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How to prepare dossiers to support
demands for import of high-risk plants and
plant products Webinar
12th February 2019
Ciro Gardi – Introduction, List of pests (EFSA)
María Belén Márquez García – High Risk Plants (EC – DG SANTE)
Stefano Preti - Commodities (EFSA)
Roel Potting – Phytosanitary Mitigation Measures (EFSA WG chair)
Speakers
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HRP Dossier Webinar - guide to attendees
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Objectives of the webinar
Introduction on High Risk Plants
How to prepare a dossier
Q&A
Closure of the webinar
Webinar Outline
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Dossiers to support demands for import of high-risk plants and plant products into the European Union
High Risk Plants/1
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High Risk Plants/2
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High Risk Plants/2
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High Risk Plants/2
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High Risk Plants/3
Commission Implementing Regulation (EU) 2018/2019
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Acer L. Cornus L. Ligustrum L. Sorbus L.
Albizia Durazz. Corylus L. Lonicera L. Taxus L.
Alnus Mill. Crataegus L. Malus Mill. Tilia L.
Annona L. Diospyros L. Nerium L. Ulmus L.
Bauhinia L. Fagus L. Persea Mill.
Berberis L. Ficus carica L. Populus L.
Betula L. Fraxinus L. Prunus L.
Caesalpinia L. Hamamelis L. Quercus L.
Cassia L. Jasminum L. Robinia L.
Castanea Mill. Juglans L. Salix L.
High Risk Plants/3
Commission Implementing Regulation (EU) 2018/2019
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High Risk Plants/3
Commission Implementing Regulation (EU) 2018/2019
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High Risk Plants/3
Commission Implementing Regulation (EU) 2018/2019
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High Risk Plants/4
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High Risk Plants/4
High Risk Plants/5
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High Risk Plants/5
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Commodity Risk Assessment Procedure
Dossier
Additional information required
Commodity RA published
Third Country
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The dossier is composed of three main sections:
1) Commodity description
2) Identification of pests associated
with the commodity and description
of the relevant ones
3) Phytosanitary mitigation measures
Dossier
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Check-list
The check-list is the first part of the dossier
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(Appendix A of the Technical Report - Pages 10-11)
Commodity data
Commodity/1
Taxonomic information
Specification, depending on the commodity types
Information on the production process (period,
phenology, general sanitary status, agronomic management, area and
climate, etc.)
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(Technical Report - Pages 6-7)
Geographical specification of the production areas and Climate classification (Köppen-Geiger)
Visual description
Commodity/2
23 (Technical Report - Pages 6-7)
Identification of all pests potentially associated
with the commodity in the exporting country
Provide a comprehensive list of all the pests that can affect the commodity species/genus in the exporting country
Explain how the list was compiled
Pest List/1
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(Technical Report - Pages 7-8)
Example of Search string:
TOPIC: (Lonicera)AND TOPIC: (host plant OR pest$ OR pathogen$ OR fung* OR oomycet* OR bacteri* OR virus* OR viroid* OR insect$ OR mite$)
Databases
ISI Web of Science
CABI
Etc.
Pest List/2 – literature search
26 (Appendix B Technical Report - Pages 12-13)
An actionable pest is a pest of regulatory significance that can be associated with the considered commodity
For these pests phytosanitary mitigation measures may be specified to ensure pest freedom of import consignments
Pests of regulatory significance include: o quarantine pests listed in Annex I or II of 2000/29/EC
o other pests under official control (emergency measures; derogation)
o pests under consideration for official regulation (pending pest categorization)
Pest List/3 – actionable pest definition
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The list of pests that are regulated in the EU can be found in the Annexes I and II of the Council Directive 2000/29/EC
Pest List/4 – actionable EU regulated pests
28 (Appendix D Technical Report - Page 15)
Pest species Pest-free
area(s)
Evidence
should be
provided
Can the pest
be
associated
with the
commodity?
Evidence
should be
provided
Pest for which
phytosanitary
mitigation
measures may
be required
Pest 1 ☐ X ☐
Pest 2 X X ☐
Pest 3 ☐ X X
Pest 4 ☐ ☐ ☐
Pest 5 X ☐ ☐
Pest n ☐ ☐ ☐
List of all the pests potentially associated with the plants species or genus that are not regulated in the EU
Pest List/5 – NON regulated in the EU
29 (Appendix D Technical Report - Page 15)
Pest
species
Absent in
EU
Association
with the
commodity
Evidence
should be
provided
Evidence of
impact
Evidence
should be
provided
Pest for
which
phytosanitary
mitigation
measures
may be
required
Pest 1 X X X X
Pest 2 ☐ X X ☐
Pest 3 X ☐ ☐ ☐
Pest 5 X X ☐ ☐
Pest 6 X ☐ ☐ ☐
Pest n ☐ ☐ ☐ ☐
Summary of the pest species, present in the country, associated with the commodity and that may represent a potential risk for EU
Pest List/8 – actionable pests
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(Appendix D Technical Report - Page 17)
Taxonomic classification
Geographical distribution and pest free area(s)
Biology of the pest
Main and alternate hosts
Part of the plant where it can be found, and type of impact it can cause to the commodity
Pest risk assessment
References
Pest List/9 - actionable pests specific data
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(Technical Report - Page 8)
Data on phytosanitary mitigation measures
For each identified actionable pest:
Assessment of the overall efficacy of phytosanitary mitigation measures
Is pest freedom achieved?
Evaluation of Phytosanitary Measures
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Technical data on the efficacy of phytosanitary measures (pesticides and other measures)
Certification systems / inspections / sampling & testing
Surveillance system
Handling, packing and export procedure
Technical Data on Phytosanitary Measures/1
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For pesticide treatment provide:
estimation and evidence of efficacy against specified pests
information on officially approved label
active ingredients
application type
application time
dosage for treatment
Technical Data on Phytosanitary Measures/2
(Appendix E Technical Report - Page 18)
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For other mitigation measures provide:
estimation and evidence of efficacy against specified pests
description
protocol standards
Technical Data on Phytosanitary Measures/3
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(Appendix E Technical Report - Page 19)
Frequency and timing of surveys in surrounding environment of nurseries / production places
If the production place is situated in a Pest Free Area provide information on surveillance system in place (including maps)
Surveillance – Pest Free Area
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Overview / Calender of Measures
Technical Data on Phytosanitary Measures/4
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(Appendix E Technical Report - Page 20)
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Insecticide 1
Insecticide 2
Fungicide 1
Fungicide2
Inspection
Root Treatment
Repotting
Assessment of the overall efficacy of phytosanitary mitigation measures for each pest species with associated uncertainties, reasoning and evidences
Overall Efficacy of Phytosanitary Mitigation Measures
Pest species
Estimation of the overall efficacy of phytosanitary mitigation measures
Associated uncertainties
Justification (reasoning and evidence) for the overall efficacy
Pest 1
Pest 2
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Evaluation of Proposed Measures per Commodity/1
Pest species
RRO1 RRO2 RRO3 RRO4 RRO5 RROn Pest
Freedom
Pest 1 x x x Almost certain
Likelihood that the combination of Risk Reducing Options (RRO) cumulatively achieve pest freedom of the commodity
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Evaluation of Proposed Measures per Commodity/2
Pest species
RRO1 RRO2 RRO3 RRO4 RRO5 RROn Pest
Freedom
Pest 1 x x x Almost certain
Pest 2 x x x Extremely likely
Pest n
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Risk manager (EU Commission) will decide for which pest(s) additional measures may be required
Evaluation of Proposed Measures per Commodity/3
Pest species
RRO1 RRO2 RRO3 RRO4 RRO5 RRO6 Pest
Freedom
Pest 1 x x x Almost certain
Pest 2 x x x Extremely likely
Pest 3 x x x Likely
Pest 4 x x x Extremely likely
Pest 5 x x x Extremely likely
Pest 6 x x x Almost certain
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The applicant may indicate the information, the disclosure of which might harm the competitive position of a certain third party and which should therefore be treated as confidential.
Annex B – List of elements of the technical dossier for which confidentiality treatment is requested by the applicant (https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2018.EN-1492).
Request for Confidentiality Treatment
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The dossier will be the starting point for the Commodity Risk Assessment (CRA), therefore it should:
contain all the information and relevant evidences requested by the Technical Report
be clear and unambiguous
The CRA will be published by EFSA.
The result of the CRA will enable the EC to take a final decision on the request of export HRP into EU as defined by the article 42 of Regulation (EU) 2016/2031.
Conclusion - Take home messages
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Dossiers should be sent to the EC according the following instructions:
The dossiers should be sent to the plant health contact point
of the European Commission, Directorate General for Health and Food Safety:
All formats will be accepted
Dossier submission
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Q&A contributors:
Svetla Kozelska (EFSA - PLH)
Maria Rosaria Mannino (EFSA - PLH)
Maria Chiara Rosace (EFSA - PLH)
Nikolaus Kriz, Giuseppe Stancanelli, EFSA PLH team and CORSER Unit for the for support.
Thank to whom is behind the scenes
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Technical and Logistic support:
Francesco Amoretti
Brunilda Cullhaj
Andrea Magni
Marella Tassini
Felix Badea
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