1. PROCEDURES IN THE CENTRAL ZONE MEMBER STATE FEEDBACK - HUNGARY Gábor Tőkés National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment HUNGARY, Budapest Bruxelles 2015-03-12

2. STRUCTURE OF GROUPS South ZSC 9 MS Central ZSC 13 MS North ZSC 6 MS Inter-Zonal SC ZSC leaders + COM Post Approval Issues Group MS experts+COM Standing Comittee All MS delegates+COM

3. Meetings in Central Zone JanFebMarAprMayJunJulAugSepOctNovDec TC PMTC Director’s meeting teleconferences Personal meeting Consultation with industry (since 2014)

4. Chairs of Central Zone. Yearly rotation of chair and co-chair MS 20112012201320142015 DEUKATNLPL

5. Important documents for work Minutes of teleconferences and meetings Table of zonal applications No special zonal guidance Experts often agree but increasing role of lawyers

6. Capacity Big differences among MSs Less than necessary > 15 applications / year: AT, CZ, DE, NL, UK < 15 applications / year: BE, HU, IE, PL, SI, SK No zRMS role: RO, LU

7. Efficacy issues Central political zone involves 3 climatic zones All relevant EPPO zones should be covered Lack of evaluation causes problems for cMS If no evaluation of an EPPO region by zRMS: cMS can refuse application or Carry out evaluation during 120 days

8. Coherent and well built biodossier Trial reports dRR sec. 7 Biol. Ass. Dossier Crops must be planned in advance by applicant EPPO zones should be evaluated separately Too much tables – some text evaluation is needed Diagrams are useful BAD should contain all relevant data (applications) dRR should be understandable alone (not copy of some pages from BAD) zRMS should evaluate all relevant EPPO zones !

9. Experiences with efficacy Applicant wanted 2 x more crops in cMS than evaluated in zRMS, referring to his similar PPP in cMS – nonsense! Mutual recognition of crops that were evaluated only as minor crops in source MS but major crops in cMS – NO! Growth regulator from zRMS, with also pesticide effect, but it is not evaluated for the S-E EPPO zone – cMS authorisation only as PGR in HU till trial results arrive zRMS refused due to national efficacy GD - we intend to issue authorisation as all other sections are OK, and efficacy is good in S-E EPPO zone

10. Ecotox, fate evaluation In case of failing in a water scenario, some zRMS stops evaluation and does not continue to Step4 refinments - cMS has to evaluate Similar case with vole (Microtus arvalis) representing small herbivorous species – no refinment in evaluation means passing it to cMS Nontarget plants study only in zRMS – same problem as in efficacy, if the agroecological region of cMS was ignored Acceptability of water monitoring from zRMS – can be subject of debate

11. Coherent an standalone dRR Again occuring problem if PPP contains more active substances A.i. data are used, but PPP evaluation is not elaborated into one dRR

12. Step2 re-registration 91/414 can be followed if a.s. was evaluated according to the directive National or voluntary zonal Use/crop extension is possible zRMS can leave out efficacy for other MSs Old studies are acceptable, but is there efficacy evaluation in BAD and dRR ? Many ‘old’ step2 applications are waiting in Eastern MSs

13. Crop extension Always zonal for 1107 authorisations Legally zonal for 91/414 authorisations, but: can be national if PPP is not evaluated according to uniform principle some MSs evaluate nationally for 91/414 authorisations Via mutual recognition from a source MS is possible For MR product in cMS during MR procedure is not possible (later yes) NOT in Art 43 (new step2) process

14. Late submission of data In zRMS: acceptable for more MS max. till end of completeness check In cMS: acceptable for more MS till beginning of 120 day process Late evaluation of confirmatory data zRMS can evaluate without regarding conf. data, do not need to wait In case of change in inclusion, authorisations are modified, otherwise not

15. Clock start 12 month zRMS evaluation starts at finishing completness check (UK interpretation) 120 day cMS accepting process: when evaluation and copy of authorisation of zRM arrived to cMS. Uploading of RR is not enough. HU: 120 day starts after zRMS authorisation and application arrived

16. zRMS procedure can be suspended for max. 6 months Only once or it can be devided to 2 or more parts? When will clock start again? At information arrival, or at decision about being it correct ? Cases for clock stop: - after completeness check - after evaluation of all aspects or even only one - if waiting for MRL Clock stop under discussion

17. What is a greenhouse? For greenhouse whole EU is 1 zone Greenhose is defined as closed system Only a part of protected use can be strictly considered as ‘greenhouse’ EFSA elaborated guidance for scenarios of different type of protected cultivation In many cases zonal evaluation is needed (under discussion)

18. Conclusions Cooperation is good and well organised among MSs Many questions solved and summarised in agreement’s list Industry is involved into consultation (once/year) Experts would need a common platform Industry would need a zonal secretariat