Guidance on data sharing - ECHA - Europa

<strong>Guidance</strong> on data sharing
Version 2.0 April 2012
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1. Introduction
1.1 Objective of the <strong>Guidance</strong> document on Data sharing
The present <strong>Guidance</strong> Document aims to provide practical guidance on the sharing of data as required under
REACH, within the same SIEF and between different SIEFs for phase-in substances and between multiple
registrants of the same non-phase-in substances.
Additionally the structure aims to allow the whole set of information related to phase-in substances and to
non-phase-in substances to be discussed in separate dedicated sections (respectively sections 3 and 4).
The <strong>Guidance</strong> contains practical recommendations to help companies meet their data sharing obligations and
includes a detailed description of the following processes:
• The late Pre-Registration;
• The formation of SIEF;
• Data Sharing for phase-in substances (within a SIEF) and potential related data sharing disputes;
• Data Sharing for non-phase-in substances and potential related data sharing disputes;
• Mandatory joint submission of data.
Figures and examples are provided in each section in order to support the description and explanation of
each specific process.
Specific explanations on Cost sharing mechanisms, on the protection of Confidential Business Information
(CBI), on Competition rules, and on forms of cooperation, including consortia are also provided.
1.2 Overview
The REACH Regulation 1907/2006 of 18 December 2006 sets up a system for the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) and establishes the European Chemicals Agency
(ECHA).
1.2.1 Registration obligation
Since 1 June 2008, companies manufacturing chemical substances in the EU or importing them into the EU
in quantities of 1 tonne or more per year have been required to register them under REACH. The registration
obligation also applies to companies producing or importing articles containing substances present in
quantities of 1 tonne or more per year that are intended to be released. Registration requires the submission
of relevant and available information on intrinsic properties of substances, as per the requirements set out
in the relevant Annexes to REACH. For substances manufactured or imported in quantities of 10 tonnes or
more a Chemical Safety Report has also to be submitted.
NB: Specific mechanisms and procedures have been introduced by REACH to enable companies to share
existing information before submitting a registration dossier in order to increase the efficiency of the
registration system, to reduce costs and to reduce testing on vertebrate animals.