herman fontier - update on the evaluation of active substances

Update on the evaluation of active substances

Herman Fontier, Head of Unit

Committed since 2002 to ensuring that Europe’s food is safe

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

3

Content



Conclusions 2006 - 2011

4

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

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



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

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


• 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


• 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

Mid-term planning

12

Mid-term planning

2012 2013 2014 2015 New a.s. 188/2011

47 (22?) 20 (45?) 0 0

New a.s. 1107/2009

0 10 10 10

Basic substances

3 3 3 3

Approval renewal

0 10 19 30?

Green track stage 4

24 0 0 0

Post approval 3 3 3 3 Total 77 (52?) 46 (71?) 35 46?

13

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

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

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

Resource management

Team PPR MRL Coordination

Resi dues

Phys-chem

Toxi colo gy

Eco tox

Fate

Staff num - ber

8 7 5 3 (3) 3 (1) 4 (2) 4 4 (2)

17

18

Content



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

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

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

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

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

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

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

CBI

• More information can be found on the EFSA website: http://www.efsa.europa.eu/en/pesticides/pesticidesconsultations.htm

• In particular: An overview document on the removal of CBI A form for the identification and justification of CBI

26

http://www.efsa.europa.eu/en/pesticides/pesticidesconsultations.htm

http://www.efsa.europa.eu/en/pesticides/pesticidesconsultations.htm

27

Content



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


• 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


• 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


• 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!

31

Thank you for your attention!

32

herman fontier - update on the evaluation of active substances

Technology

peer review planning

regulation ec no332008

g of regulation ec

post approval conclusions

underregulation ec

regulations ec

darand conclusions

application ofregulation