How to submit a CLH dossier
This Practical Guide on `How to submit a CLH dossiers´ aims to provide practical tips and advice to help the Dossier Submitter (DS) in the preparation of a good quality dossier. This guide takes into account the CLP Regulation, the best regulatory practices, and ECHA´s Committee for Risk Assessment (RAC) needs to be able to make conclusions on the hazard classifications proposed: all of this helps to pass the so called `accordance check´ performed by ECHA. This check is to ensure the dossier complies with the CLP Regulation Article 36 for submitting a CLH dossier. This practical guide also takes into account the experience gained from the numerous dossiers processed through the harmonised classification process ans discussed at RAC.
This document should be used in combination with other ECHA guidance, particularly the "Guidance on the preparation of the dossiers for harmonised classification and labelling" which explains more `adminstrative´ aspects, for example who can submit a CLH dossier, the differences between `REACH chemicals´ and `active substances´ under either the Biocidal Products Regulation (BPR) or the Plant Protection Products (PPP) Regulation. In addition, the "Guidance on the Application of the CLP Criteria" provides information on the interpretation of the criteria for each hazard class and incorporates examples of classifications based on the available data and the ECHA Practical Guide "How to report robust study summaries" lays out the minimum details to be included in the reporting of a study for it to be considered a `robust study summary´This practical guide aims to bring together information from the CLP Regulation, the ECHA guidance, other relevant documentations and experience from RAC, to facilitate the task of the DS. However, readers are reminded that the text of the CLP Regulation is the only authentic legal reference and that the information in this document does not constitute legal advice.
How to submit a CLH dossier.
1. edition. Helsinki: European Chemicals Agency (ECHA) 2021.
ISBN: 978-92-9481-908-6, pages 35, PDF-Datei, DOI: 10.2823/124801
download file "How to submit a CLH dossier" (PDF, 562 KB, Not barrier-free file.)