Scientific Advice Mechanism (SAM) EU authorisation processes of Plant Protection Products Group of Chief Scientific Advisors Scientific Opinion 5/2018 Research and Innovation EU Authorisation processes of plant protection products - from a scientific point of view Group of Chief Scientific Advisors European Commission Directorate-General for Research and Innovation Unit RTD.DDG1.02 - Scientific Advice Mechanism E-mail [email protected] [email protected] European Commission B-1049 Brussels Manuscript completed in June 2018. The contents of this report are the sole responsibility of the High Level Group of Scientific Advisors. Although staff of the Commission services participated in the preparation of the report and provided information and assistance in assembling it, the views expressed in this report reflect the collective opinion of the Members of the High Level Group of Scientific Advisors, and may not in any circumstances be regarded as stating an official position of the European Commission. More information on the European Union is available on the internet (http://europa.eu). Luxembourg: Publications Office of the European Union, 2018 Print ISBN 978-92-79-67736-6 doi:10.2777/71851 KI-04-17-354-EN-C PDF ISBN 978-92-79-67735-9 doi:10.2777/238919 KI-04-17-354-EN-N © European Union, 2018 Reuse is authorised provided the source is acknowledged. The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39). For any use or reproduction of photos or other material that is not under the EU copyright, permission must be sought directly from the copyright holders. Cover image: ©Mizzy Mish, #102460398, 2018. Source: Fotolia.com. EUROPEAN COMMISSION Scientific Advice Mechanism (SAM) INDEPENDENT SCIENTIFIC ADVICE FOR POLICY MAKING EU authorisation processes of Plant Protection Products from a scientific point of view Group of Chief Scientific Advisors Scientific Opinion 5, (Supported by SAPEA Evidence Review Report No. 3) Brussels, 4 June 2018 2018 Directorate-General for Research and Innovation Scientific Opinion EU authorisation processes of Plant Protection Products Table of Contents ACKNOWLEDGEMENTS ................................................................................ 5 EXECUTIVE SUMMARY ................................................................................. 7 1. INTRODUCTION & BACKGROUND ........................................................... 13 2. RECOMMENDATIONS .............................................................................. 21 2.0 Establish a shared, comprehensive and long-term EU vision for food production, including the role of PPPs therein ...................................... 21 2.1. Clarify the protection goals of the EU PPP system and improve their communication ................................................................................ 25 2.2. Improve the organisation and operation of the EU PPP system .............. 28 2.2.1. Separation between risk assessment and risk management ......... 28 2.2.2. Risk assessment ..................................................................... 28 2.2.3. Risk management ................................................................... 31 2.3. Implement systematic post-market vigilance ...................................... 34 2.4. Secure and strengthen scientific knowledge and capacity in risk assessment ..................................................................................... 36 2.5. Improve guidance, oversight and transparency of pre-market studies .... 38 2.6. Re-examine the treatment of hazards, risks, costs and benefits............. 40 2.6.1. The role of hazard-based cut-off criteria .................................... 40 2.6.2. The role of comparative risk and risk-cost-benefit analyses.......... 42 2.7. Augment mechanisms to resolve divergent scientific assessments ........ 43 2 June 2018 SAM Group of Chief Scientific Advisors Scientific Opinion EU authorisation processes of Plant Protection Products List of Boxes BOX 1 – OVERVIEW OF THE EU PPP DUAL SYSTEM ....................................................... 14 BOX 2 – COMPARISON WITH NON-EU OECD COUNTRIES ................................................ 15 BOX 3 – THE PRECAUTIONARY PRINCIPLE ................................................................... 26 BOX 4 – CURRENT INFORMATION MANAGEMENT ISSUES .................................................. 33 BOX 5 – BIOLOGICAL CONTROL AGENTS (BCAS) ......................................................... 38 BOX 6 – HAZARD CUT-OFF DETERMINATION ............................................................... 42 List of Tables TABLE 1 – OVERVIEW OF SPECIFIC RECOMMENDATIONS .................................................. 24 TABLE 2 – CURRENT APPROVAL PROCESS FOR ACTIVE SUBSTANCES ..................................... 32 TABLE 3 – CURRENT AUTHORISATION PROCESS FOR PPPS ............................................... 32 TABLE 4 – PROPOSED INTEGRATED PROCESS FOR ACTIVE SUBSTANCES & PPPS ....................... 33 List of Figures FIGURE 1 – LINES OF EVIDENCE USED IN THIS SCIENTIFIC OPINION .................................... 53 List of Annexes ANNEX 1 – SCOPING PAPER .................................................................................. 49 ANNEX 2 – METHODOLOGY ................................................................................... 52 ANNEX 3 – LIST OF EXPERTS AND STAKEHOLDER REPRESENTATIVES CONSULTED ...................... 54 ANNEX 4 – REFERENCES...................................................................................... 58 ANNEX 5 – LIST OF ABBREVIATIONS ........................................................................ 61 ANNEX 6 – GLOSSARY ........................................................................................ 62 SAM Group of Chief Scientific Advisors June 2018 3 Scientific Opinion EU authorisation processes of Plant Protection Products Group of Chief Scientific Advisors Janusz Bujnicki Professor of Biology, International Institute of Molecular and Cell Biology, Warsaw Pearl Dykstra Deputy Chair Professor of Sociology, Erasmus University Rotterdam Elvira Fortunato Professor, Materials Science Department of the Faculty of Science and Technology, NOVA University, Lisbon Rolf-Dieter Heuer Chair Former Director-General of the European Organization for Nuclear Research (CERN), Geneva Carina Keskitalo Professor of Political Science, Department of Geography and Economic History, Umeå University Paul Nurse Director of the Francis Crick Institute, London 4 June 2018 SAM Group of Chief Scientific Advisors Scientific Opinion EU authorisation processes of Plant Protection Products ACKNOWLEDGEMENTS This Scientific Opinion on the authorisation processes of Plant Protection Products in Europe from a scientific point of view (hereafter ‘the Opinion’) was delivered to the European Commission by the Scientific Advice Mechanism (SAM) Group of Chief Scientific Advisors (hereafter ‘the Scientific Advisors’). It responds to a request by the European Commission and in particular by Commissioner Vytenis Andriukaitis (Health & Food Safety), which the Scientific Advisors accepted on 23 March 2017 with the adoption of the corresponding Scoping Paper (Annex 1 on page 49). The Scientific Advisors in charge of developing this Opinion were Paul Nurse (lead), Rolf Heuer and Janusz Bujnicki. The Opinion has been endorsed by all members of the Group of Chief Scientific Advisors. The Scientific Advisors wish to thank the many contributors for their support and input in the preparation of this Scientific Opinion: The Science Advice for Policy by European Academies (SAPEA) consortium1 – a key component of the Scientific Advice Mechanism, which provided an Evidence Review Report (ERR) concentrating on risk assessment aspects for health. The ERR was prepared under the leadership of the SAPEA Working Group chair Evangelia Ntzani (University of Ioannina Medical School) and deputy chair David Coggon (University of Southampton); with Alan Boobis (Imperial College London), Jean Golding (University of Bristol), Susanne Hougaard Bennekou (Danish Environmental Protection Agency), Paul Miller (Cranfield University), Colin Ockleford (Lancaster University); aided by the SAPEA staff Nina Hobbhahn, Cosmas Lambini and Céline Tschirhart; and with the support of Ole Petersen, representative of the SAPEA Board for the topic. The European Commission’s DG Joint Research Centre, in particular Alexandre Anger, Amalia Pineiro Munoz, Mauro Petrillo and Barbara Raffael who assisted with aspects of the literature review. All the scientific experts, expert practitioners and stakeholders from the science, policy, industry and civil society communities who contributed to the SAPEA ERR, expert workshops, stakeholder meeting and other ad-hoc meetings and consultations, and in particular, participants of the expert sounding board meeting: Thomas Backhaus, Hubert Deluyker, Daniel Dietrich, and Jørgen Schlundt – a comprehensive list can be found in Annex 3 (page 54). 1 SAPEA brings together knowledge and expertise from over 100 academies and learned societies in over 40 countries across Europe. Funded through the EU’s Horizon 2020 programme, the SAPEA consortium comprises Academia Europaea (AE), All European Academies (ALLEA), the European Academies Science Advisory Council (EASAC), the European Council of Academies of Applied Sciences, Technologies and Engineering (Euro-CASE) and the Federation of European Academies of Medicine (FEAM) SAM