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 iuclid6@echa.europa.eu 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