ECHA ARN documents: chemical grouping without a toxicological rationale

Abstract

The EU chemical strategy for sustainability (CSS) plans to use chemical grouping to “prioritise (…) substances for restrictions for all uses through grouping, instead of regulating them one by one”. Thus, toxicological grouping will become a key tool used by regulatory authorities in Europe. Over the last 2 years, ECHA has published a high number of documents labelled “Assessment of Regulatory Needs (ARN)” which are based on groups of chemicals based on structural considerations. The ARN documents are legally non-binding, yet they present the public impression of a conclusion about restrictions for groups or sub-groups of chemicals and hence may set a precedent for further binding actions. ECHA has set out definitions on what is considered a group in REACH Annex XI. However, as shown in this commentary based on five examples, the ARN do not follow these principles and propose toxicological groupings without taking into consideration mode of action and the toxicological information on the chemicals. Given the emphasis on grouping projected by the CSS, the groupings in the ARN set an unfortunate precedent on what a toxicological group means and they do not follow clear scientific standards or established toxicological principles. They also lead to a public image of guilt by association for chemicals, without any recourse for registrants to establish the scientific basis for their safe use, as presented within REACH registrations.

Refine and Strengthen SAR-Based Read-Across by Considering Bioactivation and Modes of Action

“…Overall, our study highlights the importance of considering multiple factors in SAR-based read-across and provides insights that can inform the development of more accurate and reliable methods for assessing the toxicity of chemicals and grouping chemicals. 64 Our findings suggest that refining and strengthening SAR-based read-across by evaluating MOAs and bioactivation pathways can improve the overall accuracy, consistency, transparency, and confidence in the analogue rating process.…”