TECHNICAL  REPORT  
 
 
APPROVED: 2 6 October 2018    
doi:10.2903/sp.efsa.2018.EN -1492     
 
 
 
www.efsa.europa.eu/publications   EFSA Supporting publication 2018:EN -1492  
 
 
 
Information required for  dossier s to support demands 
for import of high risk plants, plant products and other 
objects  as foreseen in Article 42  of Regulation (EU) 
2016/2031  
 
European Food Safety Authority (EFSA), Katharina Dehnen -Schmutz, Josep Anton Jaques 
Miret, Michael Jeger, Roel Potting, Antonia  Corini , Gabbi Simone, Svetla Kozelska, Irene 
Munoz Guajardo , Giuseppe  Stancanelli  and Ciro Gardi.  
Abstract  
Article 42 of the new  Plant Health Law ( Regulation (EU) 2016/2031 on protective measures against 
pests of plants ), introduce a concept of "high risk plants, plant products and other objects"  in relation 
to the presence of a pest risk of an unacceptable level for the Union terr itory, identified on the basis 
of a preliminary assessment to be followed by a risk assessment. Upon request of the European 
Commission (EC), the European Food Safety Authority (EFSA) defined  the information required and 
developed a format for the preparation and submission of technical dossiers from third countries to 
support demands for import of  high risk plants, plant products and other objects  as foreseen in Article 
42(5) of Regulation (EU ) 2016/2031 . The draft of this Technical Report was  circulated to the EFSA 
Scientific Network for Risk Assessment in  Plant health for commenting. The aim of this Technical  
Report is to enable the applicants to provide in the ir technical dossiers the inform ation needed by 
EFSA to perform a Commodity Risk Assessment. The information required concerns: 1) the commodity 
(characterization of product and the description of the production process); 2) the pests potentially 
associated with the commodity in the expo rting country; 3) the data on phytosanitary mitigation 
measures and inspections.  Instructions on how this information should be presented are also 
provided.  
© European Food Safety Authority, 2018 
Keywords:  commodity risk assessment, third country , European Union, plants for planting, wood, 
fruit, phytosanitary mitigation measure .  
 
Requestor:  European Commission  
Question number : EFSA-Q-2018-00116  
Correspondence:  alpha@efsa.europa.eu  
 
 
 
   
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www.efsa.europa.eu/publications  2 EFSA Supporting publication 2018:EN -1492  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Suggested citation:  European  Fo od  Safety  Authority  (EFSA), Dehnen -Schmutz  K, Jaques Miret   
JA, Jeger  M, Potting  R, Corini A, Simone G, Kozelska S, Munoz Guajardo I , Stancanelli G  and Gardi C, 
2018.  Information required for dossiers to support demands for import of high risk plants, plant 
products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031 . EFSA supporting 
publication 2018:EN -1492, 22 pp. doi:10.2903/ sp.efsa.2018. 1492 
ISSN:  2397-8325 
 
© European Food Safety Authority, 2018 
Reproduction is authorised provided the source is acknowledged.  
  
 
 
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Table of contents  
 
Abstract  ................................ ................................ ................................ ................................ .........  1 
1. Introduction  ................................ ................................ ................................ ........................  4 
1.1. Backgro und as provided by the European Commission  ................................ ..........................  4 
1.2. Terms of Reference as provided by the European Commission  ................................ ...............  4 
1.3. Interpretation of the Terms of Reference  ................................ ................................ ..............  4 
2. Data and information required to initiate High Risk Plant (HRP) Risk Assessment  ....................  5 
2.1. Confidentiality  ................................ ................................ ................................ .....................  5 
2.2. Public access  ................................ ................................ ................................ ......................  6 
3. Commodity data  ................................ ................................ ................................ .................  6 
4. Identific ation of all pests potentially associated with the commodity in the exporting country  .. 7 
5. Data on phytosanitary mitigation measur es ................................ ................................ ..........  8 
References  ................................ ................................ ................................ ................................ ..... 9 
Appendix A – Check -list of the data provided in the technical dossier  ................................ .........  10 
Appendix B – Explanatory note on literature search  ................................ ................................ ... 12 
Appendix C – Classification of plants for planting  ................................ ................................ ....... 14 
Appendix D – Steps to select pests that may require phytosanitary mitigation measures  ..............  15 
Appendix E – Evidence to support the assessment of the efficacy of phytosanitary mitigation 
measures   ................................ ................................ ................................ .........................  18 
Annex A – Member States’ comments on the draft EFSA Technical Report  ................................ .. 22 
Annex B – List of elements of the technical dossier for which confidentiality treatment is requested 
by the applicant  ................................ ................................ ................................ ................  22 
 
   
 
 
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1. Introduction  
1.1. Background as provided by the European Commission  
Regulation (EU) No 2016/20311, on the protective measures against pests of plants, will be applying 
from December 2019. Provisions within the above Regulation are in place for the listing of "high risk 
plants, plant products and other objects" (Article 42) on the basis of a preliminar y assessment, and to 
be followed by a risk assessment. A first list of "high risk plants, plant products and other objects" is 
to be adopted by end 2018. Scientific opinions are therefore needed to support the European 
Commission and the Member States in t he work connected to Article 42 of Regulation (EU) No 
2016/2031, as stipulated in the terms of reference.  
1.2. Terms of Reference as provided by the European Commission  
In view of the above and in accordance with Article 29 of Regulation (EC) No 178/20022, the 
Commission asks EFSA to provide scientific opinions in the field of plant health.  
In particular, EFSA is expected to prepare and deliver risk assessments for commodities that shall be 
listed in the relevant Implementing Acts as "High risk plants, plant pro ducts and other objects". Article 
42, paragraph 4 and 5, establishes that a risk assessment is needed as a follow -up to evaluate 
whether the commodities will remain prohibited, removed from the list and additiona l measures will 
be applied or removed from t he list without any additional measures. This task is expected to be on -
going, with a regular flow of dossiers being sent by Third Countries required for the risk assessment.  
Therefore, to facilitate the correct handling of the  technical dossiers and the a cquisition of the 
required data for the commodity risk assessment, a format for the submission of the required data for 
each technical  dossier is needed.   
In addition, the European Commission asked  EFSA to liaise with the EU Member States  (MSs)  and 
consult them on this Technical Report.  
Furthermore, a standard methodology for the performance of "commodity risk assessment" based on 
the work already done by Member States and other international organizations needs to be set.  
1.3. Interpretation of the Terms of Reference  
In January 201 8, the European Commission (EC) requested the European  Food Safety Authority 
(EFSA) to provide scientific assistance in standardizing the information requirements for technical  
dossiers  to support  demands (from third count ries) for import of high risk plants, plant products and 
other objects as specified in Regulation (EU) No 2016/2031.  
In this document EFSA specifies the information and data  to be included in the  technical  dossier s 
submitted to the European Commission by t hird country . 
With regard to the consultation with MS s, the draft of this Technical Report was circulated to the EFSA 
Scientific Network for Risk Assessment in Plant health for commenting.  The received comments and 
the EFSA replies are reported in Annex A.  
The information and data provided  by the applicant , as well further data and  information EFSA can 
search for, will be used by EFSA to perform a commodity risk assessment and to identify the pest3 
species for which phytosanitary mitigation measures may be required.  
                                                           
1 Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against 
pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European 
Parliament and of the Counc il and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 
2006/91/EC and 2007/33/EC. OJ L 317, 23.11.2016, p. 4 –104. 
2 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general 
principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in 
matters of food safe ty. OJ L 31, 1.2.2002, p. 1 –24.  
 
 
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The guidance on how to perform the commodity risk assessment  is not included in this Technical 
Report and it will be  delivered , after public consultation, in March 2019.  
2. Data a nd information required to initiate High Risk Plant (HRP) 
Risk Assessment  
The following section s of this document (from section 3 to section 5) outline the data to be provided  
in the  technical dossier submitted by applicants (third countries) to the European Commission on the 
commodity, pest lists and phytosanitary mitigation measures.  
A technical dossier for carrying out the risk assessment referred to in Article 42(4) of Regulation (EU) 
2016/2031 on the basis of a demand for import into the U nion territory  should be submitted to the 
European Commission . The European Commission shall acknowledge the reception of the technical 
dossier , examine t he completeness of the technical dossier and may ask the applicant for additional 
information or clari fications, as required by the content and the subject of that application. Where the 
European Commission concludes that those requirements are fulfilled, it shall transmit the technical 
dossier to EFSA.  
EFSA shall verify that the technical dossier complies  with the requirements of this Technical Report 
and may ask the applicant for additional information or clarifications, as required by the content and 
the subject of that application. Following that verification, EFSA shall proceed with the commodity risk 
assessment . 
For technical dossiers submitted in the English  language , EFSA shall complete the commodity risk 
assessment within a reasonable period of time . Technical dossiers submitted in another official 
language  of the European Union  will first need to b e translated into English bef ore transmission  by the 
European Commission to EFSA . 
Information should be provided to EFSA in machine readable format. The check -list as specified in 
Appendix A of this document  should be the front page of the technical  dossier.  
Without prejudice to the validity and completeness checks to be performed by EFSA, the applicant  has 
the full responsibility for the completeness, accuracy  and correctness  of the data provided to EFSA to 
perform the assessment.  In case additional information is required EFSA may contact the applicant. 
The compilation of the pest list s should be supported by a literature search (see Appendix  B for 
detailed instructions ). 
2.1. Confidentiality  
The legal framework applicable to EFSA pre scribes a high level of transparency as well as the 
possibility for an applicant to have commercially sensitive information protected insofar as recognised 
as confidential by EFSA or the European Commission. Award of confidential status implies that in 
principle this information is not to be disclosed to the public or with a third party. Information deemed 
to deserve confidential status by EFSA may however be shared with Member States ’ authorities or the 
European Commission, or chartered auditors.  
The appl icant 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.  
Requests for confidential treatment should be processed in line with informatio n provided in Annex B 
of this guidance . Applicants should strive to keep confidentiality claims to a minimum, indicate the 
elements, bits of data, paragraph or pages claimed confidential and provide verifiable and specific 
justification for each request. W hen entire pages are claimed confidential, confidential pages of a 
                                                                                                                                                                                     
3 According to ISPM n. 5 ( (FAO, 2018b) pest is defined as “Any species, strain or biotype of plant, animal or 
pathogenic agent injurious to plants or plant products.”  
   
 
 
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document, in a limited numbe r, they should bear a watermark reading ‘CONFIDENTIAL’. If the name 
of an author is claimed as confidential, it should not be included in the file name and citation.  
A list containing all the personal  data to be treated as confidential should be included i n the technical  
dossier  in order to facilitate sanitisation by EFSA at a later stage.  
By no means, information for which the claim of confidential ity has been accepted and awarded  
should be part of the public access version of the technical  dossier . 
When s ubmitting additional information, the accompanying cover letter should always indicate 
whether such additional information contains confidential information, and provide the necessary 
verifiable justification supporting the request.  
Applicants should be aw are that submission of a confidentiality claim or request does not ensure 
acceptance and award of confidential status.  
2.2.  Public access  
In providing the supporting information, the applicant should take into account that all the information 
provided would p otentially be made publicly available by EFSA as background documents to the EFSA 
Scientific Report, or disclosed in case a request under Regulation EC No 1049/20014, unless the 
applicant can justify confidentiality in the data provided.  
In accordance with  Article 38 of Regulation (EC) No 178/2002, EFSA’s opinions as well as background 
information on which opinions are based , excluding confidential information, shall be made accessible 
to the public.  According to the same provision,  all documents held by EFSA are subject to Regulation 
(EC) No 1049/2001 on public access to documents held by EU institutions . Further, environmental 
information held by EFSA is subject to Regulation (EC) No 1367/20065 on the application of the 
provisions of the Aarhus Convention on Access to Information, Public Participation in Decision -making 
and Access to Justice in Environmental Matters to Community institutions and bodies . 
As a consequence, EFSA may be requested by any citizen and any natural and legal person residing or 
havin g its registered office in a Member State of the European Union to grant access to documents 
submitted in the frame of applications in accordance with the principles, exceptions, conditions and 
limits laid down in Regulation (EC) No 1049/2001  and Regulatio n (EC) No 1367/2006 . The general 
principle set out in the above Regulation is that all documents held by EU institutions by default are 
accessible, unless one or more of the exceptions set out in Article 4 of Regulation (EC) No 1049/2001 
apply.  
In case of  third parties’ documents and in accordance with Article 4(4) of the aforementioned 
Regulation , EFSA consults the third parties concerned with a view to assessing whether an exception 
to disclosure is applicable , unless it is clear that the document shall or shall not be disclosed.  
EFSA’s decisions under these Regulations may be challenged before the General Court of the 
European Union at the conditions set out under Article 263 Treaty on the Functioning of the European 
Union.  
3. Commodity data  
To perform a c ommodity risk assessment, detailed information is required for those plants, plant 
products and other objects classified as high risk  within the meaning of Article 42 of Regulation (EU) 
2016/2031 . Information must be provided , in the technical dossier subm itted by a third country, plant 
species, commodity type and production methods and areas, as follows:  
                                                           
4 Regulation (EC) No  1049/2001 of the European Parliame nt and of the Council of 30 May 2001 regarding public access to 
European Parliament, Council and Commission documents. OJ L 145, 31.5.2001, p. 43 –48. 
5 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the ap plication of the 
provisions of the Aarhus Convention on Access to Information, Public Participation in Decision -making and Access to Justice in 
Environmental Matters to Community institutions and bodies, OJ L 264, 25.9.2006, p. 13 –19.  
 
 
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3.1 Provide scientific name (genus and species), synonyms and if applicable, common name(s) in 
English, and relevant taxonomic classification, including culti var or variety if applicable, of the 
plant (product) to be imported into the EU.  
3.2 In case of plants for planting (including seeds) indicate the type and age of plants and the 
growing conditions, as defined in Annex 1 of ISPM 36 (FAO, 201 2) (reported in App endix C of 
this document).  Specify crop, cultivar description of the products or by -products of plant 
origin to be imported into the EU. Describe the growing media used in production and at the 
moment of export according to ISPM 40  (FAO, 201 7a). 
3.3 If applicable, indicate whether the plant is grown from certified seeds and/or in a certified 
nursery. In the case of seeds, specify the type of certification in relation to the absence of the 
pest(s).  
3.4 In the case of fruit or vegetables, describe the part/s o f the plant, as well as the presentation 
(i.e. the presence of leaves, sepals, or fruit on the vine, etc.).  
3.5 In the case of wood, describe the type of wood according to ISPM 39  (FAO, 2017b)  (i.e. 
commodity’s type, level of processing, presence/absence of b ark, etc.)  
3.6 In the case of other commodities provide detailed descriptions.  
3.7 Indicate the period of the year when the commodity is produced and the phenology of the 
crop (including sowing/planting, flowering, fruiting and harvesting periods).  
3.8 Describe the general sanitary status and phytosanitary management of the crop in the 
production area designated for export. If there are differences with other production areas 
within the country, describe these differences and the reasons for them.  
3.9 Indicate the intend ed use of the commodity (i.e., direct distribution to final consumers, 
repacking for consumption, propagation, milling, transformation, etc.).  
3.10 Include a map of the exporting country highlighting the production areas and the production 
areas designated for export.  
3.11 Indicate how you ensure separation between production areas designated for export and 
other production areas, if adjacent to the first ones.  
3.12 Provide the Köppen -Geiger  climate classification (sub -group level) relevant for the production 
areas (http ://koeppen -geiger.vu -wien.ac.at/)  
3.13 Attach colour pictures with a brief description of the commodity intended to be exported into 
EU and of the main stages/steps of production, handling and shipping processes.  
4. Identification  of all pests potentially associa ted with  the 
commodity  in the exporting country  
The applicant should provide  lists of all pests potentially associated with the commodity in the 
exporting country  and provide the requested information  as indicated below . The compilation of the se 
pest list s by the applicant  should be supported by a documented literature search  (see Appendix B).  
4.1 List all the pests potentially associated with the plants species or genus of the commodity in 
the exporting country  supported by evidence (Appendix B). 
4.2 List all the pests potentially associated with  the plants species or genus of  the commodity in 
the exporting country  that are EU regulated and provide information as indicated in Table D1 
(Appendix D).  
4.3 List all the pests potentially associated with the plants species or genus of the commodity in 
the exporting country  that are not regulated  in the EU , and for these pests provide 
information as indicated in Table D2 (Appendix D).  
  
 
 
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4.4 For each pest listed in  the summary  Table D3 (see Appendix D)  submit th e following 
information (substantiate this information with the appropriate references, which should be 
provided together with the technical  dossier):  
4.4.1  Scientific name , synonyms  and if applicable, common name(s) in English .  
4.4.2  Taxonomic classification, includ ing at least class, order, family, genus, species and 
information below species level if relevant (e.g. sub -species, pathovar, etc.) . 
4.4.3  Geographical distribution of the pest in the country, providing if applicable , pest 
distributions/pest free areas maps for each pest, considering map provided under 
3.10 as background layer.  
4.4.4  Prevalence of the pest during the season (e.g. percentage of infested plant s/fruit 
during the different phenological stages indicated in paragraph 3. 7). 
4.4.5  Relevant biolog ical chara cteristics (i.e., life cycle, association with the pathway, 
thermal requirements) of the pest .  
4.4.6  Main hosts of the pest, including alternate hosts if relevant . 
4.4.7  In the case of arthropods and nematodes, for each stage (e.g., egg, 
larva/nymph, pupa, adult), in dicate the part of the plant where it can be found, 
describe the type of damage. Provide information whether any latent phase or 
asymptomatic infestation/infection stages are known for the pest species. 
Indicate also if the arthropod/nematode can be vector  of plant disease.  
4.4.8  In the case of fungi, bacteria, viruses, phytoplasmas, describe the symptom(s) in 
the commodity and the part of the plant where it can be found, describe the type 
of damage. Provide information whether any latent phase or asymptomatic 
infestation/infection stages are known for the pest species.  
4.4.9  In the case of any other living organism (e.g. parasitic plants), describe their 
association with the commodity.  
4.4.10  Indicate the impact caused by the pest  on the commodity and /or relevant hosts 
other than the commodity.   
4.4.11  If available provide pest risk assessment(s) .  
Please note that t he applicant is invited to submit any additional information or evidence that is 
considered useful in supporting the risk assessment  (e.g. list of all pests known to use the plant 
species or genus of the commodity as hosts at the global level, records of interceptions  on the 
exported commodity , etc.) .  
Please also note that EFSA reserves the right to request the information referred to in points from 
4.4.1 to 4. 4.11 an d in section 5 , also for other pests than those listed in Table D3 (e.g,. other pests 
isted in Table D1 and/or Table D2 or other pests found by EFSA in its review ).  
5. Data on phytosanitary mitigation measures  
5.1 Describe phytosanitary mitigation measures  (including the ones intended to be applied when 
exporting the commodity into  the EU) of the commodity and their effectiveness , supported by 
evidences (i.e. probit 9, average survival time, etc.)  following Appendix E.  
5.2 Indicate phytosanitary regulations and ins pection systems related to the crop of interest or 
associated quarantine  pests in the country of origin .  
5.3 Describe surveillance and monitoring systems of the pests associated with the commodity as 
detailed as possible (e.g. sampling and inspection strategi es, frequencies, intensities, 
diagnostic protocols, etc.) . 
5.4 Indicate volume , frequencies and seasonal timing planned for export to the  EU.  
 
 
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5.5 Describe  the post-harvest processes and transport system  (from farm to processing  and from 
processing to point of expo rt), including type of pack aging material, size of packaging, 
shipping capacity. Likewise, indicate temperature and relative humidity of the containers, if 
applicable.  
 
References  
CABI, online.  Crop Protection Compendium . Available online : https://www.cabi.org/cpc/  
EFSA PLH Panel (EFSA Panel on Plant Health), 2012. Guidance on methodology for evaluation of the 
effectiveness of options for reducing the risk of introduction and spread of organisms harmful to 
plant health in the EU territory.  EFSA Journal 2012;10(6):2755, 92 pp. 
https://doi.org/10.2903/j.efsa.2012.2755  
EFSA PLH Panel (EFSA Panel on Plant Health), Jeger M, Bragard C, Caffier D, Candresse T, 
Chatzivassiliou E, Dehnen -Schm utz K, Gregoire J -C, Jaques Miret JA, MacLeod A, Navarro MN, 
Niere B, Parnell S, Potting R, Rafoss T, Rossi V, Urek G, Van Bruggen A, Van der Werf W, West J, 
Winter S, Hart A, Schans J, Schrader G, Kozelska S, Mosbach -Schultz O, Vos S and Gilioli G, 2018. 
Guidance on quantitative pest risk assessment. EFSA Journal 2018; 16(8):5350, 86 pp. 
https://doi.org/10.2903/j.efsa.2018.5350  
EPPO, online. EPPO Global Database . Available online : https://gd.eppo.int  
FAO (Food and Agriculture Organization of the United Nat ions), 201 2. ISPM (International standards 
for phytosanitary measures) 36  — Integrated measures for plants for planting. 22 pp. Available 
online: https:// www.ippc.int/en/publications/636/  
FAO (Foo d and Agriculture Organization of the United Nations), 2017a. ISPM (International Standards 
for Phytosanitary Measures) 40 — International movement of growing media in association with 
plants for planting. 18 pp. Available online: https://www.ippc.int/en/p ublications/84342/  
FAO (Food and Agriculture Organization of the United Nations), 2017 b. ISPM (International Standards 
for Phytosanitary Measures) 39 — International movement of wood. 18 pp. Available online: 
https://www.ippc.int/en/publications/84341/  
FAO (Food and Agriculture Organization of the United Nations), 2017c. ISPM (International standards 
for phytosanitary measures) 8 — Determination of pest status in an area. 16 pp. Available online: 
https://www.ippc.int/en/publications/612/  
FAO (Food and Agriculture Organization of the United Nations), 2017 d. ISPM (International standards 
for phytosanitary measures) 4 — Requirements for the establi shment of pest free areas. 12 pp. 
Available online: https://www.ippc.int/en/publications/614/   
FAO (Food and Agriculture Organization of the United Nations), 2018 a. ISPM (International standards 
for phytosanitary measures) 15 — Regulation of wood packaging material in international trade. 21 
pp. Available online: https://www.ippc.int/en/publications/640/  
FAO (F ood and Agriculture Organization of the United Nations), 2018 b. ISPM (International standards 
for phytosanitary measures) 5 — Glossary of phytosanitary terms . 35 pp. Available online: 
https://www.ippc.int/en/publications/6 22/ 
Glanville J, Varley D, Brazier  H, Arber M, Wood H and Dooley G, 2014. Inventory of sources of 
scientific evidence relevant to EFSA‘s risk assessments and information sessions on literature 
searching techniques (CFT/EFSA/SAS/2011/03 Inventory Report). EFSA Supporting Publications, 
11, 1–73. Supporting information, Glanville J, Wood H, Arber M, Varley D, Frampton G and Brazier 
H. Technical manual for performing electronic literature searches in food and feed safety . Available 
online:  efs3593e -sup-0001-SupInfo.pdf  
   
 
 
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Appendix A – Check -list of the data provided in the technical  
dossier  
This check -list should be the front page of the technical  dossier. The column in blue should be filled 
by EFSA.  
  
Provided  Not 
provided  EFSA 
agrees  EFSA 
comments  
3 COMMODITY DATA  
3.1 Taxonomic information  ☐ ☐ ☐  
3.2 Plants for planting specification (ISPM 36  – FAO, 2012 ) ☐ ☐ ☐  
3.3 Seeds specification  ☐ ☐ ☐  
3.4 Fruit and vegetable specification  ☐ ☐ ☐  
3.5 Wood specification  ☐ ☐ ☐  
3.6 Other commodities specification  ☐ ☐ ☐  
3.7 Production period  ☐ ☐ ☐  
3.8  Phytosanitary status and management  ☐ ☐ ☐  
3.9 Intended use  ☐ ☐ ☐  
3.10 Production area  ☐ ☐ ☐  
3.11 Separation of production areas      
3.12 Climatic classification  ☐ ☐ ☐  
3.13 Pictures and description  ☐ ☐ ☐  
     
4 PESTS LIST  
4.1 List of all the pests potentially associated with the 
commodity plant species or genus in the exporting country  ☐ ☐ ☐  
4.2 List of EU regulated pests (Table D1) ☐ ☐ ☐  
4.3 List of non -regulated pests (Table D2) ☐ ☐ ☐  
4.4 Summary table of relevant pests associated with the 
commodity (Table D3) ☐ ☐ ☐  
Details of the  literature search  according to Appendix B  ☐ ☐ ☐  
OPTIONAL - Additional information or evidence ( e ☐ ☐ ☐  
     
Data for each pest  of Table D3  
4.4.1 Scientific name  ☐ ☐ ☐  
4.4.2 Taxonomic classification  ☐ ☐ ☐  
4.4.3 Geographical distribution  ☐ ☐ ☐  
4.4.4 Prevalence of the pest during the season  ☐ ☐ ☐  
4.4.5 Biology of the pest  ☐ ☐ ☐  
4.4.6 Main hosts      
4.4.7 Arthropods and nematodes description  ☐ ☐ ☐  
4.4.8 Pathogens description  ☐ ☐ ☐  
4.4.9 Other living organisms description  ☐ ☐ ☐  
4.4.10 Impact of the pest  ☐ ☐ ☐  
4.4.11 Information from other pest risk assessment(s)  ☐ ☐ ☐  
 ☐ ☐ ☐  
5 DATA ON PHYTOSANITARY MITIGATION MEASURES  
5.1 Description of phytosanitary mitigation measures  ☐ ☐ ☐  
5.2 Description of phytosanitary regulations  ☐ ☐ ☐  
5.3 Description of surveillance and monitoring  ☐ ☐ ☐  
5.4 Trade volumes and frequencies  ☐ ☐ ☐  
5.5 Description  of post -harvest procedures  
 ☐ ☐ ☐  
Appendix  E tables       
 
 
Information required for dossiers to support demands for import of high risk plants  
 
 
 
 
 
 
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Table E1  - Details of pesticide treatment  ☐ ☐ ☐  
Table E2  - Details of other treatments/measures  ☐ ☐ ☐  
Table E3  - Calendar including relevant crop phenology 
data, pest presence in the crop and timing of treatment  ☐ ☐ ☐  
Table E4 - Assessment of the overall efficacy of 
phytosanitary mitigation measures  ☐ ☐ ☐  
 
   
 
 
Information required for dossiers to support demands for import of high risk plants  
 
 
 
 
 
 
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Appendix B – Explanatory note on  literature search   
A literature search involves the development of a search strategy and the identification of information 
sources to retrieve relevant information. The appropriate sources of information should be searched in 
a structur ed manner , and the search strategies and information sources used should be documented 
and reported.  
Sources of information  
Applicants should make reasonable efforts to locate all the sources that yield relevant information, and 
provide the rationale behind the selection of the sources.  
The search should consider sources of scientific, technical and grey literature. Bibliographic databases, 
repositories, websites of organizations, websites of conferences, tables of contents of specific jour nals, 
etc. might be used in order to retrieve journal articles, books, reports, conference abstracts, 
datasheets, maps, and other types of information relevant to build the list of pest associated to the 
commodity in the exporting country.  
Sources of infor mation with a broader coverage (e.g. Web of Science, CAB Abstracts) may need to be 
supplemented with sources published in the specific geographic region relevant for the applicant.  
Developing search strategies  
Applicants shall design and develop appropriat e search strategies (i.e. search terms and their 
combinations). The search strategies should be designed to be sensitive in order to retrieve as much 
potentially relevant information as possible.  This usually involves using as many synonyms and 
related te rms as useful  to represent a concept (e.g. scientific name, and common names of a 
commodity) and combining free -text with controlled vocabulary when available. The combination of 
the terms using proximity or Boolean operators (when available) should be als o designed to maximize 
the retrieval of relevant information.  
The search strategies should be also adapted to the characteristics, and requirements of each source 
of information. The adaptation might include, among others, the search syntax or the languag e used 
for the search terms.  
Applicants should follow the recommendations of the “Technical Manual for Performing Electronic 
Literature Searches in Food and Feed Safety ” (Glanville et al., 2014)  when performing the searches 
and documenting its outcome.   
 
Reporting the search  in the technical dossier submitted by third countries  
In order to promote transpare ncy and allow the evaluation and replication of the process, the search 
methodology and its results must be documented and reported in detail.  
For database searches, the following information should be reported for each result:  
- The name of the database and  the service provider used;  
- The URL of the database (internet address);  
- The justification for choosing the database:  
- The date on which the search was conducted;  
- The date of  the most recent update of the bibliographic database (when available);  
- The date sp an of the search;  
- Any limits applied to the search (e.g. publication types)  
- The complete search strategy or strategies used (as run in the database), and the number of 
results retrieved.  
For resources other than databases , the following information should  be reported for each result :  
 
 
Information required for dossiers to support demands for import of high risk plants  
 
 
 
 
 
 
www.efsa.europa.eu/publications  13 EFSA Supporting publication 2018:EN -1492  
 
a) For w ebsites or tables of contents of journals : 
- The name of the resource (i.e. website name, journal name in case of searching in a specific 
table of content).  
- The URL of the resource (internet address);  
- The justification for choosing the website or journal:  
- The date on which the search was conducted, and the date rage of the search, or the dates, 
volumes and issues searched in the case of table of contents.  
- The method of searching (e.g. browsing, using the search engine in cluded in the website, 
scanning in the case of tables of contents).  
- The search terms used to search, and the number of relevant records retrieved.  
b) For reference lists :  
-  The bibliographic details of the documents whose reference lists were scanned;  
-  The number of relevant bibliographic references retrieved.  
 
Reporting the results of the search  in the technical dossier submitted by third countries  
A full list of references retrieved from the literature search as well as a list of references used to 
develop the technical dossier should be provided in English  and in machine readable format . 
Copies of the full -text documents (or relevant sections of la rge documents) used for developing the 
technical  dossier should be provided preferably in English; however, full -text documents (or relevant 
sections of large documents) used for developing the  technical  dossier in other official EU languages 
would also be  accepted. Documents in non -EU languages should be translated preferably into English , 
or in other  official language of the EU , before submission to  the European Commission .   
Copies of the full -text documents not used for developing the technical dossier  do not  need to be 
submitted with the technical  dossier. However, the applicants should be prepared to provide them  
later if requested by EFSA.   
Ensuring that  copyright, licensing and data protection issues concerning the information included in 
the technical  dossiers  have been fully satisfied remains the responsibility of the applicant. The 
applicant should consult  the competent  national copyright licensing authority (ies) for guidance on 
purchasing copyright licenses to reproduce  copyright publicatio ns which must be submitted within the 
technical dossier . It should be  noted that the applicant  remain s the sole legal or natural person  
responsible and liable for obtaining all  necessary authorisations and rights to use, reproduce and 
share the publication s submitted in their  applications. Under no circumstances may EFSA be kept 
accountable for breaches of intellectual property rights infringed by applicants by including  the 
relevant datasets or information in the technical dossier . 
 
 
 
 
 
 
  
 
 
Information required for dossiers to support demands for import of high risk plants  
 
 
 
 
 
 
www.efsa.europa.eu/publications  14 EFSA Supporting publication 2018:EN -1492  
 
Appendix C – Classification of  plants for planting  
 
In Annex 1 of ISPM 36  (FAO, 2012)  nine types of plants for planting (excluding seeds) are 
distinguished ranked from lowest to highest pest risk:  
1. meristem tissue culture  
2. in vitro culture  
3. budwood/graftwood  
4. unrooted cuttings  
5. rooted cutt ings 
6. root fragments, root cuttings, rootlets or rhizomes  
7. bulbs and tubers  
8. bare root plants  
9. rooted plants in pots  
Furthermore, pest risk may increase with plant age, as older plants have been exposed to potential 
pests for longer.  
Examples of growing condit ions ranked from lowest to highest pest risk:  
1. growth chamber  
2. greenhouse  
3. screen house  
4. field grown in containers (pots, tubs etc.)  
5. field grown  
6. plants collected from the wild   Information required for dossiers to support demands for import of high risk plants  
 
 
 
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Appendix D – Steps to select pests that may require phytosanitary mitigation measures  
The sequence of steps described below should be supported by a literature search ( Appendix B ).  
1. List in the Table D1 the pests that are EU regulated and known to use the plant species or genus of the commodity as host6 (e.g., using the CABI , 
online, EPPO online) , providing the following information for each pest:     
 Pest species  (Latin name)  
 Taxonomic information  (class, order, family)  (e.g. in case of  Thaumatotibia leucotreta : Insecta, Lepidoptera, Tortricidae)  
 Provide a pest status  statement, for example referring to ISPM 8 (FAO, 2017c) and supported by the appropriate evidence  
 If applicable, provide evidence  for pest free area  according to ISPM 4  (FAO, 2017d)  
 Indicate the regulatory status  of the pest in your country. E.g. regulated quarantine pests, regulated non -quarantine pests, pests 
considered for official control, pests that require evaluation for regul atory action as well as common non -regulated pests.  
 Can the pest be associated with the commodity (irrespective of any treatment)?:  Applicant should provide  evidence if the pest 
can or cannot be associated with the commodity  
 Identify pests that may need phytosanitary mitigation measures : present in the country as well as clarify whether pest is associated 
with the commodity (copy these species to Table D3) 
 
Table D1 – List of EU regulated pests , present in the applicant third c ountry  and known to use the plant species or genus of the commodity as host  
 
Pest 
species  Taxonomic 
information  Pest 
status  in 
the 
applicant 
third 
country  Pest free 
area(s)  Evidence 
and 
uncertainty 
on 
pest status 
and pest 
free area(s)  Regulatory 
status in 
the 
applicant 
third 
country   Can the 
pest be 
associated 
with the 
commodity?  
 Evidence and 
uncertainty on 
association with the 
commodity  Pest for which 
phytosanitary 
mitigation measures 
may be required  
      ☐  ☐ 
      ☐  ☐ 
      ☐  ☐ 
      ☐  ☐ 
      ☐  ☐ 
 
 
                                                           
6 The list of pest as sociated with the commodity in your country should be obtained and documented by a literature search (see Appendix D).   Information required for dossiers to support demands for import of high risk plants  
 
 
 
www.efsa.europa.eu/publications  16 EFSA Supporting publication 2018:EN -1492  
 
2. List in Table D2 all the other pests present in your countr y associated with the plants species or genus of the commodity  (exclud ing the pest s already 
listed in Table D1) , according to T able D2 and provide the information  indicated below.  The list of pests associated with the commodity in your 
country should be obtained and documented by a literature search conducted following the Appendix B including search of scien tific and grey 
literature and international database as e.g., EPPO , online  and CABI , online. 
 
 Pest species  (Latin name)  
 Taxonomic information  (class, order, family)  (e.g. in case of  Thaumatotibia leucotreta : Insecta, Lepidoptera, Tortricidae)  
 Status in the EU : Absent (A), Restricted distribution under official control (R), Present (P).  Check and provide evidence (e.g. EPPO , online , 
CABI, online  data bases)  
 If applicable, provide evidence for pest free area  
 Indicate  the regulatory status  of the pest in your country  
 Can the pest be associated with the commodity (irrespective of any treatment) ?:  check and provide evidence  
 Does the pest have impact in your country ?: check and provide evidence  on the level of impact7 
 Pest of potential risk for EU  - pests that fulfil the following criteria: it is absent in EU  or it has restricted distr ibution under official control  + 
the pest is associated with the commodity  + it has or can have  potential  impact  (copy these species to T able D3) 
 
Table D2 – List of pests not regulated in the EU ,  present in the applicant third country  and known to use the plant species or genus of the 
commodity as host  
Pest 
species  Taxonomic 
information  Status
in EU Pest free 
area(s)  Evidence 
and 
uncertainty 
on 
pest status  
and pest 
free area(s)  Regulatory 
status in 
applicant 
third 
country  Can the pest 
be associated 
with the 
commodity?  
 Evidence 
uncertainty 
on 
association 
with the 
commodity  Does the 
pest have 
impact in 
applicant 
third 
country  Evidence 
and 
uncertainty 
on the level 
of impact5 Pest of 
potential risk 
for EU  
      ☐  ☐  ☐ 
      ☐  ☐  ☐ 
      ☐  ☐  ☐ 
      ☐  ☐  ☐ 
 
 
 
                                                           
7 If the pest has an impact in your country please describe the impact and the symptoms and provide reference; if you consider the pest d oes not have an impact in your 
country please explain why and provide reference if available.   Information required for dossiers to support demands for import of high risk plants  
 
 
 
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Table D3 – Summary table of pest specie s, present in the applicant third c ountry ,  associated with  the commodity and that m ay have a potential risk 
for EU for which technical data will be requested in Appendix E.  
For the pest species associated to the commodity and that may have a potential risk for EU  (selected from tables D1 and D2) .provide the following 
information:  
 
 Pest species  (Latin name)  
 Regulated pest in EU: indicate if the pest is a quarantine pest in the  EU according to the current plant health legislation8. 
 
Pest species associated with the commodity  Regulated pests in EU  
 ☐ 
 ☐ 
 ☐ 
 ☐ 
 ☐ 
 
For each of the pests in Table D3 provide the data indicated in point 4. 4 of this document.  
                                                           
8 Consult the latest legislation current at the moment of the application.   Information required for dossiers to support demands for import of high risk plants  
 
 
 
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Appendix E – Evidence to support the assessment of the efficacy of phytosanitary mitigation measures  
 
Applicant should provide, using Tables E1 and E2, the technical data supporting the evaluation of the efficacy of the phytosanitary mitigation measures  for each 
of the pest s listed in Table D3 . Please provide, using Table E3 as template  (this template may need to be adapted for different commodities) , a calendar where 
pest presence and mitigation measu re/s are presented.  It is essential that the estimation of efficacy provided by the applicant is s upport ed by scientific and 
technical evidence (i.e., probit 9, average survival time, etc.) . 
Then use T able E4 for summarising the overall efficacy for each o f the pest s listed  in Table D3, emphasizing the likelihood of pest -freedom of the commodity 
and its associated uncertainties . Include a clear justification  and provide supporting evidence where appropriate . 
 
Table E1 - Details of pesticide treatment  
 
 
  
                                                           
9 Indicate month and production phase (pre -harvest, harvest, post -harvest); provide a calendar where pest presence and treatment/s are presented (see Table E3). 
10 Specify if the dose refers to the active substance or to the commercial product.  
11 Provide the specific value for efficacy of the pesticide treatment to control the target plant species on the commodity if available, or indicate at least one of the following 
classes adapted from Table 2 of EFSA 2017: Extremely high (>95%), Very high(90 –95%), High (6 6–90%), Medium (33 –66%), Low (10 –33%), Very low (5 –10%), Extremely low 
(<5%).  
12 Please list here the evidence supporting the estimation of efficacy provided by the applicant:e.g., Plant Protection Products  labels, papers, technical reports, experimental 
data, grey literature, etc. Copy of such evidence should also be provided as attachment to the technical dossier.  For more details on the required information and evaluation 
of phytosanitary mitigation measures see EFSA PLH Panel, 2012.  Pesticid e/s 
used (active 
substance /s) Scientific 
name of the 
target pest 
species  Targeted 
life stage 
of the 
pests Timing of 
the 
treatment9  Dose in kg/ha 
used for each 
treatment10 Use the information 
reported in the officially 
approved label  Restrictions 
if any Estimation  
of efficacy11 
 Evidence  for 
the efficacy12 
      Application type  
 Application time  
 Time period for which 
a treatment remains 
effective  
 Life stages affected     
           Information required for dossiers to support demands for import of high risk plants  
 
 
 
www.efsa.europa.eu/publications  19 EFSA Supporting publication 2018:EN -1492  
 
Table E2  - Details of other mitigation measures  (other than pesticides)  
 
 
 
 
 
 
 
 
 
 
  
                                                           
13 Refer to the check -list of Risk Reducing Options (EFSA PLH Panel, 2018)  
14 Indicate month and production phase (pre -harvest, harvest, post -harvest); provide a calendar where pest presence and treatment/s are presented (see Table E3). 
15 Provide the specific value for efficacy of the measure to control the target pest species on the commodity if available, or i ndicate at least one of the following classes 
adapted from Table 2 of EFSA 2017: Extremely high (>95%), Very high(90 –95%), High (6 6–90%), Medium (33 –66%), Low (10 –33%), Very low (5–10%), Extremely  low (<5%).  
16 Please list here the evidence supporting the estimation of efficacy provided by the applicant:  e.g., Plant Protection Produc ts labels, papers, technical reports, experimental 
data, grey literature, etc. Copy of such evidence should also be provided as attachment to the technical dossier . For more details on the required information and evaluation 
of phytosanitary mitigation measures see EFSA PLH Panel, 2012.  Measures  used13  
 
 Scientific n ame 
of the target 
pest species  Targeted life 
stage of the 
pests Timing of 
the 
treatment
14  Details on 
the measure 
used Reference to 
a protocol 
standards  Restrictions 
if any  Estimation  
of efficacy15 Evidence  
for the 
efficacy 16 
    e.g. 
temperature  e.g. ISPM 
15 (FAO, 
2018a)    
          
           Information required for dossiers to support demands for import of high risk plants  
 
 
 
www.efsa.europa.eu/publications  20 EFSA Supporting publication 2018:EN -1492  
 
Table E3  - Example of a calendar including relevant crop phenology data, pest presence in the crop  and timing of treatment  
 
 
 
 
Jan 
Feb 
Mar 
Apr 
May 
Jun 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
Crop phenology    B l o o m     Mature fruit    
Presence of target stage  A     d     u     l     t     s  
       E g      
       L a     
u        P  u  p  a  e  
 
 
Treatments        Mass trapping     
S t e r i l e      I  n s e c t      T e c h n i q u e  
      Pesticide X     
C u l t u r a l / B i o l o g i c a l     c o n t r o l  :   c o v e r     c r o p s  
Sanitation        Sanitation  
 
 
 
   Information required for dossiers to support demands for import of high risk plants  
 
 
 
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Table E4 - Assessment of the overall efficacy of phytosanitary mitigation measures  (combination of pesticide and non -pesticide measures) . 
 
 
 
 
 
                                                           
17 Provide for each pest associated with the commodity a specific estimation of the overall efficacy of the phytosanitary mitigation measure appl ied, if available, or indicate at 
least one  of the following classes ad apted from Table 2 of EFSA 2017: Extremely high (>95%), Ver y high(90 –95%), High (66 –90%), Medium (33 –66%), Low (10 –33%), Very low 
(5–10%), Extremely low (<5%).   
18 Please summarise here the evidence and reasoning supporting  the  estimation of efficacy provided by the applicant :e.g., Plant Protection Products labels, papers, technical 
reports, experimental data, grey literature, etc. Copy of such evidence should also be provided as attachment to the technical dossier.  For more de tails on the required 
information and evaluation of phytosanitary mitigation measures see EFSA PLH Panel, 2012.  Pest species   Estimation of the o verall efficacy of 
phytosanitary mitigation 
measures17 Associated uncertainties  Justification  (reasoning and evidence)  for the 
overall efficacy18 
    
    
    Information required for dossiers to support demands for import of high risk plants  
 
 
 
 
www.efsa.europa.eu/publications  22 EFSA Supporting publication 2018:EN -1492  
 
Annex A – Member States’ comments on the draft EFSA Technical Report  
 
Annex B – List of elements of the technical dossier for which 
confidentiality treatment is requested by the applicant   
 
Annexes A and B can b e found in the online version of this output (in the “Supporting information 
section”) : https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2018.EN -1492