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? Advocacy actions needed to ensure a clear and smooth procedure Reg. 396/2005 Article 12 Purpose and 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 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) Completion of Article 12 MRL reviews Delayed 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: 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 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 What should we 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. 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, 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 RMS completes PRoFile/issues Residues Evaluation Report 6w: MSs comment GAPs/data RMS Consultation with Notifiers 2W: notifier confirms /submits data Scenario 1: no identified data gaps RMS updates PRoFile, comments on
Draft Reasoned Opinion 2 months RO 2 months DR O 6 months E R EI F 2W Annex I Inclusion/
Non-Inclusion 4 months COM SC/EP EFSA : DRAFT Reasoned Opinion to MS/COM EFSA : Reasoned Opinion Regulation 3m: MSs submit authorised GAPs /data notifiers confirm /submit data for evaluation
ECPA proposal: process for Article 12 of 396/2005 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 Mismatching timelines: AIR - 1107/2009 and MRLs - 396/2005 AIR Submission
COM decision 2 years EIF 9 months Active substance renewal 12 months New MRL submission 36 months 2+6 months 6 months EFSA conclusion RMS review start
Endpoints available 3m 12 months Data Generation ~18m Dossier preparation 6 months Consumer evaluation +Residues field residue data generation >18 m MRL request Article 12 MRL reviews and AIR
process AIR Submission RMS review 6 months 12 months Ideal case EFSA conclusion COM decision 6 months 12 months Active substance renewal
MRLs reviewed, Exist new Regulation Product Renewal AS Dossier / MRLs on existing MRL Regulation (= old residue data) 1. MRLs review YES and some RO exist 2. MRLs review not scheduled or DRO not available Active Renewal Decision may include art.12 review decision Regulation? 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 3 months PRODUCT Submission AS Dossier preparation based on new MRLs regulation Cases to identify cRMS zRMS decision decision EIF
Data Generation ECPA Proposal: MRLs during AS renewals, alignment to Article 43 of 1107/2009 A.S. vote EFSA conclusion Authorisations Renewal Art. 43.5 AS approval renewal 6m 3m 3m Information Full evaluation and decision 12m
3 m: cMSs Decision Time depending nature of data required 9 m: zRMS Decision Decision: toxicological endpoints, metabolism, residue-definition Industry: outline information required & timelines for submission of the dossier + including residue data. EIF+3y MRLs evaluation and decision 12m Full dossier submitted when
complete new residue data dossier for MRL modification or confirmation. Next steps 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 ECPA ResEG proposal 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 roadshow, 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 ECPAs 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 Your feedback is welcome!
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