1. Committed since 2002
to ensuring that Europe’s food is safe
Update on the evaluation of active
substances
Herman Fontier, Head of Unit

2. Content
• Overview peer review activities in 2011
• Peer review planning 2012 and beyond
• Implementation of Regulation (EC) No
1107/2009
• Commenting on draft EFSA Conclusions
2

3. Content
• Overview peer review activities in 2011
• Peer review planning 2012 and beyond
• Implementation of Regulation (EC) No
1107/2009
• Commenting on draft EFSA Conclusions
3

4. Conclusions 2006 - 2011
4

5. Conclusions 2011
• Resubmissions under Regulation (EC) No
33/2008: 14 (the resubmission programme is
finalised)
• Renewals under Regulation (EC) No 737/2007:
1 (the AIR 1 programme is finalised)
• Green track active substances (a.s.) of stage 4
(post approval conclusions in application of
Regulation (EC) No 2229/2004): 34
5

6. Conclusions 2011
• New a.s. under Regulation (EU) No 188/2011: 3
• Post approval (confirmatory data; application for
amendment of the approval conditions): 2
• With 2 exceptions, all conclusions have been
delivered within the legal time lines
6

7. Content
• Overview peer review activities in 2011
• Peer review planning 2012 and beyond
• Implementation of Regulation (EC) No
1107/2009
• Commenting on draft EFSA Conclusions
7

8. Conclusions 2012
• According to EFSA’s Management Plan 2012,
EFSA will adopt 77 Conclusions in 2012:
 New a.s. under Regulation (EU) No 188/2011: 47
 Green track a.s. stage 4: 24
 Basic substances: 3
 Post approval Conclusions: 3
8

9. Regulation (EU) No 188/2011
• 70 substances are reviewed under Regulation
(EC) No 188/2011; situation on 13 April 2012:
 3 Conclusions delivered in 2011
 4 Conclusions delivered in 2012
 47 draft assessment reports (DARs) under peer
review
 6 a.s. for which additional information is requested
under Art. 11(6) with updated DAR awaited
 10 DARs awaited
9

10. Regulation (EU) No 188/2011
• Major progress has been made with the pending
new a.s. programme
• On 13/04, for 54 of the 70 a.s., the peer review
was ongoing or finalised
• However, for almost all a.s., additional
information needs to be requested after the
commenting phase, leading to a stop of the
clock of maximum 5 or 8 months (depending on
the date of the completeness decision)
10

11. Regulation (EU) No 188/2011
• As a result, it is now becoming clear that in
2012, the number of Conclusions under
Regulation (EU) No 188/2011 will be
considerably lower than the 47 anticipated in the
Management Plan 2012
• On the other hand, the number of post approval
conclusions might be higher than expected
11

12. Mid-term planning
12

13. Mid-term planning
2012 2013 2014 2015
New a.s. 47 (22?) 20 (45?) 0 0
188/2011
New a.s. 0 10 10 10
1107/2009
Basic 3 3 3 3
substances
Approval 0 10 19 30?
renewal
Green track 24 0 0 0
stage 4
Post approval 3 3 3 3
Total 77 (52?) 46 (71?) 35 46?
13

14. Planning the peer review
• Two major problems continue to affect the peer
review planning:
 The unpredictability at several levels (planning by
Commission (COM), stops of the clock at RMS level
and during the peer review, end of stop of the clock,
timely input by the RMS)
 The important yearly fluctuation of the workload
14

15. Resource management
• In order to address both these fluctuations and
the lack of resources in the area of Reasoned
Opnions (ROs; Art. 10, 12(1) and 12(2) of
Regulation (EC) No 396/2005), the Pesticides
Unit has initiated a training programme for
scientific officers working for the peer review, so
that they can contribute to the drafting of ROs
15

16. Resource management
• The Pesticides Unit has 49 staff members:
 1 Head of Unit
 38 scientific officers (SOs; 1 position open; 3
seconded national experts)
 10 assistants
• In the next slide, the distribution of the SOs over
the different teams is given; between brackets
the number of SOs that can also do work in the
area of the ROs
16

17. Resource management
Team PPR MRL Coor Resi Phys- Toxi Eco Fate
dinati dues chem colo tox
on gy
Staff 8 7 5 3 (3) 3 (1) 4 (2) 4 4 (2)
num -
ber
17

18. Content
• Overview peer review activities in 2011
• Peer review planning 2012 and beyond
• Implementation of Regulation (EC) No
1107/2009
• Commenting on draft EFSA Conclusions
18

19. Regulation (EC) No 1107/2009
• Classification and labelling
• MRL applications submitted with an a.s.
approval application other than for
representative uses (« extra » MRL applications)
• Confidential business information (CBI)
19

20. Classification and labelling
• BfR Workshop in April 2011 (Berlin)
• Working document on processes as a follow-up
of the BfR Workshop (parallel evaluations under
the Regulations (EC) No 1107/2009 and
1272/2008)
• Discussion in the Pesticide Steering Committee
(PSC)
• Selection of a new a.s. assessed under
Regulation (EC) No 1107/2009 for testing of the
working document in a pilot project 20

21. MRL applications
• Art. 8(1)(g) of Regulation (EC) No 1107/2009
provides for the possibility to add copies of MRL
applications to a dossier for approval of an a.s.
• The MRL applications are evaluated together
with the a.s. approval application according to
the time lines of Regulation (EC) No 1107/2009
• Several practical questions can arise with regard
to the reporting, the procedure, the time lines
• These questions have been discussed in the
PSC 21

22. MRL applications
• Separation of information on the representative
uses and on « extra » MRL applications in DAR
and Conclusions?
• Yes, it should be clear whether information
evaluated or a data gap identified is linked to an
« extra » MRL application or not; an « extra »
MRL application data gap cannot lead to the
identification of a critical area of concern
22

23. MRL applications
• Integration of information on « extra » MRL
applications in the peer review process
(commenting, expert consultation)?
• Yes, but
 « extra » MRL applications should never trigger an
expert consultation (should not prolong the a.s.
approval process)
 residue trials for « extra » MRL applications would
normally not be scheduled for an expert consultation
23

24. MRL applications
• What happens in the case of data gaps for the
« extra » MRL applications, hampering the
evaluation of the proposed MRLs?
• The « extra » MRL applications should not lead
to a delay in the a.s. approval process, and
therefore the processes under Regulations (EC)
No 1107/2009 and 396/2005 may need to be
separated again
24

25. CBI
• EFSA has to make available to the public
several documents: summary dossiers,
applications for renewal, DARs, EFSA
Conclusions
• EFSA together with the MSs (in the PSC)
analysed the legal requirements; an approach
on who will do what was agreed
25

26. CBI
• More information can be found on the EFSA
website:
http://www.efsa.europa.eu/en/pesticides/pesticid
esconsultations.htm
• In particular:
 An overview document on the removal of CBI
 A form for the identification and justification of CBI
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27. Content
• Overview peer review activities in 2011
• Peer review planning 2012 and beyond
• Implementation of Regulation (EC) No
1107/2009
• Commenting on draft EFSA Conclusions
27

28. Commenting on draft
Conclusions
• MSs are invited to comment on the draft
Conclusions
• The comments are collated in a table; the EFSA
evalution of the comments is added; the table is
part of the background documents to the
Conclusion and publicly available
• Applicants are invited to identify CBI in the
Conclusions
28

29. Commenting on draft
Conclusions
• Applicants are not invited to comment on the
draft Conclusion for the following reasons:
 There is no legal requirement for EFSA to do so
 EFSA has strict and challenging time lines for the
drafting of the Conclusions; there is no time to
address possibly lengthy comments from the
applicants
 COM invites the applicants to comment on the EFSA
Conclusions
29

30. Commenting on draft
Conclusions
• EFSA looks into the comments sent to COM
• Factual errors pointed out by the applicant are
addressed quickly
• EFSA cannot react to new information
• EFSA will make an effort to react consistently to
unfair comments (such as « EFSA identified a
data gap at the very last moment », whereas the
issue was already identified during the
commenting…)
30

31. Commenting on draft
Conclusions
• Some comments should have been made during
the commenting on the DAR (example: EFSA
based its evaluation on the wrong GAP; the
mistake was made by the RMS in the DAR)
• Don’t miss the opportunity to comment on
the DAR!
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32. Thank you for your attention!
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