1. Revision of Regulation 1107/2009 & Regulation 396/2005
Euros Jones
March 2014

3. Objectives Proposal to amend Regulations 1107/2009 & 396/2005
ECPA is looking to:
Highlight key areas of concern
Ask the Commission to meet its legal obligations to report and make proposals to both pieces of legislation
Start a discussion with authorities and stakeholders

4. We expect the ECPA view to evolve…
ECPA’s intention in developing this paper is to start a discussion with stakeholders and policy makers!
We expect the ECPA view to evolve…

5. Review clause dates… Regulation 1107/2009 - Article 82
By 14 December 2014, a report on the functioning of mutual recognition the division of the Community into three zones and the application of the criteria for the approval of active substances
Regulation 396/ Article 47
By 5 April 2015, a report on the implementation of the residues Regulation and any appropriate proposals
Regulation 1107/ Article 62(5)
By 14 December 2016, a report on the effects of the Regulation on data protection of tests and studies involving vertebrate animals

6. Improve the regulatory process: Key elements…
ECPA view:
There is a need for one review of Regulation 1107/2009 and Regulation 396/2005 to improve efficiency and coordination
ECPA proposes that:
A proposal to amend Article 43 is made in 2014
In 2014, an external review by consultants be initiated to provide input for a future review
A report and proposal to amend both pieces of legislation is put forward in 2015

7. Looking to improve the regulatory process
Looking at future changes
For both Reg.1107/2009 and Reg.396/2005
Suggestions in 4 phases…:
Phase 1: > Implement current framework
> Amend Article 43
Phase 2: > 2015 review: 1107/2009 & 396/2005
Phase 3: > Data protection review
Phase 4: > Long-term review

8. Improve the regulatory process: Phase 1
Implement current framework…
Zonal
Removing national requirements (inc. Efficacy data needs)
Inter-zonal cooperation
Zonal helpdesk
AS evaluation
Guidance document development
EFSA dialogue
MRL evaluation
Improve application of Article 12
One lead EMS
Clear procedure for MRL review after AS approval

9. Improve the regulatory process: Phase 1
Amend Article 43
Given the complexity of Article 43, there is a need change the legislation to make it workable
The aim must be to reduce unnecessary complexity!
The key necessary changes would be:
The 43(2) which requires a ‘full submission’ 3 months after active substance re-approval
The need for a full review after the approval of each active substance in a formulation
Amending Article 43 would require a co-decision process with Parliament and Council
We believe that a technical amendment can be carried out more quickly (with a single reading!)

10. Improve the regulatory process: Phase 2
2015 review for 1107/2009 and 396/2005
Zonal
Removal of zonal concept
AS evaluation
Replace hazard based cut-off criteria by risk assessment
Replace candidates for substitution criteria by risk assessment
Unlimited approval period for ASs
MRL evaluation
Improve MRL review process (after AS re-authorisation)
Central (on-line) evaluation system
Timelines for MRL evaluations
Remove scrutiny (or delegated act) procedure for MRL setting
Fast-track MRLs (e.g. default MRLs, minor uses)
(Include provisions on biocides and ‘Lisbon-ise’)

11. More information on: Proposal to remove zonal concept
Why is ECPA advocating removal of Zonal system?
The zonal system can only work with the removal of national requirements
Experience shows that most national requirements are not being removed
Zonal therefore becomes an extra layer when it was intended to provide simplification
Product authorisations are taking longer in many cases
If zonal system does not provide the efficiencies that were expected and promised, we should remove it!
FOOTNOTES:
The zonal system remains
> ECPA is committed to improve its functioning
Harmonisation remains the goal
> with or without zonal
The zonal system will not be removed in the short term!!
We need to continue working to improve its functioning as much as possible

12. Improve the regulatory process: Phase 3
Data protection review (1107/2009)
AS evaluation
Data call-in system for AS review
Data sharing provisions
10 years data protection
Similar to US system…

13. Improve the regulatory process: Phase 4
Long-term review (1107/2009)
AS evaluation
Single evaluation of ASs (with centralised coordination)
Evaluation of the benefits of uses/PPPs/ASs

14. ECPA’s intention in developing this paper is to start a discussion…

16. Thank you!