IUCLID pesticides pilot report Phase 1

Jane Richardson

DATA Unit

26&27 FEB 2020

▪ Participants: 2 Industry associations, 1 contractor, 5 Rapporteur Member States, DG SANTE, ECHA & EFSA

▪5 Dataset types created (PPP Mixture, Active Substance, Basic, Microrganism, Relevant metabolite/impurity)

▪77 OECD Harmonised templates, 65 Summary templates, >9,000 data elements

▪Draft dossier creation manual available

▪9 Training sessions on different aspects of IUCLID

▪102 questions answered

▪353 issues identified

▪ POC for New Active Substance and Renewal

Pilot Achievements

2

•Cloud instances available and accessible for all applicants. Shared EFSA instance was used regularly by RMS and EFSASetting up cloud instances

•Draft submission manual under review by Knoell. Prototype reports available in the EFSA IUCLID instanceSubmissions and Tooling

•Four scenarios defined; these will be available for testing in March Validation Assistant

•First version of dissemination preview for PPP available from 17 FebruaryFiltering and Dissemination

•New active substance and Renewal POC imported to EFSA IUCLID instanceCreation of Test Dossiers

•Results of industry ‘Stress Test’ to be presented at meetingTechnical Action Industry

•Information life-cycle analysed to understand most effective use of annotation and report generatorTechnical Action RMS/EFSA

•1 meeting Parma, weekly technical meetings, Final meeting of Phase 1 todayStakeholder Engagement

Project Plan

3

Expected benefits

4

Benefit Status Next Steps1) Proof of concept of a structured pesticides dossier using all relevant OECD templates

New Active Substance and Renewal POCs created The POC approach has proved to very successful and should be extended to micro-organisms in the next phase of the project

2) Harmonisation of dossier management and improved collaboration between EFSA and RMS

Sharing a common IUCLID instance and use of tools like ‘Report Generator’ and ‘Annotation’ is stimulating collaboration between the regulatory agencies and alignment of processes. Re-use from biocides is also creating synergies across regulations.

The ‘Information Lifecycle’ needs further discussion to identify IUCLID adaptions to support process alignment. Partial alignment would be achievable.

3) Improved traceability of the dossier life cycle

IUCLID allows new versions of the dossier to be submitted and the Comparison tool visualises all changes between versions. Since a dossier cannot be amended by a recipient the use of annotations separates applicant changes from evaluator comments and decisions.

Further discussion needed to ensure the final validated endpoints of the evaluator are stored and retrievable

4) Automated validation of dossier content and filtering of confidential information

The Filtering tools are being tested and the Validation assistant testing will begin in March

Pesticide specific rules for validation and filtering to be defined and agreed

5) Understanding of ECHA Project and Change Advisory board and ECHA IUCLID team roles to ensure effective collaboration after the pilot phase

Participants in the project are now aware to the IUCLID release schedule and the role of OECD in the governance of changes to templates and IUCLID

Submit requests for change to the IUCLID backlog

Would you recommend adopting IUCLID for pesticides?

Yes (100%) No (0%)

N = 8

Technical Group Reaction to IUCLID

5

https://ec.europa.eu/eusurvey/runner/c89207e1-f8fc-208b-083d-fa00db3561af

How to move forward

6

Development of templates/formats for info other

than OHTs

Allow PDF attachments for content that is currently not structured and ramp up to more structured data

over time

A central submission point ensures that all entities

are working with the same dossier version/

same information

No cross-reference to

other data points

Regarding QSAR -

structural information should be

implemented at a prominent

spot in the dossier

OHT improvement and Definition

including reduction of Rich

Text Fields

The concept of IUCLID to

transport needed information for

metabolites

Next Phase

7

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