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MRL implementation process Learning from 5 years of implementation of Regulation 396/2005

MRL implementation process Learning from 5 years of implementation of Regulation 396/2005. ResEG proposal – March 13th, 2013. Scope. MRL submissions & reviews: Lessons learnt Potential improvements : What should we do?

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MRL implementation process Learning from 5 years of implementation of Regulation 396/2005

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  1. MRL implementation processLearning from 5 years of implementation of Regulation 396/2005 ResEG proposal – March 13th, 2013

  2. Scope • MRL submissions & reviews: Lessonslearnt • Potentialimprovements: Whatshouldwe do? • Advocacy actions needed to ensure a clear and smoothprocedure

  3. Reg. 396/2005 Article 12 – Purposeand current status. Aim: Review existing MRLs and consumer risk of authorised uses, in the light of Annex I decision [Directive 91/414]  EIF + 1 year What has been achieved 5 years after EIF? - Significant number of compounds not yet scheduled for review; repeated changes of the ROs, conflicting processes

  4. Reg. 396/2005 Article 12 – Purposeand current status. What are the reasons? • Data collection: inconsistent or partial data provided to EFSA by RMS, notifier not involved – often actively excluded • Duplicated reviewof data: overloading RMS and EFSA, as well as industry, due to incorrect basis used for first evaluation • Reasoned opinion revisions: due to incorrect initial data or changes expected by later decisions on ‘Confirmatory data’ • Prioritization issues- overlapping or conflicting procedures: ResEG examples given to Commission, on ROs for Article 12 reviews not aligned to modifications of MRLs Workload was underestimated as well as the interference of MRL review with other procedures (Confirmatory data, changing Residue Definitions, Annex III AIR, etc)

  5. Completion of Article 12 MRL reviewsDelayed Art.12 reviews are blocking other procedures!! • ECPA ResEG sent to the COM the ‘difficulties experienced’ due to conflicts between procedures. Main issues were compiled under following categories: • ProceduresProcedural conflict between Art.10 and Art.12 decisions (under 396/2005)Uncoordinated process to1107/2009 (AIR, Article 43 re-authorisations) • RolesInterpretation of the roles of RMS, EMS and other zRMS, MSs, EFSA and notifier • Decision makingNational decision linked to delayed MRL setting.Confirmatory data evaluations-decisions

  6. Completion of Article 12 MRL reviews • ECPA ResEG proposed to COM a pragmatic and efficient way to accomplish review of MRLsCommission and some MSs agree on the need, the subject is a regular point of discussion in the Standing Committees. ECPA believes the above points need to be amended by Guidance Documents urgently

  7. Whatshouldwe do? Advocate for solutions: • Completion of the Article 12 MRL reviews – a proposal for how this can be completed, efficiently and pragmatically • Ensuring 396/2005 is fit for the 1107/2009 regulatory world – a process Guidance Document and/or revision of the regulation.

  8. What is a potential solution? ECPA ResEG proposal for completion of Article 12 : • Involve the notifier to verify that the correct data is used to complete the Evaluation Report (early in the process) • Reduces difficulty and time to compile late comments avoiding duplication of evaluations and revisions of RO. • Avoids loss of uses and additional authorisation work, when a safe MRL is identified • Uses the Art. 6 process as a basis for a process to complete the Art.12 process (Art.12 delays invalidate the process to check compliance of MRLs to a.s. inclusion end points) • Remaining Art.12 reviews, shouldbedonejointly with the AIR reviews. (i.e. ER as part of dRR and RO as part of the renewaldecision)

  9. What is a potential solution? ECPA ResEG proposal for completion of Article 12 : • Commission set as priority, a shorter time to MRLs ! and fitting timelines between 396/2005 and 1107/2009 procedures. Several MSs, EU COM and EFSA see the need for a pragmatic solution which does not increase workload and reduces duplication

  10. ECPA proposal: process for Article 12 of 396/2005 notifiersconfirm /submit data for evaluation RMS Consultation withNotifiers 2W: notifier confirms /submits data 3m: MSssubmitauthorisedGAPs /data 6w: MSs comment GAPs/data Scenario 1:no identified data gaps RMS completesPRoFile/issues Residues Evaluation Report RMS updates PRoFile, comments on DraftReasoned Opinion Regulation DRO 2W EIF ER RO 6 months 2 months 2 months 4 months COM SC/EP EFSA : Reasoned Opinion EFSA : DRAFT Reasoned Opinion to MS/COM Annex I Inclusion/ Non-Inclusion

  11. Why do we need to link Regulations 396/2005 and 1107/2009? Reg. 396/2005 was conceived with Dir. 91/414 in mind and the timelines do not match those now mandated in Reg. 1107/2009 To ensure Reg. 396/2005 continues to be fit for purpose in the 1107/2009 world, urgent guidance is required on: • Roles, responsibilities – RMS, EMS, z-RMS, EFSA, EU COM, Notifier - and timelines for completion of the various steps in MRL setting • A derogation process that MS can use should the timelines not be met • If MRL changes consequential to re-Authorisation of the active substance are requested, how this will take place and what it will entail with accountabilities • A process for maintaining safe MRLs while suitable supporting data is generated to allow re-registration of existing uses in a timely manner

  12. Mismatching timelines: AIR - 1107/2009 and MRLs - 396/2005 EIF New MRL submission 36 months AIR Submission COM decision 2 years 9 months 12 months start MRL evaluation Product Renewal Active substance renewal 3 m 3 m 6 months ≤3 months 6 months 2+6 months 12 months zRMS decision Product Renewal Submission cRMS decision EFSA conclusion RMS review Dossier Submission 24 months Dossier preparation Assessment Data Generation ~18m 6 months Endpoints available

  13. Article 12 MRL reviews and AIR process AIR Submission COM decision cRMS decision RMS review EFSA conclusion zRMS decision EIF 6 months 12 months 6 months 12 months Active substance renewal Product Renewal 3 months Ideal case MRLs reviewed, Exist new Regulation AS Dossier preparation based on new MRLs regulation PRODUCT Submission Cases to identify AS Dossier / MRLs on existing MRL Regulation (= old residue data) Active Renewal Decision may include art.12 review decision Regulation? 1. MRLs review YES and some RO exist Data Generation 2. MRLs review not scheduled or DRO not available Art.12 review should follow AIR decision? 3. MRLs review ongoing, DRO = no risk for changes Art.12 review should follow AIR decision? 4. MRLs review may lead to changes (end points –DoR) End point decisions according to AIR Decision •

  14. ECPA Proposal: MRLs during AS renewals, alignment to Article 43 of 1107/2009 A.S. vote AuthorisationsRenewal Art. 43.5 Full evaluation and decision EFSA conclusion AS approval renewal 6m 3m 12m 3 m Information 3 m: cMSs Decision 9 m: zRMS Decision Decision: toxicological endpoints, metabolism, residue-definition EIF+3y Time depending nature of data required Full dossier submitted when complete new residue data dossier for MRL modification or confirmation. MRLs evaluation and decision 12m Industry: outline information required & timelines for submission of the dossier + including residue data.

  15. Nextsteps How do we get these proposals on the ‘Agenda’, to make things move? Taking into account the need to evaluate impact of the scheduled • Anticipated update of Reg. 396/2005 and • Expected Guidance Document on ‘Interplay between Regulation (EC) No 396/2005 and Regulation (EC) No 1107/2009 in the area of MRL setting’

  16. Industry to make a road-show and activate the “silent majority” of MSs Define actions to start soon: ResEG with support from EAN to start a road-show, meeting MSs. Most Important MSs to meet : DE, FR, UK, NL, AU, GR? Others? Define common actions with the support of RPT and EAN (include MRLs in zonal discussions, include 396/2005 update in 1107/2009 update discussions) – Regulatory Outreach Program Prepare for an ECPA meeting with MSs around a SC meeting, e.g. early 2014, as COM asked for time to show results from the modified process Advocacy Expert Group to be involved in 396/2005 update (and 1107/2009 update) High level political advocacy by ECPA’s top management aiming to Show the cumulative impact of the different GDs on PPP authorisations. Obtain proportional weight/impact and timely implementation of legislation in Europe. Commitment of the Authorities to fulfil legislation (COM, EFSA, MSs Authorities). ECPA ResEG proposal

  17. ECPA ResEG proposal • Stakeholders forum (long term initiative to start in 2014?) • Objective: to gather experience made under 396/2005 and commonly develop proposals and push for amending 396/2005 • Possible Stakeholders: ECPA, Authorities, Commission (DG SANCO, DG AGRI, DG TRADE), EFSA, FC partners, WTO, missions of exporting regions) • Support organisation or find Consultants to organise conferences…

  18. Your feedback is welcome!

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