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Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting Virtual meeting, 01-02.07.2020

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Page 1: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Sustainability

through Partnerships

Bernhard UrlExecutive Director

Guilhem de SezeHead of the REPRO Department

76th Advisory Forum meeting

Virtual meeting, 01-02.07.2020

Page 2: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

The journey to new partnership models

2

Page 3: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Experts: Panels & Working Groups

Total of 10.000 days/year in meeting + 10.000 days/year preparation

Grants & Procurement: Average 10 Million euro/year

Sourcing is not new to EFSA

3

= 100 FTE

+

= 100 FTE

_________

200 FTETOTAL non-EFSA staff =

Page 4: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Transparency Regulation new opportunities

• + indemnity

• + training

opportunities

• + expertise

• + preparatory

work (G&P)

• + capacity

building in MS

• + harmonized methodologies

& innovation

• Building a Pan

European RA model

• Investment in

partnerships with MSs

Page 5: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

EFSA sourcing at a glance

PROCUREMENT(non)science

EXPERTSWGs

Scientific PanelsScientific Committee

Increase EFSA production

capacity

Innovate to master future

complexity

Align on common EU Risk

Assessment approach

SOURCING PILLARS

TASKS & PARTNERSHIPNEEDS/OPPORTUNITIES

GRANTS GRANTS

TR Art 28 (5e)

partnering

Page 6: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Piloting Partnerships

6

Cooperation on enzymes

risk assessments

Framework partnership

agreement on sharing tools

and knowledge

Framework partnership

agreement on MCRA of

pesticides in food

commodities

Page 7: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

EFSA-BfR sharing knowledge and tools (1/2)

7

What?

BfR to share national knowledge and tools (e.g. Food chain lab) with EFSA

to adapt into EU standard tools

Objective:

Partnership EFSA & BfR to share tools/guidance/models and work towards EU solutions

Challenges:

Correct level of co-financing, both partners benefit

Matching of policies

Opportunities for involvement of other MS (partnering):

• Area 1: Map and analyse global food and feed supply chains • Area 2: Knowledge Hub on food processing and handling, as well as on RA studies• Area 3: Evidence appraisal for epidemiological studies• Area 4: Evidence management for the safety assessment of Plant Protection Products• Area 5: Open interfaces to identify, analyse, exchange of evidence for emerging risks• Area 6: Evidence-based risk communication

Page 8: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Benefits for other MS

Provision of software tools,e.g. FoodChain-Lab

Transparent and harmonised RA, e.g. model repository

Aligned procedures,e.g. uncertainty assessment

Training and preparedness,e.g. crisis exercises

Opportunities for other MS

Review and testing of prototypes, user feedback

Exchange of national guidance documents, standards, topic related networking

Training of staff

Coaching of institutions on the implementing new working procedures

EFSA-BfR sharing knowledge and tools (2/2)

8

Page 9: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

EFSA-ANSES enzymes risk assessment (1/2)

9

What?

ANSES WG to perform the RA for enzymes, EFSA Panel to adopt

Objective:

Partnership between EFSA & MSs for EU-wide RA capacity to meet demand of innovation

Challenges:

Guidelines and data requirement

Use harmonised criteria in RA: how to minimise intrinsic differences in expert judgement

Operational issues: DoI policy, harmonisation of workflow, efficiency

Page 10: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

EFSA-ANSES enzymes risk assessment (2/2)

10

Opportunities for partnering:

EC Mandate -> EFSA requested to update the “Guidance on food enzymes”

Timeline: 18 months, including public consultation

MS invited to nominate experts (with RA experience, preferably on food enzymes) to form a pool of experts -> EFSA to invite experts on ad-hoc basis

Staff exchange or visiting scientists

Feedback from MS since the last AF: new ideas, proposals…

Page 11: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

EFSA-RIVM Cumulative Risk Assessment (1/2)

11

What?

Framework Partnership Agreement on the Implementation of Cumulative Risk

Assessment for Pesticides

Objective:

Improvement and maintenance of the Monte Carlo Risk Assessment (MCRA) software

Cumulative exposure assessments for the effects of pesticides on various organs and

systems

Challenges:

Complexity and transparency of the MCRA software

Dependency on other outside developments (e.g. exposure scenarios by the EC)

FPAs have a budget ceiling not a guaranteed budget, that can be difficult for planning

Page 12: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

EFSA-RIVM Cumulative Risk Assessment (2/2)

12

Opportunities for partnering:

Capacity-building, harmonisation and accelerated implementation

with Member States

Improve connectivity with EFSA’s Data Warehouse and other data

repositories

Enhance co-creation through an open source and modular MCRA

software

Page 13: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Proposed next steps - work in progress

13

Pilot projects to inform draft concept partnerships

- Engage in current pilots

- Express interest in topics for upcoming partnerships

AF meetings in 2020 (October / December)

- discussions on draft concept for a partnership framework

During 2021

- pilot projects under the newly agreed partnership framework

Page 14: Sustainability through Partnerships · Sustainability through Partnerships Bernhard Url Executive Director Guilhem de Seze Head of the REPRO Department 76th Advisory Forum meeting

Topics for (pilot) partnerships 2020/2021

1 Annual summary reports (TSE, zoonoses, contaminants,…) (call soon to be launched)

2 GLP compliance check of studies submitted in the context of RA dossiers/files (as applicable)

3 Nutrients Upper Levels e.g. systematic reviews / screening / data extraction for Upper Levels, appraisal of studies (mandate not yet received)

4 Assessment of recycling processes for Food Contact Materials

5 Systematic reviews and Critical Appraisal Tools e.g. ecotox

6 Scientific and statistical expertise to assess toxicological studies