PARC – Partnership for the Assessment of Risks from Chemicals

One objective of the PARC partnership is to further innovation in chemicals risk assessment. This should enable the sustainable use and management of chemicals while simultaneously protecting human health and the environment. These objectives are to be achieved by strengthening the scientific basis for risk assessment of chemical substances in the EU, by closing data gaps and developing new methods and concepts, and by the joint work of risk assessors and scientists in compiling the necessary data and findings, thus providing risk managers with essential information for decision-making processes. Another priority objective is the continuation of EU-wide human biomonitoring and the development of a sustainable and long-term human-biomonitoring-system in Europe, building on HBM4EU. Furthermore, based on new concepts and data on exposure, the foundations for risk assessment increasingly based on "New Approach Methodologies" (NAMs) (Bajard et al 2023)¹ will be developed and proposals for implementation will be made.

One goal of policy makers around the world is the commitment to a high level of consumer health and environmental protection as well as to sustainable development. As chemicals can have major impacts on human health, the environment and a sustainable development, PARC is central to the development of chemical risk assessment in the European context.

¹ Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations

Framework of the Partnership
In May 2022, the partnership "European Partnership for the Assessment of the Risk from Chemicals" (PARC) was launched, within the EU Horizon Europe programme. The intention of PARC is to serve as a pan-European partnership to support European and national risk assessment and risk management authorities in the field of chemicals assessment. The partnership will span seven years (May 2022 to April 2029) with a total budget of €400 million and is supported by the participating member states or their national partners through a financial contribution of 50 percent. The 27 EU member states, as well as the United Kingdom and Switzerland, are involved in the partnership with varying levels of funding, whereby Germany and France are providing the largest financial contributions. The overall coordination of the PARC partnership has been taken on by France through the French Agency for Food, Environment and Occupational Safety (Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, ANSES). Each participating country is represented by corresponding national governmental authorities, as grant signatories (GS), which for Germany are the German Environment Agency (UBA) and the German Federal Institute for Risk Assessment (BfR). Affiliated entities (AE), in the form of additional national partners, are then in turn connected to each GS. The UBA has six such AE and BfR ten (see section "PARC - National Hub -> Affiliated entities "). Furthermore, the European Environment Agency (EEA), the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) are participating. Finally, five European Directorates General (DGs) of the European Commission provide technical guidance to the partnership: Directorate General for Research and Innovation (DG R&I); Directorate General for Environment (DG ENV); Directorate General for Health and Food Safety (DG SANTE); Directorate General for Internal Market, Industry and Entrepreneurship (DG GROW); and the Joint Research Center (JRC).

Organisational Framework of the Partnership
PARC builds on the work done in HBM4EU, under the European Joint Programme, which was coordinated and led by the Department of Toxicology, Health-Related Environmental Monitoring at UBA (Kolossa-Gehring et al. 2023)². PARC aims to further this work, amongst other, in particular on an EU-wide human biomonitoring system.
In order to fulfil the set goals and meet the research and innovation needs, PARC is divided into nine content-related work packages (WP). These WP cover a broad range of topics on research and methods while considering aspects of sustainability, as well as innovation and integration, and are supplemented by WP for coordination and steering. For the overall steering of PARC, various decision-making bodies have been established in which e. g. representatives of the national ministries of the participating member states partake. For Germany, representatives of the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) and the Federal Ministry of Food and Agriculture (BMEL) participate in these steering bodies.

Content Framework of the Partnership
UBA is represented in eight of the nine WP with a total of 36 employees. Furthermore, UBA has taken on the co-leadership of WP 4 ("Monitoring and Exposure") whereas BfR, as the second GS in Germany, has taken on the co-leadership of WP 5 ("Hazard Assessment"), among other. In WP 4, the exposure of humans and the environment to chemicals will be considered jointly. The studies are focused on the "one-substance-one-assessment approach" (van Dijk et al, 2021)³ with the aim to strengthen the linkage between human health and the environmental data, enabling an integrated assessment. In addition, new methods will be developed and tested in PARC with the goal, inter alia, to improve exposure assessment of particularly vulnerable populations. In WP 4, method development is focused on so-called "screening-methods", which should enable the simultaneous determination of the presence of a large number of chemicals in the environment and in humans. For this purpose, existing monitoring programmes will be further developed and the monitoring results should be systematically used for future authorization of hazardous substances.

² HBM4EU from the Coordinator's perspective: lessons learnt from managing a large-scale EU project
³ Towards ‘one substance – one assessment’: An analysis of EU chemical registration and aquatic risk assessment frameworks 

In Europe, chemicals are registered, evaluated and in some cases require additional approval according to their intended use and often fall under different legal frameworks. While there often are already established legal frameworks for risk assessment for the environmental domain, a comprehensive legal framework for the human health domain is missing, as often not all sources of exposure are considered. Prioritization under PARC for the HBM domain (WP4) builds on work started in HBM4EU for the prioritization of hazardous substances in the human health domain. At the same time, the prioritization in PARC will be coordinated jointly with the environment domain, for which decades of experience already exist. The prioritization criteria of substances, will be based on the hazardous properties of the substance/group of substances, as well as the exposure and/or risks to human health and the environment and their regulatory relevance.

One of the biggest challenges in PARC is to fill data gaps for priority substances, which correspond to each step in the risk assessment process: hazard, exposure (to humans or the environment) and risk assessment. Some substances, such as pesticides and biocides, are already well studied as the toxicity data required by specific legislation are already quite extensive, while for other groups of substances data are almost non-existent. Depending on data availability, the different areas in PARC (WP) focus on different substances/groups.

A list of the WP4 prioritized substances and substance groups will follow.

At the national level, participating member states have established so-called National Hubs (NHs), which, in addition to the AE, contribute wider scientific expertise in the field of research and risk assessment of chemicals. Furthermore, a network of German stakeholders and decision-makers from various research communities will be linked to the NH in order to discuss results and to contribute knowledge, expertise and as any research needs, for the partnership. Another central goal of the NH work is to process PARC results into appropriate and target audience specific information for the (expert) public communities.

As part of their participation in the European PARC partnership, UBA and BfR jointly coordinate and support the German NH. At EU level, the NH will help to ensure meaningful cooperation for risk assessment and risk management in exchange with and between the member states engaged in PARC. For this purpose, each country participating in PARC appoints a national contact person so-called National Hub Contact Point (NHCP). In Germany, this position, which coordinates national cooperation in PARC, is split between the two GS, UBA and BfR, each providing one representative. This collaboration of BfR and UBA as NHCP, creates an additional bridge between the research communities from the fields of human and environmental toxicology. This synergy will further enhance the protection of human health and the environment. The German NHCP position is financed by the Federal Ministry of Education and Research (BMBF, FKZ: 01DT21043A).

In addition to UBA and the BfR as GS, the German NH integrates representatives from the ministries BMUV and BMEL, representatives from the German AE (research institutions and authorities) and selected experts not otherwise involved in PARC. In order to further meet the needs of the different subject areas, the German NH is divided into two sub-hubs one with the focus on "Human-Tox", led by BfR and one on "Human-Biomonitoring/ Environment", led by UBA.

German affiliated entities of UBA in PARC with the respective representative in the National Hub:

• Federal Institute of Hydrology (BfG) - representative in the NH: Martina Fenske
• Institute and Polyclinic for Occupational, Social and Environmental Medicine, University Hospital Munich (KUM) - representative in the NH: Stefan Rakete
• Helmholtz Centre for Environmental Research (UFZ) - representative in the NH: Werner Brack
• Rhineland-Palatinate Technical University Kaiserslautern-Landau (RPTU) - representative in the NH: Ralf Schäfer
• University of Osnabrück (UOS) - representative in the NH: Andreas Focks
• Fraunhofer Institute for Biomedical Engineering (IBMT) - representative in the NH: Sylvia Wagner
• Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) - representative in the NH: Bernd Göckener

External experts in the Sub Hub "Human-Biomonitoring/ Environment" of the PARC National Hub without involvement of the employer in PARC:

• Peter Kujath - Employer: Federal Institute for Occupational Safety and Health (BAuA)
• Holger Koch - Employer: Institute for Prevention and Occupational Medicine of the German Social Accident Insurance - Institute of the Ruhr University Bochum (IPA DGUV)
• Jörg Oehlmann - Employer: Goethe University Frankfurt am Main
• Thomas Schettgen - Employer: RWTH University Hospital Aachen
• Rita Triebskorn - Employer: Eberhard Karls University of Tübingen
• Martina Roß-Nickoll - Employer: RWTH University of Aachen
• Nathalie Costa Pinheiro - Employer: Lower Saxony State Health Office NLGA (NLGA)

Stakeholders of the German PARC National Hub:

The members of the National Hub meet twice a year, once virtually and once in hybrid format. German stakeholders are also invited to the hybrid format event. When inviting stakeholders, care was taken to ensure a balanced composition of representatives from industry, authorities, associations and NGOs who cover the core topics of human health and the environment. Some selected German stakeholders are already part of the stakeholder forum of the PARC partnership, while the majority of German stakeholders are not involved in PARC themselves.

German PARC National Hub

Source: Federal Institute for Risk Assessment / Federal Environment Agency

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As part of conferences, meetings and other events the PARC partnership, its work and results are presented by various representatives from various German partners.

Information on the date, event title, topic and the German collaborative partner responsible for the presentation, is listed below.

The list will follow after completion.

First stakeholder dialogue of the German PARC National Hub on 20 November 2023

The photo shows representatives of the UBA, the BfR, the BMUV, the NH and the invited stakeholders. Further representatives took part virtually.

Source: Liana Liebmann / Umweltbundesamt