Update on the IUCLID 6 project - Europa IT... · IUCLID 6 –9th BPR IT User Group Meeting –23...

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 version 2.0.0

New release of IUCLID – 15 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


Installation and update

https://www.youtube.com/watch?v=jeZ-v6qoeds

https://www.youtube.com/watch?v=attg0gSc-AM


• 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


Extension of the compatibility between IUCLID versions

Current situation Target

Overview of the new or updated functionalities



• 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


• 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


Split of the IUCLID flags



• New option added to print a record or a

dataset without the fields marked

confidential in IUCLID

Print option



• 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


• 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


Product type in section 6.1



• The only option related to all kinds of

plastic is now ‘plastic’ with an additional

field for specify

Material of packaging


• Flammable liquids in section 4.6 with an own template (in the past it was a reference section)


Flammable liquids


• Endpoint summary available in all submission types:

- 9.2 – all substances

- 9.2.2 – biocidal product, representative product

- 9.1.2 – basic information (mixture)


Terrestrial toxicity, initial tests


• 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)


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


• 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.


Readability of tables


IUCLID Report Generator

Available reports


• 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


Summary of product characteristics (SPC) report


• 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)


Literature References Report


• 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/


• 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.


BPR – Confidentiality Report (BPR Article 66)

https://idp-authority.echa.europa.eu/idp/


• 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


• Bug occurring in 1.3.0 fixed: correct file type shown


List of attachments for BPR datasets and dossiers


• Which fields of an annotation should be displayed in the report?


List of annotations (under development)



IUCLID home page

Starting points to generate a report

List of dataset / dossiers in Navigation Panel



Create your own reports


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



New approach to report in IUCLID: all components reported



New approach to report in IUCLID:

all concentrations reported, at both stages of the process



New approach to report in IUCLID:

all reaction pathways described

substance

mixture



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

https://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals

Current plans


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


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


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 web interface

Create new

substances

Launch the IUCLID Cloud Client

for full IUCLID 6 functionalities

Import IUCLID

data

Support

functionalities


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 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


• 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


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

https://iuclid6.echa.europa.eu/project-iuclid-6#ServiceRelease

Long term plans


• 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

• 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

https://www.linkedin.com/groups/12043483


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

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

Manuals and webinars

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

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

Feedback received prior to the meeting


Searching for mixture/product

…by non active components

Thank you!

Update on the IUCLID 6 project - Europa IT... · IUCLID 6 –9th BPR IT User Group Meeting –23...

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