Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015...
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Transcript of Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015...
Bénédicte VagenendePesticides Unit
Crop Protection European Regulatory Conference, March 2015
EFSA’s role in the evaluation of active substances
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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
CONTENT
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EFSA VISIONEFSA VISION
• EEuropean
• FFood
• SSafety
• AAuthority
• The European reference body
• Covers the entire food chain
• Assess, advise, communicate
• 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 NetworkNew services for applicants
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Pesticides Unit activitiesPesticides Unit activities
Maximum Residue Levels MRLs
Reasoned Opinions Annual report
Supports the Scientific Panel for pesticides PPR (Plant Protection Product and their Residues).
Opinions Guidance documents Ad-hoc mandates
Coordinates the Peer Review of active substances
Provides Conclusions for single active substances to support the EU decision-makers
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Pesticides Unit activitiesPesticides Unit activities
Maximum Residue Levels MRLs
Reasoned Opinions Annual report
Supports the Scientific Panel for pesticides PPR (Plant Protection Product and their Residues).
Opinions Guidance documents Ad-hoc mandates
Coordinates the Peer Review of active substances
Provides Conclusions for single active substances to support the EU decision-makers
The Peer Review ProcessThe Peer Review ProcessDossier submission
EFSA
PEER REVIEW
EFSA, (co)RapporteurMS, other MSs, Commission, Applicant, Public
1. Commenting phase
2. Evaluation of comments and possible clock-stop
3. Expert’s consultation
Commission +MSsPlants, Animals, Food and Feed
Committee
Approval/Non ApprovalD/RARDraft/ReviewAssessment
Report National authorisation PPP by MSs
EFSAConclusion
EFSA Risk Assessment
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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
EFSA CONCLUSIONEFSA CONCLUSION
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• 40 Conclusions• New active substances
• First conclusions under Reg. 1107/2009
• Renewals and amendments of approvals• 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)
EFSA PEER-REVIEW OUTPUTS 2014EFSA PEER-REVIEW OUTPUTS 2014
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Assessment of “cut-off” criteria in the EFSA conclusions
Scientific assessment of risks associated to endocrine effects Complementing the interim criteria
Next steps for cooperation with ECHA on C&L proposals Aligning DARs and CLH reports
MRL applications as part of the dossier Import tolerances included in the conclusion
if approved in the exporting country Scientific peer reviewed literature
NEW ELEMENTS IN EFSA CONCLUSIONS
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Literature search in Reg (EC) No 1107/2009
SCIENTIFIC PEER REVIEWED LITERATURE
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”.
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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.
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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
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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
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Published during 2014 Health assessment of chlorpyrifos Aquatic risk of imidacloprid Bee study protocols
On going Risk of neonicotinoids foliar uses to bees …
SPECIFIC REQUEST FROM EC
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Pesticides Unit activitiesPesticides Unit activities
Maximum Residue Levels MRLs
Reasoned Opinions Annual report
Supports the Scientific Panel for pesticides PPR (Plant Protection Product and their Residues).
Opinions Guidance documents Ad-hoc mandates
Coordinates the Peer Review of active substances
Provides Conclusions for single active substances to support the EU decision-makers
MRL REASONED OPINIONSMRL 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
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MRL REASONED OPINIONSMRL 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, lambda-cyhalothrin
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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
OTHER ON-GOING ACTIVITIES AND FUTURE PLANS
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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
PESTICIDES STEERING NETWORK ACTIVITIES
Main title
Major tasks:
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cooperation on Classification and labelling alignment: aligning DAR and CLH report
Proposals for new guidance development on• Birds and mammals• FOCUS Repair action• Isomers
PESTICIDES STEERING NETWORK ACTIVITIES
Main title
On-going activities:
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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
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Thank you for your attention
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