- Guiding future legislation regarding chemical risk assessment and sustainable risk management
- Enhancing understanding of decision benchmarks among regulators, legislators, and stakeholders
- Addressing challenges in using uncertainty expressions in assessments and providing guidance on their implementation and benefits
Key messages
- At present, risk assessment approaches are not coherent across different regulatory frameworks compromising the consistency of decision making and the achievement of policy objectives.
- Level of required protection or safety margins for human health and the environment may vary significantly between different frameworks even in similar regulatory contexts and exposure settings.
- Certain approaches in regulatory risk assessment need further validation, including better understanding of the mechanisms of mixture toxicity and causal linkages between critical effects and exposure at environmentally relevant levels.
- Open interdisciplinary and cross-sectoral dialogue is needed to advance justified regulatory policies on chemical risk assessment and sustainable risk management practices.
Overview
The European Green Deal ↗ and the Chemicals Strategy for Sustainability ↗ aim to improve chemical safety assessments with the "One substance, one assessment ↗" approach. By promoting a more transparent, consistent, and scientifically robust approach, it seeks to enhance the protection of human health and the environment. Currently, chemical risks assessments are conducted under multiple regulations, often leading to inconsistencies, data gaps, and uncertainties. This fragmentation makes it difficult to coherently evaluate chemical risks and implement sustainable and effective safety measures. The project addresses these challenges by identifying weaknesses in existing methodologies and proposing improvements to regulatory frameworks.
The main objectives of the project are to:
- harmonising risk assessment approaches across different legislations,
- improve transparency and reliability in decision-making,
- addressing uncertainties and data gaps,
- evaluating the effectiveness and sustainability of risk reduction measures,
- supporting regulatory bodies in developing better safety standards.
To achieve these goals, the project includes case studies covering environmental and occupational risk assessment, such as workplace chemical exposure, ecosystem protection, and evaluating the impact of regulatory decisions. These case studies analyze methodologies, decision benchmarks, test requirements, and the challenges of implementing uncertainty analysis while assessing the effectiveness of current regulations in reducing chemical risks.
By refining risk assessment strategies, this initiative aims to strengthen chemical safety regulations and support the development of effective and justified policies.
Ultimately, it contributes to a safer and more sustainable future by ensuring that scientific information and data are consistently and transparently evaluated within and across regulatory frameworks.
Achievements & Results
Nine case studies regarding tools, criteria, and methods of regulatory risk assessment initiated since the beginning of the project, covering both environmental and occupational risk frameworks, and prospective and retrospective risks. The case studies have provided various reviews and analyses on the above topic, including two peer-reviewed publications and numerous conference presentations.
Policy relevance
The project will address loopholes and gaps in selected regulatory risk frameworks, providing information and recommendations for their improvement and harmonisation. The project will also facilitate necessary dialogue across different regulatory bodies, EU agencies and other stakeholders, supporting consistent and justified decision making and policy development.
Related Publications
53 % of Repr1A/B-substances have >1 exposure limit (counting groups of metals once).
Numerical values could be highly variable for the same substances.
Weight given to reproductive toxicity in scientific basis varied.
Reproductive toxicity may not be the most sensitive endpoint, but further research and safety margin evaluations are needed to confirm this.
This study identifies potential gaps in workers' protection from exposure to reproductive toxicants.
We investigated the level of protection of reproductive and developmental toxicity offered through occupational exposure limits (OELs) and Derived No-Effect Levels for workers’ inhalation exposure (wDNELs). We compared coverage of substances that have a harmonised classification as reproductive toxicant 1 A or 1B (Repr.1 A/B), numerical values and scientific basis of 12 lists of OELs and wDNELs from REACH Registrants’ and the Committee for Risk Assessment. Across the 14 sources of OELs and wDNELs, 53 % of the Repr1A/B-substances had at least one exposure limit (counting groups of metals as one entry). Registrants’ wDNELs covered the largest share, 40 %. The numerical values could be highly variable for the same substance across the lists. How often reproductive toxicity is identified as the critical effect varies between the examined lists, both due to different assessments of the same substance and different substance coverage. Reviewing the margin of safety to reproductive toxicity cited in the documents, we found that 15 % of safety margins were lower to reproductive toxicity than the critical effect. To conclude, neither the REACH nor work environment legislation supply wDNELs or OELs for a substantial share of known reproductive toxicants. EU OELs cover among the fewest substances in the range, and in many cases national OELs or wDNELs are set at more conservative levels.
The level of health protection embedded in per- and polyfluoroalkyl substances (PFAS) regulatory thresholds varies substantially between the studied thresholds.
The availability and transparency of thresholds established for PFAS are met for some of the studied thresholds (EFSA's tolerable weekly intake). Transparency on the fundaments and risk level of drinking water quality standard and maximum level of contaminant in food is needed.
Allowing flexibility to consider case-specific factors (e.g. local background concentrations, region-specific food consumption rates or risk-benefits analysis) in the application or derivation of the thresholds could partly solve the impracticability of some present thresholds.
We call for an open dialogue between scientists and policy makers at European and also national/regional level in the setting of regulatory thresholds to promote rationale regulatory development on PFAS and other persistent chemicals.
Open policy dialogue is needed to advance justified regulatory policy on per- and polyfluoroalkyl substances.
Recognition of per- and polyfluoroalkyl substances (PFAS) as widespread environmental pollutants and a consequent risk to human health, has recently made the European Union (EU) adopt several regulatory measures for their management. The coherence of these measures is challenged by the diversity and the ubiquitous occurrence of PFAS, which also complicates the EU’s endeavor to advance justified, harmonized, and transparent approaches in the regulatory assessment of chemical risks. Our study critically reviews the European approach for the risk assessment of PFAS, by applying a comparative analysis of the current and pending regulatory thresholds issued for these chemicals in water bodies, drinking water, and certain foodstuffs. Our study shows that the level of health protection embedded in the studied thresholds may differ by three orders of magnitude, even in similar exposure settings. This is likely to confuse the common understanding of the toxicity and health risks of PFAS and undermine reasonable decision-making and the equal treatment of different stakeholders. Wealso indicate that currently, no consensus exists on the appropriate level of required health protection regarding PFAS and that the recently adopted tolerable intake value in the EU is too cautious. Based on our analysis, we propose some simple solutions on how the studied regulations and their implicit PFAS thresholds or their application could be improved. We further conclude that instead of setting EU-wide PFAS thresholds for all the environmental compartments, providing the member states with the flexibility to consider case-specific factors such as regional background concentrations or food consumption rates, in their national regulatory procedures would likely result in more sustainable management of environmental PFAS without compromising the scientific foundation of risk assessment, the legitimacy of the EU policy framework and public health.