iuclid 5 workshop

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Your Reliable Quality Solution Partner CMA Testing and Certification Laboratories CMA Testing and Certification Laboratories Your Reliable Quality Solution Partner Implementation and Support Programme to deal with the EU Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) TID SDF Project (Ref. No.: D09 002 006) IUCLID 5 WORKSHOP 17 th December, 2010 Part 1 Your Reliable Quality Solution Partner Agenda Introduction of IUCLID 5 System Overview Layout & Navigation Terminology Introduction of Flag Your Reliable Quality Solution Partner What is IUCLID 5? International Uniform ChemicaLInformation Database A software that can be used (especially chemical industry companies and government authorities) to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances.

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Page 1: IUCLID 5 WORKSHOP

Your Reliable Quality Solution Partner

CMA Testing and Certification Laboratories

CMA Testing and Certification Laboratories

Your Reliable Quality Solution Partner

Implementation and Support Programme to deal with the EU Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals

(REACH)TID SDF Project (Ref. No.: D09 002 006)

IUCLID 5 WORKSHOP17th December, 2010

Part 1

Your Reliable Quality Solution Partner

Agenda

► Introduction of IUCLID 5

► System Overview� Layout & Navigation� Terminology� Introduction of Flag

Your Reliable Quality Solution Partner

What is IUCLID 5?

International Uniform ChemicaL Information Database

A software that can be used (especially chemical industry companies and government authorities) to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances.

Page 2: IUCLID 5 WORKSHOP

Your Reliable Quality Solution Partner

What can IUCLID 5 do for you?

► IUCLID 5 enables industry to compile complete, REACH-conforming registration dossiers and to manage these data on-site.

► It also enables the European Chemicals Agency (ECHA), the European Commission and the Member State Competent Authorities to receive, further treat and manage industry registrations.

Your Reliable Quality Solution Partner

Data collection and evaluation in the context of REACH

► According to Article 10 of REACH a technical dossier and, depending on the tonnage band, a chemical safety report (CSR) has to be submitted by industry to the ECHA.

Your Reliable Quality Solution Partner

IUCLID 5 in support of REACH processesIUCLID 5 in support of REACH processes

SIEF Formation

REACH-IT

SIEF Operation

SIEF

Database

Data Sharing Decision onJoint Submission

Joint Submission

Submission

JS Member

IndividualSubmission

Pre-registrationdata

Pre-registration

Registration

Dossier

Submission

Lead Registrant

Agency

Industry

Company

Your Reliable Quality Solution Partner

IUCLID 5 installation processesIUCLID 5 installation processes

IUCLID5Download

IUCLID 5Installation

Prepare Organisation

Create User Account(s)

Sign-up at

IUCLID 5 website

DownloadLEOX(s)

DownloadEC Inventory

DownloadReference Substances

Import LEOX(s)

ImportEC Inventory

ImportReference Substances

Ready to go

Agency

Company

Sign-up at

REACH-IT website

Create / maintainLEO(s)

Page 3: IUCLID 5 WORKSHOP

Your Reliable Quality Solution Partner

Minimum Requirements Stand-alone installation

► Software� Java Runtime Environment

� Acrobat Reader

� Microsoft Windows 2000, XP Professional, or VISTA

► Hardware� RAM: Minimum 1GB (2GB recommended)

� 2GHz CPU

Your Reliable Quality Solution Partner

Agenda

► Introduction of IUCLID 5

► System Overview� Layout & Navigation� Terminology� Introduction of Flag

Your Reliable Quality Solution Partner

System Overview

► Layout & Navigation

Menu bar

Toolbar

Bottom pane

Task Panel

Your Legal Entity

Your Username

Your Reliable Quality Solution Partner

System Overviewcompany

information

substanceproperties

list of substancesin EINECS,ELINCS,…Migration

of existing

data

sites ofproduction

or use

substanceidentification

data exchange

Page 4: IUCLID 5 WORKSHOP

Your Reliable Quality Solution Partner

System Overview

- Selecting from the Menu Bar- Using the toolbar- Using keyboard shortcuts

Your Reliable Quality Solution Partner

System Overview

Navigation window

Data (Entry) window

Your Reliable Quality Solution Partner

Agenda

► Introduction of IUCLID 5

► System Overview� Layout & Navigation� Terminology� Introduction of Flag

Your Reliable Quality Solution Partner

System Overview

► Terminology

Reference SubstanceEC Inventory

DossierTemplate

MixtureSubstance

Legal Entity SiteLegal Entity

Page 5: IUCLID 5 WORKSHOP

Your Reliable Quality Solution Partner

IUCLID 5 Structure

EC Inventory(read only)

ReferenceSubstance

Substance(data set)

Legal entity(owner)

Site

Endpointstudy record

Your Reliable Quality Solution Partner

Agenda

► Introduction of IUCLID 5

► System Overview� Layout & Navigation� Terminology� Introduction of Flag

Your Reliable Quality Solution Partner

System Overview

► Introduction of Flag� Confidentiality Flag� Regulatory Purpose Flag� Purpose Flag� Robust Study Summary Flag� Used for Classification Flag� Used for MSDS Flag� Data Waiving� Study Result Type Reliability

Your Reliable Quality Solution Partner

System Overview

► Introduction of Flag� Purpose of flags:

• Filter data while exporting,creating a dossier or printing

• Indicate to the Authorities, e.g. ECHA, that the information is confidential (data protection)

Page 6: IUCLID 5 WORKSHOP

Your Reliable Quality Solution Partner

System Overview

� Red: mandatory� Green: option

Your Reliable Quality Solution Partner

►Next Topic: IUCLID 5 Getting Start!

THANK YOU