Periodic Reporting for period 2 - PARC (Partnership for the Assessment of Risks from Chemicals)
Période du rapport: 2023-11-01 au 2025-04-30
The Partnership for the Assessment of Risks from Chemicals (PARC) is a European initiative launched in response to global and EU-level calls—such as the UN’s Global Environment Outlook and the EU Green Deal—for a non-toxic environment. This partnership addresses the pressing challenge of managing the risks posed by the estimated 40,000–60,000 industrial chemicals in global markets, many of which lack sufficient regulatory assessment. In the EU, over 60% of chemical volumes are hazardous to human health, and 35% to the environment, with limited data and inconsistent methodologies hindering effective risk evaluation.
PARC’s main purpose is to support chemical risk assessment and management by advancing regulatory science. It brings together 200 partners from 29 countries to:
• Develop harmonised methods for monitoring, hazard identification, exposure, and risk assessment.
• Integrate innovative tools like non-animal testing, computational models, and omics technologies.
• Improve the governance and use of FAIR (Findable, Accessible, Interoperable, Reusable) data.
• Bridge the gap between science and policy to ensure research informs regulation.
• Build capacity and infrastructure at both national and EU levels.
Aligned with the EU’s zero pollution ambition and the Chemicals Strategy for Sustainability, PARC also promotes Safe and Sustainable by Design (SSbD) chemicals and materials, and is establishing an Early Warning System (EWS) for chemical risks.
The initiative has three strategic objectives:
1. Build a sustainable, interdisciplinary EU network to identify and address R&I needs in chemical risk assessment.
2. Conduct joint R&I activities aligned with regulatory priorities and emerging challenges.
3. Strengthen and expand platforms for knowledge sharing, methodological harmonisation, and training.
PARC’s main purpose is to support chemical risk assessment and management by advancing regulatory science. It brings together 200 partners from 29 countries to:
• Develop harmonised methods for monitoring, hazard identification, exposure, and risk assessment.
• Integrate innovative tools like non-animal testing, computational models, and omics technologies.
• Improve the governance and use of FAIR (Findable, Accessible, Interoperable, Reusable) data.
• Bridge the gap between science and policy to ensure research informs regulation.
• Build capacity and infrastructure at both national and EU levels.
Aligned with the EU’s zero pollution ambition and the Chemicals Strategy for Sustainability, PARC also promotes Safe and Sustainable by Design (SSbD) chemicals and materials, and is establishing an Early Warning System (EWS) for chemical risks.
The initiative has three strategic objectives:
1. Build a sustainable, interdisciplinary EU network to identify and address R&I needs in chemical risk assessment.
2. Conduct joint R&I activities aligned with regulatory priorities and emerging challenges.
3. Strengthen and expand platforms for knowledge sharing, methodological harmonisation, and training.
PARC has undertaken a wide range of technical and scientific activities to advance chemical risk assessment and regulatory science in Europe. Its work is structured around cross-cutting initiatives and targeted project portfolios, focusing on monitoring, exposure estimation, hazard characterization, and risk assessment.
Key scientific activities and achievements include:
• Human and Environmental Monitoring: PARC has launched harmonized human biomonitoring (HBM) studies across several EU countries, including occupational studies in the e-waste and healthcare sectors. Environmental monitoring has begun for PFAS and endocrine disruptors in various ecosystems.
• Laboratory Network and Methods Development: A European network of laboratories has been established, supported by an online catalogue of monitoring capabilities. New sampling and analytical methods are being developed to enhance environmental and health surveillance.
• Exposure Science and Data Integration: PARC is contributing to a European exposure science strategy. It has integrated national HBM data into the dedicated exposure simulation tool, enabling GDPR-compliant, FAIR data use for aggregated exposure assessments.
• Toxicity Testing and New Approach Methodologies (NAMs): The programme is addressing regulatory data gaps by studying priority substances like mycotoxins and BPA substitutes. It is advancing NAMs for human health endpoints (e.g. endocrine disruption, neurotoxicity) and environmental risk, including omics, adverse outcome pathways, physiologically based toxicokinetic models, and bioinformatics tools.
• FAIR Data and Infrastructure: PARC has launched the first version of the Chemical Risk Assessment Hub (CRA-Hub), a central FAIR-compliant platform hosted by the EIRENE infrastructure.
• Toolbox Development: Two major toolboxes have been initiated:
o Safe and Sustainable by Design: Criteria and methodologies are being tested with stakeholders.
o Integrative FAIR Models: Work is ongoing to ensure interoperability for exposure, hazard, and risk assessment.
• Scientific Community Building: PARC fosters collaboration across disciplines, including biodiversity impact research, and contributes to the EU roadmap for phasing out animal testing.
Key scientific activities and achievements include:
• Human and Environmental Monitoring: PARC has launched harmonized human biomonitoring (HBM) studies across several EU countries, including occupational studies in the e-waste and healthcare sectors. Environmental monitoring has begun for PFAS and endocrine disruptors in various ecosystems.
• Laboratory Network and Methods Development: A European network of laboratories has been established, supported by an online catalogue of monitoring capabilities. New sampling and analytical methods are being developed to enhance environmental and health surveillance.
• Exposure Science and Data Integration: PARC is contributing to a European exposure science strategy. It has integrated national HBM data into the dedicated exposure simulation tool, enabling GDPR-compliant, FAIR data use for aggregated exposure assessments.
• Toxicity Testing and New Approach Methodologies (NAMs): The programme is addressing regulatory data gaps by studying priority substances like mycotoxins and BPA substitutes. It is advancing NAMs for human health endpoints (e.g. endocrine disruption, neurotoxicity) and environmental risk, including omics, adverse outcome pathways, physiologically based toxicokinetic models, and bioinformatics tools.
• FAIR Data and Infrastructure: PARC has launched the first version of the Chemical Risk Assessment Hub (CRA-Hub), a central FAIR-compliant platform hosted by the EIRENE infrastructure.
• Toolbox Development: Two major toolboxes have been initiated:
o Safe and Sustainable by Design: Criteria and methodologies are being tested with stakeholders.
o Integrative FAIR Models: Work is ongoing to ensure interoperability for exposure, hazard, and risk assessment.
• Scientific Community Building: PARC fosters collaboration across disciplines, including biodiversity impact research, and contributes to the EU roadmap for phasing out animal testing.
Key achievements include the implementation of harmonised human biomonitoring and occupational exposure surveys and environmental monitoring, which will provide EU-wide comparable data to inform policy. Laboratory networks have been mapped and harmonised QA/QC systems introduced, enhancing data reliability and comparability.
The initiative supports the EU’s “One Substance, One Assessment” (OSOA) strategy by contributing to a common data platform and facilitating the transition to Next Generation Risk Assessment (NGRA). Tools like PARCopedia and the CRA-Hub foster knowledge sharing and long-term data accessibility.
To ensure future uptake and impact, several needs must be addressed:
• Continued FAIR data harmonisation and QA/QC standardisation.
• Supportive regulatory frameworks to enable adoption of NAMs and NGRA.
• Sustainable networks and platforms, with adequate resources and stakeholder engagement.
• Training, demonstration, and integration strategies for practical application of new tools.
• Legal clarity on data use, balancing transparency with confidentiality and IPR.
• Ongoing stakeholder collaboration, especially with EU agencies and industry.
Meeting these needs will be critical to translating PARC’s innovations into lasting regulatory and societal benefits.
The initiative supports the EU’s “One Substance, One Assessment” (OSOA) strategy by contributing to a common data platform and facilitating the transition to Next Generation Risk Assessment (NGRA). Tools like PARCopedia and the CRA-Hub foster knowledge sharing and long-term data accessibility.
To ensure future uptake and impact, several needs must be addressed:
• Continued FAIR data harmonisation and QA/QC standardisation.
• Supportive regulatory frameworks to enable adoption of NAMs and NGRA.
• Sustainable networks and platforms, with adequate resources and stakeholder engagement.
• Training, demonstration, and integration strategies for practical application of new tools.
• Legal clarity on data use, balancing transparency with confidentiality and IPR.
• Ongoing stakeholder collaboration, especially with EU agencies and industry.
Meeting these needs will be critical to translating PARC’s innovations into lasting regulatory and societal benefits.