The European Union is entering a new phase in its chemicals policy with the forthcoming “One Substance, One Assessment” (OSOA ↗) Regulation, a major reform designed to streamline chemical risk assessment across Europe with initial discussions in 2023. After several years of preparation and political negotiation, the OSOA package has been fully adopted by both co-legislators, the European Parliament and the Council ↗, and it will enter into force ↗ on the second of January 2026.

This reform represents a major opportunity to improve how chemical risks are assessed, data are shared and public health and the environment are protected. With OSOA, the EU wants to ensure that chemical assessment is simplified, in a coordinated way, with results shared and re-used across relevant authorities to reduce duplication and speed up regulatory action where needed.

In particular, the OSOA package consists of three key legislative proposals: a Directive on the re-attribution of scientific and technical tasks, a Regulation to strengthen cooperation among EU agencies working on chemicals and a Regulation establishing a Common Data Platform on Chemicals (CDPC). Managed by European Chemicals Agency (ECHA ↗), the CDPC will bring together chemical data from several EU agencies, including the European Environment Agency (EEA ↗), the European Food Safety Authority (EFSA ↗), the European Medicines Agency (EMA ↗) and European Agency for Safety and Health at Work (EU-OSHA ↗). The platform will cover information on hazards, environmental occurrence, emissions, uses and regulatory status of chemicals, following FAIR (findable, accessible, interoperable and reusable) data principles.

In this context, PARC is well positioned to support the transition from legislation to implementation, particularly through its work on human biomonitoring (HBM), FAIR data management and science-to-policy translation, helping ensure that evidence can be effectively communicated and used as OSOA is rolled out.

One of PARC’s biggest achievements is its ability to translate complex exposure and monitoring data into evidence that policymakers can use, says Joana Lobo Vicente, expert on chemicals, environment and human health at the European Environment Agency. As OSOA enters into force, this experience will be crucial to ensure that human biomonitoring sample collection, harmonised methodologies and data integration support prevention, early warning systems, and the protection of health and the environment. Under OSOA, the EEA will host the Human Biomonitoring and Indoor Air Quality platform and we look forward to continuing our collaboration with PARC partners and policymakers to support effective implementation.

PARC’s key contribution to OSOA and future human biomonitoring in Europe 

Although OSOA establishes a legal framework, its successful implementation will rely on effective sample collection, harmonised methodologies that are quality assured and controlled and operational experience, including through collaborative initiatives such as PARC.

During the legislative process, PARC provided structured feedback to the OSOA public consultation, stressing the importance of a sustainable long-term framework for human biomonitoring, robust laboratory quality assurance and quality control, continuous method development, and strong integration between national and EU-level activities to ensure consistency and comparability of data.

Building on the experience of its predecessors DEMOCOPHES ↗ and HBM4EU ↗, PARC has demonstrated that EU-wide harmonised human biomonitoring is technically feasible when common protocols, questionnaires, laboratory standards and communication approaches are applied. Within PARC, dedicated activities, particularly under the “Monitoring and exposure” work (led by the German Environment Agency ↗ and the Santé publique France ↗), already support the sustainability of an EU human biomonitoring system, strategies to phase out hazardous chemicals, the interface between research data and regulatory policy, and capacity building and coordination among Member States. Furthermore, the PARC work package on FAIR data, led by Flemish Institute for Technological Research ↗ (VITO) and the University of Birmingham ↗, develops common standards, tools, and a data platform that allow for the FAIRification of human biomonitoring data.  

OSOA also provides a legal basis for an EU-wide human biomonitoring study. Within four years of its entry into force, ECHA and EFSA, in cooperation with the EEA, will commission a harmonised biomonitoring study across EU Member States to better assess real-life chemical exposure in the European population.

In parallel, PARC is already generating evidence and practical experience that can support this future effort. As explained by Liese Gilles, from VITO and project lead of the PARC Aligned Studies project, PARC is conducting a large-scale HBM study in 24 European countries covering children, teenagers and adults, and a wide range of substances including bisphenols, pesticides, PFAS, metals and phthalates. 

This data will be shared and integrated into the future HBM data platform hosted by the EEA, she explains, with the occupational component collected by ECHA. After data curation, part of it will be sent to the Common Data Platform on Chemicals. In parallel, PARC work is strengthening the foundations for a sustainable European human biomonitoring framework by harmonising methods, reinforcing laboratory capacity, FAIR data management and improving data quality across countries, highlights Gilles. Our co-leading partners at Carlos III Health Institute (ISCIII) play a key role in reinforcing laboratory capacity, ensuring robust infrastructure for high-quality biomonitoring.

This experience will feed into discussions on the design and governance of the future EU-wide HBM study under OSOA,” she adds. 

Indicators and early warning: turning data into action

Another flagship element of OSOA is the creation of an EU Indicator Framework for chemicals, designed to track key trends and progress across Europe. The framework measures drivers and impacts of chemical exposure, assesses the effectiveness of EU chemicals legislation, and monitors progress towards safe and sustainable chemicals. The current version ↗, published in April 2024, represents a first step towards this ambition and was developed by the EEA and ECHA in cooperation with the European Commission and other agencies.

Eylem Doğan-Subaşı, expert on pollution-free ecosystems at the EEA, says 

the indicator framework includes an online dashboard and a synthesis report, featuring 25 indicators. Some indicators build on existing metrics, while others are newly developed from available data streams. It also includes ‘signals’ to describe emerging trends where data are limited.

She adds that PARC can contribute directly to this agenda by supplying harmonised knowledge and data that allow the development of indicators to track exposure and impacts of chemicals over time. Building on this, the EEA has already begun working with PARC to strengthen existing indicators with new data streams and to develop new indicators and “signals” where evidence is still emerging. Doğan-Subaşı says that we have contacted relevant PARC project managers to explore promising datasets, including on PFAS, endocrine-disrupting chemicals and occupational exposure.

PARC is also helping drive a more proactive EU chemicals policy by developing tools that support prevention and anticipation of emerging risks. A key example is PARC’s work on an Early Warning System (EWS), which acts as an innovation and testing ground for advanced early-warning approaches, including improved signal generation from monitoring data and supporting computational tools.

Magnus Løfstedt, an expert in environmental and human health effects of chemicals at the EEA explains that 

it is very important that the scientific work and resources under PARC are used to feed into the EU-level early-warning system foreseen under the OSOA package, where the EEA will compile early-warning signals and coordinate inputs from EU agencies, Member States and research.

He adds that PARC’s contributions have the potential to reinforce the EU system by providing tools, tested methodologies, workflows and data-driven approaches that can be taken up within the formal framework when sufficiently matured. 

Looking ahead 

As OSOA moves from legislation to implementation, PARC provides the scientific capacity, harmonised FAIR data and operational experience needed to turn this new framework into practice. Through its work on human biomonitoring, FAIR data, indicators and early warning systems, PARC will continue to play a key role in supporting a more coherent, preventive and evidence-based EU chemicals policy, strengthening protection of human health and the environment across Europe.