Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
4 Data sharing procedures
Aim:
Structure:
This chapter provides an overview on the data sharing provisions set out in
REACH to facilitate the sharing of data between registrants. It describes the
main principles of data sharing as well as the pre-registration and inquiry
process. If in need of further information, the reader is advised to refer to the
<strong>Guidance</strong> on data sharing where the data sharing procedures are described in
detail.
The structure of this chapter is as follows:
DATA SHARING PROCEDURES
BASIC PRINCIPLES OF
DATA SHARING
Section 4.1
PRE-REGISTRATION
Section 4.2
SIEF FORMATION
Section 4.3
INQUIRY
Section 4.4
4.1 Basic principles of data sharing procedures
The purpose of data sharing is to increase the efficiency of the registration system as well as to
reduce costs and to reduce testing on vertebrate animals. Duplicate animal testing has to be
avoided and tests on vertebrate animals must only be undertaken as a last resort (Article 25).
In order to facilitate data sharing, the REACH Regulation requires that, prior to registration,
all substances must either be pre-registered or an inquiry must be submitted. In
general, pre-registration is relevant for phase-in substances and inquiry for non phase-in and
phase-in substances that have not been pre-registered (see section 2.3.1 for the definition of
phase-in and non phase-in substances).
The communication mechanism for phase-in substances is the Substance Information
Exchange Forum (SIEF) established following pre-registration. For non phase-in substances the
mechanism is the inquiry process.
With respect to data sharing, the following principles apply:
Data must be shared for the same substance in the case of information
involving tests on vertebrate animals. Before testing is carried out on vertebrate
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