Unlocking the potential of data harmonization and FAIRness in chemical risk assessment: lessons from practice and insights for policy development

Abstract

Persistent and toxic chemicals remain a significant pollution concern, underscored by the European Union's Zero Pollution Action Plan. Daily exposure to complex chemical mixtures starts early and continues throughout life, for instance for consumer products such as toys, plasticware, furniture, and synthetic fibres. EU-funded research projects like COPHES/DEMOCOPHES, HBM4EU, and PARC have documented population exposure to these substances. The outcomes of such research initiatives have contributed to highlighting the adverse health impacts of Substances of Concern (SoCs), leading to several regulatory actions within the EU. SoCs include hazardous chemicals such as carcinogens, mutagens, endocrine disruptors, and “persistent, bioaccumulative, and mobile” (PBM) chemicals. The digital transformation in chemicals management has resulted in policies that mandate electronic submissions of chemical risk assessment-relevant data, and the creation of industry-specific databases like the Substances of Concern in Products (SCIP) database, established by the European Chemicals Agency (ECHA) under the revised Waste Framework Directive (WstFD). These databases describe SoCs and their link with products, offering a comprehensive view of chemical quantities, emission sources, exposure pathways, and other relevant data, contingent on robust data governance. Effective chemical risk assessment requires characterizing hazards, exposure sources and levels, and drawing conclusions concluding on potential risks, supported by a well-defined problem formulation and monitoring. This includes setting objectives and defining the scope of the risk assessment and decision-making, particularly regarding early warning signal detection for the purpose of public health protection. Successful risk assessment hinges on access to robust, traceable, accessible, and interoperable data across scientific disciplines and regulatory frameworks. This paper discusses the challenges of aggregating human health risk assessment-relevant chemical information from multiple sources, especially from the perspective of data fusion and reuse. It presents findings from a research project focused on utilizing chemicals datasets from various governmental and scientific sources. The study highlights the need for improved data presentation and availability to enhance usability for all stakeholders. Recommendations are made for the EU Commission, ECHA, industry, and academia to support harmonized data practices, increased transparency, and the development of sustainable chemical applications fostering safer market introductions. These recommendations can also be useful to other data providers that care about the reusability of the data they publish or manage.