IUCLID 5 – Preparing REACH dossiers - Biznet

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17 Νοε 2013 (πριν από 3 χρόνια και 7 μήνες)

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Turning our REACH expertise into practical help for industry

SIG meeting


special seminar on REACH

Paul Nguyen

ReachCentrum © 2010
-
2011

2

Contents


Overview of IUCLID 5



Training for IUCLID 5



Using IUCLID 5


as a Joint Submission member



ReachCentrum Support




ReachCentrum © 2010
-
2011

3

IUCLID 5


an overview


IUCLID (International Uniform ChemicaL Information Database) is a
software application to capture, store, maintain and exchange data on
intrinsic and hazard properties of chemical substances.



Is designed to be independent of legislations


REACH
-
compliant Registration Dossiers


Dossiers for other
Programmes / Legislations
, e.g. Biocides, OECD



Is compliant with
OECD Harmonised Data Formats

(for Endpoint data)


Contains approx. 9000 data fields


Can be installed as stand
-
alone or network system


Can be installed using:


Open source software


Commercial software


Can be downloaded from

http://iuclid.eu

ReachCentrum © 2010
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2011

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IUCLID 5 in support of REACH processes

Agency

Industry

Company

SIEF

Formation

REACH
-
IT

SIEF Operation

SIEF

Database

D
ata Sharing

Decision on


Joint Submission


Joint

Submission


Submission


JS Member


Individual


Submission

Pre
-
registration

data

Pre
-
registration

Registration

Dossier



Submission


Lead Registrant

ReachCentrum © 2010
-
2011

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IUCLID 5 installation processes

IUCLID5

Download

IUCLID 5

Installation

Prepare

Organisation

Create

User Account(s)

Sign
-
up at


IUCLID 5 website

Download

LEOX(s)

Download

EC Inventory

Download

Reference

Substances

Import

LEOX(s)

Import

EC Inventory

Import

Reference

Substances

Ready to go

Agency

Company

Sign
-
up at

REACH
-
IT website

Create / maintain

LEO(s)

ReachCentrum © 2010
-
2011

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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

ReachCentrum © 2010
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2011

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Minimum Requirements


Network installation (1)


DBMS = DataBase Management System
:
the following products are tested,
certified and supported


Oracle 10g


PostgreSQL 8.2.x



Application Servers
:
the following products (i.e. tested and certified)


Apache Tomcat 5.5.x

(
recommended
, since no additional features of
BEA WebLogic will be needed by the IUCLID 5 server application)



BEA WebLogic. Version 9.0

However, IUCLID 5 has no dependencies to libraries or mechanisms
specific to the BEA WebLogic server (e.g. IUCLID 5 does not depend on
JRockit, although this JVM may be used). IUCLID 5 only depends on a
J2EE compliant implementation of the included servlet container. Support
of WebLogic has been foreseen only for those bound to a commercial
product, not willing to switch to Tomcat.

ReachCentrum © 2010
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2011

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The HW requirements for distributed installation depend on:


the number of users


to the amount of data


requirements on fail safe and redundancy


Recommendation for the following scenario:


20 users


data for 1000 different substances


one server for database and servlet engine

Client:


Software:

-

JRE

(Version 1.5 and above),


Acrobat Reader


Hardware

-

RAM
: Minimal:
1GB

(2 GB ideal)

-

2GHz CPU

clock rate

Server

(recommendation):

Operating System:


-

Linux Centos

or
Linux RedHat ES

or

-

Windows 2003 Server

Hardware

-

2 CPUs with 2 GHz

clock rate

-

4GB RAM


-

200 GB

free disk space

Minimum Requirements


Network installation (2)

ReachCentrum © 2010
-
2011

9

Contents


Overview of IUCLID 5



Training for IUCLID 5



Using IUCLID 5


as a Joint Submission member



ReachCentrum Support



ReachCentrum © 2010
-
2011

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Logistics


Computer (one per participant):


All minimum requirements for software and hardware for stand
-
alone
IUCLID 5 installed.


Latest IUCLID 5 version with all appropriate plug
-
ins installed:


EC inventory and light reference substance list imported


At least one LEOX file imported


Maximum delegates: 20


Trainer: 2


Training room (U sharp set
-
up) can handle up to 20 participants and
enough place for trainers to move in between the participants to help


Projector; flipchart; notepads and pens


Internet connection


Attendee list; evaluation forms


Manuals + case studies (colour hard copies)


Lunches; coffee; refreshes

ReachCentrum © 2010
-
2011

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Prerequisites


Trainers:


Training skills


Basic knowledge of REACH and related REACH
-
IT tools


Good knowledge of IUCLID 5


Up
-
to
-
date the related REACH knowledge (e.g. guidances)



Participants:


Basic knowledge of REACH and REACH
-
IT


Understand the Registration requirements and process




ReachCentrum © 2010
-
2011

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Contents


Overview of IUCLID 5



Training for IUCLID 5



Using IUCLID 5


as a Joint Submission member



ReachCentrum Support




ReachCentrum © 2010
-
2011

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Overview REACH dossier structure

S E P A R A T E L Y


Identification of
manufacturer or importer


Identification of
substance


Information on
manufacture and use


For substances 1
-
10 t/a,
exposure information
(section 6 of Annex VI)


Indication about review
by an assessor

C H O I C E


Guidance on safe use
(section 5 of Annex VI)



Chemical Safety Report


JOINTLY


Classification and
labelling


Study summaries and
robust study summaries
of information derived
from application of
Annexes VII to XI


Proposals for testing
where listed in Annexes
IX and X


Indications about review
by an assessor

ReachCentrum © 2010
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2011

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REACH dossier within IUCLID 5


Red
: mandatory


Green
: option

ReachCentrum © 2010
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2011

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JS members


dossier requirements

ReachCentrum © 2010
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2011

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Substance Creation

Dossier Creation

Dossier Submisson

CSA/CSR

Guidance on Safe Use

Preparation


Preparation process


JS member

ReachCentrum © 2010
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2011

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2011

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JS member


dossier requirements

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2011

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Reference substance management

EC #

CAS #

No

No

No

Check the requirements

Create new Reference
Substance(s) to Use


Consortia


Associations


Other Sources

Share to Use

Yes

IUCLID5
website

Download to Use

Yes

Yes

IUCLID5
system

No

Yes

ReachCentrum © 2010
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2011

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The requirements for Reference substance


EC number and EC name


CAS number and CAS name


IUPAC name


Description

ReachCentrum © 2010
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2011

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The requirements for Reference substance


Molecular formula and
Molecular weight range


Remarks

ReachCentrum © 2010
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2011

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Using the TCC tool

1

2


3

4

5

6

ReachCentrum © 2010
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2011

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Create JS dossier as a member

1

2

REACH Registration JS
member dossier template

3

ReachCentrum © 2010
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2011

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Contents


Overview of IUCLID 5



Training for IUCLID 5



Using IUCLID 5


as a Joint Submission member



ReachCentrum Support



ReachCentrum © 2010
-
2011

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ReachCentrum can support


Expertise


Long distance support (webinar)


Helpdesk service


Consultancy



ReachCentrum © 2010
-
2011

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For more information in IUCLID 5 training:

www.reachcentrum.eu



or


Contact us at:

workshops@reachcentrum.eu



Paul Nguyen:
png@reachcentrum.eu


ReachCentrum © 2010
-
2011

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Thank you very much !!!

Turning our REACH expertise into practical help for industry