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PARC Management Board responds to the EU’s ‘One substance, one assessment' legislative proposal
The “One substance, one assessment” legislative package and PARC
The PARC Management Board (MB) has reviewed the ‘One substance, one assessment’ legislative proposal package ↗ introduced by the European Commission on December 7, 2023. This proposal aims to streamline chemical assessments across EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks. PARC activities align with this proposal, particularly through the Proposal for a Regulation establishing a common data platform on chemicals ↗ - COM(2023) 779 final. PARC’s work on FAIR data, monitoring, including in the environment and human biomonitoring, early warning system and Safe and Sustainable by Design (SSBD) is crucial for this common data platform, providing reliable data for chemical risk assessments.
PARC Management Board highlights priorities and supports EU chemical regulation proposal
This feedback was mainly based on the first deliverable on PARC’s exit strategy which included a survey that was sent to PARC National Hubs (NH) about which activities need to be sustainable. Most NHs identified human biomonitoring as the top priority for sustainability. However, other activities were also highlighted as requiring a sustainable framework in Europe. These include toxicology (through a European Toxicology Programme), environmental monitoring, data storage and analysis, detecting emerging substances and approaches for safe and sustainable by design. Prioritising chemical substance for additional studies on exposure and hazards was also considered important at the EU level.
Overall, PARC’s MB emphasised the importance of bridging the science and policy for regulating the risks from using chemicals, as well as highlighted the role of scientists in making sure their work is relevant and useful for regulations. Enhancing the efficiency and effectiveness of data generation and use is key, and to share data in a way that is more “FAIR”.
The PARC MB fully supports the regulation proposal. In many ways, PARC activities and the data generated by PARC contribute significantly to various elements of the proposal, particularly the common data platform. The PARC MB underlined the importance of the SSbD concept and highlighted important elements to be considered, such as sustainability, data application, data access, and the capability of hosting specific types of data. Another important aspect for the PARC MB is that the generation and sustainability of data which required a legal framework, notably for human biomonitoring data. The proposed repository of reference values will guarantee a robust resource for interpretating monitoring campaigns. It would be beneficial to include all supporting information for the values stored in the repository. Additionally values beyond statistically derived reference values, such as toxicologically derived guidance values, should also be integrated. The PARC MB highlighted that the process used for to derive these guidance values is important for risk assessment and management and should be coordinated at the European level. The PARC MB also supports the early warning and action system, and insisted that, to capture emerging chemical-related problems at an early stage, there is a need to systematically also apply additional methods, such as those developed in PARC. They stressed the importance of defining and harmonising monitoring systems that generate signals, as well as clearly defining roles in the regulatory process for handling these signals, prioritising them, and ultimately leading to actions. Furthermore, The PARC MB expressed great support for the data generation mechanism to close gaps and move towards next generation risk assessment and highlighted the integrative risk assessment platform of PARC and the importance of building confidence in and acceptance of new approach methodologies.
PARC’s activities and their sustainability, in addition to feeding the common data platform, also contribute to the implementation of the ‘One substance, one assessment' approach. All these elements are central to PARC’s work programme. The PARC MB is interested in contributing further to the discussions and provide recommendations for implementation as the Partnership’s activities progress.
The PARC MB feedback was submitted to the open consultation on the regulation early April.