Faster Testing for more Substances – Potential for an Improved Regulation of Chemicals

On November 7, 2024, Helmholtz SynCom hosted a Parliamentary Evening under the patronage of Harald Ebner, MP at the German Parliamentary Society. The event addressed the urgent need for faster and more efficient chemical regulation in Germany and Europe.

Despite the political turbulences caused by the government coalition’s breakup just the day before, it was decided not to cancel the event. Both Harald Ebner and Helmholtz SynCom agreed: Even in times of crisis, dialogue must continue, and we must work together on solutions and innovations that balance ecological and economic needs. This decision was welcomed by the members of parliament, parliamentary staff, scientists, regulatory authorities, industry representatives, and NGOs who engaged into the lively discussion.

Following Harald Ebner’s opening remarks, three presentations by Helmholtz researchers Dr. Pia-Johanna Schweizer, Prof. Dr. Beate Escher, and Prof. Dr. Sina Leipold were held. The central message of the evening was that current methods for chemical assessment are inadequate to keep up with the increasing pace and complexity of new substances. New Approach Methodologies (NAMs) or In Vitro Assays, were highlighted as crucial tools to more efficiently and rapidly identify hazardous chemicals.

Dr. Pia-Johanna Schweizer from the Research Institute for Sustainability – Helmholtz Centre Potsdam (RIFS) gave an overview on the environmental chemicals issue. She presented findings from the ModHaz project, explaining how a co-creative process was used to align the interests of industry, NGOs, scientists, and regulatory authorities to develop practical solutions for chemical assessment. Schweizer emphasized that dialogue among diverse stakeholders is vital for overcoming regulatory barriers and paving the way for innovative approaches like NAMs.

Prof. Dr. Beate Escher from the Helmholtz Centre for Environmental Research (UFZ) stressed the need for modern, efficient chemical assessment methods due to the growing complexity and number of substances. She demonstrated how broader use of NAMs could replace animal testing with faster and more resource-efficient alternatives, thus addressing critical gaps in current regulations. Escher focused particularly on the concepts of 'Cumulative Toxicity Equivalents' (CTE) and 'Persistent Toxicity Equivalents' (PTE). The combination of these concepts allows for the evaluation of chemical persistence and toxicity characteristics and is applicable to individual substances, mixtures, and substances that are difficult to analyze. She illustrated how NAMs can prevent 'regrettable substitutions', where one harmful substance is replaced by another equally hazardous one, using examples such as PFAS and Bisphenol-A alternatives. She also pointed out that regulatory acceptance of NAMs is often hindered by limited resources and conservative structures within agencies – a concern echoed by attendees in the later discussion.

Prof. Dr. Sina Leipold from the UFZ explored how Germany could take a leading role in European chemical regulation and promote NAMs. She emphasized the economic and political influence of the German chemical sector in Europe. Germany could contribute more actively to expert groups at the EU level (such as CARACAL) to modernize the REACH regulation and integrate NAMs systematically. Faster incorporation of NAMs into REACH could reduce the risks posed by hazardous chemicals, especially from mixture effects. Leipold discussed strategic approaches identified in stakeholder workshops, such as "chemical simplification," which involves reducing the number and diversity of chemicals used in products to lower exposure to harmful substances. Alternatively, there is the strategy of enhancing chemical diversity to support Germany and Europe’s competitiveness and to provide the material basis for sustainable technological innovations. She highlighted the importance of considering mixture effects in regulation and noted that science is already able to offer knowledge and methodologies for safer chemical governance.

Key points were further discussed:

• Mechanisms of NAMs: How to investigate the specific characteristics of substances and the variations between different compounds.
• Ways to introduce NAMs into regulation: Their potential role in relation to Classification, Labeling, and Packaging regulations. Should new labels and limits be introduced, or should NAMs serve as preliminary tests for further evaluation steps?
• Validation and Regulatory Hesitancy: Steps necessary to accelerate regulatory acceptance of NAMs.
• Industry Implementation: How to support companies in integrating NAMs into their processes without jeopardizing competitiveness.

The attendees expressed the evening’s enriching contribution. The scientific presentations, the discussions, and the involvement of diverse sectors – science, industry, regulatory authorities, and politics – were particularly appreciated. There were also suggestions to make the demands more concrete, especially tailored towards decision-makers at the EU level.

The evening concluded with informal conversations that further deepened the exchange between science, politics, and industry. The event showed the importance of interdisciplinary and cross-institutional dialogue to sustainably address pressing challenges like chemical regulation.