Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 69
5 Preparation of the registration dossier
Aim:
The aim of this chapter is to describe how to prepare a registration dossier. It
offers an overview on the information the registrant has to submit as part of his
registration dossier and explains how this information has to be reported. It does
not, however, provide specific practical instructions on how to successfully
submit a registration dossier to ECHA. For this latter information, the reader is
advised to consult Part II of this guidance where the different steps to generate
and submit a dossier are described in detail.
Structure: The structure of this chapter is as follows:
PREPARATION OF THE
REGISTRATION DOSSIER
INTRODUCTION
Section 5.1
TECHNICAL DOSSIER
Section 5.2
CHEMICAL SAFETY REPORT
Section 5.3
General information
Section 5.2.1
Steps of the
Chemical Safety Assessment
Section 5.3.1
Classification and labelling
Section 5.2.2
Chesar tool
Section 5.3.2
Manufacture, use and
exposure
Section 5.2.3
Information requirements
Section 5.2.4
<strong>Guidance</strong> on safe use
Section 5.2.5
Review by an assesor
Section 5.2.6
Confidential information
Section 5.2.7
5.1 Introduction
All relevant and available information has to be documented in both the technical dossier and
(for substances manufactured or imported in quantities of 10 tonnes or more per year per
registrant) in the chemical safety report (CSR). The information needs to be reported in
IUCLID format, and submitted to ECHA via REACH-IT, as shown in figure 3.
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