Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
3 The registration process
Aim:
The aim of this chapter is to present the information that the registrant has to
submit as part of his registration and to explain how to submit it to ECHA. It also
describes what a joint submission of registration data is and how to submit
jointly the registration information to ECHA.
Structure: The structure of this chapter is as follows:
THE REGISTRATION PROCESS
INFORMATION REQUIREMENTS
Section 3.1
REGISTRATION DOSSIER
Section 3.2
JOINT SUBMISSION OF DATA
Section 3.3
ACCESS TO INFORMATION &
CONFIDENTIAL DATA
Section 3.4
3.1 Information requirements
Manufacturers and importers will need to obtain information on the substances they
manufacture or import and use this information to assess the risks arising from the
manufacture and uses of the substances and to ensure that the risks that the substances may
present are controlled.
The information gathered and the assessment performed has to be documented in the
registration dossier and submitted to ECHA for the registration of the substance.
3.1.1 Fulfilling the information requirements
Manufacturers and importers have to collect all available existing information on the
properties of the substance for registration purposes, regardless of the tonnage manufactured
or imported. This information has in turn to be compared with the standard information
requirements set up by the REACH Regulation.
The information to be gathered includes:
test data (in vivo and in vitro);
non test data from alternative methods such as (Q)SARs ((Quantitative) Structure
Activity Relationships), grouping of substances and read across;
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