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9th BPR IT User Group meeting
23 November 2017, Brussels
Update on the IUCLID 6 project
Dorota Burchard-Sosnowska
IUCLID Team
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• State of play
– IUCLID 6 release 2.0.0
• Overview of the new or updated functionalities
– Improvement related for biocides
– Report Generator
– new approach to reporting in situ generated active substances in IUCLID
• Current plans
– IUCLID 6 roadmap
– Microorganisms
– Poison Centre Notification
– IUCLID 6 web interface
• Long term plans
– Technical completeness check for biocides
• More information
• Feedback
Contents
State of play
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
New release of IUCLID – 15 November 2017
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Industry: Desktop (one user on his computer), Server (multi-user system)
- How to install IUCLID Desktop https://www.youtube.com/watch?v=jeZ-v6qoeds
- How to update to the latest IUCLID 6 version using the updater
https://www.youtube.com/watch?v=attg0gSc-AM
• Competent Authorities: IUCLID database hosted and upgraded by ECHA
IUCLID 6 version 2.0.0
Installation and update
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Aim: export of .i6z files from IUCLID 6 v2.0.0 that can be loaded in IUCLID6 v1.x.y
• Backward migration rules have been defined
• In the future, this feature would reduce the pressure of format updates for integrated tools
while allowing the format to evolve based on user requirements
IUCLID 6 version 2.0.0
Extension of the compatibility between IUCLID versions
Current situation Target
Overview of the new or updated functionalities
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
• Using the export function, there is an
option to export to the previous IUCLID 6
format ‘Export to previous major version’
• This option is available for datasets and
dossiers
• Also available for bulk export
• You can use this option when you need to
exchange information with a user who is
still using IUCLID 6 version 1.x
Export in the previous version format
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Make the data protection association of Document fields to confidentiality fields explicit,
instead of currently being implicit
• Each document element (field, block, or even the document itself) is explicitly linked to the
confidentiality fields
• The data protection information is following these rules :
– the first field of a document is protecting the document
– otherwise the first field of a block is protecting the block
– otherwise the confidentiality field protects the direct following field
– otherwise there is no data protection
IUCLID 6 version 2.0.0
Split of the IUCLID flags
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
Split of the IUCLID flags
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
• New option added to print a record or a
dataset without the fields marked
confidential in IUCLID
Print option
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
Split of the IUCLID flags
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
• The same updated pick list in sections:
- 6.1 Function and mode of control
- 7.6 Method of application and description
of this method
• Remarks field
Method of application
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Product type pick list in 6.1 (Function and mode of control) adapted to the requirements
of the Biocidal Products Regulation
• Relevant also for pesticides
IUCLID 6 version 2.0.0
Product type in section 6.1
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 version 2.0.0
• The only option related to all kinds of
plastic is now ‘plastic’ with an additional
field for specify
Material of packaging
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Flammable liquids in section 4.6 with an own template (in the past it was a reference section)
IUCLID 6 version 2.0.0
Flammable liquids
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Endpoint summary available in all submission types:
- 9.2 – all substances
- 9.2.2 – biocidal product, representative product
- 9.1.2 – basic information (mixture)
IUCLID 6 version 2.0.0
Terrestrial toxicity, initial tests
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• The OECD have updated their series of OECD Harmonised Templates on Pesticide Residue
Chemistry to cover the entire set of OECD Test Guidelines
• Substances (BPR Annex II)
• Products/mixtures (BPR Annex III)
IUCLID 6 version 2.0.0
Updated Pesticides’ OECD Harmonised Templates (OHTs)
- 8.10 Other test(s) related to the exposure to humans
- 8.8 Food and feedingstuffs studies
- 8.9 Effects of industrial processing and/or domestic preparation on the nature and
magnitude of residues of the biocidal product
- 8.16.4 Estimation of potential or actual exposure of humans to the active substance
and residues through diet and other means
- 8.16.5 Feeding and metabolism studies in livestock
- 8.16.6 Effects of industrial processing and/or domestic preparation on the nature
and magnitude of residues of the active substance
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• The height of the tables increased so that the minimum number of rows displayed increases to
four even when each row is taking three lines.
IUCLID 6 version 2.0.0
Readability of tables
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID Report Generator
Available reports
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Main purpose: extraction of the IUCLID data that are relevant for the Summary of
Product Characteristics (SPC)
• Relevant for a single biocidal product
• Generates an XML file compatible with the SPC Editor
IUCLID Report Generator
Summary of product characteristics (SPC) report
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Main purpose: extraction of all literature references included in a dossier (in all its
components)
• Relevant for datasets and both types of BPR dossiers
• Generates an RTF file
• Gives a reference to IUCLID section number and name, and to BPR Annex II/III
requirements
• Hyperlink included (IUCLID Production, server)
• Bug occurring in 1.3.0 fixed: if two active substances are linked to section 2.3, then both
are displayed in the report (only first one in 1.3.0)
IUCLID Report Generator
Literature References Report
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Main purpose: extraction of all confidentiality claims from a dossier, so MSCA could
decide on whether these claims can be accepted or not
• Relevant for both types of BPR dossiers
• Available file formats: RTF, PDF, CSV (easily conversion to xls)
• Completed assessment can be sent to ECHA via the R4BP messaging system
https://idp-authority.echa.europa.eu/idp/
• Hyperlink included (IUCLID Production, server)
• Disclaimer: Please note that the contents of this report is based on Biocidal Products
Regulation Articles 67(3) and 67(4). Any confidentiality claims made outside of this context will
not be taken into account.
IUCLID Report Generator
BPR – Confidentiality Report (BPR Article 66)
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Main purpose: listing of all attachments included in a dossier (in all its components)
• Relevant for datasets and both types of BPR dossiers
• Available file formats: RTF, CSV (easily conversion to xls)
• Gives a reference to IUCLID section number and name, and to BPR Annex II/III
requirements
• Hyperlink included (IUCLID Production, server)
• Bug occurring in 1.3.0 fixed: correct file type shown
IUCLID Report Generator
List of attachments for BPR datasets and dossiers
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Which fields of an annotation should be displayed in the report?
IUCLID Report Generator
List of annotations (under development)
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID Report Generator
IUCLID home page
Starting points to generate a report
List of dataset / dossiers in Navigation Panel
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID Report Generator
Create your own reports
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
In situ generated Active substance
WebEx on 21 June 2017 for WG Analytical Methods and Physico-Chemical
Properties
• How to report all the components of the in situ (technical active) generated substance
– All relevant concentrations….
– Initial concentrations of the precursors vs. final concentrations in a “In situ (technical
active) generated substance”
• How to (better) report impurities of in situ
• How to report disinfection by products
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
In situ generated Active substance
New approach to report in IUCLID: all components reported
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
In situ generated Active substance
New approach to report in IUCLID:
all concentrations reported, at both stages of the process
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
In situ generated Active substance
New approach to report in IUCLID:
all reaction pathways described
substance
mixture
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
In situ generated Active substance
Next steps
• Analysis of the outcome of the consultation with BPR IT User Group to be finalised soon
• Publication of the Annex II to the BSM Technical guide: how to prepare a biocides dossier
https://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals
• Integration within the help system within the IUCLID
Current plans
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
Note: Plans for next year are still being discussed at the OECD level and within ECHA based on
the requirements collected from the different user groups
• Draft high level scope
– Evolutionary maintenance services, including supporting integration with other IT
solutions
– Update of the formats due to the latest development of the OECD Test Guidelines
reflected in the OECD Harmonised Templates.
– Changes due to the on-going internationalization activities (e.g. adoption of IUCLID by
other Authorities Australia, Canada, etc.)
– Implementation of the Poison Centre notification format into IUCLID
– Progressive extension and release of the web user interface (initially developed for the
Cloud platform) to selected group of users (ECHA, MSCAs, Industry)
IUCLID 6 roadmap
Plans for 2018
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
Microorganisms
• Consultation with Ad hoc WG
Microorganisms
– new options in a picklist ‘Type of
substance’ in section 2.1 (one
implemented so far)
– section dedicated to microorganisms
or alternatively an IUCLID submission
type specifically for microorganisms
– “translation” document indicating for
the relevant IUCLID entries to which
number in Annex of the BPR they
correspond to
• Plans (under analysis)
– collection of requirements for a
section dedicated to microorganisms
– reuse of some existing BPR
endpoints for microorganisms (more
choices in endpoint picklists)
– “translation” document or a help text
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
Poison Centre Notification
Reuse of biocides templates
• Annex VIII to CLP: obligation for importers and downstream users placing hazardous
mixtures on the market to notify national appointed bodies
• Feasibility Study Report
– Central Notification Portal
– similarities between the notification content and the content of existing IUCLID
documents
• Details of the products similar to BPR templates, for example:
– Trade name
– Packaging type and size
– Use (consumer, professional, industrial)
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 web interface
Create new
substances
Launch the IUCLID Cloud Client
for full IUCLID 6 functionalities
Import IUCLID
data
Support
functionalities
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 web interface
IUCLID Tree view and
shortcuts to all
sections
Open the document
for editing
Access to additional
information and
attachments
Collapsible
menu
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6 Cloud
Benefits with Cloud distributionAlways work on the latest version of the
application
Reduced risks of data loss (backups
managed by ECHA)
Facilitate working anywhere (easier
remote access) and delegation to consultants
Possibilities for better online support
No cost for users managing
installations and hardware
Data is more secure because of reduced
number of local copies
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Two services
– IUCLID Cloud for SMEs: aimed for SMEs, and their consultants, to prepare registration
dossiers for REACH 2018 deadline
– IUCLID Trial: available for everybody to try the service and to use as a training
environment
• Access using your ECHA account
• After the 2018 registration deadline ECHA will assess the use and the cost of the Cloud and
assess whether to extend the services to other user groups
IUCLID 6 Cloud
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
Release plan for 2018
• One release in October 2018
• Web interface could be released for MSCA
and ECHA users before Summer 2018 in
addition to the standard user interface
• More information on the planned IUCLID 6
releases can be found on the IUCLID 6
website
https://iuclid6.echa.europa.eu/project-
iuclid-6#ServiceRelease
Long term plans
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• Benefits:
– Quality of dossier
– Comparability
– Harmonization of requirements on active substance between different MSCAs (Industry)
– Dissemination
– Retrieving information from IUCLID BPR dossiers (for example data waivers)
• Some statistics on submitted dossiers
– 2,790 BPR Biocidal product authorisation
– 934 BPR Active substance application (representative product)
– 706,234 documents in all dossiers (that could be checked with TCC rules)
• Technical completeness check for biocides – next steps
– Survey on the interest among BPR IT User Group
No decision yet…
Technical completeness check for biocides
More information
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
IUCLID 6
• LinkedIn group
https://www.linkedin.com/groups/12043483
• Platform to exchange, discuss and provide
feedback on the use of IUCLID and on
future evolutions of the product
• Join now to be involved in the development
of our database
News and next events
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
• https://iuclid6.echa.europa.eu/support
• https://iuclid6.echa.europa.eu/videos
Manuals and webinars
Feedback received prior to the meeting
IUCLID 6 – 9th BPR IT User Group Meeting – 23 November 2017
Searching for mixture/product
…by non active components
Thank you!