Periodic Reporting for period 1 - PARC (Partnership for the Assessment of Risks from Chemicals)
Periodo di rendicontazione: 2022-05-01 al 2023-10-31
PARC, an EU-wide Research and Innovation (R&I) Risk Assessment (RA) hub with 200 partners from 29 countries, was established to support chemical RA and risk management (RM) authorities. It aims to address current and emerging chemical safety challenges, reinforce chemical monitoring networks, develop early warning systems, and facilitate the transition to the Next Generation Risk Assessment (NGRA). This is in line with the European Green Deal’s zero-pollution ambition for a toxic-free environment and the ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (CSS).
PARC’s main objectives are to:
1. Develop the scientific skills needed to address current and future challenges in chemical safety.
2. Provide new data, methods, and innovative tools for risk assessment and management.
3. Strengthen networks of stakeholders in chemical risk assessment.
PARC’s main objectives are to:
1. Develop the scientific skills needed to address current and future challenges in chemical safety.
2. Provide new data, methods, and innovative tools for risk assessment and management.
3. Strengthen networks of stakeholders in chemical risk assessment.
PARC engages in a structured approach combining transversal activities with project portfolios, which revolve around chemical monitoring, exposure, hazard assessment, and risk assessment for both human health and the environment.
PARC designs and documents the necessary framework for EU Aligned Human Biomonitoring (HBM) studies in the general population. Occupational studies for e-waste workers and healthcare workers have been designed. Technical requirements and Quality Assurance/Quality Control schemes and working groups are also defined, together with an inventory of existing guidance.
The first Environmental monitoring studies focus on PFAS in freshwater and endocrine disruptors in various environmental compartments.
Exploration of new sampling and analytical methods for environmental and human monitoring is ongoing.
PARC contributes to the development of a European exposure science strategy. Existing models and datasets are reviewed and inter-operability is developed. Progress has been made in assessing HBM data collected within the HBM4EU framework by comparing it with exposure simulations based on external exposure data. Ongoing work involves developing aggregate modelling to combine different exposure routes, adapting existing models, and providing access to relevant databases.
PARC investigates regulatory data gaps by studying the toxicity of prioritised substances, including Mycotoxins and BPA alternatives. The development of new approach methodologies (NAMs) focuses on various toxicity endpoints, such as non-genotoxic carcinogens, thyroid disruption, immune disruption, and neurotoxicity. Close collaboration with other research projects enhances understanding of toxicity mechanisms. Core/specialty groups and case studies explore new tools and concepts such as omics, Adverse Outcome Pathways (AOPs), bioinformatics, and Physiologically Based ToxicoKinetics (PBTK).
A network of relevant AOPs has been created for selected health effects (e.g. genotoxic carcinogenicity, endocrine disruption) to map relevant NAMs related to these endpoints. The goal is to design Integrative Approaches for Testing and Assessment (IATAs) with improved workflow.
Risk assessment of mixtures based on human biomonitoring data is underway, simulating different sources of exposure for various chemicals.
A review of existing regulatory assessment systems explores the use of NAMs and mixture allocation factors (MAF) beyond REACH.
PARC initiates projects to explore the impact of chemicals on biodiversity and will develop collaborations on this topic with external activities.
PARC designs and documents the necessary framework for EU Aligned Human Biomonitoring (HBM) studies in the general population. Occupational studies for e-waste workers and healthcare workers have been designed. Technical requirements and Quality Assurance/Quality Control schemes and working groups are also defined, together with an inventory of existing guidance.
The first Environmental monitoring studies focus on PFAS in freshwater and endocrine disruptors in various environmental compartments.
Exploration of new sampling and analytical methods for environmental and human monitoring is ongoing.
PARC contributes to the development of a European exposure science strategy. Existing models and datasets are reviewed and inter-operability is developed. Progress has been made in assessing HBM data collected within the HBM4EU framework by comparing it with exposure simulations based on external exposure data. Ongoing work involves developing aggregate modelling to combine different exposure routes, adapting existing models, and providing access to relevant databases.
PARC investigates regulatory data gaps by studying the toxicity of prioritised substances, including Mycotoxins and BPA alternatives. The development of new approach methodologies (NAMs) focuses on various toxicity endpoints, such as non-genotoxic carcinogens, thyroid disruption, immune disruption, and neurotoxicity. Close collaboration with other research projects enhances understanding of toxicity mechanisms. Core/specialty groups and case studies explore new tools and concepts such as omics, Adverse Outcome Pathways (AOPs), bioinformatics, and Physiologically Based ToxicoKinetics (PBTK).
A network of relevant AOPs has been created for selected health effects (e.g. genotoxic carcinogenicity, endocrine disruption) to map relevant NAMs related to these endpoints. The goal is to design Integrative Approaches for Testing and Assessment (IATAs) with improved workflow.
Risk assessment of mixtures based on human biomonitoring data is underway, simulating different sources of exposure for various chemicals.
A review of existing regulatory assessment systems explores the use of NAMs and mixture allocation factors (MAF) beyond REACH.
PARC initiates projects to explore the impact of chemicals on biodiversity and will develop collaborations on this topic with external activities.
PARC’s efforts to consolidate and strengthen the EU’s R&I capacity for chemical RA have resulted in several key outcomes. These include the establishment of a constant Science-to-Policy Dialogue with ministries and EC DGs, the implementation of regular consultation and prioritisation processes, and the organisation of targeted surveys and workshops. These initiatives have helped to identify gaps and needs, establish PARC priorities, and ensure the relevance of its activities to support regulatory RA, fill data gaps, and reduce uncertainty in RA.
Three toolboxes associated to the CSS are under development:
• Safe and Sustainable by Design (SSbD) approach for new chemicals: PARC has worked on the EC criteria and methodology and started the development of the toolbox in close collaboration with stakeholders to test its applicability
• Early warning system (EWS) to detect chemicals of emerging concern: A review of the concept based on new analytical methodologies has been published
• Integrative FAIR models for exposure, hazard and risk assessment: work is ongoing to support their interoperability and use by the stakeholders
PARC promotes the use of reliable data in chemical RA and established a network (SYNnet) to facilitate collaboration and knowledge sharing with other initiatives. A community platform, PARCopedia, has been established to share knowledge and develop dialogues between professionals. The success will depend of the participation of scientists as well as the continuous improvement of its capacity.
PARC is also developing a series of strategic roadmaps guiding the uptake of innovative science into the regulatory practice of chemical RA in the EU. One was about exposure science strategy. Another one will be NGRAroute, an activity to implement NGRA in all major legislations on chemicals in the EU. Close collaboration between industry, agencies and scientific communities will be key for successful implementation in the different regulatory frameworks.
PARC supports the work done by the Commission on FAIR data and models and has established links with international organisations (OECD, WHO, ISES, etc.) for discussion of common standards. PARC activities support regulatory activities and European Agencies have expressed their Key Areas for Regulatory Challenges where the scientific communities can provide outputs.
Finally, PARC is building capacities by developing and carrying out training and exchange programmes. The first step was the identification of training needs providing crucial information for forthcoming activities to map existing training and define of a training plan. Some training on how to upload HBM data to MCRA, a training and webinar series on FAIR data and tools as well as a contribution in the summer school on SSbD have already been implemented. A second step concerns the mapping of laboratory networks in different field and first laboratory catalogues on HBM and air domains, and a laboratory dashboard have been designed.
Three toolboxes associated to the CSS are under development:
• Safe and Sustainable by Design (SSbD) approach for new chemicals: PARC has worked on the EC criteria and methodology and started the development of the toolbox in close collaboration with stakeholders to test its applicability
• Early warning system (EWS) to detect chemicals of emerging concern: A review of the concept based on new analytical methodologies has been published
• Integrative FAIR models for exposure, hazard and risk assessment: work is ongoing to support their interoperability and use by the stakeholders
PARC promotes the use of reliable data in chemical RA and established a network (SYNnet) to facilitate collaboration and knowledge sharing with other initiatives. A community platform, PARCopedia, has been established to share knowledge and develop dialogues between professionals. The success will depend of the participation of scientists as well as the continuous improvement of its capacity.
PARC is also developing a series of strategic roadmaps guiding the uptake of innovative science into the regulatory practice of chemical RA in the EU. One was about exposure science strategy. Another one will be NGRAroute, an activity to implement NGRA in all major legislations on chemicals in the EU. Close collaboration between industry, agencies and scientific communities will be key for successful implementation in the different regulatory frameworks.
PARC supports the work done by the Commission on FAIR data and models and has established links with international organisations (OECD, WHO, ISES, etc.) for discussion of common standards. PARC activities support regulatory activities and European Agencies have expressed their Key Areas for Regulatory Challenges where the scientific communities can provide outputs.
Finally, PARC is building capacities by developing and carrying out training and exchange programmes. The first step was the identification of training needs providing crucial information for forthcoming activities to map existing training and define of a training plan. Some training on how to upload HBM data to MCRA, a training and webinar series on FAIR data and tools as well as a contribution in the summer school on SSbD have already been implemented. A second step concerns the mapping of laboratory networks in different field and first laboratory catalogues on HBM and air domains, and a laboratory dashboard have been designed.