Coordination and Assessment Strategies

Coordination and administrative tasks

The unit Coordination and Assessment Strategies coordinates the processes for human health risk assessment of chemicals, fibres and particles under Regulation (EC) 1272/2008 (CLP) and Regulation (EC) 1907/2006 (REACH) in line with the legal tasks of the BfR acc. to the German Chemicals Act (ChemG), as well as other departmental or interdepartmental statements with the participation of the Department of Chemical and Product Safety.

At the global level, the unit coordinates the contributions from the BfR to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) and to the Working Party on Manufactured Nanomaterials (WPMN) of the Organisation for Economic Co-operation and Development (OECD).

Further administrative tasks of the unit include participation in quality management according to DIN EN ISO 9001 and DIN EN ISO/IEC 17025 as well as IT coordination for the Department of Chemical and Product Safety.

Science and Research

Scientists of the unit support the lead Unit Safety of Chemicals with the risk assessment of chemicals under REACH and CLP. In addition, the unit also leads the interdisciplinary development of within the Department of concepts for identifying priority substances and products in need of further regulation.

The research work in the unit focuses on the further development of testing and assessment strategies for the health evaluation of chemicals, with an emphasis on the acceptance of so-called "New Approach Methodologies" (NAMs) for the transformation of regulatory practice towards a "Next-Generation Risk Assessment" (NGRA):

• Together with its Portuguese partner agency INSA, the Division leads Task 2.2 ("Knowledge Management and Uptake into Policy") in Work Package 2 ("A Common Science-Policy Agenda") of the European Partnership for the Assessment of Risks from Chemicals (PARC). The focus here is on work on a concrete roadmap for establishing NGRA as a standard approach in European legislation, as well as the provision of a knowledge management and community platform (PARCopedia, from November 2023) for all actors professionally involved in the risk assessment of chemicals.
• In the EU Horizon2020 project PANORAMIX, the unit is leading work package 7, in which case studies on NAM-based risk assessment of real-life mixtures are being prepared.
• As a contribution to the Horizon2020 project RISK-HUNT3R, research is being carried out on the development of in vitro test methods for the detection of possible epigenetic effects of chemicals. The unit is also involved in this project in an advisory capacity via the Scientific and Regulatory Advisory Board (SRAB).

Publications

Escher BI et al. (2022): Mixture Risk Assessment of Complex Real-Life Mixtures - The PANORAMIX Project. https://doi.org/10.3390/ijerph192012990

Escher SE et al. (2019): Towards grouping concepts based on new approach methodologies in chemical hazard assessment: the read-across approach of the EU-ToxRisk project. https://doi.org/10.1007/s00204-019-02591-7

Herzler M et al. (2021): The “EU chemicals strategy for sustainability” questions regulatory toxicology as we know it: is it all rooted in sound scientific evidence? https://doi.org/10.1007/s00204-021-03091-3

Krebs A et al. (2019): Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data. https://doi.org/10.14573/altex.1909271

Marx-Stoelting P et al. (2023): A walk in the PARC: developing and implementing 21st century chemical risk assessment in Europe. https://doi.org/10.1007/s00204-022-03435-7

Moné MJ et al. (2020): Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience. https://doi.org/10.1007/s00204-020-02866-4

Pallocca G et al. (2022): Next-generation risk assessment of chemicals – rolling out a human-centric testing strategy to drive 3R implementation: The RISK-HUNT3R project perspective. https://doi.org/10.14573/altex.2204051

Rovida C et al. (2020): Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology. https://doi.org/10.14573/altex.1912181

Rovida C et al. (2021): NAM-supported read-across: from case studies to regulatory guidance in safety assessment. https://doi.org/10.14573/altex.2010062

Schmeisser S et al. (2023): New approach methodologies in human regulatory toxicology – not if, but how and when! https://doi.org/10.1016/j.envint.2023.108082

Tralau T et al. (2021): A prospective whole-mixture approach to assess risk of the food and chemical exposome. https://doi.org/10.1038/s43016-021-00316-7