Update on the Implementation of

Transparency Regulation

Claudia Paoletti & Dirk Detken

Programme Manager &

Head of Legl and Assurance Services

Management Board

17th December 2020

Timeline

New, updated EFSA’s documents

External engagement, communication, training

Risk Communication

Technology and Organisation

Conclusions

Content

2

Progresses with respect to plan

3

ImplementationART Programme Entry into application

Mar2019

Jul2022

Sep2019

Mar2021

Dec2020

Jul2020

New Management Board

CompletionPublication

In view of the Transparency Regulation EFSA is developing and updating numerous documents:

New, updated EFSA’s documents

4

Practical Arrangements

Guidance Documents

Decisions of Management

Board

Quality Management Documents

Practical Arrangements

5

Nature of Practical Arrangements:

➢ Implementing legal act

➢ Delegation of power to EFSA

➢ Binding nature

➢ Rights & obligations

➢ PAs on 38, 39 & 41 regulate fundamental rights

➢ Non-compliance

Notificationof studies

General pre –submission advice

Renewals:Notification intended studies,Public consultation, Pre-submission advice

Publication non-confidential dossier

Adapted non-confidential dossierPublic consultation

Publication of Opinion

Dossier validation/admissibility

Public access to documents

Confidentiality decision making

Review of Confidentiality decision making

RA work

Application

Practical Arrangements (2)

Practical Arrangements (3)

7

4. Consistency of MS confidentiality assessments (PPPs)(Reg. 1107/2009, Art. 7 and 16)

3. Transparency and Confidentiality Assessment by EFSA(Reg. 178/2002, Art. 38 and 39d(5)

2. Pre-submission advice and Public Consultation(Reg. 178/2002, Art. 32a, b, c)

1.Public Access to Documents

(Reg. 178/2002, Art. 41)

Adopted in March 2020 by

MBAdoption in the end 2020 by ED

Informal Consultation with SANTE

Formal consultation with SANTE

Expert Group GFL

Informal consultation with SANTE

Advisory Group, Sounding Board

Informal consultation with SANTE

Formal consultation with MS

EFSA’s Guidance documents

8

Scientific 15

Administrative12

EFSA updated 27 guidance documents

▪EFSA's Catalogue of services

during the lifecycle of

applications

▪General for regulated products

▪Feed additives

▪GMO renewal

▪GMO authorisation

▪Food contact materials (3 GDs)

▪Food enzymes, additives and

flavourings

▪Smoke flavourings

▪ Pesticides and MRL

▪ Novel food

▪Food enzymes▪Flavourings▪Food additives▪Novel food▪Nutrient sources▪Health claims (2 GDs)▪Allergenic foods▪Traditional foods from 3rd

countries▪Infant formulae▪Foods for special medical purposes▪Decontamination of surface from foods of animal origin▪Food contact materials (3 GDs)

All will be published before 27th March 2021

▪Decisions of the Management Board to be updatede.g. The Decision concerning the establishment and operation of European Networks of scientific organisations operating in the fields within the Authority’s mission to be adopted during this MB meeting

▪Quality management documents to be updated or newly written to comply with EPA2.5 in support of TR

Other EFSA’s documents

9

12 SOPs

98 WINs

15 MB decisions

External engagement throughout the process

Stakeholders and Member

States

EFSA’s Advisory Forum

PAFF meetings

DG SANTE-led GFL

Expert Group

DG SANTE Ad Hoc

Advisory Group

EFSA’s TGs

-Notification of studies

- IUCLID

EFSA’s Sounding

Board

In Q1 2021: Joint DG SANTE-EFSA info session with ENVI CommitteeDG SANTE celebratory event with the participation of EFSA

3 meetings4 meetings

External communication

11

Development of Strategy

Development of tailored content

creation of channels with more technical focus for affected stakeholders

Milestones: new EFSA website in February, Open.EFSA in March, continuation of stakeholders’ engagement activities throughout the year

Timeline: Implementation of strategic plan starts in Q1 2021

When: January - March 2021

Depending on the trainings’ outcome and feedback, additional sessions might be organised after March.

Information (Introduction webinar) session was on 19 November

What: Notification of studies, Pre-submission advice, EFSA’s guidance documents update, submission of applications in FSCAP and in IUCLID, account registration and others

How: Trainings will be recorded and made available in the training space on the website (link). Every session will allow up to 10 000 participants

Promotion: EFSA’s website, mailing list campaigns to: Advisory Forum, Focal Points, Art.36 organisations, applicants and stakeholders

Training activities targeted to external parties

12

General Plan on Risk Communication

13

Science of Risk Communication (Mandate – deadline March 2021)

Communication Products Catalogue (Mandate – deadline March 2021)

Dissemination Best Practice Guidance (Mandate – deadline March 2021)

Mapping of EU risk communication mechanisms (Mandate – deadline March 2021)

Establish a societal listening tool (pilot until Sept 2021)

Web platform pilot – one-stop-shop for food safety in the EU (Food.eu) (End of 2021)

Customer Relations Management – Marketing module (Q1 2021)

Technology

14

MICROSOFT AZURE✓ Secure storage

and controlled access

✓ Dissemination✓ Proactive

disclosure

FSCAP Dossier eSubmission (except pesticides)

SALESFORCE

✓ Notification of studies✓ Pre-submision advice✓ Public access to

documents✓ Public Consultation

IUCLID Pesticides PPP & MRL eSubmission

APPIAN✓Risk assessment workflow✓Confidentiality assessment

Construction completed:

by September 2020

ValidationIn Progress:

by December 2020

BusinessSimulation:

by March 2021

Further features beyond March 2021

▪ Sanitisation (document redaction) software

▪ Confidentiality assessment for all EFSA data sets (beyond regulated products)

▪ IUCLID workflow integration for confidentiality assessment of Pesticides dossiers

▪ Additional IUCLID features for Pesticides

Change management

15

One-stop-shop for all

training material

TrainingsSeries of

info-sessions

Internal Communicat

ion

For EFSA’s panels:

For EFSA staff:

Access to One-stop-shop

Two waves of update

▪Additional tasks and newly recruited staff are absorbed by the existing organizational structure

Organization during “Interim year 2021”

16

New tasks

▪ Pre-submission advice

▪ Notification of studies

▪ Public consultations

▪ Confidentiality assessment

▪ Proactive disclosure of evidence

▪ Verification studies

New staff

▪ In 2020 – 38▪ In 2021 – 33 ▪ In 2022 – 31

o Misalignment between the old organisation and the new processes (TR/ End to End)/related automation (e.g. Appian, Salesforce)

o Automation not fully deployed (e.g. IUCLID)

o Planned centralised services (SSO, Admin Centre, Scientific planning) not operational

o EFSA strategy 2020-2027 in the making

Challenges of the “Interim year” 2021

▪ Flexible planning

▪ Interim staff/external contractors as buffer

▪ Keep Business As Usual in strict check

▪ Reduce non-TR related Development Projects

▪ Nurture staff motivation

Remedies

Conclusions

18

Expectations for 03/2021 should be kept on realistic levels

The requirements of TR will be delivered on time

Joint efforts needed from EFSA, SANTE and stakeholders

EFSA staff commitment is excellent

Complexity is high

Strict prioritization needed