Guidance on registration - ECHA - Europa

8
<strong>Guidance</strong> on registration
Version 2.0 May 2012
5.3.1.1.1 Human health hazard assessment.....................................................................................................79
5.3.1.1.2 Physicochemical hazard assessment..................................................................................................79
5.3.1.1.3 Environmental hazard assessment ....................................................................................................79
5.3.1.1.4 PBT/ vPvB assessment ....................................................................................................................80
5.3.1.2 Exposure assessment.........................................................................................................................80
5.3.1.3 Risk characterisation..........................................................................................................................80
5.3.2 Chesar tool..................................................................................................................... 81
5.3.2.1 Assessment workflow supported by Chesar...........................................................................................81
6 OTHER DUTIES OF REGISTRANTS .......................................................................... 83
6.1 Registrants duty of communication ....................................................................................... 83
6.1.1 Provide a Safety Data Sheet (SDS) to customers ................................................................. 83
6.1.2 Provide other information to customers .............................................................................. 84
6.2 Classification and Labelling notification.................................................................................. 85
7 When and how to update a registration................................................................. 86
7.1 Duty to keep information up to date ..................................................................................... 86
7.2 Required update on the registrant's own initiative................................................................... 87
7.3 Update as a consequence of an ECHA or A Commission decision ............................................... 90
7.4 Update of registration dossier for substances regarded as being registered under REACH.............. 91
8 Appeal procedures................................................................................................. 93
9 Fees....................................................................................................................... 94
9.1 Applicable fees and calculation of fees................................................................................... 94
9.2 Fee for updating of a registration dossier............................................................................... 94
10 Duties of ECHA..................................................................................................... 96
10.1 Initial verification ............................................................................................................. 96
10.1.1 Virus Scan .................................................................................................................... 96
10.1.2 File format validation ..................................................................................................... 97
10.1.3 Internal structure validation ............................................................................................ 97
10.1.4 Business rule validation .................................................................................................. 97
10.2 Assigning submission number ............................................................................................ 97
10.3 Completeness check and invoicing procedures ...................................................................... 97
10.3.1 Technical completeness check ......................................................................................... 97
10.3.2 Financial completeness check .......................................................................................... 98
10.3.3 Completeness check procedures ...................................................................................... 98
10.4 Rejection of the registration dossier .................................................................................... 98
10.5 Assigning a Registration Number ........................................................................................ 99
10.6 Informing the relevant Member State Competent Authority .................................................... 99
10.7 Agency Procedure in the case of a registration update ........................................................... 99
PART II: Practical instructions on how to prepare and submit a dossier .................. 101
11 Registration dossier ............................................................................................ 102
11.1 Practical information/recommendations ............................................................................... 102
11.3 How to prepare a dossier................................................................................................... 105
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu