Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

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2 Data Submission Manual Version: 2.0 Version Changes 2.0 Update to reflect changes due to IUCLID and submission web form updates (multiple screenshots), redrafting of ch.5.8, addition of ch. 5.9, redrafting of ch. 5.2, redrafting of ch. 9.2, web links verified and updated, document in new layout, minor textual revision 1.0 First version Part 14 - How to Prepare and Submit a Request for Use of an Alternative Chemical Name for a Substance in a Mixture using IUCLID 5 Reference: ECHA-12-G-36-EN Publ.date: July 2012 Language: EN © European Chemicals Agency, 2012 Cover page © European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form “Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written notification is given to the ECHA Communication Unit (publications@echa.europa.eu). This document will be available in the following 22 languages: Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovakian, Slovenian, Spanish and Swedish If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: http://echa.europa.eu/about/contact_en.asp European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Part 14 - How to Prepare and Submit a Request for Use of an Alternative Chemical Name for a Substance in a Mixture using IUCLID 5 Release date: July 2012 3 Table of Contents 1. INTRODUCTION .................................................................................................................. 6 2. LEGAL ENTITIES ................................................................................................................. 8 3. REFERENCE SUBSTANCES ................................................................................................... 10 3.1. Querying / updating Reference substances in your inventory ................................................... 10 3.2. Creating a Reference substance .......................................................................................... 13 4. CREATING A SUBSTANCE DATASET ..................................................................................... 17 4.1. Create a substance dataset – “CLP alternative name request” template..................................... 17 4.2. Copy/update from a registered Substance dataset ................................................................. 19 5. IUCLID 5 SECTIONS TO COMPLETE ..................................................................................... 20 5.1. IUCLID 5 view mode selector .............................................................................................. 20 5.2. Information requested for an alternative chemical name request.............................................. 21 5.3. Information to be provided in IUCLID 5 section 1.1 – Identification (mandatory) ........................ 22 5.3.1. Identity of the applicant .................................................................................................. 23 5.3.2. Identification of the substance for which an alternative chemical name is requested................. 23 5.3.3. Suggested alternative chemical name for the substance....................................................... 27 5.3.4. Contact person .............................................................................................................. 28 5.4. Information to be provided in IUCLID 5 section 1.2 - Composition (mandatory).......................... 29 5.5. Information to be provided in IUCLID 5 section 1.3 - Identifiers (optional)................................. 32 5.6. Information to be provided in IUCLID 5 section 1.4 - Analytical information (optional)................. 34 5.7. Information to be provided in IUCLID 5 section 2.1 – GHS (mandatory) .................................... 35 5.7.1. General information........................................................................................................ 36 5.7.2. Classification ................................................................................................................. 37 5.7.3. Labelling ....................................................................................................................... 44 5.8. Information to be provided in IUCLID 5 section 13 - Assessment Reports (mandatory)................ 47 5.9. Information to be provided in IUCLID 5 section 14.2 – Alternative name request (mandatory)...... 49 6. CREATING AN ALTERNATIVE NAME REQUEST DOSSIER ...................................................... 52 7. EXPORTING YOUR ALTERNATIVE NAME REQUEST DOSSIER ............................................... 59 8. UPDATING A DOSSIER ........................................................................................................ 62 8.1. Requested update ............................................................................................................. 62 8.2. Spontaneous update.......................................................................................................... 63 9. SUBMITTING AN ALTERNATIVE NAME REQUEST DOSSIER TO ECHA ................................... 64 9.1. Company sign-up in REACH-IT ............................................................................................ 64 9.2. Submit a request for an alternative chemical name ................................................................ 64 9.3. Next steps and final decision on the alternative name request ................................................. 66 Table of Figures Figure 1: Overview of an “alternative name request” dossier creation in IUCLID 5........... 7 Figure 2: Transfer of a LEO between the IUCLID 5 website and REACH-IT via a LEOX file. 9 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
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