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


Meeting 5 – Parma/BXL xx 2018

EFSA SEA launched

Registered stakeholders Business and food industry

4

STAKEHOLDER ENGAGEMENT


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


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


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


DISCUSSION GROUPS - GMO GD ALLERGENICITY (2/3)

History – a pilot

Objectives

Expected deliverables

Feedback from experience

Have your say

8


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


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


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




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









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EVALUATIONS – COMMUNICATION - AOB


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)


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

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AOB - REPRO CATALOGUE (2/3)


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AOB - REPRO CATALOGUE (3/3)


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

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

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