French feed back

about AIR 2 & AIR3

Léa Riffaut, Jérémy Pinte

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

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

AIR 2

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

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

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

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.

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

AIR 3

FR Outcomes for AIR3

• Pre-notification steps• Some pre-submission meetings• …

• Some delays for decisions for pre-notifications

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– Old studies not peer-reviewed

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

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

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?

Conclusions

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

Thank you!

www.agriculture.gouv.frwww.anses.fr