ECHA compliance checks on REACH dossiers: lessons learned for UVCB- and multiconstituent substances
MARION WEBER, BARBARA LOHMANN
CFCS-Consult GmbH, Essen, Germany
Abstract
The ECHA routinely performs compliance checks and issues draft decisions on REACH dossiers.
The focus is on higher tier endpoints, mainly those requested in REACH Annex IX and X: mutagenicity/genotoxicity – repeated-dose toxicity – prenatal developmental toxicity – reproduction toxicity – carcinogenicity – long-term aquatic toxicity – biodegradation – bioaccumulation. Compliance checks regard substances (a) with wide dispersive uses / potential hazards, (b) structurally related to substances listed in CORAP, (3) with adaptations used for higher tier endpoints. Whilst the testing requirements are identical for all substances, compliance may prove more challenging for UVCB- and multiconstituent substances. We present case studies where the ECHA rejected adaptations, illustrate how the registrants defended their choices and discuss the ECHA’s final decisions.
INTRODUCTION
The compliance check of registrations is governed by Article 41 of the REACH regulation (1). The Agency may verify the technical dossier, the Chemical Safety Assessment (CSA) and Chemical Safety Report (CSR), the explanations for opt-outs applied to specific endpoints and the adaptations of the information requirements and related justifications. In this context, adaptations are justifications provided instead of experimental study data as defined in Column 2 of the Annexes VII to X of the REACH regulation.
Compliance checks focus on eight key endpoints (2): genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. These are the key endpoints for identification of substances of concern.
Among the criteria for the selection of dossiers to undergo a compliance check, the Agency looks at substances with wide dispersive use and/or potential hazards, those with a structure related to CoRAP listed substances or those with adaptations for higher tier endpoints which are particularly cruc ...
