28.10.2008
Agenda REACh
Workflows and Software Tools for the Process of Registration,R • REACh Regulation and Timetable EEvaluation, AuthorisationA and • REACh Implementation Plan Restriction of European Chemicals • REACH-IT-Workflows and Functionalities • Software Application IUCLID 5 Gerlinde Knetsch • Network Topology and Realization in FEA Federal Environment Agency • Outlook Unit IV2.1- Information Systems on Chemical Safety
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REACh REACh Registration, Evaluation, Authorisation Registration, Evaluation, Authorisation and restriction of Chemicals and restriction of CHemicals
REACh Regulation 2006/1907/EC REACh Information Sharing
REACh The legislation should ensure a high level of REACh Manufacturers and importers are Regulation Regulation encouraged to collaborate to the 2006/1907/ protection of human health and the 2006/1907/ EC envitfthikbhilironment from the risk by chemical EC preparation of registration dossiers , by substances. Manufacturers and importers of substances in quantities of 1 tonne or Æ sharing information on hazard and more shall submit a registration to exposure for the chemical substances theEuropean Chemical Agency (ECHA) in Æ formation of voluntary consortia to Helsinki. facilitate the information sharing.
Æ finally adopted by EU Member States in December 2006
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REACh Concept of REACh Timetable
Greater Responsibility on Industry • 1 June 2007 REACh - Regulation entered into force
• 1 June 2008 Pre-registration period for chemicals started Æ Risk assessment for humans and the REACh environment (exposure scenarios) Timetable • European Chemicals Agency (ECHA) provided/s information rules, ECHA-WebSide and IT-Tools (REACh -IT and IUCLID 5) No data – no Æ Conducting Chemical Safety • 1 December 2008 Pre-registration period ends Assessment (CSA) market! • 1 January 2009 ECHA publishes list of pre-registered substances and commences listing substances potentially requiring Æ Preparing detailled Chemical Safety authorisation Report (CSR) • 1 December 2010 Registration deadline for phase-in substances manufactured or imported 1,000 tonnes + per annum
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REACh Implementation Plan What does it means ? RIP 2.1 REACh-IT REACh Implementation Plan – RIP 2.1 REACh-IT
REACh Regulation, Article 111 Objectives of REACh-IT: „Formats and software for submission of information to the European Chemical Agency“ • Development of an IT-system that enables the ECHA "The Agency shall specify formats and make them available free of charge [...] on its website for any to receive and store pre-registration and inquiry submissions to the Agency. Member States, manufactures, dossiers, registrations, notifications, reports and importers, distributors or downstream users shall use No Data – payments these formats [...] in their submissions to the Agency no Market pursuant to this Regulation. [...] For the purposes of REACh • Simply and protected retrieval to the information via registration, the format of the technical dossier [...] Art. 111 REACh-Portal WebSide by the Industry, Agency and shall be IUCLID. The Agency shall coordinate the further development of this format with the MSCAs Organisation for Economic Cooperation and Development (OECD) • Dissemination of non-confidential registration dossier to ensure maximum harmonisation." data and other relevant data for the public
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Three pillars of REACh-IT Two Main IT-Systems View of Users
REACH-IT: Industry Agency / MSCAs Public • Support for managing the complete system Company Agency / MSCA Dissemination homepage homepage homepage • Agency web portal • Workflow system • Dissemination REACh-IT IUCLID 5: Workflow for day-to- Company sign-up Dissemination data: day work, including: •Search • Industry: tool for Submit dossier •Authorisation Dissemination Pre-registration •Print •Evaluation •Download capturing data on SIEF participation •Restriction Dossier submission chemicals, preparing Dossier management Invoice download Consultation Comments Public consultation and submitting dossiers Dossier status Invoice management Search & Reporting Administrative functions • Agency and MS: central data repository for all REACH-IT dossiers submitted and tool for preparing dossiers Quelle: ECHA Stand: 08.05.2008
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REACH-IT-Workflows: Workflows and Interaction Functionalities for Industry
Industry • Data sharing: Pre-registration, SIEF, inquiry process • Submission of dossiers prepared in IUCLID 5 (e.g. registration) • Online encoding and submission of dossiers with limited data requirements • Follow-up functionalities – submission reports sent back to registrants – notification systems (e.g. deadlines reminders) – status of dossiers (i.e. a company can consult REACH-IT for tracking its own dossiers)
Quelle: • Consultation of information (e.g. guidelines) ECHA 2008
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REACH-IT-Workflows: Functionalities for Authorities REACH-IT: How it will works?
ECHA/Agency and Member States (MS) ÆSupport for • Workflow system accessed by Agency staff Agency (ECHA) and MS staff (notification system by email, and MS work on evaluation, dashboards,…) authorisation and • Follow-up of dossiers and updates restriction • Follow-up of Committee work, decisions, opinions, etc. • Dissemination of information • Third parties consultation Æ Objectives of REACH
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REACH-IT-Workflows: Software Application Functionalities for the public IUCLID 5
General Public and trusted parties ….it implements the 86 Harmonised Templates developed by the OECD (Organisation for Economic Cooperation and Development) According the regulation of REACh Art. 117 (1) and 119: …. it allows to enter, manage, store and exchange information on intrinsic The Agency and Member States and hazard properties of chemical substances should allow electronic public access to information in ….it allows to prepare and submit dossiers in XML-standard format accordance with Directive 2003/4/EC… … it’s compatible with chemical legislation and programme requirements in different part of the world, inter alia the EU Biocides Directive and the OECD …selected non-confidential data of the registration dossier shall High Production Volume (HPV) Programme published International Uniform Chemical Information …Retrieval and requests via the Database „Dissemination Website“ of IUCLID REACh-IT
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Functional data model Functional data model IUCLID 5 IUCLID 5
Each data object y
Æ Universal Unique IDentifier (UUID)
Substance data set, Dossier data set Study summary report Reference substance set Legal entity object
Imperative for Integration and Exchange between the IUCLID 5 and REACh-IT data base
References to substances Updates unique identification
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IUCLID 5 Data content „Key“ - Software IUCLID 5
„Starting page“ of IUCLID 5:
• Tasks
• Inventories
• Tools and aministration Import via XML- Interface
• PlugIns for migration of IUCLID 4-Data into IUCLID 5 - format, Pre-registration ….
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IUCLID 5: abstraction layers Technical architecture IUCLID 5
Multiple data layers in IUCLID 5 Two technological concepts:
Distributed Network Application with several Web-Clients ENTERING raw data layer Stand-alone Application
Data Base: FREEZING / dossier layer RDBMS ORCALE 10.2 (commercial data base system) SUBMITTING PostgreSQL (open source-product)
Servlet Engine: COMMENTING annotation layer BEA Web Logic Apache Tomcat FrontEnd: XML layer EXCHANGING Client User Interface (Java Swing) Java Runtime Environment Access via Webbrowser (Internet Explorer, Firefox)
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Technical Architecture Enhancements of IUCLID 5 of IUCLID 5
Plugins for IUCLID 5
9 Migration tool IUCLID 4ÆIUCLID 5, (New Chemicals) 9 Pre-Registrierung o Search- and Reportingtool ÆPlanning: October 2008 o Tools for configuration and generation of: oExposure scenarios (ES) oChemical Safety Assessment (CSA) oChemical Safety Reports (CSR) Æ Planning: September 2009
Souce: TechniData GmbH (2006) •
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Search-Plugin Network Topology of the IUCLID 5 IT-Infrastructure
9 I 5 Standardqueries: Basic functionalities Internet o I 5 Flexiblequeries: Internet Virtuell Private Search of all available data Network (VPN) incl. Endpoint fact data European Chemical Agency in Helsinki o REACh – IT-Queries: Basic functionalities for
10/100 SSG 5 TX/RX LINKTX/RX LINKTX/RX LINKTX/RX LINKTX/RX LINKTX/RX LINKTX/RX LINK POWER802.11a CH1 B administrative data, number STATUS b/g CH2 B Firewall WLAN ISDN v.92/RJ11 CONSOLE 0/0 0/1 0/2 0/ 3 0/4 0/5 0/6 of pre-registration and dossiers data Cryptobox o Complex query module for LAN / e.g. BAuA research in REACh-ITund I /FEA/Authorities 5: Meta-daten of the legal entitiy in combination with fact data e.g. substance LAN: Local Area Network Cryptobox: Encoding of the requests properties Firewall: Software and Hardware components in the Authorities/Agencies e.g..Router
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Dataflow from ECHA to FEA Outlook - Perspectives
• Complex IT System IUCLID 5 with a lot of functionalities can be used for a large number of purposes. • Data storage formats implemented have been developed in co-operation with the Organisation for Economic Co-operation and Development (OECD) • Highly acceptance by many national and international regulatory authorities. • Use of IUCLID 5 for non-REACH jurisdictions is therefore explicitly endorsed.
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Use for other legislations Outlook - Perspectives of chemicals
• The fact that data in IUCLID 5 can be used for Dossiers can be created for: other purposes than REACH may offset some of the data collection costs. • OECD High Production • UCLID 5 data model also features Value chemicals Biocides/Pesticides elements and data collected under REACH can thus be re-used once • EU Biocides complemented with data on biocidal or pesticidal properties - for data reporting obligations under – Active substance other legislation. – Product (preparation)
• In discussion: – EU Pesticides
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HPV Global Portal Outlook IUCLID 6 ? WebService
I5/I6 could be a solution for efficient data collection and exchangeof information between parties 6
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REACh-IT
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