hazardous substances in companies, as well as occupational medical and epidemiological expertise.
In our view, the comprehensive transfer of power to the European Commission to adopt the entire processes and implementation strategies on the basis of delegated acts provided for in Chapter VIII must be viewed extremely critically in the context of the short-term transfer of numerous tasks to the ECHA. This applies even if this is only intended for a period of five years. This is because the involvement of the European Parliament would be reduced to an objection. Delegated acts serve to supplement or amend certain non-essential provisions of a legislative act, but there are indications of a broad approach here.
Finally, it should be emphasised that the increase in workload resulting from the allocation of additional tasks and responsibilities, particularly to the ECHA and the EEA, will be acknowledged and taken into account with appropriate funding for staff and other costs. Accordingly, the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the Commission's Joint Research Centre (JRC) also recognise and pay for additional work. The DSV believes that this should also apply to the European Agency for Safety and Health at Work (EU-OSHA). The EU-OSHA should therefore be strengthened on an equal footing and be appropriately staffed and funded. Only a joint and comprehensive consideration of all areas involved can ensure success of the initiative.
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 74 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.