Léa RIFFAUT ANSES PPP Coordination Unit Experiences in the AIR III evaluation process Feedback from ANSES Léa RIFFAUT ANSES PPP Coordination Unit

Purpose of this presentation  General aspects of the AIR III program Basic guidances and regulatory aspects Overview process and timing for AIR III Allocation of AIR III dossiers for FR Worksharing with RMS or Co-RMS at ANSES  AS Renewal and Classification  AS Renewal and MRL  Difficulties and Challenges with AIR III  Conclusion

General aspects of the AIR III program

Some Basic Guidances and Regulatory Aspects The procedure describing the implementation of the renewal for Active Substances under Reg. 1107/2009 is developped in Reg 844/2012 and detailed in GD SANCO/2012/11251. Under AIR III program  full implementation of Reg. 1107/2009 (approval criteria, « cut off » criteria and other criteria apply) AIR III Active Substance dossiers must follow the New Data Requirements  Reg. 283/2013 and 284/2013 apply Procedural and technical GD noted at the time of submission of the dossier must be used for the assessment RMS shall prepared a standalone Renewal Assessment Report (RAR) under the New DAR Template (Doc SANCO/12592/2012)

Overview process and timing for AIR III Admissibility Check 30 days RMS Evaluation 11 months No stop of the clock foreseen to request additional info EFSA Peer Review Once sanitised and available on the EFSA website, RAR for comments EFSA/MS/APP Commenting period on RAR – 60 days EFSA potential request for additional info – 30 days RMS evaluation of additional info requested – 60 days Potential expert consultation Potential RMS homework after expert meeting – 2 weeks EFSA conclusion – 6 weeks after RMS Homework MS comments on draft EFSA Conclusion – 2 weeks Decision Making COM presents draft Review Report and draft Regulation within 6 months of receiving EFSA conclusion

Allocation of AIR III dossiers for FR According to Reg. 686/2012 allocating the actives substances to RMS and Co-RMS, ANSES (FR) is involved in the assessment of 28 AIR dossiers  Important workload

Worksharing with RMS or Co-RMS at ANSES Role of Co-RMS is not especially defined in GD SANCO/2012/11251 but 2 options can be proposed as reviewer only or writer of some parts Considering ANSES workload in the AIR III program we follow the principles: Sole writer of the RAR when we are RMS Only reviewer of the RAR when we are Co-RMS As RMS, we inform the Co-RMS, as far as possible, of our progress and potential issues on the evaluation

AS Renewal and Classification

AS Renewal and Classification As mentioned in the GD on renewal procedure (SANCO/2012/11251), if it is considered necessary, a revised proposal for classification & labelling should be submitted to ECHA in parallel with the procedure of renewal of the AS Necessity to align procedures under Reg. 844/2012 and Reg. 1272/2008

AS Renewal and Classification Experience so far as RMS in dealing with AIR and classification Up to now, among the AIR III dossiers received so far, ANSES identified : 1 AS that needs a harmonised classification 2 AS that would need a potential revision of the current classification. For these cases, we focus on AS suspected to be CMR Category 1A, 1B or 2 This is discussed during pre-submission meetings and in these cases ANSES request applicant to submit: for a harmonised classification a « light » IUCLID dossier (Identity part - 1.1; 1.2; 2.1) and to prepare a full draft CLH report for potential revision of classification, an updated CLH dossier including a draft CLH report focussing only on these aspects

AS Renewal and MRL

AS Renewal and MRL COM confirmed that the procedure foreseen in Art. 12(1) of Reg. 396/2005 is not applicable following the renewal of an AS According to the GD on renewal procedure (SANCO/2012/11251), it is strongly recommended that applicants should submit all MRLs applications which they considered necessary for extension of uses or possible amendment of existing MRLs (not only those relevant to the representative uses)

AS Renewal and MRL RAR prepared by RMS, includes where relevant and necessary, a proposal to set new MRLs or modify existing ones. A notification is sent to EFSA at the same time of RAR release. MRL proposals are considered during the EFSA Peer Review EFSA conclusion includes both evaluation of AS renewal and MRL application

Difficulties and Challenges with AIR III

Difficulties and Challenges with AIR III Heavy workload within very short timelines Not always easy to deal with when RMS changes from first approval Sometimes difficult to plan the reviewing work when we are Co-RMS  Smooth communication between RMS and Co-RMS is important to cope with this

Difficulties and Challenges with AIR III Sometimes difficult to have access to the old dossier submitted for first approval under an exploitable format AIR III dossiers not always completed at the time of submission. ANSES can accept that final reports be sumitted during the evaluation but this should be discussed on a case by case basis during pre-submission meetings No stop of the clock foreseen in the procedure for RMS to request additionnal information during assessment while it is most of the time necessary

Difficulties and Challenges with AIR III As requested by Reg. 1107/2009, applicants shall provide in their dossier a review of the scientific open literature according to the EFSA GD (EFSA Journal 2011; 9(2):2092). However, this is not always exhaustive or done properly Some lack of predictability during pre-submission meetings on the availability/use of some technical GD (e.g. operator or bees GD) which should apply at the time of submission of the dossier Cut Off criteria apply but are not always clearly defined (e.g. interim criteria for ED)

Conclusion

Conclusion AIR III procedures and timelines are clearly defined However these short timelines and workload are really challenging especially for dossiers submitted in 2014 and 2015 And these challenges and difficulties increase when: Several applicants submit separate dossiers Number of representative uses and/or PPP are high CLH report shall also be prepared in the same time Major issues are raised by the RMS during the evaluation  Difficulties to finalise the evaluation within the timelines

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