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

2

HRP Dossier Webinar - guide to attendees

This webinar is being recorded!

The webinar is in English and questions should be submitted in English

You are automatically connected to the audio broadcast. One-way audio (listen only mode)

Q&A box: For any

questions on the topic of

the webinar

Video window

Presentation window

3

Objectives of the webinar

Introduction on High Risk Plants

How to prepare a dossier

Q&A

Closure of the webinar

Webinar Outline

4

5

Dossiers to support demands for import of high-risk plants and plant products into the European Union

High Risk Plants/1

6

High Risk Plants/2

7

High Risk Plants/2

8

High Risk Plants/2

9

High Risk Plants/3

Commission Implementing Regulation (EU) 2018/2019

10

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

11

High Risk Plants/3

Commission Implementing Regulation (EU) 2018/2019

12

High Risk Plants/3

Commission Implementing Regulation (EU) 2018/2019

13

High Risk Plants/4

14

15

High Risk Plants/4

High Risk Plants/5

16

High Risk Plants/5

17

Commodity Risk Assessment Procedure

Dossier

Additional information required

Commodity RA published

Third Country

18

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

19

Check-list

The check-list is the first part of the dossier

20

(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.)

22

(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

25

(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

27

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

30

(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

31

(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

33

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

34

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)

35

For other mitigation measures provide:

estimation and evidence of efficacy against specified pests

description

protocol standards

Technical Data on Phytosanitary Measures/3

36

(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

37

Overview / Calender of Measures

Technical Data on Phytosanitary Measures/4

38

(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

39

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

40

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

41

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

42

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

43

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

44

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:

SANTE-G1-PLANT-HEALTH@ec.europa.eu

All formats will be accepted

Dossier submission

45

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

46

Technical and Logistic support:

Francesco Amoretti

Brunilda Cullhaj

Andrea Magni

Marella Tassini

Felix Badea

Thank you for attending our webinar!

In case we did not manage to answer all your questions, please feel free to re-submit them via e-mail at:alpha@efsa.europa.eu

Please take 5 more minutes to fill out the evaluation form that you will receive shortly in your inbox. Your feedback will help us improve our service.

47