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EFSA’s role in the evaluation of active substances Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 1 CONTENT Introduction to EFSA and the Pesticides Unit Peer review of active substances New actives and review programme Commission specific mandates on approved substances Pesticides residues and MRL MRL Reasoned opinions Commission specific mandates and other activities Pesticides Steering Network activities New procedure DAR/RAR dispatch and background documents conclusion 2 EFSA VISION • European • Food • The European reference body • Safety • Authority • Assess, advise, communicate • Covers the entire food chain • Independent, trusted, based on sound science Openness & transparency • Technical reports on confirmatory data published • New format for MRL Reasoned Opinions, publication of Evaluation Report • Documents of the Pesticide Steering Network New services for applicants 3 Pesticides Unit activities Supports the Scientific Panel for pesticides PPR (Plant Protection Product and their Residues). Coordinates the Peer Review of active substances Maximum Residue Levels MRLs Opinions Guidance documents Ad-hoc mandates Provides Conclusions for single active substances to support the EU decisionmakers Reasoned Opinions Annual report 4 Pesticides Unit activities Supports the Scientific Panel for pesticides PPR (Plant Protection Product and their Residues). Coordinates the Peer Review of active substances Maximum Residue Levels MRLs Opinions Guidance documents Ad-hoc mandates Provides Conclusions for single active substances to support the EU decisionmakers Reasoned Opinions Annual report 5 The Peer Review Process Dossier submission 1. Commenting phase PEER REVIEW EFSA, (co)RapporteurM S, other MSs, Commission, Applicant, Public 2. Evaluation of comments and possible clock-stop 3. Expert’s consultation EFSA Conclusion EFSA Risk Assessment EFSA D/RAR Draft/Review Assessment Report Commission +MSs Plants, Animals, Food and Feed Committee Approval/Non Approval National authorisation PPP by MSs 11 EFSA CONCLUSION Output of a scientific peer review Identity and Phys/Chem properties Mammalian Toxicology & Workers/Bystander/residents risks Residues & Consumers risks Environmental Fate and Behaviour Ecotoxicology & environmental risks Conducted by EFSA scientific staff and risk assessment experts from the Member States Includes: Data gaps and identified concerns List of endpoints proposed by EFSA 7 EFSA PEER-REVIEW OUTPUTS 2014 • 40 Conclusions • New active substances • • Renewals and amendments of approvals • • • First conclusions under Reg. 1107/2009 First conclusions of AIR-II renewals Confirmatory data Reviews under Art 21 • 40 Technical reports • • • Basic substances Confirmatory data (new EFSA responsibility) Bee study protocols (new EFSA involvement) 8 NEW ELEMENTS IN EFSA CONCLUSIONS Assessment of “cut-off” criteria in the EFSA conclusions Scientific assessment of risks associated to endocrine effects Next steps for cooperation with ECHA on C&L proposals Aligning DARs and CLH reports MRL applications as part of the dossier Complementing the interim criteria Import tolerances included in the conclusion if approved in the exporting country Scientific peer reviewed literature 9 SCIENTIFIC PEER REVIEWED LITERATURE Literature search in Reg (EC) No 1107/2009 Article 8(5) of Regulation (EC) No 1107/2009 requires that applicants provide “Scientific peer-reviewed open literature, [...], on the active substance and its relevant metabolites dealing with side-effects on health, the environment and non-target species and published within the last ten years before the date of submission of the dossier...” as determined by the European Food Safety Authority. Literature search in Reg (EU) No 844/2012 (AIR III) Article 7(1)(m) of Regulation (EU) No 844/2012 requires that “the supplementary dossier should contain summaries and results of scientific peer-reviewed open literature, as referred to in Article 8(5) of Reg (EC) No 1107/2009”. 10 SCIENTIFIC PEER REVIEWED LITERATURE Objectives of the EFSA guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092 To ensure that literature search is exhaustive and covers all the relevant data requirements for the active substance and metabolites. To ensure that the literature search and the selection of the relevant papers is done minimising bias and according to the principles of systematic review (i.e. methodological rigour, transparency, reproducibility). To ensure that relevant scientific papers are properly incorporated in the dossier and assessed. 11 SCIENTIFIC PEER REVIEWED LITERATURE Literature review reports Should contain: title, authors, summary, protocol (objectives and relevance criteria), search methods and results (Table 2), results of study selection process (Table 3, Table 4, Table 5 and Table 6). All Literature Review Reports should be incorporated in Doc K of the dossier (Section 9 or 11, in accordance with SANCO/10181/2013 – rev. 2.1). Relevant or unclearly relevant full papers are incorporated in the respective Doc K and summarised/assessed in Doc M 12 SCIENTIFIC PEER REVIEWED LITERATURE Doc K should contain the Literature Review Reports covering scientific literature searches for data requirements in toxicology, residues in food/feed, enviromental fate and ecotoxicology Doc K should contain full papers identified as relevant or of unclear relevance in the respective folders Doc M should contain summaries and assessment of relevant or unclearly relevant full papers 13 SPECIFIC REQUEST FROM EC Published during 2014 Health assessment of chlorpyrifos Aquatic risk of imidacloprid Bee study protocols On going Risk of neonicotinoids foliar uses to bees … 14 Pesticides Unit activities Supports the Scientific Panel for pesticides PPR (Plant Protection Product and their Residues). Coordinates the Peer Review of active substances Maximum Residue Levels MRLs Opinions Guidance documents Ad-hoc mandates Provides Conclusions for single active substances to support the EU decisionmakers Reasoned Opinions Annual report 15 MRL REASONED OPINIONS • Reviewing MRLs for approved/non-approved active substances (Art 12 ROs) – 2014: Reasoned opinions on 44 substances – Work-plan published as appendix to the dedicated PSC minutes http://www.efsa.europa.eu/en/events/event/140619-m.pdf • New proposals and modifications of existing MRL (Art 10 ROs) – 2014: Reasoned opinions on 42 applications – Streamlined RO and MS Evaluation reports to be published as background documents to EFSA Opinions 17 MRL REASONED OPINIONS • EC Request under Art. 43 – 2014: fosetyl, didecyldimethylammonium chloride (DDAC) and benzalkonium chloride (BAC), carbofuran, fipronil, saflufenacil – On-going: atrazine, metalaxyl and metalaxyl-M, lambdacyhalothrin 18 OTHER ON-GOING ACTIVITIES AND FUTURE PLANS EFSA comments on the proposed Codex MRLs evaluated by JMPR New version of PRIMo Revision of MRL review procedures and templates Database with List of Endpoints trusted by EFSA 18 Main title PESTICIDES STEERING NETWORK ACTIVITIES Major tasks: plan and monitor the risk assessment process integrate risk assessment and MRL setting processes coordinate with the European Chemicals Agency (ECHA) prioritisation of guidance development 19 Main title PESTICIDES STEERING NETWORK ACTIVITIES On-going activities: cooperation on Classification and labelling alignment: aligning DAR and CLH report Proposals for new guidance development on • • • Birds and mammals FOCUS Repair action Isomers 20 NEW PROCEDURE DAR/RAR DISPATCH AND BACKGROUND DOCUMENTS CONCLUSION EFSA Document Management System as file exchange platform instead of courier Facilitate sanitisation procedure and dossier submission Unique project: single user name and password, access limited in time for security reasons Alignment of commenting period for Applicant, Member States and Public 21 22 Thank you for your attention 23