PROCEDURES IN THE CENTRAL ZONEMEMBER STATE FEEDBACK - HUNGARY

Gábor Tőkés

National Food Chain Safety OfficeNational Food Chain Safety OfficeDirectorate of Plant Protection , Directorate of Plant Protection , Soil Conservation and Agri-environmentSoil Conservation and Agri-environment

HUNGARY, BudapestHUNGARY, Budapest

Bruxelles 2015-03-12

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

Meetings in Central Zone

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

TC TC PM TC TC TC

Director’s meeting

teleconferences

Personal meeting

Consultation with industry(since 2014)

Chairs of Central Zone

.Yearly rotation of chair and co-chair MS

2011 2012 2013 2014 2015

DE UK AT NL PL

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

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

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

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 !zRMS should evaluate all relevant EPPO zones !

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

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

Coherent an standalone dRR

• Again occuring problem if PPP contains more active substancesA.i. data are used, but PPP evaluation is not elaborated into one dRR

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

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

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

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

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 stopunder discussion

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)

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