A Systematic Analysis of Read-Across Adaptations in Testing Proposal Evaluations by the European Chemicals Agency.

ABSTRACT: An important element of the European Union's "Registration, Evaluation, Authorisation and Restriction of Chemicals" (REACH) regulation is the evaluation by the European Chemicals Agency (ECHA) of testing proposals submitted by the registrants to address data gaps in standard REACH information requirements. The registrants may propose adaptations, and ECHA evaluates the reasoning and issues a written decision. Read-across is a common adaptation type, yet it is widely assumed that ECHA often does not agree that the justifications are adequate to waive standard testing requirements. From 2008 to August 2023, a total of 2,630 Testing Proposals were submitted to ECHA; of these, 1,538 had published decisions that were systematically evaluated in this study. Each document was manually reviewed, a

SUBMITTER: Roe HM 

PROVIDER: S-EPMC11384022 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature