Webinar for Inexperienced Registrants Creation of the Substance Dataset and of the Registration Dossier Ricardo Simoes ECHA – Registration & Dossier Submission Unit

2 Chapter 2 – IUCLID What do you need to do in IUCLID? 1) Make sure you are using the same Legal Entity (LE) in IUCLID and in Reach-IT and make it available for the IUCLID User that will prepare the dossier Create and assign a Site to your LE 2) Preparing the Dossier EC inventory Reference substance Substance Dataset Dossier creation steps for Member dossier

3 Chapter 2 – IUCLID Make sure you are using the same Legal Entity (LE) in IUCLID and in Reach-IT

4 Chapter 2 – IUCLID make the LE available for the IUCLID User that will prepare the dossier NOTE: You need to have Administrator rights in IUCLID to have access to the User Management menu!

5 Chapter 2 – IUCLID make the LE available for the IUCLID User that will prepare the dossier

6 Chapter 2 – IUCLID make the LE available for the IUCLID User that will prepare the dossier -The user that will prepare the dossier can now login and confirm that the Legal Entity is available for him to use.

7 Chapter 2 – IUCLID Create and assign a Site to your LE

8 Chapter 2 – IUCLID Create and assign a Site to your LE

9 Chapter 2 – IUCLID What do you need to do in IUCLID? 1) Make sure you are using the same Legal Entity (LE) in IUCLID and in Reach-IT and make it available for the IUCLID User that will prepare the dossier create and assign a Site to your LE 2) Preparing the Dossier EC inventory Reference substance Substance Dataset Dossier

10 Chapter 2 – IUCLID Preparing the Dossier

11 Chapter 2 – IUCLID Preparing the Dossier – The EC Inventory

12 Chapter 2 – IUCLID Preparing the Dossier – The EC Inventory

13 Chapter 2 – IUCLID Preparing the Dossier – The Reference Substance

14 Chapter 2 – IUCLID Preparing the Dossier – The Reference Substance

15 Chapter 2 – IUCLID Preparing the Dossier – The Reference Substance

16 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset

17 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset

18 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset

19 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset 1.1 Identification 1.2 Composition 1.3 Identifiers 3.3 Sites 11 Guidance on safe Use 13 Chemical safety report BR STEP SUCCEDED

20 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset 1.2

21 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset 1.3

22 Chapter 2 – IUCLID Preparing the Dossier – The Substance Dataset 3.3

23 Chapter 2 – IUCLID Preparing the Dossier – Guidance on safe use 11

24 Chapter 2 – IUCLID Preparing the Dossier – Chemical Safety Report 13

25 Chapter 2 – IUCLID Preparing the Dossier – Run the TCC Tool on your Substance Dataset

26 Chapter 2 – IUCLID Preparing the Dossier – The Dossier Creation Wizard

27 Chapter 2 – IUCLID Preparing the Dossier – The Dossier Creation Wizard

28 Chapter 2 – IUCLID Preparing the Dossier – Run the TCC Tool on your dossier

29 Chapter 2 – IUCLID Preparing the Dossier – Export the Dossier