Characterisation and analysis of key studies used to restrict substances under REACH

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.

Circular Economy and Green Chemistry: The Need for Radical Innovative Approaches in the Design for New Products

“…On the one hand, REACH requires chemical companies to disclose more information about the risks that their products pose to the environment and human health; on the other hand, it offers the possibility of registration exemptions for a process that supports new, sustainable innovation for five years. To establish a sustainable chemical industry, other nations have been inspired by the European Union to develop rules along similar lines [141].…”

Conflicts of Interest in the Assessment of Chemicals, Waste, and Pollution

“…In terms of reliability, data provided by industry within chemical legislation have been questioned in terms of compliance, quality, and usefulness for risk-reduction measures. − A large, systematic evaluation of EU REACH registration dossiers revealed that the chemical industry often failed to comply with the data requirements. Of 1932 dossiers of chemicals produced or imported to the EU in amounts of >1000 tonnes per year, only one dossier complied with the requirements for all end points .…”

Key Principles for the Intergovernmental Science–Policy Panel on Chemicals and Waste

“…This highlights the importance for the Panel to make use of all available reliable and relevant data and not to limit itself to prescribed data formats such as those defined by specific test guidelines or good laboratory practice (GLP), as such a limitation may exclude studies of significance, especially from all geographic areas. Studies from the scientific literature have proven to be valuable in the restriction of chemicals under the EU chemicals regulation, REACH, meaning that these studies were considered of sufficient reliability and relevance . As a model, the new Transparency Regulation in the European Union’s food laws is also expected to open up previously unavailable data for use in other domains of chemical oversight in the EU and beyond.…”

“…Studies from the scientific literature have proven to be valuable in the restriction of chemicals under the EU chemicals regulation, REACH, meaning that these studies were considered of sufficient reliability and relevance. 12 As a model, the new Transparency Regulation in the European Union’s food laws is also expected to open up previously unavailable data for use in other domains of chemical oversight in the EU and beyond. Transparency of data and the Panel’s workflow is crucial.…”