title of presentation · • published in august 2014 • bug fixes in section 3.5 and 3.7.1 ......
TRANSCRIPT
IUCLID report
7th BPR IT User Group meeting
9 November 2015
Francois Le Goff
IUCLID Product Manager
Computational Assessment and Dissemination Unit (C3)
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Content
• IUCLID 5 and support materials
• IUCLID 6
• ECHA IUCLID Biocides database
Overall release plan
IUCLID 5
IUCLID 6 beta version
July 2015
IUCLID 6 official release
Q2 2016
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IUCLID 5
Maintenance
Maintenance
• Now limited to bug fixes (and only for the latest version of IUCLID available, 5.6 since April 2014)
• Patch 5.6.0.1
• Published in August 2014
• Bug fixes in section 3.5 and 3.7.1
• Patch 5.6.0.2
• Published in March 2015
• Scope • Fix for missing attachments
• Wrong record type for section 11 in application for authorisation dossiers
• Reference to attachment lost when records are imported using the IUCLID clipboard
• Errors when copying tables
• Update of supported softwares (PostgreSQL 9.3, Oracle 12, Tomcat 8, Java 8)
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IUCLID 5.6.1
• This maintenance release concentrates on preparing the IUCLID 5 database for the IUCLID 6 migration
• Issues identified with corrupted references will be addressed by:
• A fix in IUCLID 5 itself, to prevent new issues from appearing
• A data corrector, to fix or identify existing issues
• Type of issues:
• Creation of orphan documents when importing via the clipboard
• Corrupted attachments due to various issues in earlier IUCLID 5 releases
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Issues mainly related to management of REACH data, in older versions of IUCLID (e.g. 5.2)
References corrector
• Provided as a separate tool from the IUCLID 5 application
• To be run after the upgrade to IUCLID 5.6.1
• The tool can be run in SCAN or FIX mode and produces the following outputs:
• 2 reports regarding user actions required for raw data / dossiers
• 2 reports regarding auto corrections for raw data / dossiers
• 1 general report from the tool's execution steps (execution.log)
• Need to define the best way(s) to release the tool
• Embedded in the IUCLID 5 standalone version installer?
• Included in the IUCLID 6 migration tool?
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Known issues / support
• Other known issues are currently not prioritised to be fixed:
• Export Dossier or Annotation fails illegal JDOM character content: 0x1 is not a legal XML character
• Error when importing the dataset cvc-complex-type.2.4.a: Invalid content was found starting with element 'i5:LIST_BELOW_POP.value‘
• Exception while trying to open the inherited templates of a BPR Active substance dossier
• Memory leak protection Tomcat 7/8
• Access right to templates does not apply to documents in the template
• Export i5z : Date field not correct (time zone specification issue)
• Exception when scrolling in 'User preferences \ Disable data sections‘
• Cannot create dossier from a category when a link exists between sections 3.5 and 3.7.1
For information. The list is maintained on the IUCLID 5 website.
Report Generator
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Extract of IUCLID data for the SPC Editor
• Published as an update of the Report generator
• From a Product dataset to the SPC XML format accepted by the Editor
• Manual available on the IUCLID 5 website (mapping of IUCLID 5 data / SPC information)
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Biocides Submission Manual on IUCLID
• Updated in February 2015 to include two annexes:
• How to include a mixture containing an active substance to a biocidal product dossier in IUCLID
• How to report active substance(s) generated in situ in IUCLID
IUCLID 6
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IUCLID 6
2013/2014 Q2 2015 Q2 2016
• User requirements collected, proposals presented, reviewed and approved at different levels: • EU Industry IUCLID User Group
• EU MSCA IUCLID User Group
• OECD Harmonised Templates and OECD IUCLID User Groups
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IUCLID 6 – technology upgrade
• New technology
• General need to bring the technology up to date
• More possibilities for ‘internationalisation’, i.e. use/acceptance of IUCLID files for other programmes
• Better security model, e.g. support business unit model
• Better support for features like reporting
Overview of the functions available in the beta version
• IUCLID entities management (substance, mixture, legal entity…)
• Dossier creation
• Basic search
• Import / export
• Migration of i5z files
• Main engines for:
• Filtering
• Printing
• Validation
• Annotations
• Information panels
• Attachments
• Secured client / server communication
• User management
• Instance-based user permissions
• Help system
• Desktop version installer
• Clipboard manager
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Features to be implemented / finalised for the official release
• Priority 1
• Plug-ins management (including legislation plugins)
• Back-up and restore (Desktop version)
• LDAP (Authorities)
• Bulk operations
• Conditional formatting
• Exception handling
• Help system
• Hyperlinks
• Literature references exchange
• User preferences
• Plug-ins • Dissemination (REACH)
• CSR report and SPC extract
• Fee calculation
• Validation assistant
• Priority 2 (maintenance)
• Announcements
• Attachments versioning
• Comparison
• Advanced search
• LDAP (Industry)
• Email server
IUCLID simplification
Desktop version installation improved
Help system reviewed and Dossier Submission Manuals included
IUCLID dossier creation online with REACH-IT
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Help System
Manuals
IUCLID 6
Other changes relevant for BPR users
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Update to the format (IUCLID and OECD Harmonised Templates)
• Harmonisation of the document management (records can be copied, reused)
• GHS information: update to CLP ATP 8 and GHS version 6
• Harmonised templates
• Administrative data updated (endpoint field to precise the information requirement, data waiving and justification picklists…)
• Test material information improved (inventory)
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Composition of mixtures and Biocidal products
Ref. substance, substance or mixture can be selected
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IUCLID updates • Independence from other
legislations implemented in IUCLID 6
• OECD templates can be updated but ECHA and the stakeholders will define the best timing for the update of the BPR dossiers (coordination with R4BP 3, Industry and MSCA users)
• More freedom to update the BPR IUCLID documents independently (please send us your feedback, change requests to the IUCLID ECHA Helpdesk)
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Annotations
• Overview of all annotations made on a dossier
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Annotations
• Possibility to copy or link annotations from one dossier to another
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Filtering of IUCLID dossiers
• The filtering logic of the dissemination plug-in will be updated to process product and active substance dossiers
• Active substances and other product components will be filtered according to different rule sets
• IUCLID 6 module to be made available before the dissemination of the information, in 2016 (maintenance release)
IUCLID
ECHA/MSCA database
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Access to the database by CAs
• 825 user accounts created
• 402 connected to IUCLID at least once
• 173 users logged-in since September, 79 since the beginning of the month
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User rights
• Read-only access to the dossier content
• Annotations
• Add annotations (>100 annotations already created)
• Import/export annotations
• Printing (added since November 2013)
• Export of dossiers (added since this summer for administrators only)
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User actions
1. Review of dossier content
2. Print
3. Annotation creation (almost 2,000 created so far)
4. Import / Export annotations
5. Export dossiers (only administrators)
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ECHA IUCLID database
• With the availability of the instance-based security, ECHA IUCLID databases will be grouped: same database for REACH and BPR
• Possibility for users to share / not share documents (e.g. draft annotations can be shared within the CA and final versions shared with other CAs in a second step)
• Same username and password for R4BP 3, REACH-IT 3 and IUCLID 6
Next steps
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Next steps
• Two IUCLID 6 testing phases starting 20 November & 5 February (contact [email protected] to join the testing team)
• IUCLID 6 official release end of April 2016 (to be confirmed by the end of the year)
• R4BP 3 and REACH-IT 3 will be adapted to accept only IUCLID 6 files one month later
• Two maintenance releases planned in 2016 (e.g. dissemination plug-in for biocides)
Thank you