Manuals

Manuals on preparing REACH and CLP dossiers

The aim of the manuals on How to prepare REACH and CLP dossiers is to help companies to prepare, create and update IUCLID dossiers.

The manuals highlight the IUCLID sections that must be completed for the different dossier types, to prepare a valid and complete dossier that can be submitted to ECHA through REACH-IT. These manuals are also integrated in IUCLID.

Step-by-step instructions for completing the different IUCLID sections and processing each submission are provided in the manuals alongside overviews of the processes and legal concepts involved.

These manuals replace the former Data Submission Manuals (DSMs).

 

How to prepare registration and PPORD dossiers

ECHA performs a completeness check on each incoming registration to ensure that the required information is provided. This check includes a manual verification of certain elements that cannot be checked automatically. You can find further information on this document:

 

 

How to prepare an inquiry dossier

 

How to prepare a classification and labelling notification

 

How to prepare a request for use of an alternative chemical name for a substance in a mixture

 

How to prepare a substance in articles notification

 

How to prepare a downstream user report

 

How to prepare an application for authorisation

 

 

Dissemination and confidentiality under the REACH Regulation

This manual helps companies who are preparing registration dossiers to understand the dissemination process, what information will be made publicly available on ECHA's website, how to make a confidentiality request, how to prepare a justification and the basic procedure that ECHA follows to assess such requests.

In addition, this document advises industry on how to derive a public name for a substance for which the IUPAC name is requested confidential.

 

Dissemination and confidentiality under the REACH Regulation

Technical document to support registrants on transition to new IT tools

This document provides a source of information for registrants with existing data in IUCLID 5 format who need to adapt and prepare their information for submission with the new IUCLID and REACH-IT versions.

This is a technical background document. Support on how to prepare a complete and compliant dossier in the IUCLID 6 format is available in the other manuals above. 

 

Transition to the IT tools – how to prepare

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