Data Submission Manual 5: How to complete a - ECHA - Europa

More documents

Recommendations

Info

Data Submission Manual Reference: ECHA-12-G-34-EN Publ.date: February 2013 Language: EN © European Chemicals Agency, 2013 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/web/guest/contact. European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Version: 3.1 4
Part 05 - How to complete a technical dossier for registrations a PPORD notifications Table of Contents Release date: February 2013 5 1. Introduction ........................................................................................................................ 9 1.1. Objective ............................................................................................................................ 9 1.2. Background ......................................................................................................................... 9 1.3. Conventions and terminology ................................................................................................ 9 2. General principles ............................................................................................................... 10 2.1. Range fields ........................................................................................................................ 10 2.2. Unit fields ........................................................................................................................... 11 2.3. Selection of other ................................................................................................................ 11 2.4. Detail level of the endpoint study records ............................................................................... 11 2.5. Repeatable blocks ................................................................................................................ 11 2.6. Confidentiality requests ........................................................................................................ 12 2.7. IUCLID 5 view mode selector ................................................................................................ 12 3. Different dossier types ........................................................................................................ 13 3.1. Special rules for joint submission dossiers............................................................................... 13 3.2. Special rules for isolated intermediate dossiers ........................................................................ 14 3.3. Special rules for PPORD dossiers ............................................................................................ 14 3.4. Special rules for notifications made under Directive 67/548/EEC (NONS) .................................... 15 4. IUCLID 5 sections to complete ............................................................................................ 15 4.1. Section 1 - General information ............................................................................................. 15 4.1.1. Section 1.1 - Identification ................................................................................................. 15 4.1.2. Section 1.2 - Composition .................................................................................................. 20 4.1.3. Additional considerations in Sections 1.1 and 1.2 .................................................................. 23 4.1.4. Section 1.3 - Identifiers ..................................................................................................... 24 4.1.5. Section 1.4 - Analytical information ..................................................................................... 25 4.1.6. Section 1.5 - Joint submission ............................................................................................ 26 4.1.7. Section 1.7 - Suppliers ...................................................................................................... 26 4.1.8. Section 1.8 - Recipients ..................................................................................................... 27 4.1.9. Section 1.9 - Product and process oriented research and development .................................... 28 4.2. Section 2 – Classification & Labelling and PBT assessment ........................................................ 28 4.2.1. C&L within a joint submission ............................................................................................. 30 4.2.2. Section 2.1 - GHS ............................................................................................................. 32 4.2.3. Section 2.2 - DSD - DPD .................................................................................................... 37 4.2.4. Section 2.3 – PBT assessment ............................................................................................ 39 4.3. Section 3 - Manufacture, use and exposure ............................................................................. 39 4.3.1. Section 3.1 - Technological process ..................................................................................... 40 4.3.2. Section 3.2 - Estimated quantities ....................................................................................... 40 4.3.3. Section 3.3 - Sites ............................................................................................................ 42
Page 1 and 2: Part 05 - How to complete a technic
Page 3: Part 05 - How to complete a technic
Page 55 and 56:
Part 05 - How to complete a technic
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97:
EUROPEAN CHEMICALS AGENCY ANNANKATU
show all

Data Submission Manual 5: How to complete a - ECHA - Europa

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?