1. biological dossier and cooperation in the Southern zone
Focus on
biological dossier and
cooperation in the Southern zone
Laurent Thibault and Véronique Mironet
Anses - Efficacy Evaluation Unit
for plant protection products and fertilisers
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

2. Overview Issues with dossiers submitted and recommandations
Cooperation between experts involved in biological efficacy
New format for the dRR template
Conclusion
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

3. Issues with dossiers submitted and recommandations
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Issues with dossiers submitted and recommandations
Zonal level
increase the complexity of dossiers and the evaluation process
Need for a clear understanding of the intended uses (GAP)
Between member states
Including the major/minor uses
To avoid inconsistencies between the GAP tables of the different sections of the dRR, the content of the dossier and the national application form
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

4. Issues with dossiers submitted and recommandations
2/4
Issues with dossiers submitted and recommandations
Efficacy trials :
Do the data (or the rationale) support all the intended uses ?
Justify the absence of data : e.g. to propose extrapolation
Quantity is not quality :
dRR should be more concise and standalone document
Data not sufficiently summarized : put together ≠ sum up
National addenda should be justified : specific use or specific practices
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015
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5. Issues with dossiers submitted and recommandations
In case of re-registration dossiers:
In principle, all uses are re-registrations
But if it is not this case, e.g. new use in zRMS then information should be given to zRMS : cMS where the product is registered
zRMS is not able to conclude for the whole zone if the information is missing
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015
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6. Issues with dossiers submitted and recommandations
4/4
Zones and dossiers:
Dossiers should be adapted to each regulatory zone.
Trials should be distributed in the whole regulatory zone.
EPPO climatic zone is not always the best solution to sumarize trials (France is cut in two EPPO zone)
To justify the distribution of trials within the zone
Avoid a single european BAD, where we have to « pick » trials.
But EPPO zones required by the majority of MS
For each regulatory zone : 1 specific BAD and 1 specific dRR.
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

7. Cooperation between experts involved in biological efficacy
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Cooperation between experts involved in biological efficacy
Zonal evaluation avoids duplication of work :
As cMS, we are able to rely on the RR produced by other MS
Save time and  workload
Since June 2011 :
Clear improvement of the quality of dRR received from applicants
Clear trend in reduction of « national requirements » in the evaluation
1) But, we can loose time elsewhere
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

8. Cooperation between experts involved in biological efficacy
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Cooperation between experts involved in biological efficacy
Exchanges on technical issues/interpretations should be improved between experts of MS of the southern zone
Currently, the most common ‘exchange’ :
By commenting tables on dRR (zonal evaluation)
To share and to improve evaluation
Transparency for MS and applicant
Proposal by Anses to organise a face to face meeting between experts of the southern zone involved in biological efficacy in 2015
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

9. Cooperation between experts involved in biological efficacy
3/3
Cooperation between experts involved in biological efficacy
Some Items for discussion in the face to face meeting e.g.:
Minimum effective dose : need to be justified ?
Distribution of trials / trial grouping
Relation between GAP, conditions of trials, acceptability of deviation
Trials : need for criteria to consider the trials valid or invalid ?
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

10. New format for the dRR template Another example of cooperation
This work is a real way to share opinions of EU efficacy experts and to improve the cooperation between MS
This new format should avoid duplication of work for MS and applicants and save time
Leader of the Working group: BVL (Germany)
One subgroup for each section of the dRR
Chair of Efficacy subgroup : France
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

11. Context and Method Calendar Members of the efficacy subgroup
February 2012: Kick-off meeting
July 2012: First version (FR) sent to subgroup for comments
March 2013: 2nd Braunschweig Meeting (coordination ; point on all sections)
November 2013: Face to face meeting – Paris (subgroup)
January 2014: Final version (from the subgroup) sent to BVL
May 2014: Presentation to ScoPAFF (SCFCAH = CPCASA) and sent for comments to all MS (27)
July 2014: Comments back in France
October 2014: Final version and reporting table, sent to BVL
December 2014: Presentation to ScoPAFF (With new reformatting from BVL and accompanying documents from HSE (UK). Sending for comments to all MS (27)
February 2014: Last final version and reporting table, sent to BVL
March 2014: Final presentation to ScoPAFF ??
Members of the
efficacy subgroup
Chair: France (Anses)
Grece (BPI)
UK (HSE)
Germany (JKI)
Netherlands (CTGB)
Danemark (AGRSCI)
Hungary (NEBIH)
ECPA
In blue, MS integrated in the efficacy subgroup, later
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

12. Some outcomes : table of contents
Current chaptering
Efficacy data …
Effects on yield and quality
Effect on yield
Effect on quality
Effects on transformation processes…
Adverse effects
Phytotoxicity to host crop
...
Propagation
Succeeding crops
Adjacent crops
Resistance
New chaptering proposed
(according to regulation 284, except MED)
Adverse effects on treated crops
Effects on yield
Effects on quality
Effects on transformation processes
Observations on other undesirable or unintended side-effects
Positive effects (efficacy...) versus adverse effects.
Adverse effects on treated crops versus on other crops.
A uniq chaptering for BAD, dRR, DAR and EU regulation 284/2013 (or almost)
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

13. Some outcomes MS approaches when transforming a dRR into a RR:
Deleting / rewriting
Use of commenting boxes
The chosen option(s) should be explained at the beginning of the RR
Use of summary tables as much as possible, instead of text:
in the template, examples of tables (with possibilities of modification) are proposed
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

14. Conclusion Issues with dossiers submitted and recommandation
Avoid overall dossiers for all zones
Importance of adapting the dossier to the regulatory zone concerned
Clear improvement of the quality of dRR received from applicants
Still need to reduce the size of dRR (without reducing the quality)
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

15. Conclusion Cooperation in the Southern zone
So far : main exchanges by commenting tables on dRR
Need to improve communication and have face to face meeting between efficacy evaluators of the southern zone:
To share experiences
To discuss and solve remaining technical open points
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

16. Conclusion dRR template :
A real way to share opinions of EU efficacy evaluators
An exemplary democratic process:
With its advantages: a collective document with high quality
And its defects:
3 years of work
An infinity of comments in an infinity of round trip of comments tables
Always new comments of the same members of subgroup, despite the accepted modifications and a face to face meeting …☺
Next step planned: validation of the template to SCOPAFF
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

17. Thank you for your attention
ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015