8th BPR IT User Group meeting

14 November 2016, Brussels

Update on the IUCLID 6 project

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• State of play– IUCLID 6 releases in 2016

• Overview of the new or updated functionalities– BPR submission types– Help system– Personal settings– Annotations– Dossiers comparison – First solution for IUCLID data extraction to support SPC drafting in SPC Editor

• Current plans– Advanced search– IUCLID data extraction to support SPC drafting in SPC Editor– List of references– IUCLID 6 REST Public API

Contents

State of play

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Timeline

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• 21 June 2016

– update containing several fixes relevant to REACH users

• 30 September 2016

– service release offering new features to all IUCLID users

– available for MSCAs (database hosted by ECHA) since 27 October

IUCLID 6 releases in 2016

IUCLID 6 – 8th BPR IT Expert Group Meeting – 14 November 2016

• The updater will bring any IUCLID 6 version to the latest one

IUCLID 6 update process

Updater

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Dossier comparison• Inventory management tool• Improvements to the UI for Mac and Linux• Database patch tool• Quality rules for the validation assistant (45)• Public API (beta version)• Improvements

– Clipboard– Filtering– Aggregation– Report generator and CSR– Help– Manual validation rules– Import (replace option)– Chesar plug-in

• Fixes– Migration issues– Performance issues– Search– User permissions– Undo function– Field labels

IUCLID 6 maintenance

Scope - service release on 30 September 2016

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Patch00A: finalisation of the migration of document s

• Patch001: attachment corrector

• Patch002: developmental toxicity / teratogenicity' (OHT #74; IUCLID section 7.8.2), migration of the field ‘Doses / concentrations’

• Patch003: inquiry; correction of the migration of ‘Toxicological information’ fields

• Patch005: BPR information: use names stored in the links from section 7.6 'Method of application and a description of this method'

Database patch tool

List of patches included in the September release

Overview of the new or updated functionalities

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

10

• IUCLID 6

• IUCLID format update (OHTs, use and exposure, etc.)

• Simplification of user interface and key functions

Test material inventory

New format

Advanced security

Annotation inventory

Modernised interfaceNew technological platform

Plug-ins redeveloped

New help system

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• BPR Active substance information • BPR Basic information (substance)• BPR Substance of concern

BPR submission types

Substances – view to be selected / displayed in the Navigation panel

2.9 Composition of the substance

• Specification on purity of the active substance as manufactured• Composition of the substance• Composition of the substance of concern

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• BPR Active substance application (representative product)• BPR Basic information (mixture)• BPR Biocidal product authorisation

BPR submission types

Mixtures/Products – view to be selected / displayed in the Navigation panel

2.3 Composition of the biocidal product / mixture

• Representative biocidal product composition• Mixture composition• Biocidal product composition

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• BPR Active substance application (representative product)• BPR Biocidal product authorisation

BPR submission types

Dossiers types

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Help system reviewed

• Dossier Submission Manuals included (End user manual)

• BSM (Technical guide: using IUCLID), included

Help system

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Default way of displaying sections in the document

Personal settings

My account on the main page of IUCLID

• Font size

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Industry prepares the datasets for the substances, mixtures and biocidal product –editable

• Industry prepares the dossier to be submitted via R4BP to the ECHA database which can be accessed by MSCA – read only

• MSCA reviews the dossier and comments on it using the annotations that will be sent to Industry

• Industry receives the annotations from MSCA and based on them corrects the information in the datasets and creates new dossier to be sent to ECHA

Annotations – how it works?

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Annotations – new features

Export from the Annotations list

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Annotations – new features

Access to all annotations created on the previous versions of a dossier

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Annotations – new features

Access to all annotations

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• To compare whether the same documents exist in two different dossiers

• To compare the content of those documents, thereby allowing you to see in much greater detail the similarities and differences between two dossiers

Dossier comparison

Purpose of the comparison tool

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Identical content• Different content• Different annotation• Included only in the first document• Included only in the second document

Dossier comparison

What you can see using the tool

Special case

• Comparison of a dossier migrated from IUCLID 5 and an update prepared in IUCLID 6

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Dossier comparison

What differences you can see - example

Hazard pictogram code is only in dossier 1

Precautionary statement is in both dossiers but has different content

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• The extraction of the IUCLID data that are relevant for the Summary of Product Characteristics (SPC), under the EU Biocidal Products Regulation. The output data format (XML) is compatible with the SPC Editor and is generated through IUCLID’s Report Generator plugin.

• The generated xml file contains information related to:� Identity of the biocidal product� Product type, formulation type� Product composition� Authorized uses� Directions for use� Packaging� Measures to protect humans, animal and the environment� Classification and Labelling information� Some administrative information

• The generated xml file can be reused in SPC Editor for Single products only.

IUCLID Report Generator

Purpose and main features

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Download the SPC template from ECHA’s IUCLID website https://iuclid6.echa.europa.eu/reports

• Step by step:1. In IUCLID find the Mixture/Product dataset /dossier you wish to generate a report from2. Press Ctrl +Alt + R to launch the Report Generator wizard3. Generate the xml file by uploading the SPC template and save it on your local IT

environment4. Import the xml file to the SPC Editor as a starting point for creating your SPC Single

Product

IUCLID Report Generator

How to extract SPC related data?

Current plans

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Provider agent for the current version of the eChemPortal• DNEL tool (1st version)• Advanced search: analyse feasibility to reuse ECHA’ s Text Analytics tool• Aggregation plug-in (for regulatory authorities), extraction of datasets from dossiers• Hyperlinks

• BPR reports– SPC XML extract– List of references– List of confidentiality claims

• Public API update

IUCLID 6 Project Scope

IUCLID6 Scope - service release – January 2017

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• In parallel to the IUCLID 6 development, ECHA has developed a search tool ‘Text Analytics’

• Text Analytics already allows the user to perform text searches in all IUCLID fields (like a IUCLID search engine, ‘IUCLID Google’)

• The IUCLID team is investigating the possibility to extend this tool so as to be a good replacement to the Query tool

• A beta version will be made available to interested users in Q1 2017 (exact conditions will be provided by ECHA)

Advanced search

Current plans

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• Allows to extract IUCLID information directly to an xml file that can be reused in the SPC Editor

BPR reports

SPC generator in IUCLID

List of references (template on IUCLID 6 website)

• Will allow to create a list of all studies included in a dossier• Publication of the template on IUCLID 6 website within next three months

List of confidentiality claims (template on IUCLID 6 website)

• List all (relevant) confidentiality claims in a IUCLID dossiers

Instructions are published on the IUCLID 6 website on how to create your own report templates (some IT skills required):

https://iuclid6.echa.europa.eu/reports

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

• IUCILD 6 comes with support for web services out of the box (both Desktop and Server version)

• IUCLID 6 offers a public REST Web Services API for integration with external systems

– Backward compatibility will be ensured– Public documentation is available

• A beta version has been published with IUCLID 6 1.1.0 on 30 September 2016

• A final version will be included to the IUCLID 6 release in January 2017

https://iuclid6.echa.europa.eu/public-api

Public API

REST Web service

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

– Two more releases in 2017• One service release

– No change to the format– Integration compatibility maintained

• One major release– Option to update the format (after impact analysis and agreement with

potentially impacted projects)– Option to change the integration points– But maintenance mode (minor changes in comparison to the IUCLID 5 to

IUCLID 6 update; backward compatibility will be maintained)• Ad-hoc maintenance releases (patches) if needed

IUCLID 6

Release plan (after the January release)

Feedback

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Window size

• Use ‘…’ on the right side of the field to enlarge it

• Scroll down

• ECHA will work on the improvement

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Copying of the free text fields

• General rules:

� Data inserted by user can be copied after marking the text to be copied

� Options from the ‘Justification for data waving’ can be copied by clicking the option ‘Copy’

� Labels cannot be copied

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Searching for dossiers

…by biocidal product name under icon dossier

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Searching for dossiers

…by biocidal product name under icon Mixture / Product

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Searching for dossiers

BPR filters

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

Attachments

Support

IUCLID 6 – 8th BPR IT User Group Meeting – 14 November 2016

IUCLID manuals and webinars• https://iuclid6.echa.europa.eu/support

• https://iuclid6.echa.europa.eu/videos

Thank you!