1. Lessons learned and improvement of the zonal system
Christian Prohaska Austrian Agency for Health and Food Safety (AGES) ECPA/ECCA Conference 2015, Brussels

2. - Keeping the timelines
Expectations
- One MS´s assessment on behalf of other MS - Speeding up of authorisations - Increase the level of harmonisation between MS
- Keeping the timelines 2

3. The zonal system? – Worth thinking about!3

4. Create an update of 1107/2009 would be an option
How long would that take?
Danger of making things worse than they are Focus on the existing system only… 4

5. Complaints? Expectations?
Timelines/capacities
Harmonisation (procedural and technical)
Article 40 (mutual recognition)
Article 43 (renewal of the products)
Article 51 (minor uses)
And many much more… 5

6. Capacities/timelines
Submitted and intended applications for new products (2012 – 2014)
Date: December 2014
To be considered: different structures of the authorities, number of experts, history, agriculture…. 6

7. Capacities/timelines
Keeping timelines (new applications according to 1107/2009 considered only) – e.g. AT as zRMS * 5 days – 3 months ** 25 days – 2 months
Time
Total number of authorizations (AT acting as zRMS)
On time
Delay
July 2011 – July 2012 17 3
14*
July 2012 – July 2013 11 5
6** 7

8. Capacities/timelines
It becomes more and more obvious, that every MS failed/will fail to keep the timelines
Additional workload to be considered - Comparative assessment - Article 43 applications 8

9. Capacities/timelines
Why is everybody complaining about capacities? - We are in the same situation as under Directive 91/414/EEC (number of applications, work load….)
- Hypothesis: For the new system, every MS tries/tried to keep the timelines, but…. 9

10. Capacities/timelines – solutions?
- Increase the number of experts (will not solve the problem)? - Reflect on the organisation in each MS (one body instead of several numbers of bodies) – political issue in MS!
- Process improvement (authorities; procedural and assessment) - Increase work-sharing within the zone and between zones (without complicating the system, like e.g. additional commenting phase)? - Zonal secretariat? Will not solve the issues with technical assessments! - Harmonisation! 10

11. Harmonisation - Aim
Increase the level of knowledge of experts (because of increase of scientific exchange) Increase the level of trust between MS (in order to simply rely on the zRMS´s assessment) Preconditions: Follow the agreed guidance (even if not in favour)! Harmonisation means the will for compromise! 11

12. Harmonisation – procedure/examples
Substance data – when to be used (product assessment)?
- Use of new substance data only if needed in order to show a safe use and/or flagged by the applicant as “adverse data” -> otherwise, use existing LoEPs only!
- Data gaps identified in EFSA conclusion If data gaps substantial -> no approval of the active or confirmatory information (to be dealt with at EU-level!) If not that substantial – to be assessed for renewal of the active 12

13. Harmonisation – procedure/examples
Guidance on Article 34
Composition of the PPP is comparable to the reference product (in the sense of GD on significant and non-significant change) and data are out of protection
No new studies needed – no new assessment (part A and C only!)
To be further elaborated if products are not comparable in the sense of the GD on significant and non-significant change 13

14. Harmonisation – procedure/examples
Label extensions (Article 33 applications)
If new use fall within the risk envelope approach for existing uses (even 91/414 registrations are concerned) Need to assess new studies only (e.g. residues, efficacy) No need to re-assess the existing uses and/or the existing risk assessment Every MS to follow the approach? 14

15. Harmonisation – technical issues
Harmonisation Workshops
- Toxicology (Berlin, June 2014; follow up in Vienna, June ) – interzonal - Ecotoxicology (Wageningen, June 2014; follow up in Vienna, April 2015) – central zone only - Fate and behaviour (Vienna, November 2014) – central zone only
- Risk harmonisation under BTSF? COM to consider! 15

16. Harmonisation – technical issues
Harmonisation Workshops – critical remark
- Accumulation of worst case assumptions? - Will/possibility for harmonisation? Supervising body needed: “Director´s meeting” at zonal level (established for the central zone): - Safeguard for the harmonised issues to be followed by MS - If no decision at experts level, the directors will decide 16

17. Harmonisation – technical issues
National addendum vs core assessment
Do not use national specifics in the core dRR Use EU-agreed methodology in the core dRR, e.g. Focus model for fate assessment! Harmonisation workshops needed in order to reduce und understand the national specifics 17

18. Harmonisation – technical issues
Technical GD (EFSA Guidance)
Development of GD: - All stakeholders to be taken on board (industry) - Transitional measures/periods to be considered - Feasibility/practicability of the GD for regulatory purposes to be considered
Examples: Operator exposure GD?? Guidance on dermal absorption
Note: It is still a MS/zonal issue, when to use what for product evaluation 18

19. Article 40 – Mutual recognition
Accelerated procedure (120 days for “real” 1107/2009 registrations)
Precondition: same uses and same GAPs as the reference MS
Registration not to be refused because on efficacy grounds only - Do really all MS follow? - Some MS refuse application if efficacy not assessed in the corresponding EPPO zone
Recommendation: Not to include MS in Article 33 application (cMS) – rather go for Article 40 – at least for MS who follow the rules 19

20. Article 43 – Renewal of the products
Preconditions for application according to Article 43: - GAPs remain unchanged (what if the GAP has to be changed because of new end-points?) - No new uses! - No new cMS (for which the product is new)! - No formulation change! (except: non-significant change according to GD SANCO/12638/2011) If preconditions are not fulfilled -> Article 33 application 20

21. Article 43 – Renewal of the products
MS may grant extension of the concerned authorisation until studies are made available [valid for cat 4 studies only] Cat. 4 studies are: - Studies in order to comply with new end points and time is too short to produce the studies required (e.g. mesocosm studies, residue trials; efficacy trials if necessary because of changed end points -> lowering of amount active/ha) 21

22. Article 43 – Renewal of the products
For the time being: Interpretation of Article 43(6): “reasons beyond the control of the authorisation holder” To be considered in the Guidance Document “Renewal, Withdrawal and Amendment of Authoristaion” (“sake of harmonisation”!)
For the “near” future: Change of the wording of Article 43.2 and/or Article 43.6? 22

23. Article 43 – Renewal of the products
Mixed products (containing > 1 active)
Consequently, for the individual sections only product data to be considered: - section physchem properties (Storage stability only) - section analytical methods (no need to be looked at) - section toxicology (toxicity data of the product including dermal adsorption) - section residues (no need to be looked at) - section fate (no need to be looked at) - section ecotox (e.g. bees, arthropods, earthworms, plants, aquatic organisms) - part C (composition of the product only)
Once the 2nd substance is renewed, there is no need to look at the 1st substance again 23

24. Article 51 – Minor uses Zonal system applies as well
Accelerated procedure possible (no efficacy, residue trials only*))
Grower´s associations may/should look for cooperation across the border - Identification of common minor uses in different MS - Joint generation of residue data needed
Implication of comparative assessment: Candidate products with minor uses – not to perform a comparative assessment at all - Increased motivation for application holders to increase the level of investment for minor uses *) If new use is within the risk envelope 24

25. The house is damaged, but still possible to make it worth living in!
Source: Steffi A. 25