Transcript Workshop on Evaluation and Authorisation of Plant

Evaluation and Authorisation of Plant
Protection Products in the Northern Zone
Common risk assessment of Plant
Protection Products
Crop Protection European Regulatory Conference
12 March 2015, Brussels
Vilma Kludsuveit
State Plant Service under the Ministry of Agriculture
12 March 2015, Brussels
ECPA, ECCA Regulatory Conference
State Plant Service / Lithuania
Assessment of PPP in the North Zone
Implementing EU PPP authorisation provisions:
• MS participants of the process
• Historical overview and the outcome of pilot project
• Current process. Overview and outcome
- focus on 2014
- issues considered by NZ SC
- harmonising different areas of assessment
• Concluding notes
12 March 2015, Brussels
ECPA Regulatory Conference
2
MS -participants of the zonal assessment
The 6 countries falling into the zone A- North
Annex I, Reg.1107/20090
- Denmark
-Estonia
-Finland
-Latvia
-Lithuania
-Sweden
and the two EFTA States
- Iceland
- Norway
12 March 2015, Brussels
ECPA Regulatory Conference
3
Historical overview
The outset - Pilot Project of work sharing, 2005;
Dir.91/414/EEC
• first meeting: 5 Dec. 2005 Saku , Estonia.
A primary meeting. Nordic and Baltic countries.
Evaluators updated the situation on the first 5 PPPs selected.
• 10-11 May 2006, Helsinki, Finnish Environmental Institute,
Helsinki. 42 participants, coordinators and risk assessors
• 11-12 June 2008, Riga, Latvia; 37 participants
• December 2009, Vilnius. Starting point to harmonization.
• Norway, July 2010, the need for NZ GD
• Further annual meetings hosted by different countries.
Experts and Steering Committees.
• 2014 (LT/SE) and 2015 (SE/NO)
12 March 2015, Brussels
ECPA Regulatory Conference
4
Process before Reg. 1107/2009
• zRMS/co-zRMS assessment based on Uniform Principles
• All areas of assessment covered:
- identity, properties, methods;
- toxicology and residues;
- ecotoxicology;
- fate and behavior in the environment;
- biological efficacy.
• the EU Registration report template and guidance
document applicable (Sanco/10798)
• Mini expert teams: one member from each country in
the coordinating team (SC) and expert team
12 March 2015, Brussels
Crop Protection European Regulatory Conference
5
The outcome of the pilot project
• Positive: MS expressed willingness to continue cooperation
• Sharing experiences and expertise
• Relatively harmonised approach (UP)
• Critical issues to all NZ MS identified
• Preparation for Zonal PPPs authorisation (Reg. 1107/2009)
• Possibility to further use risk assessment in all NZ MS (MR)
• NZ GD rev.0 Jan.2011 for Zonal Assessment (Reg.1107/2009)
12 March 2015, Brussels
ECPA Regulatory Conference
6
Work sharing activities in the Zone in 2014
Teleconferences and meetings
NZ Steering Committe
5 teleconferences;
2 face to face meetings (June and November)
Meeting with Industry (6 November)
in parallel:
Teleconferences and e-consultations of different areas of assessment
The outcome: NZ GD new revision (rev.3 of April 2014) based on
agreement of NZ MS.
12 March 2015, Brussels
ECPA Regulatory Conference
7
Issues considered by NZ SC in 2014 (1)
•Worksharing in the Zone: registration, re-registration of PPPs.
Coordination.
•Inter-zonal issues followed
- Art.43 and stringent deadlines
- Art. 34 provisions and assessment of PPPs
- Comparative assessment
- Negligible exposure and Endocrine disruptors
•dRR for label extensions and relavant parts of assessment
• commenting on dRRs
• mixed applications (indoor & outdoor uses)
• planning future worksharing. Priorities
• CLP GHS process in MS
• optimising PPP authorization
12 March 2015, Brussels
ECPA Regulatory Conference
8
Harmonising assessment in different areas (1)
Considerations of zonally independent assessment
Section 1. Identity and physical and chemical properties
Identity: formulation changes, equivalence, comparability of
formulations (dRR part C). Parallel trade; further procedures.
Packaging. Shelf- life.
Section 2. Residue analytical methods assessment (AII data).
General consensus towards residue methods: the methods are EU
agreed EP. Not to be re-assessed until re-approval of substance
unless this is relevant (4 criteria).
12 March 2015, Brussels
ECPA Regulatory Conference
9
Harmonising assessment in different areas(2)
Toxicology
• Consensus towards non-prefessional uses reached. Assessment of
PPPs for non-professional uses harmonised. NZ GD will be amended in
by a separate chapter (2015).
Background: Workshop in Stockholm Oct. 2013 (Tox., ecotox., fate)
Riga workshop Nov.2014;
2TCs (March 2014 & February 2015).
• New EFSA GD (23 Oct.2014) Guidance on the assessment of exposure
of operators, workers, residents and bystanders in risk assessment for
plant protection products. EFSA Journal 2014; 12(10):3874, 55pp of 23
October 2014). Submitted to Standing Committee on plants, animals,
food and feed for comments. Will be considered by NZ MS.
Possibly higher level of the EU harmonized evaluation achievable.
12 March 2015, Brussels
ECPA Regulatory Conference
10
Harmonising assessment in different areas (3)
Ecotoxicology
• New interception values for orchards and spring cereals are
relevant to NZ. They will be updated in B & M GD (Northern zone
Higher tier Risk Assessment for Birds and Mammals).
• New EFSA Guidance on tiered risk assessment for plant protection
products for aquatic organisms in edge-of-field surface waters.
Considered in NZ to amend NZ GD..
• New EFSA Guidance Document for evaluating laboratory and field
dissipation studies to obtain DegT50 values of active substances of
plant protection products and transformation products of these
active substances in soil will be considered.
• RIVM guidance (Report 601712006/2010) for summarizing and
evaluating field studies with non-target arthropods will be
considered in the NZ GD
Critical issues: refinements for birds, mammals and aquatics.
12 March 2015, Brussels
ECPA Regulatory Conference
11
Harmonising assessment in different areas(4)
Fate and behaviour
• Ongoing project of Northern Zone ground water
The aim to compare the scenarios at the EU level to the actual
soil conditions in the NZ. To find out how sensitive and
conservative they are.
Update: final stage of project- draft report circulated for
comments.
Workshop 15-16 April 2015, Copenhagen.
Project presentation to MS and industry.
12 March 2015, Brussels
ECPA Regulatory Conference
12
Harmonising assessment in different areas (5)
Efficacy assessment
Quality of dossiers is of key importance.
NZ MS apply the Guidance on requirements for efficacy data
for zonal evaluation of a plant protection product in the
Northern Zone
Version 4, July 2014
The GD was discussed during NORBARAG meetings by the
representatives of Industry and MS.
Annex 1 of the NZ GD is currently under revision
12 March 2015, Brussels
ECPA Regulatory Conference
13
Concluding Notes
• Harmonised views of MS to risk assessment and management
is the best way to ensure
not only plant health by availability of PPPs on the market
but also
the minimized risk to human and environment from PPPs.
• This is a rather challenging task.
Not only because of scientific development and new
technologies coming up but also new DR, CLP, transitional
measures and the renewal of AS taken into account.
Challenging task for the Member States.
12 March 2015, Brussels
ECPA Regulatory Conference
14
Thank you for your attention!
12 March 2015, Brussels
ECPA Regulatory Conference
15