bénédicte vagenende pesticides unit crop protection european regulatory conference, march 2015...

23
Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

Upload: paula-lewis

Post on 15-Jan-2016

235 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

Bénédicte VagenendePesticides Unit

Crop Protection European Regulatory Conference, March 2015

EFSA’s role in the evaluation of active substances

1

Page 2: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

2

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

Page 3: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

3

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

Page 4: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

4

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

Page 5: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

5

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

Page 6: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

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

11

Page 7: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

7

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

Page 8: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

8

• 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

Page 9: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

9

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

Page 10: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

10

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”.

Page 11: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

11

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.

Page 12: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

12

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

Page 13: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

13

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

Page 14: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

14

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

Page 15: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

15

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

Page 16: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

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

17

Page 17: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

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

18

Page 18: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

18

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

Page 19: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

19

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:

Page 20: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

20

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:

Page 21: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

21

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

Page 22: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

22

Page 23: Bénédicte Vagenende Pesticides Unit Crop Protection European Regulatory Conference, March 2015 EFSA’s role in the evaluation of active substances 1

Thank you for your attention

23