We can't find the internet
Attempting to reconnect
Something went wrong!
Hang in there while we get back on track
Characterisation and analysis of key studies used to restrict substances under REACH
Summary
Researchers analyzed key studies cited in REACH (European chemicals regulation) substance restriction dossiers, evaluating how well the selected studies reflect the full evidence base for regulated contaminants. The analysis found that dossiers sometimes relied on a narrow subset of available studies, with implications for the robustness of regulatory decisions.
Abstract Background Understanding how scientific studies are used in regulatory risk assessments is important since it influences the outcome of an assessment, and thus the level of protection of human health and the environment. Within the REACH legislation (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC Nr. 1907/2006) hazard information on clearly defined (eco-)toxicological endpoints are submitted for the registration of substances, and this information is intended for concluding on potential hazards and risk as well as subsequent risk management measures such as restrictions. The present study aimed to (1) characterise key studies used by the European Chemicals Agency’s Committee for Risk Assessment to restrict hazardous substances; (2) analyse if the REACH registration database provided the key studies used in these restrictions, and (3) investigate potential expert disagreements related to the use of non-standard studies in the restrictions. Results Our analysis showed that 58% of the 53 scrutinised key studies were non-standard studies, all available by paying a fee or through open access. Sixteen (30%) of the key studies were consulted from external sources outside the REACH registration database by the Committee for Risk Assessment. Only one study of the 16 external key studies was a standard study. Further, 9% (5/53) of the key studies used by the Committee for Risk Assessment were inaccessible to third parties, all were standard studies. The uses of non-standard studies were (unsuccessfully) challenged for five substances during the public consultation. Conclusions These results suggest that non-standard studies contributed to the identification and management of substances of concern, that the REACH registration database may not be sufficient for the identification and management of uncontrolled hazards and risks, and that the transparency of the decisions made by the Committee for Risk Assessment was partially hampered due to the use of standard studies inaccessible to third parties.
Sign in to start a discussion.
More Papers Like This
Restricting microplastics in the European Union: Process and criteria under REACH
Researchers analyzed the European Union's regulatory process for restricting intentionally added microplastics under the REACH chemical regulation, finding that the procedure requires extensive socio-economic justification alongside environmental and health risk assessments. The study notes that the precautionary principle plays a limited role, meaning that the less data available on a microplastic's harm, the harder it is to restrict it.
DataRequirements for Implementing the “Essential-Use”Concept in Chemical Legislation
Researchers examined the data requirements needed to implement the 'essential-use' concept within the Stockholm Convention and EU REACH Regulation chemical legislation frameworks. The study analyzed what types of substance-specific data would be necessary to determine whether a chemical's uses qualify as essential, informing proposed revisions to global and European chemical governance.
DataRequirements for Implementing the “Essential-Use”Concept in Chemical Legislation
Researchers examined the data requirements needed to implement the 'essential-use' concept within the Stockholm Convention and EU REACH Regulation chemical legislation frameworks. The study analyzed what types of substance-specific data would be necessary to determine whether a chemical's uses qualify as essential, informing proposed revisions to global and European chemical governance.
La Révision de REACH : Quels Impacts sur la Santé Humaine, l'Environnement et l'Industrie Attendus?
This study examines the anticipated impacts of the revision of the European REACH regulation on human health, environmental protection, and industrial practices. The analysis addresses how updated chemical regulations are expected to affect the management of hazardous substances including plastic additives and pollutants across the value chain.
Data Requirements for Implementing the “Essential-Use” Concept in Chemical Legislation
Researchers analyzed how the essential-use concept could be implemented in chemical legislation by examining existing cases under the Stockholm Convention and the EU REACH Regulation, including the restriction on intentionally added microplastics. The study suggests that current regulatory frameworks already consider elements of essential-use decision-making and that no drastic changes to data requirements would be necessary to apply this concept.