IUCLID 5 WORKSHOP
Transcript of IUCLID 5 WORKSHOP
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CMA Testing and Certification Laboratories
CMA Testing and Certification Laboratories
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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
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Agenda
► Introduction of IUCLID 5
► System Overview� Layout & Navigation� Terminology� Introduction of Flag
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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.
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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.
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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.
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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
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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)
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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
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Agenda
► Introduction of IUCLID 5
► System Overview� Layout & Navigation� Terminology� Introduction of Flag
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System Overview
► Layout & Navigation
Menu bar
Toolbar
Bottom pane
Task Panel
Your Legal Entity
Your Username
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System Overviewcompany
information
substanceproperties
list of substancesin EINECS,ELINCS,…Migration
of existing
data
sites ofproduction
or use
substanceidentification
data exchange
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System Overview
- Selecting from the Menu Bar- Using the toolbar- Using keyboard shortcuts
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System Overview
Navigation window
Data (Entry) window
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Agenda
► Introduction of IUCLID 5
► System Overview� Layout & Navigation� Terminology� Introduction of Flag
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System Overview
► Terminology
Reference SubstanceEC Inventory
DossierTemplate
MixtureSubstance
Legal Entity SiteLegal Entity
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IUCLID 5 Structure
EC Inventory(read only)
ReferenceSubstance
Substance(data set)
Legal entity(owner)
Site
Endpointstudy record
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Agenda
► Introduction of IUCLID 5
► System Overview� Layout & Navigation� Terminology� Introduction of Flag
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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
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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)
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System Overview
� Red: mandatory� Green: option
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►Next Topic: IUCLID 5 Getting Start!
THANK YOU