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EFSA 4th Roundtable with industry associations Parma, 22 June 2017
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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
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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)
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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
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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
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AOB - REPRO CATALOGUE (2/3)
EFSA 4th Roundtable Industry Associations
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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