1. The Zonal Experience of the CP Industry
Kerry Gamble, Syngenta CP, Basel
ECPA-ECCA Conference, March, Brussels

2. Overview of the presentation
The role of Zonal and Mutual Recognition
Quantitative analysis
Qualitative feedback
How to address the key outstanding issues?
Managing the timelines
Managing the requirements
Delivering the objectives of 1107
ECPA Proposal for the Way Forwards
Conclusions

3. The objectives of 1107 re Zonal and MR
Regulation 1107/2009 Preamble:
(8) ‘The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture ’
(9) ‘In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States, this Regulation should also lay down harmonised rules on the mutual recognition of authorisations and on parallel trade. The purpose of this regulation is thus to increase the free movement of such products and availability of these products in the Member States.’

4. The objectives of 1107 re Zonal and MR
Regulation 1107/2009 Preamble:
(25) ‘In the interest of predictability, efficiency and consistency, criteria, procedure and conditions for the authorisation of PPPs should be harmonised, account being taken of the general principles of protection of human and animal health and the environment.’
(29) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community.....
To avoid any duplication of work
To reduce the administrative burden for industry and for MSs
To provide for more harmonised availability of plant protection products.....
Therefore the Community should be divided into zones.....
With national adaptation allowed under certain conditions

5. Quantitative Analysis
The number of new plant protection products coming to the market every year has dropped by 70%.
The Anderson Report 2014 found that, in the next 5-7 years:
40-87 of the 250 AIs left are likely to be lost
Up to 44,000 jobs lost in the UK
36% loss in farm incomes

6. zRMS Registrations for New Formulations
ECPA Conference 2014:
Submissions Jun 11 – Dec 12
12 companies responded
177 submissions were made
58 decisions taken to date
Equal in C and S; less in N
ECPA Conference 2015:
Submissions Jun 11 – Dec 13
8 companies responded
408 submissions were made
184 decisions taken to date (45%)
Equal in C and S; less in N

7. zRMS Registrations for New Formulations
2014: Decisions by Time
Number of Pending
2015: Decisions by Time
Number of Pending

8. zRMS Registrations for New Formulations Decision Time Taken by Zone

9. Mutual Recognition Applications
ECPA Conference 2014:
Applications Jun 11 – Sep 13
12 companies responded
369 applications
177 decisions taken to date
ECPA Conference 2015:
Applications Jun 11 – Sep 14
8 companies responded
484 applications
254 decisions taken to date

10. Mutual Recognition Applications
2014: Decisions by Time
Number of Pending
2015: Decisions by Time
Number of Pending

11. Mutual Recognition Applications
Average time to decision by Zone

12. Key insights from the data
Registration of new formulations in 12 months, and the mutual reocognition of existing registrations in 4 months, can be achieved but the majority take longer
And a high percentage remain pending; many zRMS registrations for longer than 18 mths and mutual recognition for longer than 4 mths
The functioning of the Zonal and Mutual Recognition system still needs to be improved to achieve the 1107 objectives
ECPA welcome the COM Review of Zonal and Mutual Recognition
And the need for an evaluation based on facts and data
Let’s look at the functioning in the context of achieving the broader objectives

13. The Key Outstanding Issues to be Resolved
Increase resources to meet the demands of the regulation
Reduce the national requirements (technical and procedural)
Increase zonal and interzonal co-operation
Zonal Helpdesks to co-ordinate the work and improve efficiency
dRR quality
Reconsideration of Article 43

14. How to address the key outstanding issues?
Managing the timelines
Resourced, prioritised, manageable plan of work
Efficient and effective processes in place to deliver it
Managing the requirements
Clearly defined and agreed external quality standard
Change management process for the implementation of new guidance
Delivering the intentions of 1107
Progress harmonisation (technical and procedural)
Increase zonal and interzonal co-operation
Establish the helpdesks

15. Managing the Timelines – Article 43
Predicted volume of product renewal submissions in 2016:
March 31st: 1,764 submissions
28 AIR2 AIs x 9 products in 7 countries (notifier only!)
July 31st Glyphosate submissions
‘63 man years of effort’
September 30th 756 submissions
12 AIR3 AIs x 9 products in 7 countries (notifier only!)
Request for phasing from Mar 2016 – manageable for industry and MSs
And a plan to understand how the totality of the work wil be delivered with the available resources in industry, consultants and Authorities – what will the priorities be?
Evaluation of new innovative products should take priority!

16. Managing the Requirements – Article 43
First submissions for AIR2 product renewal in Mar 2016
In Mar 2015: Still no final GD for renewal
Industry welcome a pragmatic approach aimed at managing the workload
But urgently need clarity, predictability and consistency
Need an EU wide adoption and not MS specific preferences
Mandatory implementation of the guidance
MS specific preferences will create absolute chaos!

17. Renewal Guidance Rev 11 – Article 43
Key points to note in Rev 11:
Revised assessments/ further data AND address new scientific guidance ONLY for areas of assessment updated as a result of new/ changed AIR endpoints (‘new information’)
GAPs may only be amended as a result of new/changed AIR endpoints – no harmonisation or use extensions
If the applicant can justify ongoing data generation, a dRR is not included in the application at 3 months after EIF – it is provided when all data is available

18. Renewal Guidance Rev 11 – Article 43
Key uncertainties remaining:
AIR2 PR submissions to old data requirements – update to Transitional Measures GD at SCoPAFF in March?
Which dRR template to be used – clarify in GD to be noted at SCoPAFF in March?
Which GAP changes will be acceptable?
How will MR be managed in future if there is no complete dRR at PR?
How to identify what is ‘new information’ if no zonal dRR to start from?
How will the registrations be managed during the extension under Article 43(6)?
Clarity, predicatability and consistency are urgently needed

19. Managing the Requirements: dRR Quality
Key message to industry is that excellence in dossier quality will support a smooth process and assist Authorities in meeting timelines
In such a complex and uncertain regulatory environment and with long lead times to dossier production, Industry feel that they are trying to hit a moving target
Quality needs definition – content, format, structure
Expectations between MSs and with industry are not always the same – Industry need one agreed understanding of what this means
Is a working group on dossier quality needed to ensure applicants know what is needed? Is this within the remit of the dRR Workgroup?

20. Delivering the Intentions of 1107
Lack of harmonisation within and across zones (even within zRMS)
Technical national requirements including mitigation
Procedural national requirements
Inconsistency in implementation of new guidance
Use of different endpoints than those established at EU level
Creates complexity
Prevents effective work-sharing
Creates additional work for industry, zRMS and cMSs
Causes delays
Further harmonisation is needed if zonal evaluation and mutual recognition are going to work

21. Delivering the Intentions of 1107
Productivity gains will only be achieved through improved zonal and interzonal co-operation
ECPA recommend a zonal and interzonal helpdesk to support the Steering Committees with:
Facilitating the work sharing
Facilitating the ways of working
Facilitating the planning according to the resources
Facilitating harmonisation initiatives
Support efficient co-ordination between zRMSs

22. ECPA Proposal for the Way Forwards
Work together to share understanding and solve the problems
Harmonisation – technical and procedural
Manageable and consitent implementation of Article 43
Create shared external quality standards for submissions
Develop a change management process for the implementation of new guidance
Provide a resourced and prioritised plan of work
Establish the helpdesks to facilitate the process

23. For the sanity and well being of everyone!
Conclusions
Successful functioning of zonal and mutual recognition are key to achieving the broader objectives of 1107
The data shows that it can work but is not fully functioning yet
There are a number of key outstanding issues to be resolved
Industry need predictability, efficiency and consistency
For the sanity and well being of everyone!