MRL implementation process Learning from 5 years of implementation of Regulation 396/2005 ResEG proposal – March 13th, 2013

MRL submissions & reviews: Lessons learnt Potential improvements: What should we do? Advocacy actions needed to ensure a clear and smooth procedure Scope

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 Reg. 396/2005 Article 12 – Purpose and current status.

What are the reasons? Data collection: inconsistent or partial data provided to EFSA by RMS, notifier not involved – often actively excluded Duplicated review of 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) Reg. 396/2005 Article 12 – Purpose and current status.

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

ECPA ResEG proposed to COM a pragmatic and efficient way to accomplish review of MRLs Commission 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 Completion of Article 12 MRL reviews

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. What should we do?

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, should be done jointly with the AIR reviews. (i.e. ER as part of dRR and RO as part of the renewal decision) 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 What is a potential solution?

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

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 Why do we need to link Regulations 396/2005 and 1107/2009?

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

Article 12 MRL reviews and AIR process Active substance renewal AIR Submission RMS review EFSA conclusion 12 months6 months COM decision 6 months EIF Product Renewal PRODUCT Submission 12 months 3 months zRMS decision cRMS decision 1. MRLs review YES and some RO exist 4. MRLs review may lead to changes (end points –DoR) 2. MRLs review not scheduled or DRO not available MRLs reviewed, Exist new Regulation MRLs reviewed, Exist new Regulation AS Dossier preparation based on new MRLs regulation Active Renewal Decision may include art.12 review decision Regulation? End point decisions according to AIR Decision Data Generation Art.12 review should follow AIR decision? AS Dossier / MRLs on existing MRL Regulation (= old residue data) Ideal case Cases to identify 3. MRLs review ongoing, DRO = no risk for changes Art.12 review should follow AIR decision?

ECPA Proposal: MRLs during AS renewals, alignment to Article 43 of 1107/2009 EFSA conclusion A.S. vote 12m Authorisations Renewal Art AS approval renewal 3 m: cMSs Decision 3 m Information 9 m: zRMS Decision 6m3m Decision: toxicological endpoints, metabolism, residue-definition Industry: outline information required & timelines for submission of the dossier + including residue data. Full dossier submitted when complete new residue data dossier for MRL modification or confirmation. EIF+3y Full evaluation and decision MRLs evaluation and decision 12m Time depending nature of data required

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’ Next steps

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

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… ECPA ResEG proposal

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