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French Assessment Scheme for AIR2 & AIR3 Substances: An Overview

Learn about the outcomes and processes of the AS assessment scheme in France for AIR2 and AIR3 substances. Understand the splitting between scientific evaluation and decision making by Anses and the Ministry of Agriculture. Explore the roles of Anses, MAAF, CoC, EFSA, and more in regulatory issues and risk mitigation. Gain insights into the assessment outcomes, drafting processes, communication, and challenges for AIR2 and AIR3 substances in France.

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French Assessment Scheme for AIR2 & AIR3 Substances: An Overview

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  1. French feed back about AIR 2 & AIR3 Léa Riffaut, Jérémy Pinte

  2. AS assessment scheme in France • Outcomes for AIR2 substances • Outcomes for AIR3 substances

  3. FR scheme for AS • Splitting between scientific evaluation and decision making: Anses vs. Ministry of Agriculture • A single desk: Anses (DPR) • Anses: scientific evaluation and administrative checks (CoC) → MAAF • MAAF: regulatory issues (data protection), risk mitigation & decision making → COM, EFSA, MSs, Notifier

  4. AIR 2

  5. FR Outcomes of AIR2 • AIR2: 31 AS, 31 RMS, 31 co-RMS • FR AIR2: 6 AS, 5 as RMS, 1 as co-RMS • As RMS: different worksharing options tested • RMS drafting, co-RMS review (3) • RMS and co-RMS co-drafting (2) • As co-RMS: review of RMS' assessment

  6. FR Outcomes of AIR2 • Assessment at FR level: approx. on time • Now at EU assessment level • 3 after 'additional information' step • 1 before 'additional information' step • 1 about to be fully evaluated by EFSA

  7. FR Outcomes for AIR2 • RMS and co-RMS usually agreed. • Few disagreements listed in Vol1/Lev3 • FR conclusions on the assessment • Proposal of non-approval due to higher protection goals • Proposal of approval • Change of end-point(s) • Change of EU-harmonised classification

  8. FR Outcomes of AIR2 • As RMS with a co-RMS co-drafting the RAR • Interesting and valuable exchanges • (Little) Extra work due to • Co-ordination of evaluator's workload and cross commenting of conclusions of assessment • Interdependance of sections: need of detailed scheduling of the evaluation in order not to await some input values from the other MS/section.

  9. FR Outcomes for AIR2 • Communication at every step • Between RMS and co-RMS • Within RMS • Between RMS, co-RMS and EFSA (in case of worksharing and co-drafting) • Hard point: referring to the existing DAR vs. drafting a stand-alone RAR • Renewal is not assessment of a NAS

  10. AIR 3

  11. FR Outcomes for AIR3 • Pre-notification steps • Some pre-submission meetings • … • Some delays for decisions for pre-notifications

  12. FR Outcomes for AIR3 • Prenotifications • Some negative decisions • Uncomplete prenotifications • On-going discussions between parties • Challenging pending questions • Notification of studies: • Partial list (possible amendment?) • Not fully own data package (physical availability / decision making before getting the letter of access) • Old studies not peer-reviewed

  13. FR Outcomes for AIR3 • Some meetings before supplementary dossier submission • Interesting and valuable steps • With co-RMS and industry • Workscheduling (pending studies, worksharing) • EU harmonised classification: • No existing classification • Existing classification challenged

  14. FR Outcomes for AIR3 • Communication • For every step, as early as possible • With(in) industry and with (co-)RMS • Quality of (finalised) prenotifications • Homogeneous treatment of notifiers

  15. FR worries for AIR3 • Access to data for very old dossiers • New procedure • New template for the RAR (stand-alone RAR & retyping paper copies of ancient DARs) • Changing deadlines for end of approval • Change of MS as RMS between approval and renewal • Workload: no spare evaluation time, difficulties for 2015 → delayed RARs? Postponed end of approval?

  16. Conclusions

  17. Conclusions • Full implementation of R(EC)1107/2009 • Heavy workload • Starting with dossiers of ASs • Which will feed the art. 43 PPP re-authorisation: RMS for AS → zRMS for PPPs • Impact on periods of approval for AIR3 ASs. • Need of planification, communication • Experiencing a new procedure with AIR3

  18. Thank you! www.agriculture.gouv.fr www.anses.fr

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