Scientific Divergence. Barbara Gallani (COMCO HoD) & Guilhem de Seze (REPRO HoD)
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1 Scientific Divergence Barbara Gallani (COMCO HoD) & Guilhem de Seze (REPRO HoD) 69 th Advisory Forum meeting
2 OVERVIEW OF PRESENTATION 69 th Advisory Forum meeting, 1. Legal and operational framework 2. Overview of past divergent opinions 3. A case-study: BPA 4. Discussion 2
3 LEGAL FRAMEWORK Article 30 of Regulation (EC) 178/2002: (1) - on vigilance -> identify potential source (2) - on information exchange -> identify potentially contentious issues (3 & 4) on cooperation with other EU Agencies / EC Scientific Committees / MSs, to: resolve divergence; or publish joint document clarifying contentious scientific issues & data uncertainties 3
4 LEGAL & OPERATIONAL FRAMEWORK ROLE OF ADVISORY FORUM ON VIGILANCE AND INFORMATION EXCHANGE Article 27 (4b) ensure cooperation with MS in case of substantive divergence AF Recommended Good Practice on substantive divergence -> actions for EFSA and MS ( ) Decision of the MB concerning the operation of the Advisory Forum -> articles ( ) TOOLS FOR VIGILANCE EFSA Register of Questions (RAW) Database on MS planned RA activities Public consultations (including planner) 4
5 OPERATIONAL FRAMEWORK Actions under AF Good Practice*: 1. Scanning for potential divergence 2. Alerting management + AF member + EC 3. Sharing missing information/data 4. Meeting(s) convened (EC may be invited as Observer, when relevant) -> discussion of divergence 5. Preparing joint document that: a. Reflects discussions and conclusions; b. If not resolved, clarifies areas of divergence and justification 6. Publication of joint document * 5
6 OVERVIEW OF PRESENTATION 69 th Advisory Forum meeting, 1. Legal and operational framework 2. Overview of past divergent opinions 3. A case-study: BPA 4. Discussion 6
7 DIVERGENT OPINIONS ( ) 13 cases of potential scientific divergences investigated 69 th Advisory Forum meeting, 7 resolved 5 confirmed 1 ongoing 7
8 DIVERGENT OPINIONS ( ) 69 th Advisory Forum meeting, Status of EFSA scientific opinions when divergence was identified 5 7 Published Draft 8
9 DIVERGENT OPINIONS ( ) 69 th Advisory Forum meeting, Types of publications clarifying the divergence Joint report Minutes of meeting 4 Statement Other 9
10 RESOLVED DIVERGENT OPINIONS ( ) YEAR * SUBSTANCE EFSA PANEL DIVERGING COUNTRY DIVERGING INSTITUTION 2006 QRA Tallow BIOHAZ Germany BfR, FLI 2014 Perchlorate CONTAM 2014 Mycotoxins T2/HT Caffeine NDA France, Germany ANSES, BfR CONTAM France ANSES France, Germany ANSES, BfR 2016 Vitamin D NDA UK SACN Chloramphenicol/ Malachite Green Titanium Dioxide (E171) CONTAM Germany BfR ANS France ANSES *Year refers to when divergence was identified 10
11 69 th Advisory Forum meeting, CONFIRMED DIVERGENT OPINIONS ( ) YEAR * SUBSTANCE EFSA PANEL DIVERGING COUNTRY DIVERGING INSTITUTION 2011 Bisphenol A CEF France ANSES 2015 Bisphenol A CEF Denmark DTU 2015 Chlorate CONTAM Germany BfR 2016 Cyanide CONTAM Greece, Germany EFET, BfR 2016 Bisphenol A CEF Netherlands RIVM *Year refers to when divergence was identified 11
12 OVERVIEW OF PRESENTATION 69 th Advisory Forum meeting, 1. Legal and operational framework 2. Overview of past divergent opinions 3. BPA: a case study 4. Discussion 12
13 BPA: A CASE-STUDY 69 th Advisory Forum meeting, Application Art. 30 Application Art. 30 EFSA Opinion on BPA 2010 review of recent scientific literature on BPA toxicity at low doses ANSES report 2011 EFSA Opinion on BPA 2015 full review of BPA exposure and toxicity data DTU report 2015 Question from RIVM 2016 EFSA s statement on immunotoxicity 13
14 How to avoid diverging views Creation of a protocol for hazard assessment of BPA Step 1 Step 2 14
15 How to avoid diverging views Collaboration between MS and EFSA on BPA the protocol development Working Group composed of members from Denmark, France, Germany, Norway, the Netherlands, Sweden and Switzerland and independent experts -4 Independent experts (in protocol development / toxicology) - 7 Experts nominated by MS (eligibility for nomination: to have completed BPA risk assessment in last 5 years) -EFSA Staff from FIP & AMU Units 15
16 Stakeholder involvement Public Consultation: an online public consultation on EFSA s draft protocol for the hazard assessment of BPA took place from 30 June-3 September 2017 The results of were presented in a stakeholder meeting 14 September 2017 in Brussels and published in a report containing all the comments received Report available at: 16
17 Plans for adoption of BPA opinion BPA re-evaluation Protocol published BPA Working Group setup Pilot of the methodology Adoption in approx. 2 years Protocol development Stakeholder involvement through the process: public consultation of protocol, stakeholder meeting, report on public consultation, open plenary discussion. 17
18 DISCUSSION 69 th Advisory Forum meeting, Can we do more / better to detect early in time potential scientific divergence? Are the actions included in the current guidance sufficient / effective to address substantive divergence? How can substantive divergence be better communicated to different target audiences? 18
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Delegations will find attached Commission document C(2008) 2976 final.
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