European partnership for the assessment of risks from chemicals (PARC)

Chemicals risk assessors and managers are faced with data and knowledge gaps and lack of tools and methods, to speed up and prioritise risk assessments and capture risks from existing and emerging substances across regulatory domains. The lack of available or accessible information increases the risk of ‘regrettable’ substitutions and slows down the design of safer chemicals. A diverse landscape of regulatory frameworks and actors carrying out risk assessment of chemicals for their specific purpose has resulted in a fragmented approach. Risks to human and environmental health are still in certain cases considered separately, while in most cases they are inherently interrelated.

To enable risk assessors and risk managers to respond to current and future challenges, the Partnership[[https://ec.europa.eu/info/files/european-partnership-chemicals-risk-assessment_en]] should stimulate research and innovation in chemicals risk assessment by developing a collaborative network with public research entities. A common research and innovation programme should be established by national and EU risk assessors and risk managers in consultation with relevant stakeholders (academia, industry, associations and others).

Activities of the Partnership should be complementary and subsidiary to obligations under existing regulatory frameworks, and should coordinate with these as relevant. The Partnership should become a reference centre for research questions related to chemicals risk assessment, including those emerging from other Horizon Europe partnerships or missions. The Partnership is expected to establish relevant collaborations with other Horizon Europe partnerships and missions as set out in the working document on ‘Coherence and Synergies of candidate European partnerships under Horizon Europe’[[https://ec.europa.eu/info/horizon-europe/european-partnerships-horizon-europe_en#synergies]] as well as to explore collaborations with other relevant activities at EU and international level. The Partnership should align with EU-wide initiatives on open access and FAIR data[[FAIR data are data, which meet principles of findability, accessibility, interoperability, and reusability.]].

The Partnership’s governance structure should engage upfront risk managers and risk assessors to coordinate, steer and frame the research and innovation activities, facilitate the use and uptake of the results in a regulatory context and contribute to a science based communication of the risk of chemicals. The Partnership’s governance and operational structures should also foster a dialogue on sustainability, beyond funding from EU research and innovation framework programmes, with political decision-makers and risk assessors.

Main blocks of activity:

1. Set-up and operate an EU-wide cross-disciplinary network to identify and agree on research and innovation needs and support research uptake into regulatory chemical risk assessment.

A dialogue and priority-setting process should be established, bringing together European regulatory entities and risk assessment agencies to develop a strategic research and innovation agenda for chemicals risk assessment in collaboration with the scientific community. This process should also facilitate access and uptake of new scientific knowledge that can contribute to regulatory science by policy-makers and risk assessors.

Relevant synergies should be fostered with other initiatives at national, EU or international level and targeted communication and dissemination should be implemented to ensure openness and transparency of this Partnership towards all concerned stakeholders. The Partnership should build on and extend the concept of National Hubs developed under the European Joint Programme on Human Biomonitoring, HBM4EU[[www.hbm4eu.eu]]. Targeted citizen actions should be envisaged to increase their understanding of risks related to exposure to chemicals and reinforce their trust in risk assessment and risk management processes.

2. Carry out joint EU research and innovation activities on identified priorities to support the current regulatory risk assessment processes and respond to emerging challenges.

The Partnership should drive innovation in environmental and human exposure assessment. . New tools and methods for environmental and human exposure monitoring, including in occupational settings, and to gather data on lifestyle and consumption behaviour, should be developed, validated and their harmonised use promoted. Biomarkers of effects in environment and in human should be developed as a proxy of environmental and health outcomes. Collaborations with existing programmes should be fostered; however, when required and relevant, the partnership can carry out monitoring and exposure assessment activities. This could entail monitoring of environmental media and human exposure to chemicals from various sources and exposure routes. For human biomonitoring, the Partnership should build on the results of HBM4EU and further exploit these as well as perform new studies for prioritised chemicals and regulatory questions. Moreover, human biomonitoring activities should be integrated in the wider exposure assessment and risk assessment contexts.

Toxicological or eco-toxicological studies to generate new data for chemical substances and mixtures relevant to public health (mechanistic, in silico, in vitro or in vivo), beyond the data required from industry under REACH or by other regulations, should be designed and performed, taking into account the Reduce-Refine-Replace (3Rs) principle and any regulatory requirements for their relevance. Novel methods for toxicological hazard assessment aligned with identified needs should be developed, and existing methods improved, including methods that can reliably screen (groups of) substances allowing to select the substances for which a full safety assessment is required. New Approach Methodologies (NAMs) should be integrated with classical experimental designs to improve hazard characterization and their regulatory acceptance promoted through validation or applicability studies.

The performance of current methodologies employed in regulatory risk assessment should be assessed to identify methodological knowledge gaps and R&I needs. Validation and standardisation of results and methods of the Partnership or from collaborating projects should be pursued, e.g. development of OECD Test Guidelines, to encourage their use in regulatory risk assessment. Integrated Approaches to Testing and Assessment (IATA), integrative exposure and exposure reconstruction models and practical approaches for regulatory risk assessment of single, aggregated or combined exposure should be developed and their regulatory uptake fostered. Causal associations between (combined) exposures to chemicals and health outcomes should be investigated.

3. Strengthen existing capacities and build EU-wide, transdisciplinary research and innovation platforms to support chemical risk assessment

A data policy in line with FAIR data principles, taking into account General Data Protection Regulation (GDPR) related challenges, should be developed and implemented in the Partnership for data management, harmonisation, interoperability and exchange. Building on accepted data formats and existing data platforms[[Examples of relevant EC data platforms:

IPCHEM https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html,

eChemPortal: https://www.echemportal.org/echemportal/.]], solutions to collect, store, manage and permit access to new data generated by R&I activities in the partnership should be proposed. Access and linkage to existing data collections should be facilitated. Innovative methods for data analysis should be pursued, including uncertainty analysis, data mining, and machine learning.

Innovative approaches in chemical risk assessment should be investigated and, if validated, promoted including at least the following: 1) supporting the European Commission’s work on defining the Safe-and-Sustainable-by-Design concept and implementation criteria and proposing a toolbox to support the application of these criteria; 2) investigating how to further support the initial pilot study on an EU Early Warning System launched by the European Commission in 2019; and 3) making models and modelling approaches accessible and compliant with FAIR principles via an open source repository.

The Partnership should, in cooperation with appropriate EU and National reference laboratory networks, identify, and, when needed, enhance existing networks and develop new networks. These networks should aim at standardising methods, making available Quality Assurance/Quality Control (QA/QC) schemes and promoting the uptake of new methods and tools through training and peer-to-peer learning. In addition, specific training should be undertaken for different groups of stakeholders, including own partners, to ensure a wide use of data, methods, tools and models promoted by the Partnership.

Partner composition, geographical coverage and funding conditions:

The Partnership is open to all EU Member States as well as countries associated to Horizon Europe and will remain open to those wanting to join during the Partnership’s lifetime.

Beneficiaries should preferably be:

• National institutions in charge of chemical risk assessment and carrying out related research and innovation activities.
• Exceptionally, if the national risk assessors prefer not to participate as beneficiaries and manage a network of affiliated entities, other solutions can be envisaged but must be duly justified and, when to conditions for participating as affiliated entities exists, the national risk assessor may participate under such status.

To encourage national coordination, participation as beneficiary should be limited to two entities per country; the use of affiliated entities is thus strongly encouraged, when the conditions for participating as affiliated entity exist.

Affiliated entities are defined under the Horizon Europe Model Grant Agreement and, in this specific topic, should be:

• Academia and research organisations that are part of the national networks on research for chemicals risk assessment and have established links to the risk-assessing institutions.
• National risk assessors or government agencies in the exceptional case they will not be beneficiaries as mentioned above.

Depending on their individual legal and operational frameworks and in agreement with the relevant services of the European Commission (partner DGs), EU Agencies involved in chemicals risk assessment and/or producing knowledge on chemicals’ safety may also join the Partnership, e.g. as beneficiaries.

Collaboration with the European Commission's Joint Research Centre (JRC) should be considered to facilitate the sharing of chemical monitoring data in IPCHEM[[https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html]], and in other areas of mutual interest, such as (bio)monitoring, novel approaches for risk assessment including non-animal approaches, safe and sustainable design of chemicals, training and capacity building.

The expected duration of the partnership is seven years.

The Horizon Europe contribution will be limited to a maximum of 50% of the total eligible costs of the action with a maximum of EUR 200 million of EU contribution.