7. Martin Streloke Regulation 1107/2009 Lessons learnt after 5 years?

Regulation 1107/2009:
Lessons learned after 5 years
Dr. Martin Streloke, BVL
Brussels, 9. March 2016
Experiences with implemeting 1107/2009
•
Much more exchange between MS
•
Administrative procedures, reporting, responsibilities have
been harmonised considerably
•
Even criteria for risk assessment and decision-making have
been developed further
•
Additional committees for discussing critical items were
established and MS met frequently
•
A lot of zonal authorisations habe been granted
•
Number of approved actives and authorised products in DE
are more or less stable
•
However, in specific crops products are not available as
needed.
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 2
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 3
Number of approvals in DE high
•
Around 600 approvals in progress
•
Number of approvals has increased considerably
•
250 new approvals in 2015
•
Number of authorisations are clearly lower, therefore
•
Considerable delays in authorisation procedures
•
Accumulation of not finalised registration procedures
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 4
Reasons for higher number of applications
•
Applicants apply in DE because:
– other MS accept only a certain number of applications
– in DE authorities must accept all applications
– authorisation are difficult to get in DE, but if yes,
acceptance in other MS often high
– applicants receive information about short-comings early
in authorisation procedure
– DE important market for PPP.
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 5
Current status of zonal procedures
•
According to 1107/2009 procedure should be finalised 12 (18)
month after time of application
•
Nearly impossible to reach this goal
•
Authorities in DE busy in improving situation
•
FVO-Audit last week in Braunschweig:
– number of applications, staff, Time of processing are
requested
– recommendations from FVO; action plan of MS to
bedelivered
– implementation will be supervised
•
COM will report to parliament next year .
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 6
Why are authorisation procedures delayed ?
•
A lot of new assessment methods and citeria for decisionmaking (Cutoffs, CfS, Comparative Assessment, …)
•
Development of guidance documents very science driven
but often not ready for regulatory practise
•
Interpretation of GD parly unclear, no clear guidance given
•
Role of Risk Managers to be clarified
•
Needs of regulatory bodies are not enough considered
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 7
Why are authorisation procedures delayed ?
•
Quality of applications partly low
•
Applicants may wish to submit good applications to reduce
workload in authorities
•
No clear arbitration procedure in central zone in place
•
Different opinions are discussed but if no agreement no
further action
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 8
Reasons for long processing time
•
Completeness of evaluation in MS still different (Art. 36 (1))
•
Efficacy assessment and wording/structure of GAPs need to
be better harmonised
•
Still a considerable number of national approaches
•
When to apply new scientific and technical knowledge ?
•
Efforts for coordinating and organising approval procedure
in DE are quite high
•
Not enough staff in authorities
•
Public discussions much more critical; workload for
responding has increased considerably (e.g. glyphosate)
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 9
Measures taken for improving situation
•
More intensive check for completeness
•
Refuse applications of low quality
•
Increase work in groups like PAI, CZSC, DCG at EU and zonal
level for more harmonisation
•
Start discussion on strengthening work of these groups
•
Clear remits and responsibilities of groups are needed and
an effective work-sharing
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 10
Measures taken for improving situation
•
Taking the lead for projects aiming more harmonisation in
RA and RM
•
More efforts for optimising process of GD development
•
More regular contacts with CA in neighbouring countries
•
Strengthening procedures in DE regulatory system
•
Increasing staff in regulatory bodies
• But overall workload for harmonisation – in particular
assessment and decision-making schemes – is high
and needs time !
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 11
Take home messages
•
Implementation of 1107/2009 increased work-sharing
amongst MS and a considerable number of zonal
authorisations were granted
•
High number of applications in DE
•
Processing time too long
•
More harmonisation for RA and RM needed
•
Clear Guidance ready for regulatory purpose needed
•
Measures to improve situation are presented.
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016
Seite 12
Thank you for your attention!
Kontakt:
Dr. Martin Streloke
Telefon:
0531 299-3401
E-Mail: [email protected]
Dr. Martin Streloke, BVL Abteilung Pflanzenschutzmittel
17. Februar 2016

Download Report