Guidance on data sharing - ECHA - Europa

<strong>Guidance</strong> on data sharing
Version 2.0 April 2012
11
7 Information sharing under competition rules.........................................................................................127
7.1 Does competition law apply to REACH activities?...................................................................................127
7.2 EU Competition law and Article 101 of the Treaty on the Functioning of the .......................................
European Union (TFEU) in brief.......................................................................................................................127
7.3 Exchange of information under REACH and EU Competition law.......................................................127
7.3.1 Avoiding misuse of REACH exchange of information to conduct cartels.........................................128
7.3.2 The scope of the activities should be limited to what is necessary under REACH ......................129
7.3.3 Type of information to be exchanged with caution...................................................................................129
7.3.3.1 Reduce frequency of exchange.........................................................................................................................130
7.3.3.2 Reference to bands rather than individual figures when feasible.......................................................130
7.3.3.3 Use of precautionary measures if individual sensitive information would still need to be ...............
exchanged .............................................................................................................................................................130
7.4 Recommended tips for REACH actors when working together...........................................................131
8 Forms of cooperation.....................................................................................................................................................132
8.1 Possible forms of cooperation.........................................................................................................................132
8.2 What is a consortium?.........................................................................................................................................132
8.3 Examples of cooperation....................................................................................................................................133
8.4 Elements of co-operation that may be included in a Consortium’s activities................................136
8.5 Categories of participants in a Consortium................................................................................................137
8.6 Typical clauses that may be included in a Consortium agreement.....................................................138
9 Confidential business information (CBI).........................................................................................................140
9.1 What is Confidential Business Information?..............................................................................................140
9.2 Are there specific provisions on CBI in REACH?.......................................................................................140
9.3 Protection of CBI at late pre-registration ..................................................................................................141
9.4 Protection of CBI during SIEF Formation....................................................................................................141
9.5 Protection of CBI in the SIEF/Joint submission........................................................................................142
9.6 Protection of CBI in the submission of the registration dossier.........................................................142
ANNEX 1 Data exchange form.........................................................................................................................................143
ANNEX 2 List of reference documents mentioned in the guidance.................................................147
Table of Figures
Figure 1: Overview of the process of the joint submission of data..........................................................................17
Figure 2: Extended deadlines for registration.................................................................................................................26
Figure 3: Late pre-registration option for phase-in substances...............................................................................27
Figure 4: Data sharing principle within the SIEF..............................................................................................................44
Figure 5: Overview of the data sharing process for phase-in substances; pre-SIEF and SIEF operation..47
Figure 6: Article 30(2) procedure..........................................................................................................................................65
Figure 7: Article 30(3) procedure..........................................................................................................................................68
Figure 8: Article 30(3) procedure..........................................................................................................................................71
Figure 9: General overview of the inquiry process .........................................................................................................79
Figure 10: Detailed inquiry process followed by joint submission...........................................................................83
Figure 11: Data sharing for non-phase-in substances and phase-in substances not pre-registered..........88
Figure 12: Data sharing dispute according to Article 27(5)........................................................................................92