efsa 4 roundtable with industry associations · 2017. 7. 11. · efsa 4th roundtable industry...

EFSA 4th Roundtable with industry associations Parma, 22 June 2017

2

AGENDA Time Items

09.15 - 09:30 Annual meeting Update issues from last meeting (ALL)

09.30 – 10.15

Stakeholders Engagement Discussion groups

• Guidance Document (All) • Feedback pilot “focus group” GMO allergenicity guidance document (EFSA) • MATRIX project (EFSA)

Support initiatives • EFSA/APDESK new support initiatives (EFSA) • Alternative for pre-submission meeting (Industry)

10.15 – 10.35 Access to document Publication/access to submitted data (Industry)

10.35 – 10.50 Coffee break

10.50 - 11:15 EFSA scientific output EFSA conclusions for risk management decisions (Industry)

11.15 – 11.50 Communications Dialogue with applicants (pre- and during evaluation) (Industry) EFSA Press release and news (Industry)

11.50 – 12.15 AOB Administrative and scientific guidance documents - update (EFSA) REPRO Catalogue – update 2017 (EFSA)

12.15 – 12.30 Closing remarks

EFSA 4th Roundtable Industry Associations

ANNUAL MEETING

Meeting 1 – Brussels – OCT 2014

Meeting 2 – Parma – JUNE 2015

Meeting 3 – Brussels – JUNE 2016

Meeting 4 – Parma - JUNE 2017

EFSA 4th Roundtable Industry Associations

Meeting 5 – Parma/BXL xx 2018

EFSA SEA launched

Registered stakeholders Business and food industry

4

STAKEHOLDER ENGAGEMENT

EFSA 4th Roundtable Industry Associations

Discussion groups

Guidance documents (all)

Feedback pilot “focus group” GMO allergenicity

guidance document (EFSA)

MATRIX project (EFSA)

Support initiatives

New support initiatives (EFSA)

Alternative for pre-submission meetings (Industry)

5

STAKEHOLDER ENGAGEMENT

EFSA 4th Roundtable Industry Associations

PERMANENT

STAKEHOLDER FORUM

STAKEHOLDER BUREAU

TARGETED

SELF-MANDATE WORKING GROUP

DISCUSSION GROUPS

INFO SESSIONS

ROUNDTABLES

COMMUNICATORS LAB

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DISCUSSION GROUPS 1/3

EFSA 4th Roundtable Industry Associations

SCER - Emerging risks

DATA - Food Chemical Occurrence Data

GMO – GD allergenicity

MATRIX - DIG1 (ongoing) & DIG2 (planned)

PESTICIDES – GD Endocrine disruptors (NEW)

FEED additives GDs (planned)

SCER – Bee health (planned)

7

EFSA 4th Roundtable Industry Associations

DISCUSSION GROUPS - GMO GD ALLERGENICITY (2/3)

History – a pilot

Objectives

Expected deliverables

Feedback from experience

Have your say

8

EFSA 4th Roundtable Industry Associations

DISCUSSION GROUPS – MATRIX (3/3)

DIG1 – Technical aspect (on going)

DIG2 – Confidential information (planned)

Expected deliverables

Feedback from experience

Have your say

9

STAKEHOLDERS ENGAGEMENT

EFSA 4th Roundtable Industry Associations

Discussion groups

Guidance documents (all)

Feedback pilot “focus group” GMO allergenicity

guidance document (EFSA)

MATRIX (EFSA)

Support initiative

New support initiatives (EFSA)

Alternative for pre-submission meetings (Industry)

10

STAKEHOLDER ENGAGEMENT – NEW

EFSA 4th Roundtable Industry Associations

Pilot support initiative: pre-submission administrative check teleconference of draft dossiers prepared by SMEs (June to December 2017)

News Story

http://www.efsa.europa.eu/en/press/news/170606

Description http://www.efsa.europa.eu/sites/default/files/documents/news/170606-ax1.pdf

Individual satisfaction applicant’s survey (from 1st June 2017)

News Story

http://www.efsa.europa.eu/en/press/news/170601-2

11

EVALUATIONS – COMMUNICATION - AOB

EFSA 4th Roundtable Industry Associations

Evaluations

EFSA conclusions for risk management decisions (Industry)

Communications

Dialogue with applicants (pre- and during evaluation) (Industry)

EFSA Press Release and news (Industry) AOB

Administrative and scientific guidance documents – update (EFSA)

REPRO Catalogue – update (EFSA)

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AOB - EFSA GUIDANCE DOCUMENTS (1/3)

EFSA 4th Roundtable Industry Associations

UNITS ADM. GD SCIEN.GD

FIP/FCM Published Published

FIP/Nutrient sources - On going (x1)

GMO On going Published On going (x1)

FEED Planned On going (x7)

NUTRI/Novel Food On going Published

NUTRI/Health claims - On going (x1)

PESTICIDES - On going

13

AOB - REPRO CATALOGUE (2/3)

EFSA 4th Roundtable Industry Associations

14

AOB - REPRO CATALOGUE (3/3)

EFSA 4th Roundtable Industry Associations

Status March 2015 – JUNE 2017

Service FEED FIP GMO NUTRI PRAS APDESK Tot

Applicant's hearing 7 5 6 18

EFSA Info session 2 1 2 1 1 7

Post-adoption teleconference 3 4 3 6 16 Roundtable with industry associations 4 4 Ad-hoc meeting with industry association 2 1 1 4

Clarification teleconference CC 13 13

REPRO Webinar 2 1 1 4

Clarification teleconference RA 7 14 16 14 51

Follow-up teleconference on web form query 1 1 2 4

Total 19 24 30 25 2 20 118

Applicant's hearing

EFSA Info session

Post-adoptionteleconference

Roundtable with industryassociations

Ad-hoc meeting withindustry association

Clarificationteleconference during CC

REPRO Webinar

Clarificationteleconference during RA

Follow-up teleconferenceon web form query

THANK YOU for your attention